論文

査読有り
2015年6月

Clinical outcomes in 66 patients with advanced gastric cancer treated in phase I trials: the NCCHE experience

INVESTIGATIONAL NEW DRUGS
  • Akihito Kawazoe
  • Kohei Shitara
  • Shota Fukuoka
  • Masaaki Noguchi
  • Yasutoshi Kuboki
  • Hideaki Bando
  • Wataru Okamoto
  • Takashi Kojima
  • Nozomu Fuse
  • Takayuki Yoshino
  • Atsushi Ohtsu
  • Toshihiko Doi
  • 全て表示

33
3
開始ページ
664
終了ページ
670
記述言語
英語
掲載種別
研究論文(学術雑誌)
DOI
10.1007/s10637-015-0231-9
出版者・発行元
SPRINGER

Background Although patients with advanced gastric cancer (AGC) have a poor prognosis when conventional therapies fail, they are often candidates for phase I trials. However, there is no detailed report on clinical outcomes of patients with AGC treated in phase I trials. Methods We retrospectively reviewed the medical records of 66 consecutive patients with AGC enrolled in phase I trials between March 2008 and July 2014 at our institution in Japan. Results Median age was 66 years (range, 28-78 years) and median number of previous lines of conventional chemotherapy was 3 (range, 1-6). Five (8.6 %) and seven (12 %) patients showed objective response and stable disease > 3 months, respectively. Although the time to treatment failure (TTF) of the best phase I treatment was shorter than that of the last line of conventional chemotherapy (median 1.5 vs. 2.3 months; P = 0.002), TTF of the best phase I treatment was longer than that of the last line of treatment in 21 patients (32 %). Severe adverse events and grade 3 or higher toxicities were reported in eight (12 %) and 13 patients (20 %), respectively. No treatment-related death was observed. Median survival time from the start of phase I treatment was 7.5 months, and four deaths (6 %) within 30 days after last administration were observed. Conclusion Phase I trials of patients with AGC was acceptably feasible with some efficacy signal. Our results suggest that phase I trials might be one treatment option for patients with AGC when conventional therapies fail.

リンク情報
DOI
https://doi.org/10.1007/s10637-015-0231-9
PubMed
https://www.ncbi.nlm.nih.gov/pubmed/25773493
Web of Science
https://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=JSTA_CEL&SrcApp=J_Gate_JST&DestLinkType=FullRecord&KeyUT=WOS:000354621100012&DestApp=WOS_CPL
ID情報
  • DOI : 10.1007/s10637-015-0231-9
  • ISSN : 0167-6997
  • eISSN : 1573-0646
  • PubMed ID : 25773493
  • Web of Science ID : WOS:000354621100012

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