Georgoulias V, Kourousis C, Kakolyris S, Androulakis N, Dimopoulos M A, Papadakis E, Kotsakis T, Vardakis N, Kalbakis K, Merambeliotakis N, Hatzidaki D
Department of Medical Oncology, University of Crete, Greece.
Semin Oncol. 1997 Aug;24(4 Suppl 12):S12-61-S12-66.
A phase II study of combination paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ)/gemcitabine was conducted in patients with non-small cell lung cancer (NSCLC) who had failed first-line docetaxel- or cisplatin-based chemotherapy. Eligibility criteria included histologically confirmed measurable stage IIIB or IV NSCLC and previous exposure to docetaxel- or cisplatin-based regimens, World Health Organization performance status between 0 and 2, adequate hematologic parameters, and adequate hepatic, renal, and cardiac function. Gemcitabine (900 mg/m2) was given on days 1 and 8 as a 30-minute infusion; paclitaxel (175 mg/m2) was administered on day 8 as a 3-hour infusion after appropriate premedication. Granulocyte colony-stimulating factor (150 microg/m2 subcutaneously) was given on days 9 to 15. Treatment was repeated every 3 weeks until patients experienced disease progression. From October 1995 to December 1996, 26 patients with advanced NSCLC were enrolled (three stage IIIB, 23 stage IV). All 26 patients were assessable for toxicity, and 24 were evaluable for response. Two complete (8%) and five partial (21%) responses were observed, for an overall response rate of 29% (95% confidence interval, 11% to 47%). The median duration of response was 2.5 months and the median survival was 8 months. A median of three courses per patient was administered, and the median interval between courses was 21 days. The median delivered dose was 579 mg/m2/wk gemcitabine and 54.5 mg/m2/wk paclitaxel, corresponding to a relative dose intensity of 0.97 and 0.96, respectively. Grade 3/4 neutropenia occurred in two patients (8%). Grade 3 conjunctivitis occurred in one (4%) patient and grade 2/3 neurotoxicity in eight (31%) patients. Grade 3/4 and grade 2 fatigue occurred in four (15%) and eight (31%) patients, respectively. Other toxicities were mild to moderate. These preliminary results suggest that the paclitaxel/gemcitabine combination is an active and well-tolerated salvage regimen in patients with NSCLC previously treated with docetaxel- or cisplatin-based chemotherapy. The paclitaxel/gemcitabine combination merits further evaluation as first-line treatment.
对一线多西他赛或顺铂为基础的化疗失败的非小细胞肺癌（NSCLC）患者进行了一项紫杉醇（泰素；百时美施贵宝公司，新泽西州普林斯顿）/吉西他滨联合用药的II期研究。入选标准包括组织学确诊的可测量的IIIB期或IV期NSCLC，以及既往接受过多西他赛或顺铂为基础的治疗方案，世界卫生组织体能状态评分为0至2，血液学参数正常，肝、肾和心功能正常。吉西他滨（900mg/m²）于第1天和第8天静脉滴注30分钟；紫杉醇（175mg/m²）在第8天经适当预处理后静脉滴注3小时。第9至15天皮下注射粒细胞集落刺激因子（150μg/m²）。每3周重复治疗，直至患者病情进展。1995年10月至1996年12月，纳入26例晚期NSCLC患者（3例IIIB期，23例IV期）。所有26例患者均进行了毒性评估，24例进行了疗效评估。观察到2例完全缓解（8%）和5例部分缓解（21%），总缓解率为29%（95%置信区间，11%至47%）。中位缓解持续时间为2.5个月，中位生存期为8个月。每位患者中位接受3个疗程的治疗，疗程之间的中位间隔为21天。吉西他滨的中位给药剂量为579mg/m²/周，紫杉醇为54.5mg/m²/周，相对剂量强度分别为0.97和0.96。2例患者（8%）发生3/4级中性粒细胞减少。1例患者（4%）发生3级结膜炎，8例患者（31%）发生2/3级神经毒性。4例患者（15%）发生3/4级疲劳，8例患者（31%）发生2级疲劳。其他毒性为轻度至中度。这些初步结果表明，紫杉醇/吉西他滨联合用药对于既往接受多西他赛或顺铂为基础化疗的NSCLC患者是一种有效的且耐受性良好的挽救方案。紫杉醇/吉西他滨联合用药作为一线治疗值得进一步评估。
