A phase II study of 9-aminocamptothecin in patients with refractory breastcancer

We evaluated 9-aminocamptothecin (9-AC) in patients with metastatic or loca lly recurrent breast cancer who were no longer responsive to standard thera py Patients were treated with 9-AC with a 72-hr continuous infusion given a t a dose of 45 mu g/m(2)/hr every 2 weeks. Granulocyte colony-stimulating f actor 5 mu g/kg was given subcutaneously for 7-10 days after completion of the treatment. Eighteen patients were treated, with all patients assessable for toxicity and 15 patients assessable for response. There were two parti al responses seen in the 15 patients lasting 3.5 and 5 months, respectively . The major toxicity seen was myelosuppression, with 12 patients having gra de 3 or greater granulocytopenia with four episodes of significant infectio us complications. In addition, significant thrombocytopenia was seen in 14 patients. The other complications commonly seen were nausea and vomiting an d alopecia. 9-AC given as a 3-day continuous infusion has limited activity in previously treated metastatic and locally recurrent breast cancer.