PURPOSE: This multicenter, prospective, randomized controlled trial compared the efficacy and toxicity of two chemotherapy regimens in advanced Hodgkin's lymphoma (HL): the weekly alternating Stanford V and the standard, twice-weekly regimen of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD). PATIENTS AND METHODS: Patients had stage IIB, III, or IV disease or had stages I to IIA disease with bulky disease or other adverse features. Radiotherapy was administered in both arms to sites of previous bulk (> 5 cm) and to splenic deposits, although this was omitted in the latter part of the trial for patients achieving complete remission (CR) in the ABVD arm. A total of 520 patients were randomly assigned and were assessed for the primary outcome measure of progression-free survival (PFS). Five hundred patients receivedprotocol treatment, and radiotherapy was administered to 73% in the Stanford V arm and to 53% in the ABVD arm. RESULTS: The overall response rates after completion of all treatment were 91% for Stanford V and 92% for ABVD. During a median follow-up of 4.3 years, there was no evidence of a difference in projected 5-year PFS and overall survival (OS) rates (76% and 90%, respectively, for ABVD; 74% and 92%, respectively, for Stanford V). More pulmonary toxicity was reported for ABVD, whereas other toxicities were more frequent with Stanford V. CONCLUSION: In a large, randomized trial, the efficacies of Stanford V and ABVD were comparable when given in combination with appropriate radiotherapy.
RCT Entities:
PURPOSE: This multicenter, prospective, randomized controlled trial compared the efficacy and toxicity of two chemotherapy regimens in advanced Hodgkin's lymphoma (HL): the weekly alternating Stanford V and the standard, twice-weekly regimen of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD). PATIENTS AND METHODS: Patients had stage IIB, III, or IV disease or had stages I to IIA disease with bulky disease or other adverse features. Radiotherapy was administered in both arms to sites of previous bulk (> 5 cm) and to splenic deposits, although this was omitted in the latter part of the trial for patients achieving complete remission (CR) in the ABVD arm. A total of 520 patients were randomly assigned and were assessed for the primary outcome measure of progression-free survival (PFS). Five hundred patients received protocol treatment, and radiotherapy was administered to 73% in the Stanford V arm and to 53% in the ABVD arm. RESULTS: The overall response rates after completion of all treatment were 91% for Stanford V and 92% for ABVD. During a median follow-up of 4.3 years, there was no evidence of a difference in projected 5-year PFS and overall survival (OS) rates (76% and 90%, respectively, for ABVD; 74% and 92%, respectively, for Stanford V). More pulmonary toxicity was reported for ABVD, whereas other toxicities were more frequent with Stanford V. CONCLUSION: In a large, randomized trial, the efficacies of Stanford V and ABVD were comparable when given in combination with appropriate radiotherapy.
Authors: Yvette L Kasamon; Heather A Jacene; Christopher D Gocke; Lode J Swinnen; Douglas E Gladstone; Brandy Perkins; Brian K Link; Leslie L Popplewell; Thomas M Habermann; Joseph M Herman; William H Matsui; Richard J Jones; Richard F Ambinder Journal: Blood Date: 2012-02-16 Impact factor: 22.113
Authors: Ranjana H Advani; Fangxin Hong; Richard I Fisher; Nancy L Bartlett; K Sue Robinson; Randy D Gascoyne; Henry Wagner; Patrick J Stiff; Bruce D Cheson; Douglas A Stewart; Leo I Gordon; Brad S Kahl; Jonathan W Friedberg; Kristie A Blum; Thomas M Habermann; Joseph M Tuscano; Richard T Hoppe; Sandra J Horning Journal: J Clin Oncol Date: 2015-04-20 Impact factor: 44.544