Chemoradiation comparing cisplatin versus carboplatin in locally advanced nasopharyngeal cancer: Randomised, non-inferiority open trial
Chemoradiation comparing cisplatin versus carboplatin in locally advanced nasopharyngeal cancer: Randomised, non-inferiority open trial
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DOI：
10.1016/j.ejca.2007.03.022
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发表时间：
2007-06-01
影响因子：
8.4
通讯作者：
Ford, Judith
中科院分区：
文献类型：
--
作者：
Chitapanarux, Imjai;Lorvidhaya, Vicharn;Ford, Judith
目的：这项单中心、开放标签、随机非劣势试验比较了局部地区晚期鼻咽癌(NPC)患者同时接受卡铂和标准同期放化疗的疗效。患者和方法：从1999年8月到2004年12月，206名局部晚期鼻咽癌患者随机分为顺铂组101例和卡铂组105例。两组放疗计划相同。结果：中位随访时间为26.3个月(3-74.6个月)，顺铂组有59%的患者完成了计划的同步放化疗，而卡铂组的这一比例为73%。42%的顺铂患者完成了3个周期的辅助治疗，相比之下，卡铂组的这一比例为70%。顺铂组有更多的肾毒性、白细胞减少和贫血，而卡铂组有更多的血小板减少。3年无瘤生存率顺铂组为63.4%，卡铂组为60.9%(P=0.9613)(HR0.70，95%可信区间：0.50~0.98)。顺铂组和卡铂组3年总生存率分别为77.7%和79.2%(P=0.9884)(HR0.83，95%CI：0.63~1.010)。结论：卡铂方案的耐受性好于顺铂方案。此外，卡铂ARM方案治疗局部地区晚期鼻咽癌的疗效与标准方案无明显差异。(C)2007爱思唯尔有限公司。保留所有权利。
Purpose: This single Centre, open labelled, randomised non-inferiority trial compared concurrent chemoradiotherapy with carboplatin versus standard concurrent chemoradiotherapy with cisplatin in patients with locoregionally advanced nasopharyngeal cancer (NPC).Patients and methods: From August 1999 to December 2004, 206 patients with locally advanced NPC were randomised with 101 to cisplatin arm and 105 to carboplatin arm. Planned radiotherapy was the same in both groups. All the patients were evaluated for toxicity and survival according to the as-treated principle.Results: With a median follow-up of 26.3 months (range 3-74.6 months), 59% of patients in the cisplatin arm completed the planned concurrent chemoradiation treatment, compared to 73% in the carboplatin arm. Forty-two percent of cisplatin patients completed the 3 cycles of adjuvant therapy compared to 70% in the carboplatin group. There were more renal toxicity, leucopenia, and anaemia in the cisplatin group, and more thrombocytopenia in the carboplatin arm. The 3 year disease free survival rates were 63.4% for the cisplatin group and 60.9% for the carboplatin group (p = 0.9613) (HR 0.70, 95% confidence interval (CI): 0.50-0.98). The 3 year overall survival rates were 77.7% and 79.2% for cisplatin and carboplatin groups, respectively (p = 0.9884) (HR 0.83, 95% CI: 0.63-1.010).Conclusion: We concluded that the tolerability of carboplatin based regimen is better than that of the cisplatin regimen. Moreover, the treatment efficacy of carboplatin arm is not different from the standard regimen in the treatment of locoregional advanced stage NPC. (C) 2007 Elsevier Ltd. All rights reserved.