"Xeloda Shows Benefits as First Choice for Metastatic Breast Cancer: Presented at IBCEF"
By Chris Berrie
VIENNA, AUSTRIA -- February 22, 2006 -- First-line capecitabine (Xeloda(R)) is a highly active, well tolerated, cost effective option after adjuvant anthracyclines and taxanes for patients with metastatic breast cancer, according to an overview of recent and ongoing trials of capecitabine.
Karen Gelmon, MD, Professor of Medicine, Clinical Head of the Investigational Drug Programme, and Head, Breast Tumour Group, Department of Medical Oncology, University of British Columbia, British Columbia Cancer Agency, Vancouver, British Columbia, Canada, presented the overview here on February 11[th at the International Breast Cancer Expert Forum: Milestones in Management, Confidence and Care (IBCEF).
With metastatic breast cancer remaining an incurable disease, there is a need to determine and discuss the treatment goals according to patient wishes and disease characteristics, Dr. Gelmon said. She therefore discussed the wide range of patient and disease characteristics that will influence these treatment decisions.
There is also a need to maintain a background of comparative efficacy and safety information relating to any potential treatment of choice. This can be seen for capecitabine, whereby as a front-line approach it compares favourably with paclitaxel, with response rates of 36% (95% confidence interval [CI], 17-59; n = 22) and 26% (95% CI, 9-51; n = 19), respectively, having been reported.
Similarly, first-line capecitabine compares favourably with cyclophosphamide/methotrexate/5-fluorouracil (CMF), with reported response rates of 30% (95% CI, 19-43; n = 61) and 16% (95% CI, 5-33; n = 32), respectively.
When compared directly with anthracyclines and taxanes in patients with metastatic breast cancer, the response rates reported are 30% to 58% for first-line capecitabine, 36% for first-/second-line capecitabine; 36% to 41% for first-line anthracyclines; 23% to 42% for docetaxel three times weekly in anthracycline-pretreated patients; and 14% to 29% for paclitaxel three times weekly in anthracycline-pretreated patients.
A more direct consideration of capecitabine use in taxane-pretreated metastatic disease indicates a large body of evidence that it has consistently high activity, with response rates of 15% to 28%. Dr. Gelmon indicated that capecitabine has been shown to be significantly more effective than other monotherapies (P = .005).
These reports also indicate the need for further consideration of capecitabine as monotherapy in taxane pre-treated metastatic breast cancer, with particular regard to its safety profile. Capecitabine monotherapy has a low incidence of grade III/IV adverse events (n = 713), where there is minimal myelosuppression and alopecia, no cumulative toxicity, and no treatment-related deaths. In addition, capecitabine resulted in stable or improved quality of life in more than 70% of women with metastatic disease (n = 1125).
Regarding the use of first-line capecitabine in sequence or in combination with other therapies, Dr. Gelmon cited a recent Mexican Oncology Study Group (MOSG) trial, which showed that the capecitabine to taxane sequence compared favourably with the capecitabine combinations tried. Furthermore, the potential importance of this data can be seen with a comparison of the costs of these same sequential and combination treatments, which show that sequential capecitabine and taxanes provide a significant cost saving.
She noted that there are new data to come that will contribute further to a rational decision regarding the use of capecitabine in metastatic disease. These include in particular the German (AGO) MoniCa trial of first-line capecitabine monotherapy at an oral dose of 1000 mg/m2 twice daily, and a Spanish randomised trial of continuous therapy at a dose of 800 mg/m2 twice daily on days 1 to 21 every 3 weeks versus a standard capecitabine dose of 1250 mg/m2 twice daily on days 1 to 14 every 3 weeks.
Further to these, there remains a large programme of ongoing phase 2/3 trials for capecitabine monotherapy in patients with metastatic breast cancer, Dr. Galmon said.
She concluded that first-line capecitabine has already been shown to be a highly active, well tolerated, cost effective option, and this needs to be taken into full consideration in the tailoring of treatments to patients' individual needs.
This conference was sponsored by Roche.
[Presentation title: Xeloda: an X-cellent first choice for metastatic breast cancer]
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