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1. Persister cell phenotypes contribute to poor patient outcomes after neoadjuvant chemotherapy in PDAC

Author

Zhou, Xu, An, Jingyu, Kurilov, Roma, Brors, Benedikt, Hu, Kai, Peccerella, Teresa, Roessler, Stephanie, Pfütze, Katrin, Schulz, Angela, Wolf, Stephan, Hohmann, Nicolas, Theile, Dirk, Sauter, Max, Burhenne, Jürgen, Ei, Shigenori, Heger, Ulrike, Strobel, Oliver, Barry, Simon T., Springfeld, Christoph, Tjaden, Christine, Bergmann, Frank, Büchler, Markus, Hackert, Thilo, Fortunato, Franco, Neoptolemos, John P., and Bailey, Peter

Published
2023
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5. Immediate surgery compared with short-course neoadjuvant gemcitabine plus capecitabine, FOLFIRINOX, or chemoradiotherapy in patients with borderline resectable pancreatic cancer (ESPAC5): a four-arm, multicentre, randomised, phase 2 trial

Author

Ghaneh, Paula, Palmer, Daniel, Cicconi, Silvia, Jackson, Richard, Halloran, Christopher Michael, Rawcliffe, Charlotte, Sripadam, Rajaram, Mukherjee, Somnath, Soonawalla, Zahir, Wadsley, Jonathan, Al-Mukhtar, Ahmed, Dickson, Euan, Graham, Janet, Jiao, Long, Wasan, Harpreet S, Tait, Iain S, Prachalias, Andreas, Ross, Paul, Valle, Juan W, O'Reilly, Derek A, Al-Sarireh, Bilal, Gwynne, Sarah, Ahmed, Irfan, Connolly, Kate, Yim, Kein-Long, Cunningham, David, Armstrong, Thomas, Archer, Caroline, Roberts, Keith, Ma, Yuk Ting, Springfeld, Christoph, Tjaden, Christine, Hackert, Thilo, Büchler, Markus W, and Neoptolemos, John P

Published
2023
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11. Immunohistochemical FAP Expression Reflects68Ga-FAPI PET Imaging Properties of Low- and High-Grade Intraductal Papillary Mucinous Neoplasms and Pancreatic Ductal Adenocarcinoma

Author

Spektor, Anna-Maria, primary, Gutjahr, Ewgenija, additional, Lang, Matthias, additional, Glatting, Frederik M., additional, Hackert, Thilo, additional, Pausch, Thomas, additional, Tjaden, Christine, additional, Schreckenberger, Mathias, additional, Haberkorn, Uwe, additional, and Röhrich, Manuel, additional

Published
2024
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14. Safety of multimodality treatment with a combination of intra- operative chemotherapy and surgical resection in locally confined or borderline resectable pancreatic cancer: The combiCaRe study

Author

Roth, Susanne, primary, Cal y Mayor, Mariana Buenrostro, additional, Alhalabi, Karam T., additional, Springfeld, Christoph, additional, Diener, Markus, additional, Tjaden, Christine, additional, Knebel, Phillip, additional, Klaiber, Ulla, additional, Mieth, Markus, additional, Michalski, Christoph, additional, Jäger, Dirk, additional, Büchler, Markus W., additional, and Hackert, Thilo, additional

Published
2023
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17. Static and Dynamic68Ga-FAPI PET/CT for the Detection of Malignant Transformation of Intraductal Papillary Mucinous Neoplasia of the Pancreas

Author

Lang, Matthias, Spektor, Anna-Maria, Hielscher, Thomas, Hoppner, Jorge, Glatting, Frederik M, Bicu, Felix, Hackert, Thilo, Heger, Ulrike, Pausch, Thomas, Gutjahr, Ewgenija, Rathke, Hendrik, Giesel, Frederik L, Kratochwil, Clemens, Tjaden, Christine, Haberkorn, Uwe A, and Röhrich, Manuel

