Adjusted Indirect Treatment Comparison of Fruquintinib-based Therapy Versus Standard Care in Advanced Gastric/Gastroesophageal Junction Adenocarcinoma: A MAIC Analysis.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,143
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
This anchored matching-adjusted indirect comparison (MAIC) evaluates the relative efficacy of fruquintinib-paclitaxel (using IPD from the FRUTIGA trial, n=703) versus ramucirumab-paclitaxel (using published AgD from RAINBOW-Asia, n=440) in advanced gastric/GEJ adenocarcinoma. Baseline characteristics are adjusted via entropy balancing weights. Primary endpoint is progression-free survival (PFS) analyzed by Bucher method; secondary endpoints include overall survival (OS) and objective response rate (ORR). Sensitivity analyses comprise restricted mean survival time (RMST) analysis and simulated treatment comparison (STC).
详细描述
This retrospective MAIC analysis employs individual patient data (IPD) from the FRUTIGA trial (fruquintinib arm) and published aggregate data (AgD) from RAINBOW-Asia (ramucirumab arm), with placebo as the common anchor. Pseudo individual participant data (Pseudo-IPD) for the RAINBOW-Asia trial were reconstructed from published Kaplan-Meier curves using the Guyot algorithm (2012).
•Weighting Methodology: Seven prognostic factors balanced: age <65, male sex, ECOG 0, GEJ primary, peritoneal metastases, metastatic sites, prior doublet chemotherapy Optimization via BFGS algorithm (convergence tolerance 1e-6) Effective sample size (ESS) retention: > 50%
•Statistical Analysis: Primary: Adjusted PFS hazard ratio (HR) using Bucher method with 95% bootstrap CI (100 iterations) Secondary: Weighted Cox models for OS; logistic regression for ORR/DCR Sensitivity: Simulated Treatment Comparison (STC) and covariate threshold analyses
•Sensitivity Analyses: RMST analyses were conducted as supportive evidence alongside primary Cox models for time-to-event endpoints violating proportional hazards assumptions.
Restricted mean survival time (RMST) Simulated Treatment Comparison (STC) Bootstrap confidence intervals (100 iterations)
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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 gastric/GEJ adenocarcinoma
- •Advanced or metastatic disease
- •Received either fruquintinib + paclitaxel or reference regimen
- •Available baseline characteristics for matching variables
排除标准
- •Missing key outcome data
- •Incomplete baseline characteristics for >2 matching variables
- •Prior fruquintinib exposure (control arm only)
研究组 & 干预措施
Fruquintinib + paclitaxel
Group 1: Fruquintinib + Paclitaxel (IPD)
干预措施: Fruquintinib+Paclitaxel (Drug)
Ramucirumab + paclitaxel
Group 2: Control Therapy (AgD from RAINBOW-Asia)
干预措施: Ramucirumab+Paclitaxel (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: about 3 years
Time from randomization to progression/death, assessed via weighted Cox model
次要结局
- Objective Response Rate (ORR)(about 3 years)
- Disease Control Rate (DCR)(about 3 years)
- Overall Survival (OS)(about 3 years)
- PFS by ECOG, metastasis burden, primary site, etc(about 3 years)
- OS by ECOG, metastasis burden, primary site, etc(about 3 years)
研究者
Feng Wang
Professor
Sun Yat-sen University