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Clinical Study

Gemcitabine as First-Line Therapy in Patients with Metastatic Breast Cancer: A Phase II Trial

Blackstein M.a · Vogel C.L.c · Ambinder R.d · Cowan J.a · Iglesias J.b · Melemed A.e

Author affiliations

aMount Sinai Hospital, Toronto, bEli Lilly and Company, Toronto, Canada, cSouthpoint Medical Center, Plantation, Fla., dThe Walt Disney Memorial Cancer Institute at Florida Hospital, Orlando, Fla., and eEli Lilly and Company, Indianapolis, Ind., USA

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Oncology 2002;62:2–8

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Article / Publication Details

First-Page Preview
Abstract of Clinical Study

Published online: January 24, 2002
Issue release date: January 2002

Number of Print Pages: 7
Number of Figures: 2
Number of Tables: 4

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

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

Abstract

Objectives: This phase II study was conducted to evaluate the efficacy and safety of gemcitabine in patients with metastatic breast cancer (MBC). Methods: Women with histologically or cytologically confirmed bidimensionally measurable MBC not amendable to curative surgery or radiation were eligible. Prior chemotherapy for metastatic disease was not permitted. Patients received gemcitabine 1,200 mg/m2 on days 1, 8 and 15 for 3 weeks every 28 days for a maximum of 8 cycles. Results: Thirty-nine patients, with a median age of 58 years, were enrolled. The overall response rate for the 35 evaluable patients was 37.1% (95% confidence interval [CI], 21.5–55.1%), with 2 complete responses and 11 partial responses. Median time to progression and survival were 5.1 months (95% CI, 3.5–8.8 months) and 21.1 months (95% CI, 11.0–26.9 months), respectively. Chemotherapy was well tolerated, with a median of 4 cycles completed. Grade 4 toxicities were 1 infection and 1 abnormal pulmonary function. Grade 3 neutropenia and thrombocytopenia occurred in 30.3% and 6.3% of patients, respectively. The most common grade 3 non-hematologic toxicity was nausea/vomiting (10.3%). Five of 21 patients had improved Karnofsky performance status (KPS) scores. Conclusion: Single-agent gemcitabine is active and well tolerated as first-line treatment in patients with MBC.

© 2002 S. Karger AG, Basel


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Article / Publication Details

First-Page Preview
Abstract of Clinical Study

Published online: January 24, 2002
Issue release date: January 2002

Number of Print Pages: 7
Number of Figures: 2
Number of Tables: 4

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

For additional information: https://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 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.
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