Published in:
01-09-2009 | Original Article
A phase I trial of gemcitabine, docetaxel and carboplatin administered every 2 weeks as first line treatment in patients with advanced breast cancer
Authors:
Vasiliki Bozionelou, Kostas Kalbakis, Lambros Vamvakas, Sofia Agelaki, Nikolaos Androulakis, Antonia Kalykaki, Vassilis Georgoulias, Dimitris Mavroudis
Published in:
Cancer Chemotherapy and Pharmacology
|
Issue 4/2009
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Abstract
Objective
To determine the maximum tolerated doses (MTDs) and dose limiting toxicities (DLTs) of gemcitabine (GEM), docetaxel (DOC) and carboplatin (CARBO) combination.
Patients and methods
A total of 33 previously untreated HER-2 negative patients with stage IIIB-IV breast cancer received escalated doses of GEM, DOC and CARBO all given sequentially on day 1 every 2 weeks. Twenty-three patients (70%) had previously received adjuvant or neoadjuvant chemotherapy.
Results
The recommended MTDs are GEM 1,500 mg/m2, DOC 50 mg/m2 and CARBO 3AUC. Seven dose levels were evaluated and neutropenia was the primary dose-limiting event. Of 319 chemotherapy cycles delivered, grade 3–4 neutropenia occurred in 13.5% of them with two cases of febrile neutropenia. Diarrhea and asthenia were the most common non-hematological toxicities. Three (16%) complete and 6 (32%) partial responses were observed among 19 patients with measurable disease.
Conclusion
The biweekly administration of GEM, DOC and CARBO is a well-tolerated regimen which merits further evaluation.