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    Clinical research framework proposal for ketogenic metabolic therapy in glioblastoma
    (2024) Duraj, Tomas; Kalamian, Miriam; Zuccoli, Giulio; Maroon, Joseph C.; D'Agostino, Dominic P.; Scheck, Adrienne C.; Poff, Angela; Winter, Sebastian F.; Hu, Jethro; Klement, Rainer J.; Hickson, Alicia; Lee, Derek C.; Cooper, Isabella; Kofler, Barbara; Schwartz, Kenneth A.; Phillips, Matthew C. L.; Champ, Colin E.; Zupec-Kania, Beth; Tan-Shalaby, Jocelyn; Serfaty, Fabiano M.; Omene, Egiroh; Arismendi-Morillo, Gabriel; Kiebish, Mİchael; Cheng, Rİchard; El-Sakka, Ahmed M.; Pflueger, Axel; Mathews, Edward H.; Worden, Donese; Shi, Hanping; Cincione, Raffaele Ivan; Spinosa, Jean Pierre; Slocum, Abdul Kadir; İyikesici, Mehmet Salih; Yanagisawa, Atsuo; Pilkington, Geoffrey J.; Chaffee, Anthony; Abdel-Hadi, Wafaa; Elsamman, Amr K.; Klein, Pavel; Hagihara, Keisuke; Clemens, Zsofia; Yu, George W.; Evangeliou, Athanasios E.; Nathan, Janak K.; Smith, Kris; Fortin, David; Dietrich, Jorg; Mokherjee, Purna; Seyfried, Thomas N.
    Glioblastoma (GBM) is the most aggressive primary brain tumor in adults, with a universally lethal prognosis despite maximal standard therapies. Here, we present a consensus treatment protocol based on the metabolic requirements of GBM cells for the two major fermentable fuels: glucose and glutamine. Glucose is a source of carbon and ATP synthesis for tumor growth through glycolysis, while glutamine provides nitrogen, carbon, and ATP synthesis through glutaminolysis. As no tumor can grow without anabolic substrates or energy, the simultaneous targeting of glycolysis and glutaminolysis is expected to reduce the proliferation of most if not all GBM cells. Ketogenic metabolic therapy (KMT) leverages diet-drug combinations that inhibit glycolysis, glutaminolysis, and growth signaling while shifting energy metabolism to therapeutic ketosis. The glucose-ketone index (GKI) is a standardized biomarker for assessing biological compliance, ideally via real-time monitoring. KMT aims to increase substrate competition and normalize the tumor microenvironment through GKI-adjusted ketogenic diets, calorie restriction, and fasting, while also targeting glycolytic and glutaminolytic flux using specific metabolic inhibitors. Non-fermentable fuels, such as ketone bodies, fatty acids, or lactate, are comparatively less efficient in supporting the long-term bioenergetic and biosynthetic demands of cancer cell proliferation. The proposed strategy may be implemented as a synergistic metabolic priming baseline in GBM as well as other tumors driven by glycolysis and glutaminolysis, regardless of their residual mitochondrial function. Suggested best practices are provided to guide future KMT research in metabolic oncology, offering a shared, evidence-driven framework for observational and interventional studies.
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    Efficacy of metabolically supported chemotherapy combined with ketogenic diet, hyperthermia, and hyperbaric oxygen therapy for stage IV triple-negative breast cancer
    (Cureus Inc, 2017) İyikesici, Mehmet Salih; Slocum, Abdul Kadir; Slocum, Ayshe; Berkarda, Ferhan Bulent; Kalamian, Miriam; Seyfried, Thomas N.
