ABSTRACT
In 2023, the NCCN Guidelines for Hepatobiliary Cancers were divided into 2 separate guidelines: Hepatocellular Carcinoma and Biliary Tract Cancers. The NCCN Guidelines for Biliary Tract Cancers provide recommendations for the evaluation and comprehensive care of patients with gallbladder cancer, intrahepatic cholangiocarcinoma, and extrahepatic cholangiocarcinoma. The multidisciplinary panel of experts meets at least on an annual basis to review requests from internal and external entities as well as to evaluate new data on current and emerging therapies. These Guidelines Insights focus on some of the recent updates to the NCCN Guidelines for Biliary Tract Cancers as well as the newly published section on principles of molecular testing.
Subject(s)
Bile Duct Neoplasms , Biliary Tract Neoplasms , Cholangiocarcinoma , Gallbladder Neoplasms , Liver Neoplasms , Humans , Biliary Tract Neoplasms/diagnosis , Biliary Tract Neoplasms/therapy , Gallbladder Neoplasms/diagnosis , Gallbladder Neoplasms/therapy , Cholangiocarcinoma/diagnosis , Cholangiocarcinoma/therapy , Liver Neoplasms/diagnosis , Liver Neoplasms/therapy , Bile Ducts, IntrahepaticABSTRACT
BACKGROUND: Objective radiographic assessment is crucial for accurately evaluating therapeutic efficacy and patient outcomes in oncology clinical trials. Imaging assessment workflow can be complex; can vary with institution; may burden medical oncologists, who are often inadequately trained in radiology and response criteria; and can lead to high interobserver variability and investigator bias. This article reviews the development of a tumor response assessment core (TRAC) at a comprehensive cancer center with the goal of providing standardized, objective, unbiased tumor imaging assessments, and highlights the web-based platform and overall workflow. In addition, quantitative response assessments by the medical oncologists, radiologist, and TRAC are compared in a retrospective cohort of patients to determine concordance. PATIENTS AND METHODS: The TRAC workflow includes an image analyst who pre-reviews scans before review with a board-certified radiologist and then manually uploads annotated data on the proprietary TRAC web portal. Patients previously enrolled in 10 lung cancer clinical trials between January 2005 and December 2015 were identified, and the prospectively collected quantitative response assessments by the medical oncologists were compared with retrospective analysis of the same dataset by a radiologist and TRAC. RESULTS: This study enlisted 49 consecutive patients (53% female) with a median age of 60 years (range, 29-78 years); 2 patients did not meet study criteria and were excluded. A linearly weighted kappa test for concordance for TRAC versus radiologist was substantial at 0.65 (95% CI, 0.46-0.85; standard error [SE], 0.10). The kappa value was moderate at 0.42 (95% CI, 0.20-0.64; SE, 0.11) for TRAC versus oncologists and only fair at 0.34 (95% CI, 0.12-0.55; SE, 0.11) for oncologists versus radiologist. CONCLUSIONS: Medical oncologists burdened with the task of tumor measurements in patients on clinical trials may introduce significant variability and investigator bias, with the potential to affect therapeutic response and clinical trial outcomes. Institutional imaging cores may help bridge the gap by providing unbiased and reproducible measurements and enable a leaner workflow.
Subject(s)
Clinical Trials as Topic/standards , Image Interpretation, Computer-Assisted/methods , Multimodal Imaging/methods , Neoplasms/pathology , Observer Variation , Oncologists/statistics & numerical data , Response Evaluation Criteria in Solid Tumors , Adult , Aged , Combined Modality Therapy , Female , Follow-Up Studies , Humans , Male , Middle Aged , Neoplasms/diagnostic imaging , Neoplasms/therapy , Prognosis , Prospective Studies , Retrospective StudiesABSTRACT
Neural tube defects (NTDs) are the most common cause of potentially preventable congenital malformations in the human fetus. Even with the universal folate supplementation the incidence of NTDs remain higher is developing world than the industrialized countries. We think that lead, a component of many herbal medicines taken during pregnancy for generalized well being of mother and fetus may have a role to play. Lead, a bivalent ion, competes with zinc for crossing into the gut wall and hence slowly decreases the zinc stores in the body and replaces them with lead. As zinc is required at many steps in the absorption and synthesis of biologically active folate moiety, this state of zinc deficiency leads to lack of folate in the metabolically active cells. Hence, the DNA repair and nucleic acid biosynthesis are largely affected in the rapidly dividing embryo leading to NTDs and other abnormalities. We suggest that the marketing of the herbal medicines should be regulated and scientific studies should be carried out on them in order to know their potential effects.