Subjects
610 Medicine & health, Radiology, Nuclear Medicine and imaging
Abstract

Purpose: Pancreatic ductal adenocarcinoma (PDAC) may arise from intraductal papillary-mucinous neoplasms (IPMN) with malignant transformation, but a significant portion of IPMN remains to show benign behavior. Therefore, it is important to differentiate between benign IPMN and IPMN lesions undergoing malignant transformation. However, non-operative differentiation by ultrasound, CT, MRI and carbohydrate antigen 19-9 (CA19-9) is still unsatisfactory. Here, we assessed the clinical feasibility of additional assessment of malignancy by positron emission tomography using 68Gallium-labeled Fibroblast Activation Protein Inhibitors (68Ga-FAPI-PET) in 25 patients with magnetic resonance imaging (MRI) - or computed tomography (CT) - proven cystic pancreatic lesions. Methods: 25 patients with cystic pancreatic lesions who were followed up in the European Pancreas Center of Heidelberg University hospital and who were led to surgical resection or fine needle aspiration (FNA) due to suspicious clinical, laboratory chemistry or radiological findings were examined by static (all patients) and dynamic (20 patients) 68Ga-FAPI-PET. Cystic pancreatic lesions were delineated and maximum and mean standardized uptake values (SUVmax / SUVmean) were determined. Time activity curves and dynamic parameters (time to peak, K1, k2, K3, k4) were extracted from dynamic PET data. Receiver operating curves (ROC) of static and dynamic PET parameters were calculated. Results: 11 of the patients suffered from menacing IPMN (high grade IPMN with (6 cases) or without (5 cases) progression into PDAC) and 11 from low grade IPMN, 3 patients from other benign entities. Menacing IMPN showed significantly elevated 68Ga-FAPI uptake compared to low grade IPMN and other benign cystic lesions. In dynamic imaging, menacing IPMN showed increasing time activity curves (TAC) followed by slow decrease afterwards, TAC of low grade IPMN showed an immediate peak followed by rapid decrease for about 10 minutes and slower decrease for the rest of the time. ROC curves showed high sensitivity and specificity (area under the curve (AUC) greater than 80%) of static and dynamic PET parameters for the differentiation of IPMN subtypes. Conclusion: 68Ga-FAPI-PET is a helpful new tool for the differentiation of menacing and low grade IPMN and shows the potential to avoid unnecessary surgery for non-malignant pancreatic IPMN.

Published
2022
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20. Central pancreatectomy prevents postoperative diabetes

Author

Klotz, Rosa, primary, Schilling, Constanze, additional, Kuner, Charlotte, additional, Hinz, Ulf, additional, Klaiber, Ulla, additional, Holze, Magdalena, additional, Tjaden, Christine, additional, Loos, Martin, additional, Büchler, Markus W., additional, and Hackert, Thilo, additional

Published
2022
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21. Abstract A010: Persister cell phenotypes contribute to poor patient outcomes after neoadjuvant chemotherapy in PDAC

Author

Zhou, Xu, primary, Kurilov, Roma, additional, Neoptolemos, John P., additional, Brors, Benedikt, additional, Hu, Kai, additional, Peccerella, Teresa, additional, An, Jing-Yu, additional, Roessler, Stephanie, additional, Pfütze, Katrin, additional, Schulz, Angela, additional, Wolf, Stephan, additional, Hohmann, Nicolas, additional, Heger, Ulrike, additional, Strobel, Oliver, additional, Barry, Simon T, additional, Springfeld, Christoph, additional, Tjaden, Christine, additional, Bergmann, Frank, additional, Büchler, Markus, additional, Hackert, Thilo, additional, Fortunato, Franco, additional, and Bailey, Peter, additional

Published
2022
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22. Central pancreatectomy prevents postoperative diabetes.

Author

Klotz, Rosa, Schilling, Constanze, Kuner, Charlotte, Hinz, Ulf, Klaiber, Ulla, Holze, Magdalena, Tjaden, Christine, Loos, Martin, Büchler, Markus W., and Hackert, Thilo

