دورية أكاديمية
Vismodegib in patients with advanced basal cell carcinoma (STEVIE) : a pre-planned interim analysis of an international, open-label trial
| العنوان: | Vismodegib in patients with advanced basal cell carcinoma (STEVIE) : a pre-planned interim analysis of an international, open-label trial |
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| المؤلفون: | N. Basset Seguin, A. Hauschild, J. . Grob, R. Kunstfeld, B. Dréno, L. Mortier, P. A. Ascierto, C. Dutriaux, L. Thomas, T. Jouary, N. Meyer, B. Guillot, R. Dummer, K. Fife, D. S. Ernst, S. Williams, A. Fittipaldo, I. Xynos, J. Hansson, L. Licitra |
| المساهمون: | N. Basset-Seguin, A. Hauschild, J.-. Grob, R. Kunstfeld, B. Dréno, L. Mortier, P.A. Ascierto, L. Licitra, C. Dutriaux, L. Thoma, T. Jouary, N. Meyer, B. Guillot, R. Dummer, K. Fife, D.S. Ernst, S. William, A. Fittipaldo, I. Xyno, J. Hansson |
| بيانات النشر: | Lancet Publishing Group |
| سنة النشر: | 2015 |
| المجموعة: | The University of Milan: Archivio Istituzionale della Ricerca (AIR) |
| مصطلحات موضوعية: | Settore MED/06 - Oncologia Medica |
| الوصف: | Background: The Hedgehog pathway inhibitor vismodegib has shown clinical benefit in patients with advanced basal cell carcinoma and is approved for treatment of patients with advanced basal cell carcinoma for whom surgery is inappropriate. STEVIE was designed to assess the safety of vismodegib in a situation similar to routine practice, with a long follow-up. Methods: In this multicentre, open-label trial, adult patients with histologically confirmed locally advanced basal cell carcinoma or metastatic basal cell carcinoma were recruited from regional referral centres or specialist clinics. Eligible patients were aged 18 years or older with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, and adequate organ function. Patients with locally advanced basal cell carcinoma had to have been deemed ineligible for surgery. All patients received 150 mg oral vismodegib capsules once a day on a continuous basis in 28-day cycles. The primary objective was safety (incidence of adverse events until disease progression or unacceptable toxic effects), with assessments on day 1 of each treatment cycle (28 days) by principal investigator and coinvestigators at the site. Efficacy variables were assessed as secondary endpoints. The safety evaluable population included all patients who received at least one dose of study drug. Patients with histologically confirmed basal cell carcinoma who received at least one dose of study drug were included in the efficacy analysis. An interim analysis was pre-planned after 500 patients achieved 1 year of follow-up. This trial is registered with ClinicalTrials.gov, number NCT01367665. The study is still ongoing. Findings: Between June 30, 2011, and Nov 6, 2014, we enrolled 1227 patients. At clinical cutoff (Nov 6, 2013), 499 patients (468 with locally advanced basal cell carcinoma and 31 with metastatic basal cell carcinoma) had received study drug and had the potential to be followed up for 12 months or longer. Treatment was discontinued in 400 (80%) patients; 180 (36%) had ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| العلاقة: | info:eu-repo/semantics/altIdentifier/pmid/25981813; info:eu-repo/semantics/altIdentifier/wos/WOS:000355246600057; volume:16; issue:6; firstpage:729; lastpage:736; numberofpages:8; journal:THE LANCET ONCOLOGY; http://hdl.handle.net/2434/484818Test; info:eu-repo/semantics/altIdentifier/scopus/2-s2.0-84930274867 |
| DOI: | 10.1016/S1470-2045(15)70198-1 |
| الإتاحة: | https://doi.org/10.1016/S1470-2045Test(15)70198-1 http://hdl.handle.net/2434/484818Test |
| حقوق: | info:eu-repo/semantics/closedAccess |
| رقم الانضمام: | edsbas.28E2D337 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1016/S1470-2045(15)70198-1 |
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