Lead Investigator: Zhi Xiao, Xiangya Hospital, Central-South University
Title of Proposal Research: Roles of neutrophil/lymphocyte ratio (NLR) in prognosis in early HER2-positive breast cancer with neuadjuvent trastuzumab and pertuzumab therapy
Vivli Data Request: 8802
Funding Source: None
Potential Conflicts of Interest: None
Summary of the Proposed Research:
HER2 is an oncogene and is associated with aggressive tumor growth and poor prognosis. An oncogene is a kind of gene that has the potential to cause a normal cell to become cancerous or can strengthen the ability of cancerous cells to invade and metastasize (i.e., spread) throughout the body. HER2 is over-expressed in 20-25% of all invasive breast cancer (BC) cases. Trastuzumab and pertuzumab are effective therapies for HER2 over-expression BC and can decrease the risk of relapse around 25%. Meanwhile, in some situations, HER2-positive BC has no response to trastuzumab and pertuzumab treatment. The mechanism of trastuzumab and pertuzumab resistance is not yet understood, and there is no factor that could predict the sensitivity to trastuzumab and pertuzumab of HER2-positive breast cancer.
Recently, many studies have found that systemic immune status (e.g., presence of white blood cells called neutrophils and lymphocytes), affects responses to therapy and even prognosis of BC patients. Some studies indicate that immune factors such as baseline neutrophil/lymphocyte ratio (NLR) is a predictive factor of disease-free survival (DFS) outcome in BC.
In our retrospective cohort study, we found that low baseline NLR value was associated with better DFS outcomes in HER2-positive BC patients with trastuzumab adjuvent treatment. In another study, we found the NLR was a prognosis factor in HER2-positive metastatic breast cancer patients with trastuzumab and pertuzumab treatment.
We believe that these immune factors will help to differentiate potential beneficiaries of trastuzumab and pertuzumab treatment. In those patients who will benefit less from trastuzumab and pertuzumab, intensive therapy, such as trastuzumab emtansine (T-DM1) or prolonged anti-HER2 therapy is needed.
Requested Studies:
A Randomized Multicenter, Double-Blind, Placebo-Controlled Comparison of Chemotherapy Plus Trastuzumab Plus Placebo Versus Chemotherapy Plus Trastuzumab Plus Pertuzumab as Adjuvant Therapy in Patients With Operable HER2-Positive Primary Breast Cancer
Data Contributor: Roche
Study ID: NCT01358877
Sponsor ID: BO25126
A Randomized, Open Label Study to Compare the Complete Pathological Response Rate Achieved With 4 Combinations of Herceptin, Docetaxel and Pertuzumab in Patients With Locally Advanced, Inflammatory or Early Stage HER2 Positive Breast Cancer
Data Contributor: Roche
Study ID: NCT00545688
Sponsor ID: WO20697
A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase III Study to Evaluate Pertuzumab in Combination With Docetaxel and Trastuzumab as Neoadjuvant Therapy, and Pertuzumab in Combination With Trastuzumab as Adjuvant Therapy After Surgery and Chemotherapy in Patients With Early-Stage or Locally Advanced HER2-Positive Breast Cancer
Data Contributor: Roche
Study ID: NCT02586025
Sponsor ID: YO28762
A Randomised, Multicentre, Multinational Phase II Study to Evaluate Pertuzumab in Combination With Trastuzumab, Given Either Concomitantly or Sequentially With Standard Anthracycline-based Chemotherapy or Concomitantly With a Non-anthracycline-based Chemotherapy Regimen, as Neoadjuvant Therapy for Patients With Locally Advanced, Inflammatory or Early Stage HER2-positive Breast Cancer
Data Contributor: Roche
Study ID: NCT00976989
Sponsor ID: BO22280
A Multicenter, Multinational, Phase II Study to Evaluate Perjeta in Combination With Herceptin and Standard Neoadjuvant Anthracycline-Based Chemotherapy in Patients With HER2-Positive, Locally Advanced, Inflammatory, or Early-Stage Breast Cancer
Data Contributor: Roche
Study ID: NCT02132949
Sponsor ID: WO29217