Abstract

Background: Central pancreatectomy (CP) can be performed as an alternative surgical approach to distal pancreatectomy (DP) in the treatment of benign or low‐grade malignant lesions located in the neck and body of the pancreas, aiming to reduce loss of parenchyma and therefore organ failure. The objective of this study was to evaluate the short‐ and long‐term outcome of CP in comparison to DP. Methods: Patients who received CP in a large tertiary care pancreatic surgery center between 2001 and 2020 were identified from a prospectively maintained database and compared via propensity score matching with patients receiving DP during the same time period. Perioperative rate of complications and long‐term outcome of pancreatic endocrine and exocrine function were evaluated. Results: One hundred and seven patients undergoing open CP were compared to 107 patients with open DP. No significant difference in rates or severity of most surgical complications could be found including postoperative pancreatic fistula, intraabdominal fluid collection, delayed gastric emptying and wound infection. However, patients receiving CP had a significantly higher risk of grade C postpancreatectomy hemorrhage (PPH) (CP: 10 patients, 9.3% versus DP: 1 patient, 0.9%; p =.0019). Perioperative mortality was comparable. Long‐term follow‐up of 60 matched pairs revealed significantly less patients with new‐onset diabetes after CP (eight patients, 13.3%) compared to DP (22 patients, 36.7%, p =.0056). Conclusion: CP offers an improved endocrine long‐term outcome at the expense of a higher risk of PPH without increased perioperative mortality. As evidence on this parenchyma sparing surgical technique is sparse, more prospective data are needed. [ABSTRACT FROM AUTHOR]

Published
2023
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27. Risk of the Watch-and-Wait Concept in Surgical Treatment of Intraductal Papillary Mucinous Neoplasm

Author

Tjaden, Christine, primary, Sandini, Marta, additional, Mihaljevic, André L., additional, Kaiser, Jörg, additional, Khristenko, Ekaterina, additional, Mayer, Philipp, additional, Hinz, Ulf, additional, Gaida, Matthias M., additional, Berchtold, Christoph, additional, Diener, Markus K., additional, Schneider, Martin, additional, Mehrabi, Arianeb, additional, Müller-Stich, Beat P., additional, Strobel, Oliver, additional, Hackert, Thilo, additional, and Büchler, Markus W., additional

Published
2021
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28. Distal Bile Duct Cancer: Radical (R0 > 1 mm) Resection Achieves Favorable Survival

Author

Tjaden, Christine, primary, Hinz, Ulf, additional, Klaiber, Ulla, additional, Heger, Ulrike, additional, Springfeld, Christoph, additional, Goeppert, Benjamin, additional, Schmidt, Thomas, additional, Mehrabi, Arianeb, additional, Strobel, Oliver, additional, Berchtold, Christoph, additional, Schneider, Martin, additional, Diener, Markus, additional, Neoptolemos, John P., additional, Hackert, Thilo, additional, and Büchler, Markus W., additional

Published
2021
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30. Protocol of a randomised controlled phase II clinical trial investigating PREoperative endoscopic injection of BOTulinum toxin into the sphincter of Oddi to reduce postoperative pancreatic fistula after distal pancreatectomy: the PREBOTPilot trial

Author

Klaiber, Ulla, primary, Sauer, Peter, additional, Martin, Eike, additional, Bruckner, Thomas, additional, Luntz, Steffen, additional, Tjaden, Christine, additional, Probst, Pascal, additional, Knebel, Phillip, additional, Diener, Markus K, additional, Buchler, Markus W, additional, and Hackert, Thilo, additional

Published
2020
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31. Noninvasive Discrimination of Low and High-risk Pancreatic Intraductal Papillary Mucinous Neoplasms

Author

Roth, Susanne, primary, Bose, Promita, additional, Alhamdani, Mohamed S. S., additional, Mustafa, Shakhawan A., additional, Tjaden, Christine, additional, Zamzow, Katharina, additional, Hinz, Ulf, additional, Michalski, Christoph W., additional, Neoptolemos, John P., additional, Hoheisel, Jörg D., additional, Büchler, Markus W., additional, and Hackert, Thilo, additional

Published
2020
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34. Patterns of Recurrence After Resection of Pancreatic Ductal Adenocarcinoma: A Secondary Analysis of the ESPAC-4 Randomized Adjuvant Chemotherapy Trial

