Originally published as JCO Early Release 10.1200/JCO.2007.11.9776 on August 6 2007

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Capecitabine and Trastuzumab in Heavily Pretreated Metastatic Breast Cancer

Rupert Bartsch, Catharina Wenzel, Gabriela Altorjai, Ursula Pluschnig, Margaretha Rudas, Robert M. Mader, Michael Gnant, Christoph C. Zielinski, Guenther G. Steger

From the First Department of Medicine and Cancer Centre, Clinical Division of Oncology; Department of Pathology, Department of Surgery, Medical University of Vienna, Vienna, Austria

Address reprint requests to Guenther G. Steger, MD, First Department of Medicine and Cancer Centre, Clinical Division of Oncology, Medical University of Vienna, Waehringer Guer A-1090 Vienna, Austria; e-mail: guenther.steger{at}meduniwien.ac.at

Purpose: In human epidermal growth factor 2 (HER-2)–positive advanced breast cancer, taxanes or vinorelbine plus trastuzumab are among the most widely applied options in the first-line setting. We evaluated the efficacy and tolerability of capecitabine plus trastuzumab after anthracycline and docetaxel or vinorelbine failure and prior trastuzumab exposure.

Patients and Methods: Forty consecutive patients were included. Capecitabine was administered at a dose of 1,250 mg/m² bid for 14 consecutive days in 3-week cycles, with dose modifications if necessary. Trastuzumab was administered every 3 weeks. Time to progression (TTP) was defined as primary end point. Response was evaluated every 3 months using International Union Against Cancer criteria.

Results: TTP was a median of 8 months, and overall survival was 24 months. No significant difference was found for second-line and beyond second-line treatment. A complete response (CR) was observed in 2.5%, partial response (PR) in 17.5%, stable disease lasting at least 6 months (SD) in 50%, resulting in a clinical benefit rate (CR + PR + SD 6 months) of 70%. Diarrhea (5%) and hand-foot syndrome (15%) were the only treatment-related adverse events that occurred with grade 3 or 4 intensity. Three patients (7.5%) developed brain metastases while receiving therapy.

Conclusion: Capecitabine plus trastuzumab appears to be an effective and safe option in a heavily pretreated population. Therefore, a direct comparison of this regimen with capecitabine monotherapy in this setting is warranted.

published online ahead of print at www.jco.org on August 6, 2007.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.