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Poster Discussion session - Immunotherapy of cancer 2

3757 - Association between immune-related adverse events and efficacy in patients treated with anti-PD-(L)1


22 Oct 2018


Poster Discussion session - Immunotherapy of cancer 2


Management of Systemic Therapy Toxicities;  Immunotherapy;  Supportive Care and Symptom Management

Tumour Site


Maria Kfoury


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


M. Kfoury1, A. Voisin2, M. Najean3, S. Champiat1, S. Laghouati2, J. Michot1, C. Robert4, C. Mateus4, L. Albiges5, B. Besse5, C. Massard1, M. Texier6, O. Lambotte7, A. Marabelle8

Author affiliations

  • 1 Drug Development Department, Institut Gustave Roussy, 94805 - Villejuif/FR
  • 2 Pharmacovigilance Unit, Institut Gustave Roussy, 94805 - Villejuif/FR
  • 3 Department Of Biostatistics And Epidemiology, Institut Gustave Roussy, 94805 - Villejuif/FR
  • 4 Department Of Dermatology, Institut Gustave Roussy, 94800 - Villejuif/FR
  • 5 Department Of Medical Oncology, Institut Gustave Roussy, 94805 - Villejuif/FR
  • 6 Department Of Biostatistics And Epidemiology, Institut Gustave Roussy, 94800 - Villejuif/FR
  • 7 Department Of Internal Medicine And Clinical Immunology, Hôpital Bicêtre, 94270 - Le Kremlin-Bicêtre/FR
  • 8 Drug Development Department, Institut Gustave Roussy, 94800 - Villejuif/FR


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Abstract 3757


Immune-related adverse events (irAE) have been associated with the efficacy of anti-PD-(L)1 in melanoma and non-small cell lung cancer patients (NSCLC). We aimed to confirm such correlation in our cohort of patients treated with anti-PD(L)1.


Patients treated at Gustave Roussy from June 2014 to October 2017 with anti-PD(L)1 have been included in our pharmacovigilance database REISAMIC. To assess the association between irAEs and overall survival (OS) and progression free survival (PFS), a landmark analysis was performed using a timepoint at 12 weeks. Kaplan-Meier curves with the log-rank test and multivariable analysis with Cox proportional hazard regression models were used.


In a cohort of 618 patients (median [range] age 63,5 years [16-72], men/women ratio was 353/265. 599 patients were treated with anti-PD-1 (96.9%) and 19 with anti-PD-L1 (3.1%), for melanoma (56.3%), NSCLC (37.1%), urothelial carcinoma (2.5%), and renal cell carcinoma (1.6%). Grade ≥ 2 irAEs were observed in 175 patients (28,3%) (irAE+) including 49 with 2 or more irAEs (7.9%). There was 65 (10,5%) high grade irAEs and 55 (8.9%) required systemic steroid or immunosuppressive therapy. The main irAEs observed included skin toxicities (40%), thyroiditis (29.1%), colitis (14.9%), hepatopathies (8%), pneumonitis (7.4%). Median time on anti-PD-(L)1 was 3,9 months [0.13-31.5] and median time off subsequent systemic treatment was 1.8 months [0-40.2]. 51 patients discontinued therapy due to severe irAE. Among these 51 patients, ORR was observed in 30 patients, 37 had PFS > 6 months, 17 had PFS > 12 months and 31 had been off treatment for > 6 months. 600 patients were evaluable for ORR: 90/171 (52.6%) of patients who experienced irAE had an ORR versus 77/429 (18.0%) of those who did not, with greater ORR ratio in patients who presented 3 or more irAEs: 15/17 (88%). ORR did not seem to differ according to irAE grade nor the use of steroids for irAE. Median OS was 9.7 months (IC95%, 8.4-11.3) and median PFS was 4.83 months (IC 95%, 4.07-5.45).


Patients that experienced irAE seem to have clinical benefit and greater ORR. Results of OS and PFS according to the development of irAE in 12-week landmark analysis will be presented at the ESMO conference.

Clinical trial identification

Legal entity responsible for the study

Institut Gustave Roussy.


Has not received any funding.

Editorial Acknowledgement


All authors have declared no conflicts of interest.

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