Kozuki Toshiyuki, Nogami Naoyuki, Hataji Osamu, Tsunezuka Yoshio, Seki Nobuhiko, Harada Toshiyuki, Fujimoto Nobukazu, Bessho Akihiro, Takamura Kei, Takahashi Kazuhisa, Satouchi Miyako, Kato Terufumi, Shukuya Takehito, Yamashita Natsumi, Okamoto Hiroaki, Shinkai Tetsu
Department of Thoracic Oncology and Medicine, National Hospital Organization Shikoku Cancer Center, Matsuyama, Ehime, Japan.
Department of Respiratory Medicine, Matsusaka Municipal Hospital, Matsusaka, Mie, Japan.
Transl Lung Cancer Res. 2020 Jun;9(3):459-470. doi: 10.21037/tlcr.2020.03.29.
The effectiveness of bevacizumab monotherapy in elderly patients with non-squamous non-small cell lung cancer (NSCLC) is unclear. The efficacy of the combinations for elderly patients was explored.
Untreated patients (≥75 years; performance status 0-1) with stage IIIB, IV, or recurrent non-squamous NSCLC were included. Patients with epidermal growth factor receptor () mutation or anaplastic lymphoma kinase () gene rearrangements were eligible even if they received tyrosine kinase inhibitors. Patients were randomized 1:1 to receive docetaxel (50 mg/m) (DB) or pemetrexed (500 mg/m) (PB) with bevacizumab (15 m/kg). The primary endpoint was progression-free survival (PFS). Treatment was administered every 3 weeks until disease progression or unacceptable toxicity.
Overall, 103 patients (DB: n=51; PB: n=52) were enrolled. In the DB and PB arms, median ages [range] were 78 [75-88] and 79 [75-94] years, respectively; median PFS were 6.1 and 4.6 months, respectively [hazard ratio (HR), 1.03; 95% confidence interval (CI), 0.66-1.61]; and response rates were 43%, and 40%, respectively (P=0.840). Grade ≥3 leukopenia, neutropenia, and fatigue incidences were significantly higher in the DB arm. Febrile neutropenia incidence did not differ significantly (16% . 12%, P=0.578). One patient in the PB arm died from a ruptured abdominal aortic aneurysm. Quality of life (QoL) analysis revealed less deterioration in the PB arm.
In previously untreated elderly patients with non-squamous NSCLC, PB shows feasibility, better QoL, and promising efficacy in terms of PFS, and an objective response rate for further analysis (UMIN000012786).
贝伐单抗单药治疗老年非鳞状非小细胞肺癌（NSCLC）的疗效尚不清楚。本研究探讨了联合用药方案对老年患者的疗效。
纳入未经治疗的ⅢB期、Ⅳ期或复发性非鳞状NSCLC患者（年龄≥75岁；体能状态0 - 1）。表皮生长因子受体（）突变或间变性淋巴瘤激酶（）基因重排的患者即使接受过酪氨酸激酶抑制剂治疗也符合条件。患者按1:1随机分组，接受多西他赛（50 mg/m）（DB组）或培美曲塞（500 mg/m）（PB组）联合贝伐单抗（15 mg/kg）治疗。主要终点为无进展生存期（PFS）。每3周进行一次治疗，直至疾病进展或出现不可接受的毒性。
共纳入103例患者（DB组：n = 51；PB组：n = 52）。DB组和PB组的中位年龄[范围]分别为78岁[75 - 88岁]和79岁[75 - 94岁]；中位PFS分别为6.1个月和4.6个月[风险比（HR），1.03；95%置信区间（CI），0.66 - 1.61]；缓解率分别为43%和40%（P = 0.840）。DB组≥3级白细胞减少、中性粒细胞减少和疲劳的发生率显著更高。发热性中性粒细胞减少的发生率无显著差异（16% 对12%，P = 0.578）。PB组有1例患者死于腹主动脉瘤破裂。生活质量（QoL）分析显示PB组的恶化程度较小。
在既往未经治疗的老年非鳞状NSCLC患者中，PB方案显示出可行性、更好的生活质量以及在PFS方面有良好疗效和客观缓解率，值得进一步分析（UMIN000012786）。
