Multiple Immune-Related Adverse Events and Anti-Tumor Efficacy: Real-World Data on Various Solid Tumors.

Immune checkpoint inhibitors (ICIs) have been approved for various types of cancer; however, they cause a broad spectrum of immune-related adverse events (irAEs). The association between the development of irAEs and the clinical benefit remains uncertain. We aimed to evaluate the association of irAEs and the treatment efficacy in real-world practice. We conducted a retrospective study on patients with recurrent or metastatic non-small-cell lung cancer, malignant melanoma, renal cell carcinoma, or gastric cancer who received anti-PD-1/PD-L1 antibodies (nivolumab, pembrolizumab, or atezolizumab) at the Keio University Hospital between September 2014 and January 2019. We recorded treatment-related AEs from medical records and graded them using the Common Terminology Criteria for Adverse Events version 4. We performed an overall survival (OS) analysis using a Cox proportional hazards model and the shared frailty model. Of 212 patients eligible for this study, 108 experienced irAEs and 42 developed multiple irAEs. The median OS was significantly longer in the irAEs than in the no-irAE group (28.1 months vs 12.7 months; hazard ratio [HR], 0.49; 95% confidence interval [CI], 0.33-0.73; P = 0.0004). Moreover, the OS of patients with multiple irAEs was significantly longer than that of patients with a single irAE (42.3 months vs 18.8 months; HR, 0.473; 95% CI, 0.346-0.647; P < 0.0001). Our single-center retrospective study revealed a significant tendency associating the development of multiple irAEs with favorable prognoses.

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© 2020 Shimozaki et al.

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Dr. Sukawa is affiliated to the department funded by Ono Pharmaceutical Co. Ltd. and has received honoraria from Ono Pharmaceutical Co. Ltd. He also received honoraria from Bayer, Bristol Myer Squibb, and Chugai Pharmaceutical. Dr. Mizuno has received honoraria from Ono Pharmaceutical Co. Ltd. and Bristol-Myers Squibb outside the submitted work. Dr. Suzuki has received honoraria from Astra Zeneca, Ono Pharmaceutical Co. Ltd., Bristol-Myers Squibb, MSD Co. Ltd., and Chugai Pharmaceutical Co. Ltd., outside the submitted work. Dr. Funakoshi has received honoraria from Ono Pharmaceutical Co. Ltd., Bristol-Myers Squibb, and MSD Co. Ltd., and grants from Ono Pharmaceutical Co. Ltd., outside the submitted work. He also reports non-financial support from Chugai Pharmaceutical Co., Ltd. Dr. Hamamoto has received honoraria from Ono Pharmaceutical Co. Ltd., Bristol-Myers Squibb, and Chugai Pharmaceutical Co. Ltd., outside the submitted work. Dr. Kanai has received honoraria from Ono Pharmaceutical Co. Ltd., Bristol-Myers Squibb, MSD Co. Ltd., and Chugai Pharmaceutical Co. Ltd, and has received designated donations from Ono Pharmaceutical Co. Ltd., and Chugai Pharmaceutical Co. Ltd., outside the submitted work. The authors report no other conflicts of interest in this work.