title: Irofulven as first line therapy in recurrent or metastatic gastric cancer: a phase II multicenter study by the Cancer Therapeutics Research Group (CTRG).
abstract: BACKGROUND
  The purpose of this study was to evaluate the tolerability and efficacy of irofulven, a DNA interacting acylfulvene analog, as first line therapy for patients with recurrent or metastatic gastric cancer.
  
  
  METHODS
  Twenty-three patients with recurrent or metastatic gastric cancer received irofulven at a dose of 0.45 mg/kg administered intravenously over 30-min infusion (up to a maximum of 50 mg), on days 1 and 8, every 3 weeks.
  
  
  RESULTS
  The median number of cycles delivered per patient was 2 (range 1-6). Two patients (9%) had >or= 1-week delay in administration of subsequent cycle of chemotherapy. For the day 8 chemotherapy, dose reductions were required in seven patients (30%); dose omitting occurred in five patients (22%). Grade 3/4 anemia and neutropenia occurred in 22 and 17% of patients, respectively. There was no grade 4 thrombocytopenia and no neutropenic fever was observed. Of the 20 evaluable patients, there were no responses observed, 3 patients had stable disease after 2 cycles of treatment which was not confirmed by a further assessment. Median overall survival was 6.05 months (95% CI 4.55-9.39).
  
  
  CONCLUSIONS
  Irofulven was tolerated at the dose of 0.45 mg/kg on days 1 and 8, every 3 weeks but showed no evidence of antitumor activity in patients with advanced gastric cancer.
authors.affiliation: Comprehensive Cancer Trials Unit, Department of Clinical Oncology, Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong. winnieyeo@cuhk.edu.hk
authors.forename: W
authors.initials: W
authors.lastname: Yeo
authors.forename: M
authors.initials: M
authors.lastname: Boyer
authors.forename: H C
authors.initials: HC
authors.lastname: Chung
authors.forename: S Y K
authors.initials: SY
authors.lastname: Ong
authors.forename: R
authors.initials: R
authors.lastname: Lim
authors.forename: Benny
authors.initials: B
authors.lastname: Zee
authors.forename: B
authors.initials: B
authors.lastname: Ma
authors.forename: K C
authors.initials: KC
authors.lastname: Lam
authors.forename: F K F
authors.initials: FK
authors.lastname: Mo
authors.forename: E K W
authors.initials: EK
authors.lastname: Ng
authors.forename: R
authors.initials: R
authors.lastname: Ho
authors.forename: S
authors.initials: S
authors.lastname: Clarke
authors.forename: J K
authors.initials: JK
authors.lastname: Roh
authors.forename: P
authors.initials: P
authors.lastname: Beale
authors.forename: S Y
authors.initials: SY
authors.lastname: Rha
authors.forename: H C
authors.initials: HC
authors.lastname: Jeung
authors.forename: R
authors.initials: R
authors.lastname: Soo
authors.forename: B C
authors.initials: BC
authors.lastname: Goh
authors.forename: A T C
authors.initials: AT
authors.lastname: Chan
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D000328:Adult; D000368:Aged; D018906:Antineoplastic Agents, Alkylating / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008198:Lymph Nodes / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D012717:Sesquiterpenes / Q000627:therapeutic use*; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D018906:Antineoplastic Agents, Alkylating; D012717:Sesquiterpenes; C102714:irofulven