采用化疗治疗晚期霍奇金病——MOPP/ABV混合方案与MOPP和ABVD交替疗程的比较：来自加拿大国家癌症研究所临床试验组的报告

Treatment of advanced Hodgkin's disease with chemotherapy--comparison of MOPP/ABV hybrid regimen with alternating courses of MOPP and ABVD: a report from the National Cancer Institute of Canada clinical trials group.

作者信息

Connors J M, Klimo P, Adams G, Burns B F, Cooper I, Meyer R M, O'Reilly S E, Pater J, Quirt I, Sadura A, Shustik C, Skillings J, Sutcliffe S, Verma S, Yoshida S, Zee B

机构信息

Division of Medical Oncology, British Columbia Cancer Agency, Vancouver, Canada.

出版信息

J Clin Oncol. 1997 Apr;15(4):1638-45. doi: 10.1200/JCO.1997.15.4.1638.

DOI:10.1200/JCO.1997.15.4.1638

PMID:9193364

Abstract

PURPOSE

This randomized, prospective trial compares outcomes for patients with advanced Hodgkin's disease treated with mechlorethamine, vincristine, procarbazine, and prednisone (MOPP)/doxorubicin, bleomycin, and vinblastine (ABV) hybrid regimen or alternating MOPP/doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD).

METHODS

Three hundred one patients with advanced Hodgkin's disease were randomized to receive MOPP/ ABV hybrid regimen or alternating MOPP/ABVD after stratification for prior treatment, B symptoms, and treatment center. Eligible patients were either previously untreated and found to have stage IIIB, IVA, or IVB disease or previously treated with wide-field irradiation. Responding patients received a minimum of eight cycles of chemotherapy. Those with residual disease in a localized region received irradiation between the sixth and seventh cycle of treatment.

RESULTS

Response rates to the two regimens were similar. Five-year overall survival rates were 81% and 83% for MOPP/ABV hybrid and alternating MOPP/ ABVD, respectively (P = .74; 95% confidence interval [CI] for the difference, -11% to 7%). Five-year failure-free survivals were 71% and 67% for MOPP/ABV hybrid and alternating MOPP/ABVD, respectively (P = .87; 95% CI for the difference, -9% to 17%). Significantly more episodes of febrile neutropenia and stomatitis were observed with the MOPP/ABV hybrid regimen; there was no significant difference in fatal toxicity. Patients with predefined, high-quality partial responses (PR-1s) had results similar to those with complete responses (CRs). Planned subset analysis showed no significant difference in outcome between the two arms of the trial for patients with newly diagnosed disease (5-year failure-free survival rates were 70% for MOPP/ABV hybrid and 59% for alternating MOPP/ABVD; P = .180), but superiority of alternating MOPP/ABVD for patients with prior irradiation (5-year failure-free survival 94% v 73%; P = .017).

CONCLUSION

MOPP/ABV hybrid and alternating MOPP/ABVD regimens are equally effective for patients with advanced Hodgkin's disease.

摘要

目的

本随机前瞻性试验比较了接受氮芥、长春新碱、丙卡巴肼和泼尼松（MOPP）/阿霉素、博来霉素和长春花碱（ABV）联合方案或交替使用MOPP/阿霉素、博来霉素、长春花碱和达卡巴嗪（ABVD）治疗的晚期霍奇金病患者的治疗结果。

方法

301例晚期霍奇金病患者在根据既往治疗、B症状和治疗中心进行分层后，随机接受MOPP/ABV联合方案或交替使用MOPP/ABVD。符合条件的患者要么是未经治疗且被发现患有IIIB期、IVA期或IVB期疾病，要么是曾接受过广野照射治疗。有反应的患者至少接受8个周期的化疗。局部区域有残留病灶的患者在治疗的第6至第7个周期之间接受照射。

结果

两种方案的缓解率相似。MOPP/ABV联合方案和交替使用MOPP/ABVD的5年总生存率分别为81%和83%（P = 0.74；差异的95%置信区间[CI]，-11%至7%）。MOPP/ABV联合方案和交替使用MOPP/ABVD的5年无失败生存率分别为71%和67%（P = 0.87；差异的95%CI，-9%至17%）。MOPP/ABV联合方案观察到的发热性中性粒细胞减少和口腔炎发作明显更多；致命毒性无显著差异。具有预先定义的高质量部分缓解（PR-1）的患者结果与完全缓解（CR）的患者相似。计划的亚组分析显示，新诊断疾病患者试验的两组之间结果无显著差异（MOPP/ABV联合方案的5年无失败生存率为70%，交替使用MOPP/ABVD为59%；P = 0.180），但交替使用MOPP/ABVD对曾接受照射的患者更具优势（5年无失败生存率94%对73%；P = 0.017）。