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培美曲塞、贝伐单抗或二者联合使用作为晚期非鳞状NSCLC的维持治疗(JCO, IF: 28.245)...

 生物_医药_科研 2019-08-11

SCI

 9 August 2019


Pemetrexed, Bevacizumab, or the Combination As Maintenance Therapy for Advanced Nonsquamous Non–Small-Cell Lung Cancer: ECOG-ACRIN 5508

  • Ramalingam SS, Dahlberg SE, Belani CP, et al. Pemetrexed, Bevacizumab, or the Combination As Maintenance Therapy for Advanced Nonsquamous Non–Small-Cell Lung Cancer: ECOG-ACRIN 5508. Journal of Clinical Oncology;0:JCO.19.01006.

  • CORRESPONDING AUTHOR Suresh S. Ramalingam, Hematology and Medical Oncology, Emory University School of Medicine, Winship Cancer Institute, 1365 Clifton Rd NE, C4014E, Atlanta, GA 30322; e-mail: ssramal@emory.edu.

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。

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