Adverse Events Induced by PD-1/PD-L1 Inhibitors: A Real-World Single-Centre Experience with a Management-Based Approach

Fabien Grimaud,1 Guillaume Penaranda,2 Chloé Stavris,3 Frédérique Retornaz,3 Véronique Brunel,4 Sylvie Cailleres,4 Hervé Pegliasco,5 Jacques Le Treut,5 Vincent Grisoni,6 Emilie Coquet,1 Laurent Chiche,3 Amélie Rognon1 1Department of Pharmacy, Hôpital Européen, Marseille, France; 2Department of Biost...

Descripción completa

Guardado en:

Detalles Bibliográficos
Autores principales:	Grimaud F, Penaranda G, Stavris C, Retornaz F, Brunel V, Cailleres S, Pegliasco H, Le Treut J, Grisoni V, Coquet E, Chiche L, Rognon A
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2021
Materias:	immunotherapy elderly pd-1 inhibitor pdl-1 inhibitor safety immune-related adverse events solid tumours prognostic biomarkers. Therapeutics. Pharmacology RM1-950
Acceso en línea:	https://doaj.org/article/cf0fa7d1c6224b17bb4974e05a1f4225
Etiquetas:	Agregar Etiqueta Sin Etiquetas, Sea el primero en etiquetar este registro!

