PERCEPTION Trial protocol

Abstract

Background: Triple negative breast cancer affects 10% to 20% of all women diagnosed with breast cancer. Due to its characteristics, treatment strategies are limited and metastatic recurrences are common in the first 5 years after treatment. However, not all patients affected by this disease develop metastases. Tumor-infiltrating lymphocytes have shown to be reliable predictive biomarkers of treatment response and metastatic recurrences. However, we need to develop simpler and faster ways to predict response to cytotoxic treatment and the possibility of eventual cancer relapse by identifying new biomarkers. Recently, new studies are emerging, suggesting a predictive role of circulating blood cells in different types of cancer. In this study, we will assess the correlation between tumor-infiltrating lymphocytes and different elements of the blood count in patients diagnosed with triple negative breast cancer. Methods: The main objective of this study is to evaluate the correlation between the peripheral neutrophil-to-lymphocyte ratio and the amount of tumor-infiltrating lymphocytes, assessed in triple negative breast cancer patients at diagnosis. Secondary objectives include evaluation of the correlation between tumor-infiltrating lymphocytes at diagnosis and the baseline absolute neutrophil, lymphocyte, and platelet counts, as well as the platelet-to-lymphocyte ratio. The triple negative breast cancer patients will be enrolled in the PERCEPTION trial during the first year after the treatment completion. Two supplementary blood tests, at 12 months after the end of treatment and at the time of the first metastatic recurrence, will be performed. Discussion: The discovery of new prognostic and predictive biomarkers is crucial for triple negative breast cancer. We set up the PERCEPTION clinical trial in order to evaluate certain blood counts as early biomarkers and to assess their correlation with tumor-infiltrating lymphocytes. Demonstration of comparative predictive and/or prognostic capacities of peripheral blood counts and tumor-infiltrating lymphocytes would allow introduction of the former as simple and cheap biomarkers in triple negative breast cancer patient management. Trial registration: The PERCEPTION study has been registered in the French National Agency of Medical Security registry on the 2nd of July 2019 under the number 2019-A01861-56 and in the ClinicalTrials.org registry under the number NCT04068623.

Neutrophil–lymphocyte ratio reflects tumour‐infiltrating lymphocytes and tumour‐associated macrophages and independently predicts poor outcome in breast cancers with neoadjuvant chemotherapy

“…One study by Lee et al ., 30 which included pretreatment and postchemotherapy NLR, reported a decrease in NLR and the same/increased TILs to be associated with prolonged DFS, but correlation analysis between NLR wih TILs was not performed. An ongoing clinical trial aiming to evaluate NLR versus TILs is currently under way 31 . Similar to previous studies, TILs on H&E slides in the current study were not associated with pretreatment NLR, but demonstrated a negative correlation to late postsurgery NLR.…”

Neutrophil-lymphocyte ratio reflects tumor infiltrating lymphocytes, tumor associated macrophages and independently predicts poor outcome in breast cancers with neoadjuvant chemotherapy

“…One study by Lee et al (30) which included pretreatment and post-chemotherapy NLR reported that a decrease in NLR and same/increased TILs to be associated with prolonged DFS, but correlation analysis between NLR with TILs was not performed. An ongoing clinical trial aiming to evaluate NLR vs. TILs is currently underway (31). In the current study, TILs on H&E slides, similar to previous studies, was not associated with pre-treatment NLR, but demonstrated negative correlation to late post-surgery NLR.…”

Platelet-to-Lymphocyte Ratio Is Associated With Favorable Response to Neoadjuvant Chemotherapy in Triple Negative Breast Cancer: A Study on 120 Patients

“…Some studies reported the association of PLR increase and pCR, whereas in others lowering of PLR was favorable for good response ( 49 , 50 ). To better determine the time point during NACT at which the PLR value is most predictive, as well as to determine the predictive value of PLR change between different time-points during NACT, prospective studies are needed, like the one our group has recently initiated (PERCEPTION trial, NCT04068623) ( 51 ).…”

“…Therefore, the findings of our study need to be validated in larger patient cohorts. In this line, our group has recently started a prospective translational trial, PERCEPTION, whose main objective is evaluation of predictive and prognostic value of blood cell counts, NLR, PLR and TILs, before, during and after anthracycline/taxane-based NACT in TNBC patients ( 51 ).…”

“…Table 1 shows clinical characteristics of those patients and histological features of their tumors. The median follow-up was 46 months [IC 95% (37)(38)(39)(40)(41)(42)(43)(44)(45)(46)(47)(48)(49)(50)(51)(52)(53)(54)(55)]. The median age at diagnosis was 56 years (range: 28 to 86).…”