Abstract
Background:
We performed a systematic review and meta-analysis to determine the risk of mucocutaneous adverse events associated with lapatinib.
Patients and methods:
Eligible studies included randomized phase II and III trials of patients with solid tumors on lapatinib; describing events of stomatitis, skin rash, hand foot syndrome, pruritus and alopecia.
Results:
Our search strategy yielded 380 potentially relevant citations on lapatinib from PubMed/Medline, CENTRAL Cochrane Registry and ASCO Meeting Library. After exclusion of ineligible studies, a total of 19 clinical trials were considered eligible for the meta-analysis. The RRs of all-grade skin rash, stomatitis, hand foot syndrome and pruritus were 3.04 (95% CI 2.33–3.96; p < 0.00001), 1.67 (95% CI 1.02–2.3; p < 0.04), 4.45 (95% CI 1.15–17.19; p = 0.03), and 2.02 (95% CI 1.46–2.8; p < 0.0001), respectively. Exploratory subgroup analysis showed no effect of treatment regimen on the RRs of the relevant adverse events.
Conclusions:
Our meta-analysis has demonstrated that lapatinib is associated with a significantly increased risk of all-grade skin rash, hand foot skin reaction and pruritus. Clinicians should be aware of these risks and perform regular clinical monitoring.
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Transparency
Declaration of funding
This study was not funded by any sponsors.
Authors’ contributions: O.A.-R. provided the idea and study design, collected the data, conducted the data analysis and wrote the manuscript. M.F. collected the data and revised the manuscript.
Declaration of financial/other relationships
O.A.-R. and M.F. have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article.
CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.