Department of Solid Tumor Oncology, Cleveland Clinic Taussig Cancer Institute, Cleveland, Ohio, USA.
J Thorac Oncol. 2009 Oct;4(10):1264-9. doi: 10.1097/JTO.0b013e3181b26f8e.
Mature results are presented from a phase II trial of postoperative concurrent chemoradiotherapy in patients with poor-prognosis cancer of the esophagus and gastroesophageal junction after primary surgical resection.
Resected patients with a pathologic stage of T3, N1, or M1a were eligible for this trial. Concurrent chemoradiotherapy was begun between 6 and 10 weeks after surgery and consisted of radiotherapy (1.8 Gy/d to a planned dose of 50.4-59.4 Gy), concurrent with two cycles of 5-fluorouracil (1000 mg/m/d) and cisplatin (20 mg/m/d), both given as 4-day continuous intravenous infusions during the first and fourth weeks of the radiation.
Between 1995 and 2006, 50 patients were enrolled. The median age was 59 (range, 33-76) years, and most patients were male (86%), Caucasian (96%), and had undergone a transthoracic esophagogastrectomy (74%) for what proved to be a node positive (86%) adenocarcinoma (86%). Postoperative concurrent chemoradiotherapy was accompanied by neutropenia requiring hospitalization for fever in only four patients (8%) and no toxic deaths. With a median follow-up of 47 (range, 36-124) months, the Kaplan-Meier 4-year projected overall survival is 51%, freedom from recurrence 50%, distant metastatic control 56%, and locoregional control 86%. An earlier pathologic stage was the only predictor for a better outcome.
This schedule of postoperative concurrent chemoradiotherapy has acceptable toxicity for patients with poor-prognosis esophageal and gastroesophageal junction cancer after surgery. Outcomes are better than historical results after surgery alone and justify further investigation of this approach.
本文报道了一项Ⅱ期临床试验的成熟结果,该试验入组了接受过以手术为主的初始治疗、术后病理分期为 T3、N1 或 M1a 的预后不良的食管和胃食管交界处癌患者,这些患者在术后 6-10 周接受同步放化疗。
同步放化疗于术后 6-10 周开始,包括放疗(1.8Gy/天,计划剂量 50.4-59.4Gy),同期给予氟尿嘧啶(1000mg/m/d)和顺铂(20mg/m/d)两个周期的化疗,均为第 1 和第 4 周的 4 天连续静脉输注。
1995 年至 2006 年,共入组 50 例患者。中位年龄为 59 岁(范围,33-76 岁),大多数患者为男性(86%)、白种人(96%),接受了经胸食管胃切除术(74%),术后病理证实为淋巴结阳性(86%)的腺癌(86%)。术后同步放化疗仅 4 例(8%)患者因中性粒细胞减少需要住院治疗伴发热,无治疗相关死亡。中位随访 47 个月(范围,36-124 个月),Kaplan-Meier 4 年总生存预计为 51%,无复发生存率为 50%,远处转移控制率为 56%,局部区域控制率为 86%。较早的病理分期是生存更好的唯一预测因素。
对于以手术为主治疗后的预后不良的食管和胃食管交界处癌患者,这种术后同步放化疗方案毒性可接受。与单纯手术的历史结果相比,该方案的疗效更好,有必要进一步研究该方法。