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Phase II evaluation of amonafide in renal cell carcinoma. A Southwest Oncology Group study
C S Higano1, P Goodman, J B Craig
1Puget Sound Oncology Consortium, Seattle, WA.
Abstract:
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.
Insights
Amonafide showed no significant anti-tumor activity in patients with advanced renal cell carcinoma during a phase II trial. The drug did not produce responders, with most patients experiencing disease progression or stable disease.
Area of Science:
- Oncology
- Pharmacology
Background:
- Advanced renal cell carcinoma (RCC) presents a significant therapeutic challenge.
- Novel chemotherapeutic agents are continuously investigated for efficacy in advanced RCC.
Purpose of the Study:
- To evaluate the anti-tumor activity and toxicity of amonafide in patients with advanced renal cell carcinoma.
- To determine the efficacy of amonafide at a specific dosage and schedule in this patient population.
Main Methods:
- A phase II clinical trial was conducted.
- Twenty-four patients with advanced renal cell carcinoma were enrolled.
- Patients received amonafide at 300-450 mg/m2/day on days 1-5 every 21 days.
Main Results:
- No objective tumor responses were observed in any of the 24 patients.
- Six patients achieved stable disease, while 14 experienced progressive disease.
- Hematological toxicities, including granulocytopenia and thrombocytopenia, were noted, along with other adverse events like diarrhea and myopathy.
Conclusions:
- Amonafide, at the tested dosage and schedule, demonstrated no meaningful anti-tumor activity in patients with advanced renal cell carcinoma.
- The observed toxicities warrant consideration, but no fatal toxicities occurred.
- Further investigation into amonafide for advanced RCC is not supported by these findings.