Abstract

e11557 Background: Neoadjuvant chemotherapy for locally advanced breast cancer was shown to improve the complete pathologic (pCR) and clinical response (cCR) as well as the disease free survival (DFS). Docetaxel, cisplatin, and trastuzumab given every 21 days in her2-positive breast cancer demonstrated a pCR rate of 23%. The concept of dose dense chemotherapy regimens has attracted much attention and we hypothesized that dose-dense regimen would further improve pCR, cCR and would maintain the safety profile while being a suitable regimen for outpatient administration. Methods: 48 patients with stage II/III HER2-positive breast cancer were prospectively enrolled on a clinical trial of a neoadjuvant regimen consisting of docetaxel 70 mg/m2 on days 1, 15, 29, and 43; carboplatinum at an AUC of 6 on days 1, 15, 29, and 43; trastuzumab 4 mg/kg on day 1 and 2 mg/kg weekly x 10 starting on day 8; peg-filgastrim 6 mg on days 2, 16, 30, and 44. Results: The median age was 50 years (range 30–78). 52% of patients were premenopausal, 63% and 22% were of Hispanic and African descent, respectively. Estrogen receptor was positive in 52% patients and median tumor size was 5 cm at the time of diagnosis. TNM stage distribution at presentation: T1 2%, T2 25%, T3 57%, T4 16%; N0 29%, N1 46%, N2 16%, N3 7%; M0 100%. pCR in breast; axilla; and both breast and axilla was observed in 19 of 44 patients (43.2%; 95% CI 28.3% - 59.0%); in 29 of 44 patients (65.9%; 95% CI 50.1% - 79.5%); and in 16 of 44 patients (36.4%; 95% CI 22.4% - 52.2%), respectively. No grade 4 or 5 toxicity occurred. The most frequent grade 3 toxicities were hand-foot syndrome (7%), neutropenia (4%), nausea/vomiting (2%), and bone pain (2%). Grade 2 cardiotoxicity was seen in 8% of patients and no grade 3 cardiotoxicity was observed. Conclusions: This neoadjuvant regimen was well tolerated and yielded a good pCR rate for this high risk group of patients. No significant financial relationships to disclose.

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