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Li, Jiwei, Tao Wu, Manbo Cai, et al. "Prognostic analysis of nimotuzumab combined with concurrent chemoradiotherapy in locally advanced cervical cancer: A multicenter real-world study." Journal of Clinical Oncology 42, no. 16_suppl (2024): 5532. http://dx.doi.org/10.1200/jco.2024.42.16_suppl.5532.
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5532 Background: Nimotuzumab is a monoclonal antibody against EGFR, which can improve the radiotherapy efficacy of nasopharyngeal carcinoma with EGFR positive. Most cervical cancers are induced by virus and express EGFR. Therefore, this study explores the efficacy and safety of Nimotuzumab combined with concurrent chemoradiotherapy (CCRT) in locally advanced cervical cancer (LACC). Methods: Information on patients with stage IIB-IVa cervical cancer who received CCRT combined with Nimotuzumab or CCRT alone at five cancer centers from January 2021 to December 2022 were collected. Nimotuzumab was administered 200mg once a week for a total of 6 weeks, starting on the same day as CCRT. The imaging examination was carried out 2 months after the end of radiotherapy. The reduction rate of lesions = (pre-treatment diameter - post-treatment diameter)/pre-treatment diameter. Patients were classified into the Nimotuzumab group and No-Nimotuzumab group. Categorical variables were compared using the χ2 test or Fisher’s exact test. Clinical outcomes were analyzed using the Kaplan–Meier method with log-rank test. Results: There are 224 patients enrolled, median age 57 years (32–90 years). The median follow-up time was 20 months (12–36months). The 2-year overall survival (OS) and progression-free survival (PFS) rates were 93% and 89.5%, respectively. The objective response rate (ORR) was 91.96%. There were 64 patients in Nimotuzumab group and 160 patients in No-Nimotuzumab group. The number of patients in Nimotuzumab group with stage IIIC and IVa, as well as those without chemotherapy, is higher than that in No-Nimotuzumab group. There was no significant difference between the Nimotuzumab and No-Nimotuzumab groups in terms of 2-year OS rate (93.2% vs.93%, p = 0.895), and PFS rate (96.2% vs.90.4%, p = 0.645). However, The Nimotuzumab group has a better CR rate (53.13% vs. 35%, P=0.012), ORR (98.44% vs. 89.38%, p=0.024), and reduction rate of cervical lesions (79.26% vs.70.94%, p=0.046) compared to the No-Nimotuzumab group (Table). Also, there was no significant difference between the Nimotuzumab and No-Nimotuzumab groups in terms of hematological toxicity (89.83% vs. 94.48%, p=0.730), nausea and vomiting (35.59% vs. 38.19, p=0.865), radiation proctitis (45% vs. 33.1%, p=0.371), radiation cystitis (8.47% vs. 7.64%, p=0.761), and grade 3-4 toxicities. Conclusions: The combination of Nimotuzumab and CCRT for LACC has a better reduction rate of lesions and ORR, without increasing side effects. [Table: see text]
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Kumar, Ashok, Nilotpal Chakravarty, Sharad Bhatnagar, and G. S. Chowdhary. "Efficacy and safety of concurrent chemoradiotherapy with or without Nimotuzumab in unresectable locally advanced squamous cell carcinoma of head and neck: Prospective comparative study - ESCORT-N study." South Asian Journal of Cancer 08, no. 02 (2019): 108–11. http://dx.doi.org/10.4103/sajc.sajc_38_18.
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Abstract Background: Nimotuzumab is an anti-epidermal growth factor receptor monoclonal antibody which can be added to chemoradiotherapy (CRT) to improve efficacy for management of locally advanced squamous cell carcinoma of the head and neck (LASCCHN). We prospectively evaluated the efficacy and safety of nimotuzumab with CRT for LASCCHN and compared with CRT alone. Materials and Methods: In this prospective study, 29 LASCCHN (Stage III–IVb) patients received Nimotuzumab plus CRT or CRT alone. Treatment included six cycles of cisplatin (40–50 mg/week) or carboplatin (area under the curve-based), nimotuzumab (200 mg/week), and radiotherapy (60–70 Gy). Tumor response was evaluated as per response evaluation criteria in solid tumors criteria. MoS was estimated using the Kaplan–Meier method. Toxicity and adverse events (AE's) were assessed as per CTCAE v 4.0. Results: At 24 weeks after completion of treatment, the tumor response rate (complete response, partial response, stable disease) was 53.3% and 35.7% favoring nimotuzumab arm while progression of disease was 40% and 35.7% in Nimotuzumab plus CRT and CRT groups, respectively. However, the objective response rate was 57% and 30% in favor of nimotuzumab arm. At median follow-up of 45.5 months, MoS was 33 months in Nimotuzumab plus CRT and 27 months in CRT group. The 5-year survival rate was 33.3% in Nimotuzumab plus CRT versus 7.1% in CRT group. Nimotuzumab was observed to be safe with no additional AE's such as hypersensitivity, hypomagnesemia, and allergic reaction was reported. Conclusion: Addition of Nimotuzumab to standard CRT showed improved survival rate in unresectable, LASCCHN patients without producing additional toxicity.
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Kumar, Ashok, Nilotpal Chakravarty, Sharad Bhatnagar, and G. S. Chowdhary. "Efficacy and safety of concurrent chemoradiotherapy with or without Nimotuzumab in unresectable locally advanced squamous cell carcinoma of head and neck: Prospective comparative study - ESCORT-N study." South Asian Journal of Cancer 08, no. 02 (2019): 108–11. http://dx.doi.org/10.4103/sajc.sajc_38_18.
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Abstract Background: Nimotuzumab is an anti-epidermal growth factor receptor monoclonal antibody which can be added to chemoradiotherapy (CRT) to improve efficacy for management of locally advanced squamous cell carcinoma of the head and neck (LASCCHN). We prospectively evaluated the efficacy and safety of nimotuzumab with CRT for LASCCHN and compared with CRT alone. Materials and Methods: In this prospective study, 29 LASCCHN (Stage III–IVb) patients received Nimotuzumab plus CRT or CRT alone. Treatment included six cycles of cisplatin (40–50 mg/week) or carboplatin (area under the curve-based), nimotuzumab (200 mg/week), and radiotherapy (60–70 Gy). Tumor response was evaluated as per response evaluation criteria in solid tumors criteria. MoS was estimated using the Kaplan–Meier method. Toxicity and adverse events (AE's) were assessed as per CTCAE v 4.0. Results: At 24 weeks after completion of treatment, the tumor response rate (complete response, partial response, stable disease) was 53.3% and 35.7% favoring nimotuzumab arm while progression of disease was 40% and 35.7% in Nimotuzumab plus CRT and CRT groups, respectively. However, the objective response rate was 57% and 30% in favor of nimotuzumab arm. At median follow-up of 45.5 months, MoS was 33 months in Nimotuzumab plus CRT and 27 months in CRT group. The 5-year survival rate was 33.3% in Nimotuzumab plus CRT versus 7.1% in CRT group. Nimotuzumab was observed to be safe with no additional AE's such as hypersensitivity, hypomagnesemia, and allergic reaction was reported. Conclusion: Addition of Nimotuzumab to standard CRT showed improved survival rate in unresectable, LASCCHN patients without producing additional toxicity.
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Tikum, Anjong Florence, Anand Krishnan Nambisan, Jessica Pougoue Ketchemen, et al. "Simultaneous Imaging and Therapy Using Epitope-Specific Anti-Epidermal Growth Factor Receptor (EGFR) Antibody Conjugates." Pharmaceutics 14, no. 9 (2022): 1917. http://dx.doi.org/10.3390/pharmaceutics14091917.
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Matuzumab and nimotuzumab are anti-EGFR monoclonal antibodies that bind to different epitopes of domain III of EGFR. We developed 89Zr-matuzumab as a PET probe for diagnosis/monitoring of response to treatment of a noncompeting anti-EGFR nimotuzumab antibody drug conjugate (ADC) using mouse colorectal cancer (CRC) xenografts. We developed 89Zr-matuzumab and performed quality control in EGFR-positive DLD-1 cells. The KD of matuzumab, DFO-matuzumab and 89Zr-matuzumab in DLD-1 cells was 5.9, 6.2 and 3 nM, respectively. A competitive radioligand binding assay showed that 89Zr-matuzumab and nimotuzumab bound to noncompeting epitopes of EGFR. MicroPET/CT imaging and biodistribution of 89Zr-matuzumab in mice bearing EGFR-positive xenografts (HT29, DLD-1 and MDA-MB-231) showed high uptake that was blocked with pre-dosing with matuzumab but not with the noncompeting binder nimotuzumab. We evaluated nimotuzumab-PEG6-DM1 ADC in CRC cells. IC50 of nimotuzumab-PEG6-DM1 in SNU-C2B, DLD-1 and SW620 cells was dependent on EGFR density and was up to five-fold lower than that of naked nimotuzumab. Mice bearing the SNU-C2B xenograft were treated using three 15 mg/kg doses of nimotuzumab-PEG6-DM1, and 89Zr-matuzumab microPET/CT was used to monitor the response to treatment. Treatment resulted in complete remission of the SNU-C2B tumor in 2/3 mice. Matuzumab and nimotuzumab are noncompeting and can be used simultaneously.
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G, Adang H., Anung Pujiyanto, Abdul Mutalib, et al. "Profil Distribusi dan Klirens Pengkontras CT SCAN AuNP-PAMAM G4- NIMOTUZUMAB disimulasikan menggunakan Senyawa 198AuNP-PAMAM G4-NIMOTUZUMAB." Jurnal Kimia Terapan Indonesia 18, no. 01 (2016): 37–43. http://dx.doi.org/10.14203/jkti.v18i01.38.
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Riset nanopartikel emas sebagai senyawa pengkontras CT-Scan telahdimulai sejak 3 tahun lalu di Indonesia. Riset interaksi antibodi monoklonal,khususnya nimotuzumab, dengan reseptor EGFR/HER1 dimulai sejak lima tahun lalu dan telah dimanfaatkan untuk penyiapan senyawa pengkontras MRI (Magnetic Resonance Imaging) spesifik target melalui pelabelan konjugat dendrimer-nimotuzumab dengan radionuklida. Sintesis senyawa AuNP-PAMAM G4-Nimotuzumab untuk diagnosis dan terapi pada kanker paru-paru telah berhasil dilakukan di PTRR dan hasil karakterisasinya dengan menggunakan beberapa metode seperti KCKT (Kromatografi Cair Kinerja Tinggi), SDS (Sodium Dodecyl Sulphate) page elektroforesa dan TEM (Transmission Electron Microscopy) menunjukkan bahwa senyawa yang terbentuk adalah sebagai AuNP-PAMAM G4-Nimotuzumab. Pada penelitian ini telah dilakukan uji pre klinis dari senyawa pengkontras AuNPPAMAM G4-nimotuzumab meliputi uji distribusi dan klirens dengan disimulasikan menggunakan senyawa radioaktiv 198AuNP-PAMAM G4- nimotuzumab. Hasil uji distribusi senyawa 198AuNP-PAMAM G4- nimotuzumab menunjukkan penimbunan pada beberapa organ seperti ginjal, hati dan limpa, sedangkan dari hasil uji klirens diperoleh waktu paruh biologis senyawa tersebut adalah 11.77 hari. Hasil pemeriksaan terhadap urin dengan menggunakan kolom PD-10 (Sephadex G25) menunjukkan bahwa ~ 85 % yang dikeluarkan lewat urin masih berbentuk AuNP-PAMAM G4- Nimotuzumab. Hasil pencitraan dengan alat autoradiography menunjukkan bahwa sampai dengan 48 jam setelah penyuntikan, akumulasi radioaktivitas yang terdeteksi masih terdapat pada hati.
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Solomon, Viswas Raja, Kris Barreto, Wendy Bernhard, et al. "Nimotuzumab Site-Specifically Labeled with 89Zr and 225Ac Using SpyTag/SpyCatcher for PET Imaging and Alpha Particle Radioimmunotherapy of Epidermal Growth Factor Receptor Positive Cancers." Cancers 12, no. 11 (2020): 3449. http://dx.doi.org/10.3390/cancers12113449.
