Hazard ratio (HR)
A hazard ratio is a number comparing the rate of bad events in two groups. An HR of 0.5 means the risk is halved at any moment.
From Cox proportional hazards models. HR <1 favours the experimental arm; confidence interval excluding 1 indicates statistical significance. Does not describe absolute benefit or duration.
For patients with advanced melanoma, immunotherapy offers a realistic chance of long-term survival and probably cure, and the ten-year data show that patients who are alive and progression-free at three years rarely die of melanoma afterwards. Nivolumab plus ipilimumab gives the best long-term results but at a high price in serious side effects; nivolumab alone or nivolumab plus relatlimab are alternatives for patients at lower risk or with autoimmune concerns. The trial is also a caution about surrogate endpoints: the survival plateau took years to become visible.
Ribociclib is a second adjuvant CDK4/6 option, and the only one with data in node-negative stage II disease. Roughly 3 in 100 patients avoid a relapse or death at three years, so the decision depends heavily on individual risk, tolerance of a three-year oral drug, and cost. Whether the benefit persists after treatment ends, as it did with abemaciclib, needs longer follow-up.
Women with hormone-receptor-positive, HER2-negative breast cancer that has spread to lymph nodes and has other high-risk features can now be offered two years of abemaciclib alongside their hormone therapy, with a durable reduction in relapse. It does not apply to node-negative or low-risk disease, and the diarrhoea and cost are real trade-offs to discuss.
A drug that shrinks tumours or delays progression on scans has not necessarily been shown to help patients live longer or better. Patients and clinicians should ask what the endpoint was; regulators should insist on timely confirmatory trials; and trialists should validate surrogates before relying on them.
Pages like this
not linked directly; found by shared links- TermOverall survival (OS)
Shares Pre-specified crossover-adjusted survival in every trial that allows crossover, Quality-adjusted survival reported in every trial publication and label, Michael LeBlanc, Landmark and milestone survival (5-year survival, median follow-up).
- TermProgression-free survival (PFS)
Shares Michael LeBlanc, Landmark and milestone survival (5-year survival, median follow-up), Publish the disagreement between trial doctors and independent reviewers for every trial, Median survival.
- TermInterim analysis, readout and data cut-off
Shares Landmark and milestone survival (5-year survival, median follow-up), Data maturity (immature vs mature survival data), Statistical significance (P values, alpha, multiplicity).
- InstitutionHaute Autorité de Santé
Shares Gemeinsamer Bundesausschuss / IQWiG, ISPOR – The Professional Society for Health Economics and Outcomes Research, National Institute for Health and Care Excellence.
- TermReal-world evidence
Shares A pre-registered standard for emulating trials with real-world data, A public rulebook for when an external or synthetic control arm is acceptable, Randomised trial, Vivli.
- InstitutionEuropean Society for Medical Oncology (ESMO)
Shares Pre-specified crossover-adjusted survival in every trial that allows crossover, Agree in advance how to borrow evidence between similar rare cancers, Power trials to detect a benefit patients would value, not the smallest detectable one, Older and multimorbid patients are excluded and undertreated.
- BottleneckFailures are hidden
Shares Bayesian shrinkage for subgroup claims to stop false 'works in this group' stories, ASPREE (ASPirin in Reducing Events in the Elderly), VITAL (VITamin D and OmegA-3 TriaL), Deposit trial results as structured data, not just PDFs.
- TermPrimary, secondary and co-primary endpoints
Shares Data maturity (immature vs mature survival data), Statistical significance (P values, alpha, multiplicity).