Phase II Study of Bendamustine and Ofatumumab in Elderly Patients with Newly Diagnosed Diffuse Large B‐Cell Lymphoma Who Are Poor Candidates for R‐CHOP Chemotherapy

LESSONS LEARNED. The combination of ofatumumab and bendamustine in elderly patients with diffuse large B‐cell lymphoma demonstrated modest efficacy compared with standard of care. The poor response may have been due to patient age and the high rate of treatment discontinuation. BACKGROUND. This phase II trial evaluated the efficacy of bendamustine and ofatumumab in elderly patients with newly diagnosed diffuse large B‐cell lymphoma (DLBCL) who were not candidates for rituximab cyclophosphamide, doxorubicin, vincristine, and prednisone (R‐CHOP). METHODS. Patients received IV 90 mg/m(2) bendamustine on days 1 and 2 of cycles 1 through 6 and IV 1,000 mg ofatumumab on days 1 and 8 of cycle 1 and on day 1 of cycles 2 through 6. Both drugs were administered at the U.S. Food and Drug Administration‐approved dose for combination therapy. All patients received premedications before each infusion of ofatumumab and hematopoietic growth factors. Treatment was administered in 21‐day cycles, with restaging after cycle 3 and cycle 6. The primary endpoint was complete response rate (CRR). RESULTS. Twelve of 21 enrolled patients completed treatment; median age was 83 years. The most common reasons for treatment discontinuation were disease progression (three patients), intercurrent illness (two patients), and death (one patient due to drug‐related sepsis and bowel necrosis and one patient due to unknown cause). Thrombocytopenia (14%), neutropenia (10%), diarrhea (10%), vomiting (10%), and dehydration (10%) were the most common grade ≥3 treatment‐related adverse events. The overall response rate was 90.5% and the CRR was 33.3%. Median progression‐free survival (PFS) and overall survival (OS) were 8.6 and 12.0 months, respectively. CONCLUSION. The combination of ofatumumab and bendamustine is feasible in elderly patients with DLBCL.