Abstract 209P
Background
Endocrine therapy (ET) + CDK4/6 inhibitors are first-line (1L) standard in patients (pts) with HR+/HER2- advanced breast cancer (ABC). High efficacy and good tolerability have been shown in randomized clinical trials. To support these findings and to obtain insights in the CDK4/6i usage in the real-world further studies are important.
Methods
The prospective, non-interventional PERFORM study aims to enroll 1, 900 pts from 320 sites across Germany and Austria to gain insights on effectiveness, tolerability, patient-reported outcomes. Here, we show results of the third interim analysis (IA3) on effectiveness in the total analysis population and chosen subgroups.
Results
Between 10/2020 and 09/2023, 1211 pts were enrolled, 1110 pts had a follow-up of >6 months and 990 pts were evaluable for analysis. The median age was 68.5 years (range 33-96), 29.1% of pts were ≥75 years old, 11.7% had ECOG ≥2 at inclusion. 99.2% of pts are female and 1% (n=8) male. The rate of de novo ABC was 39.5%. Regarding the sites of metastases, 45.9% had visceral, 34.7% bone only, 11.1% non-visceral metastases and 8.3% no metastases present at inclusion. Median progression-free survival (PFS) was 29.6 months in the total population. 12-month-PFS rate was 71.0%; overall response rate (ORR) and clinical benefit rate (CBR) were 34.1% and 63.4%, respectively. Notably, 12-month-PFS rate, ORR and CBR were similar across age subgroups: 12-month-PFS rate was 70.5% for pts <75 years vs. 72.2% for pts ≥75 years, ORR 33.9% vs. 34.7% and CBR 64.4 % vs. 61.1%, respectively. De novo disease was associated with higher ORR compared to non-de novo disease. Pts with no metastasis [LMP1] [SW2] at inclusion showed higher PFS rates compared to pts with bone-only metastases or non-visceral disease. Visceral involvement was associated with lowest PFS rates at 6 and 12 months.
Conclusions
The IA3 of PERFORM shows results regarding PFS, ORR and CBR of 1L treatment with palbociclib + ET in a broad real world patient population and chosen subgroup. The obtained results are in line with the data of clinical trials and support use of palbociclib-based treatment independent of e.g. age.
Legal entity responsible for the study
Pfizer Pharma GmbH.
Funding
Pfizer Pharma GmbH.
Disclosure
G. Pfeiler: Financial Interests, Personal, Invited Speaker: Pfizer, AstraZeneca, Accord, Novartis, Roche, Seagen, Daiichi, Lilly, Amgen, MSD; Financial Interests, Personal, Advisory Board: Pfizer, AstraZeneca, Accord, Novartis, Roche, Seagen, Daiichi, Lilly, Amgen, MSD; Financial Interests, Personal, Research Grant: Pfizer, AstraZeneca, Accord. J.C. Radosa: Financial Interests, Institutional, Invited Speaker: Pfizer, MSD, Roche, Novartis, AstraZeneca, Gedeon Richter, Lilly, Pierre Fabre, Daiichi Sankyo, Theramex, Seagen, Stemline; Financial Interests, Institutional, Advisory Board: Pfizer, Eisai, MSD, Roche, Novartis, Gedeon Richter, Lilly, Pierre Fabre, Daiichi Sankyo, Theramex, Seagen, Stemline; Financial Interests, Personal and Institutional, Funding: Pfizer, MSD, Roche, Novartis, Gedeon Richter, Lilly, Pierre Fabre, Daiichi Sankyo, Theramex, Seagen, Stemline, Medac. T. Decker: Financial Interests, Personal, Advisory Board: Novartis, Lilly; Financial Interests, Personal, Principal Investigator: Aio, iOMEDICO. T.J. Fietz: Financial Interests, Personal, Advisory Board: Novartis, Pfizer, Daiichi. A. Koehler: Financial Interests, Personal, Advisory Board: Roche, Amgen, Pfizer, Novartis, AbbVie, Lilly, Astra, Daiichi; Non-Financial Interests, Personal, Principal Investigator: Roche, Novartis, GBG, Pfizer; Non-Financial Interests, Personal, Member: DGHO; Financial Interests, Personal and Institutional, Sponsor/Funding: GBG, Novartis, Roche, Astra, Daiichi, Pfizer, Hexal, Accord, WSG, Stemline, BMS. A. Breitbach: Financial Interests, Personal and Institutional, Full or part-time Employment: Pfizer; Financial Interests, Personal and Institutional, Stocks/Shares: Pfizer. A. Adams: Financial Interests, Personal and Institutional, Full or part-time Employment: Pfizer; Financial Interests, Personal and Institutional, Stocks/Shares: Pfizer; Non-Financial Interests, Personal and Institutional, Project Lead: Pfizer. S. Seidel: Financial Interests, Personal, Full or part-time Employment: Pfizer; Financial Interests, Personal, Stocks/Shares: Pfizer. M.P. Lux: Financial Interests, Personal, Invited Speaker: Pfizer, Novartis, Lilly; Non-Financial Interests, Personal, Writing Engagements: Pfizer; Financial Interests, Personal, Advisory Board: Pfizer, Novartis; Financial Interests, Personal and Institutional, Principal Investigator: Pfizer; Financial Interests, Institutional, Sponsor/Funding: Pfizer, Novartis, Lilly; Financial Interests, Personal, Other, Travel expenses: Pfizer. R. Bartsch: Financial Interests, Personal and Institutional, Invited Speaker: AstraZeneca, BMS, Daiichi, Eisai, Eli Lilly, Gilead, Gruenenthal, MSD, Novartis, Pfizer, Pierre-Fabre, Roche, Seagen; Financial Interests, Institutional, Research Grant: Daiichi; Financial Interests, Personal and Institutional, Project Lead: Daiichi, Pierre-Fabre, Pfizer, Seagen; Financial Interests, Personal, Advisory Role: AstraZeneca, Daiichi, Eisai, Eli Lilly, Gilead, Gruenenthal, MSD, Novartis, Pfizer, Pierre-Fabre, Puma, Roche, Seagen, Stemline. All other authors have declared no conflicts of interest.