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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. 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. 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. 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.
Korell et al. (Wed,) studied this question.