标准方案（CHOP）与三种强化化疗方案治疗晚期非霍奇金淋巴瘤的比较。

Comparison of a standard regimen (CHOP) with three intensive chemotherapy regimens for advanced non-Hodgkin's lymphoma.

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

Stritch School of Medicine, Loyola University, Maywood, Ill.

出版信息

N Engl J Med. 1993 Apr 8;328(14):1002-6. doi: 10.1056/NEJM199304083281404.

DOI:10.1056/NEJM199304083281404

PMID:7680764

Abstract

BACKGROUND

CHOP is a first-generation, combination-chemotherapy regimen consisting of cyclophosphamide, doxorubicin, vincristine, and prednisone that has cured approximately 30 percent of patients with advanced stages of intermediate-grade or high-grade non-Hodgkin's lymphoma in national cooperative-group trials. However, studies at single institutions have suggested that 55 to 65 percent of such patients might be cured by third-generation regimens such as ones consisting of low-dose methotrexate with leucovorin rescue, bleomycin, doxorubicin, cyclophosphamide, vincristine, and dexamethasone (m-BACOD); prednisone, doxorubicin, cyclophosphamide, and etoposide, followed by cytarabine, bleomycin, vincristine, and methotrexate with leucovorin rescue (ProMACE-CytaBOM); and methotrexate with leucovorin rescue, doxorubicin, cyclophosphamide, vincristine, prednisone, and bleomycin (MACOP-B).

METHODS

To make a valid comparison of these regimens, the Southwest Oncology Group and the Eastern Cooperative Oncology Group initiated a prospective, randomized phase III trial. The study end points were the response rate, time to treatment failure, overall survival, and incidence of severe or life-threatening toxicity. Dose intensity was calculated and analyzed.

RESULTS

Of the 1138 patients registered for the trial, 899 were eligible. Each treatment group contained at least 218 patients. Known prognostic factors were equally distributed among the groups. There were no significant differences among the groups in the rates of partial and complete response. At three years, 44 percent of all patients were alive without disease; there were no significant differences between the groups (41 percent in the CHOP and MACOP-B groups and 46 percent in the m-BACOD and ProMACE-CytaBOM groups; P = 0.35). Overall survival at three years was 52 percent (50 percent in the ProMACE-CytaBOM and MACOP-B groups, 52 percent in the m-BACOD group, and 54 percent in the CHOP group; P = 0.90). There was no subgroup of patients in which survival was improved by a third-generation regimen. Fatal toxic reactions occurred in 1 percent of the CHOP group, 3 percent of the ProMACE-CytaBOM group, 5 percent of the m-BACOD group, and 6 percent of the MACOP-B group (P = 0.09).

CONCLUSIONS

CHOP remains the best available treatment for patients with advanced-stage intermediate-grade or high-grade non-Hodgkin's lymphoma.

摘要

背景

CHOP是一种第一代联合化疗方案，由环磷酰胺、阿霉素、长春新碱和泼尼松组成。在全国性协作组试验中，该方案使大约30%的中高度非霍奇金淋巴瘤晚期患者得到治愈。然而，单机构研究表明，55%至65%的此类患者可能通过第三代方案治愈，如包含低剂量甲氨蝶呤及亚叶酸解救、博来霉素、阿霉素、环磷酰胺、长春新碱和地塞米松的方案（m-BACOD）；泼尼松、阿霉素、环磷酰胺和依托泊苷，随后给予阿糖胞苷、博来霉素、长春新碱和甲氨蝶呤及亚叶酸解救的方案（ProMACE-CytaBOM）；以及甲氨蝶呤及亚叶酸解救、阿霉素、环磷酰胺、长春新碱、泼尼松和博来霉素的方案（MACOP-B）。

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启动了一项前瞻性随机III期试验。研究终点为缓解率、治疗失败时间、总生存期以及严重或危及生命毒性的发生率。计算并分析了剂量强度。

结果

在登记参加试验的1138例患者中，899例符合条件。每个治疗组至少有218例患者。已知的预后因素在各组中分布均衡。各组之间部分缓解和完全缓解率无显著差异。三年时，所有患者中有44%无病存活；各组之间无显著差异（CHOP组和MACOP-B组为41%，m-BACOD组和ProMACE-CytaBOM组为46%；P = 0.35）。三年总生存率为52%（ProMACE-CytaBOM组和MACOP-B组为50%，m-BACOD组为52%，CHOP组为54%；P = 0.90）。没有哪一组患者通过第三代方案使生存率得到提高。CHOP组1%、ProMACE-CytaBOM组3%、m-BACOD组5%、MACOP-B组6%发生致命毒性反应（P = 0.09）。