Rituximab plus bendamustine as front-line treatment in frail elderly (>70 years) patients with diffuse large B-cell non-Hodgkin lymphoma: a phase II multicenter study of the Fondazione Italiana Linfomi

We conducted a phase II study to assess activity and safety profile of bendamustineand rituximab in elderly patients with untreated Diffuse Large B Cell Lymphomawho were prospectively defined as frail using a simplified version of a Comprehensive GeriatricAssessment. Patients had to be > 70 years of age, with histologically confirmed Diffuse Large B Cell Lymphoma. Frail patients were those younger than 80 years with a frail profile at Comprehensive GeriatricAssessment or older than 80 years with an unfit profile. Treatment consisted of 4-6 courses of bendamustine(90 mg/m2 d 1-2) and rituximab (375 mg/m2 d1) administered every 28 days. Co-primary study endpoints were Complete Remission rate and the rate of extra-hematological adverse events. Forty-nine patients were enrolled and 45 confirmed eligible. Overall 24 patients achieved a complete remission (53%; 95% CI 38 to 68%) and the Overall Response Rate was 62% (95% CI 47-76%). The most frequent grade 3-4 adverse event was neutropenia in 37.8%; grade 3-4 extra-hematological adverse events were observed in 7 patients (15.6%, 95%CI 6.5-29.5%); the most frequent one was grade 3 infection in two patients. With a median follow-up of 33 months (range 1-52) the median Progression Free Survival was 10 months (CI95% 7-25). The study allows to conclude on the promising activity and manageable toxicity profile of BR combination as first line therapy for patients with Diffuse Large B Cell Lymphomawho are prospectively defined as FRAIL according to a simplified Comprehensive GeriatricAssessment as adopted in this trial (NCT01990144).