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To develop imaging and therapeutic agents, antibodies are often conjugated randomly to a chelator/radioisotope or drug using a primary amine (NH2) of lysine or sulfhydryl (SH) of cysteine. Random conjugation to NH2 or SH groups can require extreme conditions and may affect target recognition/binding and must therefore be tested. In the present study, nimotuzumab was site-specifically labeled using ∆N-SpyCatcher/SpyTag with different chelators and radiometals. Nimotuzumab is a well-tolerated anti-EGFR antibody with low skin toxicities. First, ΔN-SpyCatcher was reduced using tris(2-carboxyethyl)phosphine (TCEP), which was followed by desferoxamine-maleimide (DFO-mal) conjugation to yield a reactive ΔN-SpyCatcher-DFO. The ΔN-SpyCatcher-DFO was reacted with nimotuzumab-SpyTag to obtain stable nimotuzumab-SpyTag-∆N-SpyCatcher-DFO. Radiolabeling was performed with 89Zr, and the conjugate was used for the in vivo microPET imaging of EGFR-positive MDA-MB-468 xenografts. Similarly, ∆N-SpyCatcher was conjugated to an eighteen-membered macrocyclic chelator macropa-maleimide and used to radiolabel nimotuzumab-SpyTag with actinium-225 (225Ac) for in vivo radiotherapy studies. All constructs were characterized using biolayer interferometry, flow cytometry, radioligand binding assays, HPLC, and bioanalyzer. MicroPET/CT imaging showed a good tumor uptake of 89Zr-nimotuzumab-SpyTag-∆N-SpyCatcher with 6.0 ± 0.6%IA/cc (n = 3) at 48 h post injection. The EC50 of 225Ac-nimotuzumab-SpyTag-∆N-SpyCatcher and 225Ac-control-IgG-SpyTag-∆N-SpyCatcher against an EGFR-positive cell-line (MDA-MB-468) was 3.7 ± 3.3 Bq/mL (0.04 ± 0.03 nM) and 18.5 ± 4.4 Bq/mL (0.2 ± 0.04 nM), respectively. In mice bearing MDA-MB-468 EGFR-positive xenografts, 225Ac-nimotuzumab-SpyTag-∆N-SpyCatcher significantly (p = 0.0017) prolonged the survival of mice (64 days) compared to 225Ac-control IgG (28.5 days), nimotuzumab (28.5 days), or PBS-treated mice (30 days). The results showed that the conjugation and labeling using SpyTag/∆N-SpyCatcher to nimotuzumab did not significantly (p > 0.05) alter the receptor binding of nimotuzumab compared with a non-specific conjugation approach. 225Ac-nimotuzumab-SpyTag-∆N-SpyCatcher was effective in vitro and in an EGFR-positive triple negative breast cancer xenograft model.
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Pendharkar, D., S. Gupta, M. K. Pal, S. Hakim, and T. Rashid. "Feasibility of combining humanized anti-epidermal growth factor receptor monoclonal antibody h-R3 (nimotuzumab) with chemotherapy-A study of toxicity profile and tolerance." Journal of Clinical Oncology 25, no. 18_suppl (2007): 14151. http://dx.doi.org/10.1200/jco.2007.25.18_suppl.14151.
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14151 Background. Anti-EGFR antibodies have been approved in combination with radiotherapy for the treatment of head and neck squamous cell carcinoma(SCCHN) and being tried in glioblastoma multiforme(GBM). The overall toxicity profile is tolerable. There is no data available on Humanized Anti EGFR antibody in combination with chemotherapeutic agents. Nimotuzumab, the humanized MAb derived from ior EGFR/R3, is a genetically engineered IgG1, with high affinity and specificity to EGFR. This study was undertaken to record the immediate and early toxicity of combining Nimotuzumab with various chemotherapeutic agents. Methods. Patients with SCCHN and GBM, scheduled to receive chemotherapy alone were additionally given 400mg of Nimotuzumab, every three weeks. Two patients with GBM received weekly Nimotuzumab 200 mg along with radiation and chemotherapy. Overall 19 events have been analyzed. The chemoschedules used in combination with Nimotuzumab included-Docetaxel, Carboplatin and Capecitabine in patients with SCCHN and Temozolamide/ Procarbazine in GBM. Antibody infusion was always preceded by antihistaminics and dexamethasone. Results.The combination of Nimotuzumab with chemotherapy was well tolerated. There were no acute infusion related events. No febrile, allergic or anaphylactic episodes were seen. Cutaneous rash classical of other EGFR blockers was not recorded. Two episodes of grade 3 diarrhea, and four events of asthenia were seen. Dryness of the mouth was a complaint in SCCHN patients. None of the patients showed neurological or cardiovascular adverse events. Hematological and biochemical derangements were not observed. Conclusion. Nimotuzumab can safely be combined with various chemotherapeutic agents .There is no unacceptable toxicity associated with combination of chemotherapy and humanized anti-EGFR monoclonal antibody. New schedules combining Nimotuzumab and chemotherapy can be safely explored. No significant financial relationships to disclose.
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Wu, Sangang, Runjie Wang, Yifeng Yu, et al. "Efficacy of nimotuzumab added to concurrent chemoradiotherapy after induction chemotherapy for patients with locally advanced nasopharyngeal carcinoma." Journal of Clinical Oncology 42, no. 16_suppl (2024): 6024. http://dx.doi.org/10.1200/jco.2024.42.16_suppl.6024.
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6024 Background: To investigate the efficacy and toxicities associated with adding nimotuzumab to concurrent chemoradiotherapy (CCRT) in locally advanced nasopharyngeal carcinoma (LANPC) patients who received induction chemotherapy (IC). Methods: Patients with stage III-IVA nasopharyngeal carcinoma who received IC (TPF/TP/GP) and platinum-based CCRT between January 2017 and October 2021 were retrospectively included. We performed propensity score matching (PSM) to balance and control confounding factors, and the matching variables included gender, age, T stage, N stage, and Epstein-Barr virus (EBV) status. Patients were divided into two treatment groups: CCRT+nimotuzumab (200mg iv, weekly for 7 courses) and CCRT alone. Primary endpoints were overall survival (OS) and disease-free survival (DFS), the secondary endpoints were locoregional recurrence-free survival (LRFS) and distant metastasis-free survival (DMFS). Results: We screened 242 patients in the analysis. After PSM, 121 (50.0%) and 121 (50.0%) had CCRT+nimotuzumab and CCRT alone, respectively. The 3-year OS was 95.4% and 88.0% in those with and without nimotuzumab treatment (P=0.041), and the 3-year DFS of the CCRT+nimotuzumab group was significantly better than that in the CCRT alone group (90.3% vs. 77.5%, P=0.003). Similar LRFS was found between those with and without nimotuzumab treatment (96.5% vs. 93.7%, P=0.297). The 3-year DMFS for CCRT+nimotuzumab versus CCRT alone was 92.9% versus 82.5% (P=0.008). No significant differences in major toxicities were found between the two treatment arms including hematologic toxicities, hepatoxicity, nephrotoxicity, gastrointestinal reactions, and mucositis (P>0.05). Conclusions: The addition of nimotuzumab to CCRT after IC in LANPC has shown promising results in treatment outcomes and acceptable toxicities.
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Huang, Yanping, Xiangdan Cuan, Weiwei Zhu, et al. "An EGCG Derivative in Combination with Nimotuzumab for the Treatment of Wild-Type EGFR NSCLC." International Journal of Molecular Sciences 24, no. 18 (2023): 14012. http://dx.doi.org/10.3390/ijms241814012.
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Inhibiting the tyrosine kinase activity of epidermal growth factor receptor (EGFR) using small-molecule tyrosine kinase inhibitors (TKIs) or monoclonal antibodies is often ineffective in treating cancers harboring wild-type EGFR. Given the fact that EGFR possesses a kinase-independent pro-survival function, more effective inhibition of EGFR-mediated signals is therefore necessary. In this study, we investigated the effects of using a combination of low-dose nimotuzumab and theasinensin A to evaluate whether the inhibitory effect of nimotuzumab on NCI-H441 cancer cells was enhanced. Here, theasinensin A, a novel epigallocatechin-3-gallate (EGCG) derivative, was identified and its potent anticancer activity against wild-type EGFR NSCLC was demonstrated in vitro; the anticancer activity was induced through degradation of EGFR. Mechanistic studies further revealed that theasinensin A bound directly to the EGFR extracellular domain, which decreased interaction with its ligand EGF in combination with nimotuzumab. Theasinensin A significantly promoted EGFR degradation and repressed downstream survival pathways in combination with nimotuzumab. Meanwhile, treatment with theasinensin A and nimotuzumab prevented xenograft growth, whereas the single agents had limited effect. Thus, the combination therapy of theasinensin A with nimotuzumab is a powerful candidate for treatment of wild-type EGFR cancers.
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Prabhash, Kumar, Kanaka Govind Babu, Ashok K. Vaid, et al. "Nimotuzumab plus chemotherapy versus chemotherapy alone in advanced non-small cell lung cancer: A phase II, open-label, multicenter, randomized study." Journal of Clinical Oncology 31, no. 15_suppl (2013): 8053. http://dx.doi.org/10.1200/jco.2013.31.15_suppl.8053.
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8053 Background: To evaluate the safety and efficacy of nimotuzumab in combination with chemotherapy (docetaxel and carboplatin) versus chemotherapy alone in stage IIIB/IV non-small cell lung cancer (NSCLC) patients. Methods: This multicenter, open-label, phase II study, randomized 110 patients to receive nimotuzumab plus chemotherapy (nimotuzumab group) or chemotherapy alone (control group), and comprised concomitant, maintenance, and follow-up phases. Nimotuzumab (200 mg) was administered once weekly for 13 weeks during the first 2 phases with 4 cycles of chemotherapy; docetaxel (75 mg/m2) and carboplatin (area under the curve [AUC] = 5 mg/ml*min), every 3 weeks for a maximum of 4 cycles during the concomitant phase. The primary endpoint was objective response rate (ORR; sum of complete response [CR] and partial response [PR]). Secondary endpoints, overall survival (OS), and progression-free survival (PFS) were estimated using Kaplan-Meier method. Efficacy was evaluated on the intent-to-treat (ITT) and efficacy-evaluable (EE) sets. Safety was assessed from adverse events (AEs) and serious adverse events (SAEs) data. Results: ORR was significantly higher in the nimotuzumab group than in the control group in the ITT (54% vs. 34.5%; P=0.04) population. CR and PR were achieved in 3.6% and 50% patients, respectively, in the nimotuzumab group, and in 4% and 30.9% patients, respectively, in the control group. No significant differences in median PFS and OS were observed. Safety profiles were comparable between the 2 groups. Conclusions: Nimotuzumab plus chemotherapy significantly improved ORR as compared to chemotherapy alone; the combination was safe and well tolerated in stage IIIB/IV NSCLC patients.
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Viada, Carmen, Aliz M. Vega, Mayte Robaina, et al. "Evaluation of Nimotuzumab for the treatment of head and neck cancer: Meta-analysis of controlled trials." Bionatura 5, no. 1 (2020): 1056–62. http://dx.doi.org/10.21931/rb/2020.05.01.8.
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Nimotuzumab, humanized monoclonal antibody, directed against the epidermal growth factor receptor: highly expressed protein in malignant tumors of epithelial origin. It has been registered for head and neck tumors since 2002. To determine the effectiveness of Nimotuzumab in head and neck cancer through the combined meta-analysis technique. A search was conducted in PubMed, in an indexed magazine with the words “Nimotuzumab”, “head and neck,” 48 articles published by Cuban and foreign authors were detected between April 1, 2005, and July 31, 2019, in which the results of clinical studies conducted with the monoclonal antibody Nimotuzumab are described. Seven clinical trials conducted in Cuba from 2005-2019 with Nimotuzumab are described; three Phase I / II (with 14, 10 and 10 patients respectively), a Phase II / III with 106 patients, a Phase II with 37 patients, two Phase IV (with 386 and 225 patients each) and a study promoted by the Researcher with 17 patients. From these studies, the three controlled trials were selected by the PRISMA flow chart. The meta-analysis consisted of the construction of the Forest Plot graph, the sensitivity analysis and the cumulative analysis. The meta-analysis shows favorable results for Nimotuzumab, without heterogeneity (I2 = 0%). The sensitivity analysis reveals that the test that differs most from the others is Phase II / III. The cumulative analysis indicates that after the second trial, there is already sufficient evidence.
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Solomon, Maria Teresa, Julio Cesar Selva, Javier Figueredo, et al. "Radiotherapy plus the anti-EGFR mAb nimotuzumab or placebo for the treatment of high-grade glioma patients." Journal of Clinical Oncology 30, no. 15_suppl (2012): 2515. http://dx.doi.org/10.1200/jco.2012.30.15_suppl.2515.
