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• W2951867890 abstract "Introduction: There is no standard treatment of refractory or relapsed (R/R) patients (pts) with DLBCL ineligible for stem cell autologous transplantation (ASCT). However, R-GemOx is widely used in these circumstances. We here report the results of a retrospective analysis of a cohort of patient treated in two academic centers in France. The main objectives were to evaluate the activity and safety profile of this regimen in a large series of R/R DLBCL pts in a real life setting. Methods: Patients selected had to have de novo or transformed DLBCL, R/R after at least one line of treatment containing doxorubicin and rituximab, to be ineligible for ASCT and to have received at least one cycle of R-GEMOX. Rituximab 375 mg/m2 was administered on D1, gemcitabine 1000 mg/m2 on D2 and oxaliplatin 100 mg/m2 on D2 as previously described (Mounier N. et al. Haematologica. 2013;98:1726–31.). Cycles were given every 2 weeks and 8 cycles were planned if at least a partial response (PR) was obtained after 4 cycles. Results: Between May 2002 and May 2017, 196 pts were treated. Baseline characteristics were: median age: 72 y (range, 24-89), international prognostic index (IPI) 3-5: 63%, refractory state to last treatment (tx): 42%, history of indolent lymphoma: 45%, prior ASCT: 16%. The median number of previous line was 1 (range 1-7) with 112 pts having received R-GemOx in second line. One hundred and thirty-six pts received at least 4 cycles, and 61 completed 8 cycles. After 4 cycles, the overall response rate (ORR) according to IWC (Cheson 1999 or 2007) was 54 % and the complete response (CR) rate was 23 %. At the end of treatment, the ORR and CR rates were 38 % and 33 %, respectively. With a median follow-up of 22 months, median (m) progression-free survival (PFS) and overall survival (OS) were 5 and 10 months (mo), respectively. mOS was significantly longer in case of prior history of indolent lymphoma (21 vs 8 mo, p < 0.001), age<75y (16 v 7mo, p < 0.001), IPI <3 (p < 0.001), non-refractory status to last treatment (18 v 7mo, p < 0.001). The mOS of patients who attained a CR was 40 mo. Among pts who were treated with R-GemOx in second line, the CR rate was similar (32%), the same factors influenced the OS and duration of a first remission longer than 12 months was a favorable factor (p=0.006). The most common toxicities during treatment were hematological and manageable. Grade 3-4 toxicities occurred in 23% of pts. Grade 1-2 peripheral neuropathy related to oxaliplatin was observed in 26%. Conclusion: This real life study of R/R DLBCL, confirms the activity and a safety of R-GemOx. This combination represents a possible platform to be combined with targeted therapies as it is currently proposed with nivolumab in the NIVEAU trial (NCT03366272). However, facing this very high unmet medical need, development of new approaches including CAR T-cells should also be considered in this patient population. Keywords: diffuse large B-cell lymphoma (DLBCL); gemcitabine." @default.
• W2951867890 created "2019-06-27" @default.
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• W2951867890 date "2019-06-01" @default.
• W2951867890 modified "2023-10-14" @default.
• W2951867890 title "RITUXIMAB PLUS GEMCITABINE AND OXALIPLATIN (R-GemOx) IN REFRACTORY/RELAPSED (R/R) DLBCL. A REAL LIFE STUDY IN PATIENTS INELIGIBLE FOR AUTOLOGOUS TRANSPLANTATION" @default.
• W2951867890 doi "https://doi.org/10.1002/hon.101_2631" @default.
• W2951867890 hasPublicationYear "2019" @default.
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