Academic literature on the topic '73.42 age groups, initiation (ethnology)'

Background: Organizations recommend that athletes should be asymptomatic or symptom-limited before initiating a graduated return-to-play (GRTP) protocol after sports-related concussion, although asymptomatic or symptom-limited is not well-defined. Hypotheses: (1) There will be a range (ie, beyond zero as indicator of “symptom-free”) in symptom severity endorsement when athletes are deemed ready to initiate a GRTP protocol. (2) Baseline symptom severity scores and demographic/preinjury medical history factors influence symptom severity scores at the commencement of the GRTP protocol. (3) Greater symptom severity scores at GRTP protocol initiation will result in longer protocol duration. (4) Symptom severity scores will not differ between those who did and did not sustain a repeat injury within 90 days of their initial injury. Study Design: Cohort study; Level of evidence, 2. Methods: Across 30 universities, athletes (N = 1531) completed assessments at baseline and before beginning the GRTP protocol, as determined by local medical staff. Symptom severity scores were recorded with the symptom checklist of the Sport Concussion Assessment Tool–3rd Edition. Nonparametric comparisons were used to examine the effect of medical, demographic, and injury factors on symptom endorsement at GRTP protocol initiation, as well as differences in symptom severity scores between those who did and did not sustain a repeat injury within 90 days. A Cox regression was used to examine the association between symptom severity scores at GRTP protocol initiation and protocol duration. Results: Symptom severity scores at the time when the GRTP protocol was initiated were as follows: 0 to 5 (n = 1378; 90.0%), 6 to 10 (n = 76; 5.0%), 11 to 20 (n = 42; 3.0%), and ≥21 (n = 35; 2.0%). Demographic (sex and age), medical (psychiatric disorders, attention-deficit/hyperactivity disorder, learning disorder), and other factors (baseline symptom endorsement and sleep) were significantly associated with higher symptom severity scores at the GRTP initiation ( P < .05). The 4 GRTP initiation time point symptom severity score groups did not significantly differ in total time to unrestricted RTP, χ2(3) = 1.4; P = .73. When days until the initiation of the GRTP protocol was included as a covariate, symptom severity scores between 11 and 20 ( P = .02; hazard ratio = 1.44; 95% CI, 1.06-1.96) and ≥21 ( P < .001; hazard ratio = 1.88; 95% CI, 1.34-2.63) were significantly associated with a longer GRTP protocol duration as compared with symptom severity scores between 0 and 5. Symptom severity scores at GRTP initiation did not significantly differ between those who sustained a repeat injury within 90 days and those who did not ( U = 29,893.5; P = .75). Conclusion: A range of symptom severity endorsement was observed at GRTP protocol initiation, with higher endorsement among those with higher baseline symptom endorsement and select demographic and medical history factors. Findings suggest that initiation of a GRTP protocol before an absolute absence of all symptoms is not associated with longer progression of the GRTP protocol, although symptom severity scores >10 were associated with longer duration of a GRTP protocol. Results can be utilized to guide clinicians toward optimal GRTP initiation (ie, balancing active recovery with avoidance of premature return to activity).