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2515 Background: Despite remarkable advances in multimodal therapy, high grade glioma (HGG) patients still face a poor prognosis. EGFR is well validated as a primary contributor of HGG initiation and progression. Nimotuzumab is a humanized monoclonal antibody (mAbs) that recognizes the EGFR extracellular domain. While it has similar preclinical and clinical activity when compared to other anti-EGFR mAbs, it does not induce skin toxicity or hypomagnesemia. Methods: A randomized, double blind, multicentric clinical trial was conducted in 70 anaplastic astrocytoma (AA) and glioblastoma multiforme (GBM) patients that received radiotherapy (RT) plus nimotuzumab or placebo. Patients received 6 weekly doses of nimotuzumab or placebo together with radiotherapy. Treatment was maintained every 3 weeks, until completing 1 year of treatment. GBM patients did not receive temozolomide since the drug cannot be sold to Cuba. The objectives of this study were to assess the overall survival, progression free survival (PFS), response rate, immunogenicity and safety in both treatment groups. Results: Seventy patients were included in the study: 41 AA and 29 GBM. The median cumulative dose was 3600 mg of nimotuzumab and the median antibody number of doses was 16. The combination of nimotuzumab and radiotherapy was very safe. The most prevalent related adverse events included grade 1-2 nausea, fever, tremors and anorexia. There was no increasing toxicity with repeated drug exposure. No anti-idyotipic response was detected. The mean and median survival time for subjects treated with nimotuzumab and RT was 31.06 and 17.76 months while the mean and median survival time for controls was 21.07 and 12.63 months, respectively. For the evaluable patients of the AA stratum, the median survival time was 44.56 months (active drug) vs. 14.6 months (control). For the evaluable patients in the GBM cohort, the median survival time was 16.06 months (nimotuzumab arm) vs. 8.36 months (placebo arm). Median PFS was 18.23 vs. 6.25 months. Conclusions: In this randomized trial, nimotuzumab continues showing an excellent safety profile and positive efficacy results in patients with high grade glioma in combination with irradiation.
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Abdo Cuza, Anselmo A., Jonathan Pi Ávila, Rafael Machado Martínez, et al. "Nimotuzumab for COVID-19: case series." Immunotherapy 14, no. 3 (2022): 185–93. http://dx.doi.org/10.2217/imt-2021-0269.
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Background: In COVID-19, EGFR production is upregulated in the alveolar epithelial cells. EGFR overexpression further activates STAT-3 and increases lung pathology. The EGFR pathway is also one of the major nodes in pulmonary fibrosis. Methods: Nimotuzumab, a humanized anti-EGFR antibody, was used to treat three patients with severe or moderate COVID-19. The antibody was administered in combination with other drugs included in the national COVID-19 protocol. Results: Nimotuzumab was well tolerated. IL-6 decreased from the first antibody infusion. Clinical symptoms significantly improved after nimotuzumab administration, and the CT scans at discharge showed major resolution of the lung lesions and no signs of fibrosis. Conclusion: Safe anti-EGFR antibodies like nimotuzumab may modulate COVID-19-associated hyperinflammation and prevent fibrosis. Clinical Trial Registration: RPCEC00000369 (RPCEC rpcec.sld.cu).
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Ommurugan, Balaji, Amita Priya, and Navin Patil. "NIMOTUZUMAB INDUCED HYPERTENSION(NIH): A MAIDEN CASE REPORT." Asian Journal of Pharmaceutical and Clinical Research 10, no. 4 (2017): 8. http://dx.doi.org/10.22159/ajpcr.2017.v10i4.16868.
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ABSTRACT Nimotuzumab is one among the latest humanized monoclonal antibody targeting against Epidermal Growth Factor Receptor (EGFR). It is approved for Head and neck squamous cancer in India, Srilanka, Cuba and Argentina, for glioma in Cuba, Argentina and Ukraine and Nasopharyngeal cancer in China. Hypertension is most common with Bevacizumab and Cetuximab, which are monoclonal antibodies against EGFR. Hence, we report here a case of Nimotuzumab induced hypertension in a 70-year-old man treated for vocal cord carcinoma. KEYWORDS: Nimotuzumab, Hypertension, EGFR, Adverse effects.
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Clapé-Laffita, Oneyda, María V. Perrand-Roberts, Milagros Domecq-Salmon, Maryenis Rodríguez-Alfaro, and Maritza Cebreco-Sardina. "Seguridad del nimotuzumab luego de ensayos clínicos en tumores epiteliales de cabeza y cuello." Journal of Pharmacy & Pharmacognosy Research 9, no. 3 (2021): 324–32. http://dx.doi.org/10.56499/jppres20.958_9.3.324.
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Context: Immunotherapy, by directing the immune response against tumor cells, complements the oncological therapy along with conventional treatments. Thus, the monoclonal antibody nimotuzumab blocks the binding of epidermal growth factor to its receptor, interfering with cell proliferation in epithelial tumors, such as those of the head and neck. Aims: To evaluate the safety of nimotuzumab after concluded the clinical trials in epithelial tumors of the head and neck, analyzing the relation with the therapeutic compliance for the patients. Methods: A retrospective descriptive study was carried out, characterizing nine patients with epithelial tumors of the head and neck, who continued to use nimotuzumab after concluding clinical trials; and evaluating adverse effects according to severity, intensity, causality, and frequency, thus establishing the safety of this medicine. The compliance of nimotuzumab therapy was analyzed, by reviewing the administration intervals to the received doses. A descriptive statistical analysis was performed. Results: In the studied sample men predominated (eight patients: 88.89%), without significance differences in age and race. All were diagnostic with epidermal carcinomas, predominated the good differentiated (six patients: 66.67%). Five adverse effects were detected in two old patients (all not serious, light or moderate, and possible or probable, occasional or frequent), evaluating to nimotuzumab as safe medication. There was inadequate therapeutic compliance to treatment, not relation with the presented adverse effects. Conclusions: Nimotuzumab represented a safe drug after concluded the clinical trials in patients with epithelial tumors of the head and neck, without relation with the existed inadequate therapeutic compliance.
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Liang, Renba, Liu Yang, and Xiaodong Zhu. "Nimotuzumab, an Anti-EGFR Monoclonal Antibody, in the Treatment of Nasopharyngeal Carcinoma." Cancer Control 28 (January 1, 2021): 107327482198930. http://dx.doi.org/10.1177/1073274821989301.
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Epidermal growth factor receptor (EGFR) is highly expressed in most of Nasopharyngeal carcinoma (NPC) samples and is associated with poor outcomes. Therefore, targeting EGFR may be a promising strategy to improve patient prognosis. Nimotuzumab is a humanized anti-EGFR monoclonal antibody. Recently, accumulating evidence has demonstrated that combination nimotuzumab and induction chemotherapy, radiotherapy, or concurrent chemoradiotherapy confer benefits for patients with NPC. Moreover, the side effects of such regimes are tolerable. In this review, we focus on the current data of nimotuzumab in clinical trials in the treatment of NPC.
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Attili, Suresh VS, Dilip Pawar, and Chinnababu Sunkavalli. "Nimotuzumab as a single agent palliative therapy in performance score 3 and above in EGFR expressing tumors." Journal of Clinical Oncology 35, no. 15_suppl (2017): e21635-e21635. http://dx.doi.org/10.1200/jco.2017.35.15_suppl.e21635.
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e21635 Background: Nimotuzumab is a humanized IgG1 monoclonal antibody against the EGFR extracellular domain that has been evaluated in solid tumors as a single agent or in combination with chemotherapy and radiation. However when used without radiation, its always used in adjunct to chemotherapy. With encouraging results of other EGFR monoclonal antibodies as single agent therapies, we explored the possibility of using Nimotuzumab as single agent by which we could avoid chemo related side effects. In view of the limited options availability for subjects with PS 3 and more we thought of choosing this population for analysis of Nimotuzumab as single agent palliative therapy in PS 3 and above EGFR expressing tumors for safety and efficacy Methods: Details of the 38 subjects with pre-treated advanced refractory or progressive solid tumors having PS of more than 2 were evaluated. Nimotuzumab was administered weekly at 200 mg/m2 as single agent for 4 weeks (induction phase) and patients were stratified into those with improved PS and those without. The subjects without PS improvement were continued on the single agent and those with improvement were offered additional chemotherapy . Nimotuzumab could be continued beyond disease progression. Results: Out of 38 patients, 18 had improvement in the PS and were offered chemotherapy later. 16 patients had stable PS and disease. 3 subjects were lost to follow up and 1 patient did not continued. The median number of nimotuzumab applications was 6 (2–11) in the induction phase and the median chemotherapy cycles were 3 (1-6). No toxicity occurred during induction phases (single agent nimotuzumab) and during chemotherapy the Grade II/IV toxicities were observed in 6 (33%) cases predominantly cytopeneas, neuropathy and diarrhea. The median PFS was 142 days (95% CI, 84 to 182), and the median improvement in QOL was 6 points on a scale of 30. Conclusions: Nimotuzumab is well tolerated and may have a role in the treatment of advanced cancers as a single agent in patients with poor performance status. 47% of the patients who are otherwise not eligible for chemo became eligible and had better QOL and longer PFS [compared to historical controls]
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Ruiz, Raiza, Daisy Hernández, Carmen Viada, Jessica García, Marta Fors, and Mayra Ramos. "Nimotuzumab and CIMAvax-EGF® in Advanced Cervical Cancer." Bionatura Journal 1, no. 4 (2024): 1–13. http://dx.doi.org/10.70099/bj/2024.01.04.20.
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Cervical cancer is the fourth cancer worldwide in the female sex in terms of incidence, becoming one of the most frequent epithelial tumors. The high overexpression of the Epidermal Growth Factor Receptor (EGFr) present in it offers the opportunity to use therapies against this receptor. A prospective, multicenter Expanded Access Program (EAP) was carried out in three randomized groups to demonstrate the safety and preliminary efficacy of humanized monoclonal antibody nimotuzumab, CIMAvax-EGF® vaccine and its combination in advanced cervical cancer, refractory to all previous oncospecific therapies. The principal endpoint was to assess overall survival time (the life expectancy of these patients at the inclusion was six months) and demonstrate the safety of those treatments. Overall survival was higher than expected in all groups. In general, 43.9% of patients were alive 2 years after the start of immunotherapy, and the 60-month survival rate was 38.8, 42.7, and 37.4% for CIMAvax-EGF®, Nimotuzumab, and combination therapies, respectively. According to overall survival, patients were separated into two groups: long (upper 24 months) and short (24 months or less) survivors. Long survivors (LS) represent 37.7% in the CIMAvax-EGF® vaccine, 49.3% in the Nimotuzumab, and 43.5% in the combination group. Adenocarcinomas (ADCs) tumors benefited from vaccine therapy, and squamous cell carcinomas with a nimotuzumab also benefited. A combination of both does not improve survival more than monotherapy. Conclusion. Nimotuzumab and CIMAvax-EGF® become an opportunity to treat refractory advanced cervical cancer. Keywords: uterine cervical cancer, CIMAvax-EGF®, Nimotuzumab, Overall Survival
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Wiwanitkit, Viroj. "(177)Lu-nimotuzumab." Nuclear Medicine and Biology 39, no. 6 (2012): 891. http://dx.doi.org/10.1016/j.nucmedbio.2012.01.009.
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RM, Pedroso. "Nimotuzumab in the Treatment of Severe Pneumonia due to COVID-19. Presentation of a Case." Pharmaceutical Drug Regulatory Affairs Journal 6, no. 1 (2023): 1–5. http://dx.doi.org/10.23880/pdraj-16000145.
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Introduction: Severe pneumonia due to COVID-19 has a high mortality, one of the therapeutic alternatives may be Nimotuzumab. Objective: To describe the clinical, humoral and radiological evolution of a patient with severe pneumonia due to COVID-19. Case Presentation: 77-year-old female patient with a history of Bronchial Asthma and COPD, psychiatric disorders who develops severe pneumonia (RALE 4 points) in the course of SARS-Cov-2 infection and after medical treatment with the Nimotuzumab monoclonal antibody is recovered. Symptoms, complementary and radiographs are shown before and after medical treatment. Conclusions: Nimotuzumab can be a t
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Sastyarina, Yurika, Ade Rizqi Ridwan Firdaus, Zuhrotun Nafisah, et al. "Modeling and Molecular Dynamic Simulation of F(ab′)2 Fragment of Nimotuzumab for Lung Cancer Diagnostics." Bioinformatics and Biology Insights 15 (January 2021): 117793222110021. http://dx.doi.org/10.1177/11779322211002174.
