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Pancreatic Neoplasms: HELP
Articles by Gianpaolo Balzano
Based on 39 articles published since 2010
(Why 39 articles?)
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Between 2010 and 2020, Gianpaolo Balzano wrote the following 39 articles about Pancreatic Neoplasms.
 
+ Citations + Abstracts
Pages: 1 · 2
1 Guideline Italian consensus guidelines for the diagnostic work-up and follow-up of cystic pancreatic neoplasms. 2014

Anonymous4770793 / Anonymous4780793 / Buscarini, Elisabetta / Pezzilli, Raffaele / Cannizzaro, Renato / De Angelis, Claudio / Gion, Massimo / Morana, Giovanni / Zamboni, Giuseppe / Arcidiacono, Paolo / Balzano, Gianpaolo / Barresi, Luca / Basso, Daniela / Bocus, Paolo / Calculli, Lucia / Capurso, Gabriele / Canzonieri, Vincenzo / Casadei, Riccardo / Crippa, Stefano / D'Onofrio, Mirko / Frulloni, Luca / Fusaroli, Pietro / Manfredi, Guido / Pacchioni, Donatella / Pasquali, Claudio / Rocca, Rodolfo / Ventrucci, Maurizio / Venturini, Silvia / Villanacci, Vincenzo / Zerbi, Alessandro / Falconi, Massimo / Anonymous4790793. ·Gastroenterology Unit, Maggiore Hospital, Crema, Italy. Electronic address: ebuscarini@rim.it. · Pancreas Unit, Department of Digestive Diseases and Internal Medicine, S. Orsola-Malpighi Hospital, Bologna, Italy. · Gastroenterology Unit, CRO-National Cancer Institute, Aviano, Italy. · Gastroenterology and Hepatology Department, A.O. San Giovanni Battista/Molinette, University of Turin, Turin, Italy. · Department of Clinical Pathology, AULSS 12, Venice, Italy. · Department of Diagnostic Radiology, Ospedale Cà Foncello, Treviso, Italy. · Department of Pathology, University of Verona, Verona, Italy. · Division of Gastroenterology and Gastrointestinal Endoscopy, Vita-Salute, Italy. · Department of Surgery, San Raffaele Scientific Institute, Milan, Italy. · Gastroenterology and Endoscopy Unit, ISMETT, Palermo, Italy. · Department of Laboratory Medicine, University Hospital, Padua, Italy. · Gastroenterology Unit, Ospedale Sacro Cuore-Don Calabria, Negrar, Verona, Italy. · Department of Radiology, S. Orsola-Malpighi Hospital, Bologna, Italy. · Digestive and Liver Disease Unit, Faculty of Medicine and Psychology, Sapienza University of Rome at S. Andrea Hospital, Rome, Italy. · Division of Pathology, CRO-National Cancer Institute, IRCCS, Aviano, Italy. · Department of Surgery, University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy. · Department of Surgery, Pancreas Unit, Università Politecnica delle Marche, Ancona, Italy. · Department of Radiology, University Hospital G.B. Rossi, University of Verona, Verona, Italy. · Department of Surgical and Gastroenterological Sciences, University of Verona, Verona, Italy. · Department of Clinical Medicine, University of Bologna, Bologna, Italy. · Gastroenterology Unit, Maggiore Hospital, Crema, Italy. · Pathology Unit, A.O. San Giovanni Battista/Molinette, Turin, Italy. · Surgery Unit IV, Department of Medical and Surgical Sciences, University of Padua, Padua, Italy. · Gastroenterology Unit, Mauriziano Hospital, Turin, Italy. · Department of Internal Medicine and Gastroenterology, Bentivoglio Hospital, Bologna, Italy. · 2nd Pathology Section, Spedali Civili, Brescia, Brescia, Italy. · Pancreatic Surgery, Department of Surgery, Humanitas Clinical and Research Center, Milan, Italy. ·Dig Liver Dis · Pubmed #24809235.

ABSTRACT: This report contains clinically oriented guidelines for the diagnostic work-up and follow-up of cystic pancreatic neoplasms in patients fit for treatment. The statements were elaborated by working groups of experts by searching and analysing the literature, and then underwent a consensus process using a modified Delphi procedure. The statements report recommendations regarding the most appropriate use and timing of various imaging techniques and of endoscopic ultrasound, the role of circulating and intracystic markers and the pathologic evaluation for the diagnosis and follow-up of cystic pancreatic neoplasms.

2 Guideline Exocrine pancreatic insufficiency in adults: a shared position statement of the Italian Association for the Study of the Pancreas. 2013

Pezzilli, Raffaele / Andriulli, Angelo / Bassi, Claudio / Balzano, Gianpaolo / Cantore, Maurizio / Delle Fave, Gianfranco / Falconi, Massimo / Anonymous260778. ·Raffaele Pezzilli, Angelo Andriulli, Claudio Bassi, Gianpaolo Balzano, Maurizio Cantore, Gianfranco Delle Fave, Massimo Falconi, Luca Frulloni; the Exocrine Pancreatic Insufficiency collaborative (EPIc) Group, Department of Digestive Diseases, Internal Medicine Sant'Orsola-Malpighi Hospital, 40138 Bologna, Italy. ·World J Gastroenterol · Pubmed #24307787.

ABSTRACT: This is a medical position statement developed by the Exocrine Pancreatic Insufficiency collaborative group which is a part of the Italian Association for the Study of the Pancreas (AISP). We covered the main diseases associated with exocrine pancreatic insufficiency (EPI) which are of common interest to internists/gastroenterologists, oncologists and surgeons, fully aware that EPI may also occur together with many other diseases, but less frequently. A preliminary manuscript based on an extended literature search (Medline/PubMed, Cochrane Library and Google Scholar) of published reports was prepared, and key recommendations were proposed. The evidence was discussed at a dedicated meeting in Bologna during the National Meeting of the Association in October 2012. Each of the proposed recommendations and algorithms was discussed and an initial consensus was reached. The final draft of the manuscript was then sent to the AISP Council for approval and/or modification. All concerned parties approved the final version of the manuscript in June 2013.

3 Review Enhanced recovery pathways in pancreatic surgery: State of the art. 2016

Pecorelli, Nicolò / Nobile, Sara / Partelli, Stefano / Cardinali, Luca / Crippa, Stefano / Balzano, Gianpaolo / Beretta, Luigi / Falconi, Massimo. ·Nicolò Pecorelli, Sara Nobile, Stefano Partelli, Stefano Crippa, Gianpaolo Balzano, Massimo Falconi, Division of Pancreatic Surgery, Pancreas Translational and Clinical Research Center, San Raffaele Scientific Institute, "Vita-Salute" University, 20132 Milan, Italy. ·World J Gastroenterol · Pubmed #27605881.

ABSTRACT: Pancreatic surgery is being offered to an increasing number of patients every year. Although postoperative outcomes have significantly improved in the last decades, even in high-volume centers patients still experience significant postoperative morbidity and full recovery after surgery takes longer than we think. In recent years, enhanced recovery pathways incorporating a large number of evidence-based perioperative interventions have proved to be beneficial in terms of improved postoperative outcomes, and accelerated patient recovery in the context of gastrointestinal, genitourinary and orthopedic surgery. The role of these pathways for pancreatic surgery is still unclear as high-quality randomized controlled trials are lacking. To date, non-randomized studies have shown that care pathways for pancreaticoduodenectomy and distal pancreatectomy are safe with no difference in postoperative morbidity, leading to early discharge and no increase in hospital readmissions. Hospital costs are reduced due to better organization of care and resource utilization. However, further research is needed to clarify the effect of enhanced recovery pathways on patient recovery and post-discharge outcomes following pancreatic resection. Future studies should be prospective and follow recent recommendations for the design and reporting of enhanced recovery pathways.

4 Review Autologous islet transplantation in patients requiring pancreatectomy for neoplasm. 2014

Balzano, Gianpaolo / Piemonti, Lorenzo. ·Pancreatic Surgery Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy. ·Curr Diab Rep · Pubmed #24915889.

ABSTRACT: Autologous islet cell transplantation is a procedure performed to prevent or reduce the severity of diabetes after pancreatic resection. Autologous islet cell transplantation is being used almost exclusively in patients undergoing pancreatectomy because of painful, chronic pancreatitis, or multiple recurrent episodes of pancreatitis that is not controlled by standard medical and surgical treatments. Here, we discuss the possibility of extending the clinical indications for this treatment on the basis of our experience in patients undergoing pancreatic surgery for both nonmalignant and malignant diseases, including patients undergoing completion pancreatectomy because of anastomosis leakage after pancreaticoduodenectomy and those with pancreatic anastomosis deemed at high risk for failure.

5 Clinical Trial Nab-paclitaxel plus gemcitabine with or without capecitabine and cisplatin in metastatic pancreatic adenocarcinoma (PACT-19): a randomised phase 2 trial. 2018

Reni, Michele / Zanon, Silvia / Peretti, Umberto / Chiaravalli, Marta / Barone, Diletta / Pircher, Chiara / Balzano, Gianpaolo / Macchini, Marina / Romi, Silvia / Gritti, Elena / Mazza, Elena / Nicoletti, Roberto / Doglioni, Claudio / Falconi, Massimo / Gianni, Luca. ·Department of Medical Oncology, IRCCS San Raffaele Scientific Institute, Milan, Italy. Electronic address: reni.michele@hsr.it. · Department of Medical Oncology, IRCCS San Raffaele Scientific Institute, Milan, Italy. · Pancreatic Surgery Unit, Pancreas Translational & Clinical Research Centre, IRCCS San Raffaele Scientific Institute, Milan, Italy. · Radiology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy. · Pathology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy; Vita-Salute San Raffaele University, Milan, Italy. · Pancreatic Surgery Unit, Pancreas Translational & Clinical Research Centre, IRCCS San Raffaele Scientific Institute, Milan, Italy; Vita-Salute San Raffaele University, Milan, Italy. ·Lancet Gastroenterol Hepatol · Pubmed #30220407.

