Vemurafenib in patients with BRAFV600 mutated metastatic melanoma: An open-label, multicentre, safety study

The Lancet Oncology

Volumn 15, Issue 4, 2014, Pages 436-444

  Larkin, James ^a   Del Vecchio, Michele ^b   Ascierto, Paolo A ^c   Krajsova, Ivana ^d   Schachter, Jacob ^e   Neyns, Bart ^f   Espinosa, Enrique ^g   Garbe, Claus ^h   Sileni, Vanna Chiarion ⁱ   Gogas, Helen ^j   Miller, Wilson H ^k   Mandalà, Mario ^l   Hospers, Geke A P ^m   Arance, Ana ⁿ   Queirolo, Paola ^o   Hauschild, Axel ^p   Brown, Michael P ^q   Mitchell, Lada ^r   Veronese, Luisa ^r   Blank, Christian U ^s  

^a INSTITUTE OF CANCER RESEARCH   (United Kingdom)

^b NATIONAL CANCER INSTITUTE   (Italy)

^c NATIONAL CANCER INSTITUTE   (Italy)

^d CHARLES UNIVERSITY   (Czech Republic)

^e SHEBA MEDICAL CENTER   (Israel)

^f UNIVERSITY HOSPITAL BRUSSELS   (Belgium)

^g HOSPITAL UNIVERSITARIO LA PAZ   (Spain)

^h UNIVERSITY OF TÜBINGEN   (Germany)

ⁱ VENETO INSTITUTE OF ONCOLOGY IOV IRCCS   (Italy)

^j UNIVERSITY OF ATHENS   (Greece)

^k MCGILL UNIVERSITY   (Canada)

^l PAPA GIOVANNI XXIII HOSPITAL   (Italy)

^m UNIVERSITY MEDICAL CENTER GRONINGEN   (Netherlands)

ⁿ HOSPITAL CLÍNIC   (Spain)

^o UNIVERSITY OF GENOA   (Italy)

^p UNIVERSITY HOSPITAL SCHLESWIG HOLSTEIN   (Germany)

^q ROYAL ADELAIDE HOSPITAL   (Australia)

^r F HOFFMANN LA ROCHE LTD   (Switzerland)

^s ANTONI VAN LEEUWENHOEK HOSPITAL   (Netherlands)

more..

Author keywords

[No Author keywords available]

Indexed keywords

B RAF KINASE; VEMURAFENIB;

ADOLESCENT; ADULT; ADVANCED CANCER; AGED; ALOPECIA; ANEMIA; ARTHRALGIA; ARTICLE; BACKACHE; BRAF GENE; CANCER CHEMOTHERAPY; CANCER GROWTH; CLINICAL EFFECTIVENESS; CONSTIPATION; COUGHING; DECREASED APPETITE; DOSE RESPONSE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRY SKIN; DYSGEUSIA; FATIGUE; FEMALE; FEVER; GENE MUTATION; HEADACHE; HUMAN; HYPERKERATOSIS; HYPERTENSION; LIVER FAILURE; MAJOR CLINICAL STUDY; MALE; METASTATIC MELANOMA; MULTICENTER STUDY; MUSCULOSKELETAL PAIN; MYALGIA; NAUSEA; OPEN STUDY; PERIPHERAL EDEMA; PHOTOSENSITIVITY; PRIORITY JOURNAL; PRURITUS; QT PROLONGATION; RASH; SEBORRHEIC KERATOSIS; SKIN CARCINOMA; SKIN PAPILLOMA; TREATMENT OUTCOME; TUMOR GENE; VERY ELDERLY; VOMITING;

ADMINISTRATION, ORAL; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; ASIA; AUSTRALIA; CANADA; DISEASE PROGRESSION; DISEASE-FREE SURVIVAL; DRUG ADMINISTRATION SCHEDULE; EUROPE; HUMANS; INDOLES; KAPLAN-MEIER ESTIMATE; MELANOMA; MIDDLE AGED; MOLECULAR TARGETED THERAPY; MUTATION; PROTEIN KINASE INHIBITORS; PROTO-ONCOGENE PROTEINS B-RAF; RISK FACTORS; SKIN NEOPLASMS; SOUTH AFRICA; SOUTH AMERICA; SULFONAMIDES; TIME FACTORS; TREATMENT OUTCOME;

EID: 84897458716     PISSN: 14702045     EISSN: 14745488     Source Type: Journal    
DOI: 10.1016/S1470-2045(14)70051-8     Document Type: Article

References (16)

1. Garbe C, Peris K, Hauschild A, et al. Diagnosis and treatment of melanoma: European consensus-based interdisciplinary guideline. Eur J Cancer 2010, 46:270-283.
2. Skin cancers World Health Organization, (accessed Jan 15, 2014). http://www.who.int/uv/faq/skincancer/en/index1.html.
3. Cancer facts and figures American Cancer Society, (accessed Jan 15, 2014). http://www.cancer.org/acs/groups/content/@epidemiologysurveilance/documents/document/acspc-036845.pdf.
4. Korn EL, Liu PY, Lee SJ, et al. Meta-analysis of phase II cooperative group trials in metastatic stage IV melanoma to determine progression-free and overall survival benchmarks for future phase II trials. J Clin Oncol 2008, 26:527-534.
5. Hodi FS, O'Day SJ, McDermott DF, et al. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med 2010, 363:711-723.
6. Sosman JA, Kim KB, Schuchter L, et al. Survival in BRAF V600-mutant advanced melanoma treated with vemurafenib. N Engl J Med 2012, 366:707-714.
7. Chapman PB, Hauschild A, Robert C, et al. Improved survival with vemurafenib in melanoma with BRAF V600E mutation. N Engl J Med 2011, 364:2507-2516.
8. Fisher R, Larkin J Treatment of brain metastases in patients with melanoma. Lancet Oncol 2012, 13:434-435.
9. Sampson JH, Carter JH, Friedman AH, et al. Demographics, prognosis, and therapy of 702 patients with brain metastases from malignant melanoma. J Neurosurg 1998, 88:11-20.
10. Retsas S, Gershuny AR Central nervous system involvement in malignant melanoma. Cancer 1988, 61:1926-1934.
11. Balch CM, Gershenwald JE, Soong SJ, et al. Final version of 2009 AJCC melanoma staging and classification. J Clin Oncol 2009, 27:6199-6206.
12. Dalle S, Poulalhon N, Debarbieux S, et al. Second primary melanomas on treatment with vemurafenib. Br J Dermatol 2013, 168:887-888.
13. Callahan MK, Rampal R, Harding JJ, et al. Progression of RAS-mutant leukemia during RAF inhibitor treatment. N Engl J Med 2012, 367:2316-2321.
14. Halait H, Demartin K, Shah S, et al. Analytical performance of a real-time PCR-based assay for V600 mutations in the BRAF gene, used as the companion diagnostic test for the novel BRAF inhibitor vemurafenib in metastatic melanoma. Diagn Mol Pathol 2012, 21:18.
15. V600K mutation-positive melanoma (BRIM-3): extended follow-up of a phase 3, randomised, open-label study. Lancet Oncol 2014, 15:323-332.
16. Bradford PT, Freedman DM, Goldstein AM, et al. Increased risk of second primary cancers after a diagnosis of melanoma. Arch Dermatol 2010, 146:265-272.