title: Risk of selected gastrointestinal toxicities in breast cancer patients treated with regimens containing lapatinib; a pooled analysis of randomized controlled studies.
abstract: We performed a pooled analysis of randomized controlled studies evaluating selected gastrointestinal adverse events associated with lapatinib use in breast cancer patients. Eligible studies included randomized Phase II and III trials of patients with breast cancer on lapatinib; describing events of diarrhea, nausea, vomiting and stomatitis. Our search strategy yielded 390 potentially relevant citations on lapatinib from Pubmed/Medline and other databases. After exclusion of ineligible studies, a total of 19 clinical trials were considered eligible for the analysis. The relative risk (RR) of all-grade diarrhea, nausea, vomiting and stomatitis were 3.09 (95% CI: 2.14-4.43; p < 0.00001), 1.24 (95% CI: 1.07- 1.43; p < 0.005), 1.35 (95% CI: 1.22-1.49; p = 0.0001), 1.96 (95% CI: 1.07-2.67; p = 0.02); respectively. Exploratory subgroup analysis showed no effect of disease stage on the RR of the relevant adverse events. While, The RR of high-grade diarrhea, nausea, vomiting and stomatitis were 6.63 (95% CI: 2.94-14.96; p < 0.00001), 1.37 (95% CI: 0.91-2.06; p = 0.13), 1.80 (95% CI: 1.21-2.68; p = 0.004), 2.44 (95% CI: 1.41-4.22 p < 0.001); respectively. Our pooled analysis has demonstrated that regimens containing lapatinib are associated with a significantly increased risk of high-grade diarrhea, vomiting and stomatitis in patients with breast cancer. Clinicians should be aware of these risks and perform regular clinical monitoring.
authors.affiliation: Clinical Oncology department, Ain Shams University, Lotfy Elsayed street, Cairo, Egypt.
authors.forename: Omar
authors.initials: O
authors.lastname: Abdel-Rahman
authors.forename: Mona
authors.initials: M
authors.lastname: Fouad
mesh_terms: D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy; D016903:Drug Monitoring / Q000379:methods; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced* / Q000453:epidemiology / Q000503:physiopathology; D006801:Humans; D000077341:Lapatinib; D011799:Quinazolines / Q000009:adverse effects*; D016032:Randomized Controlled Trials as Topic; D012306:Risk
chemical_list: D000970:Antineoplastic Agents; D011799:Quinazolines; D000077341:Lapatinib
keywords: breast cancer; diarrhea; lapatinib; pooled analysis; vomiting