Author

Jones, Robert P, Psarelli, Eftychia-Eirini, Jackson, Richard, Ghaneh, Paula, Halloran, Christopher M, Palmer, Daniel H, Campbell, Fiona, Valle, Juan W, Faluyi, Olusola, O'Reilly, Derek A, Cunningham, David, Wadsley, Jonathan, Darby, Suzanne, Meyer, Tim, Gillmore, Roopinder, Anthoney, Alan, Lind, Pehr, Glimelius, Bengt, Falk, Stephen, Izbicki, Jakob R, Middleton, Gary William, Cummins, Sebastian, Ross, Paul J, Wasan, Harpreet, McDonald, Alec, Crosby, Tom, Ting, Yuk, Patel, Kinnari, Sherriff, David, Soomal, Rubin, Borg, David, Sothi, Sharmila, Hammel, Pascal, Lerch, Markus M, Mayerle, Julia, Tjaden, Christine, Strobel, Oliver, Hackert, Thilo, Buchler, Markus W, Neoptolemos, John P, Hill, Mark, Corrie, Pippa, Hickish, Tamas, Napier, Mark, Slater, Sarah, Valle, Juan, Shablak, Alaaeldin, Cunnell, Michelle, Guimbaud, Rosine, Roques, Tom, Iveson, Tim, Jamil, Arshad, Robinson, Angus, Garcia-Alonso, Angel, Chang, David, Tsang, David, Wadd, Nick, Wall, Lucy, Nielsen, Niels Hilmer, Lerch, Markus, Mehta, Ajay, Sivaramalingam, Muthiah, Fyfe, David, Osborne, Richard, Blesing, Claire, Bulusu, Venkata Ramesh, Rathbone, Emma, Seitz, Jean-Francois, Beaumont, Erica, Dernedde, Ulrike, McAdam, Karen, Dimopoulos, Prokopios, Cominos, Mathilda, Askill, Colin, Piwowar, Andrzej, Bachet, Jean-Baptiste, Sumpter, Kate, Raouf, Sherif, Nicoll, Jonathan, Rees, Charlotte, Dhinakaran, Kathirvelu, Haux, Johan, Bengrine-Lefevre, Leila, Terrebonne, Eric, Shankland, Catherine, Palmer, Cheryl, Medley, Louise, Toy, Elizabeth, Kaur, Jasvinder, Gupta, Kamalnayan, Cheeseman, Sue, Patterson, Daniel, Candish, Charles, Thompson, Joyce, Coxon, Fareeda, Connolly, Caroline, McPhail, Neil, Williams, Rachel, Flygare, Petra, Elmlund, Mattias, Artru, Pascal, Millat, Bertrand, and Canc, European Study Grp Pancreatic

Subjects
medicine.medical_specialty, Chemotherapy, Randomization, business.industry, medicine.medical_treatment, 030230 surgery, medicine.disease, Gastroenterology, Gemcitabine, law.invention, Capecitabine, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, 030220 oncology & carcinogenesis, Internal medicine, Pancreatic cancer, medicine, Carcinoma, Surgery, Prospective cohort study, business, medicine.drug
Abstract

