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培美曲塞-铂类双药化疗联合或不联合贝伐珠单抗作为中国未经治疗的晚期非鳞状非小细胞肺癌患者一线治疗的疗效比较。

Comparative Effectiveness of Pemetrexed-platinum Doublet Chemotherapy With or Without Bevacizumab as First-line Therapy for Treatment-naive Patients With Advanced Nonsquamous Non-small-cell Lung Cancer in China.

机构信息

Department of Medical Oncology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.

Department of Medical Oncology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China; Department of Clinical Pharmacy, School of Basic Medicine and Clinical Pharmacy, China Pharmaceutical University, Nanjing, China.

出版信息

Clin Ther. 2019 Mar;41(3):518-529. doi: 10.1016/j.clinthera.2019.02.004. Epub 2019 Mar 4.

Abstract

PURPOSE

Bevacizumab plus platinum-based doublet chemotherapy is recommended by the National Comprehensive Cancer Network as a category 1 regimen and is widely used in patients with advanced nonsquamous non-small-cell lung cancer (NS-NSCLC). In China, a common first-line chemotherapy for NS-NSCLC is the pemetrexed-platinum doublet regimen (Pem-Pt). However, limited evaluation exists to show the effectiveness of the Pem-Pt + bevacizumab (Bev) regimen in advanced NS-NSCLC. This study describes the treatment patterns, effectiveness, and safety profile of Pem-Pt + Bev in patients with NS-NSCLC in China in clinical practice.

METHODS

Data from eligible patients with advanced NS-NSCLC who received Pem-Pt with (136 patients) or without (97 patients) bevacizumab from January 2012 to March 2017 were retrospectively evaluated. The effectiveness outcomes included the assessment of progression-free survival (PFS) and objective response rate (ORR) in the overall population, the percentage of patients with pleural effusion or brain metastasis, as well as the percentage of patients receiving maintenance therapy. Moreover, the intracranial remission rate in patients with brain metastasis was estimated. Finally, the adverse events with the 2 treatments were addressed.

FINDINGS

Compared with the Pem-Pt regimen, the Pem-Pt + Bev regimen was associated with a significantly longer median PFS and a higher ORR in the overall population (P = 0.0002). An improvement in ORR was observed in Pem-Pt + Bev-treated patients with brain metastasis (P = 0.0045). Moreover, patients receiving Pem-Pt + Bev and maintenance therapy not only showed a longer median PFS than that in those whose treatment was interrupted after induction but also a longer median PFS than that in patients who received Pem-Pt and maintenance therapy. The safety profile was acceptable in all groups, with no observations of hypertension, proteinuria, severe bleeding (1 case of grade I epistaxis was reported with Pem-Pt + Bev), or any unexpected findings reported.

IMPLICATIONS

These results from clinical practice further support the concept that pemetrexed-platinum doublet plus bevacizumab could be an effective and tolerable regimen in patients with advanced NS-NSCLC in China.

摘要

目的

贝伐珠单抗联合铂类双联化疗被美国国家综合癌症网络(National Comprehensive Cancer Network,NCCN)推荐为 1 类治疗方案,广泛用于晚期非鳞状非小细胞肺癌(NS-NSCLC)患者。在中国,NS-NSCLC 的常用一线化疗方案是培美曲塞-铂类双联方案(Pem-Pt)。然而,目前尚缺乏评估培美曲塞-铂类双联方案联合贝伐珠单抗(Bev)治疗晚期 NS-NSCLC 有效性的研究。本研究描述了培美曲塞-铂类双联方案联合贝伐珠单抗在中国晚期 NS-NSCLC 患者中的治疗模式、疗效和安全性。

方法

本研究回顾性分析了 2012 年 1 月至 2017 年 3 月期间接受培美曲塞-铂类双联方案(136 例)或不联合贝伐珠单抗(97 例)治疗的晚期 NS-NSCLC 患者的数据。疗效评估指标包括总体人群的无进展生存期(PFS)和客观缓解率(ORR)评估、胸腔积液或脑转移患者比例,以及维持治疗患者比例。此外,还评估了脑转移患者的颅内缓解率。最后,比较了两种治疗方案的不良反应。

结果

与培美曲塞-铂类双联方案相比,培美曲塞-铂类双联方案联合贝伐珠单抗治疗可显著延长总体人群的中位 PFS(P = 0.0002)和 ORR(P = 0.0002)。培美曲塞-铂类双联方案联合贝伐珠单抗治疗脑转移患者的 ORR 有所提高(P = 0.0045)。此外,接受培美曲塞-铂类双联方案联合贝伐珠单抗治疗并维持治疗的患者,不仅中位 PFS 长于诱导治疗后中断治疗的患者,而且也长于接受培美曲塞-铂类双联方案和维持治疗的患者。两组患者的安全性特征均可接受,均未观察到高血压、蛋白尿、严重出血(1 例培美曲塞-铂类双联方案联合贝伐珠单抗治疗患者发生 I 级鼻出血)或其他意外发现。

结论

这些来自临床实践的结果进一步支持了在我国,培美曲塞-铂类双联方案联合贝伐珠单抗治疗晚期非鳞状非小细胞肺癌可能是一种有效且耐受良好的方案。

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