How a patient actually feels and functions day to day: symptoms, energy, mood, ability to work and live normally. Measured with questionnaires, it is the outcome that matters most alongside survival, and the one trials have historically neglected.
Standard instruments (EORTC QLQ-C30, FACT-G, EQ-5D) ask patients to rate pain, fatigue, nausea, physical and social function, and are collected repeatedly during a trial; results are reported as change from baseline or time until quality of life deteriorates. They matter because a drug that extends progression-free survival by two months while making patients feel worse may not be a good trade, and because regulators and health systems increasingly weigh them in approval and pricing. Performance status (ECOG 0 to 4) is the clinician's brief summary of how well a patient functions and gates who is fit enough for treatment and for trials.
Showing the technology this term belongs to: Geriatric assessment.
The first randomised evidence that the order in which prostate cancer treatments are given changes how long they work, independently of which treatments they are. It is also a rare trial in which quality of life pointed one way and the primary endpoint pointed nowhere.
The current shape of the screening question in the United States, and the best short statement of the trade-off in numbers a man can weigh. The three-to-one ratio between metastatic cases prevented and deaths prevented is also the argument for using metastatic presentation, not mortality, to judge a screening programme sooner.
The trial that made observation a defensible choice for low-risk prostate cancer found by a blood test, and that supplied the number a man needs when weighing surgery: the progression it prevents is mostly progression on a scan or a blood test, and the harms it causes are felt every day.
The reason intermittent androgen deprivation is offered as a choice in metastatic disease rather than recommended, and a case study in what an inconclusive non-inferiority trial should say. For a man weighing the side effects, the honest statement is that the quality-of-life gain is real but brief and the survival question is open.
An oral drug that works after chemotherapy has failed, in a disease where the previous option was more chemotherapy. Together with abiraterone it moved castration-resistant prostate cancer from a chemotherapy disease to a hormonal one, and set up the sequencing questions the field is still arguing about.
The end of therapeutic nihilism in castration-resistant prostate cancer. It is also the trial that set the field's expectation of what a positive result looks like in this disease: a hazard ratio near 0.75 and a median gain measured in months, not years.
This trial introduced a patient-centred composite endpoint and a drug that remained the backbone of pancreatic cancer treatment for a generation. Its small survival gain also shows how low the bar was, which is the context for the FOLFIRINOX and MPACT trials that followed.
The QLQ-C30 made patient-reported quality of life a standard trial endpoint and is the instrument behind many of the quality of life claims on drug labels and in health technology assessments. Cancer-specific modules were later added on top of the core questionnaire.
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