Lead Investigator: Damian J. Ralser, University Hospital Bonn
Title of Proposal Research: Evaluation of the easy-to-implement modified Glasgow prognostic score (mGPS) in patients with previously treated human epidermal growth factor receptor 2-positive advanced breast cancer in the KATE2 clinical trial
Vivli Data Request: 8287
Funding Source: None
Potential Conflicts of Interest: None
Summary of the Proposed Research:
Breast cancer (BC) is the most common cancer and the second most common cause of cancer mortality in women worldwide. Breast tumors are further characterized by presence or absence of proteins on the tumor cell surface (estrogen-, progesterone- and human epidermal growth factor receptor 2 (Her2)). The receptor expression on the breast cancer cell is determined applying immunohistochemistry which is a tissue-based laboratory method. Her2 expressing breast tumors are referred to as Her2 positive BC. The proportion of Her2 positive BC is approximately 15-20%.
Her2 positivity enables targeted therapy against Her2. In metastatic disease, first-line therapy is a taxane (docetaxel or paclitaxel; both are drugs that block cell growth by stopping mitosis) in combination with dual Her2 blockade (Trastuzumab plus Pertuzumab). If cancer progression occurs under this therapy, the second-line therapy for many years was trastuzumab emtansine (T-DM1). In the KATE 2 trial, addition of Atezolizumab to T-DM1 was evaluated in BC patients who had disease progression after previous treatment with trastuzumab and a taxane. Atezolizumab is an immunotherapeutic agent. Immunotherapeutic agents has evolved as a promising treatment approach in recent years. It works by enabling the patient´s immune system to attack and kill the tumor. This is achieved by blocking signals on the tumor cells that prevent the immune system from attacking the cells, these signals are called immune checkpoints. In the KATE 2 trial, however, addition of Atezolizumab to T-DM1 did not show a clinically meaningful improvement with regard to progression-free survival.
The overarching goal in modern oncology is to provide a tailored therapy to the individual patient. This involves integrating various aspects into the therapy decision process (tumor biology, general condition of the patient, etc.). The modified Glasgow prognostic score (mGPS) allows a statement about the systemic inflammation situation and the nutritional status of the patient. A large number of studies have demonstrated the prognostic significance of this score in various tumor entities. Data on mGPS in metastatic Her2 positive breast cancer are not yet reported.
A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase II Study of the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizumab or Atezolizumab-Placebo in Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab and Taxane Based Therapy
Data Contributor: Roche
Study ID: NCT02924883
Sponsor ID: WO30085