Cheng Susanna, Evans William K, Stys-Norman Denise, Shepherd Frances A
Toronto-Sunnybrook Regional Cancer Centre, Toronto, Canada.
J Thorac Oncol. 2007 Apr;2(4):348-54. doi: 10.1097/01.JTO.0000263720.15062.51.
This clinical practice guideline, based on a systematic review, evaluates chemotherapy options for patients with relapsed small cell lung cancer (SCLC).
Relevant randomized trials and meta-analyses were identified through a systematic search of the literature. External feedback was obtained from practitioners in Ontario, and the guideline was approved by the provincial lung cancer disease site group.
Six randomized trials met the eligibility criteria and were included for review. One randomized phase III trial of oral topotecan versus no treatment in patients receiving best supportive care found topotecan to have a significant benefit in terms of 6-month survival and quality of life. A randomized phase III trial compared outcomes of carboplatin in patients receiving a combination of etoposide and cisplatin (EP) and found no significant improvement associated with carboplatin, although it was associated with significantly higher grade 3/4 thrombocytopenia. Two randomized trials directly compared chemotherapy regimens (intravenous [i.v.] topotecan versus cyclophosphamide, doxorubicin, and vincristine (CAV); and bis-chloro-ethylnitrosourea, thiotepa, vincristine, and cyclophosphamide (BTOC) versus EP), but these trials found no significant differences in terms of disease response or survival. I.v. topotecan was associated with significantly higher toxicities (grade 4 thrombocytopenia and grade 3/4 anemia) and greater improvement in patient-reported symptoms compared with CAV. Two randomized trials of topotecan-treated patients comparing route of administration (i.v. versus oral) found no significant differences in terms of disease response, survival, or quality of life, although oral administration was associated with increased grade 3 or 4 diarrhea in both trials.
Evidence on the clinical benefit of second-line therapy in SCLC is limited. Topotecan is the most studied agent in this population; it has a response and survival benefit in comparison with placebo, but it also has greater toxicity in comparison with CAV. To date, significant differences in terms of response and survival are not evident in studied chemotherapy options.
本临床实践指南基于系统评价，评估复发性小细胞肺癌（SCLC）患者的化疗方案。
通过系统检索文献确定相关随机试验和荟萃分析。从安大略省的从业者处获得外部反馈，该指南经省级肺癌疾病部位组批准。
六项随机试验符合纳入标准并被纳入综述。一项关于口服拓扑替康与接受最佳支持治疗的患者不治疗的随机III期试验发现，拓扑替康在6个月生存率和生活质量方面有显著益处。一项随机III期试验比较了接受依托泊苷和顺铂（EP）联合治疗患者中卡铂的疗效，发现卡铂未带来显著改善，尽管其与3/4级血小板减少症显著增加相关。两项随机试验直接比较了化疗方案（静脉注射拓扑替康与环磷酰胺、阿霉素和长春新碱（CAV）；双氯乙基亚硝脲、噻替派、长春新碱和环磷酰胺（BTOC）与EP），但这些试验在疾病反应或生存率方面未发现显著差异。与CAV相比，静脉注射拓扑替康的毒性显著更高（4级血小板减少症和3/4级贫血），且患者报告的症状改善更大。两项比较拓扑替康治疗患者给药途径（静脉注射与口服）的随机试验在疾病反应、生存率或生活质量方面未发现显著差异，尽管两项试验中口服给药均与3级或4级腹泻增加相关。
SCLC二线治疗临床获益的证据有限。拓扑替康是该人群中研究最多的药物；与安慰剂相比，它有反应和生存获益，但与CAV相比毒性也更大。迄今为止，在研究的化疗方案中，反应和生存率方面的显著差异并不明显。
