Real-world safety and efficacy data of immunotherapy in patients with cancer and autoimmune disease: the experience of the Hellenic Cooperative Oncology Group

Elena Fountzilas, Sofia Lampaki, Georgia-Angeliki Koliou, Anna Koumarianou, Sofia Levva, Anastasios Vagionas, Athina Christopoulou, Athanasios Laloysis, Amanda Psyrri, Ioannis Binas, Giannis Mountzios, Nikolaos Kentepozidis, Athanassios Kotsakis, Emmanouil Saloustros, Anastasios Boutis, Adamantia Nikolaidi, George Fountzilas, Vassilis Georgoulias, Miltiadis Chrysanthidis, Elias Kotteas, Henry Vo, Marinos Tsiatas, Eleni Res, Helena Linardou, Dimitrios Daoussis, Iliada Bompolaki, Anna Andreadou, George Papaxoinis, Dionisios Spyratos, Helen Gogas, Konstantinos N Syrigos, Dimitrios Bafaloukos, Elena Fountzilas, Sofia Lampaki, Georgia-Angeliki Koliou, Anna Koumarianou, Sofia Levva, Anastasios Vagionas, Athina Christopoulou, Athanasios Laloysis, Amanda Psyrri, Ioannis Binas, Giannis Mountzios, Nikolaos Kentepozidis, Athanassios Kotsakis, Emmanouil Saloustros, Anastasios Boutis, Adamantia Nikolaidi, George Fountzilas, Vassilis Georgoulias, Miltiadis Chrysanthidis, Elias Kotteas, Henry Vo, Marinos Tsiatas, Eleni Res, Helena Linardou, Dimitrios Daoussis, Iliada Bompolaki, Anna Andreadou, George Papaxoinis, Dionisios Spyratos, Helen Gogas, Konstantinos N Syrigos, Dimitrios Bafaloukos

Abstract

Background: Data on the safety and efficacy of immune checkpoint inhibitors (ICI) in patients with concurrent autoimmune diseases (AID) are limited.

Methods: We performed a retrospective multicenter review of medical records of patients with cancer and underlying AID who received ICI. The primary endpoint was progression-free survival (PFS).

Results: Among 123 patients with pre-existing AID who received ICI, the majority had been diagnosed with non-small cell lung cancer (NSCLC, 68.3%) and melanoma (14.6%). Most patients had a rheumatologic (43.9%), or an endocrine disorder (21.1%). Overall, 74 (60.2%) patients experienced an immune-related adverse event (irAE) after ICI initiation, AID flare (25.2%), or new irAE (35%). Frequent irAEs included thyroiditis, dermatitis and colitis. ICI was permanently discontinued due to unacceptable (8.1%) or fatal (0.8%) toxicity. In patients with NSCLC, corticosteroid treatment at the initiation of immunotherapy was associated with poor PFS (HR = 2.78, 95% CI 1.40-5.50, p = 0.003). The occurrence of irAE was associated with increased PFS (HR = 0.48, 95% CI 0.25-0.92, p = 0.026). Both parameters maintained their independent prognostic significance.

Conclusions: ICI in patients with cancer and pre-existing AID is associated with manageable toxicity that infrequently requires treatment discontinuation. However, since severe AID flare might occur, expected ICI efficacy and toxicity must be balanced.

Clinical trial identifier: NCT04805099.

Keywords: Autoimmune disease; Corticosteroid; Efficacy; Immune-related adverse events; Immunomodulatory drugs; Non-small cell lung cancer.

Conflict of interest statement

EF: Advisory Role: LEO Pharma. Speaker fees: Roche, Pfizer, AstraZeneca. Stock ownership: GENPREX INC, Deciphera Pharmaceuticals, Inc. Travel grant: Merck, Pfizer, and K.A.M Oncology/Hematology and DEMO. AK: Advisory Role: Genesis Pharma. Honoraria: Pfizer. Speaker’s bureau: Roche. Research Funding: Merck. Travel: MSD. AK: educational grants: Novartis, Pfizer, Merck, Roche, BMS, MSD, Genesis, and Ipsen. AP: Consultation Fees: Amgen, Merck Serono, Roche, BMS, AstraZeneca, MSD. Honoraria: Amgen, Merck Serono, Roche, BMS, AstraZeneca, MSD. Research funds: BMS, Kura. GM: Honoraria/Consultancy: AstraZeneca, Roche, Pfizer, BMS, MSD, Takeda, Boehringer, Merck, Novartis, Amgen, Travel Fees: AstraZeneca, Roche, Pfizer, BMS, MSD, Takeda, Boehringer, Merck, Novartis, Astellas, Pierre Fabre. AK: Consulting or advisory role: Amgen, Roche, BMS, AstraZeneca, MSD, IPSEN. AN: Advisory Board and Speaker fees: Pfizer, Novartis. GF: Advisory Board of Pfizer, Novartis and Roche. Honoraria from AstraZeneca, Genprex stock, Daiichi Sankyo stock. ARIAD stock. RFL Holdings. FORMYCON. HG: Advisory Role: Bristol-Myers Squibb, MSD Oncology, Amgen, Novartis, Roche, Pierre Fabre, Honoraria: Bristol-Myers Squibb, MSD Oncology, Roche, Amgen, Novartis, Research Funding: Bristol-Myers Squibb, Roche, MSD Oncology, Travel: Roche, Bristol-Myers Squibb. The rest of the authors declare no conflict of interest.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
Duration of immunotherapy treatment, toxicity and clinical outcomes of patients treated with immune checkpoint inhibitors
Fig. 2
Fig. 2
Clinical outcomes. (A) Progression-free survival (PFS) based on the use of corticosteroids in the entire cohort, (B) PFS based on the use of corticosteroids in patients with advanced non-small cell lung cancer (NSCLC) and (C) association of the occurrence of immune-related adverse events (irAEs) with PFS in patients with advanced NSCLC
Fig. 3
Fig. 3
Immunotherapy for treatment of patients with cancer and underlying autoimmune disease (AID). The administration of immunotherapy to patients of our study was associated with manageable adverse events that infrequently required permanent discontinuation of treatment. However, since severe flare of the underlying AID might occur in selected patients, expected efficacy and possible toxicity need to be balanced before treatment administration

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Source: PubMed

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