Activity and safety of biweekly docetaxel plus capecitabine as first-line treatment for patients with metastatic breast cancer

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788 Background: The combination of docetaxel (D) plus capecitabine (CAP) administered every three weeks significantly improves survival over D alone in anthracycline- pretreated patients (p) with metastatic breast cancer. Biweekly administration of these agents may result in better activity/toxicity ratios. We have tested the activity and safety of D plus CAP as first-line treatment in p with metastatic breast cancer. Methods: P with histologically confirmed metastatic breast cancer, age older than 18 years, measurable disease, performance status 2 or better (ECOG) and adequate bone marrow, renal, hepatic and cardiac functions were eligible. Previous adjuvant or neoadjuvant chemotherapy was allowed. No prior chemotherapy for metastatic disease was allowed. Treatment consisted of D 50 mg/m2 i.v. on day 1 and CAP 750 mg bid po days 1–10 of a 14-day cycle. Vitamin B6 300 mg bid day 1–14 was also given. In the absence of progression or unacceptable toxicity, treatment was to be continued for 12 courses. Primary endpoint was response. Results: To date 37 p have been included. Median age was 55 years (range: 35–82). Performance status was 0–1 in 33 p (89%). Estrogen receptors were positive in 16 p, negative in 16 and unknown in 5. Previous treatment included surgery in 28 p (75%), (neo)adjuvant chemotherapy in 24 (65%) (22 with anthracyclines), hormonal therapy in 13 (35%) and radiotherapy in 17 (46%). Median number of metastatic sites was 3. In total, 249 treatment courses were given (median: 7 per p, range 2–12). Median received dose intensity was 90% for CAP and 98% for D. All p were evaluable for safety. Grade 3–4 toxicities per p included neutropenia (3 p, 8%), thrombocytopenia (2 p, 5%), febrile neutropenia (1 p, 3%), nail disorders (5 p, 13%), stomatitis (3 p, 8%) and hand-foot syndrome (2 p, 5%). Response was evaluated in 26 p (11 too early): 4 (15%) achieved complete response, 12 (46%) partial response, 4 (15%) stable disease and 6 (23%) progressive disease. Median time to progression and survival have not yet been reached. Conclusions: Biweekly D plus CAP is an active and well tolerated first-line first-line treatment for metastatic breast cancer. No significant financial relationships to disclose.