Abstract 324P
Background
Patients(pts) with hormone receptor (HR) positive, HER2-negative advanced breast cancer (ABC) currently have three options for first-line treatment: CDK4/6-inhibitors with endocrine therapy (CDK4/6i), endocrine (ET) or chemotherapy (CT). What affects decision making?.
Methods
OPAL (NCT03417115) is a prospective clinical registry that continues the Tumor Registry Breast Cancer. By March 2019, a total of 5582 pts had been recruited, of whom 1082 since start of OPAL. Details on all treatments, patient and tumour characteristics, clinical and patient-reported outcomes are collected. Here factors potentially influencing treatment decision were analysed for 346 pts with HR-positive, HER2-negative ABC, recruited between September 2018 and August 2019.
Results
In 2018 (n=97), first-line treatments consisted of 62% CDK4/6i, 20% CT and 19% ET. In 2019 (n=249) use of CDK4/6i increased to 66% (16% CT, 18% ET). In Q1 2020 (n=75) use of CDK4/6i increased to 76% (13% CT, 11% ET, current data). Pts receiving CT (n=61) were younger than pts receiving CDK4/6i (n=222) (median 60 vs. 67 years) and more often had a Charlson comorbidity index (CCI) 0 (90% vs. 83%). ECOG was similar. The following physician-reported factors were reported to favor CT vs. CDK4/6i: rapid remission required (strong/considerable influence: 62% vs. 32%), presence of visceral metastasis (54% vs. 26%), while the factor “oral application” was reported in favor of CDK4/6i (11% vs. 53%). Pts receiving ET (n=61) were older (median 75 vs. 67 years), less often had ECOG 0 (31% vs. 38%) or CCI 0 (74% vs. 83%) than pts receiving CDK4/6i. These factors were reported to favor ET vs. CDK4/6i: patient preference (45% vs. 35%), advanced age (31% vs. 15%), poor general condition (26% vs. 13%), low application frequency (23% vs. 15%).
Conclusions
CDK4/6-inhibitors with ET have quickly become standard of care for pts with HR-positive, HER2-negative ABC. For some younger pts with visceral metastases physicians still favour CT, while older, frail pts may still be receiving ET alone. Longer follow-up will reveal the impact of these new treatments on clinical and patient-reported outcomes in routine.
Clinical trial identification
NCT03417115.
Editorial acknowledgement
Legal entity responsible for the study
iOMEDICO.
Funding
Roche Pharma AG, Eisai GmbH, Lilly Deutschland GmbH, Mundipharma GmbH, Mylan Germany GmbH, Onkovis GmbH, Pfizer Pharma GmbH.
Disclosure
A. Welt: Full/Part-time employment: University Hospital Essen; Advisory/Consultancy: Roche; Advisory/Consultancy, Contracted Research: Novartis; Advisory/Consultancy: Pfizer; Advisory/Consultancy: Tesaro; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Lilly; Advisory/Consultancy: Eisai; Advisory/Consultancy: Amgen; Advisory/Consultancy: Daiichi Sankyo; Advisory/Consultancy: Interplan. M. Thill: Advisory/Consultancy, Lecture/speaker engagement fees, Manuskript fees: Amgen; Advisory/Consultancy, Lecture/speaker engagement fees: AstraZeneca; Advisory/Consultancy: Biom'Up; Advisory/Consultancy, Lecture/speaker engagement fees, Manuskript fees: Celgene; Advisory/Consultancy: Daiichy Sankyo; Advisory/Consultancy, Lecture/speaker engagement fees: Eisai; Advisory/Consultancy, Lecture/speaker engagement fees, Trial funding: Genomic Health; Advisory/Consultancy: Lilly; Advisory/Consultancy, Lecture/speaker engagement fees: MSD; Advisory/Consultancy: Norgine; Advisory/Consultancy: Neodynamics; Advisory/Consultancy, Lecture/speaker engagement fees: Novartis; Advisory/Consultancy, Lecture/speaker engagement fees: Pfizer; Advisory/Consultancy, Lecture/speaker engagement fees: pfm Medical; Advisory/Consultancy, Lecture/speaker engagement fees: Roche; Advisory/Consultancy, Lecture/speaker engagement fees: RTI Surgical; Advisory/Consultancy: Tesaro; Honoraria (self), Lecture/speaker engagement fees: Clovis; Honoraria (self), Lecture/speaker engagement fees: Hexal; Honoraria (self), Lecture/speaker engagement fees: MCI; Honoraria (self), Lecture/speaker engagement fees: Medtronic; Honoraria (self), Lecture/speaker engagement fees: Omniamed. E. Stickeler: Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Novartis; Advisory/Consultancy: Roche; Advisory/Consultancy: Trinovis. M. Zaiss: Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Celgene; Advisory/Consultancy: Janssen; Advisory/Consultancy, presentation fees: Pfizer; Advisory/Consultancy: Novartis; Advisory/Consultancy, presentation fees: Roche; Honoraria (self), presentation fees: Vifor. V. Hagen: Honoraria (institution), Travel/Accommodation/Expenses, Institution received remuneration for documentation of patient data and travelling expenses: iOMEDICO; Honoraria (self): Roche; Honoraria (self), Travel/Accommodation/Expenses: Celgene; Honoraria (self): Pfizer; Shareholder/Stockholder/Stock options: BMS; Travel/Accommodation/Expenses, Shareholder/Stockholder/Stock options: JNJ; Honoraria (self): FomF; Travel/Accommodation/Expenses: Novartis; Travel/Accommodation/Expenses: Gilead. N.W. Marschner: Full/Part-time employment: iOMEDICO; Advisory/Consultancy: Novartis; Advisory/Consultancy, Contracted Research: Roche; Advisory/Consultancy, Contracted Research: Celgene; Advisory/Consultancy, Contracted Research: Lilly; Advisory/Consultancy, Contracted Research: Mundipharma; Advisory/Consultancy, Contracted Research: Mylan; Advisory/Consultancy, Contracted Research: Amgen; Advisory/Consultancy, Contracted Research: Pfizer. A. Wöckel: Advisory/Consultancy: Amgen; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Aurikamed; Advisory/Consultancy: Celgene; Advisory/Consultancy: Eisai; Advisory/Consultancy: Lilly; Advisory/Consultancy: Novartis; Advisory/Consultancy: Pfizer; Advisory/Consultancy: Roche; Advisory/Consultancy: Tesaro; Advisory/Consultancy: Sirtex; Advisory/Consultancy: MSD. N. Harbeck: Advisory/Consultancy: Agendia; Advisory/Consultancy, Speaker Bureau/Expert testimony: AstraZeneca; Advisory/Consultancy: Celgene; Advisory/Consultancy, Speaker Bureau/Expert testimony: Daiichi Sankyo; Advisory/Consultancy, Speaker Bureau/Expert testimony: Lilly; Advisory/Consultancy, Speaker Bureau/Expert testimony: MSD; Advisory/Consultancy, Speaker Bureau/Expert testimony: Novartis; Advisory/Consultancy: Odonate; Advisory/Consultancy, Speaker Bureau/Expert testimony: Pfizer; Advisory/Consultancy, Speaker Bureau/Expert testimony: Roche; Advisory/Consultancy: Sandoz/Hexal; Advisory/Consultancy: Seattle Genetics; Speaker Bureau/Expert testimony: Amgen; Speaker Bureau/Expert testimony: Genomic Health; Shareholder/Stockholder/Stock options: West German Study Group. T. Decker: Advisory/Consultancy: iOMEDICO; Advisory/Consultancy: Novartis. All other authors have declared no conflicts of interest.