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Lenalidomide plus R-CHOP21 safe, effective in elderly patients with DLBCL
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The addition of lenalidomide to a regimen of rituximab, cyclophosphamide, doxorubicin, vincristine and prednisolone every 21 days appeared active and well tolerated in elderly patients with untreated diffuse large B-cell lymphoma, according to results of an open-label phase 2 study.
Up to 40% of elderly patients with treatment-naive diffuse large B-cell lymphoma (DLBCL) who receive rituximab (Rituxan, Genetech/Biogen Idec), cyclophosphamide, doxorubicin, vincristine and prednisolone every 21 days (R-CHOP21) relapse or develop refractory disease, Umberto Vitolo, MD, of Azienda Ospedaliera Città della Salute e della Scienza di Torino in Italy, and colleagues wrote.
Because lenalidomide (Revlimid, Celgene) is active in relapsed or refractory B-cell lymphomas, Vitolo and colleagues assessed the safety and efficacy of lenalidomide plus R-CHOP21.
The analysis included 49 patients aged 69 to 80 years with newly diagnosed, untreated CD20-positive, stage II to IV DLBCL or grade 3b follicular lymphoma.
Patients received 15 mg oral lenalidomide on days 1 to 14 of 21-day cycles for six cycles, plus standard doses of R-CHOP21.
Forty-five of the 49 patients (91.8%) achieved a response; 42 achieved complete response and three achieved partial response. One patient died from a cause unrelated to DLBCL or treatment, and three patients did not respond.
The combination appeared tolerable, as 94% of planned treatment cycles were completed.
Researchers reported grade 3 or grade 4 neutropenia in 87 cycles (31%), leukopenia in 77 cycles (28%) and thrombocytopenia in 35 cycles (13%). Researchers reported no grade 4 non-hematological adverse events, and no toxicity-related deaths occurred.
Disclosure:The study was funded by Celgene and Fondazione Italiana Linfomi.
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