Time to Treatment Discontinuation and Cost Effectiveness of Third-Line Therapies in Advanced Colorectal Cancer: Real-World Evidence from the NIH All of Us Research Program - Scorecard - MDSpire
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Time to Treatment Discontinuation and Cost Effectiveness of Third-Line Therapies in Advanced Colorectal Cancer: Real-World Evidence from the NIH All of Us Research Program
Clinical Scorecard: Duration of Treatment and Economic Viability of Third-Line Options for Advanced Colorectal Cancer: Insights from the NIH All of Us Research Initiative
At a Glance
Category
Detail
Condition
Advanced colorectal cancer (CRC) requiring third-line systemic therapy
Key Mechanisms
Immune checkpoint inhibitors (ICI) provide durable responses in MSI-H/dMMR tumors; regorafenib and trifluridine/tipiracil offer modest survival benefits
Target Population
Adults (≥18 years) with stage IV or metastatic CRC initiating third-line or later therapy after fluorouracil exposure
Care Setting
Real-world clinical practice across diverse US healthcare settings including academic centers, community health centers, and VA facilities
Key Highlights
ICI treatment associated with longer treatment persistence but substantially higher costs compared to regorafenib or trifluridine/tipiracil.
Time to treatment discontinuation (TTD) used as a pragmatic endpoint reflecting treatment durability in absence of complete survival data.
Real-world cost-effectiveness analyses reveal tension between clinical benefit and affordability of immunotherapy in later-line CRC care.
Guideline-Based Recommendations
Diagnosis
Biomarker testing (KRAS, NRAS, BRAF, MSI status) is essential to guide targeted and immunotherapy use in metastatic CRC.
Next-generation sequencing (NGS) is recommended but uptake and documentation remain inconsistent in real-world settings.
Management
Third-line treatment options include regorafenib, trifluridine/tipiracil, and immune checkpoint inhibitors, with choice influenced by biomarker status.
ICI preferred for patients with MSI-H or dMMR tumors due to potential for durable responses.
Monitoring & Follow-up
Monitor time to treatment discontinuation as a real-world measure of treatment durability.
Track healthcare utilization and costs to assess economic impact of therapies.
Risks
Incomplete biomarker data may lead to clinical and economic uncertainty in treatment selection.
Higher costs associated with ICI may limit affordability and access.
Patient & Prescribing Data
Third-line or later advanced CRC patients with documented prior fluorouracil exposure in a diverse, national cohort.
ICI use correlates with longer treatment persistence but incurs substantially higher costs compared to regorafenib or trifluridine/tipiracil; real-world data highlight gaps in biomarker documentation affecting precision oncology implementation.
Clinical Best Practices
Ensure comprehensive biomarker testing to guide precision oncology in advanced CRC.
Use time to treatment discontinuation as a pragmatic endpoint to evaluate treatment durability in real-world settings.
Balance clinical benefits of immunotherapy with economic considerations to optimize patient access and healthcare resource utilization.
