Four ABVD and Involved-Field Radiotherapy in Unfavorable Supradiaphragmatic Clinical Stages (CS) I-II Hodgkin’s Lymphoma (HL): Preliminary Results of the EORTC-GELA H9-U Trial.

Abstract

Abstract The aim of the trial was to compare three modalities of chemotherapy and involved-field radiotherapy (IF-RT) in adult patients with supradiaphragmatic CS I-II HL with risk factors. Patients were randomized if they presented with age ≥ 50, or CS II4–5, or A + ESR ≥ 50, or B + ESR ≥ 30, or MT ratio ≥ 0.35. The trial compared ABVD x 6 cycles and IF-RT (36–40 Gy) vs ABVD x 4 cycles and IF-RT vs BEACOPP baseline x 4 cycles and IF-RT. From October 1998 to September 2002, 808 patients were enrolled in 111 institutions from 10 European countries. The proportions of grade 3–4 chemotherapy-related hematological toxicity (mainly WBC) were 74%, 70% and 63%, respectively; That of grade 1–3 RT-related hematological toxicity were 10%, 12% and 17%, respectively. Ten (2+3+5, 1%) patients stopped chemotherapy because of toxicity and 8 (2+2+4, 1%) refused the treatment; Six (2+2+2, 1%) patients stopped radiotherapy because of toxicity and 9 (3+1+5, 1%) refused the treatment. The proportions of patients in CR/CRu were 74%, 71% and 59% after 6, 4 ABVD and 4 BEACOPP, respectively. After a median follow-up of 57 months (range 33–81), 78 events (26 progressions, 37 relapses, 15 deaths) were observed. At July 2005, the 4-year event-free survival (EFS) and overall survival (OS) rates are as follows: Treatment No. Pts CR-CRu /PR /NC-PD 4-yr EFS 4-yr OS 6 ABVD + IF-RT 276 87% /8% /5% 91% 95% 4 ABVD + IF-RT 277 86% /11% /3% 87% 94% 4 BEACOPP + IF-RT 255 84% /12% /4% 90% 93% P value 0.607 0.380 0.978 Overall, 42 patients have died of progressive disease (5, 7 and 7 patients), treatment-related complication (7, 5 and 2), intercurrent disease (1, 0 and 2), second malignancy (1 NHL, 0 and 1 AML) or cause unspecified (0, 3 and 1). These preliminary results indicate that a combination of 4 cycles of ABVD and IF-RT is sufficient to cure a large majority of HL patients with unfavorable early stage disease and that BEACOPP baseline has no advantage over ABVD in these patients.