Cisplatinum, idarubicin, prednisone (CIP) after P-VABEC chemotherapy improves survival in elderly patients with diffuse large cell lymphoma: Long term follow-up

Background: P-VABEC regimen resulted a safe and active therapy for elderly patients (pts) with DLCL. However in spite of an high response rate, the overall and lymphoma free survival decrease for an high incidence of relapses.A phase II study demonstrated that CIP regimen was an active and safe regimen. Aims: To compare the activity and toxicity of CIP consolidation therapy after P-VABEC versus a standard P-VABEC regimen in a prospective multicenter randomized phase III study. Methods: From October 1995 to June 2000 we enrolled 214 previously untreated elderly pts with DLCL. The median age was 70 yrs (range 60– 85). Patients were randomized at diagnosis to receive P-VABEC (arm A) or P-VABEC-CIP (arm B). The P-VABEC regimen was delivered on out-patient basis as previously described. The CIP regimen consisted of: Cis-platinum (40 mg/td day 1), Idarubicin (15 mg/m 2 day 8), and Prednisone (40 mg/td days 1–4/ 8–11) q. 21 days for a total of 3 courses. Now 202 pts are evaluable for response, 107 pts randomized for P-VABEC and 95 for P-VABEC-CIP. According to the age-adjusted IPI score 89 pts were considered as Low Risk (IPI 0–1) and 113 as High Risk (IPI 2–3). Results: At a median follow up of 52 months (range 1–99) the CR/CRu rate was 58% and 64% (P = ns), the 5-yrs OS was 41% and 60% (P = 0.01) and 5-yrs PFS 39% and 53% (P = 0.05) respectively in arm A and arm B. According to the IPI score in the High Risk the 5yrs OS was 25% vs 52% (P = 0.008) and 5-yrs PFS was 25% vs 36% (P = ns) for Arm A and Arm B respectively while in the Low Risk no significant difference was found. Thirteen/202 (13%) toxic deaths related to chemotherapy occurred, all during P-VABEC induction therapy. Conclusions: P-VABEC-CIP resulted a safe chemotherapy regimen and improves survival in this group of elderly pts with DLCL.