Drugs in clinical trials Flashcards
current cancer treatments?
surgery, chemotherapy, radiotherapy, hormone therapy, immunotherapy, biological therapies
Define complete response, partial response, progressive disease, stable disease in target lesion response
Complete response: disappearance of all target lesions
Partial response: at least 30% decrease in the sum of the diameters of the target lesions
Progressive disease: at least 20% increase in sym of diameter of target lesions
Stable disease: neither sufficient shrinkage to qualify for partial not sufficient increase to qualify for progressive
define complete response, non-CR/PD, progressive disease in non-target lesions
Complete response: disappearance of all non targeted lesions
Non-CR/Non-PD: persistence of one or more non-target lesions
progressive disease: unequivocal progression of existing non-target lesions
define overall survival time, disease free survival time, progression-free survival time
overall survival time: time from start of treatment to date of death
disease-free survival time: time prior to tumour relapse after radical treatment
progression free survival time: survival time prior to tumour progression
purpose of phase 1/2/3 trials
phase 1: test a new drug in humans at low dose and escalate to find toxicity
phase 2: dose found where it is causing shrinkage in tumour or disease
phase 3: look for long term benefit by testing survival time or cure rate
in kapler-meier survival curves what do the steps represent and what do markers of triangle represent
steps: each patient dying
triangle: censored survival time so no further follow up on that patient
hazard ratio=
hazard ratio= risk of death on new drug divide by risk of death on standard
to change clinical practice what trial needs to take place
Randomised controlled clinical trial where efficacy of new treatment compared to standard treatment
define biomarker
biomarkers are indicative of disease process
