al-Sarraf M, Martz K, Herskovic A, Leichman L, Brindle J S, Vaitkevicius V K, Cooper J, Byhardt R, Davis L, Emami B
Providence Cancer Center, Southfield, MI 48075, USA.
J Clin Oncol. 1997 Jan;15(1):277-84. doi: 10.1200/JCO.1997.15.1.277.
The present intergroup phase III randomized study compared combined chemotherapy (CT) plus radiotherapy (RT) treatment versus RT only in patients with locally advanced esophageal cancer.
Two courses of chemotherapy during 50 Gy RT followed by additional two courses of the same CT, versus 64 Gy RT alone were investigated. CT consisted of cisplatin 75 mg/m2 on day 1 [corrected] and fluorouracil (5FU) 1,000 mg/m2/d on days 1 to 4 every 4 weeks with RT and every 3 weeks post-RT. The main objective of the study was to compare overall survival between the two randomized treatment groups. Patients were stratified by tumor size, histology, and degree of weight loss.
Sixty-two assessable patients were randomized to receive RT alone, and 61 to the combined arm. Patients characteristics were as follows: squamous cell cancer, 90% versus 85%; weight loss greater than 10 lb, 61% versus 69%; and tumor size, > or = 5 cm, 82% versus 80% on the RT and CT-RT arms, respectively. Systemic side effects, which consisted of nausea, vomiting, and renal and myelosuppression, occurred more frequently on the combined arm, while local side effects were similar in both groups. With a minimum follow-up time of 5 years for all patients, the median survival duration was 14.1 months and the 5-year survival rate was 27% in the combined treatment group, while the median survival duration was 9.3 months with no patients alive at 5 years in the RT-alone group (P < .0001). Additional patients (69) were treated with the same combined therapy and were analyzed. The results of the last group confirmed all of the results obtained with combined CT-RT in the randomized trial, with a median survival duration of 17.2 months and 3-year survival rate of 30%.
We conclude that cisplatin and 5FU infusion given during and post-RT of 50 Gy is statistically superior to standard 64-Gy RT alone in patients with locally advanced esophageal cancer.
本项组间III期随机研究比较了局部晚期食管癌患者接受联合化疗（CT）加放疗（RT）与单纯放疗的疗效。
研究了在50 Gy放疗期间进行两个疗程化疗，随后再进行两个相同疗程化疗，与单纯64 Gy放疗的疗效。CT方案为第1天顺铂75 mg/m²[校正后]，氟尿嘧啶（5FU）1000 mg/m²/天，于放疗期间每4周的第1至4天给药，放疗后每3周给药。本研究的主要目的是比较两个随机治疗组的总生存期。患者按肿瘤大小、组织学类型和体重减轻程度进行分层。
62例可评估患者被随机分配接受单纯放疗，61例被分配至联合治疗组。患者特征如下：鳞状细胞癌，分别为90%和85%；体重减轻超过10磅，分别为61%和69%；肿瘤大小≥5 cm，放疗组和放化疗组分别为82%和80%。联合治疗组恶心、呕吐、肾毒性和骨髓抑制等全身副作用发生率更高，而两组局部副作用相似。所有患者的最短随访时间为5年，联合治疗组的中位生存期为14.1个月，5年生存率为27%，而单纯放疗组的中位生存期为9.3个月，5年时无患者存活（P<0.0001）。另外69例患者接受了相同的联合治疗并进行了分析。最后一组的结果证实了随机试验中放化疗联合治疗的所有结果，中位生存期为17.2个月，3年生存率为30%。
我们得出结论，对于局部晚期食管癌患者，在50 Gy放疗期间及放疗后给予顺铂和5FU静脉输注在统计学上优于单纯标准64 Gy放疗。
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