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Outcomes in 50 Patients with Advanced Gastric Cancer Treated in Phase I Trials: the Ncche Experience
Annals of Oncology 25 (Supplement 5): v44–v74, 2014 doi:10.1093/annonc/mdu435.26
Oral Session (Oral presentations categorized by each organ) O1
13
3
Akihito Kawazoe, Kohei Shitara, Yasutoshi Kuboki, Hideaki Bando, Wataru Okamoto, Takashi Kojima, Nozomu Fuse, Takayuki Yoshino, Toshihiko Doi, Atsushi Ohtsu Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East
abstracts
Background: Patients with advanced gastric cancer (AGC) have a poor prognosis once standard therapies fail. This retrospective study presents the characteristics and outcomes in AGC patients treated in phase I trials in our institution.
© The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: [email protected].
Downloaded from https://academic.oup.com/annonc/article-abstract/25/suppl_5/v50/2240248 by guest on 26 October 2019
OUTCOMES IN 50 PATIENTS WITH ADVANCED GASTRIC CANCER TREATED IN PHASE I TRIALS: THE NCCHE EXPERIENCE
Methods: We retrospectively reviewed the clinical outcomes in 50 consecutive patients with AGC who were treated in phase I trials after standard chemotherapies between March 2008 and November 2013. Results: Median age was 65 years (range, 28-74 years) and all had performance status ECOG 0 or 1. The median number of previous systemic chemotherapy was 3 (range, 2-6) with the median interval from beginning of first-line chemotherapy to enrollment for phase I trials of 17 months. Ten patients were enrolled for two or more phase I trials. The median time to treatment failure (TTF) of the best phase I treatment was shorter than those of the last line of systemic chemotherapy (1.4 vs. 2.3 months; HR 1.73; P = 0.01). TTF of best phase I trial was longer than the last line of systemic chemotherapy in 15 patients (30%). Objective response was observed in 4 patients (8%) and additional 5 patients (10%) achieved stable disease >3 months. Severe adverse events and grade >3 toxicities were reported in 8 patients (16%) and 10 patients (20%), respectively. No treatment related death was observed. Median survival time after enrollment for phase I trials was 5.8 months and 3 death (6%) within 30 days after last administration was observed. Conclusions: The median TTF of AGC patients in phase I treatment was shorter than those of their last line of systemic chemotherapy. Although it offer some clinical benefit for small subset of AGC patients after all standard chemotherapy, better studies might be necessary to improve its outcome.
Oral Session (Oral presentations categorized by each organ) O1
13
3
Akihito Kawazoe, Kohei Shitara, Yasutoshi Kuboki, Hideaki Bando, Wataru Okamoto, Takashi Kojima, Nozomu Fuse, Takayuki Yoshino, Toshihiko Doi, Atsushi Ohtsu Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East
abstracts
Background: Patients with advanced gastric cancer (AGC) have a poor prognosis once standard therapies fail. This retrospective study presents the characteristics and outcomes in AGC patients treated in phase I trials in our institution.
© The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: [email protected].
Downloaded from https://academic.oup.com/annonc/article-abstract/25/suppl_5/v50/2240248 by guest on 26 October 2019
OUTCOMES IN 50 PATIENTS WITH ADVANCED GASTRIC CANCER TREATED IN PHASE I TRIALS: THE NCCHE EXPERIENCE
Methods: We retrospectively reviewed the clinical outcomes in 50 consecutive patients with AGC who were treated in phase I trials after standard chemotherapies between March 2008 and November 2013. Results: Median age was 65 years (range, 28-74 years) and all had performance status ECOG 0 or 1. The median number of previous systemic chemotherapy was 3 (range, 2-6) with the median interval from beginning of first-line chemotherapy to enrollment for phase I trials of 17 months. Ten patients were enrolled for two or more phase I trials. The median time to treatment failure (TTF) of the best phase I treatment was shorter than those of the last line of systemic chemotherapy (1.4 vs. 2.3 months; HR 1.73; P = 0.01). TTF of best phase I trial was longer than the last line of systemic chemotherapy in 15 patients (30%). Objective response was observed in 4 patients (8%) and additional 5 patients (10%) achieved stable disease >3 months. Severe adverse events and grade >3 toxicities were reported in 8 patients (16%) and 10 patients (20%), respectively. No treatment related death was observed. Median survival time after enrollment for phase I trials was 5.8 months and 3 death (6%) within 30 days after last administration was observed. Conclusions: The median TTF of AGC patients in phase I treatment was shorter than those of their last line of systemic chemotherapy. Although it offer some clinical benefit for small subset of AGC patients after all standard chemotherapy, better studies might be necessary to improve its outcome.