Summary
Twenty four patients with advanced renal cell carcinoma were treated in a phase II trial with amonafide 300–450 mg/m2/day on days 1–5 every 21 days. There were no responders, 6 patients had stable disease, 14 experienced progressive disease and 4 were assumed to be non-responders as no evaluation was performed. There were no fatal toxicities although 8 patients had grade 3 or 4 granulocytopenia, 1 patient had grade 4 thrombocytopenia. Other toxicities included grade 3 diarrhea in 1 patient, grade 3 myopathy in 1 patient, severe nausea and vomiting in 1 patient and a facial rash, possibly a hypersensitivity reaction, in 1 patient. The median survival is 7.5 months. At this dosage and schedule, there is no evidence that amonafide has meaningful anti-tumor activity in patients with advanced renal cell carcinoma.
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Address for offprints: Southwest Oncology Group (SWOG- 8716), Operations Office, 5430 Fredericksburg Road, Suite #618, San Antonio, TX 78229-6197, USA
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Higano, C.S., Goodman, P., Craig, J.B. et al. Phase II evaluation of amonafide in renal cell carcinoma. Invest New Drugs 9, 361–363 (1991). https://doi.org/10.1007/BF00183582
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DOI: https://doi.org/10.1007/BF00183582