Biostatistics and epidemiology
Oncology trials: dose escalation, response criteria and survival endpoints
The 3+3 dose-escalation design, RECIST 1.1 and iRECIST response with a worked tumour measurement, and how to read overall survival, progression-free survival and hazard ratios in cancer trials.
Tier 2Medical sciences concept
Written with AI assistance and fact-checked against the sources below. For exam study, not clinical decisions. How notes are made
At a glance
- Cancer drugs are developed through the same phases as other medicines (see phases of drug development), with three differences the exam tests:
- Phase 1 is done in patients, and escalates dose to find the maximum tolerated dose (MTD).
- Phase 2 often uses objective response rate by RECIST 1.1 in a single-arm study.
- Phase 3 compares overall survival (OS) or progression-free survival (PFS) with hazard ratios and Kaplan–Meier curves.
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Sources
- New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1)European Journal of Cancer (Eisenhauer et al., 2009;45:228-47), 1.1
- iRECIST: guidelines for response criteria for use in trials testing immunotherapeuticsLancet Oncology (Seymour et al., 2017;18:e143-52)
- ESMO-Magnitude of Clinical Benefit Scale version 2.0Annals of Oncology (Cherny et al., 2025;36:866-908), 2.0
- Dose escalation methods in phase I cancer clinical trialsJournal of the National Cancer Institute (Le Tourneau, Lee and Siu, 2009;101:708-20)
- eviQ cancer treatments onlineAU/NZCancer Institute NSW
- Last updated
- 14 November 2026
What changed
- 14 November 2026 Turnstile bot check on sign-in and signed-out feedback