Comparison of BEACOPP and ABVD chemotherapy in intermediate stage Hodgkin’s lymphoma: Results of the fourth interim analysis of the HD 11 trial of the GHSG

Abstract

6507 Background: Combined modality treatment is the standard treatment for intermediate stage Hodgkin’s lymphoma (HL). Despite high complete remission (CR) rates, failure rates are remarkably higher in this group of patients. In the HD 11 multicenter trial of the GHSG the BEACOPP regimen was introduced to intermediate stages in an attempt to improve therapy outcome. Simultaneously, the possibility to reduce the IF-RT dose from 30 Gy to 20 Gy is evaluated. Methods: Between May 1998 and July 2002, 1363 patients (16–75 years old) with intermediate stage HL (CS I, IIA with risk factors or IIB with elevated ESR and/or >= 3 nodal areas) were randomised according to a 2 x 2 factorial design between: 4 ABVD + 30 Gy IF-RT (arm A), 4 ABVD + 20 Gy IF-RT (arm B), 4 BEACOPP basis + 30 Gy IF-RT (arm C), and 4 BEACOPP basis + 20 Gy IF-RT (arm D). Results: In the fourth interim analysis in August 2003, 1047 (77%) patients were evaluable for chemotherapy and 982 (72%) for radiotherapy. Patient characteristics were well balanced between the treatment arms with regard to age, gender, clinical stage, histopathology and performance status. 95.1% patients reached CR, 2.0% suffered from progression, the relapse rate was 5.9%, the mortality rate 3.2%. The most frequent haematological toxicity was leucopenia observed in 33% of patients (ABVD: 27%, BEACOPP: 40%). Infection rate was 5% (ABVD: 4%, BEACOPP:7%). Nine secondary neoplasias were observed: 2 AML, 3NHL, 4 solid tumors. After a median observation time of two years overall survival (OS) was 97.4% (95%-CI: 96–98) and freedom from treatment failure (FFTF) was 89.9% (95%-CI: 88–92). Both for FFTF and OS, there was no sequential significant difference either between ABVD and BEACOPP arms nor between 30 Gy and 20 Gy IF-RT arms. Conclusions: Thus far, no differences in treatment outcome were detected, neither between the two chemotherapy regimes nor between the different doses of radiotherapy. The low FFTF (89,9% at two years) led us to further intensification of chemotherapy by the introduction of 2 cycles of escalated BEACOPP (+ 2 ABVD) versus 4 ABVD in the subsequent HD14 trial for intermediate stage HL. No significant financial relationships to disclose.