PMID- 23457002
OWN - NLM
STAT- MEDLINE
DCOM- 20130930
LR  - 20220310
IS  - 1549-490X (Electronic)
IS  - 1083-7159 (Print)
IS  - 1083-7159 (Linking)
VI  - 18
IP  - 3
DP  - 2013
TI  - Analysis of dermatologic events in vemurafenib-treated patients with melanoma.
PG  - 314-22
LID - 10.1634/theoncologist.2012-0333 [doi]
AB  - BACKGROUND: Vemurafenib has been approved for the treatment of patients with 
      advanced BRAF(V600E)-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 BRAF(V600E) 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 
      <10% of patients.
FAU - Lacouture, Mario E
AU  - Lacouture ME
AD  - Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, New 
      York 10022, USA. lacoutum@mskcc.org
FAU - Duvic, Madeleine
AU  - Duvic M
FAU - Hauschild, Axel
AU  - Hauschild A
FAU - Prieto, Victor G
AU  - Prieto VG
FAU - Robert, Caroline
AU  - Robert C
FAU - Schadendorf, Dirk
AU  - Schadendorf D
FAU - Kim, Caroline C
AU  - Kim CC
FAU - McCormack, Christopher J
AU  - McCormack CJ
FAU - Myskowski, Patricia L
AU  - Myskowski PL
FAU - Spleiss, Olivia
AU  - Spleiss O
FAU - Trunzer, Kerstin
AU  - Trunzer K
FAU - Su, Fei
AU  - Su F
FAU - Nelson, Betty
AU  - Nelson B
FAU - Nolop, Keith B
AU  - Nolop KB
FAU - Grippo, Joseph F
AU  - Grippo JF
FAU - Lee, Richard J
AU  - Lee RJ
FAU - Klimek, Matthew J
AU  - Klimek MJ
FAU - Troy, James L
AU  - Troy JL
FAU - Joe, Andrew K
AU  - Joe AK
LA  - eng
SI  - ClinicalTrials.gov/NCT00949702
SI  - ClinicalTrials.gov/NCT01006980
SI  - ClinicalTrials.gov/NCT01107418
GR  - P30 CA008748/CA/NCI NIH HHS/United States
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20130301
PL  - England
TA  - Oncologist
JT  - The oncologist
JID - 9607837
RN  - 0 (Indoles)
RN  - 0 (Sulfonamides)
RN  - 207SMY3FQT (Vemurafenib)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Clinical Trials as Topic
MH  - Female
MH  - Humans
MH  - Indoles/*adverse effects/*therapeutic use
MH  - Male
MH  - Melanoma/*drug therapy/pathology
MH  - Middle Aged
MH  - Neoplasms, Second Primary/*chemically induced/therapy
MH  - Randomized Controlled Trials as Topic
MH  - Skin Diseases/*chemically induced
MH  - Skin Neoplasms/*drug therapy/pathology
MH  - Sulfonamides/*adverse effects/*therapeutic use
MH  - Treatment Outcome
MH  - Vemurafenib
MH  - Young Adult
PMC - PMC3607529
COIS- Disclosures of potential conflicts of interest may be found at the end of this 
      article.
EDAT- 2013/03/05 06:00
MHDA- 2013/10/01 06:00
PMCR- 2014/03/01
CRDT- 2013/03/05 06:00
PHST- 2013/03/05 06:00 [entrez]
PHST- 2013/03/05 06:00 [pubmed]
PHST- 2013/10/01 06:00 [medline]
PHST- 2014/03/01 00:00 [pmc-release]
AID - theoncologist.2012-0333 [pii]
AID - 3824066 [pii]
AID - 10.1634/theoncologist.2012-0333 [doi]
PST - ppublish
SO  - Oncologist. 2013;18(3):314-22. doi: 10.1634/theoncologist.2012-0333. Epub 2013 
      Mar 1.