Background:Access to assays of circulating anti-Mullerian hormone (AMH) levels has opened a new page in the assessment of ovarian function and fertility in various diseases, including rheumatic diseases (RDs). The definition of AMH as a marker of ovarian reserve significantly simplified its interpretation as well as measuring the contribution of the disease itself to the patients’ infertility.Objectives:To evaluate the effects of the disease and it’s treatment on serum AMH levels for Behcet’s disease (BD), systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and systemic scleroderma (SSD).Methods:The study included 73 patients with RDs from 18 to 40 years: 42 patients with BD, 12 with SLE, 11 with RA, 8- with SSD, the control group consisted of 15 healthy women. Enzyme-linked immunosorbent assay (ELISA) was used to measure AMH levels. Parametric and nonparametric statistical methods of Statistica 8.0 package were used for statistical processing of data.Results:Mean age in BD patients was 30.0 years, in SLE and RA -33.5 years, in SSD - 35.0 years, and 32.0 years in the control group. The average disease duration was 4.5 years, 11.5 years, 4.0 years and 6.0 years, respectively.BD, n=42SLE, n=12RA, n=11SSD, n=8Control, n=15Mean age, years30,0[26;35]33.5[29;38]33,5[24;36]35,0[28;40]32,0[26;35]Average disease duration, years4,5[2,6;9,0]11,5[2,8;18]4,0[4,0;6,0]6,0[2,0-10,0]-Mean AMH level, ng/ml2,5[1,1;3,7]3,5[0,4-7,1]3,35[2,0;7,6]2,5 [0,3;7,1]3,1[1,9;5,4]There were no significant differences in the mean AMH levels between the groups. No association between AMG levels and clinical manifestations, disease activity or duration of rheumatic disease was found. Baseline AMH – in treatment-naïve patients before initiation of any DMARDs was assessed in 11 BD patients. A significant (p>0.05) decrease of AMH levels was established in patients with high SLE activity treated with CP. Of notice, all examined patients were additionally receiving a GEBD -Rituximab.Conclusion:Decreased ovarian function was found in patients with high SLE activity treated with CP with Rituximab.Disclosure of Interests:None declared

8526 Background: Evidence from the PACIFIC study and real-world data highlight the benefit of durvalumab in patients with stage III unresectable non-small cell lung cancer (UR-NSCLC). However, limited literature exists regarding disparities in durvalumab treatment patterns such as treatment initiation delays (TID), treatment interruptions (TI), number of doses, duration of therapy (DOT), adverse effects (AEs), and treatment discontinuation (TD) in minority populations. Methods: Patients with stage III UR-NSCLC and a self-reported racial identity of Black or White treated with durvalumab following chemoradiotherapy (CRT) at any Veterans Health Administration (VHA) facility from January 1, 2017 to June 30, 2020 were included. Patients were followed from their date of durvalumab initiation through the earliest of their last VHA visit, loss to follow up, death, or end of the study; therefore, all patients had the opportunity to be treated for 12 months. Patients were excluded if durvalumab therapy was ongoing at the end of the study. Patient charts were retrospectively reviewed for baseline characteristics and durvalumab treatment patterns including TID (>42 days from end of CRT to durvalumab start), TI (>28 days between doses), number of doses, DOT, AEs, and TD. Nominal variables were compared using chi-square/Fisher’s exact tests. Continuous variables were compared using Student’s t-tests/Wilcoxon Rank Sum tests. Results: Among 924 patients, Black patients were younger than White patients (median age 67 years [IQR, 63-71] vs. 70 years [IQR, 65-73]; p<0.01), more likely to be current smokers (54% vs. 45%; p=0.03), with more chronic liver disease (22% vs. 9%; p<0.01), but less COPD (63% vs. 72%; p=0.01). Black patients experienced more TI (25% vs. 18%; p=0.03) but TID, number of doses, DOT, and TD were similar between the groups. Black patients were less likely to have an immune-related AE (irAE) (28% vs. 36%; p=0.03) (and less pneumonitis (7% vs. 14%; p<0.01)). Toxicity was the reason for TD in 12% of Black patients vs. 20% of White patients (p=0.01), with no other significant (α < 0.05) differences in reported reasons for TID, TI, or TD between the groups. Conclusions: In this real-world study, Black patients experienced similar TID, number of doses, and DOT as White patients. Black patients were less likely to experience an irAE (including pneumonitis) but experienced more TI; TD were similar but more likely to be from toxicity for White patients. Future research is needed to validate these findings.[Table: see text]

