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A Gynecologic Oncology Group phase II study of amonafide (NSC 308847) in epithelial ovarian cancer
R F Asbury1, J A Blessing, K Y Look
1Department of Oncology, University of Rochester School of Medicine, New York.
Abstract:
In this study, 19 evaluable patients with epithelial ovarian cancer were treated with amonafide 300 mg/m2 over an hour for 5 consecutive days every 3 weeks. One partial response (5%) was seen. Hematologic toxicity was substantial with grade 3 or 4 toxicity occurring as follows: leukopenia, 10 patients (45%); thrombocytopenia, 6 patients (27%); granulocytopenia, 8 patients (36%). No other unusual or severe toxicity occurred. In view of the low response rate and high toxicity, amonafide does not warrant further investigation in epithelial ovarian cancer.
Insights
Amonafide showed a low response rate and substantial hematologic toxicity in epithelial ovarian cancer patients. Further investigation of amonafide for this cancer is not recommended due to these findings.
Area of Science:
- Oncology
- Pharmacology
- Clinical Trials
Background:
- Epithelial ovarian cancer remains a significant health challenge with limited treatment options.
- Amonafide, an investigational chemotherapeutic agent, was explored for its efficacy and safety.
- Previous studies suggested potential activity, necessitating further clinical evaluation.
Purpose of the Study:
- To evaluate the efficacy and safety of amonafide in patients with epithelial ovarian cancer.
- To determine the overall response rate and characterize the toxicity profile of amonafide.
- To assess the potential of amonafide for further clinical development in this patient population.
Main Methods:
- A phase II clinical trial was conducted involving 19 evaluable patients with epithelial ovarian cancer.
- Patients received amonafide at a dose of 300 mg/m2 intravenously over 1 hour daily for 5 consecutive days every 3 weeks.
- Response was assessed using standard criteria, and toxicity was graded according to established guidelines.
Main Results:
- A single partial response (5% response rate) was observed among the 19 evaluable patients.
- Significant hematologic toxicities were noted, including grade 3 or 4 leukopenia (45%), thrombocytopenia (27%), and granulocytopenia (36%).
- No other unexpected severe toxicities were reported during the study.
Conclusions:
- Amonafide demonstrated a low response rate in patients with epithelial ovarian cancer.
- The observed high incidence of severe hematologic toxicity limits its therapeutic potential.
- Based on these findings, amonafide does not appear to be a promising agent for further investigation in epithelial ovarian cancer.