A RANDOMIZED TRIAL TO COMPARE INTRAVENOUS AND ORAL ETOPOSIDE IN COMBINATION WITH CISPLATIN FOR THE TREATMENT OF SMALL-CELL LUNG-CANCER
A RANDOMIZED TRIAL TO COMPARE INTRAVENOUS AND ORAL ETOPOSIDE IN COMBINATION WITH CISPLATIN FOR THE TREATMENT OF SMALL-CELL LUNG-CANCER
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DOI：
10.1002/1097-0142(19910101)67:1
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发表时间：
1991-01-01
期刊：
影响因子：
6.2
通讯作者：
LOKICH, J
中科院分区：
文献类型：
--
作者：
JOHNSON, DH;RUCKDESCHEL, JC;LOKICH, J
在一项随机多中心研究中，83例小细胞肺癌患者被随机分配到顺铂100mg /m2静脉注射（IV）第1天，依托泊苷120mg /m2静脉注射第1、2和3天，或顺铂100mg /m2静脉注射第1天，依托泊苷120mg /m2静脉注射第1天，240 mg/m2口服第2和3天。两种方案每4周重复一次。在随机化之前，患者按疾病程度、运动状态和性别分层。共有41例患者被随机分配到单肠外治疗方案，42例患者接受顺铂和IV/口服依托泊苷治疗。两个治疗组在患者特征方面具有可比性。局限性疾病（LD）患者分别占口服和静脉注射依托泊苷方案患者总数的52%和49%。口服依托泊苷方案的总完全缓解率（CR）和部分缓解率（PR）为50%(95%可信区间[CI] 35%至65%)，静脉注射依托泊苷方案的总完全缓解率（CR）为59% (95% CI 44%至74%)（P = 0.438）。在两种方案中，55%的LD患者达到了CR或PR。两个治疗组的进展时间和生存期相当。两个治疗组的血液学毒性相当，80%的患者出现3级或4级中性粒细胞减少或血小板减少。与口服方案相比，静脉注射方案以中度至重度贫血和体重减轻为主。
In a randomized multi-center study, 83 patients with small cell lung cancer were randomly assigned to treatment with cisplatin 100 mg/m2 intravenously (IV) day 1 and etoposide 120 mg/m2 IV days 1, 2, and 3 or cisplatin 100 mg/m2 IV day 1 and etoposide 120 mg/m2 IV day 1 and 240 mg/m2 orally days 2 and 3. Both regimens were repeated every 4 weeks. Prior to randomization, patients were stratified by extent of disease, performance status, and gender. A total of 41 patients were randomly assigned to the parenteral treatment only regimen, and 42 patients received cisplatin and IV/oral etoposide therapy. Both treatment arms were comparable regarding patient characteristics. Limited disease (LD) patients constituted 52% and 49% of the patient population for the oral and IV etoposide regimens, respectively. The overall complete response (CR) and partial response (PR) rate was 50% (95% confidence interval [CI] 35% to 65%) for the oral etoposide regimen and 59% (95% CI 44% to 74%) for the IV etoposide regimen (P = 0.438). For both regimens, 55% of the LD patients achieved either CR or PR. Time to progression and survival were comparable for both treatment arms. Hematologic toxicity was comparable in both treatment arms, with 80% of patients experiencing grade 3 or 4 neutropenia or thrombocytopenia. Moderate to severe anemia and weight loss were more predominant with the IV than with the oral regimen.