Trial Endpoints and Methodology

How oncology trials measure what they claim to measure: central review versus investigator assessment, cure-fraction and adaptive-dosing models, and patient-reported outcomes as an endpoint rather than a footnote.

6 articles in this topic

• September 11, 2026The Lancet OncologySYMPRO-Lung

  Weekly Symptom Monitoring Linked to 5-Month Survival Gain in Lung Cancer

  A post-hoc analysis of the SYMPRO-Lung trial, a multicentre, stepped-wedge, cluster-randomised study across 14 Dutch centres, reports that weekly online patient-reported symptom monitoring was associated with longer overall survival in patients with lung cancer, extending follow-up well beyond the trial's original quality-of-life readout.

• August 6, 2026JAMA Oncology

  First-Cycle PSA Math Model Predicts Who Benefits Most From Adaptive Prostate Cancer Therapy

  A first-cycle "adaptive therapy score," derived from a mathematical model of competing drug-sensitive and drug-resistant tumor cell populations, more strongly predicted time to progression than any standard PSA metric across two independent prostate cancer cohorts (n=53 total).

• August 6, 2026JAMA OncologyPRO B Trial (DRKS00024015)

  Weekly Digital Symptom Monitoring Cuts Fatigue in Metastatic Breast Cancer

  The multicenter PRO B trial randomized 924 patients with metastatic breast cancer across 52 German centers to weekly alert-based electronic patient-reported outcome (ePRO) monitoring or usual quarterly PRO monitoring, with fatigue at 6 months as the primary endpoint.

• July 16, 2026JAMA OncologySystematic review and trial-level meta-analysis of 21 randomized trials (no single ClinicalTrials.gov registration)

  Investigator-Assessed PFS Matches BICR in HR+/HER2-Negative Metastatic Breast Cancer

  A systematic review and trial-level meta-analysis of 21 randomized trials (9,165 pooled patients) in HR+/HER2-negative metastatic breast cancer compares investigator (local site)-assessed progression-free survival against blinded independent central review (BICR), asking whether the added cost and complexity of BICR is actually needed.

• July 17, 2026Clinical Cancer ResearchPooled Mixture-Cure-Model Analysis of HIMALAYA (NCT03298451), CheckMate 9DW (NCT04039607), RATIONALE-301 (NCT03412773)

  Immunotherapy Achieves Durable Survival, Modest Cure Fractions in Advanced Liver Cancer

  A pooled, secondary mixture-cure-model analysis of three mature Phase III trials (HIMALAYA, CheckMate 9DW, RATIONALE-301) plus a large real-world cohort estimates how many patients with advanced hepatocellular carcinoma (HCC) achieve durable, cure-like outcomes on first-line immune checkpoint inhibitor (ICI) regimens.

• July 10, 2026Journal of Clinical OncologyCARES (CAEL101-301 / CAEL101-302; NCT04504825 & NCT04512235)

  Anselamimab Misses Primary Endpoint Overall but Cuts Mortality 62% in Kappa AL Amyloidosis

  Pooled analysis of the phase III CARES program (CAEL101-301 and CAEL101-302, n=406) testing whether adding the antifibril monoclonal antibody anselamimab to standard anti-plasma cell dyscrasia therapy improves a composite mortality/hospitalization endpoint in advanced (Mayo stage IIIa/IIIb) AL amyloidosis