Patient-reported outcomes (PROs) including treatment expectation and satisfaction in HR+/HER2- Advanced Breast Cancer patients treated: Real-world Results of the PERFORM study from interim analysis 3 (IA3)

Background: Endocrine therapy (ET)+CDK4/6 inhibitors are 1L standard-therapy in HR+/HER2- advanced breast cancer patients. Real-world insights into effectiveness and Quality of Life (QoL) are important and complementary to clinical trial data.

Methods: The prospective, non-interventional PERFORM study aims to enroll 1,900 patients from 320 sites across Germany and Austria to gain insights into effectiveness, tolerability, and PROs of 1L palbociclib+endocrine therapy. Here, we present the results of IA3 on 1. FACT-B PROs, collected at baseline and then every 3 months beyond disease progression; 2. treatment expectation before and satisfaction 3 months after treatment start. PROs were compared with normative data.

Results: Between 10/2020 and 09/2023, 1,211 patients were enrolled. 1,110 were followed>6 months. 990 were evaluable for general, 702 patients for PRO analyses, respectively. On average, the decrease in the FACT-B total score in the first 24 months was below the threshold of 7 points (Eton et al. 2004) compared to baseline (106 evaluable patients). 84% of patients expected therapy benefits, 11% expected bad side effects before 1L treatment. Three months after start of treatment, 43% evaluated taking palbociclib easier than anticipated, 46% experienced better side effects than expected, 51% stated that benefits met expectations, and 10% reported benefits exceeded expectations.

Conclusion: Maintenance of QoL is the highest goal in the metastatic setting. The PERFORM IA3, 36 months after FPI, shows that QoL was maintained during palbociclib treatment corroborating results of the pivotal trials. Furthermore, high treatment satisfaction after 3 months of treatment was reported.

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: Matthias Korell, Mustafa Deryal, Björn Schöttker, Jochen Wilke, Jan Knoblich, Volker Petersen, Maria Dietrich, Thomas Gabrysiak, Martin Glasstetter and Ursula Oppermann: no conflict of interest. Vesna Bjelic-Radisic: Invited Speaker for Lilly, Novartis, Astra Zeneca and Pfizer; Speaker’s Bureau for Lilly, Novartis and Pfizer; Advisory Board for Lilly, Astra Zeneca and Pfizer; Principal Investigator for Astra Zeneca and Novartis. Georg Pfeiler: Invited Speaker for Pfizer, Astra Zeneca, Accord, Novartis, Roche, Seagen, Daiichi, Lilly, Amgen and MSC; Advisory Board: Pfizer, Astra Zeneca, Accord, Novartis, Roche, Seagen, Daiichi, Lilly, Amgen and MSD; Research Grant from Pfizer, Astra Zeneca and Accord. Julia Radosa: Invited Speaker for Pfizer, MSD, Roche, Novartis, Astra Zeneca, Gedeon Richter, Lilly, Pierre Fabre, Daiichi, Theramex, Seagen and Stemline; Advisory Board for Pfizer, Eisai, MSD, Roche, Novartis, Gededon Richter, Lilly, Pierre Fabre, Daiichi, Thermamex, Seagen and Stemline; Funding from Pfizer, MSD, Roche, Novartis, Gedeon Richter, Lilly, Pierre Fabre, Daiichi, Theramex, Seagen, Stemline and Medac. Thomas Decker: Advisory Board for Novartis and Lilly; Principal Investigator for AIO and iOMEDICO. Thomas Fietz: Advisory Board for Novartis, Pfizer and Daiichi; Andreas Köhler: Advisory Board for Roche, Amgen, Pfizer, Novartis, Abbvie, Lilly, Astra Zeneca and Daiichi; Principal Investigator for Roche, Novartis, GBG and Pfizer; Member of DGHO, Sponsor/Funding from GBG, Novartis, Roche, Astra Zeneca, Daiichi, Pfizer, Hexal, Accord, WSG, Stemline and BMS. Rupert Bartsch: Invited Speaker for Astra Zeneca, BMS, Daiichi, Eisai, Lilly, Gilead, Grünenthal, MSD, Novartis, Pfizer, Pierre-Fabre, Roche and Seagen; Research-Grant from Daiichi; Project Lead for Daiichi, Pierre-Fabre, Pfizer and Seagen; Advisory Role for Astra Zeneca, Daiichi, Eisai, Lilly, Gilead, Grünenthal, MSD, Novartis, Pfizer, Pierre-Fabre, Puma, Roche, Seagen and Stemline. Michael Lux: Invited Speaker for Pfizer, Novartis and Lilly; Writing Engagements for Pfizer; Advisory Board for Pfizer and Novartis; Principal Investigator for Pfizer; Sponsor/Funding from Pfizer, Novartis and Lilly; Travel expenses by Pfizer. Anne Adams: Pfizer Employment (Project Lead) and Stocks/Shares. Maria Kontou, Esther Glastetter: Pfizer Employment and Stocks/Shares.

Publication History

Article published online:
03 May 2024