Incidence of Cutaneous Adverse Events With Adjuvant PI3K Inhibitor Therapy

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In a systematic review and meta-analysis reported in JAMA Oncology, Jfri et al identified risk for cutaneous adverse events among patients with cancer receiving adjuvant phosphoinositide 3-kinase (PI3K) inhibitor therapy.

Study Details

The analysis included 15 phase II or III randomized controlled trials identified through September 2021 with a total of 4,200 patients, including 2,208 who received PI3K inhibitors and 1,992 who received control treatment.

Key Findings

Cutaneous adverse events of any grade occurred in 647 patients (29.30%) in the PI3K inhibitor group vs 259 patients (13%) in the control group (pooled odds ratio [OR] = 2.55, 95% confidence interval [CI] = 1.74–3.75). Grade ≥ 3 cutaneous adverse events occurred in 6.95% of the PI3K inhibitor group, with an odds ratio of 4.64 (95% CI = 2.70–7.97) vs the control group.

In PI3K inhibitor subgroup analyses, odds ratios vs control groups for any-grade cutaneous adverse events were 0.79 (95% CI = 0.18–3.44) for studies (n = 1) with dual PI3K/mTOR inhibitors, 2.85 (95% CI = 1.52–5.36) for studies (n = 5) with isoform-selective inhibitors, and 2.72 (95% CI = 1.65–4.5) for studies (n = 9) with pan-class inhibitors; the difference in odds ratios for isoform-selective vs pan-class inhibitors was not significant (P = .27). Odds ratios for grade ≥ 3 cutaneous adverse events were 0.79 (95% CI = 0.33–1.87), 6.37 (95% CI = 3.25–12.48), and 6.67 (95% CI = 4.28–10.38), respectively; a significant difference in odds ratios was observed between isoform-selective and pan-class inhibitors (P < .001). The investigators cautioned that these subgroup analyses should be considered inconclusive.  

The investigators concluded, “This systematic review and meta-analysis identified an overall incidence of PI3K inhibitor cutaneous adverse events of any grade to be 29.30%, with a pooled odds ratio of 2.55 (95% CI = 1.74–3.75). These findings clarify the risk of cutaneous adverse events associated with this important class of anticancer therapies.”

Lauren Guggina, MD, of Harvard Medical School, is the corresponding author for the JAMA Oncology article.

Disclosure: For full disclosures of the study authors, visit

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