Differences in health-related Quality of Life in patients with or without progression on palbociclib therapy. Preliminary results from the Non-Interventional Study PERFORM

Objective: CDK4/6-inhibitor+endocrine-therapy (ET) is standard first-line (1L) treatment for HR+/HER2- advanced breast cancer based upon demonstrated efficacy, safety, tolerability and quality of life (QoL) from randomized clinical trials (RCT). Real-world evidence is an important complement to RCTs. A highly relevant and rarely addressed question is the correlation of disease progression (PD) and QoL. The interim analysis 4 of the PERFORM study explores these aspects.

Methods: The German/Austrian non-interventional study PERFORM assesses effectiveness, safety, tolerability, and QoL during 1L palbociclib+ET and after progression using the FACT-B questionnaire at baseline, end of palbociclib and every 3 months throughout study participation. Changes from baseline in FACT-B scores were analyzed for patients with and without PD in 3-months intervals.

Results: Between 10/2020 and 09/2024, 1,412 patients were enrolled; 783 had evaluable QoL data, with a median age of 67.5 years, and median progression-free survival of 27.8 months. Patients with PD showed a more pronounced decline in FACT-B total score, FACT-G total score and TOI compared to those without PD, particularly in the 3-6 and 6-9 months intervals. This seemed to be based on respective changes in the physical, emotional and functional well-being scales of FACT-G. Consequently, time to permanent deterioration (TTPD) of FACT-B total score is currently being explored.

Summary: PERFORM supports findings from the PALOMA-2 trial, showing decreased TTPD in QoL in patients with PD. These real-world insights during and beyond 1L palbociclib treatment highlight the importance of QoL assessment and indicate PD as patient-relevant endpoint.

 

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Interessenskonflikt

Ich erkläre als korrespondierende/r AutorIn, dass ich oder einer bzw. mehrere meiner Ko-AutorenInnen während der letzten 3 Jahre wirtschaftliche oder persönliche Verbindungen im oben genannten Sinne hatten: Interessenskonflikt Details: Vesna Bjelic-Radisic: Speaker's Bureau, Responsible Investigator Study Site, Travel/Accomodation Expenses. Matthias Korell: Responsible Investigator Study Site. Georg Pfeiler: Honoraria, Consulting or Advisory Role, Speaker's Bureau, Responsible Investigator Study Site, Travel/Accomodation Expenses. Thomas Gabrysiak, Volker Petersen, Mustafa Deryal: Responsible Investigator Study Site Thomas Fietz: Consulting or Advisory Role, Responsible Investigator Study Site Julia Caroline Radosa: Honoraria, Consulting or Advisory Role, Expert Testimony, Responsible Investigator Study Site, Travel/Accomodation Expenses Thomas Decker: Honoraria, Consulting or Advisory Role, Speaker's Bureau, Responsible Investigator Study Site. Björn Schöttker, Jan Knoblich, Uwe Rhein: Responsible Investigator Study Site. Alexander Wegenast: Full/Part-time employment, Leadership, Stocks/Shares, Honoraria. Esther Glastetter: Full/Part-time employment, Leadership, Stocks/Shares. Miguel Cordova: Full/Part-time employment, Stocks/Shares. Emanuele Zanucco: Full/Part-time employment, Leadership, Stocks/Shares, Honoraria. Martin Glasstetter: Full/Part-time employment. Ursula Oppermann: Full/Part-time employment. Rupert Bartsch: Honoraria, Consulting or Advisory Role, Responsible Investigator Study Site, Travel/Accomodation Expenses. Michael Patrick Lux: Honoraria, Consulting or Advisory Role, Speaker's Bureau, Responsible Investigator Study Site, Travel/Accomodation Expenses​.

Publication History

Article published online:
04 June 2025