Federico Massimo, Luminari Stefano, Iannitto Emilio, Polimeno Giuseppe, Marcheselli Luigi, Montanini Antonella, La Sala Antonio, Merli Francesco, Stelitano Caterina, Pozzi Samantha, Scalone Renato, Di Renzo Nicola, Musto Pellegrino, Baldini Luca, Cervetti Giulia, Angrilli Francesco, Mazza Patrizio, Brugiatelli Maura, Gobbi Paolo G
Dipartimento di Oncologia ed Ematologia, Centro Oncologico Modenese, Università di Modena e Reggio Emilia, Modena, Italy.
J Clin Oncol. 2009 Feb 10;27(5):805-11. doi: 10.1200/JCO.2008.17.0910. Epub 2009 Jan 5.
To compare doxorubicin, bleomycin, vinblastine, dacarbazine (ABVD) versus bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPP) versus cyclophosphamide, lomustine, vindesine, melphalan, prednisone, epidoxirubicin, vincristine, procarbazine, vinblastine, and bleomycin (COPPEBVCAD; CEC) for advanced Hodgkin's lymphoma (HL).
Three hundred seven patients with advanced HL (stage IIB, III, and IV) were randomly assigned to receive six courses of ABVD, four escalated plus two standard courses of BEACOPP, or six courses of CEC, plus a limited radiation therapy program.
After a median follow-up of 41 months, BEACOPP resulted in a superior progression-free survival (PFS), with a significant reduction in risk of progression (hazard ratio [HR] = 0.50) compared with ABVD. No differences between BEACOPP and CEC, or CEC and ABVD were observed. The 5-year PFS was 68% (95% CI, 56% to 78%), 81% (95% CI, 70% to 89%), and 78% (95% CI, 68% to 86%), for ABVD, BEACOPP, and CEC, respectively (BEACOPP v ABVD, P = .038; CEC v ABVD and BEACOPP v CEC, P = not significant [NS]). The 5-year overall survival was 84% (95% CI, 69% to 92%), 92% (95% CI, 84% to 96%), and 91% (95% CI, 81% to 96%) for ABVD, BEACOPP, and CEC, respectively (P = NS). BEACOPP and CEC resulted in higher rates of grade 3-4 neutropenia than ABVD (P = .016); BEACOPP was associated with higher rates of severe infections than ABVD and CEC (P = .003).
As adopted in this study BEACOPP is associated with a significantly improved PFS compared with ABVD, with a predictable higher acute toxicity.
比较多柔比星、博来霉素、长春碱、达卡巴嗪(ABVD)方案与博来霉素、依托泊苷、多柔比星、环磷酰胺、长春新碱、丙卡巴肼和泼尼松(BEACOPP)方案以及环磷酰胺、洛莫司汀、长春地辛、美法仑、泼尼松、表柔比星、长春新碱、丙卡巴肼、长春碱和博来霉素(COPPEBVCAD;CEC)方案治疗晚期霍奇金淋巴瘤(HL)的效果。
307例晚期HL(IIB期、III期和IV期)患者被随机分配接受6个疗程的ABVD方案、4个强化疗程加2个标准疗程的BEACOPP方案或6个疗程的CEC方案,以及有限的放射治疗计划。
中位随访41个月后,与ABVD方案相比,BEACOPP方案的无进展生存期(PFS)更优,疾病进展风险显著降低(风险比[HR]=0.50)。未观察到BEACOPP方案与CEC方案之间或CEC方案与ABVD方案之间存在差异。ABVD方案、BEACOPP方案和CEC方案的5年PFS分别为68%(95%CI,56%至78%)、81%(95%CI,70%至89%)和78%(95%CI,68%至86%)(BEACOPP方案与ABVD方案比较,P = 0.038;CEC方案与ABVD方案比较以及BEACOPP方案与CEC方案比较,P = 无显著差异[NS])。ABVD方案、BEACOPP方案和CEC方案的5年总生存率分别为84%(95%CI,69%至92%)、92%(95%CI,84%至96%)和91%(95%CI,81%至96%)(P = NS)。BEACOPP方案和CEC方案导致3-4级中性粒细胞减少的发生率高于ABVD方案(P = 0.016);BEACOPP方案与严重感染发生率高于ABVD方案和CEC方案相关(P = 0.003)。
在本研究中采用的BEACOPP方案与ABVD方案相比,PFS显著改善,但急性毒性可预测地更高。