Liposome-encapsulated doxorubicin plus paclitaxel and trastuzumab as neoadjuvant chemotherapy for operable and locally advanced breast cancer.

Abstract

e11069 Background: Schedules with anthracyclines and taxanes are one of the best options for primary chemotherapy. The addition of trastuzumab showed an impressive percentage of pathological complete responses in Buzdar trial (66.7%). Recently, liposome- encapsulated doxorubicin (Myocet) has been widely used in advanced breast cancer with high response rates (92% in Cortes study). The aim of our study was to assess clinical and pathological responses with liposome-encapsulated doxorubicin plus paclitaxel (and trastuzumab in pts with Her2 overexpression). Methods: 30 patients entered the study: 8 locally advanced and 22 operable. Median age was 57 years (range: 31-73). 23 pts without Her-2 3+ expression (or FISH not amplified) were treated with liposome-encapsulated doxorubicin 50 mg/m2 every three weeks for 3 courses and weekly paclitaxel 80 mg/m2 (Taxol) for 8 courses. 7 pts with Her-2 3+ expression or FISH amplified were treated with the same schedule plus trastuzumab (Herceptin) 4 mg/kg for the first administration and 2 mg/Kg for the following 7 weekly administrations. Results: Objective clinical responses were documented in 18 out of 24 evaluable pts (75%): 7 complete (29%), 7 partial (29%) and 4 minimal responses (17%). Pathological complete response was not documented in any pts. Clinical response in pts with HER-2 pverexpression treated with trastuzumab and chemotherapy was 100% (4 complete and 3 partial responses). Conservative surgery was performed in 8 out of 14 operable pts (57%) and mastectomy in 11 pts. Main toxicity was neutropenia: febrile in 3 pts (10%) and gr. 3-4 in 10 (34%). Other grade 3 toxicities were as follows: vomiting in 2 pts, asthenia in 1 pt. Conclusions: Paclitaxel and liposome-encapsulated doxorubicin was active in terms of clinical response and conservative surgery for pts with potentially operable and locally advanced breast cancer. Our study confirmed high activity of the combination with trastuzumab in pts with Her2 overexpression. However, these results in terms of clinical responses didn't turn into pathological responses. No significant financial relationships to disclose.