Risk of mucocutaneous toxicities in patients with solid tumors treated with lapatinib: a systematic review and meta-analysis

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.