Importance The patterns of disease recurrence after resection of pancreatic ductal adenocarcinoma with adjuvant chemotherapy remain unclear. Objective To define patterns of recurrence after adjuvant chemotherapy and the association with survival. Design, Setting, and Participants Prospectively collected data from the phase 3 European Study Group for Pancreatic Cancer 4 adjuvant clinical trial, an international multicenter study. The study included 730 patients who had resection and adjuvant chemotherapy for pancreatic cancer. Data were analyzed between July 2017 and May 2019. Interventions Randomization to adjuvant gemcitabine or gemcitabine plus capecitabine. Main Outcomes and Measures Overall survival, recurrence, and sites of recurrence. Results Of the 730 patients, median age was 65 years (range 37-81 years), 414 were men (57%), and 316 were women (43%). The median follow-up time from randomization was 43.2 months (95% CI, 39.7-45.5 months), with overall survival from time of surgery of 27.9 months (95% CI, 24.8-29.9 months) with gemcitabine and 30.2 months (95% CI, 25.8-33.5 months) with the combination (HR, 0.81; 95% CI, 0.68-0.98;P = .03). The 5-year survival estimates were 17.1% (95% CI, 11.6%-23.5%) and 28.0% (22.0%-34.3%), respectively. Recurrence occurred in 479 patients (65.6%); another 78 patients (10.7%) died without recurrence. Local recurrence occurred at a median of 11.63 months (95% CI, 10.05-12.19 months), significantly different from those with distant recurrence with a median of 9.49 months (95% CI, 8.44-10.71 months) (HR, 1.21; 95% CI, 1.01-1.45;P = .04). Following recurrence, the median survival was 9.36 months (95% CI, 8.08-10.48 months) for local recurrence and 8.94 months (95% CI, 7.82-11.17 months) with distant recurrence (HR, 0.89; 95% CI, 0.73-1.09;P = .27). The median overall survival of patients with distant-only recurrence (23.03 months; 95% CI, 19.55-25.85 months) or local with distant recurrence (23.82 months; 95% CI, 17.48-28.32 months) was not significantly different from those with only local recurrence (24.83 months; 95% CI, 22.96-27.63 months) (P = .85 andP = .35, respectively). Gemcitabine plus capecitabine had a 21% reduction of death following recurrence compared with monotherapy (HR, 0.79; 95% CI, 0.64-0.98;P = .03). Conclusions and Relevance There were no significant differences between the time to recurrence and subsequent and overall survival between local and distant recurrence. Pancreatic cancer behaves as a systemic disease requiring effective systemic therapy after resection. Trial Registration ClinicalTrials.gov identifier:NCT00058201, EudraCT 2007-004299-38, and ISRCTN 96397434.

Published
2019

35. Protocol of a prospective, monocentric phase I/II feasibility study investigating the safety of multimodality treatment with a combination of intraoperative chemotherapy and surgical resection in locally confined or borderline resectable pancreatic cancer: the combiCaRe study

Author

Roth, Susanne, Springfeld, Christoph, Diener, Markus K, Tjaden, Christine, Knebel, Phillip, Klaiber, Ulla, Michalski, Christoph W, Mieth, Markus, Jäger, Dirk, Büchler, Markus W, and Thilo, Hackert

Subjects
gastrointestinal tumours, Protocol, gastroenterology, Gastroenterology and Hepatology, pancreatic surgery, pancreatic disease
Abstract

Introduction Pancreatic cancer is a devastating disease with an exceptionally poor prognosis. Complete resection of the primary tumour followed by adjuvant chemotherapy is the current standard treatment for patients with resectable disease and the only curative treatment option. However, long-term survival remains rare. Tumour cell dissemination due to manipulation during surgery may increase the rate of future metastases and local recurrence, and perioperative chemotherapy might diminish local, distant and circulating minimal residual disease. Yet, safety and feasibility of systemic chemotherapeutic treatments during pancreatic cancer resection have to be evaluated in a first instance. Methods and analysis This is a prospective, single-centre phase I/II feasibility study to investigate the safety and tolerability of a combination of intraoperative chemotherapy and surgical resection in pancreatic cancer. Forty patients with locally confined or borderline resectable pancreatic cancer, meeting all proposed criteria will be included. Participants will receive 400 mg/m2 calcium folinate over 2 hours and 2000 mg/m2 5-fluorouracil over 48 hours, started on the day before pancreatic surgery and thus continuing during surgery. Participants will be followed until 60 days after surgery. The primary endpoint is the 30-day overall complication rate according to the Clavien-Dindo classification. Secondary endpoints comprise toxicity and treatment associated complications. Patients receiving perioperative chemotherapy will be compared with a propensity score matched contemporary control group of 70 patients with pancreatic cancer receiving the standard treatment. This trial also contains an ancillary translational study to analyse disseminated tumour cells and effects of pharmacological interventions in pancreatic cancer. Ethics and dissemination CombiCaRe has been approved by the German Federal Institute for Drugs and Medical Devices (reference number 4042787) and the Medical Ethics Committee of Heidelberg University (reference number AFmo-269/2018). The results of this trial will be presented at national and international conferences and published in peer-reviewed journals. Trial registration number German Clinical Trials Register (DRKS00015766).

