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Phase II trial of amonafide in patients with stage III and IV non-small-cell lung cancer
M Z Berger1, M G Kris, R J Gralla
1Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY 10021.
Abstract:
Amonafide (benzisoquinolinedione, nafidimide, NSC 308847) is an anticancer agent that functions as a DNA intercalator. Sixteen patients with stage III or IV non-small-cell lung cancer who had not previously received chemotherapy were given amonafide at an initial dose of 300 mg/m2 i.v. daily for 5 days every 21 days. No major objective responses were observed among the 14 patients adequately treated (95% confidence limits 0-20%). Local reactions at the injection site or phlebitis were seen in 14 of the 16 patients. Leukopenia (44%), nausea or vomiting (38%), and thrombocytopenia and rash (each 25%) were also noted. With the low response rate and the toxicity observed, amonafide at this dosage and schedule has limited use in the treatment of non-small-cell lung cancer.
Insights
Amonafide, a DNA intercalator, showed limited efficacy in treating advanced non-small-cell lung cancer. The anticancer agent caused significant toxicity and few objective responses in patients.
Area of Science:
- Oncology
- Pharmacology
Background:
- Amonafide (benzisoquinolinedione) is an anticancer agent functioning as a DNA intercalator.
- Non-small-cell lung cancer (NSCLC) remains a significant global health challenge requiring novel therapeutic strategies.
Purpose of the Study:
- To evaluate the efficacy and safety of amonafide in patients with advanced non-small-cell lung cancer.
- To determine the objective response rate and tolerability of amonafide in this patient population.
Main Methods:
- A phase II clinical trial was conducted involving 16 patients with stage III or IV NSCLC.
- Patients received amonafide at a dose of 300 mg/m2 intravenously daily for 5 days every 21 days.
- Efficacy was assessed by objective response rate, and safety was monitored through adverse event reporting.
Main Results:
- No major objective responses were observed in the 14 adequately treated patients (95% confidence limits 0-20%).
- Common adverse events included local injection site reactions or phlebitis (88%), leukopenia (44%), nausea or vomiting (38%), thrombocytopenia (25%), and rash (25%).
Conclusions:
- Amonafide, at the tested dosage and schedule, demonstrated limited clinical utility in treating advanced non-small-cell lung cancer due to a low response rate and significant toxicity.
- Further investigation into alternative dosing or combination therapies may be warranted, but current use is restricted.