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Lung cancer is one of the leading causes of cancer-related deaths in the world among both men and women. Several studies in the literature report that overexpression and mutation of the epidermal growth factor receptor (EGFR) are implicated in the pathogenesis of some lung cancers. Nimotuzumab is a humanized monoclonal antibody (mAb) that inhibits EGF binding because it binds to the extracellular domain of the EGFR. Nimotuzumab requires bivalent binding for stable attachment to cellular surface, which leads to nimotuzumab selectively binding to cells that express mAbs of moderate to high EGFR levels, and this could explain its low toxicity. This property has an advantage for development of nimotuzumab as a therapeutic and diagnostic agent. Monoclonal antibodies are large in size (150 kDa), thus penetrating slowly and residing in the blood for extended periods of time (from days to weeks); their use in imaging studies can result in low signal-to-background ratios and poor image quality. A reduction in the size of the immunoglobulin molecule has also been proposed as a means for increasing tumor penetration by mAbs. Nevertheless, it is known that the penetration of mAb into tumor cell is slow, due to its high molecular weight. Therefore, mAb is not very attractive to be used for imaging diagnostic purpose because of its kinetics and potential to elicit antibody response. The objective of this research was to study the homology modeling of a simpler functional molecule based on nimotuzumab, which consists of 2 antigen-binding fragments (Fab), namely, F(ab′)2, using MODELER. The crystal structure of Fab of nimotuzumab from protein data bank was used as a template to construct the model of F(ab′)2. Molecular dynamic simulation was performed to evaluate the stability of F(ab′)2 and conformational changes of F(ab′)2 in simulation. The result showed the dynamic behavior of antigen-binding site region of F(ab′)2 throughout simulation. This result is expected to be useful in the further development of F(ab′)2 fragment nimotuzumab as a lung cancer diagnostic.
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Bhatnagar, Aseem Rai, Dharam Pal Singh, Rameshwaram Sharma, et al. "A comparative study of monoclonal antibody against EGFR (nimotuzumab) used in combination with chemoradiation versus chemoradiation alone in the treatment of locally advanced inoperable squamous cell carcinoma of the head and neck." Journal of Clinical Oncology 30, no. 15_suppl (2012): e16012-e16012. http://dx.doi.org/10.1200/jco.2012.30.15_suppl.e16012.
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e16012 Background: To determine the efficacy, safety and tolerability of concurrent Nimotuzumab (monoclonal antibody against epidermal growth factor receptor) used in combination with chemoradiation versus chemoradiation (CRT) alone in advanced inoperable squamous cell carcinoma of the head and neck (SCCHN). Methods: 56 patients were randomly assigned to either of the two treatment arms, nimotuzumab + CRT arm and CRT alone arm. Both arms received concurrent cisplatin 30 mg/m2 repeated weekly for 6-7 cycles along with external beam radiotherapy 64-70 Gy (200cGy/day for 5 days a week for 6-7 weeks). Nimotuzumab arm additionally received nimotuzumab 200 mg weekly for 6-7 cycles. The patients were followed for 6 months after completion of CRT. The study end points were tumor response evaluation according to the RECIST Criteria version 1.1 and safety analysis using RTOG Acute Radiation Morbidity Scoring Criteria. Patients were evaluated weekly with hematologic tests and for adverse events like mucositis and dermatitis during the CRT. Tumor assessment was performed with clinical and endoscopic methods regularly during the CRT and then at 1 month, 3 month and 6 month interval after CRT. One MR imaging was done before starting the CRT to evaluate the baseline tumor characteristics and another was done after the completion of CRT either at 3 months or 6 months or at both the intervals. Results: 25 patients each were evaluable in both the arms who completed the 6 months study. The overall response rate (complete response + partial response) was 96% in Nimotuzumab + CRT arm whereas it was only 72% in CRT alone arm after 6 months of completion of CRT, which is statistically significant (p-value = 0.0206 by chi square test). Additionally, nimotuzumab did not potentiate toxicities of CRT and there was no significant difference in the acute radiation mucositis, dermatitis or hematological toxicities in both the groups (p-value>>0.05). Conclusions: Nimotuzumab can be safely added to the standard CRT treatment for advanced inoperable SCCHN, to achieve better tumor response without potentiating toxicity.
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Bhatnagar, Aseem Rai, and Dharam Pal Singh. "A comparative study of a monoclonal antibody against EGFR (nimotuzumab) used in combination with chemoradiation versus chemoradiation alone in the treatment of locally advanced inoperable squamous cell carcinoma of the head and neck." Journal of Clinical Oncology 30, no. 30_suppl (2012): 51. http://dx.doi.org/10.1200/jco.2012.30.30_suppl.51.
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51 Background: To determine the efficacy, safety and tolerability of concurrent nimotuzumab (monoclonal antibody against epidermal growth factor receptor) used in combination with chemoradiation versus chemoradiation (CRT) alone in advanced inoperable squamous cell carcinoma of the head and neck (SCCHN). Methods: 56 patients were randomly assigned to either of the two treatment arms, nimotuzumab + CRT arm and CRT alone arm. Both arms received concurrent Cisplatin 30 mg/m2 repeated weekly for 6-7 cycles along with external beam radiotherapy 64-70 Gy (200cGy/day for 5 days a week for 6-7 weeks). Nimotuzumab arm additionally received nimotuzumab 200 mg weekly for 6-7 cycles. The patients were followed for 6 months after completion of CRT. The study end points were tumor response evaluation according to the RECIST Criteria version 1.1 and safety analysis using RTOG Acute Radiation Morbidity Scoring Criteria. Patients were evaluated weekly with hematologic tests and for adverse events like mucositis and dermatitis during the CRT. Tumor assessment was performed with clinical and endoscopic methods regularly during the CRT and then at 1 month, 3 months, and 6 months intervals after CRT. One MR imaging was done before starting the CRT to evaluate the baseline tumor characteristics, and another was done after the completion of CRT either at 3 months or 6 months or at both the intervals. Results: 25 patients each were evaluable in both the arms who completed the 6-month study. The overall response rate (complete response + partial response) was 96% in nimotuzumab + CRT arm, whereas it was only 72% in CRT alone arm after 6 months of completion of CRT, which is statistically significant (p value = 0.0206 by Chi Square test). Additionally, nimotuzumab did not potentiate toxicities of CRT, and there was no significant difference in the acute radiation mucositis, dermatitis, or hematological toxicities in both the groups (p value>>0.05). Conclusions: Nimotuzumab can be safely added to the standard CRT treatment for advanced inoperable SCCHN, to achieve better tumor response without potentiating toxicity.
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Zhao, Chong, Jingjing Miao, Guanzhu Shen, et al. "Nimotuzumab combined with cisplatin plus fluorouracil chemotherapy in patients with metastatic nasopharyngeal carcinoma after radical radiotherapy: A multicentre, open-label, phase II clinical trial." Journal of Clinical Oncology 35, no. 15_suppl (2017): 6028. http://dx.doi.org/10.1200/jco.2017.35.15_suppl.6028.
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6028 Background: Cisplatin plus fluorouracil (PF) is main therapy for metastatic nasopharyngeal carcinoma (NPC). However, the efficacy is not satisfactory, especially in patients with metastasis after radical radiotherapy. The purpose of this study was to investigate the efficacy and toxicity of Nimotuzumab combined with PF in patients with metastatic NPC after radical radiotherapy. Methods: Patients with untreated metastatic NPC after radical radiotherapy were recruited from 9 hospitals in China with Simon’s two-stage design. All patients received Nimotuzumab (200mg/w) and cisplatin (100mg/m2, day 1) plus fluorouracil (4g/m², day 1-4) every 3 weeks until progressive disease (PD) or unacceptable toxicity or a maximum of 6 cycles. If patients had still not progressed at this stage, Nimotuzumab (200mg/w) as monotherapy would be delivered until PD. This study was registered in ClinicalTrials.gov, Number NCT01616849. Results: Between Jun, 2012 and April, 2015, 35 patients were enrolled (Table). The objective response rate (ORR) and disease control rate (DCR) were 71.4% and 85.7%, and the median time of progression free survival (PFS) and overall survival (OS) were 6.97 and 11.01 months. The most common toxicities were leukopenia (94.1%), vomiting (97.1%) and nausea (97.1%); the grade 3/4 toxicities were leukopenia (62.9%) and mucositis (20.0%). There was only 1 patient have mild hypotension which related to Nimotuzumab. The ORR, DCR, median time of PFS and OS were 88.9%, 100.0%, 7.29 and 11.47 months in patients who received a total dose of Nimotuzumab ≥ 2400mg, respectively. Conclusions: Nimotuzumab combined with PF has achieved encouraging efficacy with an acceptable safety profile in metastatic NPC after radical radiotherapy. A phase III randomised study is needed. Clinical trial information: NCT01616849. [Table: see text]
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Imperial, M., J. Batara, and P. Opinaldo. "P18.32.B OUTCOME OF NIMOTUZUMAB USE ON NEWLY DIAGNOSED AND RECURRENT MALIGNANT GLIOMAS: A PHILIPPINE RETROSPECTIVE STUDY ON TWO TERTIARY INSTITUTIONS." Neuro-Oncology 26, Supplement_5 (2024): v104. http://dx.doi.org/10.1093/neuonc/noae144.348.
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Abstract BACKGROUND High Grade gliomas have poor overall survival with no standard of care for recurrent disease. Despite treatment, recurrence is inevitable and prognosis remains poor with median survival rate of 12-15 months. EGFR is a membrane bound receptor that is greatly expressed in high grade glioma patients and gene amplification is one of the most frequent alterations of this tumor type. EGFR is present in 60% of GBMs. Nimotuzumab is a humanized monoclonal antibody targeting EGFRV3 with high penetration into the blood brain barrier that has been shown in phase 2 trials to benefit high grade gliomas especially unmethylated gliomas. This study determined if there is an added survival benefit in combining nimotuzumab with the current treatment practices available to our local neuro-oncologists. METHODS Chart review was done for all patients with newly diagnosed or recurrent IDH wild type glioblastoma, and recurrent IDH positive malignant gliomas treated with nimotuzumab plus either radiation + chemotherapy with temozolomide followed by adjuvant temozolomide, metronomic temozolomide or bevacizumab alone from 2007-2022 in two institutions in the Philippines. A total of 53 patients were given nimotuzumab, 48 patients were analyzed. Patients included were given Nimotuzumab 200-400 mg intravenously every two weeks for at least four sessions either until recurrence, continuous for six to 12 months or until death. Patients who received less than four sessions of Nimotuzumab and mortality from other causes were excluded from the analysis. Patient’s demographic data, date of surgery and recurrences, histopathologic reports, nimotuzumab doses, and date of death were collected. Primary endpoints were overall survival (OS) and Progression Free Survival (PFS). Side effects and complications were also investigated. RESULTS Forty eight patients were analyzed, 21 females and 27 males aged 21-70 with mean age of 48. Median PFS was 13 months (95%, CI 10.2-17.4) and Median Survival 43 months (95%, CI 34-57). Overall Survival Proportion after 1, 2, 3 and 5 years are 93.7%, 72.1%, 63.2 and 34.4% respectively. In the recurrent glioblastoma group, median PFS was 11 months and median OS was 22.11 months. In the recurrent IDH+ high grade gliomas, median PFS was 22 months and median OS was 75 months. Minimal side effects were noted. CONCLUSION There is an increased survival benefit in combining nimotuzumab with the current treatments available for malignant gliomas with minimal side effects.
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de Castro-Suárez, Niurys, Mirjam N. Trame, Mayra Ramos-Suzarte, et al. "Semi-Mechanistic Pharmacokinetic Model to Guide the Dose Selection of Nimotuzumab in Patients with Autosomal Dominant Polycystic Kidney Disease." Pharmaceutics 12, no. 12 (2020): 1147. http://dx.doi.org/10.3390/pharmaceutics12121147.
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Autosomal dominant polycystic kidney disease (ADPKD) is a genetic disease characterized by an overexpression of epidermal growth factor receptor (EGFR). Nimotuzumab is a recombinant humanized monoclonal antibody against human EGFR. The aim of this study was to develop a population pharmacokinetic model for nimotuzumab and to identify demographic and clinical predictive factors of the pharmacokinetic variability. The population pharmacokinetics (PopPK) of nimotuzumab was characterized using a nonlinear mixed-effect modeling approach with NONMEM®. A total of 422 log-transformed concentration-versus-time datapoints from 20 patients enrolled in a single-center phase I clinical trial were used. Quasi steady state approximation of the full TMDD (target-mediated drug disposition) model with constant target concentration best described the concentration-time profiles. A turnover mediator was included which stimulates the non-specific clearance of mAb in the central compartment in order to explain the reduced levels at higher doses. Covariates had no influence on the PK (pharmacokinetics) parameters. The model was able to detect that the maximum effective dose in ADPKD subjects is 100 mg. The developed PopPK model may be used to guide the dose selection for nimotuzumab during routine clinical practice in patients with polycystic kidney disease. The model will further support the ongoing investigations of the PK/PD relationships of nimotuzumab to improve its therapeutic use in other disease areas.
