J Cancer 2019; 10(1):120-130. doi:10.7150/jca.28120 This issue

Research Paper

Incidence of Ipilimumab-Related Serious Adverse Events in Patients with Advanced Cancer: A Meta-Analysis

Chang-Ying Guo1,2,3*, Si-Cong Jiang3*, Yu-Kang Kuang1, Hao Hu1✉

1. Department of Thoracic Surgery, Jiangxi Cancer Hospital, People's Republic of China.
2. Department of Thoracic Surgery, Ji'an Central Hosipital, People's Republic of China.
3. Department of Thoracic Surgery, Medical College of Nanchang University, People's Republic of China.
*Chang-Ying Guo and Si-Cong Jiang contributed equally to this work.

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Guo CY, Jiang SC, Kuang YK, Hu H. Incidence of Ipilimumab-Related Serious Adverse Events in Patients with Advanced Cancer: A Meta-Analysis. J Cancer 2019; 10(1):120-130. doi:10.7150/jca.28120. Available from https://www.jcancer.org/v10p0120.htm

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Background: Little is known about the incidence of ipilimumab-related serious adverse events (SAEs) across various tumor types, drug doses and treatment regimens.

Methods: PubMed database was searched up to November, 2017 to identify prospective clinical trials of ipilimumab therapy for adult patients with cancer. Comparisons of the incidence were based on the χ2 test in univariate analysis and the logistic regression model in multivariate analysis.

Results: Twenty-four studies (4549 patients) with 35 independent study cohorts (21 melanoma, 6 prostate cancer, 5 NSCLC, and 3 SCLC cohorts) of ipilimumab were included in the meta-analysis. The overall incidence of SAEs during ipilimumab mono-therapy was 26.1% (95% CI, 21.1%-31.8%). SAEs were more frequent in the 10 mg/kg groups than in the 3 mg/kg groups (35.9% vs 17.3%; P < 0.001). Combination therapy showed significantly higher incidence than mono-therapy in melanoma (33.8% vs 25.0%; P = 0.002). After adjustment for potential confounders, multivariable analyses demonstrated lower odds of SAEs in NSCLC (odds ratio [OR] 0.52, 95% CI 0.40-0.69, P < 0.001) and SCLC (OR 0.41, 95% CI 0.31-0.54, P < 0.001) compared with melanoma. The 10mg/kg cohort presented significantly higher odds than the 3mg/kg (OR 2.84, 95% CI 2.35-3.43, P < 0.001). The combination therapy showed significantly higher odds than the mono-therapy (OR 1.38, 95% CI 1.11-1.71, P = 0.003).

Conclusions: The incidence of ipilimumab-related SAEs was higher in melanoma, the 10mg/kg group and during combination therapy. Clinicians should enhance awareness of these risk factors in clinical practice and carefully monitor patients.

Keywords: incidence, ipilimumab, serious adverse events, meta-analysis, risk factors