Chemotherapy followed by surgery versus surgery alone in patients with resectable oesophageal squamous cell carcinoma: long-term results of a randomized controlled trial.
Chemotherapy followed by surgery versus surgery alone in patients with resectable oesophageal squamous cell carcinoma: long-term results of a randomized controlled trial.
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DOI：
10.1186/1471-2407-11-181
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发表时间：
2011-05-19
期刊：
影响因子：
3.8
通讯作者：
van der Gaast A
中科院分区：
文献类型：
--
作者：
Boonstra JJ;Kok TC;Wijnhoven BP;van Heijl M;van Berge Henegouwen MI;Ten Kate FJ;Siersema PD;Dinjens WN;van Lanschot JJ;Tilanus HW;van der Gaast A
这是一项对接受食管鳞状细胞癌 (OSCC) 手术的患者进行术前化疗的随机对照试验。患者被分配接受化疗，包括2-4个周期的顺铂和依托泊苷，然后进行手术（CS组）或单独手术（S组）。 1997 年仅以摘要形式报告的初步结果证明了 CS 组总体生存的优势。该试验的结果已在本研究进行的时间范围内更新和讨论。该试验招募了 169 名 OSCC 患者，其中 85 名患者接受术前化疗，84 名患者接受立即手术。主要研究终点是总生存期（OS），次要终点是无病生存期（DFS）和失败模式。生存率是根据卡普兰-迈耶曲线和对数秩检验进行的治疗比较来确定的。死亡人数为 148 人，其中 CS 组 71 人，S 组 77 人。 CS 组的中位 OS 时间为 16 个月，而 S 组为 12 个月； 2年生存率分别为42%和30%； 5年生存率和5年生存率分别为26%和17%。意向治疗分析显示，CS 组患者的总体生存获益显着（通过对数秩检验，P = 0.03；风险比 [HR] 0.71；95%CI 0.51-0.98）。 CS 组的 DFS（从随机化日期后 6 个月的标志性时间开始）也优于 S 组（P = 0.02，根据对数秩检验；HR 0.72；95%CI 0.52-1.0）。两个治疗组之间没有观察到失败模式的差异。术前联合依托泊苷和顺铂化疗可显着改善 OSCC 患者的总生存期。
This is a randomized, controlled trial of preoperative chemotherapy in patients undergoing surgery for oesophageal squamous cell carcinoma (OSCC). Patients were allocated to chemotherapy, consisting of 2-4 cycles of cisplatin and etoposide, followed by surgery (CS group) or surgery alone (S group). Initial results reported only in abstract form in 1997, demonstrated an advantage for overall survival in the CS group. The results of this trial have been updated and discussed in the timeframe in which this study was performed. This trial recruited 169 patients with OSCC, 85 patients assigned to preoperative chemotherapy and 84 patients underwent immediate surgery. The primary study endpoint was overall survival (OS), secondary endpoints were disease free survival (DFS) and pattern of failure. Survival has been determined from Kaplan-Meier curves and treatment comparisons made with the log-rank test. There were 148 deaths, 71 in the CS and 77 in the S group. Median OS time was 16 months in the CS group compared with 12 months in the S group; 2-year survival rates were 42% and 30%; and 5-year survival rates were 26% and 17%, respectively. Intention to treat analysis showed a significant overall survival benefit for patients in the CS group (P = 0.03, by the log-rank test; hazard ratio [HR] 0.71; 95%CI 0.51-0.98). DFS (from landmark time of 6 months after date of randomisation) was also better in the CS-group than in the S group (P = 0.02, by the log-rank test; HR 0.72; 95%CI 0.52-1.0). No difference in failure pattern was observed between both treatment arms. Preoperative chemotherapy with a combination of etoposide and cisplatin significantly improved overall survival in patients with OSCC.
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