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Liu, Li-Ting, Xue-Song Sun, Ting-Ting Quan, et al. "Concurrent chemoradiotherapy with or without nimotuzumab in induction chemotherapy resistant locoregionally advanced nasopharyngeal carcinoma: An open-label randomised, controlled, phase 2 trial." Journal of Clinical Oncology 43, no. 16_suppl (2025): 6064. https://doi.org/10.1200/jco.2025.43.16_suppl.6064.
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6064 Background: Induction chemotherapy (IC) followed by concurrent chemoradiotherapy (CCRT) is the current standard of care for locoregionally advanced nasopharyngeal carcinoma (LA-NPC). Patients resistant to IC have a high risk of treatment failure. Nimotuzumab, a humanized anti-epidermal growth factor receptor (EGFR) antibody, has shown potential efficacy in combination with CCRT. This randomized phase 2 trial aimed to evaluate the efficacy and safety of nimotuzumab plus CCRT compared to CCRT alone in IC-resistant LA-NPC. Methods: We conducted an open-label, randomized phase 2 trial at Sun Yat-sen University Cancer Center, Guangzhou, China. Eligible patients (aged 18–70) had untreated, nonkeratinizing, IC-resistant stage II–IVa (the 8 th edition of the American Joint Committee on Cancer classification system) LA-NPC, defined as detectable plasma Epstein-Barr virus (EBV) DNA and/or stable/progressive disease after two cycles of IC. Other inclusion criteria were ECOG performance status of 0–1, positive EGFR expression and adequate organ function. Patients were randomized (1:1) to receive CCRT plus nimotuzumab or CCRT alone. Cisplatin (100 mg/m²) was given on days 1, 22, and 43 of intensity-modulated radiotherapy in both groups. In the experimental group, nimotuzumab (200 mg) was administered weekly during CCRT. Randomization was done using a computer-generated code random number code with a block size of six, stratified by disease stage. The primary endpoint was 2-year progression-free survival (PFS) in the intention-to-treat population. Safety was assessed in all participants who received at least one dose of the assigned treatment. The study was registered at ClinicalTrials.gov (NCT04223024), and patients are under follow-up. Results: Two hundred forty-six patients were enrolled and randomized (121 to CCRT plus nimotuzumab, 125 to CCRT alone). At a median follow-up of 47 months (IQR 44–50), the 2-year PFS was 81.0% (95% CI 72.8–86.9) in the CCRT plus nimotuzumab group and 80.8% (95% CI 72.7–86.7) in the CCRT group (stratified HR 0.93 [95% CI 0.59–1.47], p=0.70). The most frequent grade 3–4 adverse events were mucositis (24 [20.2%] vs 22 [17.6%]), leukopenia (23 [19.3%] vs 21 [17.2%]), and nausea (14 [11.8%] vs 16 [13.8%]) in the CCRT plus nimotuzumab group compared with CCRT group. A higher frequency of grades 1–2 rash was observed in the CCRT plus nimotuzumab group (15 [12.6%] vs 6 [4.9%]). Late adverse events were predominantly mild, with no grade 4 events reported in either group. No treatment-related deaths occurred in either group. Conclusions: In IC-resistant LA-NPC, the addition of nimotuzumab to CCRT did not provide a significant survival benefit. Further research into predictive biomarkers and novel combinations is needed to optimize treatment for high-risk populations. Clinical trial information: NCT04223024 .
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Brade, A. M., L. Siu, A. M. Oza, et al. "A phase I study of the humanized anti-epidermal growth factor receptor (EGFR) monoclonal antibody (mAb) TheraCIM-h-R3 (nimotuzumab) in patients with advanced solid tumors." Journal of Clinical Oncology 24, no. 18_suppl (2006): 13054. http://dx.doi.org/10.1200/jco.2006.24.18_suppl.13054.
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13054 Background: Nimotuzumab is a humanized mAb against the extracellular ligand binding domain of EGFR. Although well tolerated when combined with radiotherapy in previous studies, the pharmacodynamics (PD) of nimotuzumab has not been elucidated. This phase I study was designed to evaluate the safety, tolerability and PD of nimotuzumab. Methods: Eligibility criteria included advanced solid tumors refractory to standard therapy and performance status of ECOG 0–2. Nimotuzumab was administered intravenously weekly × 6 and then every other week (6 weeks = 1 treatment cycle). Tumor and skin biopsies were obtained at baseline and after 2 weeks of treatment. Results: To date, 9 patients (7 m/2 f, median age 60, 7 colorectal cancer, ECOG 0:1:2 = 5:3:1, prior therapy 1:2:3+ = 1:3:5) have been treated on the first 2 dose levels (100 mg and 200 mg) for a total of 13 treatment cycles. The most common toxicities, mainly grade 1- 2, were lymphopenia (n = 8 patients), fatigue (n = 8), abnormal liver function tests (n = 7) and anemia (n = 6). Observed grade 3 toxicities include: pain (n = 3), hyponatremia (n = 2), elevated ALP (n = 2), fatigue (n = 1), hyperglycemia (n = 1) and hyperkalemia (n = 1). One patient at the first dose level experienced grade 3 fatigue, at least possibly attributable to nimotuzumab, and thus considered as a dose-limiting toxicity (DLT). No DLT were observed in the expanded cohort and dose level 2. No skin toxicities were observed. Stable disease was seen in 3 patients with colorectal cancer. PD from tumor and skin biopsies will be presented, and may clarify the reason for the lack of skin toxicity. Conclusions: Overall nimotuzumab was well tolerated, with disease stabilization observed in heavily pretreated patients. Accrual continues at dose level 3 (400 mg) with one further planned dose level (800 mg). [Table: see text]
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Kim, Han Sang, and Byoung Chul Cho. "A phase I trial of gefitinib and nimotuzumab in patients with advanced non-small cell lung cancer (NSCLC)." Journal of Clinical Oncology 30, no. 15_suppl (2012): e18080-e18080. http://dx.doi.org/10.1200/jco.2012.30.15_suppl.e18080.
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e18080 Background: Nimotuzumab (TheraCIM) is a humanized anti-epidermal growth factor receptor (EGFR) monoclonal antibody (mAb) with minimal skin toxicity. Combining a different class of anti-EGFR drug with gefitinib is a new strategy to overcome intrinsic and acquired resistance to gefitinib. The aim of this phase I trial was to determine recommended phase II dose (RPIID) and the safety of gefitinib and nimotuzumab combination treatment. Methods: Patients with advanced/metastatic NSCLC were treated with escalating doses of weekly nimotuzumab (100 mg or 200 mg, IV) and fixed doses of daily gefitinib (250 mg/day, PO) until disease progression or unacceptable toxicity. We designed to enroll additional 10 patients at RPIID for the safety analysis. EGFR mutations and KRAS mutations were analyzed from available tumor samples. Results: A total of 16 patients were enrolled (3 in 100 mg cohort, 13 in 200 mg cohort). Six patients (40%) were female, and 5 (33.3%) were never smokers. Adenocarcinoma was the major histologic type (13 patients, 81.3%).Treatment was well-tolerated without dose-limiting toxicity (DLT). Three patients (18.7%) experienced grade 2 skin toxicity (1 in 100 mg cohorts, 2 in 200 mg cohort). Other common grade 1/2 toxicities were fatigue (37.5%) and diarrhea (25.0%). Among 16 evaluable patients, four patients (28.6%) achieved partial response and 5patients (35.7%) had stable disease. Two of 4 responders had EGFR mutation (exon 19 deletion). Conclusions: Dual agent molecular targeting of EGFR with nimotuzumab and gefitinib in patients with advanced NSCLC is well-tolerated. The RPIID for nimotuzumab is 200mg weekly IV and for gefitinib 250 mg/day PO. Based upon this phase I trial, we are planning to conduct a randomized phase II trial comparing gefitinib and nimotuzumab with gefitinib alone in patients with advanced NSCLC.
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Sun, Yan, Chaosu Hu, Qin Lin, et al. "Nimotuzumab plus chemoradiotherapy versus placebo plus chemoradiotherapy in patients with locally advanced nasopharyngeal carcinoma (NPC): A prospective, randomized-controlled, double-blinded, multicenter phase III clinical trial." Journal of Clinical Oncology 40, no. 16_suppl (2022): 6001. http://dx.doi.org/10.1200/jco.2022.40.16_suppl.6001.
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6001 Background: Epidermal growth factor receptor (EGFR) is highly expressed in most NPC, and it is also an essential factor of prognosis for NPC. nimotuzumab is a humanized anti-EGFR monoclonal antibody. Retrospective clinical studies showed that nimotuzumab combined with chemo-radiotherapy had better survival benefits in locally advanced NPC. The present study is a confirmatory study that aims to assess the clinical efficacy of long-term survival and safety of nimotuzumab combined with chemo-radiotherapy in locally advanced NPC patients. Methods: Patients with locally advanced NPC were randomized (3:1) to receive nimotuzumab (200 mg, weekly, 7-8 weeks) plus chemo-radiotherapy (Arm A) versus chemo-radiotherapy (intensity-modulated radiation therapy or conventional radiotherapy, cisplatin100mg/m 2 /d, 21days/cycle, three cycles) plus placebo (Arm B) as front-line therapy. The primary endpoint was a 5-year OS rate, and the secondary endpoints included disease-free survival and safety. Results: 482 patients in 24 study sites were enrolled (361 in Arm A vs. 121 in Arm B). Both groups were well balanced regarding age, gender, race and ethnicity. The 5-year OS rate was 76.9% in Arm A compared to 64.3% in Arm B (log-rank=4.125, p=0.042). The median DFS was 50.6 months and 42.6 months in Arm A and B, respectively. The 5-year DFS rate was 40.0% in Arm A compared to 14.4% in Arm B (log-rank=1.701, p=0.192). The combination of nimotuzumab plus chemo-radiotherapy was well tolerated. The incidence of adverse drug reactions (ADRs) in Arm A was similar to Arm B (35.7% vs. 42.1%, p=0.207), and the grade 3-5 ADRs as well (17.7% vs.15.7%, p=0.609). Conclusions: Nimotuzumab plus chemo-radiotherapy increase 5-year OS of NPC patients with good safety profile. Clinical trial information: 01074021.
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Izquierdo-Sánchez, Vanessa, Saé Muñiz-Hernández, Héctor Vázquez-Becerra, et al. "Biodistribution and Tumor Uptake of 67Ga-Nimotuzumab in a Malignant Pleural Mesothelioma Xenograft." Molecules 23, no. 12 (2018): 3138. http://dx.doi.org/10.3390/molecules23123138.
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Malignant pleural mesothelioma (MPM) is the most common tumor of the pulmonary pleura. It is a rare and aggressive malignancy, generally associated with continuous occupational exposure to asbestos. Only a multimodal-approach to treatment, based on surgical resection, chemotherapy and/or radiation, has shown some benefits. However, the survival rate remains low. Nimotuzumab (h-R3), an anti-EGFR (epidermal growth factor receptor) humanized antibody, is proposed as a promising agent for the treatment of MPM. The aim of this research was to implement a procedure for nimotuzumab radiolabeling to evaluate its biodistribution and affinity for EGF (epidermal growth factor) receptors present in a mesothelioma xenograft. Nimotuzumab was radiolabeled with 67Ga; radiolabel efficiency, radiochemical purity, serum stability, and biodistribution were evaluated. Biodistribution and tumor uptake imaging studies by microSPECT/CT in mesothelioma xenografts revealed constant nimotuzumab uptake at the tumor site during the first 48 h after drug administration. In vivo studies using MPM xenografts showed a significant uptake of this radioimmunoconjugate, which illustrates its potential as a biomarker that could promote its theranostic use in patients with MPM.
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Tham, Chee Kian, Paula Lam, Siewju See, Siang Hui Lai, John Thomas, and Wai Hoe Ng. "A preclinical study on the combined treatment of nimotuzumab and sirolimus in glioblastoma." Journal of Clinical Oncology 30, no. 15_suppl (2012): 2066. http://dx.doi.org/10.1200/jco.2012.30.15_suppl.2066.