Published
2019

36. Patterns of Recurrence After Resection of Pancreatic Ductal Adenocarcinoma : A Secondary Analysis of the ESPAC-4 Randomized Adjuvant Chemotherapy Trial

Author

Jones, Robert P., Psarelli, Eftychia-Eirini, Jackson, Richard, Ghaneh, Paula, Halloran, Christopher M., Palmer, Daniel H., Campbell, Fiona, Valle, Juan W., Faluyi, Olusola, O'Reilly, Derek A., Cunningham, David, Wadsley, Jonathan, Darby, Suzanne, Meyer, Tim, Gillmore, Roopinder, Anthoney, Alan, Lind, Pehr, Glimelius, Bengt, Falk, Stephen, Izbicki, Jakob R., Middleton, Gary William, Cummins, Sebastian, Ross, Paul J., Wasan, Harpreet, McDonald, Alec, Crosby, Tom, Ting, Yuk, Patel, Kinnari, Sherriff, David, Soomal, Rubin, Borg, David, Sothi, Sharmila, Hammel, Pascal, Lerch, Markus M., Mayerle, Julia, Tjaden, Christine, Strobel, Oliver, Hackert, Thilo, Buchler, Markus W., Neoptolemos, John P., Hill, Mark, Corrie, Pippa, Hickish, Tamas, Napier, Mark, Slater, Sarah, Valle, Juan, Shablak, Alaaeldin, Cunnell, Michelle, Guimbaud, Rosine, Roques, Tom, Iveson, Tim, Jamil, Arshad, Robinson, Angus, Garcia-Alonso, Angel, Chang, David, Tsang, David, Wadd, Nick, Wall, Lucy, Nielsen, Niels Hilmer, Lerch, Markus, Mehta, Ajay, Sivaramalingam, Muthiah, Fyfe, David, Osborne, Richard, Blesing, Claire, Bulusu, Venkata Ramesh, Rathbone, Emma, Seitz, Jean-Francois, Beaumont, Erica, Dernedde, Ulrike, McAdam, Karen, Dimopoulos, Prokopios, Cominos, Mathilda, Askill, Colin, Piwowar, Andrzej, Bachet, Jean-Baptiste, Sumpter, Kate, Raouf, Sherif, Nicoll, Jonathan, Rees, Charlotte, Dhinakaran, Kathirvelu, Haux, Johan, Bengrine-Lefevre, Leila, Terrebonne, Eric, Shankland, Catherine, Palmer, Cheryl, Medley, Louise, Toy, Elizabeth, Kaur, Jasvinder, Gupta, Kamalnayan, Cheeseman, Sue, Patterson, Daniel, Candish, Charles, Thompson, Joyce, Coxon, Fareeda, Connolly, Caroline, McPhail, Neil, Williams, Rachel, Flygare, Petra, Elmlund, Mattias, Artru, Pascal, Millat, Bertrand, Jones, Robert P., Psarelli, Eftychia-Eirini, Jackson, Richard, Ghaneh, Paula, Halloran, Christopher M., Palmer, Daniel H., Campbell, Fiona, Valle, Juan W., Faluyi, Olusola, O'Reilly, Derek A., Cunningham, David, Wadsley, Jonathan, Darby, Suzanne, Meyer, Tim, Gillmore, Roopinder, Anthoney, Alan, Lind, Pehr, Glimelius, Bengt, Falk, Stephen, Izbicki, Jakob R., Middleton, Gary William, Cummins, Sebastian, Ross, Paul J., Wasan, Harpreet, McDonald, Alec, Crosby, Tom, Ting, Yuk, Patel, Kinnari, Sherriff, David, Soomal, Rubin, Borg, David, Sothi, Sharmila, Hammel, Pascal, Lerch, Markus M., Mayerle, Julia, Tjaden, Christine, Strobel, Oliver, Hackert, Thilo, Buchler, Markus W., Neoptolemos, John P., Hill, Mark, Corrie, Pippa, Hickish, Tamas, Napier, Mark, Slater, Sarah, Valle, Juan, Shablak, Alaaeldin, Cunnell, Michelle, Guimbaud, Rosine, Roques, Tom, Iveson, Tim, Jamil, Arshad, Robinson, Angus, Garcia-Alonso, Angel, Chang, David, Tsang, David, Wadd, Nick, Wall, Lucy, Nielsen, Niels Hilmer, Lerch, Markus, Mehta, Ajay, Sivaramalingam, Muthiah, Fyfe, David, Osborne, Richard, Blesing, Claire, Bulusu, Venkata Ramesh, Rathbone, Emma, Seitz, Jean-Francois, Beaumont, Erica, Dernedde, Ulrike, McAdam, Karen, Dimopoulos, Prokopios, Cominos, Mathilda, Askill, Colin, Piwowar, Andrzej, Bachet, Jean-Baptiste, Sumpter, Kate, Raouf, Sherif, Nicoll, Jonathan, Rees, Charlotte, Dhinakaran, Kathirvelu, Haux, Johan, Bengrine-Lefevre, Leila, Terrebonne, Eric, Shankland, Catherine, Palmer, Cheryl, Medley, Louise, Toy, Elizabeth, Kaur, Jasvinder, Gupta, Kamalnayan, Cheeseman, Sue, Patterson, Daniel, Candish, Charles, Thompson, Joyce, Coxon, Fareeda, Connolly, Caroline, McPhail, Neil, Williams, Rachel, Flygare, Petra, Elmlund, Mattias, Artru, Pascal, and Millat, Bertrand