Objectives. Levonorgestrel implants (Norplant) and medroxyprogesterone acetate injections (Depo-Provera) represent additional contraception options for adolescents. The purpose of this study was to examine prospectively clinical profiles among adolescents who chose one of the two long-term contraceptives compared with profiles among those who chose the combined oral contraceptive pill (OCP). Methods. Girls who needed contraception and did not require confidentiality were presented with a contraceptive menu consisting of Norplant (n = 58), Depo-Provera (n = 66), or OCP (n = 75). At baseline and follow-up visits over 6 months, patients were interviewed regarding gynecologic history, side effect symptoms, and satisfaction. The average age of subjects was 15.5 years (range 11 to 20 years); 66% were African-American and 34% white. Results. Significantly more teens who chose Depo-Provera (73%) reported having used some method of birth control previously than those selecting either Norplant (30%) or OCP (26%). Adolescents who chose either Norplant (34%) or Depo-Provera (43%) were significantly more likely to have been pregnant previously than those choosing OCP (12%). Those selecting Depo-Provera were significantly more likely to report a history of genital infection with Chlamydia trachomatis (42%) than those in the other two contraceptive groups (22%). Prevalences of reported recent depression and fatigue before initiation of treatment were high, exceeding 35% across the three groups. A total of 105 and 40 adolescents were assessed at 3 and 6 months, respectively. At follow-up, more than 80% of OCP users maintained regular menstrual cycles, whereas over 80% of those choosing Norplant or Depo-Provera had disrupted cycles. Complaints of nausea and dizziness among Norplant users and fatigue among Depo-Provera and OCP users increased significantly between the baseline and follow-up visits. Reports of local reactions to the Norplant device were common but not clinically significant. Blood pressure readings, facial acne, and body mass index did not change over time in any treatment group. Subjects in the Norplant and Depo-Provera groups appreciated freedom from daily compliance to maintain contraceptive effectiveness and the "hidden" nature of the method. Appointment compliance at the end of 6 months was 78% for Depo-Provera, 40% for Norplant, and 46% for OCP. Conclusions. The implant and injection forms of contraception appear to be especially popular among girls with previous pregnancies or birth control use. The common occurrences of medical symptoms and sexually transmitted diseases before initiation of therapy underscore the importance of baseline evaluation. Norplant users may be warned about nausea and dizziness as well as minor local symptoms around the insertion site and unpredictable uterine bleeding patterns. Adolescent patients choosing Depo-Provera may expect amenorrhea by the end of 6 months of therapy along with possible fatigue. Early intervention may be needed with adolescents who choose Norplant or OCP to encourage better compliance with follow-up appointments.

e22005 Background: TIL include antigen specific clonal T cells responding to tumor antigens (TA) in the tumor microenvironment. Biological relevance of TIL at the PCM following ICI treatment of MM is not clear. Since there is overlap of TA between primary and its metastasis, we hypothesized that TIL at PCM site may serve as a biomarker of response to ICI treatment of MM. Methods: We did a retrospective analysis of MM patients (pts.) receiving ICI treatment between 2012 and 2019 following an IRB approved protocol. Response and survival at 12, 24 and 36 months (mths) was correlated with PCM site TIL. Pts. who received at least one dose of ICI for MM were eligible and those with metastasis from unknown PCM, received anti-BRAF treatment or lacked information on TIL at PCM were excluded. Pts. were stratified as group (gr.) A, B and C representing brisk, non-brisk and absent TIL respectively. Responses defined by RECIST criteria (response, no response, stable disease) as well as overall survival calculated from time of initiation of ICI to death from any cause (OS) at 12, 24 and 36 mths was correlated to TIL at PCM. Results: 42 pts. received ICI for MM between 2012-2019 meeting the eligibility criteria. Median age is 68 years (yrs.) (63, 71 and 73 yr. respectively for group A, B and C), 27 male, 15 women. The median thickness of PCM was 3.5, 3.75 and 4.75 mm in group A, B and C respectively. 11 of 14, 9 of 16 and O of 12 pts. responded to ICI while 2, 5, 14 and 1,2, 0 patients showed no response and stable disease respectively. O.S. at 12, 24, and 36 mths. was 12/14, 11/16 and 1/12 pts.; 10/14, 7/16, 0/12 pts. and 8/14, 6/16 and 0/12 pts. respectively in three groups. Conclusions: Brisk and absent TIL correlated with favorable and unfavorable response to ICI treatment of MM while non-brisk TIL showed intermediate outcomes. Larger data set could help validate our findings.

