The 2016-2019 ImmunoTOX Assessment Board Report: Results from a Descriptive Real-Life Study of a Collaborative Management of Immune-Related Adverse Events Induced by Immune Checkpoint Inhibitors - European Medical Journal
×

Browse

The 2016-2019 ImmunoTOX Assessment Board Report: Results from a Descriptive Real-Life Study of a Collaborative Management of Immune-Related Adverse Events Induced by Immune Checkpoint Inhibitors

Authors:
Jean-Marie Michot
Disclosure:

Principal/sub-Investigator of clinical trials for: Abbvie, Aduro, Agios, Amgen, Argen-x, Astex, AstraZeneca, Aveo pharmaceuticals, Bayer, Beigene, Blueprint, BMS, Boeringer Ingelheim, Celgene, Chugai, Clovis, Daiichi Sankyo, Debiopharm, Eisai, Eos, Exelixis, Forma, Gamamabs, Genentech, Gortec, GSK, H3 biomedecine, Incyte, Innate Pharma, Janssen, Kura Oncology, Kyowa, Lilly, Loxo, Lysarc, Lytix Biopharma, Medimmune, Menarini, Merus, MSD, Nanobiotix, Nektar Therapeutics, Novartis, Octimet, Oncoethix, Oncopeptides AB, Orion, Pfizer, Pharmamar, Pierre Fabre, Roche, Sanofi, Servier, Sierra Oncology, Taiho, Takeda, Tesaro, and Xencor. Personal fees (money paid for services rendered, generally honoraria, royalties or fees for consulting, lectures, speakers bureaus, expert testimony, employment, ad-boards, etc.): Celgene, Bristol-Myers Squibb, AstraZeneca, and Janssen. Non-financial support (drugs, equipment supplied by the entity, travel paid by the entity, writing assistance, administrative support, etc.): AstraZeneca, Roche, Novartis, Gilead, Celgene, and Bristol-Myers Squibb.

Acknowledgements:

The author would like to thank the patients, the patients’ families, and all the study investigators and personnel. The author also thanks David Fraser (Biotech Communication SARL, Ploudalmézeau, France) for his precious and much appreciated copy-editing assistance. Lastly, the author thanks Janine Nda, Cécile Geniez, Stéphanie Demirdjian, and Sandrine Thorel for their assistance with patient management, and Alexandre Maria and Julie Perrin for their contributions and referral advice.

Support:

Immune-related adverse event (irAE), multidisciplinary collaborative approach, patient care network.

Citation
EMJ Oncol.. ;7[1]:46-47. Abstract No AR04.

Each article is made available under the terms of the Creative Commons Attribution-Non Commercial 4.0 License.

BACKGROUND

Although immunotherapy is better tolerated globally than chemotherapy, immune checkpoint inhibitors may be associated with immune-related adverse events (irAE), characterised by their diversity, unpredictability, and corticosteroid responsiveness.1,2 The author investigated the ImmunoTOX meeting’s activities: a multidisciplinary real life and case-by-case approach to manage irAE and capture the salient medical needs in the management of immunological toxicities.

METHODS

The ImmunoTOX assessment board is an academic, multidisciplinary group of oncologists and organ specialists that was set up in April 2016 at Gustave Roussy cancer centre in France. The board meets every 2 weeks to discuss the case-by-case management of patients presenting with irAE. This report describes ImmunoTOX’s meeting activities between 6th April 2016 and 2nd January 2019.

Figure 1: Distribution of irAE organ categories considered by the ImmunoTOX assessment board. In the figure, only irAE that occurred in three or more patients are shown.
CLS: capillary leak system; CRS: cytokine release syndrome; GB syndrome: Guillain-Barré syndrome; irAE: immune-related adverse event.

RESULTS

Over the 32 months of study period, 398 requests concerning 356 patients were submitted to the ImmunoTOX board. The most common tumour types of patients were thoracic cancers (n=105, 29%), skin cancers (n=82, 23%), and renal carcinomas (n=28, 8%). The requests most frequently asked were causal link between immunotherapy and adverse event (n=148, 37%), the possibility for retreatment after hold due to previous adverse event (n=109, 27%), the clinical management of complex situation (n=100, 25%), and the initiation of immunotherapy in patients with pre-existing comorbidities (n=41, 10%). The ImmunoTOX board found a relationship between immunotherapy and adverse event in 273 (77%) of the 356 patients. The organ systems most frequently involved by irAE were the lung (n=58, 21%), gastrointestinal tract (n=36, 13%), liver or biliary tract (n=33, 12%), musculoskeletal system (n=27, 10%), and nervous system (n=23, 8%). The retreatment by immunotherapy after holding due to previous adverse event and the initiation of immunotherapy in patients with pre-existing autoimmune comorbidities were assessed as precaution for use and not formally contraindication in 65% and 93% of the cases, respectively.

CONCLUSION

The medical needs in the management of immune-related adverse events involves five salient organ systems, namely the lung, gastrointestinal, liver and biliary tract, musculoskeletal, and nervous systems. Retreatment after holding due to previous adverse events and immunotherapy initiation in patients with autoimmune comorbidities were mostly assessed as precaution for use and not formal contraindication. A multidisciplinary and case by case approach can be helpful and complementary of general guidelines in the management of immunological toxicities.

References
Postow MA et al. Immune-related adverse events associated with immune checkpoint blockade. N Engl J Med. 2018;378:158-68. Weber JS et al. Safety profile of nivolumab monotherapy: A pooled analysis of patients with advanced melanoma. J Clin Oncol. 2017;35(7):785-92.