Τίτλος:
Real-world clinical outcome and toxicity data and economic aspects in patients with advanced breast cancer treated with cyclin-dependent kinase 4/6 (CDK4/6) inhibitors combined with endocrine therapy: The experience of the Hellenic Cooperative Oncology Group
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
Background We evaluated real-world clinical outcomes and toxicity data and assessed treatment-related costs in patients with advanced breast cancer who received treatment with cyclin-dependent kinase inhibitors (CDKi). Patients and methods We conducted a prospective-retrospective analysis of patients with advanced hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer who received a CDKi, in combination with endocrine therapy, at any line of treatment. The primary endpoint was progression-free survival (PFS). Cost analysis was conducted from a public third-payer (National Organization for Healthcare Services Provision (EOPYY)) perspective, assessing only costs related to direct medical care, including drug therapy costs and adverse drug reaction (ADR)-related costs. Results From July 2015 to October 2019, 365 women received endocrine therapy combined with CDKi; median age was 61 years, postmenopausal 290 (80.6%) patients. CDKi were administered as first-line treatment in 149 (40.9%) patients, second-line treatment in 96 (26.4%) and third-line treatment and beyond in 119 (32.7%) patients. The most common adverse events were neutropenia, anaemia, thrombocytopenia and fatigue. Grade 3-4 adverse events occurred in 86 (23.6%) patients, whereas 8 (2.2%) patients permanently discontinued treatment due to toxicity. The median PFS for patients who received CDKi as first-line, second-line and third-line treatment and beyond was 18.7, 12 and 7.4 months, respectively. The median overall survival since the initiation of CDKi treatment was 29.9 months (95% CI: 23.0-not yet reached (NR)). The mean pharmaceutical therapy cost estimated per cycle was 2 724.12 € for each patient, whereas the main driver of the ADR-related costs was haematological adverse events. Conclusions Treatment with CDKi was well tolerated, with a low drug discontinuation rate. Patients who received CDKi as first-line treatment had improved PFS and OS compared with second-line treatment and beyond. The main component of direct medical costs assessed in the cost analysis comprises CDKi pharmaceutical therapy costs. Trial registration number NCT04133207. © Author (s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ on behalf of the European Society for Medical Oncology.
Συγγραφείς:
Fountzilas, E.
Koliou, G.-A.
Vozikis, A.
Rapti, V.
Nikolakopoulos, A.
Boutis, A.
Christopoulou, A.
Kontogiorgos, I.
Karageorgopoulou, S.
Lalla, E.
Tryfonopoulos, D.
Boukovinas, I.
Rapti, C.
Nikolaidi, A.
Karteri, S.
Moirogiorgou, E.
Binas, I.
Mauri, D.
Aravantinos, G.
Zagouri, F.
Saridaki, Z.
Psyrri, A.
Bafaloukos, D.
Koumarianou, A.
Res, E.
Linardou, H.
Mountzios, G.
Razis, E.
Fountzilas, G.
Koumakis, G.
Εκδότης:
BMJ Publishing Group
Λέξεις-κλειδιά:
cyclin dependent kinase 4; cyclin dependent kinase 6; cyclin dependent kinase inhibitor; fulvestrant; letrozole; palbociclib; ribociclib; tamoxifen; taxane derivative; antineoplastic agent; CDK4 protein, human; CDK6 protein, human; cyclin dependent kinase 4; cyclin dependent kinase 6, adult; aged; anemia; Article; blood toxicity; breast cancer; cancer chemotherapy; cancer hormone therapy; cancer patient; cancer survival; clinical outcome; cohort analysis; cost benefit analysis; data analysis; diarrhea; drug cost; drug dose reduction; drug tolerability; drug withdrawal; economic aspect; estrogen receptor positive breast cancer; fatigue; female; fever; health care cost; human; human epidermal growth factor receptor 2 negative breast cancer; incidence; major clinical study; medical care; multiple cycle treatment; nausea; neutropenia; overall survival; postmenopause; progesterone receptor positive breast cancer; progression free survival; reimbursement; retrospective study; skin disease; stomatitis; survival analysis; thrombocytopenia; vomiting; breast tumor; endocrine system; middle aged; prospective study, Aged; Antineoplastic Combined Chemotherapy Protocols; Breast Neoplasms; Cyclin-Dependent Kinase 4; Cyclin-Dependent Kinase 6; Endocrine System; Female; Humans; Middle Aged; Prospective Studies; Retrospective Studies
DOI:
10.1136/esmoopen-2020-000774
