PMID- 36349599 OWN - NLM STAT- MEDLINE DCOM- 20221220 LR - 20230212 IS - 1879-0887 (Electronic) IS - 0167-8140 (Linking) VI - 177 DP - 2022 Dec TI - Safety of CDK4/6 inhibitors and concomitant radiation therapy in patients affected by metastatic breast cancer. PG - 40-45 LID - S0167-8140(22)04518-2 [pii] LID - 10.1016/j.radonc.2022.10.023 [doi] AB - PURPOSE: Cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) currently represent the standard of care for the initial treatment of patients with metastatic hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer. The aim of our study is to evaluate the safety of the use of concomitant radiation therapy (RT) in a consecutive series of HR+/HER2- patients treated in two academic institutions with CDK4/6i in the metastatic setting. METHODS AND MATERIALS: From September 2017 to February 2020, we retrospectively collected and analysed data on a sequential series of patients treated with CDK4/6i, receiving RT or not, at two European institutions. Primary outcome of the study was the association between RT and any adverse events (AEs) >/= G3. Secondary outcomes were the association between RT and any AEs (any grade), CDK4/6i dose reduction rate, and CDK4/6i treatment discontinuation rate. RESULTS: We analysed a total of 132 consecutive women; RT was prescribed in 57 (43.2%) patients (70 irradiated lesions). The median age of the series was 52.1 years (range 32.3-78.2). Concomitant RT administration was not significantly related to higher AEs >/= G3 (p = 0.19) and any grade AEs (p = 1.0); there was no association with RT and CDK4/6i dose reduction (p = 0.49) and discontinuation rates (p = 0.14). At a median follow-up of 18.8 months, the progression-free survival (PFS) rate was 35% and the overall survival (OS) rate was 38.7% in the whole group. The use of concomitant RT did not affect both PFS (p = 0.71) and OS rates (p = 0.55). CONCLUSIONS: Our data are encouraging regarding the safety of this combination, showing that concurrent RT did not increase severe toxicity and did not have an impact on systemic treatment conduction. CI - Copyright (c) 2022 Elsevier B.V. All rights reserved. FAU - Visani, Luca AU - Visani L AD - Department of Experimental and Clinical Biomedical Sciences "M. Serio", University of Florence, Florence, Italy. FAU - Livi, Lorenzo AU - Livi L AD - Department of Experimental and Clinical Biomedical Sciences "M. Serio", University of Florence, Florence, Italy; Radiation Oncology Unit, Oncology Department, Azienda Ospedaliero Universitaria Careggi, Florence, Italy. FAU - Ratosa, Ivica AU - Ratosa I AD - Division of Radiation Oncology, Institute of Oncology Ljubljana, Ljubljana, Slovenia; Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia. FAU - Orazem, Miha AU - Orazem M AD - Division of Radiation Oncology, Institute of Oncology Ljubljana, Ljubljana, Slovenia; Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia. FAU - Ribnikar, Domen AU - Ribnikar D AD - Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia; Division of Medical Oncology, Institute of Oncology Ljubljana, Ljubljana, Slovenia. FAU - Saieva, Calogero AU - Saieva C AD - Cancer Risk Factors and Lifestyle Epidemiology Unit, Institute for Cancer Research Prevention and Clinical Network, Florence, Italy. FAU - Becherini, Carlotta AU - Becherini C AD - Radiation Oncology Unit, Oncology Department, Azienda Ospedaliero Universitaria Careggi, Florence, Italy. FAU - Salvestrini, Viola AU - Salvestrini V AD - Department of Experimental and Clinical Biomedical Sciences "M. Serio", University of Florence, Florence, Italy; Radiation Oncology Unit, Oncology Department, Azienda Ospedaliero Universitaria Careggi, Florence, Italy. FAU - Scoccimarro, Erika AU - Scoccimarro E AD - Department of Experimental and Clinical Biomedical Sciences "M. Serio", University of Florence, Florence, Italy; Radiation Oncology Unit, Oncology Department, Azienda Ospedaliero Universitaria Careggi, Florence, Italy. FAU - Valzano, Marianna AU - Valzano M AD - Department of Experimental and Clinical Biomedical Sciences "M. Serio", University of Florence, Florence, Italy; Radiation Oncology Unit, Oncology Department, Azienda Ospedaliero Universitaria Careggi, Florence, Italy. FAU - Cerbai, Cecilia AU - Cerbai C AD - Department of Experimental and Clinical Biomedical Sciences "M. Serio", University of Florence, Florence, Italy; Radiation Oncology Unit, Oncology Department, Azienda Ospedaliero Universitaria Careggi, Florence, Italy. FAU - Desideri, Isacco AU - Desideri I AD - Department of Experimental and Clinical Biomedical Sciences "M. Serio", University of Florence, Florence, Italy; Radiation Oncology Unit, Oncology Department, Azienda Ospedaliero Universitaria Careggi, Florence, Italy. FAU - Bernini, Marco AU - Bernini M AD - Breast Surgery Unit, Careggi University Hospital, Florence, Italy. FAU - Orzalesi, Lorenzo AU - Orzalesi L AD - Breast Surgery Unit, Careggi University Hospital, Florence, Italy. FAU - Nori, Jacopo AU - Nori J AD - Diagnostic Senology Unit, Careggi University Hospital, Florence, Italy. FAU - Bianchi, Simonetta AU - Bianchi S AD - Division of Pathological Anatomy, Department of Health Sciences, University of Florence, Florence, Italy. FAU - Morandi, Andrea AU - Morandi A AD - Department of Experimental and Clinical Biomedical Sciences "M. Serio", University of Florence, Florence, Italy. FAU - Meattini, Icro AU - Meattini I AD - Department of Experimental and Clinical Biomedical Sciences "M. Serio", University of Florence, Florence, Italy; Radiation Oncology Unit, Oncology Department, Azienda Ospedaliero Universitaria Careggi, Florence, Italy. Electronic address: icro.meattini@unifi.it. LA - eng PT - Journal Article DEP - 20221028 PL - Ireland TA - Radiother Oncol JT - Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology JID - 8407192 RN - EC 2.7.11.22 (Cyclin-Dependent Kinase 6) RN - EC 2.7.11.22 (Cyclin-Dependent Kinase 4) RN - 0 (Receptors, Progesterone) RN - 0 (Receptors, Estrogen) RN - 0 (Protein Kinase Inhibitors) RN - EC 2.7.11.22 (CDK4 protein, human) SB - IM MH - Humans MH - Female MH - Adult MH - Middle Aged MH - Aged MH - *Breast Neoplasms/drug therapy/radiotherapy MH - Cyclin-Dependent Kinase 6/metabolism/therapeutic use MH - Cyclin-Dependent Kinase 4/metabolism/therapeutic use MH - Receptors, Progesterone/metabolism MH - Receptors, Estrogen/metabolism MH - Retrospective Studies MH - Protein Kinase Inhibitors/adverse effects MH - Antineoplastic Combined Chemotherapy Protocols/therapeutic use OTO - NOTNLM OT - Breast cancer OT - CDK4/6 inhibitors OT - Concomitant treatment OT - Oligometastatic disease OT - Radiotherapy EDAT- 2022/11/10 06:00 MHDA- 2022/12/21 06:00 CRDT- 2022/11/09 04:09 PHST- 2022/03/20 00:00 [received] PHST- 2022/10/12 00:00 [revised] PHST- 2022/10/20 00:00 [accepted] PHST- 2022/11/10 06:00 [pubmed] PHST- 2022/12/21 06:00 [medline] PHST- 2022/11/09 04:09 [entrez] AID - S0167-8140(22)04518-2 [pii] AID - 10.1016/j.radonc.2022.10.023 [doi] PST - ppublish SO - Radiother Oncol. 2022 Dec;177:40-45. doi: 10.1016/j.radonc.2022.10.023. Epub 2022 Oct 28.