ABSTRACT: BACKGROUND: Current treatment for metastatic pancreatic ductal adenocarcinoma includes combination chemotherapy, such as FOLFIRINOX or nab-paclitaxel plus gemcitabine. We investigated the activity of a novel four-drug regimen, consisting of cisplatin, nab-paclitaxel, capecitabine, and gemcitabine, compared with nab-paclitaxel plus gemcitabine, in the PACT-19 trial. METHODS: This single-centre, randomised, open-label, phase 2 trial was done in San Raffaele Hospital in Italy. We enrolled patients aged 18-75 years with pathologically confirmed stage IV pancreatic ductal adenocarcinoma who had received no previous chemotherapy and had Karnofsky performance status of at least 70. Patients were randomly assigned (1:1) by computer-generated permutated block randomisation (block size of four) stratified by baseline concentration of carbohydrate antigen 19-9 to PAXG (cisplatin 30 mg/m FINDINGS: Between April 22, 2014, and May 30, 2016, we randomly assigned 83 patients to treatment: 42 patients to PAXG and 41 patients to nab-paclitaxel plus gemcitabine. At 6 months, 31 (74%, 95% CI 58-86) of 42 patients in the PAXG group were alive and free from disease progression compared with 19 (46%, 31-63) of 41 patients in the nab-paclitaxel plus gemcitabine group. The most frequent grade 3 adverse events were neutropenia (12 [29%] of 42 in the PAXG group vs 14 [34%] of 41 in the nab-paclitaxel plus gemcitabine group), anaemia (nine [21%] vs nine [22%]), and fatigue (seven [17%] vs seven [17%]). The most common grade 4 adverse event was neutropenia (five [12%] in the PAXG group vs two [5%] in the nab-paclitaxel plus gemcitabine group). Two (5%) treatment-related deaths occurred in the nab-paclitaxel plus gemcitabine group compared with none in the PAXG group. INTERPRETATION: Despite the small sample size, our findings suggest that the PAXG regimen warrants further investigation in a phase 3 trial in patients with metastatic pancreatic ductal adenocarcinoma. FUNDING: Celgene.

6 Clinical Trial A randomised phase 2 trial of nab-paclitaxel plus gemcitabine with or without capecitabine and cisplatin in locally advanced or borderline resectable pancreatic adenocarcinoma. 2018

Reni, Michele / Zanon, Silvia / Balzano, Gianpaolo / Passoni, Paolo / Pircher, Chiara / Chiaravalli, Marta / Fugazza, Clara / Ceraulo, Domenica / Nicoletti, Roberto / Arcidiacono, Paolo Giorgio / Macchini, Marina / Peretti, Umberto / Castoldi, Renato / Doglioni, Claudio / Falconi, Massimo / Partelli, Stefano / Gianni, Luca. ·Department of Medical Oncology, IRCCS Ospedale San Raffaele, Via Olgettina 60, 20132 Milan, Italy. Electronic address: reni.michele@hsr.it. · Department of Medical Oncology, IRCCS Ospedale San Raffaele, Via Olgettina 60, 20132 Milan, Italy. · Pancreatic Surgery Unit, Pancreas Translational & Clinical Research Center, IRCCS Ospedale San Raffaele, Via Olgettina 60, 20132 Milan, Italy. · Department of Radiotherapy, IRCCS Ospedale San Raffaele, Via Olgettina 60, 20132 Milan, Italy. · Department of Radiology, IRCCS Ospedale San Raffaele, Via Olgettina 60, 20132 Milan, Italy. · Pancreato-Biliary Endoscopy and Endosonography Division, IRCCS Ospedale San Raffaele, Via Olgettina 60, 20132 Milan, Italy. · Pathology Unit, IRCCS Ospedale San Raffaele, Via Olgettina 60, 20132 Milan, Italy; Università Vita e Salute, Milan, Italy. · Pancreatic Surgery Unit, Pancreas Translational & Clinical Research Center, IRCCS Ospedale San Raffaele, Via Olgettina 60, 20132 Milan, Italy; Università Vita e Salute, Milan, Italy. ·Eur J Cancer · Pubmed #30149366.

ABSTRACT: BACKGROUND: The current trial assessed whether the addition of cisplatin and capecitabine to the nab-paclitaxel-gemcitabine backbone is feasible and active against borderline and locally advanced pancreatic adenocarcinoma (PDAC). METHOD: Fifty-four chemo-naive patients, aged between 18 and 75 years, with a pathological diagnosis of locally advanced or borderline resectable PDAC were randomised to receive either nab-paclitaxel, gemcitabine, cisplatin and oral capecitabine (PAXG; arm A; N = 26) or nab-paclitaxel followed by gemcitabine (AG; arm B; N = 28). The primary end-point was the tumour resection rate. If at least four such resections were performed, the treatment was considered as active. The secondary end-points were progression-free survival (PFS), overall survival (OS), Response Evaluation Criteria in Solid Tumours response rate, Hartman's pathologic response, carbohydrate antigen 19.9 response rate and toxicity. RESULTS: Eight patients (31%) in the PAXG arm and nine (32%) in the AG arm underwent resection. PFS at 1-year was 58% in arm A and 39% in arm B. OS at 18-month was 69% in arm A and 54% in arm B. CONCLUSIONS: In this phase II study, the addition of cisplatin and capecitabine to the AG backbone was feasible and yielded promising results in terms of disease control without detrimental impact on tolerability. The approach warrants further investigation in a phase III study. TRIAL REGISTRATION: NCT01730222.

7 Clinical Trial Safety and efficacy of preoperative or postoperative chemotherapy for resectable pancreatic adenocarcinoma (PACT-15): a randomised, open-label, phase 2-3 trial. 2018

Reni, Michele / Balzano, Gianpaolo / Zanon, Silvia / Zerbi, Alessandro / Rimassa, Lorenza / Castoldi, Renato / Pinelli, Domenico / Mosconi, Stefania / Doglioni, Claudio / Chiaravalli, Marta / Pircher, Chiara / Arcidiacono, Paolo Giorgio / Torri, Valter / Maggiora, Paola / Ceraulo, Domenica / Falconi, Massimo / Gianni, Luca. ·Department of Medical Oncology, IRCCS San Raffaele Scientific Institute, Milan, Italy. Electronic address: reni.michele@hsr.it. · Department of Pancreatic Surgery, IRCCS San Raffaele Scientific Institute, Milan, Italy. · Department of Medical Oncology, IRCCS San Raffaele Scientific Institute, Milan, Italy. · Pancreatic Surgery, Humanitas University, Humanitas Clinical and Research Center, Milan, Italy. · Medical Oncology and Hematology Unit, Humanitas Cancer Center, Humanitas Clinical and Research Center, Milan, Italy. · Department of Surgery, Papa Giovanni XXIII Hospital, Bergamo, Italy. · Onco-Hematology Department, Oncology Unit, Papa Giovanni XXIII Hospital, Bergamo, Italy. · Pathology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy; Pathology Unit, Vita-Salute San Raffaele University, Milan, Italy. · Pancreato-Biliary Endoscopy and Endosonography Division, IRCCS San Raffaele Scientific Institute, Milan, Italy. · IRCCS Mario Negri Institute for Pharmacological Research, Milan, Italy. · Department of Pancreatic Surgery, IRCCS San Raffaele Scientific Institute, Milan, Italy; Department of Pancreatic Surgery, Vita-Salute San Raffaele University, Milan, Italy. ·Lancet Gastroenterol Hepatol · Pubmed #29625841.

ABSTRACT: BACKGROUND: Pancreatic ductal adenocarcinoma are known to metastasise early and a rationale exists for the investigation of preoperative chemotherapy in patients with resectable disease. We aimed to assess the role of combination chemotherapy in this setting in the PACT-15 trial. METHODS: We did this randomised, open-label, phase 2-3 trial in ten hospitals in Italy. We report the phase 2 part here. Patients aged 18-75 years who were previously untreated for pancreatic ductal adenocarcinoma, with Karnofsky performance status of more than 60, and pathologically confirmed stage I-II resectable disease were enrolled. Patients were randomly assigned (1:1:1), with a minimisation algorithm that stratified treatment allocation by centre and concentrations of carbohydrate antigen 19-9 (CA19-9 ≤5 × upper limit of normal [ULN] vs >5 × ULN), to receive surgery followed by adjuvant gemcitabine 1000 mg/m FINDINGS: Between Oct 5, 2010, and May 30, 2015, 93 patients were randomly allocated to treatment. One centre was found to be non-compliant with the protocol, and all five patients at this centre were excluded from the study. Thus, 88 patients were included in the final study population: 26 in group A, 30 in group B, and 32 in group C. In the per-protocol population, six (23%, 95% CI 7-39) of 30 patients in group A were event-free at 1 year, as were 15 (50%, 32-68) of 30 in group B and 19 (66%, 49-83) of 29 in group C. The main grade 3 toxicities were neutropenia (five [28%] of 18 in group A, eight [38%] of 21 in group B, eight [28%] of 29 in group C before surgery, and ten [48%] of 21 in group C after surgery), anaemia (one [6%] in group A, four [19%] in group B, eight [28%] in group C before surgery, and five [24%] in group C after surgery), and fatigue (one [6%] in group A, three [14%] in group B, two [7%] in group C before surgery, and one [5%] in group C after surgery). The main grade 4 toxicity reported was neutropenia (two [11%] in group A, four [19%] in group B, none in group C). Febrile neutropenia was observed in one patient (3%) before surgery in group C. No treatment-related deaths were observed. INTERPRETATION: Our results provide evidence of the efficacy of neoadjuvant chemotherapy in resectable pancreatic ductal adenocarcinoma. Since the trial began, the standard of care for adjuvant therapy has altered, and other chemotherapy regimens developed. Thus, we decided to not continue with the phase 3 part of the PACT-15. We are planning a phase 3 trial of this approach with different chemotherapy regimens. FUNDING: PERLAVITA ONLUS and MyEverest ONLUS.

