A PHASE-III COMPARISON OF CHOP VS M-BACOD VS PROMACE-CYTABOM VS MACOP-B IN PATIENTS WITH INTERMEDIATE-GRADE OR HIGH-GRADE NON-HODGKINS-LYMPHOMA - RESULTS OF SWOG-8516 (INTERGROUP 0067), THE NATIONAL HIGH-PRIORITY LYMPHOMA STUDY
A PHASE-III COMPARISON OF CHOP VS M-BACOD VS PROMACE-CYTABOM VS MACOP-B IN PATIENTS WITH INTERMEDIATE-GRADE OR HIGH-GRADE NON-HODGKINS-LYMPHOMA - RESULTS OF SWOG-8516 (INTERGROUP 0067), THE NATIONAL HIGH-PRIORITY LYMPHOMA STUDY
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DOI：
10.1093/annonc/5.suppl_2.s91
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发表时间：
1994-01-01
影响因子：
50.5
通讯作者：
MILLER, TP
中科院分区：
文献类型：
--
作者：
FISHER, RI;GAYNOR, ER;MILLER, TP
背景。CHOP是一种四药联合化疗方案，在国家合作组试验中，已治愈了约30%的中重度非霍奇金淋巴瘤晚期患者。对m-BACOD、ProMACE-CytaBOM和MACOP-B等第三代治疗方案的初步单机构研究表明，55%-60%的患者可能得到治愈。患者和方法：为了在这些方案之间进行有效的比较，西南肿瘤组和东部合作肿瘤组启动了CHOP、m-BACOD、ProMACE-CytaBOM和MACOP-B的随机III期比较。研究的终点是反应率、治疗失败时间、总生存期和严重或危及生命的毒性。还进行了接受剂量强度计算和亚群分析。结果：1138例患者入组临床试验。每个治疗组包含218至233名符合条件的患者。已知的预后因素分布均匀。这项研究的初步结果最近发表于2010年。治疗组之间的部分缓解率和完全缓解率均无显著差异。现在，中位随访49个月，最长随访84个月，到治疗失败的时间（p = 0.40）和总生存期（p - 0.68）仍无差异。没有发现第三代方案显著改善了患者的生存。接受的剂量强度数据与先前发表的这些方案的数据相当。CHOP的致死毒性为1%，ProMACE-CytaBOM为3%，m-BACOD为5%，MACOP-B为6%。结论：基于相似的无故障生存期和总生存期，低成本和低严重毒性，CHOP仍然是晚期、中期或高度非霍奇金淋巴瘤患者的标准化疗方案。需要制定新的治疗策略来改善这些患者的预后。
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 [1]. 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.