2019
DOI: 10.1001/jamaoncol.2019.1022
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Evaluation of Readministration of Immune Checkpoint Inhibitors After Immune-Related Adverse Events in Patients With Cancer

Abstract: IMPORTANCE Although immune checkpoint inhibitors (ICIs), such as anti-PD-1 (programmed cell death 1) or anti-PD-L1 (programmed cell death 1 ligand 1), have proved effective in treating many cancers, patients receiving ICIs may experience immune-related adverse events (irAEs). Little evidence exists on the safety of resuming these treatments after an irAE. OBJECTIVE To investigate the safety of a rechallenge with anti-PD-1 or anti-PD-L1 immunotherapies after an irAE. DESIGN, SETTING, AND PARTICIPANTS This cohor… Show more

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Cited by 309 publications
(251 citation statements)
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“…Rechallenging patients with ICIs after discontinuation for toxicity resulted in another irAE (new or recurrent) in 50% of patients with mRCC, which was similar to published data from small series in melanoma, NSCLC, lymphoma and other solid tumors (50%-55%). [17][18][19] However, these irAEs appear to be manageable with no grade 4 toxicity or treatment-related deaths in our experience. Clinicians were no doubt more vigilant about toxicity monitoring in patients retreated with ICIs, and, in our study, tended to discontinue therapy on new or recurrent onset of irAEs after retreatment (72.2%), irrespective of the irAE grade.…”
Section: Discussionmentioning
confidence: 60%
See 1 more Smart Citation
“…Rechallenging patients with ICIs after discontinuation for toxicity resulted in another irAE (new or recurrent) in 50% of patients with mRCC, which was similar to published data from small series in melanoma, NSCLC, lymphoma and other solid tumors (50%-55%). [17][18][19] However, these irAEs appear to be manageable with no grade 4 toxicity or treatment-related deaths in our experience. Clinicians were no doubt more vigilant about toxicity monitoring in patients retreated with ICIs, and, in our study, tended to discontinue therapy on new or recurrent onset of irAEs after retreatment (72.2%), irrespective of the irAE grade.…”
Section: Discussionmentioning
confidence: 60%
“…The literature is scarce regarding restarting ICI therapy after recovery from high-grade irAEs and is mostly derived from experiences in melanoma and non-small cell lung cancer (NSCLC), with no reported studies in RCC. [16][17][18][19][20] The overarching objective of this international, multicenter collaboration was to characterize the safety and efficacy of restarting ICI therapy after a clinically significant irAE, defined as one requiring treatment interruption or discontinuation, in patients with mRCC.…”
Section: Introductionmentioning
confidence: 99%
“…In the case of immunotherapy, the mechanism of action, involving resetting the immune memory, and the possibility of predicting clinical response from biomarkers [21,22], the notion of a second course of immunotherapy is an attractive one. Retreatment with PD-1 inhibitor, as a subsequent therapy, has been reported in limited numbers of patients in randomised clinical trials of nivolumab or pembrolizumab in NSCLC [19,23,24] and there are a limited number of reports of rechallenge with immunotherapy, which have generally involved small numbers of patients [25][26][27][28][29][30][31]. Regarding the relative benefit of rechallenge compared to the initial treatment course, the available data are encouraging [27,28] even though no definitive conclusions can be drawn given the limited experience and the heterogeneity in the definitions of retreatment and in the protocols used.…”
mentioning
confidence: 99%
“…Regarding the relative benefit of rechallenge compared to the initial treatment course, the available data are encouraging [27,28] even though no definitive conclusions can be drawn given the limited experience and the heterogeneity in the definitions of retreatment and in the protocols used. Importantly, in patients restarting PD-1 inhibitor after discontinuation due to the occurrence of an adverse event, safety seems acceptable [29,30].…”
mentioning
confidence: 99%
“…The drug-free period is recommended until the symptoms are resolved and the eventual steroid treatment is completed. According to the results of retrospective studies patients who restarted ICIs had a 30-60% of risk of recurrence of the same irAE or of a new one; no clear benefit in terms of progression-free survival, or overall survival, were demonstrated [18][19][20][21]. For grade ≥ 2 diarrhea/colitis, American Society of Clinical Oncology (ASCO) and European Society for Medical Oncology (ESMO) guidelines recommend high dose steroid-therapy or infliximab in case of steroid-refractory diarrhea [3,13].…”
Section: Treatment Of Gastrointestinal Toxicitymentioning
confidence: 99%