Risk of mucocutaneous toxicities in patients with solid tumors treated with everolimus; a systematic review and meta-analysis.

BACKGROUND

We performed a systematic review and meta-analysis of mucocutaneous toxicities associated with the use of everolimus in solid tumors.

PATIENTS AND METHODS

Eligible studies included randomized Phase II and III trials of patients with solid tumors on everolimus; describing events of stomatitis, skin rash, pruritus and mouth ulceration.

RESULTS

Our search strategy yielded 380 potentially relevant citations on everolimus from Pubmed/Medline, CENTRAL Cochrane registry and American Society of Clinical Oncology meeting library. After exclusion of ineligible studies, a total of 10 clinical trials were considered eligible for the meta-analysis, including eight Phase III trials and two Phase II trials. The relative risk of all-grade stomatitis, skin rash, pruritus and mouth ulceration were 3.86(95% CI: 2.23-6.68; p < 0.001); 3.49(95% CI: 2.39-5.08; p < 0.0001); 2.85(95% CI: 2.04-3.97; p = 0.0001); 3.31 (95% CI: 1.46-7.50; p = 0.004); respectively. Exploratory subgroup analysis showed no effect of tumor types or treatment regimen on the relative risk of the relevant adverse events.

CONCLUSION

Our meta-analysis has demonstrated that everolimus is associated with a significantly increased risk of all-grade stomatitis, skin rash, and pruritus and mouth ulceration. Clinicians should be aware of these risks and perform early clinical assessment and intervene accordingly.