Abstract P6-17-04: 3-year relapse-free survival of stage II-III HER2-neu positive breast cancer treated with pertuzumab and trastuzumab-containing neoadjuvant therapy compared to trastuzumab-containing therapy
Authors: Murthy RK , Raghavendra AS , Hess KR , Barcenas CH , Lim B , Moulder SL , Giordano SH , Mittendorf EA , Thompson A , Ueno NT , Valero V , Litton JK , Tripathy D , Chavez-Macgregor M 
Published: May 2019

Background: Pertuzumab (P) in combination with trastuzumab (H) based chemotherapy is FDA-approved as a standard neoadjuvant treatment for patients with clinical stage II-III HER2-positive (HER2+) breast cancer (BC). The goal of this study was to evaluate the pathologic complete response (pCR) rate for neoadjuvant HP-containing regimens compared to H-containing regimens and report the 3-year relapse-free survival (RFS) for patients who had a pCR compared to those with residual disease (RD).

Methods: All patients with stage II-III non-inflammatory HER2+ BC who received neoadjuvant H-containing or HP-containing therapy and underwent definitive breast and axillary surgery were identified from 2005 to 2016 through an institutional database. Medical records were examined for patient demographics, breast cancer stage, pathology results, surgical outcomes, and treatment details. pCR was defined as ypT0/is, ypN0. RFS was defined as the interval from surgery to date of last followup or death from any cause. Descriptive statistics, Cox proportional hazards, and Kaplan-Meier estimates were used for statistical analysis.

Results: Patient characteristics and results by pCR or RD status are shown in the table below. The median age was 51 (22-84) years for the HP group and 50 (21-87) years for the H group. The median follow-up time was 1.9 (0-4.2) years for the HP group and 5.3 (0.1-12) years for the H group. For the HP group, the 3-year RFS was 98% (95% CI: 95, 100) for the pCR group and 90% (95% CI: 83, 97) for the RD group; HR 0.17 (0.04, 0.82), p=0.012. For the H group, the 3-year RFS was 91% (95% CI: 88,94) for the pCR group and 75% (95% CI: 71-79) for the RD group; HR 0.31 (0.22, 0.44), p&lt;0.0001. Among the 520 patients who achieved pCR and the 502 patients who had RD, the effect of HP vs. H was statistically significant (pCR: HR 0.24 (0.06, 1.00); p=0.015) (no pCR: HR 0.46 (0.22, 0.94); p=0.017).

Conclusion: Patients who achieve pCR have an improved 3-year RFS compared to patients who have RD. Treatment with HP-containing neoadjuvant regimens is associated with a high 3-year RFS.

VariableHP (n=215)H (n=807)  pCR n=121RD n=94pCR n=399RD n= 408Age at Diagnosis&lt;5043%46%46%51% ≥5057%54%54%49%Menopausal StatusPremenopausal46%50%53%57% Postmenopausal54%50%47%43%Clinical Stage at DiagnosisIIA40%29%34%29% IIB29%31%23%28% IIIA14%15%17%16% IIIB0%5%5%9% IIIC17%20%21%18%Clinical Nodal StatusNode (+)63%76%69%73% Node (-)37%24%31%27%Nuclear Grade1II25%32%22%28% III75%65%78%72%HR statusHR(+)52%74%52%67% HR(-)48%26%48%33%Adjuvant therapyTrastuzumab88%80%100%100% Trastuzumab and Pertuzumab3%5%0%0% Unknown9%15%20%0%11 patient in the HP pCR group had nuclear grade 1; 2 patients in the HP RD group had nuclear grade 1 tumors 2 2 patients received adjuvant TDM-1 on the NSABP B50 protocol

Citation Format: Murthy RK, Raghavendra AS, Hess KR, Barcenas CH, Lim B, Moulder SL, Giordano SH, Mittendorf EA, Thompson A, Ueno NT, Valero V, Litton JK, Tripathy D, Chavez-Macgregor M. 3-year relapse-free survival of stage II-III HER2-neu positive breast cancer treated with pertuzumab and trastuzumab-containing neoadjuvant therapy compared to trastuzumab-containing therapy [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P6-17-04.