Phase II study of docetaxel and cisplatin in patients with previously untreated metastatic non-small-cell lung cancer
Phase II study of docetaxel and cisplatin in patients with previously untreated metastatic non-small-cell lung cancer
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多西紫杉醇和顺铂治疗既往未经治疗的转移性非小细胞肺癌患者的 II 期研究
DOI：
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发表时间：
2000
影响因子：
3.3
通讯作者：
H. Niitani
中科院分区：
文献类型：
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作者：
H. Okamoto;K. Watanabe;Y. Segawa;Y. Ichinose;A. Yokoyama;S. Yoneda;H. Niitani
背景这项II期研究旨在确定低剂量多西他赛联合标准剂量顺铂治疗转移性非小细胞肺癌（NSCLC）患者的毒性和疗效。
方法.入选标准包括NSCLC转移性疾病（IV期）和体能状态（PS）为0-2。顺铂80 mg/m2第1天静脉注射，多西他赛60 mg/m2第1天静脉注射。每3 - 4周重复治疗。
结果45例患者入组研究，中位年龄为63岁。42例患者（93%）的PS为0-1，38例（84%）接受了2 - 4个疗程的化疗。主要毒副反应为中性粒细胞减少，3/4级发生率为36%/49%。其他血液学毒性为轻度。在45例患者中，仅5例患者（11%）因毒性而延迟后续化疗，仅3例患者（7%）需要调整剂量。无治疗相关死亡。非血液学毒性相对较轻。过敏（2%）、皮疹（11%）、水肿（9%）和神经病变（9%）的发生率较低，均为1级毒性。45例患者中，19例显示部分缓解，缓解率为42%。中位生存期为43.3周，所有患者的1年生存率为38.7%。
结论这种顺铂/多西他赛联合化疗是转移性NSCLC患者的一种有效且无毒的方案，这一结果表明该组合可能适用于随机对照试验。
AbstractBackground. This phase II study was designed to determine the toxicity and efficacy of a low dose of docetaxel plus a standard dose of cisplatin for patients with metastatic non-small-cell lung cancer (NSCLC).
Methods. Eligibility criteria included metastatic disease (stage IV) of NSCLC and a performance status (PS) of 0-2. Cisplatin 80 mg/m2 was given i.v. on day 1 and docetaxel 60 mg/m2 was given i.v. on day 1. Treatment was repeated every 3 to 4 weeks.
Results. Forty-five patients were enrolled in the study, and the median age was 63 years. Forty-two patients (93%) had a PS of 0-1 and 38 (84%) received two to four courses of chemotherapy. The principal toxicity was neutropenia, and grade 3/4 occurred in 36%/49%. Other hematologic toxicities were mild. Of the 45 patients, subsequent chemotherapy was delayed due to toxicities in only 5 patients (11%), and dose modifications were needed in only 3 patients (7%). There were no treatment-related deaths. Non-hematological toxicities were relatively mild. Allergy (2%), skin rash (11%), edema (9%), and neuropathy (9%) occurred infrequently, and all were grade 1 toxicity. Of the 45 patients, 19 showed partial response, giving a response rate of 42%. The median survival time was 43.3 weeks, and the 1-year survival rate of all patients was 38.7%.
Conclusion. This cisplatin/docetaxel combination chemotherapy is an active and non-toxic regimen in patients with metastatic NSCLC, a result which suggests that the combination may be suitable for randomized controlled trials.
DOI：
10.1093/jnci/83.4.288
发表时间：
1991-02-20
期刊：
JOURNAL OF THE NATIONAL CANCER INSTITUTE
影响因子：
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作者：
RINGEL, I;HORWITZ, SB
通讯作者：
HORWITZ, SB