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时间调节诱导化疗联合放疗治疗鼻咽癌的单中心Ⅱ期随机临床研究 被引量:9

Single-Center Randomized Controled Phase Ⅱ Trial of Combined Chronomodulated Chemotherapy and Radiotherapy for Nasopharyngeal Carcinoma
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摘要 目的:观察奥沙利铂+5-氟尿嘧啶时间调节诱导化疗治疗鼻咽癌的疗效、不良反应及远期生存率。方法:46例患者随机分为CC组(时间调节化疗组)23例,RC组(常规化疗组)23例。均行2个周期诱导化疗后放疗,CC组奥沙利铂总量为130mg/m^2,每天10:00给药至22:00结束,分3天使用;5-Fu 1 g/m^2·d,于22:00给药至次日10:00结束,d1~3,14 d为1个周期,共2个周期。RC组用药量同CC组,按常规时间给药,均采用鼻咽、颈部常规外照射病灶剂量60~70Gy/6~7w,颈部预防剂量50Gy/5w。结果:CC组周围神经炎、血液学毒性、腹泻不良反应发生率均较RC组低(P<0.05)。近期有效率(CR+PR)CC组为95.6%,RC组为86.9%,CC组有增高趋势。1、3、5年生存率两组无显著性差异(P>0.05)。结论:CC组较RC组治疗鼻咽癌明显减轻化疗不良反应,未降低远期生存率,提示该方案是治疗鼻咽癌安全有效的化疗方案。 Objective: This study aims to evaluate the efficacy, toxicity, and long-term survival in oxaliplatin and 5-fluorouracil combined with chronomodulated chemotherapy treated nasopharyngeal cancer patients. Method: Forty-six patients were randomly and equally distributed into the chronomodulated ( CC ) and conventional ( RC ) chemotherapy groups. All patients received two cycles of induced chemotherapy followed by radiotherapy. The patients in the CC group received full chemotherapy with a daily dose of 130 mg/m3 of ox- aliplatin from 10:00 to 22:00 for three days. In addition, 1 g/m2- d of 5-fluorouracil was given from 22:00 of the first day to 10:00 of the second day. Each patient received at least two cycles ( one cycle = 14 days ) of treatment. The dosage and administration times for the RC group was the same as that of the CC group. Both groups received conventional doses of external beam radiation ( 60 Gy to 70 Gy for every 6 to 7 weeks ) for their neck and nasopharyngeal lesions. The prophylactic dose for the neck was 50 Gy per 5 weeks. Results: The incidence rates of peripheral neuropathy, blood toxicity, and diarrhea in the CC group were lower than in the RC group ( P 〈 0.05 ). The response ratios ( CR + PR ) of the CC and RC groups were 95.6 % and 86.9 %, respectively. However, that of the CC group had an increasing trend. The 1-, 3-, and 5-year survival rates of the two groups were not significantly different ( P 〈 0.05 ). Conclusion: The nasopharyngeal cancer treatment administered to the CC group can significantly reduce the toxicity of oxaliplatin and 5-fluorouracil, without reducing patients' long-term survival. Moreover, the chronomodulated chemotherapy is safer and more effective in treating nasopharyngeal cancer than the conventional method.
出处 《中国肿瘤临床》 CAS CSCD 北大核心 2012年第6期336-339,共4页 Chinese Journal of Clinical Oncology
关键词 鼻咽癌 奥沙利铂 5-氟尿嘧啶 时间调节化疗 Nasopharyngeal carcinoma Oxaliplatin 5-Fluorouracil Chronomodulated chemotherapy
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