Original Article

Cancer Chemotherapy and Pharmacology

, Volume 59, Issue 3, pp 295-300

Irofulven as first line therapy in recurrent or metastatic gastric cancer: a phase II multicenter study by the Cancer Therapeutics Research Group (CTRG)

  • W. YeoAffiliated withComprehensive Cancer Trials Unit, Department of Clinical Oncology, Chinese University of Hong Kong, Prince of Wales HospitalComprehensive Cancer Trials Unit, Department of Surgery, Chinese University of Hong Kong, Prince of Wales Hospital Email author 
  • , M. BoyerAffiliated withSydney Cancer Centre, Royal Prince Alfred Hospital
  • , H. C. ChungAffiliated withDivision of Haematology–Oncology, Yonsei Cancer Center, Yonsei University College of Medicine
  • , S. Y. K. OngAffiliated withDepartment of Medical Oncology, National Cancer Centre
  • , R. LimAffiliated withDepartment of Haematology–Oncology, National University Hospital
  • , Benny ZeeAffiliated withComprehensive Cancer Trials Unit, Department of Clinical Oncology, Chinese University of Hong Kong, Prince of Wales HospitalComprehensive Cancer Trials Unit, Department of Surgery, Chinese University of Hong Kong, Prince of Wales Hospital
  • , B. MaAffiliated withComprehensive Cancer Trials Unit, Department of Clinical Oncology, Chinese University of Hong Kong, Prince of Wales HospitalComprehensive Cancer Trials Unit, Department of Surgery, Chinese University of Hong Kong, Prince of Wales Hospital
  • , K. C. LamAffiliated withComprehensive Cancer Trials Unit, Department of Clinical Oncology, Chinese University of Hong Kong, Prince of Wales HospitalComprehensive Cancer Trials Unit, Department of Surgery, Chinese University of Hong Kong, Prince of Wales Hospital
  • , F. K. F. MoAffiliated withComprehensive Cancer Trials Unit, Department of Clinical Oncology, Chinese University of Hong Kong, Prince of Wales HospitalComprehensive Cancer Trials Unit, Department of Surgery, Chinese University of Hong Kong, Prince of Wales Hospital
    • , E. K. W. NgAffiliated withComprehensive Cancer Trials Unit, Department of Clinical Oncology, Chinese University of Hong Kong, Prince of Wales HospitalComprehensive Cancer Trials Unit, Department of Surgery, Chinese University of Hong Kong, Prince of Wales Hospital
    • , R. HoAffiliated withComprehensive Cancer Trials Unit, Department of Clinical Oncology, Chinese University of Hong Kong, Prince of Wales HospitalComprehensive Cancer Trials Unit, Department of Surgery, Chinese University of Hong Kong, Prince of Wales Hospital
    • , S. ClarkeAffiliated withSydney Cancer Centre, Royal Prince Alfred Hospital
    • , J. K. RohAffiliated withDivision of Haematology–Oncology, Yonsei Cancer Center, Yonsei University College of Medicine
    • , P. BealeAffiliated withSydney Cancer Centre, Royal Prince Alfred Hospital
    • , S. Y. RhaAffiliated withDivision of Haematology–Oncology, Yonsei Cancer Center, Yonsei University College of Medicine
    • , H. C. JeungAffiliated withDivision of Haematology–Oncology, Yonsei Cancer Center, Yonsei University College of Medicine
    • , R. SooAffiliated withDepartment of Haematology–Oncology, National University Hospital
    • , B. C. GohAffiliated withDepartment of Haematology–Oncology, National University Hospital
    • , A. T. C. ChanAffiliated withComprehensive Cancer Trials Unit, Department of Clinical Oncology, Chinese University of Hong Kong, Prince of Wales Hospital

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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.

Patients and 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 ≥ 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.

Keywords

Irofulven Stomach cancer First line chemotherapy