Stahl M, Vanhoefer U, Stuschke M, Walz M K, Müller C, Wilke H
Department of Internal Medicine (Cancer Research), Essen University Medical School, Germany.
Eur J Cancer. 1998 Apr;34(5):668-73. doi: 10.1016/s0959-8049(97)10109-5.
The purpose of this trial was to examine the feasibility of intensive, sequential chemo- and radiochemotherapy followed by surgery in patients with locally advanced carcinomas of the lower oesophagus and the gastro-oesophageal junction (GO junction). The chemotherapy consisted of two courses of 6 weekly administrations of 5-fluorouracil (5-FU) (2.0 g/m2, 24 h infusion) and folinic acid (FA) (500 mg/m2, 2 h infusion) combined with twice weekly cisplatin (50 mg/m2, 1 h infusion). Irradiation of 30 Gy was given concurrently with one course of cisplatin and etoposide. 25 patients with locally advanced (T3-T4 NX M0) squamous cell or adenocarcinoma of the lower oesophagus and GO junction were included and evaluated. Toxicity was usually mild to moderate (WHO grade 1 and 2) with mucositis as the most important side-effect of the pre-operative treatment. Of the patients, 94 and 88% completed the chemo- and radiochemotherapy according to the protocol, respectively. A major response (= partial remission with subjective improvement) to chemotherapy was achieved in 6/10 patients with squamous cell carcinoma and 10/15 with adenocarcinoma. 19 patients had subsequent surgery and complete resection was achieved in 16 (3 patients had intra-abdominal metastases observed at laparotomy). The operative mortality rate was 16% (3/19). 10 of the 16 patients with tumour resection had a pathological complete response. 15 patients (43%) remain alive at a median follow-up of 20 months and the median survival exceeds 16+ months. Our data suggest that this intensive pre-operative chemoradiotherapy programme is feasible and remarkably effective in patients with locally advanced carcinomas of the lower oesophagus or GO junction.
本试验的目的是研究在局部晚期下食管癌和胃食管交界（GO 交界）癌患者中，先进行强化序贯化疗及放化疗，然后进行手术的可行性。化疗包括两个疗程，每 6 周进行一次，使用 5-氟尿嘧啶（5-FU）（2.0 g/m²，持续输注 24 小时）和亚叶酸（FA）（500 mg/m²，持续输注 2 小时），并联合每周两次顺铂（50 mg/m²，持续输注 1 小时）。30 Gy 的放疗与一个疗程的顺铂和依托泊苷同时进行。纳入并评估了 25 例局部晚期（T3-T4 NX M0）下食管鳞状细胞癌或腺癌以及 GO 交界癌患者。毒性通常为轻至中度（世界卫生组织 1 级和 2 级），黏膜炎是术前治疗最重要的副作用。在这些患者中，分别有 94%和 88%按照方案完成了化疗和放化疗。10 例鳞状细胞癌患者中有 6 例、15 例腺癌患者中有 10 例对化疗产生了主要反应（=部分缓解且主观症状改善）。19 例患者随后接受了手术，16 例实现了完全切除（3 例在剖腹手术时发现有腹腔内转移）。手术死亡率为 16%（3/19）。16 例肿瘤切除患者中有 10 例达到了病理完全缓解。15 例患者（43%）在中位随访 20 个月时仍存活，中位生存期超过 16 个月。我们的数据表明，这种强化术前放化疗方案在局部晚期下食管癌或 GO 交界癌患者中是可行且非常有效的。
