Perioperative versus Preoperative Chemotherapy with Surgery in Patients with Resectable Squamous Cell Carcinoma of Esophagus A Phase III Randomized Trial
Perioperative versus Preoperative Chemotherapy with Surgery in Patients with Resectable Squamous Cell Carcinoma of Esophagus A Phase III Randomized Trial
复制标题
DOI：
10.1097/jto.0000000000000612
复制
发表时间：
2015-09-01
影响因子：
20.4
通讯作者：
Wang, XiJing
中科院分区：
文献类型：
--
作者：
Zhao, Yang;Dai, ZhiJun;Wang, XiJing
背景：可切除食管鳞状细胞癌的围手术期化疗仍然是一个难题。因此，我们评估了与术前单独化疗相比，紫杉醇、顺铂和5-氟尿嘧啶（PCF）围手术期方案是否改善了可治愈食管鳞状细胞癌患者的预后。总的来说，346例可切除的食管鳞状细胞癌患者被随机分配接受手术加围手术期化疗（175，A组）或术前化疗（171，B组）。两组患者术前均接受两个周期的PCF治疗：第1天静脉注射紫杉醇（100 mg/m2体表面积）和顺铂（60 mg/m2体表面积），并持续静脉输注5-氟尿嘧啶（700 mg/m2体表面积/天）5天。A组接受了两个额外的术后PCF周期。主要终点为无复发生存期，次要终点为总生存期。结果：与术前化疗组相比，围手术期化疗组5年无复发生存的可能性更大（复发的风险比，0.62; 95%可信区间，0.49-0.73; 31%对17%，p < 0.001）和5年总生存率（死亡风险比，0.79; 95%置信区间，0.59-0.95; 38%对22%，p < 0.001）。在320例化疗后接受切除术的患者中，77例（24.1%）实现了病理完全缓解率。增加PCF相关的毒性事件没有检测到与增加两个术后周期的PCF。结论：在可手术的食管鳞癌患者，PCF的围手术期方案可以显着提高5年无复发和总生存率相比，术前化疗。(The试验已在ClinicalTrials.gov上注册，编号为NCT 01225523）。
Background: Perioperative chemotherapy for resectable squamous cell carcinoma of esophagus remains elusive. Thus, we assessed whether a perioperative regimen of paclitaxel, cisplatin, and 5- fluorouracil (PCF) improved outcomes among patients with curable squamous cell carcinoma of esophagus comparing with preoperative chemotherapy alone.Methods: Overall, 346 patients with resectable squamous cell carcinoma of esophagus were randomly assigned to receive surgery plus perioperative chemotherapy (175, arm A) or preoperative chemotherapy (171, arm B). Both arms received two preoperative cycles of PCF: intravenous paclitaxel (100mg per square meter of body surface area) and cisplatin (60mg per square meter of body surface area) on day 1, and a continuous intravenous infusion of 5- fluorouracil (700mg per square meter of body surface area per day) for 5 days. Arm A received two added postoperative cycles of PCF. The primary end point was relapse-free survival, and the secondary end point was overall survival.Results: Compared with preoperative chemotherapy group, perioperative chemotherapy group had a greater likelihood of 5-year relapse-free survival (hazard ratio for relapse, 0.62; 95% confidence interval, 0.49-0.73; 31% versus 17%, p < 0.001) and of 5-year overall survival (hazard ratio for death, 0.79; 95% confidence interval, 0.59-0.95; 38% versus 22%, p < 0.001). A pathologic complete response rate was achieved in 77 of 320 patients (24.1%) who underwent resection after chemotherapy. The increased PCF-related toxic events were not detected with the addition of two postoperative cycles of PCF.Conclusion: In patients with operable esophageal squamous cell carcinoma, perioperative regimen of PCF can significantly improve 5-year relapse-free and overall survival comparing with preoperative chemotherapy alone. (The trial has been registered at ClinicalTrials.gov, number NCT01225523.)