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.

Autor:	Fountzilas E; Second Department of Medical Oncology, Euromedica General Clinic, Thessaloniki, Greece elenafou@gmail.com., Koliou GA; Section of Biostatistics, Hellenic Cooperative Oncology Group, Data Office, Athens, Greece., Vozikis A; Department of Economics, University of Piraeus, Piraeus, Greece., Rapti V; Second Department of Internal Medicine, Agios Savvas Cancer Hospital, Athens, Greece., Nikolakopoulos A; Division of Oncology, Department of Medicine, University Hospital, University of Patras Medical School, Patras, Greece., Boutis A; First Department of Clinical Oncology, Theagenio Hospital, Thessaloniki, Greece., Christopoulou A; Medical Oncology Unit, S. Andrew Hospital, Patras, Greece., Kontogiorgos I; Department of Economics, University of Piraeus, Piraeus, Greece., Karageorgopoulou S; Third Department of Medical Oncology, IASO Clinic, Athens, Greece., Lalla E; Third Department of Clinical Oncology, Theagenio Hospital, Thessaloniki, Greece., Tryfonopoulos D; Second Department of Internal Medicine, Agios Savvas Cancer Hospital, Athens, Greece., Boukovinas I; Oncology Department, Bioclinic of Thessaloniki, Thessaloniki, Greece., Rapti C; Department of Medical Oncology, 251 Airforce General Hospital, Athens, Greece., Nikolaidi A; Oncology Clinic, Mitera Hospital, Athens, Greece., Karteri S; Division of Oncology, Department of Medicine, University Hospital, University of Patras Medical School, Patras, Greece., Moirogiorgou E; Oncology Department, Hygeia Hospital, Athens, Greece., Binas I; Second Department of Medical Oncology, Metropolitan Hospital, Piraeus, Greece., Mauri D; Department of Medical Oncology, University Hospital of Ioannina, Ioannina, Greece., Aravantinos G; Second Department of Medical Oncology, Agii Anargiri Cancer Hospital, Athens, Greece., Zagouri F; Department of Clinical Therapeutics, Alexandra Hospital, National and Kapodistrian University of Athens School of Medicine, Athens, Greece., Saridaki Z; Asklepios Oncology Department, Asklepios, Heraklion, greece., Psyrri A; Section of Medical Oncology, Department of Internal Medicine, Attikon University Hospital, National and Kapodistrian University of Athens School of Medicine, Athens, Greece., Bafaloukos D; First Department of Medical Oncology, Metropolitan Hospital, Piraeus, Athens, Greece., Koumarianou A; Hematology-Oncology Unit, Fourth Department of Internal Medicine, Attikon University Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece., Res E; Third Department of Medical Oncology, Agii Anargiri Cancer Hospital, Athens, Greece., Linardou H; Fourth Oncology Department, Metropolitan Hospital, Athens, Greece., Mountzios G; Second Oncology Department and Clinical Trials Unit, Henry Dunant Hospital Center, Athens, Greece., Razis E; Third Department of Medical Oncology, Hygeia Hospital, Athens, Greece., Fountzilas G; Laboratory of Molecular Oncology, Hellenic Foundation for Cancer Research, Aristotle University of Thessaloniki, Thessaloniki, Greece.; Aristotle University of Thessaloniki, Thessaloniki, Greece.; German Oncology Center, Limassol, Cyprus., Koumakis G; Second Department of Internal Medicine, Agios Savvas Cancer Hospital, Athens, Greece.
Jazyk:	angličtina
Zdroj:	ESMO open [ESMO Open] 2020 Aug; Vol. 5 (4).
DOI:	10.1136/esmoopen-2020-000774
Abstrakt:	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. Competing Interests: Competing interests: EF: stock ownership: GENPREX INC, ARIAD and Deciphera Pharmaceuticals, Inc. Travel grant: Merck, Pfizer and K.A.M Oncology/Hematology. Advisory: LEO Pharma. Speaker fees: Roche and Pfizer. AV: advisory boards: Angelini and Takeda. Speaker fees: Bristol-Myers Squibb, Roche and MSD. Training programmes: Astellas, Genesis Pharma, Pfizer, LEO, Abbvie and TEVAAN. Travel fees: Pfizer, Merck, Hospira, Sanofi, Roche, Astra Zeneca, Kyowa Kirin-Anabiosis and Rafarm. AB: advisory role and honorarium: Pfizer and Novartis. SK: consultation/advisory: Astra Zeneca and Roche. Research: Novartis and Roche. Speaker: Astra Zeneca, Novartis and Roche. IB: advisory board: Pfizer and Novartis. Educational grant: Pfizer. Research Fund: Novartis and Lilly. AN: advisory board and speaker fees: Pfizer and Novartis. GA: advisory boards: Novartis, BMS, Roche Hellas, Astra Zeneca, Sanofi, Amgen, Genesis Pharma, Merck and Pfizer. AP: consultation fees: Amgen, Merck Serono, Roche, BMS, Astra Zeneca and MSD. Honoraria: Amgen, Merck Serono, Roche, BMS, Astra Zeneca and MSD. Research funds: BMS and Kura. AK: advisory role: Genesis Pharma. Honoraria: Pfizer. Speaker’s bureau: Roche. Research funding: Merck. Travel: MSD. Educational grants: Novartis, Pfizer, Merck, Roche, BMS, MSD, Genesis and Ipsen. GM: honoraria/consultancy: Astra Zeneca, Roche, Pfizer, BMS, MSD, Takeda, Boehringer, Merck, Novartis and Amgen. Travel fees: Astra Zeneca, Roche, Pfizer, BMS, MSD, Takeda, Boehringer, Merck, Novartis, Astellas and Pierre Fabre. ER: consulting or advisory role: Astra Zeneca, Bristol-Myers Squibb and Pfizer. Research funding: Novartis, Demo Pharmaceutical, EORTC, Radius Pharmaceuticals, Tesaro, Parexel and Anabiosis Pharmaceuticals. Travel: Sanofi, Ipsen, Genesis Pharmaceuticals, LEO Pharma, Merck, Roche and Genekor. GF: advisory board: Pfizer, Sanofi and Roche. Honoraria: Astra Zeneca. Stock ownership: ARIAD and GENPREX. The rest of the authors declare no conflict of interest. (© 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.)
Databáze:	MEDLINE
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