SCI 9 August 2019 Pemetrexed, Bevacizumab, or the Combination As Maintenance Therapy for Advanced Nonsquamous Non–Small-Cell Lung Cancer: ECOG-ACRIN 5508
PURPOSE 目的 Pemetrexed or bevacizumab is used for maintenance therapy of advanced nonsquamous non–smallcell lung cancer (NSCLC). The combination of bevacizumab and pemetrexed has also demonstrated efficacy. We conducted a randomized study to determine the optimal maintenance therapy. 培美曲塞或贝伐单抗用于晚期非鳞状非小细胞肺癌(NSCLC)的维持治疗。贝伐单抗和培美曲塞联合用药也显示出疗效。我们进行这项随机研究,以确定最佳的维持治疗方案。 PATIENTS AND METHODS 患者及方法 Patients with advanced nonsquamous NSCLC and no prior systemic therapy received carboplatin (area under the curve, 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg) for up to four cycles. Patients without progression after four cycles were randomly assigned to maintenance therapy with bevacizumab (15 mg/kg), pemetrexed (500 mg/m2), or a combination of the two agents. The primary end point was overall survival, with bevacizumab serving as the control group. 晚期未接受系统治疗的非鳞状NSCLC患者,接受卡铂(曲线下面积6)、紫杉醇(200 mg/m2)和贝伐单抗(15 mg/kg)共 4个周期的治疗。四个周期后无进展的患者随机分配接受贝伐单抗(15 mg/kg)、培美曲塞(500 mg/m2)或两种药物的联合维持治疗。主要终点是总体生存率,贝伐单抗组作为对照组。 RESULTS 结果 Of the 1,516 patients enrolled, 874 (57%) were randomly assigned after induction therapy to one of the three maintenance therapy groups. With a median follow-up of 50.6 months, median survival with pemetrexed was 15.9 months, compared with 14.4 months with bevacizumab (hazard ratio [HR], 0.86; P = .12); median survival with pemetrexed and bevacizumab was 16.4 months (HR, 0.9; P = .28); median progression-free survival was 4.2, 5.1 (HR, 0.85; P = .06), and 7.5 months (HR, 0.67; P,.001) for the three groups, respectively. Incidence of worst grade 3 to 4 toxicity was 29%, 37%, and 51%, respectively, for bevacizumab, pemetrexed, and the combination regimen. 共招募1516例患者,其中874例(57%)在诱导治疗后被随机分配到三个维持治疗组。中位随访时间为50.6个月,培美曲塞的中位生存期为15.9个月,贝伐单抗的中位生存期为14.4个月(危险比[HR] 0.86;P =0.12);培美曲塞联合贝伐单抗的中位生存期为16.4个月(HR, 0.9;P =0.28);三组的无进展中位生存期分别为4.2月,5.1个月 (HR, 0.85; P=0.06) 和7.5个月(HR, 0.67;P=0. 001)。贝伐单抗、培美曲塞和联合用药最严重的3 - 4级毒性反应发生率分别为29%、37%和51%。 CONCLUSION 结论 Single-agent bevacizumab or pemetrexed is efficacious as maintenance therapy for advanced nonsquamous NSCLC. Because of a lack of survival benefit and higher toxicity, the combination of bevacizumab and pemetrexed cannot be recommended. 贝伐单抗或培美曲塞单药作为晚期非鳞状NSCLC的维持治疗是有效的。由于缺乏生存优势且具有更高的毒性,不推荐贝伐单抗和培美曲塞联合使用。 喜欢SCI天天读的理由 陪您一起学习SCI医学论文 每天5分钟,让自己的英语牛逼起来 特殊福利让您惊喜连连 |
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