Background: Because MDRl RNA is frequently encountered in advanced breast cancer, we have initiated a phase I/II study with pirarubicin in combination with the multidrug resistance modifier quinidine. Patients and Methods: Fourteen patients with metastatic breast cancer refractory to conventional anticancer chemotherapy with anthracyclines and/or vinca alkaloids were entered into this trial. All patients were given 250 mg quinidinebisulfate twice daily for a total of 5 days, and the anthracycline derivative pirarubicin was administered on the 4th day of the cycle. The pirarubicin starting dose was 50 mg/m2 body surface and was escalated during the study in cohorts of 3 patients each. Cycles were repeated every 3-4 weeks. Results: All patients were evaluable for toxicity and response assessment. The maximum tolerated dose of pirarubicin was 70 mg/m2. Overall treatment-associated toxicity was mild and comparable with conventional pirarubicin monotherapy. The median leukocyte nadir was 2000/mm3, partial alopecia (70%) and nausea/emesis (20%) were the most frequently encountered nonhematologic side effects. Quini-dine-associated side effects were not reported. There was no objective response. Six patients had stable disease, while the tumor progressed in eight. Conclusions: Quinidine in combination with pirarubicin is not active in advanced refractory breast cancer.

Keywords:
Breast cancer, Multidrug resistance, Quinidine, Pirarubicin
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© 1993 S. Karger AG, Basel
1993
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