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Vol. 68, No. 4-6, 2005
Issue release date: August 2005
Section title: Clinical Study
Oncology 2005;68:438–445
(DOI:10.1159/000086986)

Weekly Docetaxel and Gemcitabine as First-Line Treatment for Metastatic Breast Cancer: Results of a Multicenter Phase II Study

Palmeri S.a · Vaglica M.a · Spada S.b · Filippelli G.c · Farris A.d · Palmeri L.a · Massidda B.e · Misino A.f · Ferraù F.g · Comella G.h · Leonardi V.i · Condemi G.l · Mangiameli A.m · De Cataldis G.n · Macaluso M.C.a · Cajozzo M.o · Iannitto E.a · Danova M.p
aDipartimento di Oncologia, Cattedra di Oncologia Medica, Università di Palermo, Palermo, bOncologia Medica, AO Umberto I, Siracusa, cOncologia Medica, Paola, dClinica Medica, Cattedra di Oncologia Medica, Università di Sassari, Sassari, eCattedra di Oncologia Medica, Università di Cagliari, Cagliari, fOncologia Medica, Istituto Oncologico di Bari, Bari, gOncologia Medica, Ospedale di Taormina, Taormina, hOncologia Medica A, Ist. Tumori, Fondazione Pascale, Napoli, iDivisione di Oncologia Medica, Ospedale Oncologico M. Ascoli, Palermo, lOncologia Medica, Lamezia Terme, mUnità Funzionale diOncologia, Catania, nOncologia, Ospedale G. da Procida, Salerno, oDipartimento di Chirurgia Generale, Università di Palermo, Palermo, pOncologia Medica, Università e IRCCS Policlinico S. Matteo, Pavia, Italia

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Article / Publication Details

First-Page Preview
Abstract of Clinical Study

Received: 7/26/2004
Accepted: 12/12/2004
Published online: 8/17/2005
Issue release date: August 2005

Number of Print Pages: 8
Number of Figures: 1
Number of Tables: 5

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

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

Abstract

Objectives: We conducted a multicenter phase II study to evaluate the clinical efficacy, toxicity, and dose intensity of a new weekly schedule of docetaxel and gemcitabine as first-line treatment of metastatic breast cancer patients. Methods: We enrolled 58 patients, 52% of whom had received a previous anthracycline-containing chemotherapy. The treatment schedule was: docetaxel 35 mg/m2 and gemcitabine 800 mg/m2 i.v. on days 1, 8, 15 every 28 days. Results: All patients were assessable for toxicity and 56 for efficacy. Overall response rate was 64.3% with 16.1% of complete responses and 48.2% of partial responses. Median survival was 22.10 months (95% CI: 15.53–28.67) and median time to tumor progression was 13.6 months (95% CI: 10.71–16.49). The most common hematological toxicity was neutropenia (no febrile neutropenia), which occurred in 28 patients (48.3%) but grade 3–4 in only 8 patients (14%). Alopecia, the most common nonhematological toxicity, occurred in 20 (34.5%) patients, but only 5 patients (8.6%) experienced grade 3 alopecia. Conclusion: The activity of docetaxel and gemcitabine in metastatic breast cancer is confirmed. The promising results of the employed schedule, in agreement with other published studies, need to be further confirmed within a phase III study.

© 2005 S. Karger AG, Basel


  

Author Contacts

Prof. Sergio Palmeri
Dipartimento di Oncologia
Università di Palermo, Piazza delle Cliniche
IT–90127 Palermo (Italy)
Tel. +39 0916552191, Fax +39 0916552258, E-Mail s_palmeri@libero.it

  

Article Information

Received: July 26, 2004
Accepted after revision: December 12, 2004
Published online: July 14, 2005
Number of Print Pages : 8
Number of Figures : 1, Number of Tables : 5, Number of References : 36

  

Publication Details

Oncology (International Journal of Cancer Research and Treatment)

Vol. 68, No. 4-6, Year 2005 (Cover Date: Released August 2005)

Journal Editor: Trump, D.L. (Buffalo, N.Y.)
ISSN: 0030–2414 (print), 1423–0232 (Online)

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


Article / Publication Details

First-Page Preview
Abstract of Clinical Study

Received: 7/26/2004
Accepted: 12/12/2004
Published online: 8/17/2005
Issue release date: August 2005

Number of Print Pages: 8
Number of Figures: 1
Number of Tables: 5

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

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


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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 goverment 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.
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