Abstract 232P
Background
CDK4/6-inhibitors (CDKi) have become standard in first-line therapy for patients (pts) with hormone receptor-positive, HER2-negative (HR+, HER2-) advanced breast cancer (ABC). However, after disease progression on CDK4/6i there are few data to drive decision making for subsequent treatment strategies. We present data of the OPAL registry platform analysing the different therapy strategies used after early progression under CDKi (less than two years from start of treatment).
Methods
OPAL (NCT03417115) is a prospective registry that continues the Tumor Registry Breast Cancer (TMK). Since start of OPAL in 01/2018 1895 patients were recruited at start of first-line treatment. Details on all (sequential) treatments, patient and tumor characteristics, biomarker testing, clinical and patient-reported outcomes are collected. Follow-Up is until death or up to 5 years. Here data were analyzed for 937 OPAL pts with HR+, HER2- ABC.
Results
Use of CDK4/6i in first-line increased from 68% in 2018 to 79% in 2021. At time of database cut August 31st, 2021, 123 pts had an early progression under CDKi and 20 pts died less than 2 years from start of first-line treatment. For 113 pts with early progression, second-line treatment was already documented. For these patients, median time to first progression was 6.8 months. Median age was 64 years at start of first-line treatment and liver/lung metastasis were documented for 34%/19% at start of first-line. As second-line treatment, 70% of pts received chemotherapy, mainly capecitabine or (nab)paclitaxel +/-bevacizumab. 20% received endocrine therapy, 9% re-challenge with CDKi and 2% of pts received a PARP-inhibitor. Median second-line progression-free survival (58% events) was 4.3 months (95%-CI 1.8-6.9 months). Updated outcome data will be presented.
Conclusions
Our data show that most patients receive chemotherapy as second-line treatment after early progression on CDKi, but regardless of subsequent therapy, prognosis of this subgroup remains poor, emphasizing the clinical need for better treatment options.
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 GmbH, Onkovis GmbH, Pfizer Pharma GmbH, AstraZeneca GmbH, Gilead Sciences GmbH, Daiichi SankyoDeutschland GmbH.
Disclosure
N.W. Marschner: Financial Interests, Ownership Interest: iOMEDICO; Financial Interests, Advisory Role: Novartis; Financial Interests, Advisory Role, Contracted Research: Roche, Celgene, Lilly, Mundipharma, Mylan, Amgen, Pfizer. N. Harbeck: Financial Interests, Personal, Invited Speaker: AstraZeneca, Daiichi Sankyo, Lilly, MSD, Novartis, Pierre Fabre, Roche, Seagen, Medscape, Art Tempi, Onkowissen, Gilead, Sanofi, Exact Sciences; Financial Interests, Personal, Advisory Board: AstraZeneca, Daiichi Sankyo, Novartis, Pfizer, Roche, Sandoz-Hexal, Seagen, Aptitude Health, Gilead, Sanofi; Financial Interests, Personal, Other, Husband: WSG (Husband); Financial Interests, Personal, Ownership Interest: West German Study Group; Financial Interests, Institutional, Funding: AstraZeneca, BMS, Daiichi Sankyo, Lilly, MSD, Novartis, Pierre Fabre, Roche, Palleos, Seagen, TRIO, WSG; Non-Financial Interests, Member, Member German AGO Breast Guideline Committee: AGO Breast Committee; Non-Financial Interests, Member, Breast Cancer Educational Programs: ESO/ESCO; Other, Other, Founding Editor: BreastCare Journal. M. Thill: Financial Interests, Advisory Role: Amgen, AstraZeneca, Biom'Up, Celgene, Daiichi Sankyo, Eisai, Genomic Health, Lilly, MSD, Norgine, Neodynamics, Novartis, Pfizer, pfm medical, Roche, RTI Surgical, Tesaro; Financial Interests, Invited Speaker: Clovis, Hexal, MCI, Medtronic, Omniamed, iOMEDICO, Amgen, AstraZeneca, Celgene, Eisai, Genomic Health, MSD, Novartis, Pfizer, pfm Medical, Roche, RTI Surgical; Financial Interests, Other, Manuscript fees: Amgen, Celgene; Financial Interests, Other, Trial funding: Genomic Health. E. Stickeler: Financial Interests, Advisory Role: AstraZeneca, Novartis, Roche, Trinovis. M. Zaiss: Financial Interests, Advisory Board: AstraZeneca, Celgene, Janssen, Novartis, Pfizer, Roche, Hexal, Takeda, BMS, Eisai; Financial Interests, Invited Speaker: Vifor, Roche, Pfizer. J. Rauh: Financial Interests, Other, remuneration for participation in clinical trials: iOMEDICO. K. Engelken: Financial Interests, Invited Speaker: Roche, Novartis, Gilead, Pfizer, AstraZeneca. A. Wöckel: Financial Interests, Advisory Role: Amgen, AstraZeneca, Aurikamed, Celgene, Eisai, Lilly, Novartis, Pfizer, Roche, Tesaro, Sirtex, MSD, Seagen, Exact Sciences. A. Welt: Financial Interests, Full or part-time Employment: University Hospital Essen; Financial Interests, Advisory Role: Roche, Pfizer, Tesaro, AstraZeneca, Lilly, Eisai, Amgen, Daiichi Sankyo, Interplan; Financial Interests, Advisory Role, Contracted Research: Novartis. T. Decker: Financial Interests, Advisory Role: Novartis, iOMEDICO. All other authors have declared no conflicts of interest.