8 Clinical Trial Phase 1B trial of Nab-paclitaxel plus gemcitabine, capecitabine, and cisplatin (PAXG regimen) in patients with unresectable or borderline resectable pancreatic adenocarcinoma. 2016

Reni, Michele / Balzano, Gianpaolo / Zanon, Silvia / Passoni, Paolo / Nicoletti, Roberto / Arcidiacono, Paolo Giorgio / Pepe, Gino / Doglioni, Claudio / Fugazza, Clara / Ceraulo, Domenica / Falconi, Massimo / Gianni, Luca. ·Department of Medical Oncology, San Raffaele Scientific Institute, via Olgettina 60, 20132 Milan, Italy. · Department of Surgery, San Raffaele Scientific Institute, via Olgettina 60, 20132 Milan, Italy. · Department of Radiotherapy, San Raffaele Scientific Institute, via Olgettina 60, 20132 Milan, Italy. · Department of Radiology, San Raffaele Scientific Institute, via Olgettina 60, 20132 Milan, Italy. · Department of Gastroenterology, San Raffaele Scientific Institute, via Olgettina 60, 20132 Milan, Italy. · Nuclear Medicine Unit, San Raffaele Scientific Institute, via Olgettina 60, 20132 Milan, Italy. · Pathology Unit, San Raffaele Scientific Institute, via Olgettina 60, 20132 Milan, Italy. ·Br J Cancer · Pubmed #27404453.

ABSTRACT: BACKGROUND: Nab-paclitaxel-gemcitabine combination significantly improved overall survival over gemcitabine in metastatic pancreatic adenocarcinoma. A phase 1b trial was performed (ClinicalTrials.gov number, NCT01730222) to determine the recommended phase 2 dose (RP2D) of nab-paclitaxel in combination with cisplatin, capecitabine, and gemcitabine at fixed dose (800, 30, and 1250 mg m(-2) every 2 weeks, respectively; PAXG regimen). METHODS: Nab-paclitaxel doses were escalated from 100 (level one) to 125 (level two) and 150 mg m(-2) (level three) every 2 weeks in cohorts of 3-6 patients with pathologically confirmed unresectable or borderline resectable pancreatic adenocarcinoma. RESULTS: Between Dec 2012 and Apr 2014, 24 patients were enroled (3 at level one, 5 at level two, 16 at level three) and received 117 cycles of PAXG. No dose-limiting toxicity occurred and level three was the RP2D. At this dose, nab-paclitaxel dose-intensity was 91%. Worse per patient grade 3/4 toxicity were neutropenia 25/31%; fatigue 19%; anaemia and hand-foot syndrome 12%, nausea 6%, and febrile neutropenia 6%. A partial response (PR) was observed in 16 (67%) and stable disease (SD) in 8 patients (33%). Among 21 patients with a baseline positive positron emission tomography (PET) scan, a complete metabolic response was observed in 9 (43%), PR in 10 (48%), SD in 2. CA19-9 decreased by ⩾49% in all the 19 patients with elevated basal value. Six patients were resected after chemotherapy. Progression-free survival at 6 months (PFS-6) was 96%. CONCLUSIONS: The RP2D of nab-paclitaxel in the PAXG regimen was 150 mg m(-2) every 2 weeks. The preliminary results are promising and warrant further exploration.

9 Clinical Trial (Ir)relevance of Metformin Treatment in Patients with Metastatic Pancreatic Cancer: An Open-Label, Randomized Phase II Trial. 2016

Reni, Michele / Dugnani, Erica / Cereda, Stefano / Belli, Carmen / Balzano, Gianpaolo / Nicoletti, Roberto / Liberati, Daniela / Pasquale, Valentina / Scavini, Marina / Maggiora, Paola / Sordi, Valeria / Lampasona, Vito / Ceraulo, Domenica / Di Terlizzi, Gaetano / Doglioni, Claudio / Falconi, Massimo / Piemonti, Lorenzo. ·Department of Medical Oncology, IRCCS San Raffaele Scientific Institute, Milan, Italy. piemonti.lorenzo@hsr.it reni.michele@hsr.it. · Diabetes Research Institute, IRCCS San Raffaele Scientific Institute, Milan, Italy. · Department of Medical Oncology, IRCCS San Raffaele Scientific Institute, Milan, Italy. · Pancreatic Surgery Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy. · Department of Radiology, IRCCS San Raffaele Scientific Institute, Milan, Italy. · Department of Pathology, IRCCS San Raffaele Scientific Institute, Milan, Italy. Vita-Salute San Raffaele University, Milan, Italy. · Pancreatic Surgery Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy. Vita-Salute San Raffaele University, Milan, Italy. · Diabetes Research Institute, IRCCS San Raffaele Scientific Institute, Milan, Italy. piemonti.lorenzo@hsr.it reni.michele@hsr.it. ·Clin Cancer Res · Pubmed #26459175.

ABSTRACT: PURPOSE: We aimed to assess the safety and efficacy of metformin for treating patients with metastatic pancreatic cancer and to identify endocrine and metabolic phenotypic features or tumor molecular markers associated with sensitivity to metformin antineoplastic action. EXPERIMENTAL DESIGN: We designed an open-label, randomized, phase II trial to assess the efficacy of adding metformin to a standard systemic therapy with cisplatin, epirubicin, capecitabine, and gemcitabine (PEXG) in patients with metastatic pancreatic cancer. Patients ages 18 years or older with metastatic pancreatic cancer were randomly assigned (1:1) to receive PEXG every 4 weeks in combination or not with 2 g oral metformin daily. The primary endpoint was 6-months progression-free survival (PFS-6) in the intention-to-treat population. RESULTS: Between August 2010 and January 2014, we randomly assigned 60 patients to receive PEXG with (n = 31) or without metformin (n = 29). At the preplanned interim analysis, the study was ended for futility. PFS-6 was 52% [95% confidence interval (CI), 33-69] in the control group and 42% (95% CI, 24-59) in the metformin group (P = 0.61). Furthermore, there was no difference in disease-free survival and overall survival between groups. Despite endocrine metabolic modifications induced by metformin, there was no correlation with the outcome. Single-nucleotide polymorphism rs11212617 predicted glycemic response, but not tumor response to metformin. Gene expression on tumor tissue did not predict tumor response to metformin. CONCLUSIONS: Addition of metformin at the dose commonly used in diabetes did not improve outcome in patients with metastatic pancreatic cancer treated with standard systemic therapy. See related commentary by Yang and Rustgi, p. 1031.

10 Clinical Trial Hypofractionated image-guided IMRT in advanced pancreatic cancer with simultaneous integrated boost to infiltrated vessels concomitant with capecitabine: a phase I study. 2013

Passoni, Paolo / Reni, Michele / Cattaneo, Giovanni M / Slim, Najla / Cereda, Stefano / Balzano, Gianpaolo / Castoldi, Renato / Longobardi, Barbara / Bettinardi, Valentino / Gianolli, Luigi / Gusmini, Simone / Staudacher, Carlo / Calandrino, Riccardo / Di Muzio, Nadia. ·Department of Radiation Oncology, San Raffaele Scientific Institute, Milan, Italy. Electronic address: passoni.paolo@hsr.it. ·Int J Radiat Oncol Biol Phys · Pubmed #24267968.

ABSTRACT: PURPOSE: To determine the maximum tolerated radiation dose (MTD) of an integrated boost to the tumor subvolume infiltrating vessels, delivered simultaneously with radical dose to the whole tumor and concomitant capecitabine in patients with pretreated advanced pancreatic adenocarcinoma. METHODS AND MATERIALS: Patients with stage III or IV pancreatic adenocarcinoma without progressive disease after induction chemotherapy were eligible. Patients underwent simulated contrast-enhanced four-dimensional computed tomography and fluorodeoxyglucose-labeled positron emission tomography. Gross tumor volume 1 (GTV1), the tumor, and GTV2, the tumor subvolume 1 cm around the infiltrated vessels, were contoured. GTVs were fused to generate Internal Target Volume (ITV)1 and ITV2. Biological tumor volume (BTV) was fused with ITV1 to create the BTV+Internal Target Volume (ITV) 1. A margin of 5/5/7 mm (7 mm in cranium-caudal) was added to BTV+ITV1 and to ITV2 to create Planning Target Volume (PTV) 1 and PTV2, respectively. Radiation therapy was delivered with tomotherapy. PTV1 received a fixed dose of 44.25 Gy in 15 fractions, and PTV2 received a dose escalation from 48 to 58 Gy as simultaneous integrated boost (SIB) in consecutive groups of at least 3 patients. Concomitant chemotherapy was capecitabine, 1250 mg/m(2) daily. Dose-limiting toxicity (DLT) was defined as any treatment-related G3 nonhematological or G4 hematological toxicity occurring during the treatment or within 90 days from its completion. RESULTS: From June 2005 to February 2010, 25 patients were enrolled. The dose escalation on the SIB was stopped at 58 Gy without reaching the MTD. One patient in the 2(nd) dose level (50 Gy) had a DLT: G3 acute gastric ulcer. Three patients had G3 late adverse effects associated with gastric and/or duodenal mucosal damage. All patients received the planned dose of radiation. CONCLUSIONS: A dose of 44.25 Gy in 15 fractions to the whole tumor with an SIB of 58 Gy to small tumor subvolumes concomitant with capecitabine is feasible in chemotherapy-pretreated patients with advanced pancreatic cancer.

