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Correlation between immune-related adverse events and prognosis in patients with various cancers treated with anti
Hiroshi Matsuoka1, Takahiro Hayashi2, Karen Takigami2
1Department of Surgery Fujita Health University, Dengakugakubo 1-98, Kutsukake-cho, Toyoake City, Aichi, Japan. mats1025@fujita-hu.ac.jp.
Background:
Immune checkpoint inhibitors (ICIs) targeting programmed cell death protein 1 (PD-1) are used for the treatment of various cancer types. However, immune-related adverse events (irAEs) occur in patients treated with ICIs. Several small-scale studies have reported the onset of irAEs and therapeutic effects of ICIs. Here we report a large-scale retrospective study covering a wide range of cancers. We evaluated irAEs and the therapeutic effects of ICIs and determined whether irAEs could be predicted.
Methods:
This study included patients treated with the anti-PD-1 antibodies nivolumab or pembrolizumab at Fujita Health University Hospital between December 2015 and March 2019. We retrospectively reviewed the electronic medical records for age, cancer type, pre-treatment blood test data, presence or absence of irAE onset, type and severity of irAEs, outcome of irAE treatment, response rate, progression-free survival and overall survival.
Results:
Two hundred-eighty patients received ICIs. The overall incidence of irAEs was 41.1% (115 patients), and the incidence of severe irAEs of grade 3 and higher was 2.8% (eight patients). The most common irAEs were skin disorders, thyroid disorders and interstitial pneumonitis. Patients with irAEs were significantly older than those without irAEs (69.7 versus 66.0 years, P = 0.02). The objective response rate (ORR) in patients with irAEs was 30.4%, which was significantly higher than in patients without irAEs (12.7%; P < 0.01). Both the median overall and progression-free survival were significantly longer in patients with irAEs (P < 0.01, p < 0.01). Based on the blood test data obtained before ICI therapy, hypothyroidism, thyroid-stimulating hormone levels and thyroglobulin antibody levels were associated with the onset of irAEs. In many patients with irAEs of Common Terminology Criteria for Adverse Events Grade 3 or higher, re-administration of ICIs was difficult, and their outcomes were poor. In contrast, many patients with irAEs of a lower grade were able to resume ICI therapy.
Conclusion:
Although the onset of irAEs was difficult to be predicted based on pre-treatment tests. It appeared that the continuation of ICI therapy, along with early detection and adequate control of irAEs, might contribute to the improved prognosis of patients.
Insights
Immune checkpoint inhibitors (ICIs) improve cancer prognosis, but can cause immune-related adverse events (irAEs). Early detection and management of irAEs are crucial for patient outcomes, even if prediction remains challenging.
Area of Science:
- Oncology
- Immunology
- Clinical Medicine
Background:
- Immune checkpoint inhibitors (ICIs) targeting programmed cell death protein 1 (PD-1) are vital cancer therapies.
- Immune-related adverse events (irAEs) are common side effects of ICIs.
- Previous studies on irAEs and ICI efficacy were small-scale.
Purpose of the Study:
- To evaluate irAEs and therapeutic effects of ICIs in a large patient cohort.
- To determine if irAEs can be predicted before ICI treatment.
Main Methods:
- Retrospective review of 280 patients treated with nivolumab or pembrolizumab.
- Analysis of electronic medical records for patient demographics, cancer type, pre-treatment blood tests, irAEs, and survival outcomes.
Main Results:
- 41.1% of patients experienced irAEs; 2.8% had severe (Grade 3+) irAEs.
- Patients with irAEs were older and had significantly higher objective response rates, progression-free survival, and overall survival.
- Pre-treatment hypothyroidism and thyroid antibodies were associated with irAE onset.
- Severe irAEs often precluded further ICI treatment, leading to poor outcomes.
Conclusions:
- While irAEs are difficult to predict pre-treatment, their early detection and management are critical.
- Continuing ICI therapy, alongside effective irAE control, may improve patient prognosis.
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