[P1-14-02] Disease-free (DFS) and overall survival (OS) data from ACOSOG Z1041 (Alliance) a randomized neoadjuvant trial comparing FEC followed by paclitaxel plus trastuzumab (FEC → P+T) with paclitaxel plus trastuzumab followed by FEC plus trastuzumab (P+T → FEC+T) in HER2-positive operable breast cancer.
Buzdar AU, Suman VJ, Meric-Bernstam F, Leitch AM, Ellis MJ, Boughey JC, Unzeitig GW, Royce ME, Ewer MS, Hunt KK.
MD Anderson Cancer Center, Houston, TX; Mayo Clinic, 201 W. Center St., Rochester, MN; University of Southwestern Medical Center, 2201 Inwood Road, Dallas, TX; Baylor College of Medicine, One Baylor Plaza, Houston, TX; Mayo Clinic, 200 First Street SW, Rochester, MN; Doctors Hospital of Laredo, 6801 Mcpherson Rd, Suite 106, Laredo, TX; University of New Mexico, Albuquerque, NM.
Background: ACOSOG Z1041 (Alliance) found pathological complete response rates in women with operable HER2-positive breast cancer were similar with FEC → P+T (Arm 1) and P+T → FEC+T (Arm 2) where treatment was administered as 5-FU 500 mg/m2, epirubicin 75 mg/m2 and cyclophosphamide 500 mg/m2 day 1 of a 21-day cycle x 4; paclitaxel 80 mg/m2 weekly x 12 and trastuzumab 4 mg/kg once then 2 mg/kg weekly x 11. We now report DFS and OS results with a median follow up of 4.4 years (range: 26 days to 6.2 years).
Methods: All patients who began study treatment were included in the analyses. Stratified log rank tests and stratified proportional hazard models were used to assess differences in DFS and OS from randomization between treatment arms.
Results: From September 15, 2007 to December 15, 2011, 282 women with HER2-positive breast cancer were enrolled. Two patients randomized to arm 1 withdrew consent prior to treatment and are excluded from these analyses. Patient and disease characteristics of the remaining 280 women (arm 1, n=138; arm 2, n=142) were similar between treatment arms. Recurrences and deaths are shown in the table. DFS were not found to differ with respect to treatment arm (stratified logrank p=0.6870; HR stratified (Arm2/Arm1)=0.88; 95%CI: 0.48-1.61). Also, OS was not found to differ with respect to treatment arm (stratified logrank p=0.8790; HR stratified (Arm2/Arm1)=1.07; 95%CI: 0.43-2.69).
Conclusions: Concurrent administration of trastuzumab with anthracyclines offers no additional benefit in terms of achieving pathologic complete response or improving survival and is not needed.
Grant Support: U10 CA76001
The study is registered with ClinicalTrials.gov, number NCT00513292.
Wednesday, December 9, 2015 5:00 PM
Poster Session 1: Treatment: Neoadjuvant Chemotherapy (5:00 PM-7:00 PM)
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