Abstract

Importance: The patterns of disease recurrence after resection of pancreatic ductal adenocarcinoma with adjuvant chemotherapy remain unclear. Objective: To define patterns of recurrence after adjuvant chemotherapy and the association with survival. Design, Setting, and Participants: Prospectively collected data from the phase 3 European Study Group for Pancreatic Cancer 4 adjuvant clinical trial, an international multicenter study. The study included 730 patients who had resection and adjuvant chemotherapy for pancreatic cancer. Data were analyzed between July 2017 and May 2019. Interventions: Randomization to adjuvant gemcitabine or gemcitabine plus capecitabine. Main Outcomes and Measures: Overall survival, recurrence, and sites of recurrence. Results: Of the 730 patients, median age was 65 years (range 37-81 years), 414 were men (57%), and 316 were women (43%). The median follow-up time from randomization was 43.2 months (95% CI, 39.7-45.5 months), with overall survival from time of surgery of 27.9 months (95% CI, 24.8-29.9 months) with gemcitabine and 30.2 months (95% CI, 25.8-33.5 months) with the combination (HR, 0.81; 95% CI, 0.68-0.98; P=.03). The 5-year survival estimates were 17.1% (95% CI, 11.6%-23.5%) and 28.0% (22.0%-34.3%), respectively. Recurrence occurred in 479 patients (65.6%); another 78 patients (10.7%) died without recurrence. Local recurrence occurred at a median of 11.63 months (95% CI, 10.05-12.19 months), significantly different from those with distant recurrence with a median of 9.49 months (95% CI, 8.44-10.71 months) (HR, 1.21; 95% CI, 1.01-1.45; P=.04). Following recurrence, the median survival was 9.36 months (95% CI, 8.08-10.48 months) for local recurrence and 8.94 months (95% CI, 7.82-11.17 months) with distant recurrence (HR, 0.89; 95% CI, 0.73-1.09; P=.27). The median overall survival of patients with distant-only recurrence (23.03 months; 95% CI, 19.55-25.85 months) or local with distant recurrence (23.82 months; 95% CI, 17.48-28.32

Published
2019
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41. Genetic variability of the ABCC2 gene and clinical outcomes in pancreatic cancer patients

Author

Gentiluomo, Manuel, primary, Puchalt García, Paula, additional, Galeotti, Alice Alessandra, additional, Talar-Wojnarowska, Renata, additional, Tjaden, Christine, additional, Tavano, Francesca, additional, Strobel, Oliver, additional, Kupcinskas, Juozas, additional, Neoptolemos, John, additional, Hegyi, Péter, additional, Costello, Eithne, additional, Pezzilli, Raffaele, additional, Sperti, Cosimo, additional, Lawlor, Rita T, additional, Capurso, Gabriele, additional, Szentesi, Andrea, additional, Soucek, Pavel, additional, Vodicka, Pavel, additional, Lovecek, Martin, additional, Hackert, Thilo, additional, Cavestro, Giulia Martina, additional, Milanetto, Anna Caterina, additional, Canzian, Federico, additional, and Campa, Daniele, additional

