Bosset J F, Gignoux M, Triboulet J P, Tiret E, Mantion G, Elias D, Lozach P, Ollier J C, Pavy J J, Mercier M, Sahmoud T
University Hospital J. Minjoz, Besançon, France.
N Engl J Med. 1997 Jul 17;337(3):161-7. doi: 10.1056/NEJM199707173370304.
We conducted a multicenter, randomized trial to compare preoperative chemoradiotherapy followed by surgery with surgery alone in patients with stage I and II squamous-cell cancer of the esophagus.
The preoperative combined therapy consisted of two one-week courses; each involved radiotherapy, in a dose of 18.5 Gy delivered in five fractions of 3.7 Gy each, and 80 mg of cisplatin per square meter of body-surface area, administered 0 to 2 days before the first day of radiotherapy. The surgical plan included one-stage en bloc esophagectomy and proximal gastrectomy by the abdominal and right thoracic routes, to be performed immediately after randomization in the group assigned to surgery alone and two to four weeks after the completion of preoperative chemoradiotherapy in the group assigned to combined therapy.
A total of 297 patients entered the study; 11 were found to be ineligible, and 4 were lost to follow-up. Of the remaining 282, 139 were assigned to surgery alone and 143 to combined therapy. After a median follow-up of 55.2 months, no significant difference in overall survival was observed; the median survival was 18.6 months for both groups. As compared with the group treated with surgery alone, the group treated preoperatively had longer disease-free survival (P=0.003), a longer interval free of local disease (P=0.01), a lower rate of cancer-related deaths (P=0.002), and a higher frequency of curative resection (P=0.017). However, there were more postoperative deaths (P=0.012) in the group treated preoperatively with chemoradiotherapy. Three prognostic factors were found to influence survival in a multivariate analysis: the disease stage, based on computed tomography; the location of the tumor; and whether the surgical resection was curative.
In patients with squamous-cell esophageal cancer, preoperative chemoradiotherapy did not improve overall survival, but it did prolong disease-free survival and survival free of local disease.
我们开展了一项多中心随机试验，比较术前放化疗后手术与单纯手术治疗I期和II期食管鳞状细胞癌患者的疗效。
术前联合治疗包括两个为期一周的疗程；每个疗程包括放疗，剂量为18.5 Gy，分5次给予，每次3.7 Gy，以及每平方米体表面积80 mg顺铂，在放疗第一天前0至2天给药。手术方案包括经腹和右胸途径进行一期整块食管切除术和近端胃切除术，在单纯手术组随机分组后立即进行，在联合治疗组术前放化疗完成后2至4周进行。
共有297例患者进入研究；11例被发现不符合条件，4例失访。其余282例中，139例被分配至单纯手术组，143例被分配至联合治疗组。中位随访55.2个月后，未观察到总生存期有显著差异；两组的中位生存期均为18.6个月。与单纯手术治疗组相比，术前治疗组的无病生存期更长（P = 0.003），无局部疾病间隔期更长（P = 0.01），癌症相关死亡率更低（P = 0.002），根治性切除频率更高（P = 0.017）。然而，术前接受放化疗的组术后死亡更多（P = 0.012）。多因素分析发现三个预后因素影响生存：基于计算机断层扫描的疾病分期、肿瘤位置以及手术切除是否为根治性。
对于食管鳞状细胞癌患者，术前放化疗并未改善总生存期，但确实延长了无病生存期和无局部疾病生存期。
