陈海霞, 金风, 吴伟莉, 李媛媛, 陈国焱, 龚修云, 龙金华, 陈潇潇. 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[J]. 中国肿瘤临床, 2012, 39(6): 336-339. DOI: 10.3969/j.issn.1000-8179.2012.06.010
引用本文: 陈海霞, 金风, 吴伟莉, 李媛媛, 陈国焱, 龚修云, 龙金华, 陈潇潇. 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[J]. 中国肿瘤临床, 2012, 39(6): 336-339. DOI: 10.3969/j.issn.1000-8179.2012.06.010
Haixia CHEN, Feng JIN, Weili WU, Yuanyuan LI, Guoyan CHEN, Xiuyun GONG, Jinhua LONG, Xiaoxiao CHEN. Single-Center Randomized Controled Phase Ⅱ Trial of Combined Chronomodulated Chemotherapy and Radiotherapy for Nasopharyngeal Carcinoma[J]. CHINESE JOURNAL OF CLINICAL ONCOLOGY, 2012, 39(6): 336-339. DOI: 10.3969/j.issn.1000-8179.2012.06.010
Citation: Haixia CHEN, Feng JIN, Weili WU, Yuanyuan LI, Guoyan CHEN, Xiuyun GONG, Jinhua LONG, Xiaoxiao CHEN. Single-Center Randomized Controled Phase Ⅱ Trial of Combined Chronomodulated Chemotherapy and Radiotherapy for Nasopharyngeal Carcinoma[J]. CHINESE JOURNAL OF CLINICAL ONCOLOGY, 2012, 39(6): 336-339. DOI: 10.3969/j.issn.1000-8179.2012.06.010

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

Single-Center Randomized Controled Phase Ⅱ Trial of Combined Chronomodulated Chemotherapy and Radiotherapy for Nasopharyngeal Carcinoma

  • 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130 mg/㎡, 每天10:00给药至22:00结束, 分3天使用; 5-Fu 1g/㎡·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60~70 Gy/6~7w, 颈部预防剂量50 Gy/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。

     

    Abstract:
      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 oxaliplatin 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.

     

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