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Table of Contents
Vol. 61, Suppl. 2, 2001
Issue release date: 2001
Section title: Paper
Oncology 2001;61(suppl 2):37–42
(DOI:10.1159/000055400)

First-Line Herceptin® Monotherapy in Metastatic Breast Cancer

Vogel C.L. · Cobleigh M.A. · Tripathy D. · Gutheil J.C. · Harris L.N. · Fehrenbacher L. · Slamon D.J. · Murphy M. · Novotny W.F. · Burchmore M. · Shak S. · Stewart S.J.
aUniversity of Miami School of Medicine, Comprehensive Cancer Research Group, Inc., and Columbia Cancer Research Network of Florida, Miami, Fla., bRush-Presbytarian-St Luke’s Medical Center, Chicago, Ill., cUCSF/Mount Zion Cancer Center, San Francisco, Calif., dVical, Inc., San Diego, Calif., eDana Farber Cancer Institute, Boston, Mass., fKaiser Permanante, Vallejo, Calif., gUCLA School of Medicine, Los Angeles, Calif., hGenentech, Inc., South San Francisco, Calif., USA

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Article / Publication Details

First-Page Preview
Abstract of Paper

Published online: 10/26/2001

Number of Print Pages: 6
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

The pivotal phase II and III Herceptin® trials proved the efficacy and safety of second- or third-line single-agent Herceptin and first-line Herceptin in combination with chemotherapy, respectively. In the current trial, 114 patients were randomized to one of two dose groups of first-line Herceptin monotherapy: standard dose of 4 mg/ kg initial dose followed by 2 mg/kg intravenous (i.v.) weekly; or high dose of 8 mg/kg initial dose followed by 4 mg/kg i.v. weekly. The regimen was generally well tolerated. A similar incidence of adverse events was demonstrated in the two dose groups with the possible exception of acute infusion-related events such as fever and chills as well as rash and dyspnea, which appear to be more prevalent in the higher dose group. The overall response rate was 26% and response rates were similar between the two dose groups (24% for the standard Herceptin dose group and 28% for the high Herceptin dose group). Subgroup analysis determined a higher response rate in IHC 3+ patients (35%) and FISH-positive patients (41%). When women with stable disease for ≧6 months were included with responders, the clinical benefit rate in IHC 3+ patients was 47%. Median survival was 24.4 months, which is comparable with the survival rate seen in the pivotal phase III combination trial (25 months). Therefore, single-agent Herceptin is an important new option for the first-line treatment of HER2-positive metastatic breast cancer patients.


Article / Publication Details

First-Page Preview
Abstract of Paper

Published online: 10/26/2001

Number of Print Pages: 6
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

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.

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    External Resources

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