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2066 Background: The human epidermal growth factor receptor (EGFR) is an ideal therapeutic target for inhibiting glioblastoma (GBM) growth as the signaling pathway is highly dysregulated in GBM. However, trials so far with EGFR inhibitors have not shown clinically meaningful improvement in response rates and survival. One of the postulated mechanisms of resistance is the constitutive activation of the downstream, PI3K/AKT/mTOR pathway, independent of the upstream EGFR activation status. Hence, the dual blockage of the pathways with an anti-EGFR agent and mTOR inhibitor is postulated to have synergistic anti-tumour effects. We aim to investigate the anti-tumour effect of combined nimotuzumab (anti-EGFR monoclonal antibody) and sirolimus (mTOR inhibitor) in a GBM preclinical model. Methods: Primary human GBM cells were derived from surgical GBM specimens. The endogenous expressions of glial-fibrillary acidic proteins and EGFR were determined by IHC staining and Western Blot analysis. Cell viability assays were then carried out in these GBM cells and immortalized human normal astrocytes (iHNA) using a range of concentrations of nimotuzumab alone, sirolimus alone or combined treatment. Results: GBM cells treated with nimotuzumab showed a dose- dependent cell kill and the optimal concentration was determined to be 2 µg/ml. Treatment of the GBM cells with sirolimus showed that the drug was capable of inducing cell death at varying levels and the optimal level was determined to be 0.1 mM. Combined treatment with nimotuzumab (2µg/ml) and rapamycin (0.1 mM) showed a dose dependent cell kill in GBM cells which was not observed in iNHA cells. The combined treatment resulted in only 10% of residual gliomas at 24 h post treatment. Single treatment with rapamycin has no cytotoxic effect whereas treatment with nimotuzumab alone exerts a cytotoxicity effect of 33%. Taken together, we observed an additive effect of cell kill when rapamycin is used together with nimotuzumab in human glioma cells. Conclusions: In this study, combined treatment of nimotuzumab and sirolimus resulted in a greater cytocidal effects in GBM cells than either agent alone. We will further examine this combination regimen in a subsequent phase I clinical trial.
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Strumberg, D., M. E. Scheulen, R. A. Hilger, et al. "Safety, efficacy and pharmacokinetics of nimotuzumab, a humanized monoclonal anti-epidermal growth factor receptor (EGFR) antibody, as monotherapy in patients with locally advanced or metastatic pancreatic cancer (PC)." Journal of Clinical Oncology 24, no. 18_suppl (2006): 12504. http://dx.doi.org/10.1200/jco.2006.24.18_suppl.12504.
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12504 Background: Nimotuzumab (OSAG101, Theraloc) is a humanized monoclonal antibody (mAb) that binds to the EGFR. In preclinical studies the antibody has shown potent antitumor activity. Based on phase I data, the recommended dose has been established at 200 mg weekly. A previous phase II study in children with high grade brain tumors showed activity of nimotuzumab as a monotherapeutic agent, even in prognostically very unfavorable pontine glioma. No drug related side effects were reported. The present ongoing phase II study was aimed at evaluating the safety and efficacy of nimotuzumab monotherapy in patients (pts) with locally advanced or metastatic PC. Methods: Pts who failed standard chemotherapy with gemcitabine or another first line regimen for advanced disease and had at least one measurable lesion were eligible for the study. Nimotuzumab was given iv as induction therapy at 200 mg once weekly for 6 weeks. Follow up by CT was performed after 8 weeks. Pts continued receiving treatment 3-weekly until disease progression or unacceptable toxicity occurred. Endpoints included tumor response (RECIST), time to disease progression, and safety. Blood samples were collected prior to first dose, at end of infusion, and 3h, 6h, 48h, as well as every time before subsequent nimotuzumab doses were administered. Nimotuzumab concentrations in serum were measured by cellular ELISA. Results: Enrollment is complete, with treatment ongoing. In total, 55 pts were treated (28 women/ 27 men; ECOG status of 1 [n= 41] or 0 [n=14], median age 63.6 yrs [range 46–83 yrs]). Pts evaluable for response: n= 36; CR:0; PR:0; SD:6 pts (median TTP 19.2 weeks; 14.1–26.1). The only reported treatment-related adverse event was rash grade 1 in 1 pt. After 200 mg single dose, the mean value of Cmax was calculated to 141 ± 33 μg/ml. The t1/2 was calculated to 45 h, volume of distribution to 1.46 ± 0.3 l, respectively. The total clearance was determined to 23 ± 6 ml/h. The trough values after 168 h were 6.2 ± 6.3 μg/ml. Conclusions: These data confirm that nimotuzumab is safe and well tolerated. To improve efficacy, a combination trial with gemcitabine is planned. [Table: see text]
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J, Alert, Chon I, Valdes J, et al. "Very long-term of survival, 5 years and more in diffuse intrinsic pontine brainstem gliomas in children and adolescents treated with Radiotherapy and Nimotuzumab." International Journal of Radiology & Radiation Therapy 8, no. 2 (2021): 86–90. http://dx.doi.org/10.15406/ijrrt.2021.08.00299.
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Diffuse intrinsic brainstem gliomas have a bad prognosis, and short-term survival time. Radiotherapy has been the principal treatment, and chemotherapy has not improved outcome. The anti –EGFR monoclonal antibody Nimotuzumab combined with Radiotherapy was tested in a series of 41 children and adolescents with diffuse intrinsic pontine gliomas (DIPG) included between January 2008 and December 2015 and a follow-up till January 2021.They were irradiated in the Instituto Nacional de Oncologia y Radiobiologia, Havana, Cuba with a median dose of 54 Gy. Nimotuzumab was applied at a dose of 150 mg/m2, weekly during the period of irradiation, then every 2 weeks by 8 doses, and them monthly for 1,2 or more years. A response was observed in 87.8% of patients. Prolonged use of Nimotuzumab was feasible and well tolerated. Median age at diagnosis was 7 years old, median survival was 18.8 months. There were minor toxicities, only Grade I or II. Survival rate at 5 years was 34.1%, stablished till years or more. Two relapsing patients were re-irradiated. The combination of irradiation and Nimotuzumab is an option to increase survival in DIPG.
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Subramanian, Sundaram, Nithya Sridharan, V. Balasundaram, and Sameer Chaudhari. "Efficacy and safety of nimotuzumab in unresectable, recurrent, and/or metastatic squamous cell carcinoma of the head and neck: A hospital-based retrospective evidence." South Asian Journal of Cancer 07, no. 03 (2018): 188–92. http://dx.doi.org/10.4103/sajc.sajc_87_18.
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Abstract Context: Role of nimotuzumab in locally advanced head and neck cancer (HNC) is well established in India; however, no clinical evidence is available for its role in recurrent and/or metastatic HNC. Aims: The aim of this study is to evaluate the efficacy and safety of nimotuzumab when added to standard treatment in unresectable, recurrent, and metastatic squamous cell carcinoma of the head and neck (SCCHN) Settings and Design: Hospital records of 14 patients diagnosed with recurrent and/or metastatic HNC with histologically confirmed squamous cell carcinoma and being treated with nimotuzumab along with standard treatments from December 2010 to December 2016 were retrospectively evaluated. Subjects and Methods: The tumor response rate and overall survival (OS) were analyzed. Toxicity and adverse events (AEs) were assessed as per common terminology criteria for adverse events (CTCAE) v 4. Results: Oral cavity was most commonly involved region followed by hypopharynx and oropharynx. At 24 weeks after completion of treatment, overall response rate (complete response (CR) + partial response (PR)) was 75%. Survival rate at 1, 2, and 3 years was 77.80%, 64.81%, and 64.81%, respectively. At a median follow-up of 15.17 months, median OS was not reached. All AEs were either Grade I (66.7%) or Grade II (33.3%). No Grade III or Grade IV AEs were observed. No added toxicity was observed due to nimotuzumab. Conclusions: In the first of its kind study, the addition of nimotuzumab to standard treatment showed promising response rate as well as survival outcomes in recurrent and/or metastatic SCCHN patients without producing additional toxicity.
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Epelman, Sidnei, Vijay Ramaswamy, Ethel Gorender, and Luis Henrique Sakamoto. "DIPG-72. LONG-TERM SURVIVAL OF A CLASSIC DIFFUSE INTRINSIC PONTINE GLIOMA TREATED WITH NIMOTUZUMAB." Neuro-Oncology 22, Supplement_3 (2020): iii301. http://dx.doi.org/10.1093/neuonc/noaa222.114.
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Abstract BACKGROUND Long-term survival in diffuse intrinsic pontine glioma is rare, and typically associated with atypical imaging and/or atypical clinical course. Although most patients harbor hotspot mutations in H3.1/3-K27M, a proportion of patients have alternate mutations, despite a typical clinicoradiological course. Herein we describe a long-term survivor with a classical presentation, treated with nimotuzumab, highlighting the challenges associated with such cases. CASE REPORT: A 5 year old male, diagnose in 2012 with a 10 day history multiple cranial neuropathies and a right hemiparesis. Cranial MRI revealed a poorly delimited diffuse pontine tumor and secondary hydrocephalus. Tumor biopsy was not performed due to the classic clinical presentation, and he received 54Gy/30 of radiation plus concomitant weekly nimotuzumab 150mg/m2. Initial tumor dimensions were 43x31x28mm. Nimotuzumab 150mg/m2 was continued every 2 weeks. Image assessment at week 12 of treatment revealed 16.9% volume increase, 4 weeks after radiotherapy completion. Nevertheless, subsequent neuroimaging at 24th, 36th, 60th, 96th and 108th weeks of nimotuzumab therapy showed a sustained and progressive tumor cytoreduction of 47.5%, 59%, 62.2%, 63.8% and 67%, respectively, when compared with post-radiotherapy dimensions. Currently, the patient is 13y old, good school performance, no neurologic disabilities. The last MRI at 394 weeks of nimotuzumab revealed dimensions of 21x19x14mm which corresponds to 70% of reduction compared with initial volume. CONCLUSIONS Our case of progressive cytoreduction over two years of a classic DIPG, diagnosed in the era prior to the discovery of the K27M mutation, highlights the challenges associated with long-term survival of this devastating entity.
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González Fernández, Sandra, Yohan Amador García, Lucien Gregoria Boris Porras, et al. "Nimotuzumab in the Treatment of Inoperable Esophageal Tumors of Epithelial Origin." Journal of Oncology 2022 (September 1, 2022): 1–11. http://dx.doi.org/10.1155/2022/4128946.
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Background. Nimotuzumab is a humanized monoclonal antibody that targets the epidermal growth factor receptor. It was approved in Cuba for the indication of inoperable malignant tumors of the esophagus of epithelial origin. The purpose of this study was to evaluate the safety, overall and progression-free survival, clinical response, and quality of life, in adult patients with inoperable esophageal tumors of epithelial origin treated with nimotuzumab in a practical context. Material and Methods. The number of patients who developed adverse events was determined, and the frequency, seriousness, causality, and severity of these adverse events were determined. It also determined the median of survival and progression-free survival and rates at 12 and 24 months and the quality of life. Results. A total of 111 patients were included. The proportion of serious and related AE with the use of nimotuzumab was 1.3%. Most of the related AEs were mild and moderate, and the most frequent AEs were diarrhea, chills, and tremors. New diagnosed patients who received nimotuzumab concurrent with chemotherapy and radiotherapy reached a median OS of 12.2 months (95% CI, 6.9–17.5) and 12- and 24-month survival rates of 51.0% and 17.0%, respectively. Median PFS was 7.8 months (95% CI, 6.2–9.5), and 12- and 24-month PFS rates were 39.3% and 11.2%, respectively. A favorable evolution of the general state of health ( p = 0.03 ) was obtained from the beginning of treatment until month 12, with a significant reduction in the appearance of nausea ( p = 0.009 ), insomnia ( p = 0.04 ), constipation ( p = 0.04 ), eating difficulties ( p = 0.0006 ), and choking when swallowing ( p = 0.0001 ), but increased in dysphagia ( p = 0.02 ). Conclusions. The administration of nimotuzumab was safe in the real-world setting. New diagnosed patients that received nimotuzumab concurrent with chemotherapy and radiotherapy reached a higher overall and progression-free survival and better quality of life than the rest of the patients. Trial registration is RPCEC00000215 (Cuban Registry of Clinical Trials; https://registroclinico.sld.cu/en/home). It is registered prospectively on June 30, 2016.
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Zhou, Jun, Lin Shen, and Jing Gao. "A dose escalation study of nimotuzumab plus irinotecan as second-line treatment in metastatic colorectal cancer with wild-type K-ras." Journal of Clinical Oncology 30, no. 15_suppl (2012): e14122-e14122. http://dx.doi.org/10.1200/jco.2012.30.15_suppl.e14122.
