Tumor Growth Rate (TGR) as an Early Predictor of Clinical Outcomes in Advanced Non-small Cell Lung Cancer Treated With PD-1 Axis Inhibitors.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 350
- 试验地点
- 3
- 主要终点
- Overall survival of patients undergoing ICI monotherapy
研究概览
简要总结
We hypothesized that TGR could serve as an early predictor of outcomes for aNSCLC patients undergoing immune checkpoint inhibitors (ICIs). A retrospective analysis was conducted to investigate the association of TGR with response and long-term survival of aNSCLC patients undergoing ICI therapy.
详细描述
Tumor growth rate (TGR) signifies percentage change in tumor size per month (%/m). Electronic medical records were retrospectively reviewed for all histologically confirmed aNSCLC patients undergoing anti-PD-1/PD-L1 therapy at Sun Yat-Sen University Cancer Center (SYSUCC) between August 2016 and June 2018.
All response and outcome evaluation were determined as per RECIST 1.1 by two senior radiologists blinded to patients'information. Discrepancy was solved by consensus.
X-tile software was used to determine cut-off values that maximumly differentiate overall survival (OS). Log-rank tests and Cox regression models were performed for survival analysis. The predictive value of TGR for clinical outcomes in ICI-treated aNSCLC patients was validated in two external cohorts, recruited form Guangdong Province Traditional Chinese Medical Hospital and Shanghai Chest Hospital.
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
- •Histologically confirmed aNSCLC patients
- •Having received anti-PD-1/PD-L1 therapy
- •Must have two consecutive computed tomography (CT) scans upon early treatment (from baseline to the first imaging evaluation)
排除标准
- •Lacking available computed tomography (CT) evaluation at any of two time points-baseline and the first evaluation
- •Without measurable lesions at baseline CT scan
- •Having received local anticancer therapy during ICI treatment, for example, radiotherapy and radiofrequency ablation
结局指标
主要结局
Overall survival of patients undergoing ICI monotherapy
时间窗: From date of ICI treatment initiation until the date of death from any causes, assessed up to 100 months.
Overall survival (OS) was defined as the time from immunotherapy initiation to death from any causes.
次要结局
- Progression-free survival of patients undergoing ICI monotherapy.(From date of ICI treatment initiation until the date of first documented progression or date of death from any causes, whichever came first, assessed up to 100 months.)
研究者
Shaodong Hong
Deputy Chief Physician, MD
Sun Yat-sen University