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XELODA Dosing

Overall 3-year DFS rates are maintained with appropriate dose reduction in adjuvant colon cancer1

XELODA: early dose reduction (between cycles 1-4) vs no dose reduction impact on DFS1*

*Data on file. (Ref. 111-036), Hoffman-La Roche Inc. Nutley, NJ 07110.

Dose modifications to manage adverse events did not appear to compromise efficacy in pivotal trials3

The approved starting dose for XELODA as monotherapy in mBC is 1250 mg/m2 orally BID.

Dose reduction for XELODA plus docetaxel vs docetaxel alone1:

Dose reduction and overall survival impact

†Adapted from O'Shaughnessy JA, Am J Oncol Rev, 2002.⁵
‡Overall survival curves of patients treated with docetaxel alone vs XELODA plus docetaxel (75 mg/m2) with and without a 25% dose reduction of XELODA for cycle 2.

25% of patients receiving XELODA required a dose reduction of 25% due to grade 3 hand-foot syndrome (HFS).
65% of patients receiving XELODA plus docetaxel required dose reduction.
36% of patients receiving docetaxel alone required dose reduction.
The single 25% dose reduction effectively prevented the recurrence of grade 3/4 toxicities in both groups.

Median overall survival was not compromised in patients who required a 25% dose reduction for both XELODA and docetaxel, beginning with cycle 2 through end of treatment, compared with those patients who received full-dose therapy throughout the study.3

REFERENCES
1. Data on file (Ref. 111-040), Hoffmann-La Roche Inc., Nutley, NJ 07110.
2. Data on file (Ref. 111-036), Hoffmann-La Roche Inc., Nutley, NJ 07110.
3. O'Shaughnessy J, Miles D, Vukelja S, et al. Superior survival with capecitabine plus docetaxel combination therapy in anthracycline-pretreated patients with advanced breast cancer: phase III trial results. J Clin Oncol. 2002;20(12):2812-2823.
4. O'Shaughnessy JA. Superior survival with the combination of docetaxel and capecitabine compared to docetaxel alone in anthracycline-pretreated metastatic breast cancer patients. Am J Oncol Rev. 2002;1(5):280-285.