PMID- 38206533 OWN - NLM STAT- MEDLINE DCOM- 20240325 LR - 20240325 IS - 1573-7217 (Electronic) IS - 0167-6806 (Print) IS - 0167-6806 (Linking) VI - 204 IP - 3 DP - 2024 Apr TI - Treatment patterns of patients with HR+/HER2- metastatic breast cancer receiving CDK4/6 inhibitor-based regimens: a cohort study in the French nationwide healthcare database. PG - 579-588 LID - 10.1007/s10549-023-07201-w [doi] AB - PURPOSE: To assess real-world treatment patterns in patients diagnosed with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer (mBC) who received cyclin-dependent kinase 4/6 (CDK4/6) inhibitors in combination with an aromatase inhibitor (AI) or fulvestrant at first line. METHODS: Patient characteristics, treatment history, and outcomes data were extracted from the French 'Systeme National des Donnees de Sante' (SNDS) database for patients diagnosed with HR+/HER2- mBC between January 2014 and June 2019 and who received combination therapy with a CDK4/6 inhibitor and endocrine therapy. Kaplan-Meier methodology was used to assess time to next treatment (TTNT) and time to treatment discontinuation (TTTD). RESULTS: The cohort comprised 6061 patients including 4032 patients who received CDK4/6 inhibitors + AIs and 2029 patients who received CDK4/6 inhibitors + fulvestrant. Median follow-up was 13.5 months (IQR 9.5-18.1). The median TTTD of first line treatment with CDK4/6 inhibitors + AIs and CDK4/6 inhibitors + fulvestrant was 17.3 months (95% CI 16.8-17.9) and 9.7 months (95% CI 9.0-10.2), respectively. Chemotherapy was the most common second line therapy. Median TTTD of subsequent treatment lines was progressively shorter following first line treatment with CDK4/6 inhibitors + AIs (2nd line: 4.6 months (95% CI 4.4-4.9) and with CDK4/6 inhibitors + fulvestrant (2nd line: 4.7 months (95% CI 4.3-5.1). TTNT was longer than TTTD across lines of therapy. CONCLUSION: This real-world analysis confirms the effectiveness of CDK4/6 inhibitor-based regimens in French patients and highlights the frequent use of chemotherapy as second line therapy. CI - (c) 2024. The Author(s). FAU - Read, Stephanie H AU - Read SH AUID- ORCID: 0000-0002-2087-7358 AD - Certara UK Limited, London, UK. Stephanie.Read@certara.com. FAU - Quignot, Nadia AU - Quignot N AUID- ORCID: 0000-0001-8718-1307 AD - Certara France, Paris, France. FAU - Kapso-Kapnang, Raissa AU - Kapso-Kapnang R AD - Certara France, Paris, France. FAU - Comerford, Erin AU - Comerford E AD - Sanofi, Cambridge, MA, USA. FAU - Zheng, Ying AU - Zheng Y AD - Sanofi, Cambridge, MA, USA. FAU - Gainford, Corona AU - Gainford C AD - Sanofi, Cambridge, MA, USA. FAU - Sasane, Medha AU - Sasane M AD - Sanofi, Cambridge, MA, USA. FAU - Vataire, Anne-Lise AU - Vataire AL AUID- ORCID: 0000-0002-3354-3189 AD - Sanofi, Paris, France. FAU - Delzongle, Laure AU - Delzongle L AD - Sanofi, Paris, France. FAU - Bidard, Francois-Clement AU - Bidard FC AUID- ORCID: 0000-0001-5932-8949 AD - Department of Medical Oncology, Institut Curie, Saint-Cloud, France. AD - Universite Versailles Saint-Quentin, Universite Paris-Saclay, Saint-Cloud, France. LA - eng PT - Journal Article DEP - 20240111 PL - Netherlands TA - Breast Cancer Res Treat JT - Breast cancer research and treatment JID - 8111104 RN - 22X328QOC4 (Fulvestrant) RN - EC 2.7.10.1 (Receptor, ErbB-2) RN - EC 2.7.11.22 (CDK4 protein, human) RN - EC 2.7.11.22 (Cyclin-Dependent Kinase 4) SB - IM MH - Humans MH - Female MH - *Breast Neoplasms/pathology MH - Fulvestrant MH - Cohort Studies MH - Antineoplastic Combined Chemotherapy Protocols/therapeutic use MH - Delivery of Health Care MH - Receptor, ErbB-2/metabolism MH - Cyclin-Dependent Kinase 4 PMC - PMC10959771 OTO - NOTNLM OT - Cyclin-dependent kinase 4/6 inhibitor OT - Endocrine therapy OT - Hormone receptor negative OT - Metastatic breast cancer OT - Real-world evidence OT - SNDS COIS- FC Bidard received research support from Pfizer, Prolynx, Merck KGaA, Rain Oncology, Roche, Seagen; consultancy honoraria from Astra-Zeneca, Caris, Daiichi-Sankyo, Exact Sciences, GE Healthcare, Gilead, GSK, Inatherys, Lilly, Menarini/Stemline, Novartis, Rain Oncology, Sanofi, Seagen; speaker fees from Astra-Zeneca, Daiichi-Sankyo, Lilly, Menarini/Stemline, Pfizer, Rain Oncology, Sanofi, Seagen; support for congress attendance from Astra-Zeneca, Pfizer and Novartis. E Comerford, Y Zheng, C Gainford, M Sasane, AL Vataire and L Delzongle are all employees of Sanofi. SH Read, N Quignot and R Kapso-Kapnang are full-time employees at Certara and received consulting fees to independently conduct this study. EDAT- 2024/01/11 12:43 MHDA- 2024/03/25 06:43 PMCR- 2024/01/11 CRDT- 2024/01/11 11:13 PHST- 2023/09/13 00:00 [received] PHST- 2023/11/26 00:00 [accepted] PHST- 2024/03/25 06:43 [medline] PHST- 2024/01/11 12:43 [pubmed] PHST- 2024/01/11 11:13 [entrez] PHST- 2024/01/11 00:00 [pmc-release] AID - 10.1007/s10549-023-07201-w [pii] AID - 7201 [pii] AID - 10.1007/s10549-023-07201-w [doi] PST - ppublish SO - Breast Cancer Res Treat. 2024 Apr;204(3):579-588. doi: 10.1007/s10549-023-07201-w. Epub 2024 Jan 11.