Bendamustine plus rituximab versus CHOP plus rituximab as first-line treatment for patients with indolent and mantle-cell lymphomas: an open-label, multicentre, randomised, phase 3 non-inferiority trial

Rummel, Mathias; Niederle, N.; Maschmeyer, Georg; Banat, Gamal-Andre; Grünhagen, Ulrich von; Losem, Christoph; Kofahl-Krause, Dorothea; Heil, Gerhard; Welslau, Manfred; Balser, Christina; Kaiser, Ulrich; Weidmann, Eckhart; Dürk, Heinz; Balló, Harald; Stauch, Martina; Roller, Fritz; Barth, Juergen; Hoelzer, Dieter; Hinke, Axel; Brugger, Wolfram

doi:10.1016/s0140-6736(12)61763-2

Cited by 1,292 publications

(1,088 citation statements)

References 24 publications

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“…The complications mentioned were mostly urological infections and haematuria. 1 Another complication that arises under this therapy is the BK polyomavirus associated hemorrhagic cystitis (BKHC), which can occur in 5%-60% of the cases. 2 Other viruses which can lead to cystitis or even hemorrhagic cystitis following allogeneic stem cell transplantation are polyomavirus JC and uropathogenic adenoviruses.…”

Section: Urological Complications Associated With Adult Allogeneic Stmentioning

confidence: 99%

Late infections and secondary malignancies after bendamustine/rituximab or RCHOP/RCVP chemotherapy for B‐cell lymphomas

2017

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First-line treatment of indolent B-cell lymphomas (including follicular[FL], marginal zone [MZL], lymphoplasmacytic [LPL]), and mantle-cell lymphoma (MCL) has undergone a shift after two randomized trials (the Study group indolent Lymphomas [StiL], and the BRIGHT trial) demonstrated noninferiority of bendamustine-rituximab (BR) compared with RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) or RCVP (rituximab, cyclophosphamide, vincristine, and prednisone) chemotherapy. 1,2 However, updates of these trials, as well as some observational data, 3 raised questions about potentially increased risk of secondary malignancies (SM) and late infections after BR. Flinn et al. reported that BR (compared with RCHOP/RCVP) was associated with more profound lymphocytopenia, a significantly higher rate of SM (19% versus 11%, P 5 .022), and a numerically higher mortality from infections, particularly pneumonias. 4 In contrast, no difference in SM between BR or RCHOP (17% and 20%, respectively) was reported in the StiL trial. Furthermore, in the GALLIUM study, which randomized FL patients to rituximab or obinutuzumab in combination with bendamustine or CHOP/CVP, patients receiving bendamustine experienced decreased T-cell counts, more fatal adverse events (5% versus 2%), grade 3-4 infections (23% versus 12%), and SM (9% versus 4%), particularly during postinduction maintenance therapy. 5 Our objective was to examine the incidence of hospitalizations, infections, and SM among patients treated with BR or RCHOP/ RCVP using population-based data from the US Surveillance, Figure S1A). Patients treated with BR were on average older (P 5 .001), and more often had MCL (31% versus 24%, P 5 .003), but there were no significant differences in performance status, comorbidities, or time from diagnosis to treatment between BR and RCHOP/RCVP groups.The incidence of hospitalizations, infections, and pneumonias was lower for BR during the first 6 months of observation (Supporting Information Figure S1B-D). Subsequently, the incidence decreased slower for BR than for RCHOP/RCVP, and consequently patients receiving BR experienced 27% higher risk of hospitalization, 54%higher risk of infections, and 93% higher risk of pneumonia throughout the 2nd year of follow-up (Table 1). The absolute increase in incidence was very small: IR difference during the second year of follow-up was 0.9 per 100 person-months for hospitalizations (95%CI, 0.2-1.6), 0.9 for infections (95%CI, 0.5-1.4), and 0.6 for pneumonia (95%CI, 0.3-1.0). AJH AJHThe differences disappeared in the third year of follow-up, and were not statistically significant when BR was compared with RCHOP only.With a median follow-up of 2.8 years and total observation time of 3779 person-years, 95 nonlymphoid SMs were observed, in 4% of patients receiving BR, and 6% of those receiving RCHOP/RCVP (Supporting Information Figure S1E). A majority of SMs were carcinomas, with <10 secondary myeloid malignancies. In a multivariable model we found no significant difference in t...