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e14122 Background: Nimotuzumab is a humanized monoclonal antibody of EGFR. We assessed the safety/tolerability and the efficacy of nimotuzumab combined with Irinotecan as the second-line treatment in Chinese patients with metastatic colorectal cancer (mCRC). Methods: Patients with mCRC refractory to oxaliplatin, K-ras WT, signed informed consent, target lesion(s), performance status (PS) ≤2, adequate organ functions, were eligible for this open-labelled, single-armed trial (NCT00972465). Irinotecan was given as 180mg/m2 d1, Q2w until progression or AEs or maximum 6 cycles. Nimotzumab was given as 200, 400, 600 or 800mg weekly until progression or AEs. The primary end points were objective response rate and toxicity. The second end points are PFS and OS. Results: A total of 31 patients (M/F = 22/9; median age 55; range 29-77) have been enrolled from July 2009 to Nov 2011. 4/11/12/4 patients received nimotuzumab as the dose of 200/400/600/800mg respectively. Most common grade 3/4 toxicity are leukopenia (14.8%,) and neutrocytopenia 18.5%). For all the patients, no grade 3/4 toxicity relating with Nimotuzumab was observed. 2 and 3 patients developed skin rash (grade 1) in 400 and 600mg arm respectively. 2 patients developed skin rash grade 2 in 600/800mg arm. The maximum tolerated dose has not yet been reached. Three patients (400/600mg: 2/1) quitted the trial because of personal reason. In 600mg arm, PR was 33.3% (4/12), SD was 25% (3/12); in 400mg arm, PR was 9.l%(1/11), SD was 36.4%(4/11); in 200mg arm, SD was 50%(2/4), PD was 50% (2/4); in 800mg arm, PR was 25%(1/4), PD was 75%(3/4). The follow-up of overall survival is ongoing. Conclusions: Addition of Nimotuzumab with 600mg weekly plus Irinotecan is safe and first data suggest a promising activity. The maximum tolerated dose of Nimotuzumab has not been reached yet.
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Zhang, Xiaodong, Ming Lu, Jifang Gong, et al. "Phase II study of nimotuzumab combination with paclitaxel and cisplatin as the first-line treatment in patients with local advanced or metastatic esophageal squamous cell cancer (ESCC): An interim analysis." Journal of Clinical Oncology 30, no. 15_suppl (2012): e14604-e14604. http://dx.doi.org/10.1200/jco.2012.30.15_suppl.e14604.
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e14604 Background: Nimotuzumab is a genetically engineered humanized antibody (mAb) that recognizes an epitope located in the extracellular domain of human EGFR. Evidences have shown that nimotuzumab is effective and safe in SCCHN. The combination of paclitaxel/cisplatin (TP) is a standard regimen for advanced or metastatic ESCC. This open uncontrolled phase II study was designed to determine the efficacy and safety of nimotuzumab in combination with TP as the first-line treatment in advanced ESCC. Methods: All patients have histology/cytology confirmed advanced or metastatic ESCC with ECOG PS 0-2. The treatment plan is as the following: paclitaxel administered intravenously (IV) 175 mg/m2 on d1 and cisplatin IV 30-35mg/ m2/d on d1-2, every 21 days for 6 cycles, and nimotuzumab IV 200mg weekly. For patients with stable disease (SD) and better, nimotuzumab will be given continuously after 6 cycles of TP. The primary endpoint is objective response rate (RR) with 56 patients enrollment (target RR >60%); secondary endpoints were progression-free survival (PFS), overall survival (OS) and safety/ tolerability. The coordinations between EGFR and ERCC1 with response of treatment will be analyzed. Results: Up to date, 25 patients (male/female, 20/5; median age 58) have been enrolled. All patients were evaluated for toxicity and 22 are evaluable for response. 14 (63.6%) had a confirmed partial response (PR) and 7 (31.8%) had SD as their best responses with disease control rate of 95.4%. Only one patient had progressive disease (PD). Grade 3 or 4 neutropenia, neutropenic fever and anemia occurred in 52.2%, 4% and 13% respectively. Nonhematological toxicities were generally mild with grade 1 or 2 alopecie, hypodynamia, anorexia, nausea, arthralgia, and itch of skin occurring in 80%, 60.9%, 43.5%, 34.8%, 30.4%, and 21.7%. One patient had a grade 3 haematuria. Conclusions: The interim analysis showed that the combination of nimotuzumab with TP is tolerated reasonably well in patients with advanced or metastatic ESCC and encouraging efficacy. The study is ongoing with coordination of biomarkers and response as well.
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Lam, Catherine, Eric Bouffet, and Ute Bartels. "Nimotuzumab in pediatric glioma." Future Oncology 5, no. 9 (2009): 1349–61. http://dx.doi.org/10.2217/fon.09.119.
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Piedra, P., G. Saurez, N. Iznaga, and C. Viada. "Nimotuzumab, Clinical Safety Profile." Drug Safety 29, no. 10 (2006): 911–1010. http://dx.doi.org/10.2165/00002018-200629100-00116.
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Cao, Caineng, Qiaoying Hu, and Xiaozhong Chen. "A phase II study of concurrent nimotuzumab and intensity-modulated radiotherapy in elderly patients with locoregionally advanced nasopharyngeal carcinoma." Journal of Clinical Oncology 37, no. 15_suppl (2019): e17562-e17562. http://dx.doi.org/10.1200/jco.2019.37.15_suppl.e17562.
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e17562 Background: The purpose of this study was to evaluate the feasibility of concurrent nimotuzumab to intensity-modulated radiotherapy (IMRT) in elderly patients with locoregionally advanced nasopharyngeal carcinoma (NPC). Methods: According to the eighth edition of the American Joint Committee on Cancer staging system, elderly patients with stage III–IVA NPC were given concurrent nimotuzumab (200 mg/week, starting 1 week before IMRT) with IMRT. They completed a geriatric assessment tool (function, comorbidity, cognition, psychological state, social activity/support, and nutritional status) before initiation of protocol therapy. Results: Thirty patients [median age of 70.5 (65-95) years] with stage III (60%), and IVA (40%) NPC were enrolled between March 2017 and November 2018. The mean scores on the comorbidity scale and instrumental activities of daily living scale were 7 (range, 1 to 12) and 12 (range, 8 to 14), respectively. Grade 3 mucositis occurred in 10 (33%) patients and 1 (3%) patient had grade 3 radiotherapy-related dermatitis. Grade 3 pneumonia occurred in 3 patients (10%) and no patients had nimotuzumab-related acneiform rash. There were 20 complete responses and 10 partial responses 1month after the completion of IMRT. Conclusions: Concurrent administration of nimotuzumab and IMRT is effective and well-tolerated for elderly patients with locoregionally advanced NPC. Clinical trial information: NCT03025958.
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Mai, Hai-Qiang, Shan-Shan Guo, Li-Ting Liu, et al. "Radiotherapy plus nimotuzumab versus cisplatin in low-risk locoregionally advanced nasopharyngeal carcinoma who had favorable response to induction chemotherapy: A randomised, phase III, non-inferiority trial." Journal of Clinical Oncology 43, no. 16_suppl (2025): 6078. https://doi.org/10.1200/jco.2025.43.16_suppl.6078.
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6078 Background: Patients with low-risk locoregionally advanced nasopharyngeal carcinoma (LA-NPC) have high survival when treated with radiotherapy (RT) plus cisplatin after induction chemotherapy (IC). Whether replacement of cisplatin with nimotuzumab—a humanized antibody against the epidermal growth factor receptor (EGFR)—can preserve high survival and reduce treatment toxicity is unknown for patients with good response to IC. Therefore, we assessed whether nimotuzumab plus RT was non-inferior to cisplatin plus RT in low-risk LA-NPC with favorable response to IC. Methods: The study was a randomised, non-inferiority, phase 3 trial at Sun Yat-sen University Cancer Centre, China. Adult patients (aged 18–70 years) with non-keratinizing stage II-IVA (except N3 category; the eighth edition of the American Joint Committee on Cancer classification system) NPC, with pre-treatment plasma EBV DNA<1500 copies/mL, positive EGFR expression and an Eastern Cooperative Oncology Group performance status of 0–1, were treated with 2 cycles of paclitaxel-cisplatin-fluorouracil IC, those achieved CR/PR with undetectable EBV DNA were randomly assigned (1:1) to receive either intravenous nimotuzumab at a dose of 200 mg weekly or cisplatin 100 mg/m² on days 1, 22 and 43 of intensity-modulated radiotherapy. Randomization was done using a computer-generated code random number code with a block size of six, stratified by overall stage. The primary endpoint was 2-year progression-free survival (PFS) in the intention-to-treat population. Safety was assessed in all participants who received at least one dose of the assigned treatment. This study is registered with ClinicalTrials.gov, number NCT 04456322. Results: Of the 381 patients who underwent randomization, 191 were assigned to RT plus nimotuzumab and 190 to RT plus cisplatin. After median follow-up duration of 39.5 months, in the evaluation of 2-year PFS, RT plus nimotuzumab was noninferior to RT plus cisplatin (94.2% and 95.8%, respectively; absolute difference, 1.6 percentage points; 95% CI, –2.8 to 6.0, [noninferiority margin, -10 percentage points], P noninferiority =0.0001). The most common grade 3-4 acute toxicities were leucopenia (37 [19.5%] of 190 patients in the cisplatin group vs. 2 [1.1%] of 189 patients in the nimotuzumab group), mucositis (36 [18.9%] vs. 28 [14.8%]), and vomiting (21 [11.1%] vs. 0). No patients died during treatment. Patients in the cisplatin group also showed more grade 1-2 auditory or hearing loss and peripheral neuropathy in late adverse events, and impaired long-term quality of life. Conclusions: Our findings show that nimotuzumab plus RT represents an alternative concurrent treatment strategy for patients with low-risk LA-NPC with a favorable response to IC. Clinical trial information: NCT04456322 .
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Parenrengi, Muhammad A., Wihasto Suryaningtyas, Asra Al Fauzi, et al. "Nimotuzumab as Additional Therapy for GLIOMA in Pediatric and Adolescent: A Systematic Review." Cancer Control 29 (January 2022): 107327482110539. http://dx.doi.org/10.1177/10732748211053927.
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Introduction Pediatric gliomas represent the most common brain tumor in children and its higher grades are associated with higher recurrence and low survival rate. All therapeutic modalities are reported to be insufficient to achieve satisfactory result, with follow-up treatment such as adjuvant radiotherapy and chemotherapy recommended to increase survival and hinder tumor progression. Nimotuzumab is a monoclonal antibody that acts as an inhibitor of epidermal growth factor receptor found on the surface of glioma cells and had been studied for its usage in pediatric gliomas in recent years. Methods A systematic review is performed according to Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines. A through literature search was conducted on PubMed, Scopus, Cochrane, and clinicaltrials.gov database. Articles were selected systematically based on the PRISMA protocol and reviewed completely. The relevant data were summarized and discussed. We measured overall survival, progression-free survival, and adverse Events (AE) for nimotuzumab usage as an adjunct therapy in pediatric glioma population. Result From 5 studies included for qualitative analysis, 151 patients are included with overall survival (OS) that vary from 3.2–22.8 mo, progression-free survival (PFS) from 1.7–21.6 mo, and relatively low serious adverse events (0–21) are recorded. Follow-up ranged from 2.4–66 mo with four studies reporting diffuse intrinsic pontine glioma (DIPG) patients and only one study reporting nimotuzumab usage in pediatric high-grade glioma (HGG) patients with better outcome in HGG patients than DIPG. Conclusion There are no significant differences in the PFS and OS of nimotuzumab as adjunct therapy for pediatric compared to result of standard therapy in majority of previous studies. There were also no differences in the AE of nimotuzumab for pediatric glioma between studies, and low event of serious adverse events indicating its safety. But still there is an evidence of possible benefit of nimotuzumab as adjuvant therapy in pediatric glioma. We recommend further studies with larger number of patients that may lead to possibly different results. There should also be more studies with better level of evidence to further validate the effect of nimozutumab on pediatric glioma.
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Liang, Jun, Luhua Wang, Mingyan E, et al. "Nimotuzumab combined with radiotherapy on esophageal cancer: Preliminary study of a phase II clinical trial." Journal of Clinical Oncology 30, no. 15_suppl (2012): e14511-e14511. http://dx.doi.org/10.1200/jco.2012.30.15_suppl.e14511.
