Journal: Blood
This publication reviews the challenges and considerations in selecting appropriate clinical end points for follicular lymphoma (FL) trials.
Given the long median overall survival (~20 years) in FL, traditional overall survival is often impractical as a primary end point.
The authors discuss the limitations of currently used end points, including delayed results and insufficient sensitivity to detect therapeutic differences.
They advocate for:
- Validated surrogate markers, such as complete remission at 30 months post-frontline immunochemotherapy, as potential primary or co-primary end points in randomized trials.
- Emerging markers like minimal residual disease, which may be valuable in early-phase studies and for accelerated approval processes.
Additionally, the review emphasizes incorporating quality of life and nonmedical burdens (e.g., time, financial toxicity) as critical secondary end points to ensure patient-centered care and better evaluate treatment impact beyond survival.