Hesketh Paul J, McCoy Jason, Dunphy Frank R, Bearden James D, Weiss Geoffrey R, Giguere Jeffrey K, Atkins James N, Dakhil Shaker R, Kelly Karen, Crowley John J, Gandara David R
Caritas St. Elizabeth's Medical Center of Boston, Boston, MA 02135, USA.
J Thorac Oncol. 2006 Nov;1(9):991-5.
This phase II study (S9914) evaluated the efficacy and toxicity of the three-drug combination of paclitaxel, carboplatin, and topotecan with granulocyte colony-stimulating factor support in previously untreated patients with extensive stage small cell lung cancer.
Patients with newly diagnosed extensive stage small cell lung cancer received topotecan 1.0 mg/m intravenously on days 1 through 4; paclitaxel 175 mg/m intravenously on day 4, and carboplatin AUC = 5 intravenously on day 4, treatments were repeated every 21 days for a maximum of six cycles. All patients also received granulocyte colony-stimulating factor 5 mug/kg/day beginning on day 5 of each cycle.
A total of 88 patients were enrolled on the study; 79 patients were assessable for survival and toxicity and 74 patients for response. Objective response was observed in 50 patients (68%; 95% confidence interval [CI]: 56%-78%) with nine patients (12%) achieving a complete response. Median progression-free survival was 7 months (95% CI: 6-8 months) and median overall survival was 12 months (95% CI: 11-14 months). The 1- and 2-year survival rates were 48% (95% CI: 37%-59%) and 20% (95% CI: 11%-29%), respectively. The most common toxicities were hematologic. Grade 3 and 4 neutropenia was noted in 17 (22%) and 27 (34%) patients, respectively. Febrile neutropenia developed in only four patients. Two patients (3%) died of treatment-related causes.
The combination of paclitaxel, carboplatin, and topotecan combined with granulocyte colony-stimulating factor support is an active and reasonably well-tolerated regimen for the treatment of extensive stage small cell lung cancer.
本II期研究（S9914）评估了在粒细胞集落刺激因子支持下，紫杉醇、卡铂和拓扑替康三药联合方案对既往未接受过治疗的广泛期小细胞肺癌患者的疗效和毒性。
新诊断为广泛期小细胞肺癌的患者在第1至4天静脉注射拓扑替康1.0mg/m；在第4天静脉注射紫杉醇175mg/m，在第4天静脉注射卡铂AUC = 5，每21天重复治疗，最多6个周期。所有患者在每个周期的第5天开始还接受粒细胞集落刺激因子5μg/kg/天的治疗。
共有88例患者入组本研究；79例患者可评估生存和毒性，74例患者可评估疗效。50例患者（68%；95%置信区间[CI]：56%-78%）观察到客观缓解，其中9例患者（12%）达到完全缓解。中位无进展生存期为7个月（95%CI：6-8个月），中位总生存期为12个月（95%CI：11-14个月）。1年和2年生存率分别为48%（95%CI：37%-59%）和20%（95%CI：11%-29%）。最常见的毒性为血液学毒性。17例（22%）和27例（34%）患者分别出现3级和4级中性粒细胞减少。仅4例患者发生发热性中性粒细胞减少。2例患者（3%）死于治疗相关原因。
紫杉醇、卡铂和拓扑替康联合粒细胞集落刺激因子支持的方案是治疗广泛期小细胞肺癌的一种有效的、耐受性较好的方案。
