Abstract 471P
Background
CDKi are standard of care for patients (pts) with advanced hormone-positive (HR+) BC, with recent results even in the adjuvant setting. Nevertheless, management and clinical implication of hepatotoxicity during CDKi are not well described in literature, even if it is reported in a non-negligible rate within trials.
Methods
A multicenter Italian retrospective study was conducted in 2023, collecting and pooling data of pts affected by HR+ HER2- BC, treated with CDKi and aromatase inhibitors (AI) or fulvestrant (FULV). This study aims to describe the incidence and the management of liver adverse events (AEs) during CDKi in a real-world setting. A descriptive analysis was performed as pivotal evaluation for designing an observational study.
Results
256 pts were included across 5 centres: 96% of pts received CDKi in the metastatic setting. Pts were treated with ribociclib (42%), abemaciclib (25%) and palbociclib (33%) associated with AI or FULV. Liver AEs occurred in 16% of pts, with a median time of onset of 90 days. 19 pts (46%) experienced grade ≥3 (G≥3) liver AEs: mostly with elevated liver enzymes (95%). No acute liver failure was reported. The rate of liver AEs was 20% for ribociclib, 17% for abemaciclib and 11% for palbociclib. Ribociclib and abemaciclib were associated with 79% and 21% of G≥3 liver AEs. Diagnostic assessments were performed in 37% of pts with liver AEs: hepatotropic viruses screening (68%), autoimmunity screening (28%) and radiological exams (4%). Only one liver biopsy was performed with a diagnosis of drug induced liver injury. Recovery of normal liver function after CDKi discontinuation was achieved in 68% of pts, with a median time of 30 days. After resolution of G≥3 liver AEs, 26% of pts discontinued any treatment, 5% continued only AI or FULV, 48% resumed CDKi with dose reduction and 21% shifted to another CDKi without any further G≥3 liver AEs.
Conclusions
In our cohort the incidence of liver AEs was significant, with a relevant number of G≥3 AEs. Since hepatotoxicity is defined by diagnosis of exclusion, a prompt screening for differential causes is crucial in case of abnormal liver function. After non serious liver AEs, resumption of lower dose or shift to another CDKi may be a safe therapeutic option.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
457P - Disparities in receipt of CDK4/6 inhibitors with endocrine therapy as therapy for hormone receptor-positive, HER2-negative metastatic breast cancer in the real-world setting
Presenter: Gretchen Kimmick
Session: Poster session 04
458P - Metastatic breast cancer: How and how often do we communicate? Results from an Italian national survey
Presenter: Camilla Lisanti
Session: Poster session 04
460P - Impact of fulvestrant utilization on prognostic outcome among patients with HR+ve/HER2-ve metastatic breast cancer: Results from a real-world dataset
Presenter: Shaheenah Dawood
Session: Poster session 04
462P - Health outcomes of treatment sequences with eribulin or other single agents’ chemotherapy for treating relapsed metastatic HER2-negative breast cancer
Presenter: Simone Rivolo
Session: Poster session 04
463P - Impact of two waves of Sars-Cov-2 outbreak on the clinical presentation and outcomes of newly referred breast cancer cases at AP-HP: A retrospective multicenter cohort study
Presenter: Sonia Priou
Session: Poster session 04
464P - Developing a prognostic risk stratification model and treatment options for HER2-positive breast cancer brain metastasis
Presenter: JiaXin Chen
Session: Poster session 04
465P - Reporting of older subgroups enrolled to registration breast cancer trials, 2012-2021
Presenter: Colm Mac Eochagain
Session: Poster session 04