Bendamustine plus rituximab (B-R) versus CHOP plus rituximab (CHOP-R) as first-line treatment in patients with indolent and mantle cell lymphomas (MCL): Updated results from the StiL NHL1 study.

Abstract

3 Background: This multicenter, randomized, phase III study compared B-R and CHOP-R as first-line treatment in indolent lymphoma and MCL and was presented at ASH 2009 including a comprehensive safety analysis. Here we present an updated analysis with a cut-off date for 31 Oct 2011. Methods: 549 patients (pts) with indolent or MCL were randomized to receive B-R or CHOP-R for a max of 6 cycles. The primary endpoint was PFS. Results: 514 pts randomized pts were evaluable (261 B-R; 253 CHOP-R). Patient characteristics were well balanced between arms; median age was 64 years. At a median follow-up of 45 months, PFS was significantly prolonged with B-R compared with CHOP-R (HR 0.58, 95% CI 0.44–0.74; P<0.001). Median PFS was 69.5 versus 31.2 months, respectively. The PFS benefit with B-R was maintained in all histological subtypes except marginal zone lymphoma. The PFS benefit with B-R was independent of age; HR 0.52 (P=0.002) in pts ≤60 years (n=199), and HR 0.62 (P=0.002) in pts >60 years (n=315). In pts with normal LDH (62%), PFS was significantly prolonged with B-R compared with CHOP-R (P<0.001), while in the elevated LDH group (38%) PFS was numerically, but not significantly increased with B-R compared with CHOP-R (P=0.118). In patients with follicular lymphoma, FLIPI subgroups defined by 0–2 factors (favorable) and 3–5 factors (unfavorable) had a longer PFS with B-R than with CHOP-R (P=0.043 and P=0.068 for the favorable and unfavorable FLIPI subgroups, respectively). Seventy four salvage treatments had been initiated in the B-R group; compared with 116 in the CHOP-R group, of those in the CHOP-R group 52 pts received B-R as salvage regimen. Overall survival did not differ between the treatment arms, with 43 and 45 deaths in the B-R and CHOP-R arms, respectively. Twenty secondary malignancies were observed in the B-R group compared with 23 in the CHOP-R group, with 1 hematological malignancy in each group (1 MDS in B-R, 1 AML in CHOP-R). Conclusions: In patients with previously untreated indolent lymphoma, and elderly patients with MCL, B-R demonstrates a PFS benefit and improved tolerability compared with CHOP-R.

Fludarabine‐mitoxantrone‐rituximab regimen in untreated intermediate/high‐risk follicular non‐Hodgkin's lymphoma: Experience on 142 patients

“…By the end of the combined regimen, 88% of the patients had achieved CR. More importantly, with a median By comparison with the other competing chemotherapies, our study confirmed an important percentage of CRs higher than those obtained with CHOP-R, CVP-R, and BR regimens [4][5][6]9,10] and an impressive DFS (also in terms of a median follow-up period) higher than those reported for the other chemoimmunotherapies.…”

“…This scenario was also the same extrapolated from the final report of ILL-FOLL05 trial [12]. An another competitor is the new entry BR regimen that appears to induce a longer PFS and to be better tolerated than CHOP-R [9,10].…”

“…In addition, Rummel et al [9,10] reported a study comparing bendamustine-rituximab (BR) with CHOP-R as firstline therapy in patients with FL and other types of indolent lymphoma. The longer progression-free survival (PFS) with BR was seen in both favorable and unfavorable Follicular Lymphoma International Prognostic Index (FLIPI) [11] subgroups.…”

An Open-Label Expanded-Access Trial of Bendamustine in Patients with Rituximab-Refractory Indolent Non-Hodgkin Lymphoma or Previously Untreated Chronic Lymphocytic Leukemia: BEND-ACT

“…Updated results after 7 years of follow-up from the stil1 study demonstrated that br has pfs and time-to-next-treatment benefit over r-chop. Although the os for the patients overall was not significantly different, treatment with br was associated with a trend toward survival benefit in the group of patients with indolent lymphomas 45 .…”

Emerging Therapies for the Treatment of Relapsed or Refractory Follicular Lymphoma

“…Updated results presented at the American Society of Hematology 2014 annual meeting showed that median time to next treatment in the br group still had not been reached after a median follow-up of 87 months 5 . In the stil-1 trial, maintenance rituximab was not given, but maintenance is routinely used in Canada; therefore, time to next treatment could in reality be even longer with br.…”