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A phase II trial of amonafide in patients with mixed mesodermal tumors of the uterus: a Gynecologic Oncology Group
R Asbury1, J A Blessing, E Podczaski
1Department of Medicine in Oncology, University of Rochester School of Medicine, New York, USA.
Abstract:
Amonafide demonstrated a poor response rate and substantial toxicity in patients who had measurable, advanced mixed mesodermal tumors of the uterus. Amonafide-a drug that acts through intercalation of tumor DNA-was used to treat 16 patients who had measurable, advanced mixed mesodermal tumors of the uterus as part of a Gynecologic Oncology Group (GOG) Phase II study. The starting dose was 300 mg/m2 intravenously over 1 hour for 5 consecutive days every 3 weeks. Severe or life-threatening hematologic toxicity occurred in 50% of the patients. Two patients experienced vomiting requiring hospitalization. Other toxicities were not severe. One patient had a partial response and one had stable disease, each lasting 4 months. This dose schedule was associated with poor response rate and substantial toxicity.
Insights
Amonafide showed limited effectiveness and significant toxicity in treating advanced uterine tumors. The drug caused severe side effects in half of the patients, with minimal anti-tumor activity observed.
Area of Science:
- Oncology
- Pharmacology
Background:
- Uterine mixed mesodermal tumors are rare and aggressive gynecologic malignancies.
- Effective treatment options for advanced stages remain limited, necessitating novel therapeutic approaches.
Purpose of the Study:
- To evaluate the efficacy and safety of Amonafide in patients with advanced uterine mixed mesodermal tumors.
- To determine the response rate and toxicity profile of Amonafide at a specific dosage regimen.
Main Methods:
- A Gynecologic Oncology Group (GOG) Phase II study was conducted.
- Sixteen patients with measurable, advanced uterine mixed mesodermal tumors received Amonafide.
- The treatment involved intravenous administration of Amonafide at 300 mg/m2 over 5 consecutive days every 3 weeks.
Main Results:
- Amonafide demonstrated a poor overall response rate.
- Severe or life-threatening hematologic toxicity was observed in 50% of the patients.
- One patient achieved a partial response and another had stable disease, both lasting 4 months.
Conclusions:
- The studied dose schedule of Amonafide is associated with substantial toxicity and a poor response rate.
- Amonafide is not an effective treatment for advanced uterine mixed mesodermal tumors at this regimen.
- Further investigation into alternative dosing or combination therapies may be warranted.