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Published in: Cancer Chemotherapy and Pharmacology 4/2009

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.
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Metadata
Title
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
Publication date
01-09-2009
Publisher
Springer-Verlag
Published in
Cancer Chemotherapy and Pharmacology / Issue 4/2009
Print ISSN: 0344-5704
Electronic ISSN: 1432-0843
DOI
https://doi.org/10.1007/s00280-009-0928-6

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