e20620 Background: Re-biopsy is important to decide the treatment after EGFR-tyrosine kinase inhibitor (TKI) failure in non-small cell lung cancer (NSCLC) patients. We hypothesized that the T790M mutation in EGFR might show heterogeneity depending on the re-biopsy site. Methods: NSCLC patients who had received initial EGFR-TKI since January 2009 to December 2016, at any stage and recurrence after surgery and at any line of treatment, were included. Results: In total, 128 patients were included. Median age at EGFR-TKI therapy initiation was 73 (range, 38–97) years; 67% patients were female, all were Asian, 56% had never smoked, and 99% had adenocarcinoma. Of total 128 patients, 109 showed progressive disease. Median progression-free survival (PFS) was 10 (0.56–57) months. Median period since EGFR-TKI failure until the first re-biopsy was 197 (0–1322) days. Re-biopsy was performed 50 times in 42 patients; the number of T790M positive, negative, and pathologically negative patients was 20, 17, and 5, respectively, and the number of re-biopsies in these patients was 20, 22, and 8, respectively. Median PFS was longer in T790M positive patients than in negative patients significantly (17 [11–24] vs. 7.6 [4.3–11] months, P = 0.007). Characteristics such as gender, smoking status, proportion of stage IV, time between EGFR-TKI failure and first re-biopsy, and number of biopsies did not affect the T790M status in the biopsies. T790M positive group had more exon 19 deletions than negative group significantly (75% vs. 23%, P = 0.012). Biopsies at primary lesion, distant, and pleural effusion (PE) were 25% vs. 50%, 60% vs. 36%, and 15% vs. 14%, respectively, in the T790M positive vs. negative groups. Compared with the biopsy-site at diagnosis, the site was same as before in 35% vs. 50% cases (primary lesion [20% vs. 45%], distant [10% vs. 4.5%], and PE [5% vs. 0%]) and was new in 55% vs. 41% cases (distant lesions [45% vs. 27%] and PE [10% vs. 14%]) in the T790M positive vs. negative groups, respectively. Conclusions: In NSCLC patients treated with EGFR-TKI, re-biopsy was performed in distant lesions more frequently in the T790M positive cases than in negative cases. However, the T790M status was not correlated with the re-biopsy site.

Abstract Background Dyslipidemia and metabolic syndrome are risk factors for cancer, and clinically aggressive CLL cells are believed to rely on lipid metabolism. Statins promote apoptosis and inhibit CLL cell growth in pre-clinical models, and statin use during salvage therapy for CLL may confer a survival advantage. Methods To investigate the prevalence of hyperlipidemia and the effect of statin therapy, lipid profiling was performed on 238 consecutive patients presenting to a specialized CLL clinic between January 2012 and February 2014. Demographics, timing of diagnosis and initiation of chemoimmunotherapy was ascertained from clinical records. Prognostic information was obtained from pathology or flow cytometeric reports. The first lipid profile following CLL diagnosis was recorded. RAI stage was determined from blood counts and radiology or clinical examination at the time of lipid profiling. Patients were grouped according to statin therapy (yes/no) and hyperlipidemia. Results Of 281 patients reviewed, 238 were evaluable with a lipid profile. 110 patients (46.2%) were either taking statins at the time of their CLL diagnosis (27.3%) or prescribed a statin during the study period (18.5%) and an additional 11 (4.2%) had a diagnosis of dyslipidemia not on therapy. Of the remaining 117 patients, 18 had LDL ³ 3.5mmol/L, giving a total of 139 patients (58.4%) with abnormal lipid profiles. The statin-exposed group was significantly older (median age 69.5 vs 65, p=0.03) and there were a larger proportion of males (68.6% vs. 53.9%, p=0.02). There were no significant differences in RAI staging, cytogenetics, beta-2-microglobulin levels, or CD38 expression between groups. (Table 1) 59.7% of all patients were treatment-free by the end of the study period and there were no differences between statin/no-statin groups. Of those requiring treatment, median time to first treatment (TFT) was 48 (IQR, 24-85.3) months. TFT was significantly longer with statins (57.5 (IQR, 32-77) vs. 36 (IQR, 11-100) months, p<0.02. Initiation of statins following diagnosis of CLL was associated with further prolongation of TFT compared to those on statins at diagnosis (74 (IQR, 62-96) vs. 45 (IQR, 30-64) months, p<0.02). Two cases of spontaneous remission were noted with statin initiation. (Figure 1) Conclusions There is an increased prevalence of hyperlipidemia in CLL patients (58.4%) compared to the general population (35-39%). Statin therapy is associated with a prolonged TFT despite a significantly older population and a higher proportion of male patients in this group. CLL patients should be