title: Clinical outcomes in 66 patients with advanced gastric cancer treated in phase I trials: the NCCHE experience.
abstract: 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East (NCCHE), 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.
authors.forename: Akihito
authors.initials: A
authors.lastname: Kawazoe
authors.forename: Kohei
authors.initials: K
authors.lastname: Shitara
authors.forename: Shota
authors.initials: S
authors.lastname: Fukuoka
authors.forename: Masaaki
authors.initials: M
authors.lastname: Noguchi
authors.forename: Yasutoshi
authors.initials: Y
authors.lastname: Kuboki
authors.forename: Hideaki
authors.initials: H
authors.lastname: Bando
authors.forename: Wataru
authors.initials: W
authors.lastname: Okamoto
authors.forename: Takashi
authors.initials: T
authors.lastname: Kojima
authors.forename: Nozomu
authors.initials: N
authors.lastname: Fuse
authors.forename: Takayuki
authors.initials: T
authors.lastname: Yoshino
authors.forename: Atsushi
authors.initials: A
authors.lastname: Ohtsu
authors.forename: Toshihiko
authors.initials: T
authors.lastname: Doi
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use; D001706:Biopsy; D017321:Clinical Trials, Phase I as Topic; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D013270:Stomach / Q000473:pathology; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents