407P - Palbociclib plus endocrine therapy in HR+/HER2- advanced breast cancer patients: Interim results of the PERFORM study

Background

CDK4/6 inhibitors plus endocrine therapy (ET) are the first-line (1L) standard for patients (pts) with HR+/HER2- advanced breast cancer (ABC). Data from clinical trials have shown high efficacy and good tolerability. Real World Studies are important to support these data and close potential knowledge gaps.

Methods

The prospective, non-interventional PERFORM study is going to enroll 1,900 pts from 320 sites across Germany and Austria to gain further insights on effectiveness, tolerability, patient-reported outcomes (PRO) and longitudinal treatment patterns after 1L treatment with palbociclib + ET. In this second interim analysis (IA 2), response rates and dose modifications in the total population and in age-related subgroups (≥75 years vs <75 years) were investigated.

Results

Between 10/2020 and 09/2022, 938 pts were enrolled and 624 pts had a follow-up of >6 months and were evaluable for analysis. The median age was 68 years (range 33-89), 39% of pts had de novo ABC and 11% ECOG ≥2, at inclusion. 30% of patients were ≥75 years of age. Of these, 22% had an ECOG performance status of ≥2 at inclusion compared to 7% of pts <75 years. The rate of de novo ABC was higher in pts ≥75 years (44%) than pts <75 years (36%), whereas the number and distribution of metastases was comparable. Progression-free survival (PFS) rate at 12 months was 71.7%; overall response rate (ORR) and clinical benefit rate (CBR) were 33.2% and 57.4%, respectively. Notably PFS, ORR and CBR were consistent across age groups. Dose modifications were performed in 74.1% of pts ≥75 years vs 61.5% of pts <75 years, respectively; >70% of pts in both subgroups are still on study treatment. Treatment discontinuation rates were comparable in both age groups (28.6% ≥75 years vs 27.3% <75 years), but (serious) adverse event as reason for treatment discontinuation was more frequent in pts ≥75 years (9.2% vs 3.0%).

Conclusions

The IA 2 of PERFORM shows comparable results regarding PFS, ORR and CBR of 1L treatment with palbociclib + ET in pts ≥ and <75 years, even though pts ≥75 years required dose modifications more frequently. These findings are in line with the data of clinical trials and support use of palbociclib based treatment independent of age.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

Pfizer Deutschland GmbH, Berlin, Germany.

Funding

Pfizer Deutschland GmbH, Berlin, Germany.

