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.
Bibliographical noteFunding Information:
Acknowledgments The study was sponsored by the Division of Cancer Treatment and Diagnosis, National Cancer Institute, USA, and its collaborator MGI Pharma, Inc. We thank Ms Jam Jun Lee for data handling and nursing input for the conduct of this study, and Drs A.Y.C. Chang, K.F. Foo, W-S Hsieh, W.H. Koo, T.S.K. Mok, S.H. Tan, H.C. Toh, J. Wong, and M. Millward of Sir Charles Gairdner Hospital, Australia, for their support in the study for their support in the study.
All Science Journal Classification (ASJC) codes
- Cancer Research
- Pharmacology (medical)