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PLF、PFM方案治疗放疗后复发或转移鼻咽癌的临床研究
Clinical evaluation of PLF and PFM regimens in recurrent or metastasis nasopharyngeal carcinona
【摘要】 目的本临床研究采用以铂类加5-氟尿嘧啶(5-FU)为主的PLF、PFM方案治疗放疗后复发或转移鼻咽癌,探讨这两个方案在晚期鼻咽癌治疗中的价值及晚期鼻咽癌的预后因素。方法对入选晚期鼻咽癌进行非随机分组,一组采用PLF方案治疗醛氢叶酸(CF,200mg·m-2,d1)静脉滴注2h加5-FU0.5g静脉推注及5-FU3.0g·m-2持续48h滴注联合DDP(25mg·m-2,d1-3)静脉滴注;另一组采用PFM方案治疗DDP(25mg·m-2,d1-3)静脉滴注加5-FU(0.4g·m-2,d1-5)静脉滴注联合PYM(5mg·m-2,d1、3、5)肌注。结果共有48例病人入选,全组总有效率为63.83%,两组有效率分别为76.92%、47.62%(P=0.066);主要的不良反应为恶心呕吐、脱发、口腔粘膜炎、白细胞下降、血红蛋白下降等,PLF方案组恶心呕吐发生率显著低于PFM方案组(P=0.032);中位随访时间为10个月,全组中位生存期为11个月,两组的中位生存期分别为12、9个月(P=0.3691);在预后方面,治疗前血红蛋白<10g·L-1、年龄≥65岁是预后不良的相关因素(P值分别为0.001、0.030)。结论PLF方案的近期疗效、生存期有优于PFM方案的趋势,且毒副作用也较轻,可作为晚期鼻咽癌化疗的标准一线治疗。治疗前血红蛋白水平、年龄是影响预后的相关因素。
【Abstract】 AIM: To evaluate the efficacy and safety of PLF and PFM regimen based on cisplatin plus 5-fluorouracil in recurrent or metastasis nasopharyngeal carcinona (NPC), and to explore prognostic factors of advanced NPC by survival analysis. METHODS: Patients with recurrent or metastasis NPC were enrolled in the study. They were nonrandomly assigned to receive a 2-hour infusion of folinic acid 200 mg·m -2 followed by a 5-FU bolus 400 mg·m -2 and 48-hour infusion 3,000 mg·m -2 combined with DDP 25 mg·m -2 on day 1-3 every 3 weeks (PLF) or DDP 25 mg·m -2 on day 1-3, 5-FU bolus 400 mg·m -2 on day 1-5 plus pingyangmycin 5 mg·m -2 on day 1, 3 and 5 every 3 weeks (PFM). RESULTS: 48 patients were enrolled. The total response rate was 63.83 %, and the response rate of PLF、PFM regimen was 76.92 % and 47.62 %(P= 0.066 , respectively. The main side effects include nausea, vomiting, alopecia, bone marrow suppression and mucositis. The DLF regimen was milder than DFM regimen in nausea-vomiting (P= 0.032 ). After a median follow-up of 10 months, the overall median survival was 11.0 months, and the median survival of group A and group B were 12 and 9 months(P= 0.3691 ),respectively. A highly significant correlation was noted between poor-prognosis to severe anemia (Hb<10 g·L -1 , P= 0.001 ) before chemotherapy and the older patients (age ≥ 65, P= 0.030 ) by Cox Regression analysis. CONCLUSION: The PLF regimen can be recommended for recurrent or metastasis NPC as first-line good treatment because its tolerable and more active. Anemia (Hb<10 g·L -1 ) and older age (age≥65) indicate poor prognosis.
【Key words】 advanced nasopharyngeal carcinoma; leucovorin; 5-fluorouracil; cisplatin;
- 【文献出处】 中国临床药理学与治疗学 ,Chinese Journal of Clinical Pharmacology and Therapeutics , 编辑部邮箱 ,2006年10期
- 【分类号】R739.63
- 【被引频次】1
- 【下载频次】53