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Pancreatic Neoplasms: HELP
Articles by Ioannis Varthalitis
Based on 1 article published since 2010
(Why 1 article?)
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Between 2010 and 2020, Ioannis Varthalitis wrote the following article about Pancreatic Neoplasms.
 
+ Citations + Abstracts
1 Clinical Trial Gemcitabine Combined with the mTOR Inhibitor Temsirolimus in Patients with Locally Advanced or Metastatic Pancreatic Cancer. A Hellenic Cooperative Oncology Group Phase I/II Study. 2018

Karavasilis, Vasilios / Samantas, Epaminontas / Koliou, Georgia-Angeliki / Kalogera-Fountzila, Anna / Pentheroudakis, George / Varthalitis, Ioannis / Linardou, Helena / Rallis, Grigorios / Skondra, Maria / Papadopoulos, Georgios / Papatsibas, George / Sgouros, Joseph / Goudopoulou, Athina / Kalogeras, Konstantine T / Dervenis, Christos / Pectasides, Dimitrios / Fountzilas, George. ·Department of Medical Oncology, Papageorgiou Hospital, School of Health Sciences, Faculty of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece. karavasv@auth.gr. · Third Department of Medical Oncology, Agii Anargiri Cancer Hospital, Athens, Greece. · Section of Biostatistics, Hellenic Cooperative Oncology Group, Athens, Greece. · Department of Radiology, AHEPA Hospital, School of Health Sciences, Faculty of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece. · Department of Medical Oncology, Ioannina University Hospital, Ioannina, Greece. · Oncology Department, General Hospital of Chania, Crete, Greece. · First Department of Medical Oncology, Metropolitan Hospital, Piraeus, Greece. · Department of Medical Oncology, Papageorgiou Hospital, School of Health Sciences, Faculty of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece. · Oncology Section, Second Department of Internal Medicine, Hippokration Hospital, Athens, Greece. · Oncology Department, University General Hospital of Larissa, Larissa, Greece. · Department of Pharmacovigilance, Hellenic Cooperative Oncology Group, Athens, Greece. · Translational Research Section, Hellenic Cooperative Oncology Group, Athens, Greece. · Laboratory of Molecular Oncology, Hellenic Foundation for Cancer Research/Aristotle University of Thessaloniki, Thessaloniki, Greece. · First Department of Surgery, General Hospital Konstantopouleio Agia Olga, Athens, Greece. · Aristotle University of Thessaloniki, Thessaloniki, Greece. ·Target Oncol · Pubmed #30488350.

ABSTRACT: BACKGROUND: The prognosis of patients with advanced pancreatic cancer is dismal, and there is a need for novel and effective treatments. OBJECTIVES: Tο determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of a novel gemcitabine (G) and temsirolimus (T) combination (phase I) and estimate the 6-month progression-free survival (PFS) in patients treated with the T + G combination (phase II). PATIENTS AND METHODS: Eligible patients with histologically confirmed inoperable or metastatic pancreatic carcinoma (MPC) were entered into the trial. G was given bi-weekly and T weekly in a 4-week cycle. The first dose level was set at G 800 mg/m RESULTS: Thirty patients were enrolled in the phase I component at the pre-planned six dose levels; one bilirubin DLT of grade III occurred at the first dose level. The MTD was established as the approved doses of both drugs. Fifty-five patients were entered into the phase II component. Median relative dose intensities administered in the first cycle were 0.75 for T and 0.99 for G. Grade 3-4 hematological toxicities were recorded in 87.3% of patients. The most common non-hematological adverse events were metabolic disorders (81.8%) followed by gastrointestinal disorders (63.6%). Median PFS was 2.69 months (95% CI 1.74-4.95) and median OS was 4.95 months (95% CI 3.54-6.85), while the 6-month PFS rate was 30.9%. CONCLUSIONS: Combination of G and T is feasible in patients with locally advanced or MPC with manageable side effects, but lacks clinical efficacy. The study was registered in the Australian New Zealand Clinical Trials Registry (ACTRN12611000643976).