The incidence of cutaneous adverse events (AEs) in cancer patients receiving PI3K inhibitors may be as high as 29%, according to a meta-analysis published in JAMA Oncology.

The meta-analysis included data from phase 2 and phase 3 randomized controlled trials reporting on the efficacy of PI3K inhibitors and the incidence of cutaneous AEs. 

There were 15 studies with data on cutaneous AEs of any grade, and the studies encompassed a total of 4200 patients. The patients had colorectal, head and neck, lung, and breast cancers, as well as renal cell carcinoma and chronic lymphocytic leukemia.

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The PI3K inhibitors patients received included apitolisib, taselisib, idelalisib, alpelisib, buparlisib, sonolisib, and pictilisib. Control treatments consisted of placebo alone or in combination with other drugs. 

Cutaneous AEs of any grade were reported in 29.30% of patients treated with PI3K inhibitors and 13.0% of patients in the control population (odds ratio [OR], 2.55; 95% CI, 1.74-3.75). 

There were 14 studies that included data on grade 3 or higher cutaneous AEs, and these studies included a total of 3750 patients. The incidence of grade 3 or higher cutaneous AEs was 6.95% among PI3K inhibitor recipients and 1.66% in the control population (OR, 4.64; 95% CI, 2.70-7.97).

The researchers also conducted a subgroup analysis looking at cutaneous AEs by PI3K inhibitor class. They found that pan-selective and isoform-selective inhibitors were associated with a higher risk of any-grade cutaneous AEs and grade 3 or higher cutaneous AEs, but data on dual PI3K/mTOR inhibitors were lacking.

The risk of any-grade cutaneous AEs was similarly increased with pan-class PI3K inhibitors (OR, 2.72; 95% CI, 1.65-4.5) and isoform-selective PI3K inhibitors (OR, 2.85; 95% CI, 1.52-5.36; P =.27). However, the risk of grade 3 or higher cutaneous AEs was greater with pan-class PI3K inhibitors (OR, 6.67; 95% CI, 4.28-10.38) than with isoform-selective PI3K inhibitors (OR, 6.37; 95% CI, 3.25-12.48; P <.001). 

Disclosures: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.


Jfri A, Meltzer R, Mostaghimi A, LeBoeuf N, Guggina L. Incidence of cutaneous adverse events with phosphoinositide 3-kinase inhibitors as adjuvant therapy in patients with cancer. A systematic review and meta-analysis. JAMA Oncol. Published online October 13, 2022. doi:10.1001/jamaoncol.2022.4327