Background: phase III RCT open label, non-inferiority German study of 514 patients with iNHL (follicular grade 1 or 2, lymphoplasmacytic, small lymphocytic, mantle cell and marginal zone lymphoma) requiring therapy. Eligibility:untreated stage III or IV, and patients with indolent lymphoma with at least one of the following: low counts(Hb <10 g/L, ANC<1.5, or PLT <100K), B-symptoms, large tumour burden (3 areas >5 cm or 1 area >7.5 cm); bulky disease with impingement on internal organs;>50% increase of tumour <6mo; hyperviscositys.

Arm A: Bendamustine 90mg/m2 day 1 and 2 every 4 weeks; Rituximab 375mg/m2 on day 1 for up to 6 cycles (274 pts)
Arm B: CHOP (cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, and vincristine 1.4 mg/m2 on day 1, and prednisone 100 mg/day day 1-5) with Rituximab 375mg/m2 on day 1 for up to six cycles (275 pts)
Rituximab maintenance allowed and censored

Primary endpoint: PFS
mFollow up: 45 mo

mPFS: 69.5mo vs 31.2mo; arm A vs arm B, HR HR 0.58, 95% CI 0.44–0.7), P<.0001
CR: 40% vs 30%, P=.021

Subgroup analysis:
FL mPFS: HR 0.61, 95% CI 0.42–0.87, P=.0072
MCL mPFS: HR 0.49, 95% CI 0.28–0.79, P=.0044
MZL mPFS: HR 0.70 (95% CI 0.34–1.43) P=.3249
MW mPFS: HR 0.70 (95% CI 0.34–1.43) P=.3249
Favourable (0–2): HR 0.56 (0.31–0.98), P=.043
Unfavourable (3–5): 0.63 (0.38–1.04), P=.068

STUDY UPDATE: Rummel, MJ et al, 2017, ASCO abstract
OS between treatment arms was not statistically significant HR 0.82, 95% CI 0.58-1.15, P=.249
10-yr OS: 71% vs 66%, P=.249
Second line treatments: 34% vs 52%

Main adverse events. Grade 3-4 events Arm A vs B respectively: neutropenia 29 vs 69%; alopecia 0 vs 100%; sepsis <1% vs 3%. Secondary malignancy 7 vs 8.3%. Any grade SE paresthesia 7 vs 29%; allergic skin reaction 1 vs 6%, infection 37 vs 50%.

Conclusions: Bendamustine Rituximab is associated with increased progression free survival and less side effects when compared to RCHOP for patients with Indolent B cell Non Hodgkin Lymphoma.

Summarized by Patricia Disperati, MD

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