id	oai:doaj.org-article:cf0fa7d1c6224b17bb4974e05a1f4225
record_format	dspace
spelling	oai:doaj.org-article:cf0fa7d1c6224b17bb4974e05a1f42252021-12-02T18:18:38ZAdverse Events Induced by PD-1/PD-L1 Inhibitors: A Real-World Single-Centre Experience with a Management-Based Approach1178-203Xhttps://doaj.org/article/cf0fa7d1c6224b17bb4974e05a1f42252021-06-01T00:00:00Zhttps://www.dovepress.com/adverse-events-induced-by-pd-1pd-l1-inhibitors-a-real-world-single-cen-peer-reviewed-fulltext-article-TCRMhttps://doaj.org/toc/1178-203XFabien Grimaud,1 Guillaume Penaranda,2 Chloé Stavris,3 Frédérique Retornaz,3 Véronique Brunel,4 Sylvie Cailleres,4 Hervé Pegliasco,5 Jacques Le Treut,5 Vincent Grisoni,6 Emilie Coquet,1 Laurent Chiche,3 Amélie Rognon1 1Department of Pharmacy, Hôpital Européen, Marseille, France; 2Department of Biostatistics, Hôpital Européen, Marseille, France; 3Department of Internal Medicine, Hôpital Européen, Marseille, France; 4Department of Haemato-Oncology, Hôpital Européen, Marseille, France; 5Department of Pulmonology, Hôpital Européen, Marseille, France; 6Department of Urology, Hôpital Européen, Marseille, FranceCorrespondence: Amélie RognonDepartment of Pharmacy, Hôpital Européen, 6 Rue Désirée Clary, Marseille, 13003, FranceTel +33 4 13 42 73 00Fax +33 4 13 42 76 80Email a.rognon@hopital-europeen.frAim: To assess the efficacy and tolerance of programmed death-1 (PD-1) and PD-ligand 1 (PD-L1) inhibitors and the impact of a standardised management-based protocol in a real-world setting.Patients and Methods: Data from patients who had received anti-PD-(L)1 were collected from our pharmacy database. Clinical response and toxicity were assessed using RECIST criteria and CTCAE version 5.0, respectively. Overall survival (OS) and progression-free survival (PFS) were estimated with the Kaplan–Meier method. Potential prognostic factors were identified using Cox’s model.Results: A total of 196 patients and 201 lines of treatment were included (median age: 66 (range: 38– 89) years). Types of cancer included non-small cell lung cancer (73%), transitional cell carcinoma (10%), renal cell carcinoma (6%), small cell lung cancer (5%), head and neck squamous cell carcinoma (4%) and classical Hodgkin’s lymphoma (1%). Twenty-five (12%) patients had pre-existing autoimmune conditions. Our standardised management-based protocol included 129 (64%) patients. Objective response rate was 29%, median OS was 10 months (IQR: 7– 15) and median PFS was 5 months (IQR: 1– 22). Patients with an abnormal baseline complete blood count had a worse OS (HR=2.48 [95% CI: 1.24– 4.96]; p=0.0103). Thirty-three (16%) patients experienced severe (grade 3 or 4) immune-related adverse event (irAE). There were three (1%) irAE-related deaths. AEs resolved faster when patients were assessed by an internist before anti-PD-(L)1 initiation (p=0.0205).Conclusion: PD-1 and PD-L1 inhibitors are effective and safe in a real-world setting. Implementation of a standardised management-based protocol with internal medicine specialists is an effective way to optimise irAE management.Keywords: immunotherapy, elderly, PD-1 inhibitor, PD-L1 inhibitor, PDL-1 inhibitor, safety, immune-related adverse events, solid tumours, prognostic biomarkersGrimaud FPenaranda GStavris CRetornaz FBrunel VCailleres SPegliasco HLe Treut JGrisoni VCoquet EChiche LRognon ADove Medical Pressarticleimmunotherapyelderlypd-1 inhibitorpdl-1 inhibitorsafetyimmune-related adverse eventssolid tumoursprognostic biomarkers.Therapeutics. PharmacologyRM1-950ENTherapeutics and Clinical Risk Management, Vol Volume 17, Pp 669-677 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	immunotherapy elderly pd-1 inhibitor pdl-1 inhibitor safety immune-related adverse events solid tumours prognostic biomarkers. Therapeutics. Pharmacology RM1-950
spellingShingle	immunotherapy elderly pd-1 inhibitor pdl-1 inhibitor safety immune-related adverse events solid tumours prognostic biomarkers. Therapeutics. Pharmacology RM1-950 Grimaud F Penaranda G Stavris C Retornaz F Brunel V Cailleres S Pegliasco H Le Treut J Grisoni V Coquet E Chiche L Rognon A Adverse Events Induced by PD-1/PD-L1 Inhibitors: A Real-World Single-Centre Experience with a Management-Based Approach
