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Eur J Cancer. 2018 Mar;91:21-29. doi: 10.1016/j.ejca.2017.12.008. Epub 2018 Jan 10.

Safety and efficacy of anti-programmed death 1 antibodies in patients with cancer and pre-existing autoimmune or inflammatory disease.

Author information

1
Gustave Roussy, Université Paris-Saclay, Département d'Innovation Thérapeutique et d'Essais Précoces, Villejuif, F-94805, France.
2
Unité Fonctionnelle de Pharmacovigilance, Gustave Roussy, F-94800, Villejuif, France.
3
Gustave Roussy, Université Paris-Saclay, Service de Biostatistique et d'Épidémiologie, F-94800, Villejuif, France.
4
Gustave Roussy, Université Paris-Saclay, Département de dermatologie, F-94800, Villejuif, France.
5
Service d'oncologie médicale, Groupe Hospitalier Pitié Salpêtrière, Assistance Publique Hôpitaux de Paris, F-75013, Paris, France.
6
Gustave Roussy, Université Paris-Saclay, Département d'Innovation Thérapeutique et d'Essais Précoces, Villejuif, F-94805, France; Clinical Trials Conduct Unit, Jules Bordet Instituut, B-1000, Brussels, Belgium.
7
Service de médecine interne 2, Groupe Hospitalier Pitié Salpêtrière, Assistance Publique Hôpitaux de Paris, F-75013, Paris, France.
8
Gustave Roussy, Université Paris-Saclay, Département d'oncologie médicale, F-94800, Villejuif, France.
9
Université de Lyon, Université Lyon 1, Hospices Civils de Lyon, Lyon, France.
10
Service de dermatologie, Université de Lyon, Hospices Civils de Lyon, Centre de Recherche en Cancérologie de Lyon, 69495, Pierre Bénite, France.
11
Gustave Roussy, Université Paris-Saclay, Département d'Innovation Thérapeutique et d'Essais Précoces, Villejuif, F-94805, France; INSERM U1015, Gustave Roussy, F-94800, Villejuif, France.
12
Assistance Publique - Hôpitaux de Paris, Hôpital Bicêtre, Service de Médecine Interne et Immunologie Clinique, F-94275, Le Kremlin-Bicêtre, France; INSERM U1184, Immunology of Viral Infections and Autoimmune Diseases, F-94276, Le Kremlin-Bicêtre, France; Université Paris Sud, UMR 1184, F-94276, Le Kremlin-Bicêtre, France; CEA, DSV/iMETI, IDMIT, F-92265, Fontenay-aux-Roses, France. Electronic address: olivier.lambotte@aphp.fr.

Abstract

OBJECTIVE:

Patients with autoimmune or inflammatory disease (AID) are susceptible to immune-related adverse events (irAEs) when treated with immune check-point inhibitors (ICIs). We decided to analyse the safety and effectiveness of anti-PD-1 antibodies in AID patients and look for an association between the presence of pre-existing AID and the clinical outcome.

METHODS:

In a prospective study of the REISAMIC registry of grade ≥2 irAEs occurring in ICI-treated patients, we studied the associations between pre-existing AID on one hand and irAE-free survival, overall survival and best objective response rate on the other.

RESULTS:

We identified 45 patients with 53 AIDs in REISAMIC. The cancer diagnoses included melanoma (n = 36), non-small-cell lung cancer (n = 6) and others (n = 3). The most frequent pre-existing AIDs were vitiligo (n = 17), psoriasis (n = 12), thyroiditis (n = 7), Sjögren syndrome (n = 4) and rheumatoid arthritis (n = 2). Twenty patients (44.4%) presented with at least one irAE: eleven of these were associated with a pre-existing AID ('AID flare'). Treatment with anti-PD-1 antibodies was maintained in 15 of the 20 patients with an irAE. The IrAE-free survival time was significantly shorter in AID patients (median: 5.4 months) than in AID-free patients (median: 13 months, p = 2.1 × 10-4). The AID and AID-free groups did not differ significantly with regard to the overall survival time and objective response rate (p = 0.38 and 0.098, respectively).

CONCLUSION:

In patients treated with anti-PD-1 antibody, pre-existing AID was associated with a significantly increased risk of irAEs. Our results indicate that cancer treatments with anti-PD-1 antibodies are just as effective in AID patients as they are in AID-free patients.

KEYWORDS:

Anti-PD-1 antibody; Autoimmune disease; Cancer; Immunotherapy

PMID:
29331748
DOI:
10.1016/j.ejca.2017.12.008
[Indexed for MEDLINE]

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