論文

2019年

A Phase II Study of Cisplatin Plus Gemcitabine followed by Maintenance Gemcitabine for Advanced Squamous Non-Small-Cell Lung Cancer: Kyoto Thoracic Oncology Research Group 1302

Oncology
  • Satoshi Ikeda
  • Hiroshige Yoshioka
  • Toshihiko Kaneda
  • Toshihide Yokoyama
  • Takashi Niwa
  • Naoyuki Sone
  • Tadashi Ishida
  • Mitsunori Morita
  • Hiromi Tomioka
  • Chihito Komaki
  • Masataka Hirabayashi
  • Yoshinori Hasegawa
  • Tetsuo Noguchi
  • Yasutaka Nakano
  • Chikara Sakaguchi
  • Kenichi Yoshimura
  • Toyohiro Hirai
  • 全て表示

97
6
開始ページ
327
終了ページ
333
記述言語
掲載種別
研究論文(学術雑誌)
DOI
10.1159/000501967
出版者・発行元
S. Karger AG

<b><i>Background:</i></b> There has been no study so far on gemcitabine continuous maintenance therapy targeting only squamous non-small-cell lung cancer (NSCLC) patients. This study aimed to assess the efficacy and safety of cisplatin plus gemcitabine followed by maintenance gemcitabine for chemotherapy- naïve Japanese patients with advanced squamous NSCLC. <b><i>Methods:</i></b> The patients received 4 cycles of gemcitabine (1,000 mg/m<sup>2</sup>, days 1 and 8) and cisplatin (80 mg/m<sup>2</sup>, day 1) every 3 weeks, followed by gemcitabine alone as maintenance therapy every 3 weeks until disease progression or unacceptable toxicity. The primary end point of the study was progression-free survival (PFS) from the date of registration. <b><i>Results:</i></b> From May 2013 to October 2018, 26 patients were enrolled, and 25 patients received ≥1 cycle of planned treatment. Eighteen patients (69.2%) received 4 cycles of cisplatin plus gemcitabine, and 16 patients (61.5%) received ≥1 cycle of maintenance gemcitabine. The median PFS from the date of registration was 5.3 months (95% CI 2.9–7.3 months). In 16 patients who received ≥1 cycle of maintenance gemcitabine, the median PFS from the date of maintenance gemcitabine initiation was 3.8 months (95% CI 2.3–5.2 months). Their median overall survival from the date of registration was 11.9 months (95% CI 7.5–26.5 months). During the maintenance therapy, adverse events (AEs) were mostly Common Terminology Criteria for AE grade 1. <b><i>Conclusions:</i></b> While this trial did not meet the primary endpoint, the sufficient efficacy and feasibility of gemcitabine maintenance therapy were suggested.

リンク情報
DOI
https://doi.org/10.1159/000501967
URL
https://www.karger.com/Article/Pdf/501967
ID情報
  • DOI : 10.1159/000501967
  • ISSN : 0030-2414
  • eISSN : 1423-0232

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