Cited by 32Cancer Immunotherapy and BiomarkersImmunotherapy and Immune ResponsesPharmacovigilance and Adverse Drug Reactions

Correlation between immune-related adverse events (irAEs) and efficacy in patients with solid tumors treated with immune-checkpoints inhibitors (ICIs).

Riudavets, Mariona, Barba, Andrés, Maroto, Pablo, SULLIVAN, IVANA GABRIELA, Anguera, Georgia, Páez, David, del Carpio, Luis, Callejo, Ana +12 more·2018·Journal of Clinical Oncology

Abstract

3064 Background: ICIs are associated with irAEs. We describe the incidence of irAEs in patients with solid tumors receiving ICIs and its correlation with efficacy. Methods: We retrospectively analyzed all patients with solid tumors receiving ICIs in our center. IrAEs were graded according CTCAE v4.0. Kaplan Meier and log-rank tests were used to evaluate progression-free (PFS) and overall survivals (OS). Analyses were performed using SPSS v24 package. Results: From March 2014 to January 2018, 178 patients received ICIs. Median age was 64.1 [33-88] years, 72% were male. Most frequent tumors were lung (63.5%), bladder (14.6%) and melanoma (11.8%). 96% presented advanced disease. Most common used ICIs were nivolumab (38.2%), pembrolizumab (28.7%) and atezolizumab (17.4%). ICIs were used as monotherapy (74.7%) or in combination with ICI (3.4%), chemotherapy (17.4%) or targeted therapies (4.5%). Median duration of immunotherapy was 6.9 [0.7-46.3] months. 95 (53.4%) patients developed 158 irAEs with a median number per patient of 1.2 [0-4]. Most frequent irAE was rash (24.7%) followed by diarrhea (17.7%), hypothyroidism (9.5%), arthritis (6.9%), hyperthyroidism (3.8%), pneumonitis (3.2%) and mucositis (3.2%). Median time to the onset irAEs was 53.2 [11-490] days. 12 (6.7%) patients presented grade (G) 3-4 irAEs: 5 G-3 diarrhea, 2 G-3-4 liver dysfunction, 1 G-3 pneumonitis, 1 G-3 hypopituitarism, 1 G-3 mucositis, 1 G-3 arthritis and 1 G-3 nephritis. There were 2 (1.1%) treatment-related deaths due to pneumonitis. 21.3% patients required steroids for irAEs management. 8.4% patients discontinued treatment due to irAEs. 73.9% irAEs had improved at the time of analysis. OS was superior in patients with advanced disease experiencing irAEs: 37.3 [95%CI, 19.2-51.4] vs 7.8 [95%CI, 4.9-10.8] months (p < 0.0001). Similarly, PFS was longer: 7.9 [95%CI, 4.4-11.4] vs 2.6 [95%CI, 2.0-3.2] months (p < 0.0001). Conclusions: There was a significant correlation between presence of irAEs and outcomes in patients with advanced solid tumors treated with ICIs.

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Crossref · 10.1200/jco.2018.36.15_suppl.3064

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  • Across disease sites, patients who experience IRAEs while on therapy with anti-PD-1 and anti-PD-L1 antibodies have been documented to experience improved outcomes as measured by overall response rate, progression-free survival and overall survival.

    “Across disease sites, patients who experience IRAEs while on therapy with anti-PD-1 and anti-PD-L1 antibodies have been documented to experience improved outcomes as measured by overall response rate (ORR), progression-free survival (PFS) and overall survival (OS) [13–20].”

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Authors
Riudavets, M., Barba, A., Maroto, P., SULLIVAN, I. G., Anguera, G., Páez, D., del Carpio, L., Callejo, A., Gonzalez Blanco, C., Garcia Planellas, E., Castillo, D., Facundo, C., Genua, I., Martin Lorente, C., Virgili, A., Sebio, A., Gallego, O., Lopez-Pousa, A., Barnadas, A., & Majem, M.
Affiliations
  • Hospital de Sant Pau (ES)
  • Hospital de la Santa Creu i Sant Pau, Barcelona, Spain;
  • Puigvert Foundation (ES)
  • Hospital de la Santa Creu i Sant Pai, Barcelona, Spain;
  • Hospital Sant Pau, Barcelona, Spain;
  • Universitat Autònoma de Barcelona (ES)
Venue
Journal of Clinical Oncology
Published
2018-05-20
Volume
36
Issue
15_suppl
Pages
3064-3064
ISSN
  • 0732-183X (ISSN-L)
  • 1527-7755
OpenAlex
W2891948100
Cited by
32
References
0
Citations by year
2025: 4 · 2024: 1 · 2023: 3 · 2022: 6 · 2021: 8 · 2020: 5 · 2019: 5
Type
conference abstract
Language
en
Open access
closed
Locations
Journal of Clinical Oncology (publishedVersion)
Topics
  • Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
  • Life Sciences › Immunology and Microbiology › Immunology › Immunotherapy and Immune Responses
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
Keywords
immune-related adverse events, immune checkpoint inhibitors, solid tumors, immune-related pneumonitis, non-relapse mortality, progression-free survival, overall survival, nivolumab, pembrolizumab, atezolizumab, corticosteroid therapy, rash, diarrhea, hypothyroidism, liver dysfunction, pneumonitis, immunotherapy efficacy

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