This Article Full Text Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Save to my personal folders Download to citation manager Rights & Permissions Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Pérez-Manga, G. Articles by Rivelles, N. Search for Related Content PubMed PubMed Citation Articles by Pérez-Manga, G. Articles by Rivelles, N. Social Bookmarking                            What's this?

Gemcitabine in Combination With Doxorubicin in Advanced Breast Cancer: Final Results of a Phase II Pharmacokinetic Trial

From the Hospital Gregorio Mara-ñ-ón, Madrid, Hospital Clínico Universitario, Valencia, Hospital Clínico de la Virgen Victoria, Málaga, and Hospital Virgen del Rocío, Seville, Spain, and Hôpital de la Pitié-Salpêtrière, Paris, France.

Address reprint requests to G. Pérez-Manga, MD, Medical Oncology Department, Institute of Oncology, Hospital Gregorio Mara-ñ-ón, c/Maiquez, 7.28007 Madrid, Spain.

PURPOSE: Gemcitabine has promising single-agent activity in advanced breast disease. The aim of this phase II study was to determine the efficacy, toxicity, and pharmacokinetic profile of gemcitabine administered with doxorubicin as first-line treatment in patients with metastatic breast cancer.

PATIENTS AND METHODS: Of the 42 women with metastatic breast cancer (age 33 to 74 years; mean age, 55 years), 13 were chemotherapy-naive and 29 had received adjuvant chemotherapy. Gemcitabine (800 or 1,000 mg/m²) and doxorubicin (25 mg/m²) were administered intravenously on days 1, 8, and 15 of each 28-day cycle. Blood samples were drawn on day 8 of cycles 1, 2, and 3 and of subsequent odd cycles for gemcitabine pharmacokinetic determinations and before and after the first dose of cycle 1 or 2 for doxorubicin determinations.

RESULTS: There were three complete and 20 partial responses, for an overall response rate of 55% (95% confidence interval [CI], 40% to 70%) and a complete response rate of 7%. The median survival time for all 42 patients was 27 months (95% CI, 13.4 to 30.0 months) and the 1-year survival rate was 80%. Toxicity was mainly hematologic. The disposition of both drugs was unchanged when they were administered on the same day compared with when they were given singly.

CONCLUSION: The combination of gemcitabine (800 mg/m²) and doxorubicin (25 mg/m²) can be safely administered using a weekly schedule. The disposition of both drugs is unchanged when they are administered on the same day. This combination shows promising activity with acceptable toxicity compared with other combination therapies.

CiteULike    Complore    Connotea    Del.icio.us    Digg    Facebook    Reddit    Technorati    Twitter    What's this?

This article has been cited by other articles:

				S. A. Veltkamp, J. H. Beijnen, and J. H.M. Schellens Prolonged Versus Standard Gemcitabine Infusion: Translation of Molecular Pharmacology to New Treatment Strategy Oncologist, March 1, 2008; 13(3): 261 - 276. [Abstract] [Full Text] [PDF]

				V. Gandhi, W. Plunkett, M. Du, M. Ayres, and E. H. Estey Prolonged Infusion of Gemcitabine: Clinical and Pharmacodynamic Studies During a Phase I Trial in Relapsed Acute Myelogenous Leukemia J. Clin. Oncol., February 1, 2002; 20(3): 665 - 673. [Abstract] [Full Text] [PDF]