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Title: Xeloda Expands Options in Adjuvant Treatment of Breast Cancer: Presented at IBCEF

"Xeloda Expands Options in Adjuvant Treatment of Breast Cancer: Presented at IBCEF"

By Chris Berrie VIENNA, AUSTRIA -- February 21, 2006 -- The proven efficacy of capecitabine (Xeloda(R)) in the metastatic setting, its association with minimal myelosuppression and alopecia, and the lack of increased toxicity when added to taxotere all point to an increasingly important role for capecitabine for early breast cancer, according to an overview of recent, ongoing and future trials. Christopher J. Poole, MD, Macmillan Senior Lecturer in Medical Oncology, Division of Cancer Studies, University Hospital, University of Birmingham, Edgbaston, Birmingham, United Kingdom, discussed the clinical data on capecitabine in the metastatic setting here on February 11[^th at the International Breast Cancer Expert Forum: Milestones in Management, Confidence and Care (IBCEF).

To illustrate the level of ongoing investigation in this area, Dr. Poole indicated that more than 20,000 patients with early breast cancer are due to be taking part in the numerous trials of capecitabine in adjuvant chemotherapy.

Dr. Poole detailed such ongoing trials as US Oncology Adjuvant Capecitabine and Docetaxel trial (US Oncology; n = 2610) which is evaluating capecitabine/taxotere in sequential adjuvant treatment; the Trial of Accelerated Adjuvant Chemotherapy with Capecitabine in Early Breast Cancer (TACT2; n = 4400); alternative combination therapy to taxotere in adjuvant breast cancer by the Grupo Español de Investigación en Cáncer de Mama (GEICAM; n = 1302); maintenance capecitabine after adjuvant anthracyclines (GEICAM-CIBOMA; n = 3538); alternative adjuvant combination (AGO GAIN; n = 3130); alternative sequential combination by the Cancer and Leukemia Group B (CALGB; n = 600); ibandronate with or without capecitabine by the Breast International Group (BIG; n = 1394); and sequential capecitabine-based combinations in the Phase III Adjuvant Study (FinXX; n = 1500).

From the toxicity point of view, the addition of capecitabine to taxotere has resulted in less life-threatening toxicity than with taxotere monotherapy, particularly grade III/IV neuropenic fever/infection and non-neutropenic infection. And capecitabine has promoted less grade IV neutropenia in various combination settings, and has shown no changes in grade III/IV adverse events in others.

Indeed, to provide further safety data, Dr. Poole referred to trial data that will be looking at doxorubicin/ cyclophosphamide (AC) versus capecitabine plus taxotere (XT) in adjuvant node-negative breast cancer being conducted by the European Organisation for Research and Treatment of Cancer/Breast International Group/Microarray for Node-Negative Disease may Avoid Chemotherapy Trial (EORTC-BIG MINDACT). This study will also have a double-risk evaluation with a 5-year disease-free survival primary endpoint. This trial is due to be launched in the summer of 2006.

Dr. Poole concluded that while the full benefits of capecitabine in early breast cancer remain to be determined, all the indications are that it will be both efficacious and well tolerated, with the particular benefit that its dosing flexibility shows promise as the key to managing toxicity.

The conference was sponsored by Roche.

[Presentation title: Xeloda: X-panding Options in the Adjuvant Treatment of Breast Cancer.]

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