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Analysis of Dermatologic Events in Vemurafenib-Treated Patients With Melanoma

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العنوان:	Analysis of Dermatologic Events in Vemurafenib-Treated Patients With Melanoma
المؤلفون:	Fei Su, Matthew J. Klimek, Axel Hauschild, Caroline Robert, Christopher McCormack, Victor G. Prieto, Caroline C. Kim, Olivia Spleiss, Andrew K. Joe, K. B. Nolop, Kerstin Trunzer, James L. Troy, Madeleine Duvic, Joseph F. Grippo, Patricia L. Myskowski, Dirk Schadendorf, B. Nelson, Mario E. Lacouture, Richard J. Lee
المصدر:	The Oncologist. 18:314-322
بيانات النشر:	Oxford University Press (OUP), 2013.
سنة النشر:	2013
مصطلحات موضوعية:	Adult, Male, Cancer Research, medicine.medical_specialty, Keratoacanthoma, Indoles, Skin Neoplasms, Cutaneous squamous cell carcinoma, Adolescent, Treatment outcome, Medizin, Skin Diseases, Young Adult, medicine, Humans, Vemurafenib, Adverse effect, Melanoma, Aged, Randomized Controlled Trials as Topic, Aged, 80 and over, Clinical Trials as Topic, Sulfonamides, business.industry, Neoplasms, Second Primary, Middle Aged, medicine.disease, Dermatology, Treatment Outcome, Oncology, Female, Melanoma and Cutaneous Malignancies, business, medicine.drug
الوصف:	Background. Vemurafenib has been approved for the treatment of patients with advanced BRAFV600E-mutant melanoma. This report by the Vemurafenib Dermatology Working Group presents the characteristics of dermatologic adverse events (AEs) that occur in vemurafenib-treated patients, including cutaneous squamous cell carcinoma (cuSCC). Methods. Dermatologic AEs were assessed from three ongoing trials of BRAFV600E mutation-positive advanced melanoma. Histologic central review and genetic characterization were completed for a subset of cuSCC lesions. Results. A total of 520 patients received vemurafenib. The most commonly reported AEs were dermatologic AEs, occurring in 92%–95% of patients. Rash was the most common AE (64%–75% of patients), and the most common types were rash not otherwise specified, erythema, maculopapular rash, and folliculitis. Rash development did not appear to correlate with tumor response. Photosensitivity occurred in 35%–63% of patients, and palmar-plantar erythrodysesthesia (PPE) occurred in 8%–10% of patients. The severity of rash, photosensitivity, and PPE were mainly grade 1 or 2. In all, 19%–26% of patients developed cuSCC, mostly keratoacanthomas (KAs). The majority of patients with cuSCC continued therapy without dose reduction after resection. Genetic analysis of 29 cuSCC/KA samples demonstrated HRAS mutations in 41%. Conclusions. Dermatologic AEs associated with vemurafenib treatment in patients with melanoma were generally manageable with supportive care measures. Dose interruptions and/or reductions were required in
تدمد:	1549-490X 1083-7159
الوصول الحر:	https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ce3b43e749f8433ef55c4c1e6676a2f9Test https://doi.org/10.1634/theoncologist.2012-0333Test
حقوق:	OPEN
رقم الانضمام:	edsair.doi.dedup.....ce3b43e749f8433ef55c4c1e6676a2f9
قاعدة البيانات:	OpenAIRE

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Vemurafenib has been approved for the treatment of patients with advanced BRAFV600E-mutant melanoma. This report by the Vemurafenib Dermatology Working Group presents the characteristics of dermatologic adverse events (AEs) that occur in vemurafenib-treated patients, including cutaneous squamous cell carcinoma (cuSCC). Methods. Dermatologic AEs were assessed from three ongoing trials of BRAFV600E mutation-positive advanced melanoma. Histologic central review and genetic characterization were completed for a subset of cuSCC lesions. Results. A total of 520 patients received vemurafenib. The most commonly reported AEs were dermatologic AEs, occurring in 92%–95% of patients. Rash was the most common AE (64%–75% of patients), and the most common types were rash not otherwise specified, erythema, maculopapular rash, and folliculitis. Rash development did not appear to correlate with tumor response. Photosensitivity occurred in 35%–63% of patients, and palmar-plantar erythrodysesthesia (PPE) occurred in 8%–10% of patients. The severity of rash, photosensitivity, and PPE were mainly grade 1 or 2. In all, 19%–26% of patients developed cuSCC, mostly keratoacanthomas (KAs). The majority of patients with cuSCC continued therapy without dose reduction after resection. Genetic analysis of 29 cuSCC/KA samples demonstrated HRAS mutations in 41%. Conclusions. Dermatologic AEs associated with vemurafenib treatment in patients with melanoma were generally manageable with supportive care measures. 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