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CLO23-030: MC200402-Single-Arm Phase 2 Study of the FGFR Inhibitor Futibatinib (Futi) in Combination With Pembrolizumab (Pem) in Patients With FGF19 Expressing Advanced or Metastatic Hepatocellular Carcinoma (aHCC)

Nguyen H. Tran, Joseph J Larson, Fang-Shu Ou, Amit Mahipal, Shaylene A. McCue, Rondell P. Graham, Martin E. Fernandez-Zapico, Alexander Revzin, Lionel A. Kankeu Fonkoua, Lynn M. Flickinger, Sean P. Cleary, Tanios S. Bekaii-Saab, Mitesh J. Borad, Robert R. McWilliams, Aminah Jatoi, and Wen Wee Ma

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CLO22-088: Phase II Trial of Trifluridine/Tipiracil in Combination With Irinotecan in Advanced Biliary Tract Cancers (BTCs)

Sri Harsha Tella, Jaclynn Wessling, Foster Nathan, Shi Qian, Tran Nguyen, Robert McWillimas, Alberts Steven, Minetta Liu, Mitesh Borad, Wen Wee Ma, Mindy Hartgers, Leslie Washburn, Fruth Briant, Martin Fernandezzapico, Tara L Hogenson, Henry Pitot, Zhaohui Jin, and Amit Mahipal

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FDG-PET Predicts Neoadjuvant Therapy Response and Survival in Borderline Resectable/Locally Advanced Pancreatic Adenocarcinoma

Amro M. Abdelrahman, Ajit H. Goenka, Roberto Alva-Ruiz, Jennifer A. Yonkus, Jennifer L. Leiting, Rondell P. Graham, Kenneth W. Merrell, Cornelius A. Thiels, Christopher L. Hallemeier, Susanne G. Warner, Michael G. Haddock, Travis E. Grotz, Nguyen H. Tran, Rory L. Smoot, Wen Wee Ma, Sean P. Cleary, Robert R. McWilliams, David M. Nagorney, Thorvardur R. Halfdanarson, Michael L. Kendrick, and Mark J. Truty

Background: Neoadjuvant therapy (NAT) is used in borderline resectable/locally advanced (BR/LA) pancreatic ductal adenocarcinoma (PDAC). Anatomic imaging (CT/MRI) poorly predicts response, and biochemical (CA 19-9) markers are not useful (nonsecretors/nonelevated) in many patients. Pathologic response highly predicts survival post-NAT, but is only known postoperatively. Because metabolic imaging (FDG-PET) reveals primary tumor viability, this study aimed to evaluate our experience with preoperative FDG-PET in patients with BR/LA PDAC in predicting NAT response and survival. Methods: We reviewed all patients with resected BR/LA PDAC who underwent NAT with FDG-PET within 60 days of resection. Pre- and post-NAT metabolic (FDG-PET) and biochemical (CA 19-9) responses were dichotomized in addition to pathologic responses. We compared post-NAT metabolic and biochemical responses as preoperative predictors of pathologic responses and recurrence-free survival (RFS) and overall survival (OS). Results: We identified 202 eligible patients. Post-NAT, 58% of patients had optimization of CA 19-9 levels. Major metabolic and pathologic responses were present in 51% and 38% of patients, respectively. Median RFS and OS times were 21 and 48.7 months, respectively. Metabolic response was superior to biochemical response in predicting pathologic response (area under the curve, 0.86 vs 0.75; P<.001). Metabolic response was the only univariate preoperative predictor of OS (odds ratio, 0.25; 95% CI, 0.13–0.40), and was highly correlated (P=.001) with pathologic response as opposed to biochemical response alone. After multivariate adjustment, metabolic response was the single largest independent preoperative predictor (P<.001) for pathologic response (odds ratio, 43.2; 95% CI, 16.9–153.2), RFS (hazard ratio, 0.37; 95% CI, 0.2–0.6), and OS (hazard ratio, 0.21; 95% CI, 0.1–0.4). Conclusions: Among patients with post-NAT resected BR/LA PDAC, FDG-PET highly predicts pathologic response and survival, superior to biochemical responses alone. Given the poor ability of anatomic imaging or biochemical markers to assess NAT responses in these patients, FDG-PET is a preoperative metric of NAT efficacy, thereby allowing potential therapeutic alterations and surgical treatment decisions. We suggest that FDG-PET should be an adjunct and recommended modality during the NAT phase of care for these patients.

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Pancreatic Adenocarcinoma, Version 2.2014

Margaret A. Tempero, Mokenge P. Malafa, Stephen W. Behrman, Al B. Benson III, Ephraim S. Casper, E. Gabriela Chiorean, Vincent Chung, Steven J. Cohen, Brian Czito, Anitra Engebretson, Mary Feng, William G. Hawkins, Joseph Herman, John P. Hoffman, Andrew Ko, Srinadh Komanduri, Albert Koong, Andrew M. Lowy, Wen Wee Ma, Nipun B. Merchant, Sean J. Mulvihill, Peter Muscarella II, Eric K. Nakakura, Jorge Obando, Martha B. Pitman, Sushanth Reddy, Aaron R. Sasson, Sarah P. Thayer, Colin D. Weekes, Robert A. Wolff, Brian M. Wolpin, Jennifer L. Burns, and Deborah A. Freedman-Cass

The NCCN Guidelines for Pancreatic Adenocarcinoma discuss the diagnosis and management of adenocarcinomas of the exocrine pancreas and are intended to assist with clinical decision-making. These NCCN Guidelines Insights summarize major discussion points from the 2014 NCCN Pancreatic Adenocarcinoma Panel meeting. The panel discussion focused mainly on the management of borderline resectable and locally advanced disease. In particular, the panel discussed the definition of borderline resectable disease, role of neoadjuvant therapy in borderline disease, role of chemoradiation in locally advanced disease, and potential role of newer, more active chemotherapy regimens in both settings.

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Pancreatic Adenocarcinoma, Version 2.2012

Featured Updates to the NCCN Guidelines

Margaret A. Tempero, J. Pablo Arnoletti, Stephen W. Behrman, Edgar Ben-Josef, Al B. Benson III, Ephraim S. Casper, Steven J. Cohen, Brian Czito, Joshua D. I. Ellenhorn, William G. Hawkins, Joseph Herman, John P. Hoffman, Andrew Ko, Srinadh Komanduri, Albert Koong, Wen Wee Ma, Mokenge P. Malafa, Nipun B. Merchant, Sean J. Mulvihill, Peter Muscarella II, Eric K. Nakakura, Jorge Obando, Martha B. Pitman, Aaron R. Sasson, Anitra Tally, Sarah P. Thayer, Samuel Whiting, Robert A. Wolff, Brian M. Wolpin, Deborah A. Freedman-Cass, and Dorothy A. Shead

The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Pancreatic Adenocarcinoma discuss the workup and management of tumors of the exocrine pancreas. These NCCN Guidelines Insights provide a summary and explanation of major changes to the 2012 NCCN Guidelines for Pancreatic Adenocarcinoma. The panel made 3 significant updates to the guidelines: 1) more detail was added regarding multiphase CT techniques for diagnosis and staging of pancreatic cancer, and pancreas protocol MRI was added as an emerging alternative to CT; 2) the use of a fluoropyrimidine plus oxaliplatin (e.g., 5-FU/leucovorin/oxaliplatin or capecitabine/oxaliplatin) was added as an acceptable chemotherapy combination for patients with advanced or metastatic disease and good performance status as a category 2B recommendation; and 3) the panel developed new recommendations concerning surgical technique and pathologic analysis and reporting.