ABVD vs. STANFORD V (SV) vs. MOPP-EBV-CAD (MEC) in advanced Hodgkin's lymphoma. Final results of the IIL HD9601 randomized trial

Abstract

6507 Background: About 30% of patients with advanced Hodgkin's lymphoma (HL) do not respond to initial therapy with ABVD or relapse. Recently SV and MEC were reported with higher cure rates. To test the superiority of SV and MEC over ABVD the Intergruppo Italiano Linfomi (IIL) conducted a three arms multicentric randomized trial. Methods: Patients with advanced stage HL (IIB-IV) and no previous treatment were randomised to receive 6 courses of ABVD or 6 courses of MEC or 12 weeks of SV. At the end of chemotherapy radiotherapy was delivered to residual masses or to the sites of previous bulky disease. The principal end point of the study was failure free survival (FFS): complete response (CR) rate, Freedom From Progression (FFP) and Overall Survival (OS) were secondary end-points of the study. Results: From January 1996 to April 2000, 355 pts were randomized; 23 cases were excluded due to missing data (22) or to revised histology (1). Finally 332 (94%) patients were assessed for response and survival. Baseline characteristics were well balanced among the three groups. Radiotherapy was delivered to 64%, 45% and 66% of patients treated with ABVD, MEC or SV, respectively. At the end of the therapy a CR was achieved by 88% of pts treated with ABVD, 94% with MEC and 72% with SV (P < 0.01). After a median follow-up of 56 months (60 months for alive pts), the 5-year FFS was 83%, 85% and 67% for ABVD, MEC and SV respectively (p<0.01); 5-year OS was 90%, 90% and 83% (p=ns) for ABVD, MEC and SV respectively. In addition 5-yrs FFP was 86% for ABVD, 93% for MEC and 76% for SV (p<0.01). Hematological toxicity was higher for MEC than for the other two regimens; grade III-IV leukopenia: 13% vs. 51% vs. 30% (p<0.01). Grade III-IV infections: 1% vs. 14% vs. 0% (p<0.01). Other extra-hematological toxicities were comparable in the three arms. At the time of present analysis, 2 pts per each arm died due to second cancer. Conclusions: The results of the HD9601 trial show an advantage of ABVD and MEC over SV in terms of response, FFS and FFP. No significant financial relationships to disclose.