摘要
目的比较单用培美曲塞(力比泰,礼来公司产品)及多西紫杉醇(泰素帝,安万特公司产品)应用于首次采用化疗治疗的体力状况评分为2的非小细胞肺癌患者的疗效与安全性。方法67例既往未采用过化疗治疗的非小细胞肺癌患者,体力状况评分(ECOG PS)2分。患者随机分入力比泰单用组:35例患者接受力比泰500 mg/m^2治疗;泰素帝单用组:32例患者接受泰素帝75 mg/m^2治疗。结果入组的67例中62例可评价疗效。单用力比泰组及单用泰素帝组的总有效率分别是6.25%及6.67%(P=0.871)。单用力比泰组及单用泰素帝组中位疾病进展时间(time to progression,TPP)分别为5.2个月及5.5个月(P=0.086)。单用力比泰组及单用泰素帝组中位生存时间分别为8.1个月及7.7个月(P=0.071)。1年生存率在单用力比泰组及单用泰素帝组分别为34.5%及32.7%(P=0.614)。发生在两治疗组内的不良反应主要表现为骨髓抑制、恶心/呕吐、乏力及皮疹。力比泰组Ⅲ~Ⅳ度中性粒细胞减少的发生率明显低于泰素帝组(6.25%vs43.3%,P〈0.001);力比泰组粒细胞减少性发热的发生率明显低于泰素帝组(3.13%vs13.3%,P〈0.001)。结论对于首次采用化疗治疗的体力状况评分为2的非小细胞肺癌患者,单药使用力比泰及单药使用泰素帝进行化疗疗效相似,但使用力比泰不良反应较低,值得临床推广。
Objective To compare the efficacy and safety of Pemetrexed versus Docetaxel for chemotherapy-naive patients with non-small-cell lung cancer (NSCLC) who had a performance status (ECOG PS )2. Methods Sixty-seven patients with NSCLC were randomly assigned to two groups: 35 patients received single-agent Pemetrexed (ALIMTA) 500 mg/m^2 and 32 patients received Docetaxel (AISU) 75 mg/m^2. Restilts Sixty-two of 67 patients were evaluable for efficacy. Overall response rates were 6.25% and 6.67% ( P = 0, 871 ) for Pemetrexed and Docetaxel respectively. The median time to disease progression (TPP) were 5.2 months vs 5.5 months ( P = 0. 086 ) for Pemetrexed and Docetaxel respectively. The median survival time was 8.1 months vs 7.7 months ( P = 0.071 ) for Pemetrexed and Docetaxel respectively, The 1-year survival rate for Pemetrexed and Docetaxel were 34.5% vs 32.7% (P =0. 614) respectively. The principal toxicities were myelosuppression, nausea/vomiting, fatigue and rash. Patients receiving Docetaxel were more likely to have grade Ⅲ or Ⅳ neutropenia (6.25% vs 43.3%, P 〈 0. 001 ) ; febrile neutropenia in Pemetrexed group was significantly lower than Docetaxel group ( 3. 13 % vs 13.3 %, P 〈 0.001 ). Conclusion Treatment with Pemetrexed resulted in clinically equivalent efficacy outcomes, but with significantly fewer side effects compared with Docetaxel in the first-line treatment of chemotherapy-naive patients with non-small-cell lung (NSCLC) who had a performance status 2 and should be recommended.
出处
《同济大学学报(医学版)》
CAS
2008年第3期54-57,共4页
Journal of Tongji University(Medical Science)
关键词
非小细胞肺肿瘤
力比泰
泰素帝
non-small-cell lung carcinoma
Pemetrexed
Docetaxel