2017 ASCO Annual Meeting!
Session: Breast Cancer—Local/Regional/Adjuvant
Type: Oral Abstract Session
Time: Monday June 5, 9:45 AM to 12:45 PM
Location: Hall D2
APHINITY trial (BIG 4-11): A randomized comparison of chemotherapy (C) plus trastuzumab (T) plus placebo (Pla) versus chemotherapy plus trastuzumab (T) plus pertuzumab (P) as adjuvant therapy in patients (pts) with HER2-positive early breast cancer (EBC).
2017 ASCO Annual Meeting
J Clin Oncol 35, 2017 (suppl; abstr LBA500)
Author(s): Gunter Von Minckwitz, Marion Jennifer Procter, Evandro De Azambuja, Dimitrios Zardavas, Adam Knott, Giuseppe Viale, Thomas M. Suter, Amal Arahmani, Nathalie Rouchet, Emma Clark, Mark Benyunes, Istvan Lang, Christelle Levy, Denise A. Yardley, Jose Bines, Richard D. Gelber, Martine J. Piccart-Gebhart, Jose Baselga; German Breast Group (GBG), Neu-Isenburg, Germany; Frontier Science (Scotland) Ltd., Kingussie, United Kingdom; Institut Jules Bordet, Brussels, Belgium; Breast International Group, Brussels, Belgium; Roche Products, Ltd., Welwyn, United Kingdom; Department of Pathology, European Institute of Oncology and University of Milan, Milan, Italy; University Hospital Bern, Bern, Switzerland; Genentech, Inc., San Francisco, CA; National Institute of Oncology, Budapest, Hungary; Centre François Baclesse, Caen, France; Sarah Cannon Research Institute and Tennessee Oncology, PLLC, Nashville, TN; National Cancer Institute, Rio de Janeiro, Brazil; Dana-Farber Cancer Institute, Boston, MA; Jules Bordet Institute, Brussels, Belgium; Memorial Sloan Kettering Cancer Center, New York, NY
Background: In previous trials P significantly prolonged progression free and overall survival and increased pCR rates when added to T+C in pts with HER2-positive breast cancer (BC). The APHINITY trial was designed to test whether the addition of P to adjuvant T+C improves pt outcomes. Methods: Pts with adequately excised HER2-positive, pT1-3 EBC were randomly assigned to receive standard adjuvant C plus one year of either T + P or T + Pla. Eligible pts had either node-positive disease, or node-negative disease (pN0) and a tumor size of > 1.0 cm. Pts with pN0, T1b tumors with high risk features were initially eligible. The primary efficacy endpoint was invasive disease-free survival (IDFS); we assumed a 3-year IDFS of 91.8% with P and 89,.2% with Pla. Results: 4805 pts were randomized to C and T plus either P (n = 2400) or Pla (n = 2405). Baseline demographics and tumor characteristics between the arms were well balanced, with 63% and 36% of pts having node-positive and hormone receptor negative EBC respectively. P and Pla treatments were completed in 84.5% and 87.4% of patients, respectively. IDFS events occurred in 171 (7.1%) P pts and 210 (8.7%) Pla pts (hazard ratio (HR) 0.81 (95% CI 0.68-1.00), P = 0.045). Estimates of IDFS at 3 years were 94.1% and 93.2% in the P and Pla arms, respectively. The node-positive cohort had a 3-year IDFS rate of 92.0% for P compared with 90.2% for Pla (HR 0.77 (95% CI 0.62-0.96), P = 0.019). The pN0 cohort had a 3-year IDFS rate of 97.5% for P and 98.4% for Pla; HR = 1.13 (95% CI 0.68-1.86). The safety profile of P was consistent with previous trials. For the primary cardiac endpoint (heart failure or cardiac death) and secondary cardiac endpoint (asymptomatic or mildly symptomatic LVEF decline) rates were low, 0.7% vs 0.3% and 2.7% vs 2.8%, in the P and Pla arms, respectively. Diarrhea grade ≥3 was more frequent with P (9.9% vs 3.7%). Conclusions: The APHINITY trial met its primary endpoint: P significantly improved IDFS in patients with HER2-positive EBC when added to T+C. No new safety signals were identified. Clinical trial information: NCT01358877