دورية أكاديمية
Erlotinib and the Risk of Oral Cancer: The Erlotinib Prevention of Oral Cancer (EPOC) Randomized Clinical Trial
| العنوان: | Erlotinib and the Risk of Oral Cancer: The Erlotinib Prevention of Oral Cancer (EPOC) Randomized Clinical Trial |
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| المؤلفون: | William, William N., Papadimitrakopoulou, Vassiliki, Lee, J. Jack, Mao, Li, Cohen, Ezra E. W., Lin, Heather Y., Gillenwater, Ann M., Martin, Jack W., Lingen, Mark W., Boyle, Jay O., Shin, Dong M., Vigneswaran, Nadarajah, Shinn, Nancy, Heymach, John V., Wistuba, Ignacio I., Tang, Ximing, Kim, Edward S., Saintigny, Pierre, Blair, Elizabeth A., Meiller, Timothy, Gutkind, J. Silvio, Myers, Jeffrey, El-Naggar, Adel, Lippman, Scott M. |
| المساهمون: | Centre de Recherche en Cancérologie de Lyon (UNICANCER/CRCL), Centre Léon Bérard Lyon -Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM) |
| المصدر: | ISSN: 2374-2437 ; JAMA oncology ; https://hal-univ-lyon1.archives-ouvertes.fr/hal-01796193Test ; JAMA oncology, American Medical Association, 2016, 2 (2), pp.209. ⟨10.1001/jamaoncol.2015.4364⟩. |
| بيانات النشر: | HAL CCSD American Medical Association |
| سنة النشر: | 2016 |
| المجموعة: | Archive ouverte HAL (Hyper Article en Ligne, CCSD - Centre pour la Communication Scientifique Directe) |
| مصطلحات موضوعية: | Time, secondary, Risk, surgery, Survival, Skin, France, Growth, history, Medical Oncology, Medicine, Palliative Care, pathology, Patients, [SDV.CAN]Life Sciences [q-bio]/Cancer |
| الوصف: | International audience ; IMPORTANCE: Standard molecularly based strategies to predict and/or prevent oral cancer development in patients with oral premalignant lesions (OPLs) are lacking. OBJECTIVE: To test if the epidermal growth factor receptor inhibitor erlotinib would reduce oral cancer development in patients with high-risk OPLs defined by specific loss of heterozygosity (LOH) profiles. Secondary objectives included prospective determination of LOH as a prognostic marker in OPLs. DESIGN: The Erlotinib Prevention of Oral Cancer (EPOC) study was a randomized, placebo-controlled, double-bind trial. Accrual occurred from November 2006 through July 2012, with a median follow-up time of 35 months in an ambulatory care setting in 5 US academic referral institutions. Patients with OPLs were enrolled in the protocol, and each underwent LOH profiling (N = 379); they were classified as high-risk (LOH-positive) or low-risk (LOH-negative) patients based on their LOH profiles and oral cancer history. The randomized sample consisted of 150 LOH-positive patients. INTERVENTIONS: Oral erlotinib treatment (150 mg/d) or placebo for 12 months. MAIN OUTCOMES AND MEASURES: Oral cancer-free survival (CFS). RESULTS: A total of 395 participants were classified with LOH profiles, and 254 were classified LOH positive. Of these, 150 (59%) were randomized, 75 each to the placebo and erlotinib groups. The 3-year CFS rates in placebo- and erlotinib-treated patients were 74% and 70%, respectively (hazard ratio [HR], 1.27; 95% CI, 0.68-2.38; P = .45). The 3-year CFS was significantly lower for LOH-positive compared with LOH-negative groups (74% vs 87%, HR, 2.19; 95% CI, 1.25-3.83; P = .01). Increased EGFR gene copy number correlated with LOH-positive status (P \\textless .001) and lower CFS (P = .01). The EGFR gene copy number was not predictive of erlotinib efficacy. Erlotinib-induced skin rash was associated with improved CFS (P = .01). CONCLUSIONS AND RELEVANCE: In this trial, LOH was validated as a marker of oral cancer risk and found ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| العلاقة: | info:eu-repo/semantics/altIdentifier/pmid/26540028; hal-01796193; https://hal-univ-lyon1.archives-ouvertes.fr/hal-01796193Test; PUBMED: 26540028 |
| DOI: | 10.1001/jamaoncol.2015.4364 |
| الإتاحة: | https://doi.org/10.1001/jamaoncol.2015.4364Test https://hal-univ-lyon1.archives-ouvertes.fr/hal-01796193Test |
| رقم الانضمام: | edsbas.317D6026 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1001/jamaoncol.2015.4364 |
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