Abstract
10685
Background: Neoadjuvant chemotherapy for the treatment of LABC has become the standard of care but the best combination is not established. The combination of docetaxel and capecitabine demonstrates synergism in patients(pts) with metastatic breast cancer (MBC). Recent studies support the value of platinum salts in LABC and MBC. Methods: pts with stage IIA-IIIC or inflammatory BC, EGOG PS 0–1, are eligible.We are evaluating the combination of weekly docetaxel 30mg/m
2
, carboplatin AUC2 on D1, 8,15 of a 4-week cycle plus capecitabine 625 mg/m
2
BID given on days 5–18 (based on the upregulation of thymidine phosphorylase) for 4 cycles prior to surgery. The primary objective of this phase II trial is pCR rate in breast. Results: 39 of 48 pts have been enrolled from 7 centers. Median age 46 (range 26–75), stage II 41%, stage III 59%. Median baseline tumor is 5.4cm (range 2.1–15); 1pt inflammatory BC; 10 pts N2 disease (36%); 12 tumors were ER+, 20 ER-, and 5 Her-2+. To date, 2,377 doses (including daily capecitabine doses) were administered out of a total of 2,560 (93% of intended doses) with only 10 dose delays and 8 dose reductions. 37 pts are evaluable for toxicities. No grade IV toxicities were seen, grade III neutropenia was seen in 3/37(8%) and grade III fatigue in 1/37(3%). There were no episodes of neutropenic fever.The most common grade I/II toxicities were nausea in 57%, diarrhea 38%, fatigue 43%, epiphora 24%, mucositis 24% and hand-foot syndrome 3%. No death related treatments have been reported. 32 pts have completed definitive surgery. Objective clinical response is 94% with 53% cCR. 5 patients had pCRs in breast(16%) and 5 pCR in breast and axilla(16%). 9 pts (28%) have microscopic residual disease in the breast (<3mm). 14 pts had complete axillary clearance (44%). Conclusions: The preoperative combination of docetaxel, carboplatin and capecitabine is feasible with very good response rate and a very acceptable toxicity profile. Accrual is ongoing.
No significant financial relationships to disclose.