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Bendamustine combined with rituximab for patients with relapsed or refractory diffuse large B cell lymphoma.

ABSTRACT: Patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) are treated with salvage regimens and may be considered for high-dose chemotherapy and autologous stem cell transplantation if disease is chemosensitive. Bendamustine is active in indolent B cell lymphomas and chronic lymphocytic leukemia but has not been extensively studied in aggressive lymphomas. This trial examines the combination of bendamustine and rituximab in patients with relapsed and refractory DLBCL. Patients received bendamustine at 90 mg/m² (n = 2) or 120 mg/m² (n = 57) on days 1 and 2 and rituximab at 375 mg/m² on day 1 every 28 days for up to 6 cycles. The study evaluated objective response rate (ORR), duration of response (DOR), progression-free survival (PFS), and treatment safety. Fifty-nine patients were treated, and 48 were evaluable for response. Median age was 74; 89 % had stage III or IV disease, and 63 % had high revised International Prognostic Index scores; the median number of prior therapies was 1. Based on analysis using the intent-to-treat population, the ORR was 45.8 % (complete response, 15.3 %; partial response, 30.5 %). The median DOR was 17.3 months, and the median PFS was 3.6 months. Grade 3 or 4 hematological toxicities included neutropenia (36 %), leukopenia (29 %), thrombocytopenia (22 %), and anemia (12 %). The combination of bendamustine and rituximab showed modest activity in patients with relapsed and refractory DLBCL and has an acceptable toxicity profile.

SUBMITTER: Vacirca JL

PROVIDER: S-EPMC3918114 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundTo inform healthcare professionals, payers and health technology organisations of estimated survival benefits of new treatments, statistical methods can be used to model the projected clinical benefits versus costs of new interventions. This is particularly relevant for new treatments where data describing all progression events are incomplete and long-term survival outcomes are not yet established. In patients with the fast-growing B-cell cancer, diffuse large B-cell lymphoma (DLBCL), heterogeneous clinical efficacy outcomes are observed with the presence of both 'cured' (long-term survivors [LTS]) and 'non-cured' patients. Mixture cure rate models represent an alternative approach to traditional standard parametric survival models as they capture this heterogeneity. The aim of this analysis was to use progression-free survival (PFS) as an intermediate endpoint to estimate long-term survival with polatuzumab vedotin (Pola) + bendamustine (B) + rituximab (R) treatment (Pola+BR); these survival estimates will be utilised to inform future economic analyses.MethodsUsing data from the Phase II randomised cohort of the GO29365 trial (NCT02257567), we estimated the overall survival (OS) benefit and proportion of LTS with Pola+BR versus BR alone in patients with relapsed/refractory (R/R) DLBCL. Alongside standard parametric survival models, a mixture cure rate model was evaluated for each treatment arm, exploring both OS and OS informed by PFS.ResultsThe estimated mean OS was 3.78 years for Pola+BR versus 1.07 years for BR using standard parametric methods and 4.00 years versus 1.02 years using a mixture cure rate model (OS informed by PFS). The proportion of LTS using the mixture cure rate model was 23.0% (95% confidence interval: 9.3, 45.36) for Pola+BR versus 0% for BR (assuming a generalised gamma distribution). Of the extrapolation methods tested, mixture cure rate model predictions were best aligned with the observed survival data in GO29365.ConclusionsThese models suggest that compared with BR alone, Pola+BR is associated with a higher proportion of LTS ranging from 22.0 to 26.6%, depending on the distribution assumed. However, the upper and lower limits of the confidence intervals of the point estimates are reaching from 9 to 45%.

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Bendamustine combined with rituximab for patients with relapsed or refractory diffuse large B cell lymphoma.

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