Vismodegib in patients with advanced basal cell carcinoma (STEVIE): A pre-planned interim analysis of an international, open-label trial

The Lancet Oncology

Volumn 16, Issue 6, 2015, Pages 729-736

  Basset Seguin, Nicole ^a   Hauschild, Axel ^b   Grob, Jean Jacques ^c   Kunstfeld, Rainer ^d   Dréno, Brigitte ^e   Mortier, Laurent ^f   Ascierto, Paolo A ^g   Licitra, Lisa ^h   Dutriaux, Caroline ⁱ   Thomas, Luc ^j   Jouary, Thomas ^k   Meyer, Nicolas ^l   Guillot, Bernard ^m   Dummer, Reinhard ⁿ   Fife, Kate ^o   Ernst, D Scott ^p   Williams, Sarah ^q   Fittipaldo, Alberto ^q   Xynos, Ioannis ^q   Hansson, Johan ^r  

^a SAINT LOUIS HOSPITAL   (France)

^b UNIVERSITY HOSPITAL SCHLESWIG HOLSTEIN   (Germany)

^c AIX MARSEILLE UNIVERSITY   (France)

^d MEDICAL UNIVERSITY OF VIENNA   (Austria)

^e HÔTEL DIEU   (France)

^f UNIV LILLE   (France)

^g NATIONAL CANCER INSTITUTE   (Italy)

^h NATIONAL CANCER INSTITUTE   (Italy)

ⁱ BORDEAUX UNIVERSITY HOSPITAL   (France)

^j CENTRE HOSPITALIER LYON SUD   (France)

^k HÔPITAL SAINT ANDRÉ   (France)

^l UNIVERSITÉ PAUL SABATIER   (France)

^m MONTPELLIER UNIVERSITY HOSPITAL   (France)

ⁿ UNIVERSITY HOSPITAL ZURICH   (Switzerland)

^o ADDENBROOKE S HOSPITAL   (United Kingdom)

^p LONDON REGIONAL CANCER PROGRAM   (Canada)

^q ROCHE PRODUCTS LTD   (United Kingdom)

^r KAROLINSKA UNIVERSITY HOSPITAL   (Sweden)

more..

Author keywords

[No Author keywords available]

Indexed keywords

VISMODEGIB; ANILIDE; PYRIDINE DERIVATIVE;

ADULT; ADVANCED CANCER; AGED; AGEUSIA; ALOPECIA; ARTICLE; ASTHENIA; BASAL CELL CARCINOMA; CLINICAL TRIAL; DECREASED APPETITE; DIARRHEA; DOSE RESPONSE; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; DYSGEUSIA; FATIGUE; FEMALE; HISTOPATHOLOGY; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MUSCLE SPASM; NAUSEA; PRIORITY JOURNAL; TREATMENT DURATION; TREATMENT OUTCOME; WEIGHT REDUCTION; ADVERSE DRUG REACTION; CANCER STAGING; CARCINOMA, BASAL CELL; CLASSIFICATION; MIDDLE AGED; PATHOLOGY; SKIN NEOPLASMS; VERY ELDERLY;

AGED; AGED, 80 AND OVER; ANILIDES; CARCINOMA, BASAL CELL; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; FEMALE; HUMANS; MALE; MIDDLE AGED; NEOPLASM STAGING; PYRIDINES; SKIN NEOPLASMS;

EID: 84930274867     PISSN: 14702045     EISSN: 14745488     Source Type: Journal    
DOI: 10.1016/S1470-2045(15)70198-1     Document Type: Article

References (27)