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e14511 Background: To evaluate the safety and therapeutic effect of Nimotuzumab (h-R3) in combination with radiotherapy on esophageal cancer. Methods: 42 patients with stage II (Inoperable or refused surgery) to IV (Supraclavicular lymph node metastasis only)were assigned to the phase II clinical trial during Nov. 2008 to Jul. 2010. Histopathological classification of all patients was squamous cell carcinoma. All patients received 50-70 Gy of three-dimensional conformal radiotherapy. 200mg of Nimotuzumab was administered once a week during radiotherapy. Results: There were 9, 25 and 8 patients with stage II, III and IV esophageal cancer, respectively. All patients received 50-70 Gy of radiation therapy except two. 37 patients (88.1%) received Nimotuzumab for more than 5 times. The recorded grade III toxicities (21.4% of all adverse events) included gastrointestinal toxicity, esophagitis, dermatology toxicity and hematological toxicity. Complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) were observed in 0, 22 (52.4%), 17 (40.5%) and 3 (7.1%) patients in one month after treatment. EGFR over-expression rate was 95.2%. Median survival time (MST) was 14 months. One-year and 2-year overall survival (OS) and progression-free survival (PFS) were 54.8%, 36.8% and 39.4, 33.3%, respectively. After a median follow-up time of 17 months, the local recurrence and distant metastases were observed in 18 (42.9%) and 14 (33.3%) patients, respectively. Conclusions: Nimotuzumab combined with radiotherapy were well-tolerated in patients with esophageal cancer. The incidence of grade III toxicity was 21.4%, no grade IV toxicity was observed. EGFR over-expression was found higher than in previous studies. One-year and 2-year OS and PFS were 54.8%, 36.8% and 39.4, 33.3%, respectively. Further study is needed to confirm the therapeutic efficacy of Nimotuzumab in esophageal cancer.
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Qu, Ang, Junjie Wang, Ping Jiang, et al. "Safety and efficacy of nimotuzumab and concurrent intensity-modulated radiation therapy and chemotherapy for locally advanced cervical squamous cell cancer." Journal of Clinical Oncology 37, no. 15_suppl (2019): 5532. http://dx.doi.org/10.1200/jco.2019.37.15_suppl.5532.
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5532 Background: To evaluate the safety and efficacy of nimotuzumab plus concurrent intensity-modulated radiation therapy (IMRT) and chemotherapy for the treatment of locally advanced cervical squamous cell cancer (LACSCC). Methods: From December 2013 to March 2017, 31 patients with stage (FIGO 2009) IB2-IVA cervical squamous cell cancer were enrolled in this single-arm clinical trial at an academic medical center and received concurrent chemoradiotherapy plus nimotuzumab. All patients underwent at least 1 year of follow-up. The prescription radiation dose was 50.4 Gy/28 F on the pelvic field with or without extended-field radiation. An additional 30-36 Gy to Point A was delivered with high-dose-rate techniques. Cisplatin 40 mg/m2 and nimotuzumab 200 mg were infused intravenously once weekly during radiotherapy. The main and secondary outcome measures were toxicity evaluated using CTCAE 4.0., and the short-term outcome evaluated by RECIST 1.1. Results: The median follow-up duration was 29.7 months (13.3-61.2 months). All patients received external beam radiotherapy, brachytherapy, and nimotuzumab six times. Twenty-seven patients received six cycles of chemotherapy while four received only 4-5 cycles. There was no life-threatening toxicity. The incidence of acute grade 3 bone marrow depression was 51.6% (16/31) and grade 3 gastrointestinal tract reaction was 9.7% (3/31). The incidence of late toxicities was 22.6% (7/31), and these included vaginal-rectal fistula, intestinal obstruction, rectal hemorrhage, hematuria, and vaginal stenosis. Complete response was achieved in 30 cases (96.8%). The 1-year disease-free survival (DFS), local progression-free survival (LPFS), and overall survival (OS) rates were 87.1%, 90.3%, and 100%, respectively. The corresponding 3-year values were 74.8%, 90.3%, and 86.7%. Conclusions: Nimotuzumab plus concurrent IMRT and chemotherapy may represent a well-tolerated and effective treatment regimen in patients with LACSCC.
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Boku, N., K. Yamazaki, N. Yamamoto, et al. "Phase I study of nimotuzumab, a humanized anti-epidermal growth factor receptor (EGFR) IgG1 monoclonal antibody in patients with solid tumors in Japan." Journal of Clinical Oncology 27, no. 15_suppl (2009): e14574-e14574. http://dx.doi.org/10.1200/jco.2009.27.15_suppl.e14574.
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e14574 Background: Nimotuzumab, a humanized IgG1 monoclonal antibody targeting EGFR, has been used in head & neck cancer or malignant glioma outside Japan, and MTD including severe skin rash were not observed up to 800mg/body. This phase I study of nimotuzumab was conducted to investigate the safety profile, MTD, DLT, PK, human antibody against nimotuzumab (HAHA) in Japanese patients (pts), and PD analysis (activation of EGFR, Akt, MAPK, Ki67) was done. Methods: Pts with advanced solid tumors having no available standard therapy were enrolled. Nimotuzumab was given intravenously at dose levels of nimotumumab 100, 200 and 400mg/body, weekly. Blood, skin samples before treatment and after 4th infusion and pre-treatment tumor were collected for PD analysis. Results: 4 pts were enrolled in each level (total 12 pts). Pt characteristics were M/F 5/7, median age 57 years, ECOG PS 0/1 7/5. No grade 3 or 4 toxicities and no DLT were observed, and MTD was not determined. The major adverse event was grade 1 or 2 skin rash (58%, 7/12). Neither infusion reaction nor HAHA was observed. AUC0-inf, Cmax and t1/2 increased and CL deceased by dose dependent manner, indicating nonlinear PK characteristic. SD and PD were observed in 8 patients (67%) and4 patients (33%), without objective responses. Median time to progression was 4 months. Time to progression seemed to be longer in the pts with amplified gene copy number of EGFR though the number of pts was limited. Conclusions: Weekly infusion of nimotuzumab was well tolerated up to 400 mg/body in Japanese pts. A correlation between anti-tumor activity and EGFR amplification was speculated. Additional PD analysis is currently ongoing. No significant financial relationships to disclose.
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Qu, Ang, Ping Jiang, Panfeng Wang, et al. "Concurrent intensity-modulated radiation therapy and chemotherapy plus nimotuzumab for locally advanced cervical squamous cell cancer: A long-term follow-up result." Advances in Radiotherapy & Nuclear Medicine 1, no. 1 (2023): 0408. http://dx.doi.org/10.36922/arnm.0408.
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The study aimed to evaluate the safety and efficacy of concurrent intensity-modulated radiation therapy (IMRT) and chemotherapy plus nimotuzumab for the treatment of locally advanced cervical squamous cell cancer (LACSCC). From December 2013 to March 2017, 34 patients with stages IB2&ndash;IVA (FIGO 2009) cervical squamous cell cancer were enrolled and received concurrent chemoradiotherapy plus nimotuzumab. The prescription radiation dose was 50.4 Gy/28 F on the pelvic field with or without extended-field radiation. An additional 30&ndash;36 Gy to Point A was delivered with high-dose-rate brachytherapy. Cisplatin 40 mg/m2 and nimotuzumab 200 mg were infused intravenously weekly. The main and secondary outcome measures were toxicity evaluated using common terminology criteria for adverse events 4.03. and the outcome evaluated using response evaluation criteria in solid tumors 1.1, respectively. The median follow-up duration was 66 months (13 &ndash; 98 months). All patients received 6 times of IMRT, brachytherapy, and nimotuzumab. Among them, 24 received six cycles of chemotherapy, while 11 received 4&ndash;5 cycles. No life-threatening toxicity was found. The incidence of acute Grade 3 bone marrow depression was 52.9% (18/34), and Grade 3 gastrointestinal tract reaction was 8.8% (3/34). The incidence of late toxicities was 58.8% (20/34), including vaginal-rectal fistula, intestinal obstruction, rectal hemorrhage, hematuria, vaginal stenosis, and paresthesia. About 90% of those were Grades 1&ndash;2. Complete response was achieved in 33 cases (97.1%). The 3-year disease-free survival, local progression-free survival (LPFS), and overall survival rates were 79.4%, 91.2%, and 82.4%, respectively. The corresponding 5-year values were 79.4%, 91.2%, and 79.3%. In conclusion, concurrent IMRT and chemotherapy plus nimotuzumab may represent a well-tolerated and effective treatment regimen in patients with LACSCC.
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Ruiz, Raiza, Daisy Hernández, Carmen Viada, Jessica García, Martha Fors, and Mayra Ramos. "Tratamiento de tumores de ovario en progresión con la combinación terapéutica del AcM Nimotuzumab y la vacuna NGGM3/VSSP." Bionatura Journal 1, no. 4 (2024): 1–11. http://dx.doi.org/10.70099/bj/2024.01.04.13.
Full textAbstract:
El cáncer de ovario ocupa el tercer lugar entre los cánceres ginecológicos y representa el 4% de los cánceres en la mujer. Las inmunoterapias antitumorales constituyen nuevas herramientas terapéuticas para la identificación de moléculas que se expresen diferencialmente en las células tumorales. Se realizó un estudio exploratorio para evaluar la seguridad y eficacia de un preparado vacunal que contiene NGlicolilGM3 (NGGM3/VSSP) y el Anticuerpo Monoclonal Nimotuzumab (AcM CIMAher). Ambos productos han demostrado ser seguros y se pueden aplicar en combinación con la quimioterapia (QTP). La supervivencia (SV) del grupo de pacientes a las que se les aplicó QTP, AcM Nimotuzumab y la vacuna NGGM3/VSSP fue superior al grupo que no recibió quimioterapia. El efecto antitumoral de la combinación puede ser sinérgico, ya que las terapias van dirigidas a dos blancos tumorales y actúan a través de mecanismos diferentes. Palabras claves: cáncer de ovario, quimioterapia, inmunoterapia, AcM Nimotuzumab, vacuna NGGM3/VSSP
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Qu, Ang, Jun jie Wang, Yanhong Zhuo, et al. "Nimotuzumab in combination with radiotherapy for elderly patients with locally advanced cervical squamous cell carcinoma: Results from a prospective, multicenter, open-label, single-arm trial." Journal of Clinical Oncology 42, no. 16_suppl (2024): 5527. http://dx.doi.org/10.1200/jco.2024.42.16_suppl.5527.
Full textAbstract:
5527 Background: Locally advanced cervical squamous cell carcinoma (LACSCC) is associated with poor survival, and elderly patients generally have fewer treatment options due to chemotherapy intolerance. Nimotuzumab is a humanized monoclonal antibody that has demonstrated therapeutic activity in many tumors. We conducted a single-arm trial to investigate the efficacy and safety of combining nimotuzumab and radiotherapy for elderly patients with LACSCC. Methods: In this prospective, multicenter, open-label, and single-arm trial, patients with LACSCC were registered (NCT04976478) and enrolled from Nov 2021 to Jan 2023. All patients were ≥ 65 years old, had ECOG of 0-2, histological diagnosis of cervical squamous cell carcinoma, clinical stage IB3-IVA (FIGO 2018), intolerant to chemotherapy, or refused chemotherapy. The regimen was nimotuzumab (200 mg once in a week for 6 weeks) combined with radiotherapy. The radiotherapy scheme contained intensity-modulated radiotherapy (IMRT)/volumetric intensity-modulated arc therapy (VMAT) with pelvic/extended field irradiation (45-50.4Gy, 1.8-2.0Gy/f, 25-28f), and brachytherapy (HR-CTV D90, 80-85Gy), of which brachytherapy plus external beam radiotherapy was completed in 8 weeks. The primary endpoints were overall survival (OS) and disease-free survival (DFS). Other assessed endpoints were objective response rate (ORR), disease control rate (DCR) and complete response rate (CRR). All adverse events were monitored and recorded. Results: As of Jan 2023, 119 elderly patients have been enrolled and all patients were included in the efficacy and safety analysis. The median follow-up was 16.16 months (95% CI: 13.14-17.45). Nimotuzumab combined with radiotherapy resulted in favorable OS (1 year-OS: 96.03%, 95% CI: 89.75-98.50; 2 year-OS: 90.21%, 95% CI: 78.98-95.60), and DFS (1 year-DFS: 85.71%, 95% CI: 76.98-91.31; 2 year-DFS: 78.31%, 95% CI: 66.67-86.29). The ORR was 89.92%, DCR was 93.28%, and CRR was 52.94%. A total of seven patients died, of which three were due to disease progression and two were of unknown causes. The most common Grade 3-5 adverse events (AEs) mainly included leukopenia (3.36%), anemia (2.52%), and neutropenia (1.68%). None of the patients developed severe AEs or deaths. So far, this trial is still ongoing. Conclusions: Among elderly LACSCC patients, adding nimotuzumab to radiotherapy indicated promising efficacy and appeared to have manageable toxicity. Nimotuzumab plus radiotherapy could represent a novel treatment strategy for this population. Clinical trial information: NCT04976478 .