A phase I-II study of high-dose melphalan, mitoxantrone and carboplatin with peripheral blood stem cell support in patients with advanced ovarian or breast carcinoma.

Summary: lowing initial surgery and chemotherapy are rarely cured of their disease by subsequent treatment. 8 Analyses of the utility of dose-escalation of chemotherapeutic agents withThe purpose of this study was to develop a high-dose chemotherapy (HDC) and peripheral blood stem cell out hematopoietic stem cell support in patients with advanced ovarian cancer have produced conflicting (PBSC) regimen for treatment of patients with ovarian carcinoma that could be administered in an outpatient results. 4,9‐12 High-dose chemotherapy (HDC) followed by the setting. Fourteen patients with advanced ovarian (n = 9) or breast (n = 5) carcinoma, who had failed conven- infusion of autologous hematopoietic stem cells consistently produces high response rates in patients with tional chemotherapy, were entered into a dose-escalation trial to determine the maximum tolerated dose advanced ovarian carcinoma who have failed chemotherapy; however, these responses are usually of short dur(MTD) of carboplatin that could be administered with fixed doses of melphalan (160 mg/m 2 ) and mitoxantrone ation with long-term survival in 10‐25% of patients. 13‐21 High-dose melphalan followed by bone marrow infusion (50 mg/m 2 ). Twenty-five additional patients were included in a phase II trial at the MTD. Two of two was evaluated in 14 patients with stage III‐IV ovarian carcinoma who were positive microscopically or macropatients had grade 4 severe regimen-related toxicities (RRT), one fatal, at a dose level of 1600 mg/m 2 . Two of scopically at second-look laparotomy. 22 Five of these 14 patients (37%) were alive and disease-free 30‐60 months