11 Clinical Trial Feasibility and safety of EUS-guided cryothermal ablation in patients with locally advanced pancreatic cancer. 2012

Arcidiacono, Paolo Giorgio / Carrara, Silvia / Reni, Michele / Petrone, Maria Chiara / Cappio, Stefano / Balzano, Gianpaolo / Boemo, Cinzia / Cereda, Stefano / Nicoletti, Roberto / Enderle, Markus Dominik / Neugebauer, Alexander / von Renteln, Daniel / Eickhoff, Axel / Testoni, Pier Alberto. ·Division of Gastroenterology and Gastrointestinal Endoscopy, Vita-Salute San Raffaele University-Scientific Institute San Raffaele, Milan, Italy. arcidiacono.paologiorgio@hsr.it ·Gastrointest Endosc · Pubmed #23021160.

ABSTRACT: BACKGROUND: New therapies are needed for pancreatic cancer. OBJECTIVE: To determine the feasibility and safety of a new endoscopic treatment. Secondary endpoints were to determine effects on tumor growth measured with CT scan and to find the overall survival. DESIGN: A cohort study of patients with local progression of advanced pancreatic adenocarcinoma after neoadjuvant therapy. The cryotherm probe (CTP), a flexible bipolar device that combines radiofrequency with cryogenic cooling, was used under EUS guidance. SETTING: San Raffaele Hospital, Milan, Italy; University Medical Center, Hamburg-Eppendorf, Germany. PATIENTS: A total of 22 patients (male/female 11/11; mean age 61.9 years) were enrolled from September 2009 to May 2011. INTERVENTION: Radiofrequency heating: 18 W; pressure for cooling: 650 psi (Pounds per Square Inch); application time: depending on tumor size. MAIN OUTCOME MEASUREMENTS: Feasibility was evaluated during the procedure. A clinical and radiologic follow-up was planned. RESULTS: The CTP was successfully applied in 16 patients (72.8%); in 6 it was not possible because of stiffness of the GI wall and of the tumor. Amylase arose in 3 of 16 patients; none had clinical signs of pancreatitis. Late complications arose in 4 cases: 3 were mostly related to tumor progression. Median postablation survival time was 6 months. A CT scan was performed in all patients, but only in 6 of 16 was it possible to clearly define the tumor margins after ablation. In these patients, the tumor appeared smaller compared with the initial mass (P = .07). LIMITATIONS: Small sample of patients, difficulty of objectifying the size of the ablated zone by CT scan. CONCLUSION: EUS-guided CTP ablation is feasible and safe. Further investigations are needed to demonstrate progression-free survival and local control.

12 Clinical Trial Adjuvant PEFG (cisplatin, epirubicin, 5-fluorouracil, gemcitabine) or gemcitabine followed by chemoradiation in pancreatic cancer: a randomized phase II trial. 2012

Reni, Michele / Balzano, Gianpaolo / Aprile, Giuseppe / Cereda, Stefano / Passoni, Paolo / Zerbi, Alessandro / Tronconi, Maria Chiara / Milandri, Carlo / Saletti, Piercarlo / Rognone, Alessia / Fugazza, Clara / Magli, Alessandro / Di Muzio, Nadia / Di Carlo, Valerio / Villa, Eugenio. ·Department of Oncology, S. Raffaele Scientific Institute, Milan, Italy. reni.michele@hsr.it ·Ann Surg Oncol · Pubmed #22237835.

ABSTRACT: BACKGROUND: Information from randomized trials on the role of combination chemotherapy in the adjuvant treatment of pancreatic adenocarcinoma is limited. This randomized phase II trial aimed to identify the most promising regimen warranting phase III evaluation. METHODS: Therapy-naive patients, age 18-75 years, Karnofsky Performance Status (KPS)>60, gross total resection of stage IB-III pancreatic adenocarcinoma, stratified for center and surgical margins, were randomly assigned to receive either gemcitabine 1 g/m2 weekly on days 1, 8, and 15 (arm A) or the PEFG regimen (cisplatin and epirubicin 40 mg/m2, day 1; gemcitabine 600 mg/m2, days 1, 8; 5-fluorouracil 200 mg/m2 daily, days 1-28) (arm B). Chemotherapy was administered every 4 weeks for 3 months and followed by irradiation concurrent to continuous infusion of 5-fluorouracil 250 mg/m2 daily. Primary endpoint was the probability of being disease-free at 1 year from surgery. Assuming P0=35% and P1=55%, α=.05 and β=.10, the study was to enroll 51 patients per arm. RESULTS: A total of 102 patients were randomized; 100 were eligible (arm A: 51; arm B: 49). Baseline characteristic (A/B) were: Median age was 61/60 years; 75% had KPS>80 75/76%; 36% grade 3 tumor 29/43%, 79% stage IIB/III 75/84%, 31% R1 resection 35/29%. Survival figures (A/B) were: Median disease-free survival was 11.7 and 15.2 months; 1-year disease-free survival 49.0% (95% confidence interval [95% CI] 35-63%) and 69.4% (95% CI 56-83%); median survival 24.8 and 28.9 months. Combination chemotherapy produced more hematological toxicity without relevant differences in nonhematological toxicities. CONCLUSIONS: The 4-drug regimen deserves further assessment in resectable pancreatic cancer.

13 Article Time to CA19-9 nadir: a clue for defining optimal treatment duration in patients with resectable pancreatic ductal adenocarcinoma. 2020

Reni, Michele / Peretti, Umberto / Zanon, Silvia / Macchini, Marina / Balzano, Gianpaolo / Mazza, Elena / Tamburrino, Domenico / Orsi, Giulia / Arcidiacono, Paolo Giorgio / Falconi, Massimo / Gianni, Luca. ·Department of Medical Oncology, IRCCS Ospedale San Raffaele, Via Olgettina 60, 20132, Milan, Italy. reni.michele@hsr.it. · Department of Medical Oncology, IRCCS Ospedale San Raffaele, Via Olgettina 60, 20132, Milan, Italy. · Pancreatic Surgery Unit, Pancreas Translational and Clinical Research Center IRCCS Ospedale San Raffaele, Via Olgettina 60, 20132, Milan, Italy. · Pancreato-Biliary Endoscopy and Endosonography Division, IRCCS Ospedale San Raffaele, Via Olgettina 60, 20132, Milan, Italy. · Università "Vita E Salute", Via Olgettina 58, 20132, Milan, Italy. ·Cancer Chemother Pharmacol · Pubmed #32157412.

ABSTRACT: BACKGROUND: Defining optimal treatment duration in patients with resectable pancreatic ductal adenocarcinoma (PDAC) receiving primary chemotherapy is an unmet need. The role of time to CA19-9 nadir and of nadir magnitude was explored in this study. PATIENTS AND METHODS: The databases of our institution's prospective trials were queried to speculate on the time to maximum chemotherapy response. Patients with pathologically proven, metastatic (N = 356) or non-metastatic non-resected (N = 163) PDAC and elevated baseline (> 34 UI/mL) CA19-9 were analyzed. Survival curves were estimated using the Kaplan-Meier method and compared by means of the log-rank test for analyses including at least 45 patients. Multivariable Cox proportional hazards model was used to estimate clinical features for their association with OS. All probability values were from two-sided tests. RESULTS: Time to CA19-9 nadir was ≥ 4 months in 184 of 346 (53%) metastatic and 121 of 163 (74%) non-metastatic patients (p = 0.002). The likelihood of a later nadir was higher with taxane-based chemotherapy as compared to taxane-free combinations (73% versus 56%; p = 0.02). Both metastatic and non-metastatic patients had significantly longer survival when nadir occurred later. Patients with a larger CA19-9 nadir magnitude had significantly longer survival. Metastatic patients with CA19-9 reduced by < 50%, 50-89%, or > 89% and had a median survival of 7.4, 9.8, and 14.7 months, respectively (p ≤ 0.001 for all comparisons). The corresponding figures for non-metastatic patients were 10.6; 17.0; and 18.7 months, respectively (p ≤ 0.02 for < 50% versus 50-89% or > 89%; p = 0.14 for 50-89% versus > 89%). Multivariable analyses showed that time to CA19-9 nadir but not CA19-9 nadir magnitude was independently predictive of survival. CONCLUSION: The present study suggests that a 4-6 months program might be a more suitable candidate for prospective assessment in comparison to shorter pre-defined period in patients who are candidates to surgery after primary chemotherapy.

