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Table of Contents
Vol. 67, No. 3-4, 2004
Issue release date: November 2004
Section title: Clinical Study
Oncology 2004;67:250–256
(DOI:10.1159/000081325)

Front-Line Chemotherapy with Docetaxel and Gemcitabine Administered Every Two Weeks in Patients with Metastatic Breast Cancer: A Multicenter Phase II Study

Mavroudis D.a · Malamos N.b · Polyzos A.c · Kouroussis C.a · Christophilakis C.d · Varthalitis I.e · Androulakis N.a · Kalbakis K.a · Milaki G.a · Georgoulias V.a
aDepartment of Medical Oncology, University General Hospital of Heraklion, Crete, bOncology Unit of ‘Marika Heliadis’ Hospital of Athens, cFirst Department of Propedeutic Medicine, Laikon Hospital, dMedical Oncology Unit, 401 Military Hospital of Athens, Athens, and eMedical Oncology Unit, General Hospital of Chania, Crete, Greece

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Article / Publication Details

First-Page Preview
Abstract of Clinical Study

Received: August 12, 2003
Accepted: April 23, 2004
Published online: November 19, 2004
Issue release date: November 2004

Number of Print Pages: 7
Number of Figures: 1
Number of Tables: 3

ISSN: 0030-2414 (Print)
eISSN: 1423-0232 (Online)

For additional information: http://www.karger.com/OCL

Abstract

Objective: To evaluate the docetaxel-gemcitabine combination administered every 2 weeks in women with untreated metastatic breast cancer (MBC). Methods: Fifty-two patients with MBC received docetaxel 65 mg/m2 as front-line chemotherapy intravenously over 1 h followed by gemcitabine 1,500 mg/m2 intravenously over 30 min on days 1 and 14. Cycles were repeated every 28 days without prophylactic growth factor support. Twenty-eight (54%) patients had previously received chemotherapy as adjuvant or neoadjuvant treatment. Thirty-six (69%) patients had visceral disease including 20 (38%) with liver metastases. All patients were evaluated for toxicity and 45 for response. Results: In an intention-to-treat analysis, a complete response occurred in 7 (13%) patients and partial response in 24 (46%) for an overall response rate of 59% (95% CI: 46.3–73.0%). The response rate was 68% for the 28 patients who had previously received adjuvant or neoadjuvant chemotherapy and 67% for the 36 patients with visceral metastases. The median duration of response was 6.1 months and the median time to disease progression 10.9 months. A total of 254 cycles were administered with dose reduction in 26 (10%) cycles and no lethal toxicity. Grade III–IV neutropenia occurred in 17 (33%) patients and thrombocytopenia in 3 (6%). Febrile neutropenia developed in 3 (6%) patients. Nonhematological toxicity was generally mild. Conclusion: The docetaxel-gemcitabine combination is an active and well-tolerated front-line treatment for patients with MBC. This regimen represents a suitable option especially for women relapsing after anthracycline-based adjuvant chemotherapy.

© 2004 S. Karger AG, Basel


Article / Publication Details

First-Page Preview
Abstract of Clinical Study

Received: August 12, 2003
Accepted: April 23, 2004
Published online: November 19, 2004
Issue release date: November 2004

Number of Print Pages: 7
Number of Figures: 1
Number of Tables: 3

ISSN: 0030-2414 (Print)
eISSN: 1423-0232 (Online)

For additional information: http://www.karger.com/OCL


Copyright / Drug Dosage / Disclaimer

Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher or, in the case of photocopying, direct payment of a specified fee to the Copyright Clearance Center.
Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.