    Triple-negative breast cancer (TNBC) is more aggressive and metastatic than other breast cancer types. Cytotoxic chemotherapy is presently the predominant systemic therapy for TNBC patients. This case report highlights the influence of metabolically supported chemotherapy (MSCT), ketogenic diet (KD), hyperthermia (HT), and hyperbaric oxygen therapy (HBOT) in an overweight 29-year-old woman with stage IV (T4N3M1) triple-negative invasive ductal carcinoma of the breast. The patient presented with an observable mass in her left breast detected during a physical examination in December 2015. Magnetic resonance imaging revealed a Breast Imaging Reporting and Data System Category 5 tumor and multiple lymphadenomegaly in the left axilla. A Tru-Cut biopsy led to the diagnosis of a triple-negative nuclear grade 2 invasive ductal carcinoma. The patient was admitted to ChemoThermia Oncology Center, Istanbul, Turkey in October 2016, and a whole body (18F)-fluorodeoxyglucose (FDG)-positron emission tomography-computed tomography (PET-CT) scan revealed a 77 mm x 55 mm primary tumor in her left breast, multiple left pectoral and axillary lymph nodes, multiple widespread liver masses, and an upper left nodular abdominal lesion. The patient received a treatment protocol consisting of MSCT, KD, HT, and HBOT. A follow-up whole body 18F-FDG PET-CT scan in February 2017 showed a complete therapeutic response with no evidence of abnormal FDG uptake. The patient continued to receive this treatment protocol and in April 2017 underwent a mastectomy, which revealed a complete pathological response consistent with the response indicated by her PET-CT imaging. This single case study presents evidence of a complete clinical, radiological, and pathological response following a six-month treatment period using a combination of MSCT and a novel metabolic therapy in a patient with stage IV TNBC.
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    Long-term outcomes of the treatment of unresectable (stageIII-IV) ductal pancreatic adenocarcinoma using metabolically supported chemotherapy (MSCT): A retrospective study
    (E S Burioni Ricerche Bibliografiche, 2016) İyikesici, Mehmet Salih; Slocum, Ayshe; Türkmen, Engin; Akdemir, Övünç; Slocum, Abdul Kadir; İpek, Turgut; Berkarda, Ferhan Bulent
    Introduction Metabolically supported chemotherapy, is defined as the application of standard chemotherapy protocols concomitant to the administration of pharmacological doses of regular insulin and the development of hypoglycemia, and following fasting starting the previous day. This study aims to present the effects of metabolically supported chemotherapy on the overall survival of locally advanced and metastatic (stage III and stage IV, respectively), or simply unresectable pancreatic adenocarcinoma patients. Material and methods This study is a retrospective analysis of a prospectively maintained database of patients. It includes all patients that applied to our clinic between July 2012 and December 2014 that were diagnosed with unresectable (stage III-IV) pancreatic adenocarcinoma. The demographic data of all the patients as well as the chemotherapy regimen received, date of treatment initiation, date of disease remission, mortality and overall survival of all patients were analyzed using SPSS 20.0. Patient follow-up was performed by means of computed tomography and positron emission tomography-computed tomography scans. Results 33 patients, 24(73%) males and 9(27%) females, were included in our study. The majority, 27(81%) patients, had metastatic disease at the time of diagnosis and were stage IV. While 11(33%) of the patients were treated using a gemcitabine-based protocol, 13(39%) received FOLFIRINOX. 9(27%) of the patients were initially treated using gemcitabine, but began receiving FOLFIRINOX following progression as second-line chemotherapy. Statistical analysis revealed a median survival of 19.5 months and a 1-year survival rate of 82.5%. Presently, 18(54%) of the patients remain healthy and alive, free of disease progression with eastern cooperative oncology group performance statuses ranging between Grade 0 -1. 4(22%) of these patients ultimately underwent radical pancreatic surgery: 3(17%) having undergone pancreaticoduodenectomies (Whipple procedures) and 1(5%) having undergone a distal pancreatectomy. Conclusion This study demonstrates that a metabolically supported form of applying standard chemotherapy regimens may enhance the overall survival rates of unresectable (stage III-IV) pancreatic adenocarcinoma patients.