2015年6月
Clinical outcomes in 66 patients with advanced gastric cancer treated in phase I trials: the NCCHE experience
INVESTIGATIONAL NEW DRUGS
- 巻
- 33
- 号
- 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
- ID情報
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- DOI : 10.1007/s10637-015-0231-9
- ISSN : 0167-6997
- eISSN : 1573-0646
- PubMed ID : 25773493
- Web of Science ID : WOS:000354621100012