Surgery plus chemotherapy compared with surgery alone for localized squamous cell carcinoma of the thoracic esophagus: A Japan Clinical Oncology Group Study - JCOG9204
Surgery plus chemotherapy compared with surgery alone for localized squamous cell carcinoma of the thoracic esophagus: A Japan Clinical Oncology Group Study - JCOG9204
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DOI：
10.1200/jco.2003.12.095
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发表时间：
2003-12-15
影响因子：
45.3
通讯作者：
Kinjo, Y
中科院分区：
文献类型：
--
作者：
Ando, N;Iizuka, T;Kinjo, Y
目的：我们进行了一项多中心随机对照试验，以确定术后辅助化疗是否能改善食管鳞状细胞癌根治手术患者的预后。患者和方法：选取1992年7月至1997年1月间17家医院行经胸食管切除术合并淋巴结切除术的患者，随机分为单纯手术组和手术加化疗组，其中顺铂（80 mg/m(2)体表面积× 1天）和氟尿嘧啶（800 mg/m(2) × 5天）两个疗程，术后2个月内化疗。适应性分层因素为制度和淋巴结状态（pN0 vs pN1）。主要终点为无病生存期。结果：242例患者中，122例单独手术，120例手术加化疗。在手术加化疗组，91例患者（75%）接受了两个完整疗程的化疗，3级或4级血液或非血液毒性受到限制。单纯手术的5年无病生存率为45%，手术加化疗的5年无病生存率为55%（单侧log-rank， P = 0.037）。5年总生存率分别为52%和61% （P = 0.13）。在有淋巴结转移的亚组中，术后化疗显著降低了风险。结论：术后辅助化疗顺铂联合氟尿嘧啶比单纯手术更能预防食管癌复发。(C) 2003年由美国临床肿瘤学会出版。
Purpose: We performed a multicenter randomized controlled trial to determine whether postoperative adjuvant chemotherapy improves outcome in patients with esophageal squamous cell carcinoma undergoing radical surgery.Patients and Methods: Patients undergoing transthoracic esophagectomy with lymphadenectomy between July 1992 and January 1997 at 17 institutions were randomly assigned to receive surgery alone or surgery plus chemotherapy including two courses of cisplatin (80 mg/m(2) of body-surface area x 1 day) and fluorouracil (800 mg/m(2) x 5 days) within 2 months after surgery. Adaptive stratification factors were institution and lymph node status (pN0 versus pN1). The primary end point was disease-free survival.Results: Of the 242 patients, 122 were assigned to surgery alone, and 120 to surgery plus chemotherapy. In the surgery plus chemotherapy group, 91 patients (75%) received both full courses of chemotherapy, grade 3 or 4 hematologic or nonhematologic toxicities were limited. The 5-year disease-free survival rate was 45% with surgery alone, and 55% with surgery plus chemotherapy (one-sided log-rank, P =.037). The 5-year overall survival rate was 52% and 61%, respectively (P =.13). Risk reduction by postoperative chemotherapy was remarkable in the subgroup with lymph node metastasis.Conclusion: Postoperative adjuvant chemotherapy with cisplatin and fluorouracil is better able to prevent relapse in patients with esophageal cancer than surgery alone. (C) 2003 by American Society of Clinkal Oncology.