Georgoulias V, Kouroussis C, Androulakis N, Kakolyris S, Dimopoulos M A, Papadakis E, Bouros D, Apostolopoulou F, Papadimitriou C, Agelidou A, Hatzakis K, Kalbakis K, Kotsakis A, Vardakis N, Vlachonicolis J
Department of Medical Oncology, School of Medicine, University of Crete, Heraklion, Greece.
J Clin Oncol. 1999 Mar;17(3):914-20. doi: 10.1200/JCO.1999.17.3.914.
To evaluate the tolerance and efficacy of the combination of docetaxel and gemcitabine in patients with advanced non-small-cell lung cancer (NSCLC).
Fifty-one chemotherapy-naive patients with NSCLC were treated with gemcitabine 900 mg/m2 intravenously on days 1 and 8 and docetaxel 100 mg/m2 intravenously on day 8 with granulocyte colony-stimulating factor (150 microg/m2, subcutaneously) support from day 9 to day 15. Treatment was repeated every 3 weeks.
The patients' median age was 64 years. The World Health Organization performance status was 0 to 1 in 39 patients and 2 in 12 patients. Fifteen patients (29%) had stage IIIB disease, and 36 (71%) had stage IV; histology was mainly squamous cell carcinoma (59%). A partial response was achieved in 19 patients (37.5%; 95% confidence interval, 24% to 50%); stable disease and progressive disease were each observed in 16 patients (31.4%). The median duration of response and the time to tumor progression were 5 and 6 months, respectively. The median survival was 13 months, and the actuarial 1-year survival was 50.7%. Grade 4 anemia and thrombocytopenia were rare (2%). Four patients (8%) developed grade 3 or 4 neutropenia, and all were complicated with fever; there was no treatment-related death. Grade 3 or 4 diarrhea occurred in three patients (6%), grade 2 or 3 neurotoxicity in four patients (8%), grade 2 or 3 asthenia in 10 patients (20%), and grade 2 or 3 edema in 10 patients (20%).
The combination of docetaxel/gemcitabine is well tolerated, can be used for outpatients, and is active for the treatment of advanced NSCLC. This treatment merits further comparison with other cisplatin- or carboplatin-based combinations.
评估多西他赛与吉西他滨联合用药治疗晚期非小细胞肺癌（NSCLC）患者的耐受性和疗效。
51例初治的NSCLC患者，在第1天和第8天静脉注射吉西他滨900mg/m²，并在第8天静脉注射多西他赛100mg/m²，从第9天至第15天给予粒细胞集落刺激因子（150μg/m²，皮下注射）支持。每3周重复治疗。
患者的中位年龄为64岁。世界卫生组织体能状态评分为0至1分的患者有39例，评分为2分的患者有12例。15例患者（29%）为ⅢB期疾病，36例患者（71%）为Ⅳ期；组织学类型主要为鳞状细胞癌（59%）。19例患者（37.5%；95%置信区间为24%至50%）获得部分缓解；16例患者（31.4%）疾病稳定，16例患者（31.4%）疾病进展。缓解持续时间的中位数和肿瘤进展时间分别为5个月和6个月。中位生存期为13个月，1年总生存率为50.7%。4级贫血和血小板减少症罕见（2%）。4例患者（8%）发生3级或4级中性粒细胞减少，且均伴有发热；无治疗相关死亡。3例患者（6%）发生3级或4级腹泻，4例患者（8%）发生2级或3级神经毒性，10例患者（20%）发生2级或3级乏力，10例患者（20%）发生2级或3级水肿。
多西他赛/吉西他滨联合用药耐受性良好，可用于门诊患者，对晚期NSCLC治疗有效。该治疗方法值得与其他基于顺铂或卡铂的联合用药方案进行进一步比较。
