Abstract
839 Background: X (Xeloda) is the reference treatment in anthracycline- and taxane-pretreated MBC, based on consistent high activity, a good safety profile with little myelosuppression and no alopecia, and evidence that its addition to docetaxel extends survival. Tolerability and efficacy also make X an interesting drug in elderly pts with hormone-refractory disease. Methods: Between May 2002 and Sep 2003, 18 elderly MBC pts received X 1000 mg/m2 twice daily on days 1–14, every 3 weeks. Study objectives were efficacy and safety of X and its impact on quality of life (QoL), assessed via the Clinical Benefit Response (CBR) every third cycle of treatment. Results: Pt characteristics were: median age 70 years (range 68–73); median ECOG PS 1 (range 0–2); 100% with visceral metastases and 53% with >2 metastatic sites. All pts had received prior adjuvant chemotherapy and at least one previous hormonal therapy for advanced disease. A total of 142 cycles were administered (median 6 cycles per pt). After 3 cycles, 5 pts (28%) showed a partial response (PR), 8 (44%) had stable disease (SD) and 1 had a minor response, resulting in a disease control rate of 78%. Biochemical response (CEA and/or CA 15.3 reduction) was observed in 56% of pts. SD has been maintained in 11 pts after 6 cycles, 5 pts after 9 cycles and 1 after 12 cycles. Treatment was well tolerated, the most common grade 3 events being mucositis (7%) and hand-foot syndrome (7%). There were no grade 3/4 hematological toxicities. All adverse events were easily managed with dose adjustments and supportive therapies as required. As a result, pt compliance was 100% with appreciable benefits in terms of pain and QoL (positive CBR in 56% of pts). Conclusions: These preliminary data indicate that X at this dose is active and well tolerated in elderly pts with hormone-refractory MBC. This dosing regimen also warrants study as first-line treatment in pts with less aggressive MBC who might not be suitable for combination therapy. No significant financial relationships to disclose.
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