Paclitaxel and carboplatin in inoperable non-small-cell lung cancer: A phase II study
Paclitaxel and carboplatin in inoperable non-small-cell lung cancer: A phase II study
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DOI：
10.1023/a:1008268911935
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发表时间：
1997-07-01
影响因子：
50.5
通讯作者：
Skarlos, D
中科院分区：
文献类型：
--
作者：
Kosmidis, PA;Mylonakis, N;Skarlos, D
背景：基于单药紫杉醇的高活性和卡铂治疗非小细胞肺癌（NSCLC）患者一年生存率的优势，一项II期试验开始在无法手术的III期和IV期疾病患者中使用这两种药物，以研究联合用药的疗效和毒性。患者和方法：自1995年7月起，60例符合所有入选标准的患者进入本研究。所有患者均接受紫杉醇175 mg/m(2) 3小时输注，卡铂每3周给药至浓度-时间曲线下7的区域。未给予粒细胞集落刺激因子。在56名男性和4名女性患者中，中位年龄为57岁（范围29至75岁），东部Go-Operative Oncology Group的中位表现状态为1。大多数患者为IV期腺癌（34例），31例为低分化腺癌（28例）。化疗周期的中位数为3个，范围为1到8个。结果：55例可评估患者中，15例（27.3%）获得部分缓解，15例（27.3%）病情稳定，25例（45.4%）病情进展。中位生存期为8.95个月，21.6%的患者存活1年以上。2/3级非血液学毒性包括脱发（59%）、神经毒性（3%）和肌痛/关节痛（10%）。213级中性粒细胞减少发生率为14%，而3/4级血小板减少发生率仅为4%。一名患者死于严重过敏反应的并发症。结论：紫杉醇联合卡铂治疗不能手术的非小细胞肺癌疗效好，耐受性好。紫杉醇的剂量-反应关系以及与其他铂基方案的比较结果仍有待确定。
Background: Based on the high activity of single-agent paclitaxel and the superior one-year survival rates of patients with non-small-cell lung cancer (NSCLC) treated with carboplatin, a phase II trial was initiated using both agents in patients with inoperable stages III and IV disease to investigate the efficacy and toxicity of the combination.Patients and methods: Since July 1995, 60 patients fulfilling all eligibility criteria entered this study. All patients received paclitaxel 175 mg/m(2) as a three-hour infusion, and carboplatin dosed to an area under the concentration-time curve of seven, every three weeks. No granulocyte colony-stimulating factor was given. Of the 56 male and four female patients, the median age was 57 years (range 29 to 75 years) and the median Eastern Go-Operative Oncology Group performance status was one. Most of the patients had stage IV (34) adenocarcinoma (31) with low differentiation (28). The median number of chemotherapy cycles was three, with a range of one to eight.Results: Of 55 evaluable patients, 15 (27.3%) achieved partial responses, 15 (27.3%) had stable disease, and 25 (45.4%) had progressive disease. The median survival was 8.95 months and 21.6% of the patients survived more than one year. Grade 2/3 nonhematologic toxicity included alopecia (59%), neurotoxicity (3%), and myalgia/arthralgia (10%). Grade 213 neutropenia occurred in 14% of patients, whereas grade 3/4 thrombocytopenia was seen in only 4%. One patient died of complications of a severe allergic reaction.Conclusion: Combination treatment using paclitaxel and carboplatin is active and well tolerated in patients with inoperable non-small-cell lung cancer. The dose-response relationship to paclitaxel and results of comparison with other platinum-based regimens remain to be determined.