Scholarlink

<p>Combination therapy with dabrafenib and trametinib has been shown to improve response and survival outcomes in patients with <i>BRAF</i> V600E-mutated non–small cell lung cancer (NSCLC). However, safety and efficacy data in Japanese patients with unresectable NSCLC are limited in clinical trials. This post marketing surveillance study investigated the safety and effectiveness of dabrafenib and trametinib in Japan between March 2018 and August 2023. Most patients included in the safety analysis set (<i>N</i> = 76) had stage IV NSCLC (82.89%) and Eastern Cooperative Oncology Group performance status 0 or 1 (85.53%). Adverse events (AEs) occurred in 70 patients (92.11%); the most common AEs (≥ 5%) were pyrexia (46.05%), progression of NSCLC (38.16%), and rash (13.16%). Incidences of adverse drug reactions of safety specifications were pyrexia (46.05%), rhabdomyolysis (11.84%), and hepatic impairment and cardiac disorder (10.53% each). In the overall response rate (ORR) analysis set (<i>n</i> = 64), ORR was 67.19% (95% confidence interval [CI], 54.31-78.41%). Seventy-four patients were analyzed for progression-free survival (PFS); PFS rates (95% CI) at 182 days and 364 days were 71.07% (58.79-80.29%) and 49.64% (37.17-60.91%), respectively. Median PFS (95% CI) survival was 364 days (246.00 to not estimable). Real-world data observed in this surveillance study were similar to those reported previously.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

A post-marketing surveillance study of dabrafenib and trametinib combination in Japanese patients with unresectable advanced or recurrent BRAF-mutated NSCLC

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年7月2日

查看全文
  • Tomoaki Kaizuka,
  • Ryohei Kurihara,
  • Yuya Yokochi,
  • Naoko Suenaga

摘要

Combination therapy with dabrafenib and trametinib has been shown to improve response and survival outcomes in patients with BRAF V600E-mutated non–small cell lung cancer (NSCLC). However, safety and efficacy data in Japanese patients with unresectable NSCLC are limited in clinical trials. This post marketing surveillance study investigated the safety and effectiveness of dabrafenib and trametinib in Japan between March 2018 and August 2023. Most patients included in the safety analysis set (N = 76) had stage IV NSCLC (82.89%) and Eastern Cooperative Oncology Group performance status 0 or 1 (85.53%). Adverse events (AEs) occurred in 70 patients (92.11%); the most common AEs (≥ 5%) were pyrexia (46.05%), progression of NSCLC (38.16%), and rash (13.16%). Incidences of adverse drug reactions of safety specifications were pyrexia (46.05%), rhabdomyolysis (11.84%), and hepatic impairment and cardiac disorder (10.53% each). In the overall response rate (ORR) analysis set (n = 64), ORR was 67.19% (95% confidence interval [CI], 54.31-78.41%). Seventy-four patients were analyzed for progression-free survival (PFS); PFS rates (95% CI) at 182 days and 364 days were 71.07% (58.79-80.29%) and 49.64% (37.17-60.91%), respectively. Median PFS (95% CI) survival was 364 days (246.00 to not estimable). Real-world data observed in this surveillance study were similar to those reported previously.