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Section: Urological Complications Associated With Adult Allogeneic Stmentioning

confidence: 99%

Late infections and secondary malignancies after bendamustine/rituximab or RCHOP/RCVP chemotherapy for B‐cell lymphomas

2017

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“…On the contrast, patients with asymptomatic advanced‐stage FL do not need to be treated immediately 1, 5, 6, 7. Once they develop symptoms, chemotherapies with rituximab are suggested as frontline treatments 1, 4, 8, 9, 10, 11…”

Section: Introductionmentioning

confidence: 99%

Rituximab maintenance improves overall survival in follicular lymphoma: A retrospective nationwide real‐world analysis from Taiwan Cancer Registry Database

et al. 2018

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Follicular lymphoma (FL) is the most frequent indolent lymphoma in Western countries, but it is less frequent in Asia. Several trials have demonstrated the progression‐free benefit of rituximab maintenance for FL patients in Western countries. However, the overall survival (OS) benefits and effectiveness of rituximab maintenance in Asian FL patients remain uncertain. We utilized the Taiwan Cancer Registry Database and the National Health Insurance Research Database to investigate the roles of rituximab maintenance for newly diagnosed FL patients in Taiwan. Among 836 patients with newly diagnosed FL during 2009‐2012, we enrolled patients with stage II‐IV diseases receiving 4‐8 cycles of rituximab‐containing induction chemotherapies (R‐induction). We excluded those who died or received additional chemotherapy within 180 days after R‐induction. Among the 396 enrolled patients, 260 underwent rituximab maintenance (R‐maintenance group), and 136 served as the observation group. The R‐maintenance group received less anthracycline and fewer cycles of R‐induction than the observation group, but they exhibited a significantly better OS both in the univariate and multivariate analyses [hazard ratio, 0.42; 95% confidence interval, 0.19‐0.91] after adjusting for age, sex, and Ann Arbor stages. Meanwhile, we also found more patients required further therapies in the first 6 months after the cease of rituximab maintenance. In the subgroup analysis, patients older than 60 years or with stage IV diseases benefited more from rituximab maintenance. Conclusively, our nationwide study is the first one to demonstrate the OS benefit of rituximab maintenance after induction therapies in newly diagnosed FL patients from Asian populations.

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“…Bendamustine was widely used in relapsed/ refractory patients with CLL and indolent NHL, and demonstrated efficacy as first-line treatment for patients with indolent and mantle-cell lymphoma. 11 Thus, bendamustine is effective in resistant patients who do not respond to alkylating agents.…”

mentioning

confidence: 99%

Bendamustine-based conditioning for non-Hodgkin lymphoma autologous transplantation: an increasing risk of renal toxicity

Garciaz

Coso

Collela

et al. 2015

Bone Marrow Transplant

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Bendamustine plus rituximab versus CHOP plus rituximab as first-line treatment for patients with indolent and mantle-cell lymphomas: an open-label, multicentre, randomised, phase 3 non-inferiority trial

Cited by 1,292 publications

References 24 publications

Late infections and secondary malignancies after bendamustine/rituximab or RCHOP/RCVP chemotherapy for B‐cell lymphomas

Late infections and secondary malignancies after bendamustine/rituximab or RCHOP/RCVP chemotherapy for B‐cell lymphomas

Rituximab maintenance improves overall survival in follicular lymphoma: A retrospective nationwide real‐world analysis from Taiwan Cancer Registry Database

Bendamustine-based conditioning for non-Hodgkin lymphoma autologous transplantation: an increasing risk of renal toxicity

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