TARGETED THERAPIES IN COMBINATION WITH NEOADJUVANT CHEMOTHERAPY FOR HER2-POSITIVE BREAST CANCER AND ECONOMIC EVALUATION

• Main Authors: Atikah Shaharudin (Author), Sze-Shir, Foo (Author), Maharita Ab Rahman (Author), Aidatul Azura Abd Rani (Author)
• Corporate Author: KEMENTERIAN KESIHATAN MALAYSIA
• Format: Book
• Language: English
• Published: Putrajaya Malaysian Health Technology Assessment Section (MaHTAS) 2021
• Series: Health Technology Assessment Report
• Subjects: Breast Neoplasms > therapy; Neoadjuvant Therapy
• Online Access: Click Here to View Status and Holdings.

 Breast cancer is the most prevalent type of malignancy in females. It is a heterogeneous disease which can be divided into several subtypes. Based on severity, breast cancer is broadly categorised into three groups which are early breast cancer (EBC), locally advanced breast cancer (LABC) and metastatic breast cancer (MBC). Human epidermal growth factor receptor 2 (HER2) is a growth-promoting protein on the outside of all breast cells. About 15 to 20% women with breast cancer have overexpression of HER2 and called as HER2-positive. HER2-positive is an aggressive subtype that exhibits unique epidemiological, clinical and prognostic differences with poor response to standard chemotherapy regimens compared with HER2-negative. The treatment of breast cancer generally depends on the stage of disease and characteristics of the tumour which involves surgery, chemotherapy, radiotherapy and hormonal therapy. Neoadjuvant therapy in breast cancer refers to the administration of treatment with the intent of down staging the tumour and improves operability and surgical outcomes. The current practices in Malaysia for management of EBC include neoadjuvant chemotherapy only while management of LABC include neoadjuvant chemotherapy and anti-HER2 therapy for operable and inoperable conditions. In Ministry of Health Medicines Formulary (MHMF) Malaysia, trastuzumab injection was approved in adjuvant setting only for patients with HER2-positive, over-expressed by FISH (Fluorescence in situ hybridization) and high risk group (>30% lifetime risk but no known genetic variant). Both drugs (pertuzumab and lapatinib) are registered under National Pharmaceutical Regulatory Agency (NPRA) but not included in the MHMF. Pertuzumab injection is indicated for neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either >2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer and indicated in combination with trastuzumab and docetaxel for patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for metastatic breast cancer. While, lapatinib is indicated in combination with capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumuors overexpressed HER2 and who have received prior therapy including an anthracycline, a taxane, and trastuzumab or in combination with letrozole for the treatment of postmenopausal women with hormone receptor-positive metastatic breast cancer. As these agents may play an important role in neoadjuvant therapy setting, their effectiveness and economic implications need to be assessed. This HTA was requested by a Clinical Oncologist from Hospital Kuala Lumpur (HKL)