14 Article Positive neck margin at frozen section analysis is a significant predictor of tumour recurrence and poor survival after pancreatodudenectomy for pancreatic cancer. 2020

Crippa, Stefano / Guarneri, Giovanni / Belfiori, Giulio / Partelli, Stefano / Pagnanelli, Michele / Gasparini, Giulia / Balzano, Gianpaolo / Lena, Marco Schiavo / Rubini, Corrado / Doglioni, Claudio / Zamboni, Giuseppe / Falconi, Massimo. ·Division of Pancreatic Surgery, Pancreas Translational & Clinical Research Center, Università Vita Salute, IRCCS San Raffaele Scientific Institute, Milan, Italy. · Department of Pathology, Università Vita Salute, IRCCS San Raffaele Scientific Institute, Milan, Italy. · Department of Pathology, Università Politecnica Delle Marche, Ospedali Riuniti, Ancona, Italy. · Department of Pathology, Ospedale Sacro Cuore-Don Calabria, Negrar, Italy. · Division of Pancreatic Surgery, Pancreas Translational & Clinical Research Center, Università Vita Salute, IRCCS San Raffaele Scientific Institute, Milan, Italy. Electronic address: falconi.massimo@hsr.it. ·Eur J Surg Oncol · Pubmed #32098733.

ABSTRACT: BACKGROUND: The possible benefit of frozen section (FS) analysis during (PD) for pancreatic ductal adenocarcinoma (PDAC) and of additional resection up to total pancreatectomy (TP) is debated. Aim of this work is to evaluate the prognostic role of positive FS analysis after PD for PDAC. METHODS: Multicentric retrospective analysis on prospective databases of three institutions. Based on FS analysis patients were classified as FS negative/FS positive. All positive FS patients underwent extended PD (EPD) or TP. Postoperative outcomes, disease-free (DFS) and disease-specific survival (DSS) were evaluated. RESULTS: Of 371 patients, 58 (16%) had positive FS. This resulted in 313 (84%) SPD (standard pancreatoduodenectomy), 22 (6%) EPD and 36 (10%) TP. Postoperative mortality was higher in patients undergoing TP (11% compared to 4.5% in EPD and 1% in SPD; p = 0.01). 26% of patients underwent neoadjuvant therapy, and it did not decrease the rate of positive FS. Systemic/local relapse rates were 59% and 41% in negative FS group, and 78% and 22% in positive FS group (p = 0.031). Median DFS and DSS were 20 and 37 months in negative FS group, and 12 and 23 months in positive FS patients (p = 0.001). Independent predictors of recurrence were G3, N1/N2 status and positive FS. R1 resection, G3, N1/N2 status, perineural invasion and positive FS were independent predictors of DSS. CONCLUSIONS: Positive FS analysis is a poor prognostic factor after PD for PDAC. It is significantly associated with a high rate of R1 resection at final histology, PDAC recurrence and poor survival.

15 Article Postoperative Outcomes and Functional Recovery After Preoperative Combination Chemotherapy for Pancreatic Cancer: A Propensity Score-Matched Study. 2019

Pecorelli, Nicolò / Pagnanelli, Michele / Cinelli, Lorenzo / Di Salvo, Francesca / Partelli, Stefano / Crippa, Stefano / Tamburrino, Domenico / Castoldi, Renato / Belfiori, Giulio / Reni, Michele / Falconi, Massimo / Balzano, Gianpaolo. ·Division of Pancreatic Surgery, Pancreas Translational & Clinical Research Center, San Raffaele Scientific Institute, Milan, Italy. · Vita-Salute San Raffaele University, Milan, Italy. · Department of Medical Oncology, San Raffaele Scientific Institute, Milan, Italy. ·Front Oncol · Pubmed #31850203.

ABSTRACT:

16 Article The IL-1/IL-1 receptor axis and tumor cell released inflammasome adaptor ASC are key regulators of TSLP secretion by cancer associated fibroblasts in pancreatic cancer. 2019

Brunetto, Emanuela / De Monte, Lucia / Balzano, Gianpaolo / Camisa, Barbara / Laino, Vincenzo / Riba, Michela / Heltai, Silvia / Bianchi, Marco / Bordignon, Claudio / Falconi, Massimo / Bondanza, Attilio / Doglioni, Claudio / Protti, Maria Pia. ·Tumor Immunology Unit, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) San Raffaele Scientific Institute, Via Olgettina 58, 20132, Milan, Italy. · Division of Immunology, Transplantation and Infectious Diseases, IRCCS San Raffaele Scientific Institute, Via Olgettina 58, 20132, Milan, Italy. · Vita-Salute San Raffaele University, Milan, Italy. · Pancreatic Surgery Unit and Pancreas Translational & Clinical Research Center, IRCCS San Raffaele Scientific Institute, Milan, Italy. · Division of Experimental Oncology, IRCCS San Raffaele Scientific Institute, Milan, Italy. · Innovative Immunotherapies Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy. · Center for Translational Genomics and Bioinformatics, IRCCS San Raffaele Scientific Institute, Milan, Italy. · Chromatin Dynamics Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy. · Division of Genetics and Cell Biology, IRCCS San Raffaele Scientific Institute, Milan, Italy. · MolMed SpA, Milan, Italy. · Pathology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy. · Tumor Immunology Unit, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) San Raffaele Scientific Institute, Via Olgettina 58, 20132, Milan, Italy. protti.mariapia@hsr.it. · Division of Immunology, Transplantation and Infectious Diseases, IRCCS San Raffaele Scientific Institute, Via Olgettina 58, 20132, Milan, Italy. protti.mariapia@hsr.it. ·J Immunother Cancer · Pubmed #30760333.

ABSTRACT: BACKGROUND: The thymic stromal lymphopoietin (TSLP), a key cytokine for development of Th2 immunity, is produced by cancer associated fibroblasts (CAFs) in pancreatic cancer where predominant tumor infiltrating Th2 over Th1 cells correlates with reduced patients' survival. Which cells and molecules are mostly relevant in driving TSLP secretion by CAFs in pancreatic cancer is not defined. METHODS: We performed in vitro, in vivo and ex-vivo analyses. For in vitro studies we used pancreatic cancer cell lines, primary CAFs cultures, and THP1 cells. TSLP secretion by CAFs was used as a read-out system to identify in vitro relevant tumor-derived inflammatory cytokines and molecules. For in vivo studies human pancreatic cancer cells and CAFs were orthotopically injected in immunodeficient mice. For ex-vivo studies immunohistochemistry was performed to detect ASC (apoptosis-associated speck-like protein containing a caspase recruitment domain) expression in surgical samples. Bioinformatics was applied to interrogate published data sets. RESULTS: We show in vitro that IL-1α and IL-1β released by pancreatic cancer cells and tumor cell-conditioned macrophages are crucial for TSLP secretion by CAFs. Treatment of immunodeficient mice orthotopically injected with human IL-1 positive pancreatic cancer cells plus CAFs using the IL-1R antagonist anakinra significantly reduced TSLP expression in the tumor. Importantly, we found that pancreatic cancer cells release alarmins, among which ASC, able to induce IL-1β secretion in macrophages. The relevance of ASC was confirmed ex-vivo by its expression in both tumor cells and tumor associated macrophages in pancreatic cancer surgical samples and survival data analyses showing statistically significant inverse correlation between ASC expression and survival in pancreatic cancer patients. CONCLUSIONS: Our findings indicate that tumor released IL-1α and IL-1β and ASC are key regulators of TSLP secretion by CAFs and their targeting should ultimately dampen Th2 inflammation and improve overall survival in pancreatic cancer.

17 Article The size of well differentiated pancreatic neuroendocrine tumors correlates with Ki67 proliferative index and is not associated with age. 2019

Partelli, Stefano / Muffatti, Francesca / Rancoita, Paola Maria Vittoria / Andreasi, Valentina / Balzano, Gianpaolo / Crippa, Stefano / Doglioni, Claudio / Rubini, Corrado / Zamboni, Giuseppe / Falconi, Massimo. ·Pancreatic Surgery Unit, Pancreas Translational & Clinical Research Center, San Raffaele Scientific Institute, "Vita-Salute" University, Milan, Italy. · University Centre for Statistics in the Biomedical Sciences, "Vita-Salute" University, Milan, Italy. · Department of Pathology, Pancreas Translational & Clinical Research Center, San Raffaele Scientific Institute, "Vita-Salute" University, Milan, Italy. · Department of Pathology, Polytechnic University of Marche Region, Ancona, Italy. · Department of Pathology, "Sacro Cuore-Don Calabria" Hospital, Negrar, Italy. · Pancreatic Surgery Unit, Pancreas Translational & Clinical Research Center, San Raffaele Scientific Institute, "Vita-Salute" University, Milan, Italy. Electronic address: falconi.massimo@hsr.it. ·Dig Liver Dis · Pubmed #30723019.

