COMPARISON OF A STANDARD REGIMEN (CHOP) WITH 3 INTENSIVE CHEMOTHERAPY REGIMENS FOR ADVANCED NON-HODGKINS-LYMPHOMA
COMPARISON OF A STANDARD REGIMEN (CHOP) WITH 3 INTENSIVE CHEMOTHERAPY REGIMENS FOR ADVANCED NON-HODGKINS-LYMPHOMA
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DOI：
10.1056/nejm199304083281404
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发表时间：
1993-04-08
影响因子：
158.5
通讯作者：
MILLER, TP
中科院分区：
文献类型：
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作者：
FISHER, RI;GAYNOR, ER;MILLER, TP
背景CHOP是第一代联合化疗方案，由环磷酰胺、多柔比星、长春新碱和泼尼松组成，在国家合作组试验中治愈了约30%的晚期中度或高度非霍奇金淋巴瘤患者。然而，在单一机构的研究表明，55%至65%的此类患者可以通过第三代方案治愈，例如由低剂量甲氨蝶呤与甲酰四氢叶酸救援，博莱霉素，阿霉素，环磷酰胺，长春新碱和地塞米松（m-BACOD）组成的方案;泼尼松、阿霉素、环磷酰胺和依托泊苷，然后是阿糖胞苷、博来霉素、长春新碱，和甲氨蝶呤与甲酰四氢叶酸救援（ProMACE-CytaBOM）;和甲氨蝶呤与甲酰四氢叶酸救援、阿霉素、环磷酰胺、长春新碱、泼尼松和博来霉素（MACOP-B）。为了对这些方案进行有效的比较，西南肿瘤组和东部肿瘤协作组启动了一项前瞻性、随机III期试验。研究终点是反应率、治疗失败时间、总生存率和严重或危及生命的毒性发生率。计算并分析剂量强度。在1138名注册参加试验的患者中，有899名合格。每个治疗组至少包含患者。已知的预后因素在各组中分布均匀。在部分和完全缓解率方面，两组之间无显著差异。三年后，44%的患者无病存活;两组之间没有显著差异（CHOP和MACOP-B组为41%，m-BACOD和ProMACE-CytaBOM组为46%; P = 0.35）。3年总生存率为52%（ProMACE-CytaBOM和MACOP-B组为50%，m-BACOD组为52%，CHOP组为54%; P = 0.90）。没有一个亚组的患者生存率通过第三代方案得到改善。CHOP组、ProMACE-CytaBOM组、m-BACOD组和MACOP-B组的致死性毒性反应发生率分别为1%、3%、5%和6%（P = 0.09）。CHOP仍然是晚期、中度或高度非霍奇金淋巴瘤患者的最佳治疗方法。
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 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.