A phase II trial of DA-125, a novel anthracycline, in advanced non-small-cell lung cancer

Purpose: DA-125 is a novel anthracycline derivative developed by Dong-A Pha rmaceutical Company, Korea. Preclinical studies have suggested that DA-125 has greater efficacy and less toxicity than doxorubicin. The maximum tolera ble dose has been shown to be 100 mg/m(2) in a phase I trial. The purpose o f this phase II study was to evaluate the efficacy and toxicity of DA-125 i n patients with non-small-cell lung cancer (NSCLC). Methods: Chemotherapy-n aive patients with histologically confirmed measurable NSCLC which was not curable by surgery or radiation therapy because of metastasis, local invasi on, or recurrence were eligible for this trial. Between May 1996 and April 1997, 20 patients entered into this trial and were treated with DA-125 admi nistered as a 5-min intravenous infusion every 3 weeks. The dose of DA-125 was 80 mg/m(2) during the first cycle, and was adjusted to between 60 and 1 00 mg/m(2) according to the observed toxicities during subsequent cycles. R esults: Among 19 evaluable patients, there was no objective response to DA- 125. Anemia, leukopenia and granulocytopenia of grade 3 or over were observ ed in 4%, 6% and 12% of chemotherapy cycles, respectively. There were no tr eatment-related deaths. With regard to nonhematologic toxicities, diarrhea, infection and elevated serum alkaline phosphatase of grade 3 or over were observed in 2% of cycles, but were tolerable and reversible. Conclusion: DA -125 at these doses and in this schedule was highly tolerable, but was not active in patients with advanced NSCLC.