Phase I study of vinorelbine and carboplatin combination in patients with taxane and anthracycline pretreated advanced breast cancer

Oncology
C KosmasVassilis Georgoulias

Abstract

To define the maximum tolerated dose (MTD) and the dose-limiting toxicities (DLTs) of the carboplatin-vinorelbine combination in pretreated patients with advanced breast cancer. Patients with histologically confirmed metastatic breast cancer relapsing or progressing after prior taxane and anthracycline containing chemotherapy were enrolled. Cohorts of 3-6 patients were treated at successive dose levels (DLs) with escalated doses of carboplatin [range, area under the curve (AUC) 4-6] on day 1 and vinorelbine (range, 20-35 mg/m(2)) on days 1 + 8 recycled every 28 days. Twenty-seven patients with a median age of 58 years and performance status (WHO) of 0-2 were treated at 6 DLs. All patients were assessable for toxicity and 20 for response. DLT was reached at carboplatin 6 AUC and vinorelbine 35 mg/m(2), and therefore, this was considered as the MTD. Prophylactic G-CSF administration could not allow further dose escalation. The recommended dose for further phase II testing was defined at carboplatin 6 AUC on day 1 and vinorelbine 30 mg/m(2) on days 1 and 8. Among 98 administered treatment cycles 41 (42%) and 7 (7%) were complicated with grades 3 and 4 neutropenia and thrombocytopenia, respectively. Nonhematologic toxicities includ...Continue Reading

Citations

Apr 8, 2006·Supportive Care in Cancer : Official Journal of the Multinational Association of Supportive Care in Cancer·Jeffrey A JonesLinda S Elting
Jan 18, 2012·Chemotherapy·Ali I Shamseddine, Fadi S Farhat
Jun 7, 2005·Annals of Oncology : Official Journal of the European Society for Medical Oncology·G FrasciG Comella

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