Weekly rituximab consolidation following four cycles of R-CHOP induction chemotherapy in very elderly patients with diffuse large B-cell lymphoma: Consortium for improving survival of lymphoma study (CISL)

This study aimed to determine the objective response, toxicity, and clinical outcome of weekly rituximab consolidation after four cycles of R-CHOP21 in very elderly patients with DLBCL. A prospective, multi-institutional phase II trial was conducted on patients with previously untreated CD20⁺ DLBCL who were older than 70 yr. Patients were treated with four cycles of R-CHOP21 followed by weekly consolidation with rituximab (375mg/m², four times infusion) (NCT01181999). We also compared the clinical outcomes with an historical case-matched control group treated conventionally with six cycles of R-CHOP21. A total of 51 patients with newly diagnosed DLBCL were enrolled at 15 institutes between June 2010 and September 2013. The median age was 76 yr (range: 70-89). Forty-one of the 51 patients completed the planned rituximab consolidation (R-consolidation). The overall response rate was 78.4%, comprising 74.5% with a complete response and 3.9% with a partial response. After a median follow-up of 20.3 months, 2-yr progression-free survival and overall survival were 63.9% and 68.7%, respectively. No serious toxicities were reported during rituximab consolidation. Weekly rituximab consolidation following four cycles of R-CHOP21 resulted in an acceptable response with high tolerability and could be a good compromise between efficacy and safety for elderly patients with DLBCL.