First interim results of the PERFORM study evaluating palbociclib in
                    combination with endocrine therapy for HR+/HER2- advanced breast
                    cancer

M.P. Lux; J. Wilke; M. Deryal; T. Fietz; B. Schöttker; L. Jacobasch; V. Petersen; M. Weigel; D. Wrobel; E. Glastetter; L. Berger; M. Frank; S.M. Woerner; A. Adams; A. Wöckel

doi:10.1055/s-0042-1748408

Senologie - Zeitschrift für Mammadiagnostik und -therapie, Table of Contents

Senologie - Zeitschrift für Mammadiagnostik und -therapie 2022; 19(02): e26-e27
DOI: 10.1055/s-0042-1748408

Abstracts | DGS

First interim results of the PERFORM study evaluating palbociclib in combination with endocrine therapy for HR+/HER2- advanced breast cancer

Authors

M.P. Lux

¹Frauenklinik St. Louise, Abteilung für Gynäkologie und Geburtshilfe, Paderborn, Deutschland

²Frauenklinik St. Josefs-Krankenhaus, Salzkotten, Deutschland

³St. Vincenz-Hospital GmbH, Paderborn, Deutschland
J. Wilke

⁴Schwerpunktpraxis Hämatologie & Internistische Onkologie, Fürth, Deutschland
M. Deryal

⁵Caritasklinikum Saarbrücken, Frauenklinik, Saarbrücken, Deutschland
T. Fietz

⁶Schwerpunktpraxis für Hämatologie und Internistische Onkologie, Gastroenterologie, Singen (Hohentwiel), Deutschland
B. Schöttker

⁷Hämatologisch-Onkologische Schwerpunktpraxis Würzburg GbR Dr. Schöttker/ Dr. Pretscher, Würzburg, Deutschland
L. Jacobasch

⁸BAG / Onkologische Gemeinschaftspraxis, Dresden, Deutschland
V. Petersen

⁹Onkologische Schwerpunktpraxis Dr. med. Volker Petersen, Heidenheim a.d.B., Deutschland
M. Weigel

¹⁰Leopoldina-Krankenhaus Frauenheilkunde und Geburtshilfe, Schweinfurt, Deutschland
D. Wrobel

¹¹Sozialstiftung Bamberg Klinik für Frauenheilkunde und Geburtshilfe, Bamberg, Deutschland
E. Glastetter

¹²Pfizer Pharma GmbH, Berlin, Deutschland
L. Berger

¹²Pfizer Pharma GmbH, Berlin, Deutschland
M. Frank

¹³iOMEDICO AG, Freiburg, Deutschland
S.M. Woerner

¹³iOMEDICO AG, Freiburg, Deutschland
A. Adams

¹²Pfizer Pharma GmbH, Berlin, Deutschland
A. Wöckel

¹⁴Universitätsklinikum Würzburg Frauenklinik und Poliklinik, Würzburg, Deutschland

Abstract

Full Text

Background 1^st-line standard of care for HR+/HER2- advanced breast cancer (ABC) patients (pts) is an endocrine-based (ET) CDK4/6 inhibitor therapy. High efficacy and safety were shown in clinical trials. The need for real-world data on treatment patterns, effectiveness and quality of life (QoL) is high. Additionally, data on the socioeconomic status (SES) and on treatment satisfaction are scarce.

Methods 1,900 pts receiving 1^st-line palbociclib/ET will be enrolled in the prospective non-interventional study PERFORM in 320 sites across Germany and Austria. Primary endpoint is progression-free survival. Secondary endpoints include treatment patterns, effectiveness, treatment expectation/satisfaction, SES and QoL. The first interim analysis was done 12 months after first patient in focusing on baseline characteristics, SES and treatment expectation/satisfaction.

Results Between 10/2020 and 09/2021, 209 of 342 enrolled pts were observed for >3 months and 179 pts were evaluable for analysis. Median age was 69 years, 99% were female and 90% postmenopausal. 64% presented with relapse at enrollment and 36% had de novo ABC. 51% of pts were married, 15% full-time employed and 11% part-time. Therapy benefits were expected by 82% of pts and bad side effects by 12% before 1^st-line treatment, 3 months after treatment start 49% reported better side effects than expected, for 51% benefits met the expectation and for 10% benefits exceeded the expectations.

Conclusion The first interim analysis of PERFORM shows a high treatment satisfaction after 3 months of treatment in 1^st-line palbociclib/ET treated pts. Furthermore, SES does not seem to be a barrier for palbociclib/ET treatment.