Landmark and milestone survival (5-year survival, median follow-up)
The percentage of patients alive (or progression-free) at a fixed time point such as 2, 5 or 10 years, read off a Kaplan-Meier survival curve. With immunotherapy the 'tail of the curve', the fraction still alive years later, often matters more than the median.
Kaplan-Meier curves show the proportion of patients event-free over time; the median is the point where the curve crosses 50%, and landmark rates are read at fixed times. Medians can mislead when curves plateau (a durable tail after checkpoint inhibitors or CAR-T) or cross (delayed immunotherapy benefit), so milestone rates and restricted mean survival time supplement hazard ratios. Landmark analyses also compare outcomes from a fixed time conditional on status at that time (e.g. survival by MRD status at 12 months), avoiding immortal-time bias. Median follow-up indicates how mature the data are; 5-year rates need at least 5 years of follow-up in a reasonable number of patients to be reliable.
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Shares Hazard ratio (HR), Overall survival (OS), Progression-free survival (PFS).
- TermPrimary, secondary and co-primary endpoints
Shares Interim analysis, readout and data cut-off, Data maturity (immature vs mature survival data), Overall survival (OS), Progression-free survival (PFS).
- IdeaQuality-adjusted survival reported in every trial publication and label
Shares Hazard ratio (HR), Overall survival (OS).
- IdeaSeamless phase 2/3 with pre-registered go rules as the default for new agents
Shares Overall survival (OS), Progression-free survival (PFS).
- IdeaPre-specified crossover-adjusted survival in every trial that allows crossover
Shares Hazard ratio (HR), Overall survival (OS).
- TermMedian survival
Shares Hazard ratio (HR), Overall survival (OS), Progression-free survival (PFS).
- IdeaReport time toxicity, the days a treatment consumes, in every trial and decision aid
Shares Overall survival (OS), Progression-free survival (PFS).
- IdeaPower trials to detect a benefit patients would value, not the smallest detectable one
Shares Hazard ratio (HR), Overall survival (OS), Progression-free survival (PFS).