Impact of neutrophil to lymphocyte ratio on prognosis in patients with HER2-positive breast cancer regarding the HER2-targeted therapy

Lead Investigator: Soong June Bae, Yonsei University Health System
Title of Proposal Research: Impact of neutrophil to lymphocyte ratio on prognosis in patients with HER2-positive breast cancer regarding the HER2-targeted therapy
Vivli Data Request: 6472
Funding Source: None
Potential Conflicts of Interest: None

Summary of the Proposed Research:

Background
The host immune system is one of the crucial factors determining the clinical outcomes in various cancers, including breast cancer. A high neutrophil to lymphocyte ratio (NLR), which reflects a defective host immune system and proinflammatory condition, can induce neutrophilia and/or lymphopenia linked to the inflammatory response and depletion of anti-tumor immune function, consequently leading to tumor progression. Most studies investigating the NLR in breast cancer have highlighted the association between a high NLR and poor response to chemotherapy and worse clinical outcomes. The baseline NLR can be calculated as the neutrophil count divided by the lymphocyte count obtained from the complete blood count (CBC) analysis that is routinely performed in patients with breast cancer before the treatment initiation. Accordingly, the NLR is very easily obtained, and through this, the patient’s immune status at baseline can be assessed.

Obesity is another major global health concern, and it has been recognized as a risk factor for breast cancer. Obesity is often determined by the degree of body mass index (BMI). BMI is calculated using body weight and height, which are usually measured in patients with breast cancer before the treatment initiation. Accumulating studies described that obesity is a significantly poor prognostic factor in breast cancer, and is closely related to the host immune status.

The application of HER2-targeted therapy such as trastuzumab and pertuzumab dramatically improved clinical outcomes in HER2-positive breast cancer. A recent study described that the efficacy of HER-targeted was different according to BMI. However, little is known about the relationship between the NLR and BMI. Moreover, the impact of NLR and BMI on the benefit of adjuvant treatment (chemotherapy vs. chemotherapy plus HER2-targeted therapy including trastuzumab or trastuzumab plus pertuzumab) is unclear in HER2-positive breast cancer.

Aim of study
The current study aimed to examine 1) the relationship between NLR and BMI in HER2-positive early breast cancer, and 2) the role of NLR and BMI as a prognostic factor in HER2-positive breast cancer regarding adjuvant treatment. To this end, we will retrospectively analyze 9,903 patients enrolled in the HERA and APHINITY trials.

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 Three-Arm, Multicenter Comparison of 1 Year and 2 Years of Herceptin Versus No Herceptin in Women With HER2-Positive Primary Breast Cancer Who Have Completed Adjuvant Chemotherapy
Data Contributor: Roche
Study ID: NCT00045032
Sponsor ID: BO16348