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| ID | Type | Description | Link |
|---|---|---|---|
| AEŞH-BADEK2-2025-452 | Other Identifier | Ankara Etlik City Hospital Scientific Research Ethics Committee |
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This study investigates the impact of sarcopenia and the CRP-TyG Index (CTI) on immunotherapy outcomes in patients with metastatic non-small cell lung cancer (NSCLC). Medical records of 115 adult patients treated with immune checkpoint inhibitors at Ankara Etlik City Hospital between November 2022 and December 2024 will be retrospectively analyzed.
Sarcopenia will be determined from CT-based skeletal muscle index (SMI) measurements at the L3 vertebral level. SMI will be calculated as skeletal muscle area (cm²) divided by height squared (m²), with sex-specific cut-offs (≤52.4 cm²/m² for men, ≤38.5 cm²/m² for women). CTI will be calculated from CRP, triglycerides, and fasting glucose values.
Primary outcome is objective response rate (ORR, RECIST 1.1). Secondary outcomes include 1-year progression-free survival (PFS), 1-year overall survival (OS), treatment duration, and adverse events (CTCAE v5.0).
Metastatic non-small cell lung cancer (mNSCLC) is among the leading causes of cancer-related mortality worldwide. Immune checkpoint inhibitors (ICIs) targeting PD-1/PD-L1 have improved survival outcomes, yet responses remain heterogeneous. Prognostic biomarkers such as sarcopenia and systemic inflammation-metabolism indices may help optimize patient selection.
This retrospective, single-center cohort study will analyze 115 adult patients with mNSCLC treated with ICIs at Ankara Etlik City Hospital between November 2022 and December 2024. Sarcopenia will be assessed from computed tomography (CT) imaging at the L3 vertebral level by calculating skeletal muscle index (SMI = skeletal muscle area [cm²] / height² [m²]). Patients will be classified as sarcopenic if SMI ≤52.4 cm²/m² for men or ≤38.5 cm²/m² for women. Both baseline and 3-month CT scans will be analyzed to assess dynamic changes (ΔSMI).
The CRP-TyG Index (CTI) will be calculated as:
TyG = ln [triglycerides (mg/dL) × fasting glucose (mg/dL) / 2] CTI = 0.412 × ln [CRP (mg/L)] + TyG Patients will be categorized into low- and high-risk groups using the published cut-off of 4.78.
The primary endpoint is objective response rate (ORR, RECIST v1.1). Secondary endpoints include 12-month progression-free survival (PFS), overall survival (OS), treatment duration, adverse events (graded by CTCAE v5.0), and sarcopenia dynamics. Associations between CTI and sarcopenia will also be explored. Statistical analyses include multivariable logistic regression for ORR and Cox proportional hazards models for PFS/OS, adjusting for age, sex, and ECOG status.
This study aims to integrate radiological (sarcopenia), biochemical (CRP, triglycerides, glucose), and clinical outcomes to determine whether sarcopenia and CTI can serve as practical prognostic markers for immunotherapy in real-world mNSCLC patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metastatic NSCLC Patients Treated With Immunotherapy | This cohort includes 115 adult patients with histologically confirmed metastatic non-small cell lung cancer (mNSCLC) who received immune checkpoint inhibitors at Ankara Etlik City Hospital between November 2022 and December 2024. Patients had available baseline and 3-month CT imaging for sarcopenia assessment and laboratory data for CRP, triglycerides, and fasting glucose to calculate the CRP-TyG Index (CTI). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immune Checkpoint Inhibitors | Drug | Retrospective analysis of patients with metastatic non-small cell lung cancer (mNSCLC) who received standard-of-care immune checkpoint inhibitors, including PD-1 and PD-L1 inhibitors (e.g., nivolumab, pembrolizumab, atezolizumab, durvalumab). Patients received these agents as part of routine clinical practice; no experimental intervention was administered in this study. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Proportion of patients achieving complete response (CR) or partial response (PR) according to RECIST 1.1 criteria, based on radiological evaluation. | Baseline to 12 months after initiation of immunotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | Time from initiation of immunotherapy to disease progression or death from any cause, whichever occurs first. | Baseline to 12 months |
| Overall Survival (OS) | Time from initiation of immunotherapy to death from any cause. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Sarcopenia (ΔSMI) | Difference in SMI between baseline and 3 months. Patients classified as stable/improved vs worsened. | Baseline to 3 months |
| CRP-TyG Index (CTI) Prognostic Value | CTI calculated as: CTI = 0.412 × ln [CRP (mg/L)] + ln [Triglycerides (mg/dL) × Fasting Glucose (mg/dL) / 2]. CTI is a continuous score with no absolute minimum/maximum; typically ranges 2-7. Higher CTI values indicate higher systemic inflammation-metabolic risk. Patients will be stratified at 4.78 (low risk vs. high risk). |
Inclusion Criteria:
Exclusion Criteria:
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This study population consists of 115 adult patients with histologically confirmed metastatic non-small cell lung cancer (mNSCLC) who received immune checkpoint inhibitors at Ankara Etlik City Hospital between November 2022 and December 2024. All included patients had available baseline and 3-month CT scans for sarcopenia assessment and laboratory data for calculation of the CRP-TyG Index (CTI).
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| Name | Affiliation | Role |
|---|---|---|
| Galip Can Uyar, MD | Etlik City Hospital Medical Oncology Department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Etlik City Hospital Medical Oncology Department | Ankara | Yenimahalle | 06270 | Turkey (Türkiye) | ||
| Etlik City Hospital Radiology Department |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D009369 | Neoplasms |
| D055948 | Sarcopenia |
| C565324 | Parkinson Disease 4, Autosomal Dominant Lewy Body |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D000082082 | Immune Checkpoint Inhibitors |
| D000077594 | Nivolumab |
| C582435 | pembrolizumab |
| C000594389 | atezolizumab |
| C000613593 | durvalumab |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000074322 | Antineoplastic Agents, Immunological |
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|
|
| Baseline to 12 months |
| Treatment Duration | Duration of immunotherapy treatment, measured from initiation to discontinuation for any reason. | Baseline to end of treatment (up to 12 months) |
| Adverse Events (Toxicity Profile) | Incidence and severity of treatment-related adverse events, graded according to CTCAE version 5.0. | Baseline to 12 months |
| Sarcopenia Status at Baseline | Skeletal Muscle Index (SMI = skeletal muscle area [cm²] / height² [m²]) measured at L3 level. Minimum value: near 0 (exceptionally low muscle mass) No theoretical maximum, but typical range: ~20-80 cm²/m² Lower values indicate worse muscle status. Cut-offs: ≤52.4 cm²/m² (men), ≤38.5 cm²/m² (women) define sarcopenia. | At baseline (0 months) |
| Sarcopenia Status at 3 Months | Skeletal Muscle Index (SMI) at 3-month CT scan. SMI reassessed at ~3 months. Same cut-offs as above. Same cut-offs as baseline (≤52.4 cm²/m² for men, ≤38.5 cm²/m² for women). | 3 months after initiation of immunotherapy |
| At baseline (0 months) |
| Correlation Between Sarcopenia and CTI | Relationship between baseline sarcopenia (SMI cut-offs) and baseline CTI (cut-off 4.78), and their combined effect on immunotherapy outcomes. | Baseline to 12 months |
| Ankara |
| Yenimahalle |
| 06270 |
| Turkey (Türkiye) |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |