Non-interventional Study to Assess the Frequency of Cachexia in Patients With Non-small Cell Lung Cancer. (CacheMire)

Frequency of Cachexia According to Modified Fearon Criteria

Percentage of NSCLC patients with a cachexia according to Fearon criteria modified for the stages of pre-cachexia and refractory cachexia in order to classify all the featured cases without ambiguity.

A patient was considered to have cachexia if he/she had:

• Weight loss >5% in the last 6 months prior to inclusion or
• BMI <20 kg/m² and weight loss between 2 and 5% in the 6 months prior to inclusion or
• Weight loss >2% and sarcopenia (as evaluated by the muscle mass index at L3) if available. If data were not available regarding possible sarcopenia, the presence of cachexia was assigned based on the 2 above conditions.

In the 3 cases defined above, patient should not have entered the refractory cachexia stage, which was defined as: ECOG performance score of 3 or 4 and a low survival expectancy as defined by Martin et al. (J Clin Oncol 2015) (BMI <20 kg/m² and weight loss ≥ 6%) or (20 ≤ BMI ≤ 21.9 kg/m² and weight loss ≥ 11%) or (22 kg/m² ≤ BMI and weight loss ≥ 15%).

Frequency of the Different Stages of Cachexia in the General NSCLC Population

Percentage of the different stages of cachexia at inclusion.

The different stages of cachexia used the following classification:

• No Cachexia: 1) no weight loss (WL<2%) or 2) weight gain AND no anorexia AND no sarcopenia
• The pre-cachexia stage : 1) 2% ≤ weight loss ≤ 5% AND BMI ≥ 20 and/or 2) anorexia (according to question 13 of the quality of life questionnaire QLQ-C30) and/or 3) weight loss < 2% AND sarcopenia
• Cachexia: 1) Weight loss > 5% OR 2) weight loss between 2 and 5% AND BMI < 20 kg/m² OR 3) weight loss > 2% AND sarcopenia. In all cases, patient should not have entered the refractory cachexia stage
• Refractory cachexia: ECOG 3 or 4 AND low survival expectancy [BMI < 20kg/m² and weight loss ≥ 6%] OR [20 ≤ BMI ≤ 21,9 kg/m² and weight loss ≥ 11%] OR [22 kg/m² ≤ BMI and weight loss ≥ 15%]

Frequency of the Different Stages of Cachexia in the General NSCLC Population According to Stage Associated With NSCLC.

Percentage of the different stages of cachexia at inclusion according to the NSCLC stage

Frequency of the Different Stages of Cachexia in the General NSCLC Population According to Histology Associated With NSCLC.

Percentage of the different stages of cachexia according to the NSCLC histology

Frequency of Sarcopenia in the General NSCLC Patients With Cachexia

Percentage of patients with sarcopenia in the general NSCLC patients with cachexia

Frequency of Sarcopenia With no Clinical Significant Weight Loss in the General NSCLC Patients With Pre-cachexia

Percentage of patient with sarcopenia and no clinical significant weight loss (sarcopenia and WL< 2%) in the general NSCLC patients with pre-cachexia:

Frequency of the Different Stages of Cachexia in the General NSCLC Population According to Molecular Abnormalities Associated With NSCLC.

Percentage of the different stages of cachexia according to the molecular abnormalities associated with NSCLC:

• EGRF, ALK, ROS1, BRAF or HER2
• K-RAS
• No mutation

Frequency of the Different Stages of Cachexia According to the Number of Treatments Received.

NSCLC patients. 84 patients with missing data

Frequency of the Different Stages of Cachexia According to the Types of Treatments Received.

Stage of cachexia at inclusion according to the type of treatments received (surgery, radiotherapy, chemotherapy, targeted therapies).

Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Nutritional State

• Nutritional state according to the different stages of cachexia The variables used will be: serum albumin levels, serum pre-albumin levels, BMI and weight.

Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Blood Glucose

Blood glucose abnormalities according to the different stages of cachexia at inclusion

Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Loss of Appetite - Dietary Intake Visual Analog Scale

Dietary Intake Visual Analog Scale (Dietary intake VAS): The question "Could you indicate the amount you currently eat, placing a vertical mark on the line between "nothing at all" and "as usual"? ". Depending on the location of the patient mark on the scale, a score of between 0 ("nothing at all") and 10 ("as usual") will be allocated.

Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Loss of Appetite - AC/S FAACT

Score of the 12-question AC/S module (Anorexia-Cachexia module) of the Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire assessing anorexia and cachexia: the AC/S module of the FAACT questionnaire consists of 12 questions to assess over the last 7 days quality of life, related to anorexia or cachexia. The score ranges between 0 and 48, the higher the score, the higher the quality of life.

Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Inflammation Markers - Neutrophil/Lymphocyte Ratio

neutrophil/lymphocyte ratio

Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Inflammation Markers - CRP

CRP level

Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Inflammation Markers - Fibrinogen

fibrinogen level

Description of the Quality of Life Associated With the Different Stages of Cachexia.

Quality of life has been analysed using scores from the functional scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire- Core 30 items (EORTC QLQ-C30 questionnaire): score ranging from 0 (malfunction) to 100 (healthy level of functioning) for the following parameters : physical, role, cognitive, emotional and social scales

Description of the Level of Physical Activity Associated With the Different Stages of Cachexia.

Three levels of physical activity are defined:

1. - Low

   • No activity is reported OR
   • An activity is reported but does not reach moderate or high levels.

2. - Moderate

   Corresponds to one of the following 3 criteria:

   • 3 or more days of intense activity lasting at least 20 min per day OR
   • 5 or more days of moderate intensity activity and / or walking for at least 30 min per day OR
   • 5 or more days of activity combining walking, activities of moderate or high intensity, thus achieving at least 600 MET-minutes / week
3. - High

Corresponds to one of the following 2 criteria:

• Intense activity at least 3 days a week and at least 1500 MET-minutes / week OR
• 7 or more days of activity combining walking, moderate and high intensity activities, achieving at least 3000 MET-minutes / week

Number of Participants Receiving a Pharmacological Treatment for Cachexia or for Associated Symptoms

Pharmacological treatment of cachexia or associated symptoms: Yes / No

Number of Participants Receiving a Non-Pharmacological Treatment for Cachexia or for Associated Symptoms

Non-pharmacological treatment of cachexia or associated symptoms: Y/N

Number of Participants Receiving Systemic Corticosteroids, Anti-inflammatory Drugs, Omega 3 Fatty Acids Treatments

Treatments with systemic corticosteroids, anti-inflammatory drugs, Omega 3 fatty acids: Yes/No

Number of Participants With Diabetes Treatments

Diabetes treatments : Yes/No

Comparison of the Proportion of Patients With Cachexia, Anorexia and Malnutrition According to the Subjective Assessment of the Clinician and the Different Objective Assessment Criteria: Cachexia

• Proportion of patients with cachexia according to the subjective assessment of the clinician
• Proportion of patients with cachexia according to the Fearon criteria

Comparison of the Proportion of Patients With Cachexia, Anorexia and Malnutrition According to the Subjective Assessment of the Clinician and the Different Objective Assessment Criteria: Anorexia

• Proportion of patients with anorexia according to the subjective assessment of the clinician
• Proportion of patients with anorexia according to the Ingesta VAS
• Proportion of patients with anorexia according to the AC/S-FAACT module score
• Proportion of patients with anorexia according to question 13 of the QLQ-C30 questionnaire: "Have you had a lack of appetite?"

Comparison of the Proportion of Patients With Cachexia, Anorexia and Malnutrition According to the Subjective Assessment of the Clinician and the Different Objective Assessment Criteria: Malnutrition

• Proportion of patients with severe malnutrition according to the subjective assessment of the clinician
• Proportion of patients with severe malnutrition according to the malnutrition criteria defined by the HAS.