ABSTRACT: BACKGROUND: Concerns exist about a conservative management of well-differentiated nonfunctioning small pancreatic neuroendocrine tumors (NF-PanNET) in young patients and when preoperative Ki67 proliferative index is ≥3%. AIM: To evaluate an association between age, tumor size and grading in patients with sporadic NF-PanNET who underwent curative resection. METHODS: Patients who underwent surgery for sporadic NF-PanNET (excluding G3) were retrospectively analyzed. Linear regression analysis was performed to evaluate a possible correlation between continuous variables, whereas multiple logistic regression analysis was performed for determining predictors of NF-PanNET-G2. RESULTS: Overall, 235 patients with NF-PanNET-G1/G2 were included. The median largest radiological diameter was 25 mm. Age correlated neither with tumor size (P = 0.675) nor with Ki67 index (P = 0.376). On multivariate linear regression analysis, factors independently associated with Ki67 index were NF-PanNET size (P = 0.031), perineural invasion (P = 0.004), microvascular invasion (P = 0.001) and necrosis (P = 0.009). The most accurate NF-PanNET size for predicting NF-PanNET-G2 was 25 mm. On multivariate analysis, a NF-PanNET size >25 mm was independently associated with the risk of having a PanNET-G2 (P = 0.025). CONCLUSION: No correlations exist between age and NF-PanNET size or proliferative index. Therefore, an a priori aggressive attitude is not justified in young patients with small NF-PanNET, as a long-life expectancy is probably unlikely to increase the risk of malignant transformation.

18 Article Minimally Invasive versus Open Distal Pancreatectomy for Ductal Adenocarcinoma (DIPLOMA): A Pan-European Propensity Score Matched Study. 2019

van Hilst, Jony / de Rooij, Thijs / Klompmaker, Sjors / Rawashdeh, Majd / Aleotti, Francesca / Al-Sarireh, Bilal / Alseidi, Adnan / Ateeb, Zeeshan / Balzano, Gianpaolo / Berrevoet, Frederik / Björnsson, Bergthor / Boggi, Ugo / Busch, Olivier R / Butturini, Giovanni / Casadei, Riccardo / Del Chiaro, Marco / Chikhladze, Sophia / Cipriani, Federica / van Dam, Ronald / Damoli, Isacco / van Dieren, Susan / Dokmak, Safi / Edwin, Bjørn / van Eijck, Casper / Fabre, Jean-Marie / Falconi, Massimo / Farges, Olivier / Fernández-Cruz, Laureano / Forgione, Antonello / Frigerio, Isabella / Fuks, David / Gavazzi, Francesca / Gayet, Brice / Giardino, Alessandro / Groot Koerkamp, Bas / Hackert, Thilo / Hassenpflug, Matthias / Kabir, Irfan / Keck, Tobias / Khatkov, Igor / Kusar, Masa / Lombardo, Carlo / Marchegiani, Giovanni / Marshall, Ryne / Menon, Krish V / Montorsi, Marco / Orville, Marion / de Pastena, Matteo / Pietrabissa, Andrea / Poves, Ignaci / Primrose, John / Pugliese, Raffaele / Ricci, Claudio / Roberts, Keith / Røsok, Bård / Sahakyan, Mushegh A / Sánchez-Cabús, Santiago / Sandström, Per / Scovel, Lauren / Solaini, Leonardo / Soonawalla, Zahir / Souche, F Régis / Sutcliffe, Robert P / Tiberio, Guido A / Tomazic, Aleš / Troisi, Roberto / Wellner, Ulrich / White, Steven / Wittel, Uwe A / Zerbi, Alessandro / Bassi, Claudio / Besselink, Marc G / Abu Hilal, Mohammed / Anonymous5620925. ·Department of Surgery, Cancer Center Amsterdam, Academic Medical Center, Amsterdam, the Netherlands. · Department of Surgery, Southampton University Hospital NHS Foundation Trust, Southampton, United Kingdom. · Department of Surgery, San Raffaele Hospital, Milan, Italy. · Department of Surgery, Morriston Hospital, Swansea, United Kingdom. · Department of Surgery, Virginia Mason Medical Center, Seattle, United States. · Department of Surgery, Karolinska Institute, Stockholm, Sweden. · Department of General and HPB surgery and liver transplantation, Ghent University Hospital, Ghent, Belgium. · Department of Surgery, Linköping University, Linköping, Sweden. · Department of Surgery, Universitá di Pisa, Pisa, Italy. · Department of Surgery, Pederzoli Hospital, Peschiera, Italy. · Department of Surgery, S. Orsola-Malpighi Hospital, Bologna, Italy. · Department of Surgery, Universitätsklinikum Freiburg, Freiburg, Germany. · Department of Surgery, Maastricht University Medical Center, Maastricht, the Netherlands. · Department of Surgery, Pancreas Institute, Verona University Hospital, Verona, Italy. · Department of Surgery, Hospital of Beaujon, Clichy, France. · Department of Surgery, Oslo University Hospital and Institute for Clinical Medicine, Oslo, Norway. · Department of Surgery, Erasmus MC, Rotterdam, the Netherlands. · Department of Surgery, Hopital Saint Eloi, Montpellier, France. · Department of Surgery, Hospital Clínic de Barcelona, Barcelona, Spain. · Department of Surgery, Niguarda Ca' Granda Hospital, Milan, Italy. · Department of Surgery, Institut Mutualiste Montsouris, Paris, France. · Department of Surgery, Humanitas University Hospital, Milan, Italy. · Department of Surgery, Heidelberg University Hospital, Heidelberg, Germany. · Department of Surgery, Oxford University Hospital NHS Foundation Trust, Oxford, United Kingdom. · Clinic for Surgery, UKSH Campus Lübeck, Lübeck, Germany. · Department of Surgery, Moscow Clinical Scientific Center, Moscow, Russian Federation. · Department of Surgery, University Medical Center Ljubljana, Ljubljana, Slovenia. · Department of Surgery, King's College Hospital NHS Foundation Trust, London, United Kingdom. · Department of Surgery, University hospital Pavia, Pavia, Italy. · Department of Surgery, Hospital del Mar, Barcelona, Spain. · Department of Surgery, University Hospital Birmingham, Birmingham, United Kingdom. · Surgical Clinic, Department of clinical and experimental sciences, University of Brescia, Brescia, Italy. · Department of Surgery, The Freeman Hospital Newcastle Upon Tyne, Newcastle, United Kingdom. ·Ann Surg · Pubmed #29099399.

ABSTRACT: OBJECTIVE: The aim of this study was to compare oncological outcomes after minimally invasive distal pancreatectomy (MIDP) with open distal pancreatectomy (ODP) in patients with pancreatic ductal adenocarcinoma (PDAC). BACKGROUND: Cohort studies have suggested superior short-term outcomes of MIDP vs. ODP. Recent international surveys, however, revealed that surgeons have concerns about the oncological outcomes of MIDP for PDAC. METHODS: This is a pan-European propensity score matched study including patients who underwent MIDP (laparoscopic or robot-assisted) or ODP for PDAC between January 1, 2007 and July 1, 2015. MIDP patients were matched to ODP patients in a 1:1 ratio. Main outcomes were radical (R0) resection, lymph node retrieval, and survival. RESULTS: In total, 1212 patients were included from 34 centers in 11 countries. Of 356 (29%) MIDP patients, 340 could be matched. After matching, the MIDP conversion rate was 19% (n = 62). Median blood loss [200 mL (60-400) vs 300 mL (150-500), P = 0.001] and hospital stay [8 (6-12) vs 9 (7-14) days, P < 0.001] were lower after MIDP. Clavien-Dindo grade ≥3 complications (18% vs 21%, P = 0.431) and 90-day mortality (2% vs 3%, P > 0.99) were comparable for MIDP and ODP, respectively. R0 resection rate was higher (67% vs 58%, P = 0.019), whereas Gerota's fascia resection (31% vs 60%, P < 0.001) and lymph node retrieval [14 (8-22) vs 22 (14-31), P < 0.001] were lower after MIDP. Median overall survival was 28 [95% confidence interval (CI), 22-34] versus 31 (95% CI, 26-36) months (P = 0.929). CONCLUSIONS: Comparable survival was seen after MIDP and ODP for PDAC, but the opposing differences in R0 resection rate, resection of Gerota's fascia, and lymph node retrieval strengthen the need for a randomized trial to confirm the oncological safety of MIDP.

19 Article Gene expression analysis of embryonic pancreas development master regulators and terminal cell fate markers in resected pancreatic cancer: A correlation with clinical outcome. 2018

Dugnani, Erica / Sordi, Valeria / Pellegrini, Silvia / Chimienti, Raniero / Marzinotto, Ilaria / Pasquale, Valentina / Liberati, Daniela / Balzano, Gianpaolo / Doglioni, Claudio / Reni, Michele / Gandolfi, Alessandra / Falconi, Massimo / Lampasona, Vito / Piemonti, Lorenzo. ·Diabetes Research Institute, IRCCS San Raffaele Scientific Institute, 20132, Milan, Italy. · Division of Genetics and Cell Biology, Genomic Unit for the Diagnosis of Human Pathologies, IRCCS San Raffaele Scientific Institute, 20132 Milan, Italy. · Pancreatic Surgery Unit, Pancreas Translational & Clinical Research Center, IRCCS San Raffaele Scientific Institute, Via Olgettina 60, 20132, Milan, Italy. · Department of Pathology, IRCCS San Raffaele Scientific Institute, 20132, Milan, Italy; Vita-Salute San Raffaele University, Milan, Italy. · Department of Medical Oncology, IRCCS San Raffaele Scientific Institute, 20132, Milan, Italy. · Pancreatic Surgery Unit, Pancreas Translational & Clinical Research Center, IRCCS San Raffaele Scientific Institute, Via Olgettina 60, 20132, Milan, Italy; Vita-Salute San Raffaele University, Milan, Italy. · Diabetes Research Institute, IRCCS San Raffaele Scientific Institute, 20132, Milan, Italy; Vita-Salute San Raffaele University, Milan, Italy. Electronic address: piemonti.lorenzo@hsr.it. ·Pancreatology · Pubmed #30293872.