screened for hyperlipidemia and statin therapy may be an adjunct to CLL treatment. Patient Characteristics by Lipid Abnormalities Abstract 5630. Table 1.Time to First Treatment (TFT) by Statin UseTotal N (%)No statin N (%)Statin Use/Dyslipidemia N (%)p -valueTotal238117121Male146 (61.3)63 (53.9)83 (68.6)0.02Median age (Q1, Q3)67 (60, 74)65 (58, 73)69 (63, 76)0.01RAI Stage0.64N1178 (74.8%)78 (66.7%)99 (81.8%)MBL73407135361341618232102232081241477Lipid profile (Mean ± Std Dev)HDL (mM)1.23 ± 0.471.33 ± 0.491.14 ± 0.420.001LDL (mM)2.55 ± 1.032.69 ± 0.872.42 ± 1.160.05TC/HDL3.92 ± 1.433.80 ± 1.254.03 ± 1.570.21Non HDL-C (mM)3.22 ± 1.143.29 ± 0.993.14 ± 1.270.29B2M (N = 0.6-2.3 m g/ml)0.52Mean ± Std Dev3.20 ± 2.143.19 ± 2.363.21 ± 1.92CD38 status0.86Unknown74 (31.1%)37 (31.6%)37 (30.6%)CD38+331419CD38-1226260Partial945Cytogenetics20.32Unknown125 (52.5%)61 (52.1%)63 (52.1%)13q-62283511q-1367+122081217p-1275normal24159>1 abnormality201010 1stage determined from those untreated at time of lipid profiling 2counted in all pertinent groups if more than one abnormality Abstract 5630. Table 2. Time to First Treatment (TFT) by Statin Initiation Total (N=238) No statin (N=128) Statin Use (N=110) P-value W&W1 (%) 142 (59.7) 74 (58.8) 68 (61.8) 0.53 Available TFT data/Total Treated2 89/96 51/54 38/42 Median TFT (IQR) (mo) 48 (24, 83) 36 (11, 100) 57.5 (32, 77) 0.02 1watch & wait 2could not determine TFT for some patients. Abstract 5630. Table 3. No statin (N=128) Statin Started (N=43) Statin Previous (N=67) P-value W&W1 (%) 74 (58.8) 29 (67.4) 39 (58.2) 0.55 Available TFT data/Total Treated2 51/54 13/14 25/28 Median TFT (IQR) (mo) 36 (11, 100) 74 (62, 96) 45 (30, 64) 0.04 1watch & wait 2could not determine TFT for some Figure 1 Figure 1. [1]Spaner DE, Lee E, Shi Y, Wen F, Li Y et al. Leukemia 2013; 27:1090-1099. [2]Chae YK, Trinh L, Jain P, Wang X, Rozovski U et al. Blood 2014; 123: 1424-1426. Disclosures No relevant conflicts of interest to declare.

Abstract Abstract 3510 Background: The outcome in FL pts relapsing after ASCT has not been well studied. While the use of nonmyeloablative allogeneic stem cell transplantation (NST) has been promising in this setting, one could not underestimate the results of selective inclusion criteria. Methods: All patients with FL who experienced a relapse after ASCT at The University of Texas M. D. Anderson Cancer Center between 1997 (the initiation of the rituximab and NST era) and 2007, were analyzed. Results: Fifty pts were identified. Fifteen (30%) pts underwent NST after ASCT relapse (Group A); 25 (50%) pts (Group B) met the eligibility criteria for NST but were not allotransplanted due to either physician/pt preference (n=14), lack of suitable donors (n=5), insurance requirements (n= 3), other causes (n=3). Ten (20%) pts (Group C) were not eligible for NST due to refractory disease or co-morbidities. At the time of progression after ASCT, the comparison of pts who were considered for NST showed that Group A pts and Group B pts had a comparable age [median 57 years(range, 45–64) vs 58 years (range, 40–70), p=0.7, respectively], serum LDH level (p=0.1), # of extranodal sites of disease (p=0.4), marrow involvement (p=0.1), and stage III/IV (p=0.2). The histology subtypes were also equally distributed in both groups (FL grades 1, 2, and 3 were found in 27%, 40% and 30% of Group A pts, respectively, and in 16%, 44% and 40% of Group B pts, respectively). The majority of pts in Groups A and B had a good ECOG PS of 0–1 (100% vs 96%, respectively). The median time from ASCT to progression was 16 months (range, 4–42) in Group A, and 19 months (range, 3–99) in Group B. Group A pts underwent their NST at a median of 8 months after their ASCT relapse. At their progression post ASCT, pts in Group B were treated with either rituximab as a single agent (n=12, 48%), or combination chemo-antibodies (n=7, 28%); the therapy received in the remaining 6 (24%) pts was unknown. With a median follow-up time of 49 months (range 23–113 months) for Group A, and 37 months (range, 17–130 months) for Group B, the actuarial survival rates at 4-year were 73%(%95 CI, 42–89) and 71% (%95 CI, 46–86), respectively, (Figure, p = 0.9). The causes of death in Group A were related to infection (1), organ failure (1), progression (2), and unknown (1). Five pts in Group B died of progression and one died of secondary leukemia. Pts in Group C had a median survival time of 7 months; only 2 pts of this group were still alive at the time of this analysis was made. Conclusions: Single institution results show that 30% of pts with FL relapsing after ASCT undertook an allotransplant. While allogeneic NST is an effective therapy for these pts, a significant proportion of pts can be observed for several years before an allotransplant should be considered. Disclosures: No relevant conflicts of interest to declare.

