TY - JOUR
TI - 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
AU - Fountzilas, E.
AU - Koliou, G.-A.
AU - Vozikis, A.
AU - Rapti, V.
AU - Nikolakopoulos, A.
AU - Boutis, A.
AU - Christopoulou, A.
AU - Kontogiorgos, I.
AU - Karageorgopoulou, S.
AU - Lalla, E.
AU - Tryfonopoulos, D.
AU - Boukovinas, I.
AU - Rapti, C.
AU - Nikolaidi, A.
AU - Karteri, S.
AU - Moirogiorgou, E.
AU - Binas, I.
AU - Mauri, D.
AU - Aravantinos, G.
AU - Zagouri, F.
AU - Saridaki, Z.
AU - Psyrri, A.
AU - Bafaloukos, D.
AU - Koumarianou, A.
AU - Res, E.
AU - Linardou, H.
AU - Mountzios, G.
AU - Razis, E.
AU - Fountzilas, G.
AU - Koumakis, G.
JO - ESMO open
PY - 2020
VL - 5
TODO - 4
SP - null
PB - BMJ Publishing Group
SN - null
TODO - 10.1136/esmoopen-2020-000774
TODO - 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
TODO - 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.
ER -