A RANDOMIZED TRIAL OF THE 4 MOST ACTIVE REGIMENS FOR METASTATIC NON SMALL-CELL LUNG-CANCER
A RANDOMIZED TRIAL OF THE 4 MOST ACTIVE REGIMENS FOR METASTATIC NON SMALL-CELL LUNG-CANCER
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DOI：
10.1200/jco.1986.4.1.14
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发表时间：
1986-01-01
影响因子：
45.3
通讯作者：
VOGL, S
中科院分区：
文献类型：
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作者：
RUCKDESCHEL, JC;FINKELSTEIN, DM;VOGL, S
1981年10月至1983年6月，美国东部肿瘤协作组（ECOG）进行了一项前瞻性随机试验（EST 1581），对转移性非小细胞肺癌（NSCLC）的四种最有效的化疗方案进行了研究。486例体能状态良好的患者（PS 0或1; 81%）随机接受环磷酰胺、多柔比星、甲氨蝶呤和甲基苄肼（CAMP）;丝裂霉素、长春碱和顺铂（MVP）;依托泊苷和顺铂（VP-P）;或长春地辛和顺铂（VDA-P）。所有方案均按照最初报告的剂量和时间表给药。四种方案的完全缓解（CR）加部分缓解（PR）率分别为CAMP 17%、MVP 31%、VP-P 20%和VDA-P 25%。组织学类型为鳞状和腺癌的患者中MVP的缓解率显著较高，但对中位生存期（总体24.5周）无影响。有15例CR（CAMP，1例; MVP，6例; VP-P，2例; VDA-P，6例），12例患者存活超过2年。毒性显著，有20例治疗相关死亡。CAMP的毒性明显低于其他方案（P <0.001）。VDA-P显示出显著更多的危及生命（7）和致死（3）的肾毒性发作（P < .001），尽管积极的水合计划本身会导致显著的发病率。然而，毒性数据的分析显示，大多数严重毒性发生在最初为PS 2的19%的患者中，这表明他们不是新药物或组合试验的合适候选者。这些方案均不能推荐作为转移性NSCLC的标准治疗。
Between October 1981 and June 1983, the Eastern Cooperative Oncology Group (ECOG) conducted a prospectively randomized trial (EST 1581) of the four most active chemotherapy regimens for metastatic non-small-cell lung cancer (NSCLC). Four hundred eighty-six good performance status patients (PS 0 or 1; 81%) were randomized to receive cyclophosphamide, doxorubicin, methotrexate, and procarbazine (CAMP); mitomycin, vinblastine, and cisplatin (MVP): etoposide and cisplatin (VP-P); or vindesine and cis-platin (VDA-P). All regimens were administered in the doses and schedules originally reported. Complete response (CR) plus partial response (PR) rates for the four regimens were CAMP, 17%, MVP, 31%; VP-P 20%; and VDA-P, 25%. The response rate for MVP was significantly higher in patients with squamous and adenocarcinoma histologies, but there was no impact on median survival (overall 24.5 weeks). The duration of response did not differ by treatment as previously suggested for VDA-P. There were 15 CRs (CAMP, one; MVP, six; VP-P, two; VDA-P, six), and 12 patients have survived more than 2 years. Toxicity was significant with 20 treatment-related deaths. CAMP was significantly less toxic than the other regimens (P < .001). VDA-P demonstrated significantly more life-threatening (seven) and lethal (three) episodes of nephrotoxicity (P < .001) despite an aggressive hydration program that in itself caused significant morbidity. Analysis of the toxicity data showed, however, that most of the severe toxicity occurred in the 19% of patients who were initially PS 2, suggesting that they are not appropriate candidates for trials of new agents or combinations. None of these regimens can be recommended as a standard therapy for metastatic NSCLC.