Nutritional Assessment of Patients With Non-small Cell Lung Cancer Treated With Osimertinib (NUTRI-CPNM)

Unic group

Patients diagnosed with NSCLC undergoing treatment with osimertinib in the Vigo Health Area, who receive pharmaceutical care in the Outpatient Clinics of the Pharmacy Service of the Álvaro Cunqueiro Hospital.

Inny: Unic group

To describe the nutritional status and body composition of patients diagnosed with non-melanoma skin cancer (NMSC) treated with osimertinib in the Vigo health area.

To evaluate the prevalence of sarcopenia in the study patients.

To observe if there is a relationship between low muscle mass or malnutrition and the development of delayed-type hyperplasia (DTH) during osimertinib treatment.

Gender

Patient gender (Female, Male)

Age

Patient age in years

Stage of NSCLC

Non-Small Cell Lung Cancer (NSCLC) is staged from 0 to IV based on tumor size (T), lymph node involvement (N), and metastasis (M).

Start date of Osimertinib treatment

Date of initiation of osimertinib therapy as recorded in the medical record.

Initial and current osimertinib dose

Dose of osimertinib in milligrams (mg/day) at treatment initiation and at the time of assessment.

Total duration of osimertinib treatment

Total duration of osimertinib therapy calculated from treatment initiation to discontinuation or last follow-up, expressed in days.

Dose-limiting toxicities (DLTs)

Incidence and type of dose-limiting toxicities experienced during osimertinib treatment, graded according to CTCAE criteria. The most common DLTs included diarrhea, mucositis, folliculitis, nausea, thrombocytopenia, paronychia, and elevated transaminases.

Body weight

Body weight measured in kilograms (kg). The tools used for anthropometric data collection included a weighing scale with an integrated stadiometer (Asimed® brand, manufactured by Sibelmed, Barcelona, Spain) and an anthropometric measuring tape.

Height

Height measured in meters (m). The tools used for anthropometric data collection included a weighing scale with an integrated stadiometer (Asimed® brand, manufactured by Sibelmed, Barcelona, Spain) and an anthropometric measuring tape.

Calf circumference

Calf circumference measured in centimeters (cm) at the point of maximum circumference. The tools used for anthropometric data collection included a weighing scale with an integrated stadiometer (Asimed® brand, manufactured by Sibelmed, Barcelona, Spain) and an anthropometric measuring tape.

Body mass index (BMI)

Body mass index calculated as weight in kilograms divided by height in meters squared (kg/m²).

Usual body weight

Self-reported usual body weight prior to disease or treatment, measured in kilograms (kg).

Weight loss during treatment

Percentage and absolute change in body weight from baseline during osimertinib treatment. It was calculated using the following formula: %WL = [(usual weight - current weight)/usual weight] × 100

Food intake recall

Dietary intake assessed 24-hour food recall, including total caloric and macronutrient intake.

Fat mass (FM) by bioimpedance

Fat mass measured in kilograms using bioelectrical impedance analysis (BIA) the InBody S10® body composition analyzer (manufactured by InBody Co., Ltd., Seoul, Republic of Korea), was used, which is a device that measures impedance using 6 frequencies (1, 5, 50, 250, 500, and 1000 kHz) for each of the 5 body segments: right arm, left arm, trunk, right leg, and left leg.

The measurements were performed with patients standing barefoot, with their legs apart and arms not touching the torso. The 8-point tactile electrodes were placed on the thumb and middle finger of each hand and on both ankles. The data obtained were analyzed using the LookinBody 120® software.

Lean body mass (LBM) by bioimpedance

Lean body mass measured in kilograms using bioelectrical impedance analysis (BIA) the InBody S10® body composition analyzer (manufactured by InBody Co., Ltd., Seoul, Republic of Korea), was used, which is a device that measures impedance using 6 frequencies (1, 5, 50, 250, 500, and 1000 kHz) for each of the 5 body segments: right arm, left arm, trunk, right leg, and left leg.

The measurements were performed with patients standing barefoot, with their legs apart and arms not touching the torso. The 8-point tactile electrodes were placed on the thumb and middle finger of each hand and on both ankles. The data obtained were analyzed using the LookinBody 120® software.

Lean body mass index (LBMI)

Lean body mass index calculated as lean body mass divided by height squared (kg/m²). A reduced muscle mass was considered for LBMI < 17 kg/m2 in men and <15 kg/m2 in women. Using bioelectrical impedance analysis (BIA) the InBody S10® body composition analyzer (manufactured by InBody Co., Ltd., Seoul, Republic of Korea), was used, which is a device that measures impedance using 6 frequencies (1, 5, 50, 250, 500, and 1000 kHz) for each of the 5 body segments: right arm, left arm, trunk, right leg, and left leg.

The measurements were performed with patients standing barefoot, with their legs apart and arms not touching the torso. The 8-point tactile electrodes were placed on the thumb and middle finger of each hand and on both ankles. The data obtained were analyzed using the LookinBody 120® software.

Muscle functionality

Muscle functionality was assessed through hand grip strength using a hydraulic dynamometer (Jamar®, manufactured by Performance Health, Warrenville, IL, USA), providing the strength of the dominant arm (kg). Three measurements were taken with the subject seated and without arm support, with a 60 s rest between each measurement to prevent muscle fatigue. Dynapenia or reduced strength was considered if the value was <27 kg in men and <16 kg in women.

Diagnosis of malnutrition

Following GLIM criteria (Global Leadership Initiative on Malnutrition):

Phenotypic Criteria:

• Involuntary weight loss: >5% in the last 6 months or >10% in more than 6 months.
• Low BMI: <20 kg/m2 if <70 years or <22 kg/m2 if ≥70 years.
• Muscle mass evaluation: assessed by LBMI (BIA) or by CC if BIA was not performed.
• Etiological Criteria:

• Reduced food intake or absorption: ≤50% of energy requirements for more than

  1 week, any reduction for more than 2 weeks, or any chronic gastrointestinal condition negatively affecting food absorption or assimilation.

• Inflammation or acute/chronic disease: the presence of inflammatory conditions or chronic diseases affecting nutritional status.

The combination of at least one phenotypic criterion and one etiological criterion enabled the diagnosis of malnutrition. The etiological criterion of inflammation, required for the diagnosis of malnutrition, was met in all study patients as they were diagnosed with NSCLC.

Sarcopenia detection and diagnosis

Applying the EWGSOP2 algorithm proposed by the European Working Group on Sarcopenia in Older People (EWGSOP).

The screening was performed using the Strength, Assistance walking, Rise from a chair, Climb stairs, and Falls (SARC-F) questionnaire, and a score of 4 or higher was considered to indicate a risk of sarcopenia. Muscle strength was determined by dynamometry, and BIA or CC assessed muscle mass. Patients with low muscle strength were classified as dynapenic; presarcopenia was diagnosed in patients showing reduced muscle mass and no significant decrease in muscle strength; finally, sarcopenia was diagnosed in patients who, in addition to low hand grip strength, also exhibited a reduction in muscle mass.

Quality of Life of the patients

It was assessed using the EQ-5D scale, a standardized tool that measures five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Additionally, patients completed a visual Analog scale (VAS) ranging from 0 to 100, reflecting their general health status.