老年进展期NSCLC培美曲塞/卡铂方案化疗中培美曲塞持续一线巩固的疗效及安全性

Efficacy and Safety of Pemetrexed First-line Continued Consolidation in Pemetrexed /Carboplatin Chemotherapy for Elderly Patients with Advanced NSCLC

目的探讨老年进展期NSCLC培美曲塞/卡铂方案化疗中培美曲塞持续一线巩固的疗效及安全性。方法选取经影像学或病理组织学确诊的ⅢB期或Ⅳ期非小细胞肺癌(NSCLC)患者76例,均为接受4个周期培美曲塞/卡铂方案诱导化疗治疗后疾病得到控制者,以1∶1随机分为巩固组和对照组。对照组治疗不变,巩固组采用培美曲赛单药治疗,以21 d为1个周期。4个周期后比较2组的临床疗效、无疾病进展生存期(PFS)、总生存期(OS)及不良反应。结果巩固组的有效率(42.11%)及疾病控制率(68.42%)和对照组(36.84%和65.79%)比较,差异无统计学意义(P>0.05)。巩固组的PFS(4.4个月)显著高于对照组(3.2个月),差异有统计学意义(P<0.05)。巩固组的平均OS(15.1个月)显著高于对照组(13.2个月),差异有统计学意义(P<0.05)。巩固组的粒细胞减少(34.21%)、血小板减少(13.16%)和贫血(44.73%)发生率明显低于对照组(分别为47.37%,23.68%,55.26%),差异有统计学意义(P<0.05)。结论培美曲塞持续一线巩固治疗老年进展期非小细胞肺癌与培美曲塞联合卡铂方案化疗的临床疗效相当,但使用培美曲塞单药进行巩固化疗药物毒性更低,是一种安全有效的治疗措施。

Objective To investigate the efficacy and safety of pemetrexed first-line continued consolidation in peme- trexed/carboplatin chemotherapy for elderly patients with advanced NSCLC. Methods 76 cases with 111 B/IV non-small cell lung cancer （NSCLC） confirmed by radiological or pathological examination were selected and they received 4 cycles of pemetrexed/ carboplatin chemotherapy and their disease were controlled. The patients were randomly divided into the control group and the consolidate group. The control group were treated by unchanged therapy and the the consolidation group were treated by peme- trexed monotherapy with 21 d a cycle. Clinical efficacy, disease progression-free survival （PFS）, overall survival （OS） and ad- verse reactions were compared between the 2 groups after 4 cycles. Results The effective rate （42.11% ） and disease control rate （68.42%） in the consolidated group were not statistically different with those of the control group （36.84% ,65.79% ） （P 〉 0.05 ）. PFS of the consolidated group （4.4 months） was significantly higher than that of the control group （3.2 months ） and the difference was statistically significant （P 〈 0.05 ）. The average OS of consolidation group （ 15.1 months） was significantly higher than that of the control group （ 13.2 months） and the difference was statistically significant （ P 〈 0.05 ）. Neutropenia （34.21%） ,incidence of thrombocytopenia （13.16%） and anemia （44.73%） in the consolidation group were significantly low- er than those of the control group （47.37%, 23.68%, 55.26 % ）, and the difference was statistically significant （P 〈 0.05 ）. Conclusion Clinical efficacy of sustained pemetrexed in first-line consolidation therapy for patients with advanced non-small cell lung cancer are similar with pemetrexed plus carboplatin program, but the chemotherapy toxicity is lower in pemetrexed consolida- tion monotheravv. It is a safe and effective treatment.