Long-Term Results of a Randomized Trial of Surgery With or Without Preoperative Chemotherapy in Esophageal Cancer
Long-Term Results of a Randomized Trial of Surgery With or Without Preoperative Chemotherapy in Esophageal Cancer
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DOI：
10.1200/jco.2009.22.2083
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发表时间：
2009-10-20
影响因子：
45.3
通讯作者：
Langley, Ruth E.
中科院分区：
文献类型：
--
作者：
Allum, William H.;Stenning, Sally P.;Langley, Ruth E.
目的
OEO2是一项针对食管癌根治性手术患者术前化疗的随机对照试验。随机分组为单纯手术组（S）或术前接受两个周期顺铂和氟尿嘧啶联合化疗组（CS）。2002年报道的初步结果显示CS组在无病生存期和总生存期方面均具有优势。在中位随访6年后，现对分析结果进行了更新。
患者与方法
OEO2招募了802名患者，其中400名在CS组，402名在S组。详细记录了首次复发事件的性质和死亡原因。通过卡普兰 - 迈耶曲线确定生存期，并使用对数秩检验进行治疗比较。展示了按切除范围划分的生存期。
结果
共有655例死亡，S组335例，CS组320例。生存优势得以维持，风险比（HR）为0.84（95%置信区间，0.72 - 0.98；P = 0.03），绝对而言，CS组的5年生存率为23.0%，而S组为17.1%。在腺癌和鳞状细胞癌中治疗效果一致。首次无病生存期事件为不完全切除（R2）导致的肉眼可见残留病灶或未切除，S组为26.4%，而CS组为14.3%，P < 0.001。按切除类型划分的3年生存率，R0为42.4%，R1为18.0%，R2为8.6%。
结论
长期随访证实术前化疗可提高可手术食管癌患者的生存率，应被视为一种标准治疗方法。
PurposeOEO2 is a randomized, controlled trial of preoperative chemotherapy in patients undergoing radical surgery for esophageal cancer. Random assignment was to surgery alone (S) or to two cycles of combination cisplatin and fluorouracil before surgery (CS). Initial results reported in 2002 demonstrated an advantage for both disease-free and overall survival in the CS group. The analysis has now been updated after a median follow-up of 6 years.Patients and MethodsOEO2 recruited 802 patients, 400 on CS and 402 on S. The nature of the first recurrence event and cause of death are detailed. Survival has been determined from Kaplan-Meier curves and treatment comparisons made with the log-rank test. Survival by extent of resection is presented.ResultsThere were 655 deaths, 335 for S and 320 for CS. The survival benefit has been maintained with a hazard ratio (HR) of 0.84 (95% CI, 0.72 to 0.98; P = .03) which in absolute terms is a 5-year survival of 23.0% for CS compared with 17.1% for S. The treatment effect is consistent in both adenocarcinoma and squamous cell carcinoma. The first disease-free survival event was macroscopic residual disease from incomplete resection (R2) or no resection in 26.4% of the S group versus 14.3% of the CS P < .001. Three-year survival by type of resection was R0 42.4%, R1 was 18.0%, and R2 was 8.6%.ConclusionLong-term follow-up confirms that preoperative chemotherapy improves survival in operable esophageal cancer and should be considered as a standard of care.