Abstract We conducted a retrospective single institution analysis to evaluate the immediate and long-term efficacy, tolerance, survival and time to progression of MM patients (pts) who received VELCADE (Vel.) as induction and in those who relapsed or were refractory after standard therapies. A total of 92 pts were included, 62 (67%) males and 30 (33%) females. Median age at treatment was 60 years [35–79]. At diagnosis, there were 48 (52%) IgG, 24 (26%) IgA, 2 (2%) IgD, 15 (16%) light chains and 3 (4%) plasma cell leukaemias, 11pts (12%) were in stage I A, 12 (13%) stage IIA and 69 (75%) stage III (51 A and 18B). The median level of β2 microglobulin was 3.28 mg/l (1.12–24). Among 42 evaluated del(13), 19 (45%) were + in which there was two t(4;14)+. We defined 3 groups: group1:16 (17%) pts who received Vel. as induction, group2:58 (63%) pts who received Vel. as 2nd line n=41 or 3rd line n=17, group 3:18 (12%) pts who received Vel. as ≥ 4th line. Prior to Vel.(groups 2 and 3), 53 (70%) pts had received an autologous hematopoietic stem cell transplantation (HSCT), 13 (14%) allogeneic HSCT and 35 (46%) thalidomide (Thal.) (median dose of 200mg/day, median duration of 4 months). The median interval between diagnosis and Vel. initiation was 28.3 months (0.2–125); 28 pts had an interval less than 12 months (16 in 1st line), 27 pts between 12 and 36 months and 37 pts with more than 36 months. The median number of Vel. cycles in group 1, 2 and 3 were 4[2–9], 5[2–12] and 5[3–12] respectively with a standard dose of 1.3 mg/m2 decreased to 1.0 mg/m2 in case of toxicity (&lt;3 cycles: n=18, 4–6: n=52; 7–8: n=14; &gt;8: n=8). Fifty-two (57%) pts received an association of dexamethasone (40mg/day). There were 6 Vel. discontinuation (&lt;3 Vel.cycles) and 25 (27%) dose reduction due to neuropathy [3cycles n=2 (17%), 4–6 cycles n=12 (23%), 7–8 cycles, n=7 (50%) and ≥9 n=4 (50%)]. Peripheral neuropathy occurred in 61 pts (66%) [32 (52%)gr1, 18 (30%)gr2, 9 (15%)gr3 and 4 (3%)gr4], in which, 25 (41%) had previously received Thal. [12 (48%)gr1, 8 (32%)gr2, 5 (20%)gr3]. The most other common toxicities were, fatigue n=35 (38%), constipation n=18(20%), diarrhea n= 11(12%), nausea n=14(15%) and vomiting n=7(8%). The overall response rate was observed in 67 (73%) pts [13 (14%)CR, 22 (24%)VGPR and 32 (35%)PR]. With a median follow-up of 23.4 months, the median overall survival (OS) for the whole population and for group 1 and 2 was not reached, and was 17 months for group 3. The probability of OS at 3 years for the whole population was 61%[50–73.5] (Figure 1) and were: 80%[62–100], 66%[54–81] and 45%[25–82.5] for groups 1, 2 and 3 respectively (Figure 2). The probability of OS at 5 years for the whole population from MM diagnosis was 72.5%[63–84]. The median time to progression (TTP) was 25.5 months for the whole population; it was not reached for group 1, were 25.5 and 13 months for group 2 and 3 respectively. The probability of progression-free survival (PFS) at 2 years was 51%[40–64,5] for the whole population and 66%[45–96], 52%[39–70] and 29%[12–71] for group 1, 2 and 3 respectively. We showed no significant difference in term of OS (p=0,166) and PFS (p=0.495) between the patients with del(13) [51% (31–83) and 42(23–78)] and without del(13) [83%(68,5–99,6) and 58%(40–85,5)]. Finally we observed a better PFS at 2 years for pts receiving lenalidomide after Vel. versus those who did not, 64%[42–96] and 48%[36–63] respectively. The multivariate analysis (studying: age, sex, stage, beta2M, del(13), previous lines, allogeneic HSCT, Thal., and interval diag-Vel.) showed only a significant impact of thalidomide HR=3.06 (1.37–6.85) (p=0,006), and a trend for interval diag-Vel. In conclusion, this analysis showed a very good percentage of long-term OS with a median not reached for Vel. naïve or 2nd, 3rd Vel line MM pts. Moreover, we showed a significant negative impact of previous Thal. treatment and no impact of del(13). Figure 1. Probability of OS for the whole population Figure 1. Probability of OS for the whole population Figure 2. Probability of OS for groups 1, 2 and 3 Figure 2. Probability of OS for groups 1, 2 and 3

