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Thomas Schmidt, Florian Lordick, Ken Herrmann and Katja Ott

In esophageal cancer, functional imaging using PET can provide important additional information beyond standard staging techniques that may eventually lead to therapeutic consequences. The most commonly used tracer is fluorodeoxyglucose (FDG), which has high avidity for both squamous cell cancer and adenocarcinoma of the esophagus. The value of FDG-PET is limited in early esophageal cancer, whereas additional information is provided in 15% to 20% of locally advanced tumors. Neoadjuvant treatment is currently the standard of care in locally advanced esophageal cancer in most countries because randomized studies have shown a significant survival benefit. Because responders and nonresponders have a significantly different prognosis, functional imaging to tailor preoperative treatment would be of interest. Metabolic imaging using FDG-PET is an established method of response evaluation in clinical trials. The value of metabolic response evaluation is known to depend on the histologic subtype and the type of preoperative treatment delivered. An association of FDG-PET-based metabolic response with clinical response and prognosis was shown for absolute standardized uptake value (SUV) or a decrease of SUV levels before, during, and after therapy. However, contradictory findings exist in the literature and prospective validation is missing. Additionally, no consensus exists on time points or cutoff levels for metabolic response evaluation. Furthermore, correct prediction of a posttherapeutic pathologic complete remission is currently not possible using FDG-PET. Of high interest is early response monitoring during preoperative chemotherapy, with potential subsequent therapy modification. This tailored approach still needs validation in prospective multicenter trials.

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Al B. Benson III, Michael I. D'Angelica, Daniel E. Abbott, Thomas A. Abrams, Steven R. Alberts, Daniel A. Anaya, Chandrakanth Are, Daniel B. Brown, Daniel T. Chang, Anne M. Covey, William Hawkins, Renuka Iyer, Rojymon Jacob, Andrea Karachristos, R. Kate Kelley, Robin Kim, Manisha Palta, James O. Park, Vaibhav Sahai, Tracey Schefter, Carl Schmidt, Jason K. Sicklick, Gagandeep Singh, Davendra Sohal, Stacey Stein, G. Gary Tian, Jean-Nicolas Vauthey, Alan P. Venook, Andrew X. Zhu, Karin G. Hoffmann and Susan Darlow

The NCCN Guidelines for Hepatobiliary Cancers provide treatment recommendations for cancers of the liver, gallbladder, and bile ducts. The NCCN Hepatobiliary Cancers Panel meets at least annually to review comments from reviewers within their institutions, examine relevant new data from publications and abstracts, and reevaluate and update their recommendations. These NCCN Guidelines Insights summarize the panel's discussion and most recent recommendations regarding locoregional therapy for treatment of patients with hepatocellular carcinoma.

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C. Anthony Blau, Arturo B. Ramirez, Sibel Blau, Colin C. Pritchard, Michael O. Dorschner, Stephen C. Schmechel, Timothy J. Martins, Elisabeth M. Mahen, Kimberly A. Burton, Vitalina M. Komashko, Amie J. Radenbaugh, Katy Dougherty, Anju Thomas, Christopher P. Miller, James Annis, Jonathan R. Fromm, Chaozhong Song, Elizabeth Chang, Kellie Howard, Sharon Austin, Rodney A. Schmidt, Michael L. Linenberger, Pamela S. Becker, Francis M. Senecal, Brigham H. Mecham, Su-In Lee, Anup Madan, Roy Ronen, Janusz Dutkowski, Shelly Heimfeld, Brent L. Wood, Jackie L. Stilwell, Eric P. Kaldjian, David Haussler and Jingchun Zhu

Accelerating cancer research is expected to require new types of clinical trials. This report describes the Intensive Trial of OMics in Cancer (ITOMIC) and a participant with triple-negative breast cancer metastatic to bone, who had markedly elevated circulating tumor cells (CTCs) that were monitored 48 times over 9 months. A total of 32 researchers from 14 institutions were engaged in the patient's evaluation; 20 researchers had no prior involvement in patient care and 18 were recruited specifically for this patient. Whole-exome sequencing of 3 bone marrow samples demonstrated a novel ROS1 variant that was estimated to be present in most or all tumor cells. After an initial response to cisplatin, a hypothesis of crizotinib sensitivity was disproven. Leukapheresis followed by partial CTC enrichment allowed for the development of a differential high-throughput drug screen and demonstrated sensitivity to investigational BH3-mimetic inhibitors of BCL-2 that could not be tested in the patient because requests to the pharmaceutical sponsors were denied. The number and size of CTC clusters correlated with clinical status and eventually death. Focusing the expertise of a distributed network of investigators on an intensively monitored patient with cancer can generate high-resolution views of the natural history of cancer and suggest new opportunities for therapy. Optimization requires access to investigational drugs.