Phase II trial of docetaxel plus doxorubicin and cyclophosphamide in locally advanced breast cancer (LABC)

Abstract

855 Introduction: It has been show that patients achieving a pathological complete response to primary chemotherapy benefit in terms of prolonged overall survival (NSABP B18). Docetaxel (D) plus doxorubicin (d) is a highly active combination in metastatic breast cancer (Mackey JR, Proc ASCO 2002) as well as in the neo-adyuvant setting (Ian C, JCO 2002). A three-drug combination could improve these results. Methods: In this study, females diagnosed of stage II-III LABC between May 2001 to October 2003 with 18–75 years, PS 0–1, and adequate renal, liver and hematological functions were included. Chemotherapy schema (TAC): D 75 mg/m2, Cyclophosphamide 500 mg/m2 and d 50 mg/m2 on day 1, every 21 days plus G-CSF days 5th to 11th. Four to six courses (c) were scheduled and assessment for clinical response (CR) was made after 2nd, 4th and 6th c. Results: 33 patients (p) were enrolled and pathological response (PR) was already available in 26p. Patient characteristics: median age 53 years (39–73); 25p had PS=0 (75,7%); 36,4% presented with stage IIA, 30,3% stage IIB, 30,3% stage IIIA, and 3,0% stage IIIB; 27p had ductal invasive histology and 6p had a lobular invasive cancer; ER were positive in 22p (66,6%) and negative in 11 p (33,4%); c-erb-B2 was +++/+++ in 7p (21,2%), ++/+++ in 9p (27,3%) and negative in 17p (51,5%). Chemotherapy: 137c were given (median 4 c/p). Surgery had been performed in 78,8% of p. Toxicity: all p had grade 3 alopecia and 4p had grade 3 asthenia; 9p had a neutropenic fever episode but none resulted in septic death. No other severe toxicity was recorded (including clinical cardiotoxicity). CR rate was assessed in 30p (90%) and it was complete in 9p and partial in 21p (overall 100%). 6p achieved a complete pathological response (PR) (18%) and 8 p a partial PR (24,2%). 15 p had a mastectomy performed (45,4%). Conclusions: This phase II study of TAC as induction chemotherapy in patients with LABC showed a high (both clinical and pathological) response rate. The main significant toxicity was the high incidence of neutropenic fever despite the routine use of stimulating factors. Final results will be presented. No significant financial relationships to disclose.