Osteonecrosis of the jaw under palbociclib: A case series description.

Autor:	Yosofi C; Regional Center of Pharmacovigilance, Pharmacoepidemiology and Drug Information - CHU Rennes, Rennes, France., Cairon-Lejeune S; Dental Care Center, CHU Rennes, Rennes, France., Lefeuvre-Plesse C; Department of Medical Oncology, Eugène Marquis Cancer Center, Rennes, France., Polard E; Regional Center of Pharmacovigilance, Pharmacoepidemiology and Drug Information - CHU Rennes, Rennes, France., Briet M; Regional Center of Pharmacovigilance, Pharmacoepidemiology and Drug Information - CHRU Angers, Angers, France., Kammerer-Jacquet SF; Department of Pathology, CHU Rennes, Rennes, France., Triquet L; Regional Center of Pharmacovigilance, Pharmacoepidemiology and Drug Information - CHU Rennes, Rennes, France., Scailteux LM; Regional Center of Pharmacovigilance, Pharmacoepidemiology and Drug Information - CHU Rennes, Rennes, France.
Jazyk:	angličtina
Zdroj:	Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners [J Oncol Pharm Pract] 2023 Dec; Vol. 29 (8), pp. 1990-1997. Date of Electronic Publication: 2023 Mar 22.
DOI:	10.1177/10781552231165434
Abstrakt:	Introduction: Cases of osteonecrosis of the jaw have been reported by dental surgeons to the pharmacovigilance center in Rennes, France, occurring among patients treated with palbociclib, a cyclin-dependent kinase 4/6 inhibitor. Although this event was not expected with the drug, a safety signal was raised. Describing a local case series, the aim of our study was to identify specific patterns that might suggest a triggering role for these drugs, and to discuss pathophysiological hypotheses. Materials and Methods: A retrospective case series of patients exposed to cyclin-dependent kinase 4/6 inhibitors between 2016 and 2020 with a diagnosis of osteonecrosis of the jaw at the Rennes Dental Care Center was analyzed. The descriptive analysis was conducted on patient demographics, breast cancer characteristics, osteonecrosis of the jaw, biological data, and exposure to cyclin-dependent kinase 4/6 inhibitors. Results: We identified eight cases, most of them at stages 0-1 (62.5%). Four patients were still exposed to palbociclib at the time of diagnosis and four had discontinued the treatment before the diagnosis. Chronological imputability could not be excluded given the drug's half-life and the variable intervals of dental monitoring from one patient to another. All patients had at least one dental osteonecrosis risk factor (including dental extraction, dentures, and denosumab exposure at the time of diagnosis). Neutropenia and mucositis were not systematically reported at the time of diagnosis. The anatomopathological characteristics were nonspecific. Conclusion: We did not identify a specific pattern that could suggest a triggering role of palbociclib in the development of ONJ. Competing Interests: Declaration of conflicting interestsThe authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Databáze:	MEDLINE
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