Abstract: Objective To analyze the patterns and characteristics of pyrexia syndrome induced by dabrafenib combined with trametinib in order to provide references for safe medication. Methods A total of 23 patients with BRAF V600-Mutant melanoma were collected, who had received dabrafenib plus trametinib, either as postoperative adjuvant therapy or for unresectable advanced diseases. Meanwhile, other case reports published between inception and June 30, 2024 were retrieved from CNKI, Wanfang, Web of Science, Elsevier and PubMed databases before being analyzed. Results A total of 33 patients were enrolled in our study, including 18 males and 15 females ages 35 to 77. The median duration of the first fever was 16.5(1-240) d. Three of the patients with fever improved without treatment while the rest were treated until fever was gone. Twenty of these patients resumed treatment with single-agent dabrafenib or dabrafenib combined with trametinib at the original dose or at a reduced dose, but fever recurred in 18 of them. Twenty of these patients experienced two or more febrile episodes and medication was permanently discontinued in three of them due to serious adverse drug reactions. Conclusion Dabrafenib combined with trametinib is likely to cause fever within 30 days of medication (69.69%), and 60.60% of patients experience two or more febrile episodes. Discontinuation of treatment, reduced drug dosage, and the use of non-steroidal anti-inflammatory drugs or steroids are key management strategies against pyrexia syndrome.

Key words: Dabrafenib, Capsules, Trametinib, Tablets, Pyrexia Syndrome, Adverse Drug Reaction, BRAF V600