Conclusions
- Treatment with phosphoinositide 3-kinase inhibitors (phosphoinositide 3-kinase, PI3K) of patients with different types of cancers is associated with a higher risk of mild to severe skin adverse events.
Why it matters
- Adherence to treatment of cancer patients is essential to achieve optimal therapeutic benefit.An important problem with the use of PI3K inhibitors stems from toxic events associated with effects on both the therapeutic target (on-target) and off-target (off-target).
- It is necessary to thoroughly educate patients and healthcare professionals about the possible skin toxic effects associated with PI3K inhibitors.
Study design
- A meta-analysis of 16 phase 2/3 studies that included participants with tumors who received PI3K inhibitors (intervention group) or control/placebo treatment.
- Funding: none revealed.
Main results
- 29.30% of participants in the PI3K inhibitor group developed events of any grade compared with 13% in the control/placebo group (15 studies; 4,200 participants; aggregate OR=2.55; 95% CI, 1.74–3.75).
- The incidence of serious skin adverse events (grade ≥3) was 6.95% in the PI3K inhibitor group compared with 1.66% in the control/placebo group (14 studies; 3,750 participants; OR of aggregate Peto = 4.64; 95% CI, 2.70–7.97).
- In subgroup analyses, the incidence of serious skin adverse events was significantly higher with PI3K class 1 pan-inhibitors (OR=6.67; 95% CI, 4.28–10.38) compared to isoform-selective PI3K inhibitors (OR=6.37; 95% CI, 3.25–12.48; P<0.001).
Limitations
- Heterogeneity of differences between treatment arms, administration protocols, duration of follow-up and combination of different treatment protocols.
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