WHO Performance Status Classification
Performance status is frequently used to quantify cancer patients’ well-being and often used to indicate whether or not a patient can tolerate certain treatment such as chemotherapy. Other uses include dose reduction, use in trial and quality of life.
Grade Explanation of activity
0: Able to carry out all normal activity without restriction
1: Restricted in physically strenuous activity, but ambulatory and able to carry out light work
2: Ambulatory and capable of all self-care, but unable to carry out work; up and about more than 50% of waking hours
3: Capable only of limited self-care; confined to bed more than 50% of waking hours
4: Completely disabled; cannot carry out any self-care; totally confined to bed or chair
Criteria of chemotherapy response (WHO)
• Complete response (CR) – resolution of all measureable or evaluable disease
• Partial response (PR) – ≥50% reduction in measureable or evaluable disease in the absence of progression in any particular disease site
• Stable disease (SD) – <50% decrease or <25% increase in measureable or evaluable disease
• Progressive disease (PD) – >25% increase in measureable or evaluable disease or development of a new lesion
Clinical Trials and Drug Development
Clinical trials are divided into different stages, called phases. The earliest phase trials may look at drug safety or side-effect profile and tolerability. A later phase trial aims to test whether a new treatment is better than existing treatments.
There are three main phases of clinical trials – phases I to III. But some trials have an earlier stage called phase 0, and there are some phase IV trials done after a drug has been licensed.
Phase 0 Trials
Phase 0 trials are aimed to find out whether the behaviour of the drug in vivo is as expected from laboratory studies.
Phase I
Aim is to establish human toxicity of new drug; to establish the safe dose at which to start further trials and to measure the pharmacokinetics of the drug.
Phase II
Aim is to establish the anti-tumour activity of the drug against a particular tumour in patients where no curative therapy is possible; further information on toxicity is obtained. Phase II studies are usually non-randomised.
Phase III
Aim is to compare the new drug with the conventional best therapy. Trials are prospective, randomised and controlled. Large number of patients required to show effect.