Preoperative Chemotherapy Plus Surgery Versus Surgery Plus Adjuvant Chemotherapy Versus Surgery Alone in Early-Stage Non-Small-Cell Lung Cancer
Preoperative Chemotherapy Plus Surgery Versus Surgery Plus Adjuvant Chemotherapy Versus Surgery Alone in Early-Stage Non-Small-Cell Lung Cancer
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DOI：
10.1200/jco.2009.27.6204
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发表时间：
2010-07-01
影响因子：
45.3
通讯作者：
Massuti, Bartomeu
中科院分区：
文献类型：
--
作者：
Felip, Enriqueta;Rosell, Rafael;Massuti, Bartomeu
目的探讨在可切除的非小细胞肺癌患者中，术前化疗加手术或手术加辅助化疗与单纯手术相比是否能提高无病生存率。患者和方法在这项III期试验中，624例IA期（肿瘤大小> 2 cm）、IB期、II期或T3 N1期患者被随机分配至单独手术组（212例）、术前3个周期紫杉醇-卡铂后手术组（201例）或手术后3个周期紫杉醇-卡铂辅助治疗组（211例）。主要终点是无病生存率。结果在术前手臂，97%的患者开始计划化疗，放射学反应率为53.3%。在辅助治疗组中，66.2%的患者开始了计划的化疗。94%的患者接受了手术;三组的手术操作和术后死亡率相似。术前组患者的无病生存期比单纯手术组患者的无病生存期更长（5年无病生存率为38.3% vs 34.1%;疾病进展或死亡的风险比[HR]为0.92; P = 0.176）。五年无病生存率分别为36.6%，在辅助武器与34.1%的手术手臂（HR 0.96; P = .74）。结论在早期患者，无病生存率无统计学显著差异，发现与术前或辅助化疗手术。在这项试验中，治疗决定是在手术前做出的，更多的患者能够接受术前治疗而不是辅助治疗。
PurposeTo address whether preoperative chemotherapy plus surgery or surgery plus adjuvant chemotherapy prolongs disease-free survival compared with surgery alone among patients with resectable non-small-cell lung cancer. Patients andMethodsIn this phase III trial, 624 patients with stage IA (tumor size > 2 cm), IB, II, or T3N1 were randomly assigned to surgery alone (212 patients), three cycles of preoperative paclitaxel-carboplatin followed by surgery (201 patients), or surgery followed by three cycles of adjuvant paclitaxel-carboplatin (211 patients). The primary end point was disease-free survival.ResultsIn the preoperative arm, 97% of patients started the planned chemotherapy, and radiologic response rate was 53.3%. In the adjuvant arm, 66.2% started the planned chemotherapy. Ninety-four percent of patients underwent surgery; surgical procedures and postoperative mortality were similar across the three arms. Patients in the preoperative arm had a nonsignificant trend toward longer disease-free survival than those assigned to surgery alone (5-year disease-free survival 38.3% v 34.1%; hazard ratio [HR] for progression or death, 0.92; P = .176). Five-year disease-free survival rates were 36.6% in the adjuvant arm versus 34.1% in the surgery arm (HR 0.96; P = .74).ConclusionIn early-stage patients, no statistically significant differences in disease-free survival were found with the addition of preoperative or adjuvant chemotherapy to surgery. In this trial, in which the treatment decision was made before surgery, more patients were able to receive preoperative than adjuvant treatment.