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Rituximab failed to improve survival after stem cell transplant for DLBCL
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Patients with diffuse large B-cell lymphoma who were treated with rituximab after autologous stem cell transplantation experienced similar outcomes as those in an observation group, according to study results.
Researchers conducted the investigation to examine the effect of maintenance rituximab (Rituxan, Genentech/Idec) after autologous stem cell transplantation in relapsed diffuse large B-cell lymphoma (DLBCL).
The analysis included 477 patients with CD20+ DLBCL who were in their first relapse or refractory to initial therapy. Researchers randomly assigned patients to one of two salvage chemotherapy regimens. After three cycles of salvage therapy, patients who responded underwent high-dose chemotherapy followed by autologous stem cell transplantation. Upon completion, 122 patients were assigned to rituximab every 2 months for 1 year, and 120 patients were assigned to observation.
Median follow-up was 44 months.
The 4-year event-free survival (EFS) rates after stem cell transplantation were 52% in the rituximab cohort and 53% in the observation cohort (P=.7).
Rituximab was associated with a 15% attributable risk for serious adverse events after day 100 of follow-up. Six deaths occurred in the treatment group and three deaths occurred in the observation group.
After stem cell transplantation, EFS was 46% among patients whose disease relapsed within 12 months and 56% among patients whose disease relapsed after 12 months (P<.05). Other factors that affected EFS included secondary age-adjusted International Prognostic Index (saaIPI) more than 1 (37% vs. 61% for saaIPI<1; P<.05) and previous treatment with rituximab (47% vs. 59% for no prior rituximab; P<.05).
Among patients in the rituximab group, women experienced higher rates of EFS than men (63% vs. 46%).
Results of a Cox model for maintenance indicated that saaIPI (P<.001) and male sex (P=.01) were significant prognostic factors.
“Rituximab maintenance therapy does not prevent relapse after ASCT and was associated with higher toxicity,” the researchers wrote. “Therefore, this treatment is not recommended in relapsed DLBCL … New drugs that are designed to increase the response rate of salvage regimens and novel approaches, including allogeneic transplantation, should be explored. An improved understanding of the biology of DLBCL derived at least in part from studies of patient tumor specimens will play a key role in the development of novel targeted therapies for this disease.”
Disclosure: Gisselbrecht reports financial ties with Baxter, Chugai Pharmaceutical and Roche.See the study for a full list of financial disclosures.
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