Le Chevalier T, Monnier A, Douillard J Y, Ruffie P, Sun X S, Belli L, Ibrahim N, Bougon N, Bérille J
Institut Gustave Roussy, Villejuif, France.
Eur J Cancer. 1998 Dec;34(13):2032-6. doi: 10.1016/s0959-8049(98)00287-1.
The activity of the combination of intravenous docetaxel 75 mg/m2 plus cisplatin 100 mg/m2 administered every 3 weeks for 3 cycles then every 6 weeks was investigated in 51 chemotherapy naive patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). The population was 92% male, with a median age of 54 years and median performance status of 1; 80% of patients had metastatic disease, including 37% with bone involvement. All patients received prophylactic premedication (ondansetron, dexamethasone plus cetirizine) and standard hyperhydration. With a median of 4 treatment cycles (range 1-9), 14 of 42 evaluable patients responded (overall response rate 33.3%, 95% CI 19.6-49.6%); the median response duration was 7.3 months, median survival 8.4 months, and 1-year survival rate 35%. The most common adverse event was neutropenia, occurring in two-thirds of patients. Neurosensory effects were cumulative but generally mild. No treatment-related deaths occurred. This combination of docetaxel/cisplatin showed activity in advanced NSCLC. While it was not clearly superior to single-agent docetaxel, due to differences in prognostic factors among the patients in open trials, a randomised study would be needed to demonstrate definitively whether cisplatin adds to the activity of docetaxel or not.
对51例初治的局部晚期或转移性非小细胞肺癌(NSCLC)患者研究了静脉注射多西他赛75mg/m²加顺铂100mg/m²的联合方案,每3周给药1次,共3个周期,之后每6周给药1次的活性。患者群体中92%为男性,中位年龄54岁,中位体能状态为1;80%的患者有转移性疾病,其中37%有骨转移。所有患者均接受预防性预处理(昂丹司琼、地塞米松加西替利嗪)和标准的水化治疗。中位治疗周期数为4个(范围1 - 9),42例可评估患者中有14例有反应(总缓解率33.3%,95%CI 19.6 - 49.6%);中位缓解持续时间为7.3个月,中位生存期8.4个月,1年生存率35%。最常见的不良事件是中性粒细胞减少,三分之二的患者发生。神经感觉效应有累积性但一般较轻。未发生与治疗相关的死亡。多西他赛/顺铂这种联合方案在晚期NSCLC中显示出活性。虽然它并不明显优于单药多西他赛,但由于开放试验中患者预后因素存在差异,需要进行随机研究来明确顺铂是否能增强多西他赛的活性。