培美曲塞和多西他赛在老年晚期非鳞非小细胞肺癌二线治疗中的疗效及安全性比较

Efficacy and safety of pemetrexed compared with docetaxel as second-line treatment in elderly patients with advanced non-squamous non-small-cell lung cancer

目的比较培美曲塞和多西他赛在老年晚期非鳞非小细胞肺癌(NSCLC)二线治疗中的疗效和安全性。方法收集2009年1月至2012年3月首都医科大学宣武医院胸外科收治的年龄≥65岁晚期非鳞NSCLC患者的病历资料进行回顾性分析。按照化疗方案将患者分为培美曲塞组(500 mg/m^2静脉滴注,第1天)和多西他赛组(75 mg/m^2静脉滴注,第1天)。每个治疗周期均约3~4周。比较2组患者治疗2个周期后的客观有效率、疾病控制率和不良反应发生率。结果纳入分析的患者共146例。培美曲塞组56例,男性30例,女性26例,年龄65~83岁,平均(69.6±4.7)岁;多西他赛组90例,男性62例,女性28例,年龄65~83岁,平均(67.9±4.5)岁。2组患者肺癌病理类型、分期和体力状况评分差异均无统计学意义。治疗2个周期后培美曲塞组客观有效率明显高于多西他赛组[32.1%(18/56)比17.8%(16/90),P=0.046],疾病控制率培美曲塞组与多西他赛组差异无统计学意义[73.2%(41/56)比77.8%(16/90),P=0.530]。2组均有患者出现粒细胞减少、血小板减少、贫血、恶心呕吐、周围神经毒性、脱发等不良反应,培美曲塞组Ⅲ~Ⅳ级粒细胞减少、脱发和Ⅰ~Ⅱ级周围神经毒性发生率均明显低于多西他赛组[7.1%(4/56)比27.8%(25/90),P=0.001;21.4%(12/56)比52.2%(47/90),P=0.000;17.9%(10/56)比33.3%(30/90),P=0.04)]。2组均无发生肾功能损害者及因化疗不良反应而死亡者。结论培美曲塞和多西他赛用于老年晚期非鳞NSCLC二线治疗均有效,但培美曲塞较多西他赛更安全。

Objective To compare the efficacy and safety of pemetrexed and docetaxel as second-line treatment for elderly patients with advanced non-squamous non-small-cell lung cancer（NSCLC）. Methods The data of patients with advanced non-squamous NSCLC and I〉65 years old in Department of Thoracic Surgery, Xuanwu Hospital of Capital Medical University from January 2009 to March 2012 were collected and analyzed retrospectively. According to the chemotherapy regimens, the patients were divided into 2 groups： the pemetrexed group （intravenous infusion of pemetrexed 500 mg/m2 on the first day） and the docetaxel group （ intravenous infusion of docetaxe175 mg/m2 on the first day）. Each treatment cycle consisted of 3 to 4 weeks. The objective response rate （ORR）, disease control rate （DCR）, and incidence of adverse reactions after 2 cycles of treatment in the 2 groups were compared. Results A total of 146 patients were entered in this study. Of them, 56 patients were in the pemetrexed group, including 30 men and 26 women with an average age of （69.6 ＋ 4.7） years ; and 90 patients were in the docetaxel group, including 62 men and 28 women with an average age of （67.9± 4.5 ） years. There were no significant differences in pathological types, stages, and performance status scores between the 2 groups. After 2 cycles of treatment, the ORR in the pemetrexed group was higher markedly than that in the docetaxel group [32. 1% （18/56） vs. 17.8% （16/90） ,P =0.0461. The differences of the DCR in the pemetrexed and the docetaxel groups were not statistically significant [73.2% （41/56） vs. 77.8% （16/90）, P=0.5301. Neutropenia, thrombocy-topenia, anemia, nausea and vomiting, neurotoxicity, alopecia, and other adverse drug reactions occurred in the 2 groups. The incidence of Ⅲ-Ⅳ levels of neutropenia and alopecia and Ⅰ-Ⅱ levels of neurotoxicity in the pemetrexed group were lower significantly than those in the docetaxel group [7. 1% （4/56） vs. 27.8% （25/90）, P = 0. 001; 21.4% （12/ 56） vs. 52.2% （47/90）, P=0.000; 17.9% （10/56） vs. 33.3% （30/90）, P=0.04）]. There were no occurrence of renal function impairment and ehemo treatment-related death in the 2 groups. Conclusion Pemetrexed and doeetaxel are both effective in the treatment for elderly patients with advanced non-squamous NSCLC, but pemetrexed is safer than doeetaxel.