description	Fabien Grimaud,1 Guillaume Penaranda,2 Chloé Stavris,3 Frédérique Retornaz,3 Véronique Brunel,4 Sylvie Cailleres,4 Hervé Pegliasco,5 Jacques Le Treut,5 Vincent Grisoni,6 Emilie Coquet,1 Laurent Chiche,3 Amélie Rognon1 1Department of Pharmacy, Hôpital Européen, Marseille, France; 2Department of Biostatistics, Hôpital Européen, Marseille, France; 3Department of Internal Medicine, Hôpital Européen, Marseille, France; 4Department of Haemato-Oncology, Hôpital Européen, Marseille, France; 5Department of Pulmonology, Hôpital Européen, Marseille, France; 6Department of Urology, Hôpital Européen, Marseille, FranceCorrespondence: Amélie RognonDepartment of Pharmacy, Hôpital Européen, 6 Rue Désirée Clary, Marseille, 13003, FranceTel +33 4 13 42 73 00Fax +33 4 13 42 76 80Email a.rognon@hopital-europeen.frAim: To assess the efficacy and tolerance of programmed death-1 (PD-1) and PD-ligand 1 (PD-L1) inhibitors and the impact of a standardised management-based protocol in a real-world setting.Patients and Methods: Data from patients who had received anti-PD-(L)1 were collected from our pharmacy database. Clinical response and toxicity were assessed using RECIST criteria and CTCAE version 5.0, respectively. Overall survival (OS) and progression-free survival (PFS) were estimated with the Kaplan–Meier method. Potential prognostic factors were identified using Cox’s model.Results: A total of 196 patients and 201 lines of treatment were included (median age: 66 (range: 38– 89) years). Types of cancer included non-small cell lung cancer (73%), transitional cell carcinoma (10%), renal cell carcinoma (6%), small cell lung cancer (5%), head and neck squamous cell carcinoma (4%) and classical Hodgkin’s lymphoma (1%). Twenty-five (12%) patients had pre-existing autoimmune conditions. Our standardised management-based protocol included 129 (64%) patients. Objective response rate was 29%, median OS was 10 months (IQR: 7– 15) and median PFS was 5 months (IQR: 1– 22). Patients with an abnormal baseline complete blood count had a worse OS (HR=2.48 [95% CI: 1.24– 4.96]; p=0.0103). Thirty-three (16%) patients experienced severe (grade 3 or 4) immune-related adverse event (irAE). There were three (1%) irAE-related deaths. AEs resolved faster when patients were assessed by an internist before anti-PD-(L)1 initiation (p=0.0205).Conclusion: PD-1 and PD-L1 inhibitors are effective and safe in a real-world setting. Implementation of a standardised management-based protocol with internal medicine specialists is an effective way to optimise irAE management.Keywords: immunotherapy, elderly, PD-1 inhibitor, PD-L1 inhibitor, PDL-1 inhibitor, safety, immune-related adverse events, solid tumours, prognostic biomarkers
format	article
author	Grimaud F Penaranda G Stavris C Retornaz F Brunel V Cailleres S Pegliasco H Le Treut J Grisoni V Coquet E Chiche L Rognon A
author_facet	Grimaud F Penaranda G Stavris C Retornaz F Brunel V Cailleres S Pegliasco H Le Treut J Grisoni V Coquet E Chiche L Rognon A
author_sort	Grimaud F
title	Adverse Events Induced by PD-1/PD-L1 Inhibitors: A Real-World Single-Centre Experience with a Management-Based Approach
title_short	Adverse Events Induced by PD-1/PD-L1 Inhibitors: A Real-World Single-Centre Experience with a Management-Based Approach
title_full	Adverse Events Induced by PD-1/PD-L1 Inhibitors: A Real-World Single-Centre Experience with a Management-Based Approach
title_fullStr	Adverse Events Induced by PD-1/PD-L1 Inhibitors: A Real-World Single-Centre Experience with a Management-Based Approach
title_full_unstemmed	Adverse Events Induced by PD-1/PD-L1 Inhibitors: A Real-World Single-Centre Experience with a Management-Based Approach
title_sort	adverse events induced by pd-1/pd-l1 inhibitors: a real-world single-centre experience with a management-based approach
publisher	Dove Medical Press
publishDate	2021
url	https://doaj.org/article/cf0fa7d1c6224b17bb4974e05a1f4225
work_keys_str_mv	AT grimaudf adverseeventsinducedbypd1pdl1inhibitorsarealworldsinglecentreexperiencewithamanagementbasedapproach AT penarandag adverseeventsinducedbypd1pdl1inhibitorsarealworldsinglecentreexperiencewithamanagementbasedapproach AT stavrisc adverseeventsinducedbypd1pdl1inhibitorsarealworldsinglecentreexperiencewithamanagementbasedapproach AT retornazf adverseeventsinducedbypd1pdl1inhibitorsarealworldsinglecentreexperiencewithamanagementbasedapproach AT brunelv adverseeventsinducedbypd1pdl1inhibitorsarealworldsinglecentreexperiencewithamanagementbasedapproach AT cailleress adverseeventsinducedbypd1pdl1inhibitorsarealworldsinglecentreexperiencewithamanagementbasedapproach AT pegliascoh adverseeventsinducedbypd1pdl1inhibitorsarealworldsinglecentreexperiencewithamanagementbasedapproach AT letreutj adverseeventsinducedbypd1pdl1inhibitorsarealworldsinglecentreexperiencewithamanagementbasedapproach AT grisoniv adverseeventsinducedbypd1pdl1inhibitorsarealworldsinglecentreexperiencewithamanagementbasedapproach AT coquete adverseeventsinducedbypd1pdl1inhibitorsarealworldsinglecentreexperiencewithamanagementbasedapproach AT chichel adverseeventsinducedbypd1pdl1inhibitorsarealworldsinglecentreexperiencewithamanagementbasedapproach AT rognona adverseeventsinducedbypd1pdl1inhibitorsarealworldsinglecentreexperiencewithamanagementbasedapproach
_version_	1718378243930718208

Adverse Events Induced by PD-1/PD-L1 Inhibitors: A Real-World Single-Centre Experience with a Management-Based Approach

Ejemplares similares