Extended Data Table 2 HRQOL over time, descriptive analysis
From: Early versus deferred use of CDK4/6 inhibitors in advanced breast cancer
- To provide insight in HRQOL, we present, per study arm, FACT-B total scores at baseline as well as over the different timepoints. For each patient, up to 11 identical questionnaires (representing distinct timepoints) were completed. Questionnaires were included in the time points (e.g., 3 months, 6 months from randomization. etc.) when they were filled in within 28 days of the required time frame. The baseline second-line questionnaire comprises patients who started second-line SONIA treatment and completed a questionnaire within 28 days of starting second-line treatment. The End of treatment (EOT) timeframe was defined from 28 days before and up to 60 days after the discontinuation of first- or second-line treatment. Extended Data Table 2 shows the number of completed questionnaires (n), mean FACT-B total scores, and mean difference in FACT-B total scores over time. The difference per patient was calculated by subtracting baseline FACT-B total score from the score per timepoint; positive values mean improvement. Results are presented separately for the CDK4/6i-first and CDK4/6i second groups, and for patients meeting the EOT timeframe during a timepoint. A difference of 7-8 points in FACT-B total score was defined as a clinically meaningful difference45. aQuestionnaire not within 28 days before or up to 60 days after the discontinuation of treatment. bQuestionnaire within 28 days before and up to 60 days after the discontinuation of treatment.
