Long-term results of a randomized trial comparing preoperative short-course radiotherapy with preoperative conventionally fractionated chemoradiation for rectal cancer
Long-term results of a randomized trial comparing preoperative short-course radiotherapy with preoperative conventionally fractionated chemoradiation for rectal cancer
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DOI：
10.1002/bjs.5506
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发表时间：
2006-10-01
影响因子：
9.6
通讯作者：
Kryj, M.
中科院分区：
文献类型：
--
作者：
Bujko, K.;Nowacki, M. P.;Kryj, M.
背景：与单纯短期放疗相比，新辅助放化疗不会改变临床分期T3或T4可切除直肠癌患者的肛门括约肌保存或术后并发症。本研究的目的是比较两个治疗组的生存、局部控制和晚期毒性。方法：本研究随机选取312例患者，分别接受术前放疗（25 Gy / 5 Gy） 7天内手术治疗或放化疗（50.4 Gy / 28 Gy / 1.8 Gy，灌注5-氟尿嘧啶和亚叶酸素）4-6周后手术治疗。在世患者的中位随访时间为48个月（31-69个月）。结果：放化疗组早期放射毒性较高（18.2% vs 3.2%; P < 0.001）。精算的4年总生存率，短疗程组为67.2%，放化疗组为66.2% （P = 0.960）。无病生存率分别为58.4%对55.6% (P = 0.820)，局部粗复发率分别为9.0对14.2% (P = 0.170)，严重晚期毒性分别为10.1%对7.1% （P = 0.360）。结论：与单纯短程放疗相比，新辅助放化疗不能提高患者的生存、局部控制和晚期毒性。
Background: Neoadjuvant chemoradiotherapy does not alter anal sphincter preservation or postoperative complications compared with short-course radiotherapy alone in patients with clinical stage T3 or T4 resectable rectal cancer. The aim of this study was to compare survival, local control and late toxicity in the two treatment groups.Methods: The study randomized 312 patients to receive either preoperative irradiation (25 Gy in five fractions of 5 Gy) and surgery within 7 days or chemoradiation (50.4 Gy in 28 fractions of 1.8 Gy, bolus 5-fluorouracil and leucovorin) and surgery 4-6 weeks later. The median follow-up of living patients was 48 (range 31-69) months.Results: Early radiation toxicity was higher in the chemoradiation group (18.2 versus 3.2 percent; P < 0.001). The actuarial 4-year overall survival was 67.2 per cent in the short-course group and 66.2 per cent in the chemoradiation group (P = 0.960). Disease-free survival was 58.4 versus 55.6 per cent (P = 0.820), crude incidence of local recurrence was 9.0 versus 14.2 per cent (P = 0.170) and severe late toxicity was 10.1 versus 7.1 per cent (P = 0.360) respectively.Conclusion: Neoadjuvant chemoradiation did not increase survival, local control or late toxicity compared with short-course radiotherapy alone.