Results from the PHERGAIN trial were presented last Friday 29th May at the 2020 ASCO Annual Meeting by Dr. Javier Cortés, one of the scientific leaders of this trial, and Head of the Breast Cancer Program at IOB Institute of Oncology (Madrid & Barcelona, Spain). Dr. Cortés reported the primary results from the neoadjuvant treatment period of the PHERGAIN trial showing that early 18F-FDG PET/CT assessment can identify patients with HER2-positive early breast cancer (EBC) who are more likely to benefit from chemotherapy-free dual HER2 blockade with trastuzumab and pertuzumab in terms of pathological complete response (PCR) rate. This de-escalation approach is clearly associated with a more favourable toxicity profile and a substantial improvement in quality of life, which represents a main goal for patients treated with curative intent.
“PET imaging is widely available, so being able to select a group of patients with HER2-positive EBC that could benefit from omitting chemotherapy is an important step forward in the management of this population, reducing side-effects and avoiding unnecessary overtreatment”, said Dr. Cortés.
PHERGAIN is a randomized, multicentre, non-comparative phase II trial to assess the efficacy and safety of dual HER2 blockade with trastuzumab and pertuzumab as exclusive neoadjuvant and adjuvant treatment in patients with HER2-positive EBC through an 18F-FDG PET/CT-based and pathological response-adapted strategy. Investigators from 45 centers located in 7 European countries enrolled a total of 356 patients with HER2-positive EBC that were randomized (1:4) to receive pertuzumab and trastuzumab with (Arm A) or without (Arm B) chemotherapy, respectively. Follow-up of the adjuvant phase is ongoing and results from the second co-primary endpoint, 3-year invasive disease-free survival (3y-iDFS), are still pending.
“This is an important clinical trial that addresses a relevant question to improve the treatment and quality of life of early HER2-positive breast cancer patients. We hope that upcoming results on the 3-y iDFS could endorse the promising data presented this year at ASCO”, said Dr. Antonio Llombart, Head of Medical Oncology Service at Hospital Arnau de Vilanova of Valencia and scientific co-leader of this trial.
For details about the results presented at ASCO 2020, you can access the abstract and the presentation at the link.