Postoperative irradiation with or without concomitant chemotherapy for locally advanced head and neck cancer
Postoperative irradiation with or without concomitant chemotherapy for locally advanced head and neck cancer
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DOI：
10.1056/nejmoa032641
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发表时间：
2004-05-06
影响因子：
158.5
通讯作者：
van Glabbeke, M
中科院分区：
文献类型：
--
作者：
Bernier, J;Domenge, C;van Glabbeke, M
背景：我们比较了顺铂联合放疗与单纯放疗作为III期或IV期头颈癌的辅助治疗。方法167例患者术后均有治愈意向，随机分为单独放疗组（66 Gy，为期6 1/2周）和放疗组（167例），分别在放疗第1、22和43天接受相同的放疗方案，每平方米体表面积100 mg顺铂。结果中位随访60个月后，联合治疗组的无进展生存率显著高于单独放疗组（log-rank检验P = 0.04；疾病进展的风险比为0.75；95%可信区间为0.56至0.99），5年Kaplan-Meier估计无进展生存率分别为47%和36%。联合治疗组的总生存率也显著高于放疗组（log-rank检验P = 0.02；死亡风险比0.70；95%可信区间0.52至0.95），五年Kaplan-Meier估计总生存率分别为53%和40%。联合治疗组局部或局部复发的累积发生率明显低于联合治疗组（P = 0.007）。估计局部或区域复发的5年累积发生率（考虑到其他原因导致的死亡风险）在放疗后为31%，在联合治疗后为18%。联合治疗后严重（3级或以上）不良反应发生率（41%）高于放疗后（21%,P = 0.001）；两组严重粘膜不良反应的类型相似，晚期不良反应的发生率相似。结论对局部晚期头颈癌患者术后联合放疗给予大剂量顺铂的疗效优于单纯放疗，且不会引起过多的晚期并发症。
BACKGROUNDWe compared concomitant cisplatin and irradiation with radiotherapy alone as adjuvant treatment for stage III or IV head and neck cancer.METHODSAfter undergoing surgery with curative intent, 167 patients were randomly assigned to receive radiotherapy alone ( 66 Gy over a period of 6 1/2 weeks) and 167 to receive the same radiotherapy regimen combined with 100 mg of cisplatin per square meter of body-surface area on days 1, 22, and 43 of the radiotherapy regimen.RESULTSAfter a median follow-up of 60 months, the rate of progression-free survival was significantly higher in the combined-therapy group than in the group given radiotherapy alone (P = 0.04 by the log-rank test; hazard ratio for disease progression, 0.75; 95 percent confidence interval, 0.56 to 0.99), with 5-year Kaplan-Meier estimates of progression-free survival of 47 percent and 36 percent, respectively. The overall survival rate was also significantly higher in the combined-therapy group than in the radiotherapy group (P = 0.02 by the log-rank test; hazard ratio for death, 0.70; 95 percent confidence interval, 0.52 to 0.95), with five-year Kaplan-Meier estimates of overall survival of 53 percent and 40 percent, respectively. The cumulative incidence of local or regional relapses was significantly lower in the combined-therapy group (P = 0.007). The estimated five-year cumulative incidence of local or regional relapses ( considering death from other causes as a competing risk) was 31 percent after radiotherapy and 18 percent after combined therapy. Severe ( grade 3 or higher) adverse effects were more frequent after combined therapy ( 41 percent) than after radiotherapy ( 21 percent, P = 0.001); the types of severe mucosal adverse effects were similar in the two groups, as was the incidence of late adverse effects.CONCLUSIONSPostoperative concurrent administration of high-dose cisplatin with radiotherapy is more efficacious than radiotherapy alone in patients with locally advanced head and neck cancer and does not cause an undue number of late complications.