Chicago, IL—The phase 3 clinical trial StiL NHL1 demonstrated that the combination of bendamustine plus rituximab (BR) delays progression in non-Hodgkin lymphoma (NHL) longer than standard treatment with cyclophosphamide-doxorubicin HCl-vincristine sulfate-prednisone chemotherapy plus rituximab (R-CHOP).
In this multicenter trial, BR more than doubled the median progression-free survival (PFS) compared with R-CHOP, reported Mathias J. Rummel, MD, PhD, Head of Hematology, University Hospital in Giessen, Germany, at a plenary session at ASCO 2012.
“BR is not only less toxic but also more effective than the most-often-used first-line approach and should be considered a preferred first-line treatment for these patients,” he said.
Bendamustine is approved for chronic lymphocytic leukemia and as a second-line therapy for rituximab-refractory NHL, but US oncologists have not yet fully adopted this regimen, despite positive results presented at the 2009 American Society of Hematology meeting, which led to its approval in the United States. BR is listed as a recommended regimen by the National Comprehensive Cancer Network.
The StiL NHL1 Trial Details
A total of 549 patients with a new diagnosis of stage III or IV indolent NHL were randomized to standard R-CHOP or to BR. After a median follow-up of 45 months, the median PFS was 69.5 months with BR versus 31.2 months with R-CHOP, a 42% reduction in the risk of progression (P <.001). The PFS benefit offered by BR was seen across all subgroups, except for patients with marginal zone lymphoma, where PFS was comparable. The 5-year overall survival (OS) rates, however, were similar—80.1% with BR and 77.8% with R-CHOP.
Dr Rummel explained that the lack of difference in OS is not unexpected, since patients with indolent lymphoma live a long time. Also, many in the R-CHOP arm crossed over to receive BR when their disease progressed, which dilutes a survival difference between the arms. BR also was associated with significantly less toxicity, with only skin toxicity being more common with this simpler regimen, he added.
Michael E. Williams, MD, Chief of Hematologic Malignancies at the University of Virginia Cancer Center, Charlottesville, discussed the findings. “BR provides equivalent or better responses versus R-CHOP, and with less toxicity,” he said. “StiL NHL1 establishes BR as a front line regimen for indolent B-cell NHL and non–transplant-eligible mantle-cell lymphoma patients.”
Studies of this regimen are ongoing. The StiL NHL 7-2008 trial will evaluate data on the effect of rituximab maintenance after BR treatment.—CH