Phase I study of Doxil and vinorelbine in metastatic breast cancer

摘要: Summary Background Vinorelbine and Doxil (liposomal doxorubicin) are active chemotherapeutic agents in metastatic breast cancer. A phase I study was designed to evaluate combination therapy. Background: Thirty women with cancer were enrolled. Dose-limiting toxicity determined through a dose escalation scheme, defined for the first treatment cycle, only. Pharmacokinetic studies performed during cycle of treatment. Results In cohort 30 mg/m2 day 1 vinorelbine 25 days 8, patients experienced severe neutropenia. administration changed thereafter 15 each cycle. Dose limiting observed at 50 mg/m2. 40 as maximally tolerated dose. Few toxicities (principally neutropenia) seen this level, notable absence significant nausea, vomiting, or alopecia. Though 63% had received prior anthracycline-based chemotherapy, only one patient developed grade 2 cardiac toxicity. revealed prolonged exposure high doxorubicin concentrations several following administration. Combination chemotherapy affords two drugs cancer, appears have favorable profile. schedule mg/m given every 28 is recommended II studies.