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Meta-Analysis
. 2014 Jun;19(6):661-8.
doi: 10.1634/theoncologist.2013-0355. Epub 2014 May 2.

Treatment-related mortality with everolimus in cancer patients

Robert Wesolowski  1 , Mahmoud Abdel-Rasoul  1 , Maryam Lustberg  1 , Maria Paskell  1 , Charles L Shapiro  1 , Erin R Macrae  2
Affiliations
Meta-Analysis

Treatment-related mortality with everolimus in cancer patients

Robert Wesolowski et al. Oncologist. 2014 Jun.

Abstract

Introduction: The overall incidence and odds of fatal adverse events (FAEs) after exposure to everolimus are not well defined. We performed a comprehensive meta-analysis of published randomized controlled trials (RCTs) to determine the role of everolimus in treatment-related mortality in patients with cancer.

Methods: PubMed databases and abstracts from the proceedings of the American Society of Clinical Oncology and the San Antonio Breast Cancer Symposium were searched for RCTs of everolimus either alone or in combination with another agent compared with the control arm without everolimus and that reported deaths from an adverse event from January 1966 to July 2013. The primary objective was to determine the difference of FAEs between everolimus-treated patients and control group patients.

Results: In total, 2,997 patients with multiple solid tumors from nine RCTs were included. The overall incidence of FAEs in cancer patients treated with everolimus was 0.7% (95% CI 0.3%-1.1%) compared with 0.4% (95% CI 0.0%-0.7%) in cancer patients who did not receive everolimus. The odds ratio of FAEs was greater in everolimus-treated patients (Peto odds ratio = 3.80, 95% CI 1.59-9.07, p = .003). In subgroup analyses, no significant difference was found in the incidence or odds of FAEs by everolimus administration (alone or in combination) or tumor type (breast cancer vs. nonbreast cancer; p = .63).

Conclusion: In patients with cancer, everolimus is associated with a small but significant increase in the odds of a treatment-related fatal events.

Keywords: Adverse events; Cancer; Everolimus; Meta-analysis; Mortality.

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Conflict of interest statement

Disclosures of potential conflicts of interest may be found at the end of this article.

Figures

Figure 1.
Figure 1.
Selection process for the randomized controlled trials included in the meta-analysis.
Figure 2.
Figure 2.
Peto odds ratio of fatal adverse events with everolimus versus control in patients with cancer. Abbreviation: CI, confidence interval.
See this image and copyright information in PMC

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