催眠药
医学
伊立替康
耐受性
内科学
胃肠病学
中性粒细胞减少症
顺铂
肿瘤科
肺癌
化疗
癌症
不利影响
结直肠癌
作者
Hirotsugu Kenmotsu,Keita Mori,Risa Mizuno,Nobuaki Mamesaya,Haruki Kobayashi,Shota Omori,Kazushige Wakuda,Akira Ono,Tateaki Naito,Haruyasu Murakami,Toshiaki Takahashi
出处
期刊:Lung Cancer
[Elsevier]
日期:2021-12-01
卷期号:164: 39-45
被引量:1
标识
DOI:10.1016/j.lungcan.2021.12.011
摘要
Previous studies have shown the potentials of anti-angiogenesis inhibitors in extensive-stage small-cell lung cancer (SCLC). This single-institutional phase 1b study aimed to determine the recommended dose of ramucirumab (anti-vascular endothelial growth factor receptor-2 antibody) in combination with irinotecan plus cisplatin for extensive-stage SCLC.Chemo-naïve patients with extensive-stage SCLC were enrolled and received ramucirumab (day 1 and 15) with irinotecan (60 mg/m2, day 1, 8, and 15) plus cisplatin (60 mg/m2, day 1) every 4 weeks for four cycles, followed by biweekly maintenance ramucirumab. The recommended ramucirumab dose (10 or 8 mg/kg) was determined using a traditional 3 + 3 design, and the number of patients treated at the recommended dose was set at 10 to evaluate drug efficacy and tolerability (UMIN000032671).The first 3 patients that received irinotecan plus cisplatin with ramucirumab 10 mg/kg did not experience dose-limiting toxicities. Thus, the recommended dose of ramucirumab was set at 10 mg/kg, and 10 patients received this dose. The objective response rate was 100% (95% CI, 69-100%), with a median progression-free survival of 7.2 months (95% CI, 5.3-9.0) and median overall survival of 22.4 months (95% CI, 12.1-not reached). Grade 3 neutropenia and hypertension were observed in 4 and 2 patients, respectively. No ramucirumab-related deaths were noted; hypertension and bleeding events were observed in 5 and 6 patients, respectively.This study showed the satisfactory tolerability and efficacy of ramucirumab at 10 mg/kg in combination with irinotecan plus cisplatin in chemo-naïve patients with extensive-stage SCLC.
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