Body Composition and Inflammatory-Metabolic Indices as Predictors of Immunotherapy Outcomes in Metastatic Non-Small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 155
- 试验地点
- 2
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
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).
干预措施: Immune Checkpoint Inhibitors (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: 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.
次要结局
- Progression-Free Survival (PFS)(Baseline to 12 months)
- Overall Survival (OS)(Baseline to 12 months)
- Treatment Duration(Baseline to end of treatment (up to 12 months))
- Sarcopenia Status at Baseline(At baseline (0 months))
- Sarcopenia Status at 3 Months(3 months after initiation of immunotherapy)
- Progression-Free Survival (PFS)(Baseline to 12 months)
- Overall Survival (OS)(Baseline to 12 months)
- Treatment Duration(Baseline to end of treatment (up to 12 months))
- Adverse Events (Toxicity Profile)(Baseline to 12 months)
- Sarcopenia Status at Baseline(At baseline (0 months))
- Sarcopenia Status at 3 Months(3 months after initiation of immunotherapy)
研究者
Galip Can Uyar
Medical Oncologist
Ankara Etlik City Hospital