ABSTRACT: BACKGROUND: Despite the recent introduction of new drugs and the development of innovative multi-target treatments, the prognosis of pancreatic ductal adenocarcinoma (PDAC) remains very poor. Even when PDAC is resectable, the rate of local or widespread disease recurrence remains particularly high. Currently, reliable prognostic biomarkers of recurrence are lacking. We decided to explore the potential usefulness of pancreatic developmental regulators as biomarkers of PDAC relapse. METHODS: We analyzed by quantitative real-time PCR the mRNA of selected factors involved either in pancreatic organogenesis (ISL1, NEUROD1, NGN3, NKX2.2, NKX6.1, PAX4, PAX6, PDX1 and PTF1α) or associated with terminally committed pancreatic cells (CHGA, CHGB, GAD2, GCG, HNF6α, INS, KRT19, SYP) in 17 PDAC cell lines and in frozen tumor samples from 41 PDAC patients. RESULTS: High baseline levels of the ISL1, KRT19, PAX6 and PDX1 mRNAs in PDAC cell lines, were risk factors for time-dependent xenograft appearance after subcutaneous injection in CD1-Nude mice. Consistently, in human PDAC samples, high levels of KRT19 mRNA were associated with reduced overall survival and earlier recurrence. Higher levels of PDX1 or PAX6 mRNAs were instead associated with a higher frequency of local recurrence. CONCLUSIONS: Our findings suggest that selected factors associated with pancreas development or its terminal differentiation might be implicated in mechanisms of PDAC progression and/or metastatic spread and that the measurement of their mRNA in tumors might be potentially used to improve patient prognostic stratification and prediction of the relapse site.

20 Article Evolution of pancreatectomy with en bloc venous resection for pancreatic cancer in Italy. Retrospective cohort study on 425 cases in 10 pancreatic referral units. 2018

Nigri, Giuseppe / Petrucciani, Niccolò / Pinna, Antonio Daniele / Ravaioli, Matteo / Jovine, Elio / Minni, Francesco / Grazi, Gian Luca / Chirletti, Piero / Balzano, Gianpaolo / Ferla, Fabio / De Carlis, Luciano / Tisone, Giuseppe / Napoli, Niccolò / Boggi, Ugo / Ramacciato, Giovanni. ·General Surgery and Hepato-pancreato-biliary Unit, Sapienza University of Rome, Sant'Andrea Hospital, Rome, Italy. Electronic address: giuseppe.nigri@uniroma1.it. · General Surgery and Hepato-pancreato-biliary Unit, Sapienza University of Rome, Sant'Andrea Hospital, Rome, Italy. · General Surgery and Transpantation Unit, University of Bologna, Policlinico Sant'Orsola Malpighi, Bologna, Italy. · General Surgery Unit, Ospedale Maggiore di Bologna, Italy. · General Surgery Unit, Policlinico Sant'Orsola Malpighi, Bologna, Italy. · Hepato-pancreato-biliary Surgery, IRCCS Regina Elena National Cancer Institute, Rome, Italy. · General Surgery Unit, Sapienza University of Rome, Policlinico Umberto I, Rome, Italy. · Pancreatic Surgery Unit, Pancreas Translational & Clinical Research Center, IRCCS San Raffaele Scientific Institute, Milan, Italy. · Department of General Surgery and Transplantation, Niguarda Ca' Granda Hospital, Milan, Italy. · Transplantation Unit, University of Tor Vergata, Policlinico Tor Vergata, Roma, Italy. · General Surgery and Transplantation Unit, University of Pisa, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy. ·Int J Surg · Pubmed #29803770.

ABSTRACT: INTRODUCTION: The aim of this study is to analyze the evolution of pancreatectomy with venous resection in 10 referral Italian centers in the last 25 years. METHODS: A multicenter database of 425 patients submitted to pancreatectomy with venous resection between 1991 and 2015 was retrospectively analyzed. Patients were classified in 5 periods: 1 (1991-1995); 2 (1996-2000); 3 (2001-2005); 4 (2006-2010); 5 (2011-2015). Indications and outcomes were compared according to the period of surgery. RESULTS: Nineteen patients were operated in period 1, 28 in period 2, 91 in period 3, 140 in period 4, and 147 in period 5. Use of neoadjuvant therapy increased from 0% in period 1 and 2-12.1% in period 5. Postoperative complications ranged from 46.3% to 67.8%, and mortality from 5.3% to 9.2%. Median survival progressively increased, from 6 months in period 1-16 months in period 2, 24 months in period 3 and 4 and 35 months in period 5 (p = 0.004). Period, venous and nodal invasion were significant prognostic factors for survival. CONCLUSION: Management and outcomes of pancreatectomy with venous resection have evolved in the last 25 years in Italy. Improvement in patients' multidisciplinary management has lead to significant improvement of median survival.

21 Article No evidence of pancreatic ductal adenocarcinoma specific autoantibodies to Ezrin in a liquid phase LIPS immunoassay. 2018

Liberati, Daniela / Marzinotto, Ilaria / Brigatti, Cristina / Dugnani, Erica / Pasquale, Valentina / Reni, Michele / Balzano, Gianpaolo / Falconi, Massimo / Piemonti, Lorenzo / Lampasona, Vito. ·Division of Genetics and Cell Biology, Genomic Unit for the Diagnosis of Human Pathologies, IRCCS San Raffaele Scientific Institute, Milan 20132, Italy. · Diabetes Research Institute, IRCCS San Raffaele Scientific Institute, Milan 20132, Italy. · Department of Medical Oncology, IRCCS San Raffaele Scientific Institute, Milan 20132, Italy. · Pancreatic Surgery Unit, Pancreas Translational and Clinical Research Center, IRCCS San Raffaele Scientific Institute, Milan 20132, Italy. · Vita-Salute San Raffaele University, Italy. ·Cancer Biomark · Pubmed #29660901.

ABSTRACT: BACKGROUND: Sensitive and specific biomarkers of Pancreatic Ductal Adenocarcinoma (PDAC) are desperately needed to allow early diagnosis and improve patient's survival. Ezrin autoantibodies were recently described as present in 93% of PDAC patients and 40% of healthy subjects who later developed PDAC. However, another prospective study failed to replicate these findings. Both studies were based on the use of a solid phase ELISA immunoassay. OBJECTIVE: We aimed at re-evaluating the usefulness of Ezrin autoantibodies as PDAC biomarkers using the Luciferase Immuno Precipitation System (LIPS), an alternative immunoassay format that found successful application for the measurement of autoantibodies against pancreatic autoantigens. METHODS: We produced a Nanoluciferase™ tagged Ezrin (NLuc-Ezrin). NLuc-Ezrin was then used as antigen in LIPS to test for Ezrin autoantibodies patients affected by PDAC (n= 40), other pancreatic diseases (OPD, n= 50), and healthy controls (n= 60). RESULTS: Overall, binding in liquid phase to Ezrin by serum antibodies was rare and low titer. Furthermore, we did not find statistically significant differences in the prevalence of Ezrin autoantibodies between patients affected by either PDAC or OPD compared to control. CONCLUSIONS: Our results do not confirm the usefulness of Ezrin autoAbs as biomarker of PDAC.

22 Article A preoperative score to predict early death after pancreatic cancer resection. 2017

Balzano, Gianpaolo / Dugnani, Erica / Crippa, Stefano / Scavini, Marina / Pasquale, Valentina / Aleotti, Francesca / Liberati, Daniela / Gandolfi, Alessandra / Belfiori, Giulio / Reni, Michele / Doglioni, Claudio / Ruffo, Giacomo / Marmorale, Cristina / Falconi, Massimo / Piemonti, Lorenzo. ·Pancreatic Surgery Unit, Pancreas Translational & Clinical Research Center, Milan, Italy. · Diabetes Research Institute, IRCCS San Raffaele Scientific Institute, Milan, Italy. · Department of Medical Oncology, IRCCS San Raffaele Scientific Institute, Milan, Italy. · Department of Pathology, IRCCS San Raffaele Scientific Institute, Milan, Italy; Vita-Salute San Raffaele University, Milan, Italy. · Division of General Surgery, Sacro Cuore Don Calabria Hospital, Verona, Italy. · Department of Surgery, Polytechnic University of Marche Region, Ancona, Italy. · Pancreatic Surgery Unit, Pancreas Translational & Clinical Research Center, Milan, Italy; Vita-Salute San Raffaele University, Milan, Italy. · Diabetes Research Institute, IRCCS San Raffaele Scientific Institute, Milan, Italy; Vita-Salute San Raffaele University, Milan, Italy. Electronic address: piemonti.lorenzo@hsr.it. ·Dig Liver Dis · Pubmed #28734776.

