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Vol. 62, No. 1, 2002
Issue release date: January 2002
Section title: Clinical Study
Oncology 2002;62:25–32
(DOI:10.1159/000048243)

A Phase I–II Study on a Gemcitabine-Cyclophosphamide-Fluorouracil/Folinic Acid Triplet Combination in Anthracycline- and Taxane-Refractory Breast Cancer Patients

Frasci G.a · D’Aiuto G.b · Comella P.a · Thomas R.b · Capasso I.b · Botti G.d · Cortino G.R.b · Di Bonito M.d · Rubulotta R.c · Vallone P.c · Comella G.a
Divisions of aMedical Oncology A and bSurgical Oncology A, cDepartment of Radiology and dService of Pathology, National Tumor Institute of Naples, Naples, Italy

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Article / Publication Details

First-Page Preview
Abstract of Clinical Study

Published online: 1/24/2002
Issue release date: January 2002

Number of Print Pages: 8
Number of Figures: 0
Number of Tables: 7

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

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

Abstract

Purpose: To define the cyclophosphamide (CTX) maximal tolerated dose when combined with fixed doses of gemcitabine, fluorouracil (5-FU) and folinic acid (leucovorin, LFA) in metastatic breast cancer patients pretreated with anthracyclines and taxanes. Methods: Metastatic breast cancer patients aged ≤75 years, with ECOG performance status 0–2, were eligible, provided that they had received previous anthracycline- and taxane-based chemotherapy for the advanced disease. Chemotherapy consisted of gemcitabine 1,000 mg/m2, 5-FU 425 mg/m2, LFA 100 mg/m2 and escalating doses of CTX, starting from 500 mg/m2, on days 1 and 8 every 3 weeks. The dose escalation was stopped if dose-limiting toxicity (DLT) occured in >33% of patients of a given cohort. After the definition of DLT, a further escalation with the addition of granulocyte colony-stimulating factor (G-CSF; on days 3–5 and 10–12) was planned. Results: Since March 1999, 69 patients have entered this trial through seven different cohorts. The dose escalation was stopped at the CTX dose of 600 mg/m2 since 3/6 patients showed DLT. A further dose escalation was attempted in the presence of G-CSF support. A CTX dose of 800 mg/m2 proved to be safe and was chosen for the phase II. A total of 33 patients were treated at this dose level. The treatment was fairly well tolerated, grade 3–4 neutropenia and thrombocytopenia occurring in 38 and 16% of patients, respectively. No cases of sepsis or bleeding were registered. Four patients required a packed red blood cell transfusion. Severe nonhematologic toxicity was also uncommon, occuring in 10 patients. Three complete and 24 partial responses were recorded for an overall response rate of 38% (95% CI = 26–50). Two complete and 12 partial responses were recorded in the 33 patients treated in the phase II for an overall response rate (ORR) of 42% (95% CI = 25–61). Conclusions: The gemcitabine-CTX-5-FU/LFA combination is a well-tolerated treatment for poor-prognosis breast cancer patients with previous exposure to anthracyclines and taxanes. With the addition of G-CSF, a cumulative CTX dose of 1,600 mg/m2 can be safely delivered every 3 weeks. The evidence of an ORR approaching 40% is very promising and justifies further evaluations in this subset of patients.

© 2002 S. Karger AG, Basel


  

Author Contacts

Giuseppe Frasci
Division of Medical Oncology A
National Tumor Institute, via Mariano Semmola
I–80131 Naples (Italy)
Tel. +39 081 5903227, Fax +39 081 5903821, E-Mail gifrasci@sirio-oncology.it

  

Article Information

Number of Print Pages : 8
Number of Figures : 0, Number of Tables : 7, Number of References : 33

  

Publication Details

Oncology (International Journal of Cancer Research and Treatment)
Founded 1948 as ‘Oncologia’ by H.R. Schinz; Continued by V. Richards (1967–1975), H. Wrba (1976–1992)

Vol. 62, No. 1, Year 2002 (Cover Date: Released January 2002)

Journal Editor: P.P. Carbone, Madison, Wisc.
ISSN: 0030–2414 (print), 1423–0232 (Online)

For additional information: http://www.karger.com/journals/onc


Article / Publication Details

First-Page Preview
Abstract of Clinical Study

Published online: 1/24/2002
Issue release date: January 2002

Number of Print Pages: 8
Number of Figures: 0
Number of Tables: 7

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

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


Copyright / Drug Dosage

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 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.
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.