Updates from the phase-3 APHINITY trial were recently presented at the ESMO 2022 congress. The results of this clinical study suggest that addition of pertuzumab to adjuvant chemotherapy and trastuzumab improved long-term clinical outcomes in HER-2 positive early breast cancer patients.
Pertuzumab is a chemotherapeutic drug that targets HER-2 and blocks cancer cells’ ability to receive growth signals. The APHINITY trial evaluated its efficacy and safety for breast cancer patients with HER-2 positive status.
The randomized, phase-3, APHINITY trial enrolled 4805 HER-2 positive breast cancer patients who were randomly assigned to either pertuzumab (n=2400) or placebo control (n=2405) in addition to chemotherapy plus trastuzumab, within eight-weeks of surgery. The study’s primary endpoint was Invasive-disease free survival (IDFS) whereas overall survival (OS) was set as the secondary endpoint.
The addition of pertuzumab significantly increased the 8 year IDFS rate in comparison to placebo (88.4% vs 85.8%, hazard ratio [HR], 0.77; 95% CI, 0.66-0.91). Particularly, the 8-year IDFS benefit with pertuzumab was seen in the node-positive cohort than in the placebo control (86.1% vs 81.2%, HR, 0.72; 95% CI, 0.60-0.87). However, no significant IDFS benefit was seen in the node-negative patients. Additionally, OS benefit was also observed in node-positive patients after treatment with pertuzumab (91.1% vs 89.2%, HR, 0.80; 95% CI, 0.63-1.00). Similar to IDFS, no OS benefit was seen in the node-negative patients. The main adverse event during the course of treatment was heart failure (0.7% in the Pertuzumab arm and 0.2% in the placebo arm).
The findings of the APHINITY study demonstrate the prolonged survival benefits of pertuzumab for HER-2 node-positive breast cancer patients.
Loibl S, Jassem J, Sonnenblick A, et al. Adjuvant pertuzumab and trastuzumab in patients with early HER-2 positive breast cancer in APHINITY: 8.4 years’ follow-up. ESMO Virtual Plenary; July 14-15, 2022. Abstract VP6-2022.