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. 2021 Jun 30:17:669-677.
doi: 10.2147/TCRM.S308194. eCollection 2021.

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 Rognon  1
Affiliations

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

Fabien Grimaud et al. Ther Clin Risk Manag. .

Abstract

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.

Keywords: PD-1 inhibitor; PD-L1 inhibitor; PDL-1 inhibitor; elderly; immune-related adverse events; immunotherapy; prognostic biomarkers; safety; solid tumours.

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Conflict of interest statement

The authors reported no conflicts of interest for this work.

Figures

Figure 1
Figure 1
Overall survival and progression-free survival curves according to occurrence of adverse events (A and B), age < or ≥70 years (C and D) and abnormal complete blood count (E and F). p values correspond to univariate analyses.
See this image and copyright information in PMC

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