[PubMed] [Google Scholar] 43. and safety. Seventy\seven patients received salvage treatment with O\IVAC. The average age was 56.8?years; 39% had an Eastern Cooperative Oncology Group (ECOG) performance status of at least 3; 78% had disease of Ann Arbor stage CCT241533 3 or 4 4; 58% received one or more prior salvage therapies. The ORR for O\IVAC was CCT241533 54.5%. The median duration of study follow\up was 70?months. The median PFS and EFS were 16.3?months each. The median OS was 22.7?months. Age, ECOG performance status and the number of prior therapy lines were impartial predictors of survival. Treatment\related mortality was 15.5%. O\IVAC showed a high response rate in a difficult\to\treat populace and is an attractive treatment to bridge to potentially curative therapies. (%)33 (42.9%)19 (50.0%)14 (35.9%)0.21Age, mean (SD), years56.8 (13.6)46.5 (11.3)70.0 (5.5) 0.0001ECOG performance status, (%)0.13113 (16.8%)9 (23.7%)4 (10.3%)234 (44.2%)18 (47.4%)16 (41.0%)330 (39.0%)11 (28.9%)19 (48.7%)Presence of systemic symptoms of the disease, (%)37 (48.1%)17 (44.7%)20 (51.3%)0.56Presence of 1 1 comorbidity, (%)50 (64.9%)20 (52.6%)30 (76.9%)0.03Ann Arbor clinical stage, (%)0.831C217 (22.1%)8 (21.1%)9 (23.1%)318 (23.4%)8 (21.1%)10 (25.6%)442 CCT241533 (54.5%)22 (57.9%)20 (51.3%)Time from diagnosis to study enrolment, Rabbit Polyclonal to SHC3 median (IQR), months13 (8C34)16 (9C34)11 (8C25)0.31Number of salvage therapies0.10032 (41.5%)9 (23.7%)23 (59.0%)117 (22.1%)9 (23.7%)8 (20.5%)217 (22.1%)12 (31.6%)5 (12.8%)311 (14.3%)8 (21.1%)3 (7.7%)Refractory to R\CHOP*, (%)46 (59.7%)18 (46.1%)28 (73.6%)0.01ASCT in the past, (%)7 (9.1%)7 (18.4%)0 (0.0%) 0.006Time since the last therapy, days0.62 6625 (32.4%)14 (36.8%)11 (28.2%)66C19626 (33.8%)13 (34.2%)23 (33.3%) 19626 (33.8%)11 (28.9%)15 (38.5%) Open in a separate windows *\ response for 6?months. Abbreviations: ASCT, autologous stem cell transplantation; ECOG, Eastern Cooperative Oncology Group; IQR, interquartile range; R\CHOP, rituximab with cyclophosphamide, doxorubicin, vincristine and prednisone. Half of the patients ((%)0.82CR22 (28.6%)10 (26.3%)12 (30.8%)PR20 (26.0%)11 (28.9%)9 (23.1%)SD8 (10.4%)3 (7.9%)5 (12.8%)PD27 (35.1%)14 (36.8%)13 (33.3%)ORR (CR?+?PR)42 (54.5%)21 (55.2%)21 (53.9%)0.91Disease control (CR?+?PR?+?SD)50 (65.9%)24 (63.1%)26 (66.7%)0.74 Open in a separate window Abbreviations: CR, complete response; ORR, overall response rate; PD, disease progression; PR, partial response; SD, stable disease. TABLE 3 Independent predictors of progression\free survival thead valign=”bottom” th align=”left” valign=”bottom” rowspan=”1″ colspan=”1″ /th th align=”left” valign=”bottom” rowspan=”1″ colspan=”1″ Median PFS (95% CI), months /th th align=”left” valign=”bottom” rowspan=”1″ colspan=”1″ HR (95% CI) /th th align=”left” valign=”bottom” rowspan=”1″ colspan=”1″ em p /em \Value /th /thead ECOG performance status1Not reached10.03823.0 (1.2C7.4)0.019312.0 (2.6C21.5)3.3 (1.3C8.6)0.012Number of treatment lines after R\CHOP0.017012.0 (5.6C18.5)1114.7 (10.7C18.7)0.5 (0.2C1.0)0.047223.4 (7.0C39.9)0.3 (0.1C0.8)0.017326.7 (1.1C52.3)0.3 (0.1C0.6)0.004Time since the last therapy, days 0.001 667.6 (3.7C11.4)166C19612.0 (7.8C16.2)0.4 (0.2C0.7)0.005 19666.4 (45.01C87.7)0.1 (0.0C0.2) 0.001 Open in a separate window Abbreviations: CI, confidence interval; ECOG, Eastern Cooperative Oncology Group; HR, hazard ratio; PFS, progression\free survival. The median follow\up was 70?months (95% CI: 63C76?months). Overall, 66 patients experienced disease progression or died during the study. The median PFS and EFS were 16.3?months (95% CI: 13.0C19.5?months) and 16.2?months (95% CI: 13.7C18.8?months) respectively (Physique?1A,B). In the multivariate analysis, ECOG performance status, number of prior salvage therapies and time from the last therapy were statistically highly significant factors predictive of PFS and EFS (Table S4). Prognostic factors associated with PFS are presented in Table?3 and Determine?S1. One\12 months PFS and EFS were 61% each (95% CI: 49.8%, 72.2%). PFS after three and fve years of observations was 33.8% (95% CI: 23.0%C44.6%) and 24.5% (95% CI: 14.3%C34.7%) respectively. Open in a separate window Physique 1 Progression\free survival (A), event\free survival (B) and overall survival (C) in transplantation\ineligible refractory and relapsed diffuse large B\cell lymphoma treated with ofatumumab with etoposide, iphosphamide and cytarabine The median OS was 22.7?months (95% CI: 15.9C29.5?months) (Physique?1C). In the multivariate analysis, age less than 60 years aged, ECOG performance status, and time from the last therapy were independent predictive factors for OS (Table?4, Table S4 and Figure?S2). OS at one, three and five years was 84.4% (95% CI: 76.1%C92.5%), 38.3% (95% CI: 27.1%C49.5%) and 30.6% (95% CI: 20.0%C41.2%). TABLE 4 Independent predictors of overall survival thead valign=”bottom” th align=”left” valign=”bottom” rowspan=”1″ colspan=”1″ /th th align=”left” valign=”bottom” rowspan=”1″ colspan=”1″ Median OS (95% CI), months /th th align=”left” valign=”bottom” rowspan=”1″ colspan=”1″ HR (95% CI) /th th CCT241533 align=”left” valign=”bottom” rowspan=”1″ colspan=”1″ em p /em \Value /th /thead Age, years 6027.8 (16.0C39.6)1 6018.4 (13.3C23.6)1.8 (1.0C3.2)0.034ECOG performance status1Not reached10.017224.8 (13.6C36.0)3.3 (1.2C9.0)0.018322.7 (15.9C29.5)4.5 (1.6C12.4)0.004Time since the last therapy, days 6610.1 (0.0C21.2)10.01766C19616.8 (10.0C23.7)0.5 (0.2C0.9)0.017 19677.8 (50.0C99.6)0.2 (0.1C0.3) 0.001 Open in a separate window Abbreviations: CI, confidence interval; ECOG, Eastern Cooperative Oncology Group; HR, hazard ratio; OS, overall survival. Safety A total of 885 adverse events were reported; the majority were grades 3 and 4 (78.9%). The most common events were 587 haematologic adverse events (66.4%) that affected every patient. Neutropenia and thrombocytopenia were the most common haematologic adverse events; 25 patients experienced febrile neutropenia (Table S5). The most common groups of adverse events are summarised in Table?5. There were no unexpected adverse events. TABLE 5 Number of adverse events with grades 1C5 in system organ.