Metastatic Non-small Cell Lung Cancer, Neoplasm
Conditions
Keywords
sarcopenia, CTI Score, Immunotherapy, Immune Checkpoint Inhibitors, PD-1 / PD-L1 Inhibitors, Prognostic Biomarker, Survival Outcomes, Skeletal Muscle Index (SMI), CRP-TyG Index (CTI)
Brief summary
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).
Detailed description
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.
Interventions
DRUGImmune Checkpoint Inhibitors
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.
Sponsors
Ankara Etlik City Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years. * Histologically confirmed diagnosis of metastatic non-small cell lung cancer (mNSCLC). * Received at least one cycle of immune checkpoint inhibitor (PD-1 or PD-L1 inhibitor) as part of routine clinical care. * Availability of baseline CT imaging (within 4 weeks before treatment initiation) and follow-up CT imaging at approximately 3 months. * Availability of baseline laboratory data including C-reactive protein (CRP), triglycerides, and fasting glucose. * Adequate clinical records for evaluation of treatment response and survival outcomes.
Exclusion criteria
* Age \<18 years. * Patients without immunotherapy treatment. * Incomplete or missing CT imaging or laboratory data required for sarcopenia or CTI assessment. * Patients lost to follow-up before first radiological evaluation. * Prior malignancy within 5 years (except adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | Baseline to 12 months after initiation of immunotherapy | Proportion of patients achieving complete response (CR) or partial response (PR) according to RECIST 1.1 criteria, based on radiological evaluation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | Baseline to 12 months | Time from initiation of immunotherapy to disease progression or death from any cause, whichever occurs first. |
| Overall Survival (OS) | Baseline to 12 months | Time from initiation of immunotherapy to death from any cause. |
| Treatment Duration | Baseline to end of treatment (up to 12 months) | Duration of immunotherapy treatment, measured from initiation to discontinuation for any reason. |
| Adverse Events (Toxicity Profile) | Baseline to 12 months | Incidence and severity of treatment-related adverse events, graded according to CTCAE version 5.0. |
| Sarcopenia Status at Baseline | At baseline (0 months) | 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. |
| Sarcopenia Status at 3 Months | 3 months after initiation of immunotherapy | 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). |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORGalip Can Uyar, MD
Etlik City Hospital Medical Oncology Department
Outcome results
None listed