ABSTRACT: BACKGROUND: This study aimed to develop and validate a preoperative prognostic model for death within one year post-surgery in patients with resectable pancreatic ductal adenocarcinoma (PDAC). METHODS: A derivation cohort study of 296 patients who underwent surgical resection of PDAC was prospectively enrolled in an observational study. Preoperative predictors of one year mortality were used to develop a risk score which was then validated in an external cohort of 182 patients with resectable PDAC. RESULTS: Seventy-eight out of 296 patients (26%) died within the first year. Preoperative independent predictors of one year mortality were: nutritional status (Geriatric Nutritional Risk Index, OR 2.23, 1.14-4.38; p=0.02), American Society of Anaesthesiologists' score (OR 2.56, 1.1-5.98; p=0.03), abdominal or back pain at presentation (OR 2.51, 1.05-5.9; p=0.038) and non metastatic liver disease as comorbidity (OR 4.5, 1.05-19.3; p=0.043). A score ranging from 0 to 7 points was developed. In the validation cohort, the model was able to predict early mortality (OR 7.1, 3.9-12.7; p<0.0001), with a predictive ability of 53.5% (Nagelkerke R CONCLUSIONS: Our new simple risk score proved reliable in forecasting one year mortality in patients with resectable PDAC.

23 Article Effect of Diabetes on Survival after Resection of Pancreatic Adenocarcinoma. A Prospective, Observational Study. 2016

Balzano, Gianpaolo / Dugnani, Erica / Gandolfi, Alessandra / Scavini, Marina / Pasquale, Valentina / Aleotti, Francesca / Liberati, Daniela / Di Terlizzi, Gaetano / Petrella, Giovanna / Reni, Michele / Doglioni, Claudio / Bosi, Emanuele / Falconi, Massimo / Piemonti, Lorenzo. ·Pancreatic Surgery Unit, Pancreas Translational & Clinical Research Center; IRCCS San Raffaele Scientific Institute, Milan, Italy. · San Raffaele Diabetes Research Institute (SR-DRI), IRCCS San Raffaele Scientific Institute, Milan, Italy. · Department of Medical Oncology, IRCCS San Raffaele Scientific Institute, Milan, Italy. · Department of Pathology, IRCCS San Raffaele Scientific Institute, Milan, Italy. · Vita-Salute San Raffaele University, Milan, Italy. ·PLoS One · Pubmed #27814399.

ABSTRACT: AIM: To investigate the effect of diabetes mellitus (DM) on disease-free and overall post-resection survival of patients with pancreatic ductal adenocarcinoma (PDAC). METHODS: Prospective observational study on patients admitted for pancreatic disease from January 2008 to October 2012. DM was classified as recent-onset (<48 months before PDAC diagnosis), longstanding (≥48 months before PDAC) or new onset (after surgery). RESULTS: Of 296 patients, 140 had a diagnosis of DM prior to surgery (26 longstanding, 99 recent-onset, 15 with unknown duration). Median follow-up time was 5.4 ± 0.22 years. Patients with recent onset DM had poorer postoperative survival than patients without DM: disease-free survival and overall survival were 1.14±0.13 years and 1.52±0.12 years in recent onset DM, versus 1.3±0.15 years and 1.87±0.15 years in non-diabetic patients (p = 0.013 and p = 0.025, respectively). Longstanding DM and postoperative new onset DM had no impact on prognosis. Compared to cases without DM, patients with recent onset DM were more likely to have residual disease after surgery and to develop liver metastases during follow-up. Multivariate analysis confirmed recent onset DM was independently associated with PDAC relapse (hazard ratio 1.45 [1.06-1.99]). CONCLUSION: Preoperative recent onset DM has an impact on survival after the resection of PDAC.

24 Article Insulin resistance is associated with the aggressiveness of pancreatic ductal carcinoma. 2016

Dugnani, Erica / Balzano, Gianpaolo / Pasquale, Valentina / Scavini, Marina / Aleotti, Francesca / Liberati, Daniela / Di Terlizzi, Gaetano / Gandolfi, Alessandra / Petrella, Giovanna / Reni, Michele / Doglioni, Claudio / Bosi, Emanuele / Falconi, Massimo / Piemonti, Lorenzo. ·Diabetes Research Institute, IRCCS San Raffaele Scientific Institute, Via Olgettina 60, 20132, Milan, Italy. · Pancreatic Surgery Unit, IRCCS San Raffaele Scientific Institute, 20132, Milan, Italy. · Department of Medical Oncology, IRCCS San Raffaele Scientific Institute, 20132, Milan, Italy. · Department of Pathology, IRCCS San Raffaele Scientific Institute, 20132, Milan, Italy. · Vita-Salute San Raffaele University, Milan, Italy. · Diabetes Research Institute, IRCCS San Raffaele Scientific Institute, Via Olgettina 60, 20132, Milan, Italy. piemonti.lorenzo@hsr.it. ·Acta Diabetol · Pubmed #27552832.

ABSTRACT: AIMS: To study whether insulin resistance accelerates the development and/or the progression of pancreatic adenocarcinoma (PDAC), we hypothesized that patients with insulin resistance, compared with those without insulin resistance, show: (1) a younger age and more advanced PDAC stage at diagnosis and (2) a shorter disease-free and overall survival after PDAC diagnosis. METHODS: Prospective observational study of patients admitted to a referral center for pancreatic disease. Insulin resistance was defined as a HOMA-IR value greater than the 66th percentile value of the patients included in this study. Survival was estimated according to Kaplan-Meier and by Cox regression. RESULTS: Of 296 patients with PDAC, 99 (33 %) met criteria for being classified as insulin resistant at diagnosis. Median follow-up time after diagnosis was 5.27 ± 0.23 years. Patients with insulin resistance received a diagnosis of PDAC at a similar age compared to patients without insulin resistance (67.1 ± 9 vs. 66.8 ± 10 years, p = 0.68), but were more likely to have a cancer stage ≥3 (23.2 vs. 14.2 %, p = 0.053) and a residual disease after surgery (R1 56.4 vs. 38 %; p = 0.007). The median overall survival was 1.3 ± 0.14 and 1.79 ± 0.11 years for the patients with and without insulin resistance, respectively (p = 0.016). Results did not change when patients with diabetes at PDAC diagnosis were excluded from the analysis. Multivariate analysis showed that insulin resistance was independently associated with overall survival. CONCLUSIONS: Insulin resistance is associated with the aggressiveness of PDAC.

25 Article Diabetes associated with pancreatic ductal adenocarcinoma is just diabetes: Results of a prospective observational study in surgical patients. 2016

Dugnani, Erica / Gandolfi, Alessandra / Balzano, Gianpaolo / Scavini, Marina / Pasquale, Valentina / Aleotti, Francesca / Liberati, Daniela / Di Terlizzi, Gaetano / Petrella, Giovanna / Reni, Michele / Doglioni, Claudio / Bosi, Emanuele / Falconi, Massimo / Piemonti, Lorenzo. ·Diabetes Research Institute, IRCCS San Raffaele Scientific Institute, Via Olgettina 60, 20132, Milan, Italy. · Pancreatic Surgery Unit, Pancreas Translational & Clinical Research Center, IRCCS San Raffaele Scientific Institute, Via Olgettina 60, 20132, Milan, Italy. · Department of Medical Oncology, IRCCS San Raffaele Scientific Institute, Via Olgettina 60, 20132, Milan, Italy. · Department of Pathology, IRCCS San Raffaele Scientific Institute, Via Olgettina 60, 20132, Milan, Italy; Vita-Salute San Raffaele University, IRCCS San Raffaele Scientific Institute, Via Olgettina 58, 20132, Milan, Italy. · Diabetes Research Institute, IRCCS San Raffaele Scientific Institute, Via Olgettina 60, 20132, Milan, Italy; Vita-Salute San Raffaele University, IRCCS San Raffaele Scientific Institute, Via Olgettina 58, 20132, Milan, Italy. · Pancreatic Surgery Unit, Pancreas Translational & Clinical Research Center, IRCCS San Raffaele Scientific Institute, Via Olgettina 60, 20132, Milan, Italy; Vita-Salute San Raffaele University, IRCCS San Raffaele Scientific Institute, Via Olgettina 58, 20132, Milan, Italy. · Diabetes Research Institute, IRCCS San Raffaele Scientific Institute, Via Olgettina 60, 20132, Milan, Italy. Electronic address: piemonti.lorenzo@hsr.it. ·Pancreatology · Pubmed #27546476.

ABSTRACT: BACKGROUND: Identification of a specific diabetes signature associated to pancreatic ductal carcinoma (PDAC) could be a key to detect asymptomatic, early stage tumors. We aim to characterize the clinical signature and the pathogenetic factors of the different types of diabetes associated with PDAC, based on the time between diabetes and cancer diagnosis. METHODS: Prospective observational study on 364 PDAC patients admitted to a referral center for pancreatic disease. Hospital and/or outpatient medical records were reviewed. Blood biochemical values including fasting blood glucose, insulin and/or C-peptide, glycosylated hemoglobin and anti-islet antibodies were determined. Diabetes onset was assessed after surgery and during follow-up. RESULTS: The prevalence of diabetes in patients was 67%. Considering 174 patients (47.8%) already having diabetes when diagnosed with PDAC (long duration, short duration, concomitant), the clinical and biochemical profile was similar to that of patients with type 2 diabetes (T2D). Diabetes was associated with known risk factors (i.e., age, sex, family history for diabetes and increased BMI) and both beta-cell dysfunction and insulin resistance were present. Considering 70 patients (19.2%) with onset of diabetes after PDAC diagnosis (early and late onset), the strongest predictor was the loss of beta-cell mass following pancreatectomy in patients with risk factors for T2D. CONCLUSION: Different types of diabetes according to the time between diabetes and PDAC diagnosis are clinical entities widely overlapping with T2D. Therefore, the success of a strategy considering diabetes onset as a marker of asymptomatic PDAC will largely depend on our ability to identify new diabetes-unrelated biomarkers of PDAC.

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