論文

国際誌
2021年

Phase 1 study of pembrolizumab plus chemotherapy as first-line treatment in Japanese patients with advanced NSCLC

Cancer Treatment and Research Communications
  • Takayasu Kurata
  • ,
  • Kazuhiko Nakagawa
  • ,
  • Miyako Satouchi
  • ,
  • Takashi Seto
  • ,
  • Takeshi Sawada
  • ,
  • Shirong Han
  • ,
  • Masae Homma
  • ,
  • Kazuo Noguchi
  • ,
  • Naoyuki Nogami

29
開始ページ
100458
終了ページ
100458
記述言語
英語
掲載種別
研究論文(学術雑誌)
DOI
10.1016/j.ctarc.2021.100458
出版者・発行元
Elsevier BV

INTRODUCTION: Pembrolizumab plus chemotherapy significantly improved outcomes over chemotherapy alone as first-line treatment in patients with advanced non-small-cell lung cancer (NSCLC) in phase 3 international trials. In the phase 1 KEYNOTE-011 study (parts B and C), we evaluated the safety/activity of pembrolizumab plus chemotherapy as first-line treatment in Japanese patients with advanced NSCLC. METHODS: Eligible patients received 4 cycles (every 3 weeks) of pembrolizumab 200 mg plus chemotherapy (cisplatin 75 mg/m2/carboplatin area under the curve [AUC] 5 mg/mL/min and pemetrexed 500 mg/m2 in part B [nonsquamous]; carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m2/nab-paclitaxel 100 mg/m2 (weekly) in part C [squamous]), followed by maintenance pembrolizumab (and pemetrexed, part B). The primary endpoint was incidence of dose-limiting toxicities (DLTs) during the first 3 weeks of treatment. Overall response rate (ORR; RECIST v1.1 by central review) was exploratory. RESULTS: In part B (median follow-up, 16.0 months; n = 12) 1 DLT occurred (grade 4 hyponatremia). Grade ≥3 treatment-related adverse events (AEs) occurred in 9 patients (75%). Two patients had grade 5 treatment-related AEs (pneumonitis and interstitial lung disease). In part C (median follow-up, 9.9 months; n = 14), 2 DLTs occurred (both grade 3 febrile neutropenia). Grade ≥3 treatment-related AEs occurred in 11 patients (79%); none were fatal. ORR was 73% in part B and 50% in part C, irrespective of PD-L1 status. CONCLUSION: Safety results show first-line pembrolizumab plus chemotherapy is feasible in Japanese patients with advanced NSCLC. Antitumor activity was observed irrespective of PD-L1 status and was comparable to that in international studies. TRIAL REGISTER: ClinicalTrials.gov, NCT01840579.

リンク情報
DOI
https://doi.org/10.1016/j.ctarc.2021.100458
PubMed
https://www.ncbi.nlm.nih.gov/pubmed/34607222
ID情報
  • DOI : 10.1016/j.ctarc.2021.100458
  • ISSN : 2468-2942
  • PubMed ID : 34607222

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