Real-world effectiveness in subgroups of palbociclib + endocrine therapy in HR+/HER2- ABC patients: Interim results of the PERFORM study

BackgroundEndocrine-therapy (ET) + CDK4/6i is 1L standard of care for HR+/HER2- ABC patients (pts) based upon demonstrated efficacy and tolerability in pivotal trials. As pts with low ECOG accrued to clinical trials may not represent a real-world cancer population, prospectively collected real-world data on effectiveness, tolerability and treatment patterns is of high medical interest.MethodsOverall, 1.900 pts receiving 1L palbociclib + ET will be enrolled in the prospective NIS PERFORM at 320 sites across Germany and Austria. Primary endpoint is PFS. Secondary objectives include treatment patterns, effectiveness, and PROs. Three years after first patient-in the IA 3 was conducted, focusing on patient- and disease-characteristics, PROs and effectiveness in all pts and in corresponding subgroups. Here we focus on ECOG subgroups.ResultsBetween 10/2020 and 09/2023, 1211 pts were enrolled. Of those, 990 pts were evaluable. Median age was 68.5 years and 91.4% of the primarily female population (99.2%) were postmenopausal. 391 (39.5%) pts presented with de novo ABC and 599 (60.5%) had relapsed from EBC. 11.7% of pts had an ECOG ≥2 at inclusion. ECOG ≥2 pts were older (median age 74.8 years) and presented more often with de novo ABC (48.3 vs 38.1%) and visceral disease (52.6 vs 44.6%) compared to ECOG <2 pts. Median PFS in the total population was 29.6 months. 12- and 24-month PFS rates were 71.0% and 52.1%, respectively. Across ECOG subgroups, 12-month PFS rate was 58.3% for ECOG ≥2 and 72.9% for <2. ORR and CBR were higher in pts with ECOG <2 vs ECOG ≥2, respectively (27.6 vs 34.8% and 50.0 vs 65.2%). Therapy was modified for 72.0% of pts in the total cohort and was comparable for ECOG subgroups with 73.3% for ECOG ≥2 and 71.8% for <2.ConclusionsThe IA3 of the PERFORM study gives further insights into effectiveness of 1L palbociclib + ET in a real-world setting. ECOG ≥2 pts were older and presented more often with de novo ABC and visceral metastases. 12-months PFS rate, ORR and CBR were higher in pts with ECOG <2. Therapy modification numbers were comparable. The results show that palbociclib + ET is tolerable and effective in this unfavorable subgroup with high therapeutical need.Legal entity responsible for the studyPfizer Pharma GmbH.FundingPfizer Pharma GmbH.DisclosureG. Pfeiler: Financial Interests, Personal, Invited Speaker: Pfizer, AstraZeneca, Accord, Novartis, Roche, Seagen, Daiichi Sankyo, Lilly, Amgen, MSD, Gilead; Financial Interests, Personal, Advisory Board: Pfizer, AstraZeneca, Accord, Novartis, Roche, Seagen, Daiichi Sankyo, Lilly, Amgen, MSD, Gilead; Financial Interests, Personal, Research Grant: Pfizer, AstraZeneca, Accord; Financial Interests, Personal, Principal Investigator: Pfizer. M. Korell: Financial Interests, Personal, Principal Investigator: Pfizer. 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, MSD, Roche, Novartis, Eisai, Gedeon Richter, Lilly, Pierre Fabre, Daiichi Sankyo, Theramex, Seagen, Stemline; Financial Interests, Institutional, Funding: Pfizer, MSD, Roche, Novartis, Gedeon Richter, Lilly, Pierre Fabre, Daiichi Sankyo, Theramex, Seagen, Stemline, Medac; Financial Interests, Personal, Principal Investigator: Pfizer. T. Decker: Financial Interests, Personal, Advisory Board: Novartis, Lilly, AstraZeneca; Financial Interests, Personal, Principal Investigator: AIO, iOMEDICO, Pfizer. M. Deryal: Financial Interests, Personal, Principal Investigator: Pfizer. T.J. Fietz: Financial Interests, Personal, Advisory Board: Novartis, Pfizer, Daiichi Sankyo; Financial Interests, Personal, Principal Investigator: Pfizer. A. Köhler: Financial Interests, Personal, Advisory Board: Roche, Amgen, Pfizer, Novartis, Abbvie, Lilly, AstraZeneca, Daiichi Sankyo; 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, AstraZeneca, Daiichi Sankyo, Pfizer, Hexal, Accord, WSG, Stemline, BMS; Financial Interests, Personal, Principal Investigator: Pfizer. B. Schöttker; J. Wilke; J. Knoblich; V. Petersen; M. Dietrich; T. Gabrysiak: Financial Interests, Personal, Principal Investigator: Pfizer. H. Krueger: Financial Interests, Personal, Full or part-time Employment: Pfizer; Financial Interests, Personal, Stocks/Shares: 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. A. Adams: 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. R. Bartsch: Financial Interests, Personal and Institutional, Invited Speaker: AstraZeneca, BMS, Daiichi Sankyo, Eisai, 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, Lilly, Gilead, Gruenenthal, MSD, Novartis, Pfizer, Pierre Fabre, Puma, Roche, Seagen, Stemline; Financial Interests, Personal, Principal Investigator: Pfizer. M.P. Lux: Financial Interests, Personal, Invited Speaker: Pfizer, Novartis, Lilly; Non-Financial Interests, Personal, Writing Engagement: 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. All other authors have declared no conflicts of interest.