Summary Background Vemurafenib has been linked to dermatological adverse events in patients with melanoma, including an increased risk of rash, cutaneous squamous cell carcinoma, photosensitivity reaction and keratoacanthoma. However, there has been no systematic attempt to assess the dermatological toxicity data of vemurafenib associated with melanoma treatment. Aim To evaluate the point prevalence of dermatological toxicities associated with vemurafenib treatment in patients with melanoma. Methods Searches were conducted of the electronic databases PubMed and EMBASE and of conference abstracts published by the American Society of Clinical Oncology. Eligible studies included prospective clinical trials and expanded‐access programmes (i.e. outside a clinical trial) of patients with melanoma assigned to vemurafenib treatment. Outcomes included prevalence of dermatological toxicities treated with vemurafenib. Statistical analyses were performed using the R2.8.1 meta package. Results In total, 11 studies comprising 4197 patients were included in the meta‐analysis. For patients assigned to vemurafenib, the overall prevalence of all‐grade cutaneous squamous cell carcinoma (cSCC) was 18.00% (95% CI 12.00–26.00%), rash 45.00% (95% CI 34.00–57.00%), photosensitivity reaction (PR) 30.00% (95% CI 23.00–38.00%), keratoacanthoma (KA) 10.00% (95% CI 6.00–15.00%) and hand–foot skin reaction (HFSR) 9.00% (95% CI 4.00–20.00%), while the prevalence of high‐grade events was: cSCC 16.00% (95% CI 11.00–23.00%), rash 12.00% (95% CI 3.00–38.00%), PR 4% (95% CI 2.00–8.00%) and KA 6.00% (95% CI 5.00–7.00%). Conclusion The most frequent dermatological toxicities associated with vemurafenib treatment in patients with melanoma were cSCC, rash, PR and KA. These data may be useful for estimation of the efficacy and safety of the drug during clinical treatment and for reducing the prevalence of adverse reactions to vemurafenib treatment in patients with melanoma.
Background:The tumour-node-metastasis (TNM) classification is the most widely used tool for penile cancer. However, the current system is based on few studies and has been unchanged since 2009. We determined whether a modified pathological N staging system that incorporates the laterality and number of lymph node metastases (LNMs) increases the accuracy of the results in predicting survival compared with the 7th edition of the pathological N staging system of the American Joint Committee on Cancer (AJCC) for penile cancer.Methods:The clinical and histopathologic data from 111 patients with penile cancer with LNMs were analysed. Univariate and multivariate Cox proportional hazard regression analyses were used to determine the impact of the clinical and pathological factors on disease-specific survival of these patients. The predictive accuracy was further assessed using the concordance index.Results:According to the 7th edition of the pathological N classification, the 3-year disease-specific survival (DSS) rates for patients with pN1, pN2, and pN3 disease are 89.6%, 65.9%, and 33.6%, respectively (PN1–N2=0.030, PN2–N3<0.001, P<0.001). Under the modified pathological N category criteria, the 3-year DSS rates for pN1, pN2, and pN3 patients were 90.7%, 60.5%, and 31.4%, respectively (PN1–N2=0.005, PN2–N3=0.004, P<0.001). In separate multivariate Cox regression models, only modified N stages (hazard ratio: 4.877, 10.895; P=0.018, P<0.001) exhibited independent effects on the outcome. The accuracy of the modified pathological N category was significantly increased.Conclusions:The modified pathological N staging system is a better reflection of the prognosis of patients with penile cancer. Our study should contribute to the improvement of prognostic stratification and systemic treatment to avoid overtreatment of patients.
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