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Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research

762 - Incidence of Immune Related Adverse Events in patients 70 years old treated with anti-PD-(L)1 therapy

Date

20 Oct 2018

Session

Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research

Topics

Immunotherapy;  Geriatric Oncology;  Supportive Care and Symptom Management

Tumour Site

Presenters

Capucine Baldini

Citation

Annals of Oncology (2018) 29 (suppl_8): viii400-viii441. 10.1093/annonc/mdy288

Authors

C. Baldini1, P. Martin-Romano2, A. Voisin3, F.X. Danlos2, S. Champiat4, S. Laghouati5, M. Kfouri1, H. Vincent6, C. Nagera6, S. Postel-Vinay7, A. Varga8, V. Ribrag2, B. Besse9, A. Hollebecque10, O. Lambotte11, J. Michot12, J. Soria13, C. Massard14, A. Marabelle15

Author affiliations

  • 1 Drug Development Department (ditep), Gustave Roussy, 94800 - VILLEJUIF/FR
  • 2 Drug Development, Institut Gustave Roussy, 94800 - Villejuif/FR
  • 3 Pharmacovigilance Unit, Gustave Roussy Institute, 94805 - Villejuif/FR
  • 4 Drug Development Department (ditep), Gustave Roussy, 94805 - Villejuif/FR
  • 5 Pharmacovigilance Unit, Institut Gustave Roussy, 94805 - Villejuif/FR
  • 6 Medical Oncology, Gustave Roussy, 94800 - Villejuif/FR
  • 7 Drug Development Department (ditep), Institut Gustave Roussy, 94800 - Villejuif/FR
  • 8 Ditep, Gustave Roussy, 94805 - Villejuif/FR
  • 9 Dept Of Cancer Medicine, Gustave Roussy Institut de Cancérologie, 94805 - Villejuif/FR
  • 10 Drug Development Department (ditep: Département D'innovations Thérapeutiques Et Essais Précoces), Institut Gustave Roussy, 94800 - Villejuif/FR
  • 11 Ile De France, hôpital kremlin bicetre, 94800 - kremlin bicetre/FR
  • 12 Drug Developpement Department, Institut Gustave Roussy, 94800 - Villejuif/FR
  • 13 Ditep, Medimmune, 20878 - Gaithersburg/US
  • 14 Ditep, Gustave Roussy Institut de Cancérologie, 94805 - Villejuif/FR
  • 15 Drug Development Department, Institut Gustave Roussy, 94800 - Villejuif/FR
More

Resources

Abstract 762

Background

Advanced age is an important risk factor of cancer and is associated with poor prognosis. Changes in the immune system called immunosenescence may occur with older age. However, the impact of aging on efficacy and safety of immune checkpoint inhibitors (ICI), such as anti-PD(L)1, remains undetermined.

Methods

Patients with advanced solid tumours treated with an anti-PD(L)1 agent monotherapy between June 2014 and October 2017 and prospectively included within the Gustave Roussy ICI-dedicated pharmacovigilance registry REISAMIC (Registre des Effets Indésirables Sévères des Anticorps Monoclonaux Immunomodulateurs en Cancérologie) were retrospectively reviewed. Incidence of immune-related adverse events (irAEs) of grade ≥2 was compared between patients aged ≥ 70 and < 70 years old using Chi-squared test.

Results

Among the 615 patients included in the analysis, 191 were ≥ 70 years old (OP) and 424 < 70 years old (YP). The median age of OP and YP were respectively 77 (70 - 93) and 59 (17 - 69). A total of 165 irAEs were included in the analysis (103 Grade 2 and 58 Grade 3-4). The overall occurrence of irAEs grade ≥ 2 was higher in OP compared to YP (33% versus 25%, p = 0.03). Statistical significance was lost when stratifying irAEs according to their severity grade, suggesting that this effect was constant whatever the grade (p = 0.08 for Grade 2 and p = 0.13 for Grade 3-4). Anti-PD(L)1-related deaths were registered in 1 OP and 3 YP (0.5% and 0.7% respectively; NS). The most frequent organs toxicities in OP were skin rash (49%), endocrine (14%), hepatic (10%); it was skin rash (28%), endocrine (25%), digestive (15%) in YP. Median time to toxicity was similar between the two groups (7 weeks in YP and 6 weeks in OP, p = 0.31).

Conclusions

Anti-PD(L)1 immunotherapies are an acceptable treatment option for OPs, by being aware that immune related adverse events are more frequent in this population. Further dedicated studies are warranted to explore prospectively immune-related safety in OPs. Impact: Older patients should be monitored closely as they may be at risk of increased significant immune-related toxicity compared to their younger counterparts.

Clinical trial identification

Legal entity responsible for the study

C. Baldini.

Funding

Has not received any funding.

Editorial Acknowledgement

Disclosure

S. Champiat: Consulting: AstraZeneca, BMS, MSD, Roche, Janssen, Novartis. J-C. Soria: Employee: AstraZeneca Medimmune; Honoraria, Advisory role: Astex, Clovis, GSK, Gammamabs, Lilly, MSD, Merus, Pfizer, Pharmamar, Pierre Fabre, Roche Genentech, Sanofi, Servier, Takeda. C. Massard: Honoraria, Consultancy fees: Sanofi, Janssen, Astellas, Genetech, Orion, Medimmune, Ipsen. A. Marabelle: Honoraria, Consultancy fees: AstraZeneca, BMS, Merck, Sanofi, Janssen, Astellas, Genetech, Orion, Medimmune, Ipsen. All other authors have declared no conflicts of interest.

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