RCTs vs. RWD
Randomized clinical trials are designed to show this
What is causality
This was the number of mPFS months with Ibrance + letrozole (as compared to 14.5 months with Ibrance alone)
What is 24.8
These were the pre-planned endpoints for the study
What are Real-world PFS and OS
This was applied to patients to balance baseline demographic an clinical characteristics
What is stabilized inverse probability treatment weighting (sIPTW)
THe median rwPFS for Ibrance + letrozole was ___ vs. ___ months with letrozole alone
What is 20.0, 11.9
Real-world observational studies are designed to assess these and are therefore unable to determine causality
what are associations
This was the hazard ratio for the mPFS months as shown with Ibrance + letrozole vs. letrozole + placebo.
What is .58
The study methodology used was a retrospective analysis of HERs from this database
What is the Flatiron Health Analytic Database
This data was not collected as part of the study
What is safety
The Hazard Ratio for rwPFS was this
What is 0.58
In RCTs, patients are _________ to treatment or comparator arms
What is randomized or randomly assigned
This was the Objective Response Rate (ORR) for Ibrance + letrozole in PALOMA2
What is 55.3
Exclusion criteria included patients who had received CDK 4/6, AI's, fulvestrant, THIS, raloxifen or toremifene in the metastatic setting
What is tamoxifen
This was not consistently available from the Flatiron Health Analytic Database and was not collected as part of this study
What is patient menopausal status
This was the Hazard Ratio associated with the secondary endpoint of overall survival
What is .66
RCTs measure the ______ of an intervention
what is efficacy (i.e. treatment performance under highly-controlled conditions)
The most common adverse reaction in the Ibrance arm was neutropenia at 80%, ___ of which was grade 3 and ___ was Grade 4
What is 56% and 10%
Index dates for Ibrance-letrozole could begin on approval data of February 3, 2015 and extending this many years
What is 4
A total of this many women with HR+/HER-2 negative mBC were identified from the Flatiron database according to the study criteria
What is 1430
In the real-world setting, this was not reached in the Ibrance + letrozole group and was ___ months in the letrozole group
What is median OS, 43.1 months
Real-world observational studies measure the ________ of an intervention
What is effectiveness (i.e. treatment performance under real-world conditions
In the non-prespecified analysis of PFS, the HR for mPFS between study groups was this
What is 0.56
The Flatiron Health Analytic Database includes EHRs from ___ cancer clinics, including ___ sites of care and represents ___ patients
What are 280, 800 and 2.4 million (respectively)
sIPTW resulted in a sample of this many (with 839 in the Ibrance + letrozole group)
What is 1537
This many deaths (27.2%) occurred in the Ibrance + letrozole group vs. this many deaths (40.4%) with letrozole alone
What is 210, 266