Androulakis N, Kouroussis C, Kakolyris S, Tzannes S, Papadakis E, Papadimitriou C, Geroyianni A, Georgopoulou T, Dimopoulou I, Souglakos J, Kotsakis A, Vardakis N, Hatzidaki D, Georgoulias V
Department of Medical Oncology, School of Medicine, University of Crete, Greece.
Ann Oncol. 1998 Oct;9(10):1127-30. doi: 10.1023/a:1008497322508.
To evaluate the tolerance and efficacy of the combination of paclitaxel and gemcitabine as salvage treatment in patients with advanced non-small-cell lung cancer (NSCLC).
Forty-nine patients with measurable NSCLC (PS 0-1: 80%; stage IV: 84%) who progressed or failed first-line chemotherapy were enrolled. Prior chemotherapy was cisplatin-based with (n = 20) or without (n = 22) docetaxel and docetaxel-vinorelbine (n = 7). Patients received gemcitabine (900 mg/m2 i.v.; days 1 and 8) and paclitaxel (175 mg/m2; day 8) every three weeks: G-CSF (150 micrograms/m2/day s.c.; days 9-15) was given prophylactically to all patients.
One (2%) complete and eight (16%) partial responses were achieved (overall response 18%; 95% CI: 4%-24%); 14 patients (29%) had stable disease and 26 (53%) progressive disease. Six responses were observed in 17 patients who responded to first-line chemotherapy. The median duration of response was seven months, the median TTP eight months and the median survival 11 months. The one-year survival rate was 37%. Grade 3-4 neutropenia occured in six (12%) patients, grade 2-3 neurotoxicity in 16 (32%) and grade 2-3 asthenia in 25 (51%). Other toxicities were mild.
The paclitaxel-gemcitabine combination is a well-tolerated and relatively active salvage regimen in patients with NSCLC and it merits further investigation.
评估紫杉醇与吉西他滨联合方案作为晚期非小细胞肺癌（NSCLC）挽救治疗的耐受性和疗效。
纳入49例一线化疗进展或失败的可测量NSCLC患者（PS 0 - 1：80%；IV期：84%）。既往化疗以顺铂为基础，联合多西他赛（n = 20）或不联合（n = 22）多西他赛以及多西他赛 - 长春瑞滨（n = 7）。患者每三周接受吉西他滨（900 mg/m²静脉注射；第1天和第8天）和紫杉醇（175 mg/m²；第8天）治疗：所有患者均预防性给予G - CSF（150微克/m²/天皮下注射；第9 - 15天）。
获得1例（2%）完全缓解和8例（16%）部分缓解（总缓解率18%；95%可信区间：4% - 24%）；14例患者（29%）病情稳定，26例（53%）病情进展。17例对一线化疗有反应的患者中观察到6例缓解。中位缓解持续时间为7个月，中位无进展生存期为8个月，中位生存期为11个月。1年生存率为37%。6例（12%）患者发生3 - 4级中性粒细胞减少，16例（32%）发生2 - 3级神经毒性，25例（51%）发生2 - 3级乏力。其他毒性反应较轻。
紫杉醇 - 吉西他滨联合方案在NSCLC患者中耐受性良好且相对有效，值得进一步研究。
