Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that HER2-positive status confers therapeutic sensitivity to Cyclophosphamide, Epirubicin, Paclitaxel, Pertuzumab, Trastuzumab in patients with Invasive Breast Carcinoma.
The Republic of Ireland's Health Service Executive (HSE) has approved pertuzumab in combination with trastuzumab and chemotherapy partially for reimbursement as a treatment option for the adjuvant treatment of adult patients with HER2-positive breast cancer at high risk of recurrence. The therapy regimen states that pertuzumab is not currently approved for reimbursement for this indication, and that trastuzumab and chemotherapy are available for reimbursement through the hospital scheme. According to the EMA product information for this indication, this indication is based on APHINITY (BO25126), a multicenter, randomized, double-blind, placebo-controlled phase 3 trial. Investigators selected one of the following chemotherapy regimes: (i) 3 or 4 cycles of FEC or 5-fluorouracil, doxorubicin and cyclophosphamide (FAC), followed by 3 or 4 cycles of docetaxel or 12 cycles of weekly paclitaxel; (ii) 4 cycles of AC or epirubicin and cyclophosphamide (EC), followed by 3 or 4 cycles of docetaxel or 12 cycles of weekly paclitaxel; or (iii) 6 cycles of docetaxel in combination with carboplatin.
This statement is based on a regulatory approval from the Health Service Executive:
Pertuzumab in combination with trastuzumab and chemotherapy for the adjuvant treatment of adult patients with HER2-positive breast cancer at high risk of recurrence.