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The molecular analysis of biomarkers in oncology is rapidly advancing, but the incorporation of new molecular tests into clinical practice will require a greater understanding of the genetic changes that drive malignancy, the assays used to measure the resulting phenotypes and genotypes, and the regulatory processes that new molecular biomarkers must face(More)
Predictive and prognostic biomarkers offer a potential means to personalize cancer medicine, although many reach the market-place before they have been validated, and their adoption is often hindered by variable clinical evidence. Because of this variability in supporting evidence, clinical practice guidelines formulated by panels of subspecialty experts(More)
Accurately staging patients is essential to oncology practice. Cancer staging contributes to prognostication, guides management decisions, and informs clinical, epidemiologic, and health services research. In hepatocellular carcinoma (HCC), staging poses unique challenges due to the geographic and biological heterogeneity of the disease and lack of(More)
PURPOSE On the basis of preclinical evidence of synergistic activity between MEK and EGFR inhibitors in pancreatic ductal adenocarcinoma (PDAC), we evaluated the safety and efficacy of selumetinib, a MEK1/2 inhibitor, plus erlotinib in patients with previously treated advanced PDAC. EXPERIMENTAL DESIGN In this single-arm phase II trial, eligible patients(More)
Biomarkers reflective of the molecular and genetic heterogeneity in colorectal cancers now guide certain aspects of clinical management and offer great potential for enrichment, stratification, and identification of novel therapeutic targets in drug development. Using case-based examples, this article reviews biomarkers that have an established role in the(More)
Hepatocellular carcinoma (HCC) is the third leading cause of cancer death globally, and its prevalence and impact are even more profound because sorafenib is the only systemic therapy proven to prolong survival in patients with advanced disease. Randomized phase III trials of other novel targeted agents including sunitinib, linifanib, brivanib, and the(More)
Single agent gemcitabine has been the mainstay of therapy for advanced pancreatic cancer over the past decade. Multiple trials of newer chemotherapeutic agents both alone and in combination have yielded disappointing results, spurring the ongoing search for new agents and combinations in this aggressive malignancy. Inhibitors of the epidermal growth factor(More)