Thomas P, Castelnau O, Paillotin D, Léna H, Robinet G, Muir J F, Delaval P, Gouva S, Balmes P, Blanchon F, Perdu D, Poirier R, Pommier De Santi P, Penot-Ragon C, Kleisbauer J P
Service d'Oncologie Respiratoire and Pharmacie, Hôpital Sainte-Marguerite, Marseille, France.
J Clin Oncol. 2001 Mar 1;19(5):1320-5. doi: 10.1200/JCO.2001.19.5.1320.
To evaluate the efficacy and safety of paclitaxel and carboplatin in the treatment of previously untreated patients with metastatic small-cell lung cancer (SCLC).
Eligible patients were aged 18 to 75 years with an Eastern Cooperative Oncology Group (ECOG) score < or = 2 and life expectancy > or = 12 weeks. Paclitaxel (200 mg/m(2)) was infused over 3 hours, before carboplatin (area under the curve [AUC] 6; Calvert formula) infused over 1 hour, once every 3 weeks for six cycles maximum. Prednisolone, dexchlorpheniramine, and ranitidine were standard premedication. Response to treatment was assessed every two cycles, and nonresponding patients were withdrawn from the trial to receive standard chemotherapy.
Of the 50 patients entering the study, 48 and 46 patients were assessable for toxicity and response, respectively. The overall response rate was 65%, with complete responses in three patients. Five patients had stable disease (11%) and 11 patients experienced progressive disease (24%). Median survival was 38 weeks, and median duration of response was 20 weeks. One-year survival was 22.5%. For a total of 232 cycles, grade 3 and 4 toxicity was 33% for neutropenia, 3.5% for thrombocytopenia, and 4% for anemia. Four patients had neutropenic fever (one toxic death). Nonhematologic toxicity was mainly grade 1 and 2 paresthesia (21% of patients); grade 3 myalgia/arthralgia was observed in 6.5% of patients.
First-line chemotherapy with paclitaxel and carboplatin in metastatic SCLC achieved a response rate and survival similar to standard regimens. With 1-day administration and a tolerable toxicity profile, this combination merits further investigation.
评估紫杉醇和卡铂治疗既往未接受过治疗的转移性小细胞肺癌（SCLC）患者的疗效和安全性。
符合条件的患者年龄在18至75岁之间，东部肿瘤协作组（ECOG）评分≤2且预期寿命≥12周。紫杉醇（200mg/m²）静脉滴注3小时，随后卡铂（曲线下面积[AUC]6；卡尔弗特公式）静脉滴注1小时，每3周1次，最多6个周期。泼尼松龙、右氯苯那敏和雷尼替丁为标准预处理药物。每两个周期评估一次治疗反应，无反应的患者退出试验接受标准化疗。
50例入组患者中，分别有48例和46例可评估毒性和反应。总缓解率为65%，3例患者完全缓解。5例患者疾病稳定（11%），11例患者疾病进展（24%）。中位生存期为38周，中位缓解持续时间为20周。1年生存率为22.5%。在总共232个周期中，3级和4级毒性中，中性粒细胞减少为33%，血小板减少为3.5%，贫血为4%。4例患者发生中性粒细胞减少性发热（1例毒性死亡）。非血液学毒性主要为1级和2级感觉异常（21%的患者）；6.5%的患者出现3级肌痛/关节痛。
紫杉醇和卡铂一线化疗治疗转移性SCLC的缓解率和生存率与标准方案相似。由于采用1天给药且毒性可耐受，该联合方案值得进一步研究。
