ASCO 2012 Report – Bendamustine with Rituximab: More than doubles PFS in certain lymphoma patients

by Marybeth Burke – Initial combination chemotherapy with bendamustine and rituximab more than doubled progression-free survival to nearly 6 years compared with standard R-CHOP therapy among patients with slow growing lymphoma and mantle cell lymphoma, according to a study presented at the American Society of Clinical Oncology annual conference in June in Chicago.

“This is the first randomized clinical trial to compare bendamustine and rituximab with a standard chemotherapy regimen for these more challenging types of lymphoma, and it clearly shows that the bendamustine-based regimen is more effective and less toxic,” said Mathias J. Rummel, MD, PhD, Professor of Medicine at the University Hospital Giessen in Germany and lead author of the study.  He presented an updated analysis from the StiL NHL1 study.

“Just as important, bendamustine-based therapy allowed patients to have a better quality of life while undergoing therapy.  These long-term findings should be strong enough to change clinical practice,” he said.

R-CHOP, a standard chemotherapy regimen for many non-Hodgkin lymphomas, includes the targeted therapy rituximab plus the drugs cycophosphamide, doxorubicin, vincristine and prednisone. Bendamustine has been in use in Europe for decades but was only approved in the US in 2008.

Study Method and Results

Exactly 549 patients with indolent or mantle cell lymphoma (MCL) were randomized to receive B-R or R-CHOP for a max of 6 cycles.  The primary endpoint was PFS.  514 randomized patients were evaluable (261 B-R; 253 R-CHOP).  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 R-CHOP (HR 0.58, 95% CI 0.44-0.74; P<0.001).  Median PFS was 69.5 months vs 31.2 months, respectively.  The PFS benefit with B-R was maintained in all histological subtypes except marginal zone lymphoma, according to Abstract #3.  The PFS benefit with B-R was independent of age.

In patients with normal LDH (62%), PFS was significantly prolonged with B-R compared with R-CHOP (P=0.118).  In patients with follicular lymphoma, FLIPI subgroups defined by 0-2 factors (favourable) and 3-5 factors (unfavorable) had a longer PFS with B-R than with R-CHOP (P=0.043 and P=0.068 for the favourable and unfavourable FLIPI subgroups, respectively), according to the abstract.

Seventy-four salvage treatments had been initiated in the B-R group; compared with 116 in the R-CHOP group, of those in the R-CHOP group 52 patients received B-R as salvage regime.  Overall survival did not differ between the treatment arms, with 43 and 45 deaths in the B-R and R-CHOP arms, respectively.  Twenty secondary malignancies were observed in the B-R group compared with 23 in the R-CHOP group, with 1 haematological malignancy in each group.

There was a higher incidence of mild skin reactions in the B-R group, but no hair loss and a lower incidence of nerve toxicity and infections compared with the R-CHOP group.  Moderate to severe declines in neutrophil counts occurred in 69% of the R-CHOP patients and 29% of the B-R group.