Metastatic Breast Cancer

XELODA—Proven efficacy after anthracyclines and paclitaxel1

An increasing proportion of women receiving first-line cytotoxic therapy for metastatic breast cancer have already received anthracycline- or taxane-based treatment.

†Clinical benefit = CR + PR + SD.
‡Resistance was defined as clear-cut progression while receiving drug.

XELODA Dosing: mBC

XELODA was associated with a 25.6% objective response rate in a subgroup of patients with unequivocal clinical resistance to both anthracyclines and paclitaxel (n=43) in a multicenter, open-label, single-arm phase II study (N=162).‡

Clinical benefit was observed in patients with extensive prior therapy and extensive visceral metastases.2

100% of patients received at least 2 but not more than 3 previous chemotherapy regimens, 1 of which had to have contained paclitaxel as treatment for metastatic disease.2
68% of responders had visceral/predominant disease.2

Patients achieving CR or PR experienced rapid response in an 8-month median duration of response.2

Most responses occurred by the first or second tumor assessment (6-12 weeks).2
Median duration of response was 241 days, or approximately 8 months.2

XELODA—Effective treatment after anthracyclines and paclitaxel in mBC

XELODA—Consistent clinical benefit in up to 60% of anthracycline- and taxane-pretreated patients3-6*

Clinical benefit demonstrated by confirmatory phase II trials

*Among all patients with measurable disease (n=135).
†Clinical benefit = CR + PR + SD.

Clinical benefit that translates into survival2

Patients achieving SD experienced survival comparable to that of patients who experienced CR or PR.2

Relationship between tumor response and survival

"These results must not be interpreted as evidence of a drug effect, as it is well recognized that responders may survive longer than nonresponders because response may identify patients with unknown pretreatment characteristics that favor longer survival."2

‡ Adapted from Blum JL, et al, J Clin Oncol, 1999.2
§ These data are taken from the published article describing the study and vary slightly from those in the XELODA prescribing information.

REFERENCES

1. The Synovate Healthcare US Tandem Oncology Monitor Quarterly Breast Cancer Supplement. MAT Quarterly Results 2003-Q2 2006.
2. Blum JL, Jones SE, Buzdar AU, et al. Multicenter phase II study of capecitabine in paclitaxel-refractory metastatic breast cancer. J Clin Oncol.1999; 17(2):485-493.
3. Blum JL, Dieras V, Lo Russo PM, et al. Multicenter, phase II study of capecitabine in taxane-pretreated metastatic breast carcinoma patients. Cancer. 2001;92(7):1759-1768.
4. Reichardt P, von Minckwitz G, Thuss-Patience PC, et al. Multicenter phase II study of oral capecitabine (XELODA®) in patients with metastatic breast cancer relapsing after treatment with a taxane-containing therapy. Ann Oncol. 2003;14:1227-1233.
5. Wist EA, Sommer HH, Ã˜stenstad B, Risberg T, Bremnes Y, Mjaaland I. Oral capecitabine in anthracycline- and taxane-pretreated advanced/metastatic breast cancer. Acta Oncologica. 2004;43(2):186-189.
6. Fumoleau P, Largillier R, Clippe C, et al. Multicentre, phase II study evaluating capecitabine monotherapy in patients with anthracycline- and taxane-pretreated metastatic breast cancer. Eur J Cancer. 2004;40:536-542.