Energy for Lymphocytes

Study Overview
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Brief Summary
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CERTIM is a cohort created in July 2015 to set up a multidisciplinary follow-up of cancer patients treated with immune checkpoint inhibitors. From the CERTIM cohort, we conducted a longitudinal, prospective, observational study (ELY) in two tertiary university centers (Cochin hospital and European Georges Pompidou Hospital), which included patients between August 2016 and October 2019 and ended follow-up in April 2020. Patients were treated with nivolumab, at a dose of 3 mg/kg every 2 weeks, or pembrolizumab, at a dose of 2mg/kg every 3 weeks. The investigators report findings from an evaluation of rest energy expenditure (REE) assessed using indirect calorimetry in the outpatient setting before treatment with checkpoints inhibitors.

Official Title
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Analysis of Nutritional Biomarkers to Predict the Efficacy of Immunotherapy by Anti-PD/PDL1 Checkpoints Inhibitors in Metastatic Non-small Cell Lung Cancer Patients

Conditions
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Non-small Cell Lung Cancer, Progression, Disease

Intervention / Treatment
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* Other: Resting Energy Expenditure measurement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older Stage IV histologically proven Non Small Cell Lung Cancer (NSCLC) Monotherapy with nivolumab or pembrolizumab. Patients were required to have measurable disease per the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. Exclusion Criteria: Active malignancy other than NSCLC, ALK or EGFR mutated NSCLC Anticancer therapy or surgery within the past 2 weeks or inability to breathe under the calorimetry.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| adult patients with NSCLC initiating nivolumab or pembrolizumab<br>Patients underwent a multidisciplinary evaluation including consultation with an oncologist and a dietitian. Such an assessment includes subjective and objective parameters such as medical history, weight loss, current dietary intake (including energy and protein balance), physical examination and anthropometric measurements, functional and mental assessment, medications, Resting Energy Expenditure measurement using indirect calorimetry and laboratory values. | Other: Resting Energy Expenditure measurement<br>* Resting Energy Expenditure measurement using indirect calorimetry<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-month Progression-free survival | Calculated as the percentage of participants alive and without disease progression, as assessed by the Investigator using RECIST v1.1 | 6 months after start of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cachexia, immunotherapy, carcinoma, Non-small cell lung cancer, Basal metabolism, Energy expenditure, inflammation, 6-month Progression free survival