CHOP方案、m-BACOD方案、ProMACE-CytaBOM方案与MACOP-B方案治疗中高危非霍奇金淋巴瘤患者的III期比较：SWOG-8516（肿瘤协作组0067）研究结果，国家高优先级淋巴瘤研究

A phase III comparison of CHOP vs. m-BACOD vs. ProMACE-CytaBOM vs. MACOP-B in patients with intermediate- or high-grade non-Hodgkin's lymphoma: results of SWOG-8516 (Intergroup 0067), the National High-Priority Lymphoma Study.

作者信息

Fisher R I, Gaynor E R, Dahlberg S, Oken M M, Grogan T M, Mize E M, Glick J H, Coltman C A, Miller T P

机构信息

Loyola University Stritch School of Medicine, Maywood, Illinois.

出版信息

Ann Oncol. 1994;5 Suppl 2:91-5. doi: 10.1093/annonc/5.suppl_2.s91.

DOI:10.1093/annonc/5.suppl_2.s91

PMID:7515652

Abstract

BACKGROUND

CHOP is a four-drug, first-generation combination chemotherapy regimen that has cured approximately 30% of all patients with advanced stages of intermediate- or high-grade non-Hodgkin's lymphoma in national cooperative group trials. Initial single-institution studies of third-generation regimens such as m-BACOD, ProMACE-CytaBOM, and MACOP-B suggested that 55%-60% of these patients might be cured.

PATIENTS AND METHODS

In order to make a valid comparison between these regimens, the Southwest Oncology Group and the Eastern Cooperative Oncology Group initiated a randomized phase III comparison of CHOP vs. m-BACOD vs. ProMACE-CytaBOM vs. MACOP-B. Endpoints of the study were response rate, time to treatment failure, overall survival, and severe or life-threatening toxicity. Received dose intensity calculations and subset analyses were also performed.

RESULTS

1138 patients were registered on this clinical trial. Each treatment arm contained between 218 and 233 eligible patients. Known prognostic factors were equally distributed. The initial results of this study were recently published. There were no significant differences in either the partial or complete response rates between treatment arms. Now after a median follow-up of 49 months and a maximum follow-up of 84 months, there is still no difference in time to treatment failure (p = 0.40) or overall survival (p = 0.68). No subset of patients was found to have significantly improved survival with the third-generation regimens. The received dose intensity data were comparable to previously published data for these regimens. Fatal toxicity was 1% for CHOP, 3% for ProMACE-CytaBOM, 5% for m-BACOD, and 6% for MACOP-B.

CONCLUSION

Based on similar failure-free and overall survival with lower cost and lower severe toxicity, CHOP remains the standard chemotherapy for patients with advanced-stage, intermediate- or high-grade non-Hodgkin's lymphoma. New treatment strategies need to be developed to improve the prognosis of these patients.

摘要

背景

CHOP是一种含四种药物的第一代联合化疗方案，在全国性合作组试验中，该方案使约30%的中高级别晚期非霍奇金淋巴瘤患者得到治愈。对诸如m-BACOD、ProMACE-CytaBOM和MACOP-B等第三代方案进行的初步单机构研究表明，这些患者中有55%-60%可能被治愈。

患者与方法

为了对这些方案进行有效比较，西南肿瘤协作组和东部肿瘤协作组开展了一项CHOP对比m-BACOD对比ProMACE-CytaBOM对比MACOP-B的随机III期对照研究。该研究的终点为缓解率、治疗失败时间、总生存期以及严重或危及生命的毒性反应。同时还进行了接受剂量强度计算和亚组分析。

结果

1138例患者登记参加了这项临床试验。每个治疗组包含218至233例符合条件的患者。已知的预后因素分布均衡。该研究的初步结果最近已发表。各治疗组之间的部分缓解率或完全缓解率均无显著差异。现在，经过中位49个月的随访以及最长84个月的随访后，治疗失败时间（p = 0.40）或总生存期（p = 0.68）仍无差异。未发现任何亚组患者使用第三代方案后生存期有显著改善。接受剂量强度数据与这些方案先前发表的数据相当。CHOP的致命毒性为1%，ProMACE-CytaBOM为3%，m-BACOD为5%，MACOP-B为6%。