title: Weekly docetaxel/carboplatin as primary systemic therapy for HER2-negative locally advanced breast cancer.
abstract: To evaluate the effectiveness and safety of weekly docetaxel/carboplatin as primary systemic therapy (PST) for locally advanced breast cancer, we conducted a phase II study. Forty-four patients with HER2-negative locally advanced or inflammatory breast cancer (IBC) received docetaxel 35 mg/m(2) and carboplatin to an area under the curve of 2 mg/mL/min for 3 of 4 weeks over 16 weeks. After completion of PST, patients had breast surgery and then received 4 cycles of adjuvant cyclophosphamide/doxorubicin, standard radiation therapy, and, for hormone receptorpositive tumors, tamoxifen. The mean tumor size was 9.3 cm (range, 5-24 cm). Thirty-seven patients (85%) had palpable lymph nodes; 13 patients (30%) had matted or fixed nodes (N2). Eight patients had IBC. There were 11 clinical complete responses (25%) and 29 clinical partial responses (66%), resulting in 40 objective responses (91% [95% CI, 78%-96%]). Invasive disease disappeared (pathologic complete response) from the breast and axilla in 6 patients (14% [95% CI, 5%-27%]) and from the axilla in 17 patients (39% [95% CI, 24%-55%]). The only significant adverse hematologic event was grade 3 neutropenia in 4 patients (9%). The most common adverse nonhematologic events were fatigue (84% of patients) and alopecia (84%), which were usually grade 1/2. Weekly docetaxel/carboplatin appears to be active and feasible as PST in patients with large breast tumors.
authors.affiliation: Sylvester Cancer Center, University of Miami, 1475 NW 12th Ave, D8-4, FL 33136, USA. jhurley@miami.edu
authors.forename: Judith
authors.initials: J
authors.lastname: Hurley
authors.forename: Isildinha
authors.initials: I
authors.lastname: Reis
authors.forename: Orlando
authors.initials: O
authors.lastname: Silva
authors.forename: Carmen
authors.initials: C
authors.lastname: Gomez
authors.forename: Fernando
authors.initials: F
authors.lastname: DeZarraga
authors.forename: Pedro
authors.initials: P
authors.lastname: Velez
authors.forename: Catherine
authors.initials: C
authors.lastname: Welsh
authors.forename: Jodeen
authors.initials: J
authors.lastname: Powell
authors.forename: Philomena
authors.initials: P
authors.lastname: Doliny
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D019540:Area Under Curve; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D016190:Carboplatin / Q000008:administration & dosage; D017024:Chemotherapy, Adjuvant; D003520:Cyclophosphamide / Q000008:administration & dosage; D000077143:Docetaxel; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008875:Middle Aged; D018719:Erb-b2 Receptor Tyrosine Kinases; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D016190:Carboplatin; D003520:Cyclophosphamide; D000077143:Docetaxel; D018719:Erb-b2 Receptor Tyrosine Kinases; D043823:Taxoids