Rituximab as Consolidation Therapy Did Not Improve Outcome in Patients with Diffuse Large B-Cell Lymphoma at Complete Response After Dose-Dense Chemotherapy (CHOP-14)

Abstract

The authors started a clinical trial to assess the efficacy and toxicity of rituximab (R) as consolidation in patients with diffuse large B-cell lymphoma, with poor prognostic factors, who were in complete response (CR) after dose-dense chemotherapy (CHOP-14). Four hundred sixty-five untreated patients, with advanced stages (III and IV), older (median age >60 years old), and high clinical risk, were treated with dose-dense CHOP-14 (cyclophosphamide 1500 mg/m², i.v., day 1; vincristine 2 mg, i.v., standard dose, day 1; epirubicin 120 mg/m², i.v., day 1; and prednisone 60 mg/m², p.o., days 1–5) every 14 days for six cycles. If CR was achieved, the patients were allocated to receive R (375 mg/m², days 1, 8, 15, and 22) at 3 and 9 months after chemotherapy. Three hundred twenty-five patients achieved CR (70%) and were allocated to receive R (151 patients) or not (174 patients). Actuarial curves at 5 years showed that progression-free survival (PFS) was 51% (95% confidence interval [CI]: 44%–58%) in the R group and 53% (95% CI: 47%–59%) in the observation group (p=0.8). Overall survival (OS) was 65% (95% CI: 58%–71%) and 66% (95% CI: 59%–72%), respectively (p=0.78). Late toxicities were more frequent in the R group. The authors showed that the use of R as a consolidation treatment was not useful to improve PFS and OS and toxicity secondary to R was frequent. They did not recommend the use of R as consolidation in this patient setting.