1. Rubin AI, Chen EH, Ratner D Basal-cell carcinoma. N Engl J Med 2005, 353:2262-2269.
2. Sekulic A, Mangold AR, Northfelt DW, LoRusso PM Advanced basal cell carcinoma of the skin: targeting the hedgehog pathway. Curr Opin Oncol 2013, 25:218-223.
3. Dreier J, Cheng PF, Bogdan Alleren I, et al. Basal cell carcinomas in a tertiary referral centre- a systematic analysis. Br J Dermatol 2014, 171:1066-1072.
4. Lear JT, Corner C, Dziewulski P, et al. Challenges and new horizons in the management of advanced basal cell carcinoma: a UK perspective. Br J Cancer 2014, 111:1476-1481.
5. Peris K, Licitra L, Ascierto PA, et al. Identifying locally advanced basal cell carcinoma eligible for treatment with vismodegib: an expert panel consensus. Future Oncol 2015, 11:703-712.
6. Goppner D, Leverkus M Basal cell carcinoma: from the molecular understanding of the pathogenesis to targeted therapy of progressive disease. J Skin Cancer 2011, 2011:650258.
7. Haves AW, Schaffer PR, Carucci JA The impact of inoperable advanced basal cell carcinoma: the economic, physical, and psychological burden of the disease. J Drugs Dermatol 2013, 12:s151-s153.
8. Wiznia LE, Shanley KM, Federman DG Advanced, Neglected Basal Cell Carcinoma. South Med J 2014, 107:242-245.
9. Epstein EH Basal cell carcinomas: attack of the hedgehog. Nat Rev Cancer 2008, 8:743-754.
10. Rudin CM Vismodegib. Clin Cancer Res 2012, 18:3218-3222.
11. LoRusso PM, Rudin CM, Reddy JC, et al. Phase I trial of hedgehog pathway inhibitor GDC-0449 in patients with refractory, locally-advanced or metastatic solid tumors. Clin Cancer Res 2011, 17:2502-2511.
12. Sekulic A, Migden MR, Oro AE, et al. Efficacy and safety of vismodegib in advanced basal-cell carcinoma. N Engl J Med 2012, 366:2171-2179.
13. Dreier J, Dummer R, Felderer L, et al. Emerging drugs and combination strategies for basal cell carcinoma. Expert Opin Emerg Drugs 2014, 19:353-365.
14. Rodon J, Tawbi HA, Thomas AL, et al. A phase I, multicenter, open-label, first-in-human, dose-escalation study of the oral smoothened inhibitor Sonidegib (LDE225) in patients with advanced solid tumors. Clin Cancer Res 2014, 20:1900-1909.
15. Migden MR, Guminski AD, Gutzmer R, et al. Two doses of sonidegib to treat patients with locally advanced or metastatic basal cell carcinoma (BOLT): a multicentre, randomised, double-blind phase 2 trial. Lancet Oncol 2015, published May 14. http://dx.doi.org/10.1016/S1470-2045(15)70100-2.
16. Dummer R, Gutzmer R, Midgen MR, et al. Patient-reported quality of life (QOL) with sonidegib (LDE225) in advanced basal cell carcinoma (basal cell carcinoma). Ann Oncol 2014, 25(suppl 4):iv374-iv393.
17. Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 2009, 45:228-247.
18. Kunstfeld R, Hauschild A, Zloty D, et al. MIKIE: a randomized, double-blind, regimen-controlled, phase II, multicenter study to assess the efficacy and safety of two different vismodegib regimens in patients with multiple basal cell carcinomas. Proc Am Soc Clin Oncol 2014, 32(suppl):TPS9121. (abst).
19. Axelson M, Liu K, Jiang X, et al. U.S. Food and Drug Administration approval: vismodegib for recurrent, locally advanced, or metastatic basal cell carcinoma. Clin Cancer Res 2013, 19:2289-2293.
20. Sekulic A, Migden MR, Basset-Seguit N, et al. Long-term safety and efficacy of vismodegib in patients with advanced basal cell carcinoma: final update (30-month) of the pivotal ERIVANCE basal cell carcinoma study. Proc Am Soc Clin Oncol 2014, 32(suppl):9013. (abst).
21. Lacouture M, Guillen J, Kudchadkar R, et al. The RegiSONIC disease registry study: treatment of vismodegib-related adverse events (AEs) in patients with locally advanced basal cell carcinoma. American Academy of Dermatology 73rd Annual Meeting, San Francisco, CA, USA, March 20-24, 2015.
22. McCusker M, Basset-Seguin N, Dummer R, et al. Metastatic basal cell carcinoma: prognosis dependent on anatomic site and spread of disease. Eur J Cancer 2014, 50:774-783.
23. Sekulic A, Hainsworth JD, Lewis KD, et al. Vismodegib for advanced basal cell carcinoma: duration of response after vismodegib discontinuation and response to vismodegib retreatment upon disease progression. Proc Am Soc Clin Oncol 2014, 32(suppl):9081. (abst).
24. Tang JY, Mackay-Wiggan JM, Aszterbaum M, et al. Inhibiting the hedgehog pathway in patients with the basal-cell nevus syndrome. N Engl J Med 2012, 366:2180-2188.
25. Alcalay J, Tauber G, Fenig E, Hodak E Vismodegib as a neoadjuvant treatment to mohs surgery for aggressive basal cell carcinoma. J Drugs Dermatol 2015, 14:219-221.
26. Ally MS, Aasi S, Wysong A, et al. An investigator-initiated open-label clinical trial of vismodegib as a neoadjuvant to surgery for high-risk basal cell carcinoma. J Am Acad Dermatol 2014, 71:904-911.
27. Chang ALS, Atwood SX, Tartar DM, Oro AE Surgical excision after neoadjuvant therapy with vismodegib for a locally advanced basal cell carcinoma and resistant basal carcinomas in Gorlin syndrome. JAMA Dermatol 2013, 149:639-641.