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Combination chemotherapy more than doubles PFS in lymphoma patients compared with R-CHOP
CHICAGO — First-line combination chemotherapy with bendamustine and rituximab more than doubled PFS in patients with indolent lymphoma and mantle cell lymphoma compared with standard R-CHOP therapy, according to results of a phase 3 multicenter study.
Patients treated with the combination regimen also experienced fewer side effects, according to researchers, who first presented their initial findings at the 2009 ASH Annual Meeting but have since updated their analysis with results through Oct. 31, 2011.
Mathias J. Rummel, MD, PhD, and colleagues conducted the study to compare the combination of bendamustine (Treanda, Cephalon) and rituximab (Rituxan, Genentech) to R-CHOP, which is widely used in the United States to treat patients with several types of non-Hodgkin’s lymphoma.
“CHOP-R is a very established regimen in the treatment of lymphoma,” Rummel, a professor of medicine at University Hospital Giessen in Germany, said during a press conference. “It has its absolute place in the diffuse large B-cell lymphoma setting, but there was always ongoing debate if you need such an aggressive regimen for the treatment of patients with indolent lymphomas.”
Rummel and colleagues enrolled 549 patients with indolent lymphoma or mantle cell lymphoma to receive the combination regimen or R-CHOP for a maximum of six cycles. Of them, 514 had evaluable results — 261 in the combination arm and 253 in the R-CHOP arm.
Median follow-up was 45 months, and the primary endpoint was PFS.
Median PFS was 69.5 months for patients assigned to the combination therapy vs. 31.2 months for patients assigned to R-CHOP (HR=0.58; 95% CI, 0.44-0.74; P<.001), a difference that was highly statistically significant, Rummel said.
OS was similar between the two groups. Researchers explained that finding, in part, by noting about half of the patients assigned to R-CHOP whose disease progressed were permitted to receive the combination therapy. Also, because patients with indolent lymphomas tend to survive for a long time, PFS becomes the most reliable way to measure clinical benefit, the researchers said.
Overall response rates were similar (92.7% in the combination group vs. 91.3% in the R-CHOP group), while complete response rates were higher in the combination arm (39.8% vs. 30%, P=.021).
Rates of grade-3/grade-4 hematotoxicity were lower in the combination group, including leukocytopenia (12.1% vs. 38.2%); neutropenia (10.7% vs. 46.5%); thrombocytopenia (0.7% vs. 1.2%); and anemia (1.4% vs. 1.9%).
Granulocyte colony-stimulating factor (G-CSF), a blood growth factor that stimulates bone marrow to produce more infection-fighting white blood cells, only had to be administered in 4% of treatment cycles in the combination group, compared with 20% of treatment cycles in the R-CHOP group, Rummel said.
Patients assigned to the combination therapy experienced higher incidence of mild skin reactions, while patients assigned to R-CHOP experienced a higher incidence of nerve toxicity and infections, the researchers said.
Researchers observed 20 secondary malignancies in patients assigned to combination therapy and 23 secondary malignancies among patients assigned to CHOP-R. One hematologic malignancy was observed in each group.
“We concluded BR is not only less toxic but also more effective than the most often-used front-line treatment approach, CHOP-R, and therefore should be considered as a preferred first-line treatment for patients with these disease entities,” Rummel said. “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.”
For more information:
Rummel MJ. Abstract #3. Presented at: the 2012 American Society of Clinical Oncology Annual Meeting; June 1-5, 2012; Chicago.
Disclosure: The researchers report receiving honoraria and research funding from Mundipharma and Roche Diagnostics.
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It’s certainly remarkable to have an agent that provides superior efficacy and decreased toxicity at the same time. A number of US physicians had already switched to this regimen after preliminary data from this trial was presented at ASH in 2009, but it’s nice to have the final data, and this is likely to become a standard of care for these individuals.