Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Adjuvant pertuzumab and trastuzumab in patients with early HER-2 positive breast cancer in APHINITY: 8.4 years' follow-up

ESMO Virtual Plenary

Session date: 14-15 July 2022

Login to get immediate access to this content.



VP6-2022: Adjuvant pertuzumab and trastuzumab in patients with early HER-2 positive breast cancer in APHINITY: 8.4 years' follow-up

Published: July 15, 2022
DOI: https://doi.org/10.1016/j.annonc.2022.06.009
Download PDF

S. Loibl; J. Jassem; A. Sonnenblick; G. Viale; J. Bines; M. Piccart
Show authors and affiliations


From Nov 2011 until Aug2013, the randomized, phase III, double-blind APHINITY trial enrolled 2400 patients with HER2+, operable breast cancer assigned to receive pertuzumab (P) added to adjuvant trastuzumab (T) and chemotherapy and 2405 to receive placebo plus T and chemotherapy.


The primary analysis demonstrated that adding P to T plus chemotherapy statistically significantly improved invasive disease-free survival (IDFS) leading to a new standard of care for high-risk patients. Two pre-specified analyses of overall survival (OS) did not reach statistical significance. We now report the results of the 3rd pre-specified analysis of OS and updated descriptive analyses of IDFS.


With 8.4 years of median follow-up (clinical cut-off date 10 Jan 2022) fewer deaths were observed in the P group [168 (7.0%) vs 202 (8.4%)]. Statistical significance (p-value < 0.0060 required) was not reached. The hazard ratio for OS is 0.83 [95% CI 0.68-1.02 (p=0.078)]; 8-year OS are 92.7% vs 92.0% (0.7% difference). Updated IDFS results based on 609 events in the ITT population are: hazard ratio 0.77 [95% CI 0.66-0.91]; 8-year IDFS are 88.4% vs 85.8% (2.6% difference), respectively. The difference was due mainly to the reduction in distant (6.2% vs 8.5%) and locoregional (1.3% vs 2.4%) BC relapses. The node positive (N+) cohort continues to derive clear IDFS benefit from the addition of P: hazard ratio 0.72 (95% CI 0.60-0.87). The benefit in terms of 8-year IDFS is 4.9% [86.1% vs 81.2%]. In the N- cohort, the IDFS hazard ratio is 1.01 with >92% of patients being event-free in both arms at 8 years. IDFS benefit of P is seen in both the HR- and HR+ cohorts: IDFS hazard ratio for HR- is 0.82 (95% CI 0.64-1.06). IDFS hazard ratio for HR+ is 0.75 (95 % CI 0.61-0.92). No new cardiac safety concerns emerged.


After 8.4 years of median follow-up, no statistically significant difference in OS was found. IDFS benefit of P in HER2+ early BC is maintained, with the benefit continuing in the N+ cohort, regardless of HR status. HR status should not guide P treatment decisions. Continued follow up of patients is needed to determine possible survival benefit and long-term safety of adding adjuvant P to T. The final OS analysis is planned when 640 deaths have occurred.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.