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

AIM: 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 databa...

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Autores principales: Grimaud, Fabien, Penaranda, Guillaume, Stavris, Chloé, Retornaz, Frédérique, Brunel, Véronique, Cailleres, Sylvie, Pegliasco, Hervé, Le Treut, Jacques, Grisoni, Vincent, Coquet, Emilie, Chiche, Laurent, Rognon, Amélie
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Dove 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8256379/
https://www.ncbi.nlm.nih.gov/pubmed/34234443
http://dx.doi.org/10.2147/TCRM.S308194
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author Grimaud, Fabien
Penaranda, Guillaume
Stavris, Chloé
Retornaz, Frédérique
Brunel, Véronique
Cailleres, Sylvie
Pegliasco, Hervé
Le Treut, Jacques
Grisoni, Vincent
Coquet, Emilie
Chiche, Laurent
Rognon, Amélie
author_facet Grimaud, Fabien
Penaranda, Guillaume
Stavris, Chloé
Retornaz, Frédérique
Brunel, Véronique
Cailleres, Sylvie
Pegliasco, Hervé
Le Treut, Jacques
Grisoni, Vincent
Coquet, Emilie
Chiche, Laurent
Rognon, Amélie
author_sort Grimaud, Fabien
collection PubMed
description AIM: 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.
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spelling pubmed-82563792021-07-06 Adverse Events Induced by PD-1/PD-L1 Inhibitors: A Real-World Single-Centre Experience with a Management-Based Approach Grimaud, Fabien Penaranda, Guillaume Stavris, Chloé Retornaz, Frédérique Brunel, Véronique Cailleres, Sylvie Pegliasco, Hervé Le Treut, Jacques Grisoni, Vincent Coquet, Emilie Chiche, Laurent Rognon, Amélie Ther Clin Risk Manag Original Research AIM: 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. Dove 2021-06-30 /pmc/articles/PMC8256379/ /pubmed/34234443 http://dx.doi.org/10.2147/TCRM.S308194 Text en © 2021 Grimaud et al. https://creativecommons.org/licenses/by-nc/3.0/This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/ (https://creativecommons.org/licenses/by-nc/3.0/) ). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms (https://www.dovepress.com/terms.php).
spellingShingle Original Research
Grimaud, Fabien
Penaranda, Guillaume
Stavris, Chloé
Retornaz, Frédérique
Brunel, Véronique
Cailleres, Sylvie
Pegliasco, Hervé
Le Treut, Jacques
Grisoni, Vincent
Coquet, Emilie
Chiche, Laurent
Rognon, Amélie
Adverse Events Induced by PD-1/PD-L1 Inhibitors: A Real-World Single-Centre Experience with a Management-Based Approach
title 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_short 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
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8256379/
https://www.ncbi.nlm.nih.gov/pubmed/34234443
http://dx.doi.org/10.2147/TCRM.S308194
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