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Systematic review of 18 case reports characterizes apalutamide-induced severe cutaneous adverse reactions in prostate cancerStudy reviews rare but severe skin reactions to prostate cancer drug apalutamide

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Key Takeaway
Recognize apalutamide is associated with potentially life-threatening SCARs, with SJS/TEN most reported.

This systematic review analyzed 18 global case reports of prostate cancer patients who developed severe cutaneous adverse reactions (SCARs) while on apalutamide. The review aimed to characterize the spectrum of these reactions and summarize management strategies. No comparator group was reported, as the evidence was compiled from individual case reports.

The main findings identified 3 cases of DRESS, 14 cases of Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), and 1 case of acute generalized exanthematous pustulosis (AGEP). SJS/TEN was the most frequent type, occurring in 14 out of the 18 cases. The median time to onset of SCARs after starting apalutamide was 39.5 days, and the majority of reported cases were from East Asia.

Safety data confirm these SCARs are potentially life-threatening. The cornerstone of management is immediate discontinuation of the suspected drug. The review's practice relevance includes a proposed set of definitive therapeutic strategies, suggesting personalized dosing based on body metrics and proactive rash management may help mitigate risk. Key limitations include the inherent nature of case report evidence, which cannot establish causality or incidence rates compared to controlled trials. The geographic predominance is based on reported cases, not population incidence.

Researchers looked at 18 reported cases of patients with prostate cancer who developed severe skin reactions while taking the drug apalutamide. They wanted to understand what types of reactions occurred and how they were managed. The patients were from around the world, though most reported cases came from East Asia.

The main finding was that the most frequent severe reaction was Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), which appeared in 14 of the 18 cases. These reactions are serious and can be life-threatening. On average, symptoms started about 40 days after patients began taking the drug.

It is very important to understand that this review only looked at existing case reports. This means we cannot tell how often these reactions actually happen in the wider population of people taking the drug. The study suggests that if a severe rash develops, stopping the drug immediately is the most critical step. Patients should contact their doctor right away if they notice any new or worsening skin issues while on this medication.

What this means for you:
Severe skin reactions to apalutamide are rare but serious; contact your doctor immediately if a rash develops.

Study Details

Study typeSystematic review
EvidenceLevel 1
PublishedApr 2026
View Original Abstract ↓
PurposeProstate cancer (PCa) is the most common fatal malignancy among men and a major cause of cancer-related death. Apalutamide, a second-generation androgen receptor inhibitor, is approved for non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic castration-sensitive prostate cancer (mCSPC). However, an increasing number of potentially life-threatening severe cutaneous adverse reactions (SCARs) associated with apalutamide have raised clinical concerns. This review aims to characterize apalutamide-induced SCARs and summarize effective management strategies based on reported cases.Materials and methodsWe systematically searched PubMed, Europe PMC, and CNKI for case reports of SCARs associated with apalutamide. Keywords included “Apalutamide” and “Drug eruptions.” A total of 18 cases were identified and analyzed.ResultsWe reviewed the clinical characteristics and treatment of 3 cases of DRESS, 14 cases of SJS/TEN, and 1 case of AGEP, all highly suspected to be caused by apalutamide, reported globally. The most frequent SCARs associated with apalutamide are SJS/TEN. The median onset time of SCARs in these cases was 39.5 days, significantly shorter than the onset time of rash in phase III clinical trials of apalutamide. Geographically, the majority of reported cases originated from East Asia. By analyzing the treatment regimens and clinical outcomes of these patients, combined with a literature review, we proposed a set of definitive therapeutic strategies.ConclusionApalutamide-induced SCARs tend to occur earlier than common rashes observed in clinical trials, with a predominance of reported cases in East Asian populations. Immediate discontinuation of the suspected drug is the cornerstone of SCAR management. Supportive care, systemic corticosteroids, intravenous immunoglobulin (IVIG), cyclosporine, plasmapheresis, and TNF-α antagonists play important roles in treatment. Personalized dosing strategies based on body weight or body surface area, along with proactive rash management, may help mitigate risk and optimize therapeutic continuity.
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