Abstract Background: Reactivation of hepatitis B virus (HBV) is a well-recognized complication in patients with chronic HBV infection undergoing cytotoxic or immunosuppressive therapy. Currently, BCR-ABL1 tyrosine kinase inhibitors (TKIs) have been a standard of first-line treatment for chronic myeloid leukemia (CML) about last two decades. As there have been several case reports of HBV reactivation in CML patients treated with TKIs, the test for hepatitis B infection before initiating TKIs is recommended. Therefore, this study aimed to evaluate the risk of HBV reactivation in a large cohort of CML patients on TKIs treatment. Methods: We retrospectively reviewed the medical records of 1817 patients, who were diagnosed with CML and had available HBV serology between 2001 and 2017 from St. Mary's Hospital, Seoul, Korea. Results: Among 1817 patients, 76 patients (4.2%) were HBs-antigen (HBs-Ag) positive and 1741 (95.2%) were HBs-Ag negative. 302 patients (17.3%) of 1741 HBs-Ag negative patients were HBc-antibody positive indicating past infection of HBV. After exclusion of 7 patients who did not receive TKIs treatment, 69 patients were analyzed for HBV reactivation. The median age at diagnosis of CML was 42 (range 21-73) years and 44 (64%) were males. Median duration of follow-up from the recognition of HBs-Ag was 66.7 months (range, 2.4 - 192.7 months). Of 69 patients, a patient had been on antiviral therapy for chronic HBV infection before the diagnosis of CML. Eighteen patients (26% of 68) received antiviral prophylaxis prior to or concomitantly with the initiation of TKIs. Additional 4 patients were simultaneously initiated antiviral treatment with TKIs due to the evidence of active HBV infection such as the high titer of HBV DNA or elevated level of Alanine aminotransferase. Among 46 patients who did not receive antiviral prophylaxis, 12 patients (26%; 95% CI, 12-36%) eventually required antiviral treatment due to the development of active HBV hepatitis while on TKI therapy. HBV reactivation according to each TKI treatment was developed in 7 patients with imatinib, 2 patients in dasatinib, 1 patient in nilotinib, and 1 patient in radotinib therapy. One patient developed HBV reactivation permanently discontinued TKI therapy. Median time to HBV reactivation from CML diagnosis was 22.1 (range, 6.3-124.6 months) months. Median duration of antiviral therapy of 35 patients who received antiviral therapy was 38.2 months (95% CI, 25.7 ~ 50.7 months). 9 patients were off antiviral therapy at the last follow-up, 5 patients from prophylaxis group and 4 patients from treatment group. There was no difference in the duration of antiviral treatment between prophylactic and treatment groups. The initial choice of antiviral therapy as prophylaxis or treatment were entecavir for 14 (41% of 34), lamivudine for 8 (24%), tenofovir for 8 (24%), telbivudine for 3 (9%), and adefovir for 1 (3%). Conclusion: We evaluated HBV reactivation in a large cohort of HBs-Ag positive patients with CML from a single center, who received TKIs treatment. The reactivation rate of HBV was high at 26% without antiviral prophylaxis, which strongly support the routine screening of HBV serology prior to initiation of TKI therapy to identify HBs-Ag positive patients and the close monitoring of hepatic functions and HBV serology during TKI therapy. Given the high incidence of HBV reactivation with TKI treatment, concomitant antiviral prophylaxis with TKIs should be considered in HBs-Ag positive patients receiving TKI treatment. Figure. Figure. Disclosures Kim: Ilyang: Research Funding; Novartis: Research Funding; BMS: Research Funding; Pfizer: Research Funding.