Disclosure

J.C. Radosa: Financial Interests, Personal and Institutional, Invited Speaker: Pfizer, Eisai, MSD, Roche, Novartis, Gedeon Richter, Lilly, Pierre Fabre, Daiichi Sankyo, Clovis; Financial Interests, Personal and Institutional, Advisory Board: Pfizer, Eisai, MSD, Roche, Novartis, Gedeon Richter, Lilly, Daiichi Sankyo, Clovis, Seagen; Financial Interests, Personal and Institutional, Funding: Medac GmbH, Daiichi Sankyo, Pfizer, Pierre Fabre; Financial Interests, Institutional, Principal Investigator: Pfizer. T. Fietz: Non-Financial Interests, Personal, Speaker’s Bureau: Novartis, Pfizer, AstraZeneca; Non-Financial Interests, Personal, Advisory Board: Novartis, Pfizer, AstraZeneca; Financial Interests, Institutional, Principal Investigator: Pfizer. J. Wilke: Financial Interests, Institutional, Principal Investigator: Pfizer. T. Decker: Financial Interests, Personal, Advisory Board: Novartis, IOMEDICO; Financial Interests, Personal, Invited Speaker: Novartis, Lilly. V. Petersen: Financial Interests, Institutional, Principal Investigator: Pfizer. M. Deryal: Financial Interests, Institutional, Principal Investigator: Pfizer. J. Knoblich: Financial Interests, Institutional, Principal Investigator: Pfizer. C. Losem: Non-Financial Interests, Personal, Advisory Board: Abbvie, Incyte; Non-Financial Interests, Personal, Member: DGHO, DKG; Financial Interests, Institutional, Principal Investigator: Pfizer. U. Rhein: Financial Interests, Institutional, Principal Investigator: Pfizer. B. Schöttker: Financial Interests, Institutional, Principal Investigator: Pfizer. D. Wrobel: Financial Interests, Personal, Invited Speaker: Novartis, Roche, Pierre Fabre; Financial Interests, Personal, Writing Engagement: Pierre Fabre; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Institutional, Principal Investigator: Pfizer. G. Pfeiler: Financial Interests, Personal, Invited Speaker: Amgen, Roche, Seagen, Novartis, Pfizer, Daiichi, MSD, Merck, AstraZeneca, Accord, Lilly; Financial Interests, Personal, Advisory Board: Amgen, Roche, Seagen, Novartis, Pfizer, Daiichi, MSD, Merck, AstraZeneca, Accord, Lilly; Financial Interests, Institutional, Research Grant: Amgen, Roche, Seagen, Novartis, Pfizer, Daiichi, MSD, Merck, AstraZeneca, Accord, Lilly; Financial Interests, Institutional, Principal Investigator: Pfizer. E. Zanucco: Financial Interests, Personal and Institutional, Full or part-time Employment: Pfizer; Financial Interests, Personal and Institutional, Stocks/Shares: Pfizer; Non-Financial Interests, Institutional, Project Lead: Pfizer; Non-Financial Interests, Institutional, Sponsor/Funding: Pfizer. J. Buncke: Financial Interests, Personal, Full or part-time Employment: Pfizer; Financial Interests, Personal, Stocks/Shares: Pfizer. A. Adams: Financial Interests, Personal, Full or part-time Employment: Pfizer; Non-Financial Interests, Personal, Full or part-time Employment: Pfizer; Financial Interests, Institutional, Stocks/Shares: Pfizer; Non-Financial Interests, Institutional, Project Lead: Pfizer; Financial Interests, Institutional, Sponsor/Funding: Pfizer. E. Glastetter: Financial Interests, Personal and Institutional, Full or part-time Employment: Pfizer; Non-Financial Interests, Personal and Institutional, Full or part-time Employment: Pfizer; Financial Interests, Personal and Institutional, Stocks/Shares: Pfizer; Non-Financial Interests, Institutional, Project Lead: Pfizer; Non-Financial Interests, Institutional, Sponsor/Funding: Pfizer. R. Bartsch: Financial Interests, Personal, Invited Speaker: AstraZeneca, Seagen, Roche, Novartis, Eli-Lilly, Pierre-Fabre, Daiichi, Gilead, MSD, Pfizer, Eisai, Gruenenthal; Financial Interests, Personal, Advisory Board: Daiichi, AstraZeneca, Roche, Novartis, Eli-Lilly, Pierre-Fabre, MSD, Gilead, Seagen, Eisai, Gruenenthal; Financial Interests, Institutional, Funding, Investigator Initiated Trial: Daiichi; Financial Interests, Institutional, Coordinating PI, Drug support for investigator initiated trial: MSD. M.P. Lux: Financial Interests, Personal, Invited Speaker: Pfizer, Novartis, AstraZeneca, Exact Sciences, Lilly; Non-Financial Interests, Personal, Writing Engagement: Pfizer, Exact Sciences, AstraZeneca; Financial Interests, Personal, Advisory Board: Pfizer, Novartis, AstraZeneca and Lilly ; Financial Interests, Personal, Advisory Role: Pfizer, Novartis, AstraZeneca, Exact Sciences, Agendia, Lilly; Financial Interests, Institutional, Principal Investigator: Pfizer; Financial Interests, Personal, Leadership Role: Pfizer; Non-Financial Interests, Personal, Leadership Role: Pfizer. All other authors have declared no conflicts of interest.