Phase II study of docetaxel, capecitabine, and cisplatin as neoadjuvant chemotherapy for locally advanced breast cancer.

Purpose: Docetaxel, capecitabine, and cisplatin are effective chemotherapeutic agents for breast cancer with significant synergistic cytotoxicity demonstrated by in vitro studies. The purpose of this study was to assess the efficacy of a combination of docetaxel, capecitabine, and cisplatin (TXP) in patients diagnosed with locally advanced breast cancer (LABC).

Methods: Patients (n = 42) with chemotherapy-naïve LABC (stage IIIa or IIIb) were enrolled. The chemotherapeutic regimen consisted of 4-6 cycles of intravenous docetaxel (60 mg/m(2)) and cisplatin (50 mg/m(2)) on day 1, plus oral capecitabine (1,800 mg/m(2)/day) on day 1-14, repeated every 3 weeks. Upon completion of therapy, the primary tumor was resected when not contraindicated.

Results: Median patient age was 48.5 years (range 31-66 years). Median tumor size was 6.8 cm (range 2.7-15 cm), 29 patients were node-positive, and 12 patients were hormone receptor positive. A total of 216 cycles (median 5; range 3-6 cycles) were administered without prophylactic G-CSF. The predominant toxicities were grade 3/4 neutropenia (30%/28%) and no grade 3/4 thrombocytopenia, febrile neutropenia, or grade 4 non-hematological toxicities were observed. Grade 3 non-hematological toxicities included hand-foot syndrome (5.6%) and vomiting (0.5%). The overall clinical response rate was 97.6% (41/42). Six of the 42 patients (14.3%) achieved a complete pathological response. Of 22 patients who completed 6 cycles of combination treatment, the complete pathological response was 27.3% (6/22).

Conclusions: A combination of TXP can be administered safely without prophylactic G-CSF, and appears to be an effective neoadjuvant regimen in patients with LABC.