Safety of Neoadjuvant Immunotherapy in Resectable Cancers: A Meta-Analysis
Jiawei Xu1, Yongfeng Wu2, Yuedan Xu1
1Stomatology Hospital, School of Stomatology, Zhejiang University School of Medicine, Zhejiang Provincial Clinical Research Center for Oral Diseases, Key Laboratory of Oral Biomedical Research of Zhejiang Province, Cancer Center of Zhejiang University, Hangzhou, China.
Background:
Neoadjuvant immunotherapy has preliminarily been effective in multiple resectable cancers. However, its safety is still largely unknown.
Methods:
A systematic literature search was conducted in PubMed, Embase, Web of Science, and Cochrane Library up to February 28th, 2021. Pooled incidence and risk ratio (RR) of adverse events were calculated using the R software.
Results:
Twenty-eight studies involving 2863 patients were included. First, the incidence for all-grade treatment-related adverse events (trAEs) was 94% (95% CI, 81%-98%), with 43% (95% CI, 24%-64%) for high-grade trAEs. For different treatment groups, neoadjuvant immune checkpoint inhibitors (ICIs) plus chemotherapy was associated with a higher incidence of all-grade [99% (95% CI, 98%-99%) vs. 76% (95% CI 47%-92%); P < 0.001] and high-grade [80% (58%-92%) vs. 15% (9%-24%); P < 0.001] trAEs compared with neoadjuvant ICIs alone. The most common high-grade trAEs were lipase increased (5%; 95% CI, 2%-10%), colitis (3%; 95% CI, 0-7%) and transaminitis (3%; 95% CI, 0-7%) for neoadjuvant ICIs, and neutropenia (53%; 95% CI, 31%-74%), anemia (8%; 95% CI, 3%-15%) and AST increased (4%; 95% CI, 2%-7%) for neoadjuvant ICIs plus chemotherapy. Furthermore, the incidence rates of progressive disease while on treatment, treatment-related surgical delays and deaths were 6% (95% CI, 4%-10%), 3.2% (12 of 377 patients) and 0.47% (5 of 1075 patients), respectively.
Conclusion:
Compared with neoadjuvant ICIs alone, neoadjuvant ICIs plus chemotherapy had a higher incidence of trAEs. In addition, neoadjuvant immunotherapy had a low rate of progressive diseases, surgical delays and deaths.
Insights
Neoadjuvant immunotherapy is effective but carries risks. Combining immune checkpoint inhibitors (ICIs) with chemotherapy significantly increases treatment-related adverse events (trAEs) compared to ICIs alone.
Area of Science:
- Oncology
- Immunotherapy
- Clinical Trials
Background:
- Neoadjuvant immunotherapy shows promise in resectable cancers.
- The safety profile of neoadjuvant immunotherapy remains largely uncharacterized.
Purpose of the Study:
- To systematically evaluate the safety and incidence of adverse events associated with neoadjuvant immunotherapy.
- To compare the safety of neoadjuvant immune checkpoint inhibitors (ICIs) alone versus ICIs plus chemotherapy.
Main Methods:
- A systematic literature search was performed across major databases (PubMed, Embase, Web of Science, Cochrane Library) up to February 2021.
- Pooled incidence and risk ratios of adverse events were calculated using R software.
Main Results:
- Twenty-eight studies with 2863 patients were analyzed.
- Overall incidence of all-grade treatment-related adverse events (trAEs) was 94%, and high-grade trAEs was 43%.
- Neoadjuvant ICIs plus chemotherapy showed significantly higher all-grade (99% vs. 76%) and high-grade (80% vs. 15%) trAEs compared to ICIs alone.
- Common high-grade trAEs included neutropenia (53%) with combination therapy and lipase increase (5%) with ICIs alone.
- Incidence of progressive disease, surgical delays, and deaths were low (6%, 3.2%, and 0.47%, respectively).
Conclusions:
- Neoadjuvant ICIs plus chemotherapy is associated with a higher incidence of trAEs than neoadjuvant ICIs alone.
- Neoadjuvant immunotherapy demonstrates a low rate of progressive disease, surgical delays, and treatment-related deaths.
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