Published
2019
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42. Randomized controlled phase I/II study to investigate immune stimulatory effects by low dose radiotherapy in primarily operable pancreatic cancer

Author

Debus Juergen, Buechler Markus W, Tjaden Christine, Koch Moritz, Rochet Nathalie, Reissfelder Christoph, Bonertz Andreas, Roeder Falk FF, Klug Felix, Winnenthal Hubertus, Timke Carmen, Werner Jens, Beckhove Philipp, Weitz Jürgen, and Huber Peter E

Subjects
pancreatic cancer, immune therapy, low dose radiation, T-cells, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Abstract Background The efficiencies of T cell based immunotherapies are affected by insufficient migration and activation of tumor specific effector T cells in the tumor. Accumulating evidence exists on the ability of ionizing radiation to modify the tumor microenvironment and generate inflammation. The aim of this phase I/II clinical trial is to evaluate whether low dose single fraction radiotherapy can improve T cell associated antitumor immune response in patients with pancreatic cancer. Methods/Design This trial has been designed as an investigator initiated; prospective randomised, 4-armed, controlled Phase I/II trial. Patients who are candidates for resection of pancreatic cancer will be randomized into 4 arms. A total of 40 patients will be enrolled. The patients receive 0 Gy, 0.5 Gy, 2 Gy or 5 Gy radiation precisely targeted to their pancreatic carcinoma. Radiation will be delivered by external beam radiotherapy using a 6 MV Linac with IMRT technique 48 h prior to the surgical resection. The primary objective is the determination of an active local external beam radiation dose, leading to tumor infiltrating T cells as a surrogate parameter for antitumor activity. Secondary objectives include local tumor control and recurrence patterns, survival, radiogenic treatment toxicity and postoperative morbidity and mortality, as well as quality of life. Further, frequencies of tumor reactive T cells in blood and bone marrow as well as whole blood cell transcriptomics and plasma-proteomics will be correlated with clinical outcome. An interim analysis will be performed after the enrolment of 20 patients for safety reasons. The evaluation of the primary endpoint will start four weeks after the last patient's enrolment. Discussion This trial will answer the question whether a low dose radiotherapy localized to the pancreatic tumor only can increase the number of tumor infiltrating T cells and thus potentially enhance the antitumor immune response. The study will also investigate the prognostic and predictive value of radiation-induced T cell activity along with transcriptomic and proteomic data with respect to clinical outcome. Trial registration ClinicalTrials.gov - NCT01027221

Published
2011
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43. Noninvasive Discrimination of Low and High-risk Pancreatic Intraductal Papillary Mucinous Neoplasms.

Author

Roth, Susanne, Bose, Promita, Alhamdani, Mohamed S. S., Mustafa, Shakhawan A., Tjaden, Christine, Zamzow, Katharina, Hinz, Ulf, Michalski, Christoph W., Neoptolemos, John P., Hoheisel, Jörg D., Büchler, Markus W., and Hackert, Thilo

Abstract

Objective: To propose a noninvasive diagnostic approach, which allows reliable distinction between low- and high-risk pancreatic intraductal papillary mucinous neoplasms (IPMNs). Background: IPMNs are identifiable precursor lesions of pancreatic cancer, of which surgical resection is warranted prior to the development of invasive carcinoma, but low-grade IPMNs should not be unnecessarily resected. However, diagnostic tools that preoperatively enable accurate risk stratification of IPMNs are missing. Methods: This single-center, retrospective cohort study included 56 patients who underwent surgical resection for IPMN including 18 low-risk (lowgrade) and 38 high-risk (high-grade/invasive carcinoma) IPMNs, from whom clinical features and serum samples were prospectively obtained. An antibody microarray platform was used to analyze the serum proteome. Based on serum markers and selected clinical characteristics support vector machine models were constructed to predict the risk of IPMN malignancy. Results: A serum protein signature discriminating low- and high-risk IPMN patients was identified. Combinations of established clinical features and the newly identified serum biomarkers correctly distinguished low- and high-risk IPMNs in 93% on 1000-fold cross-validation. Conclusions: This study highlights the synergistic predictive value of combining a novel serum protein signature with conventional clinical characteristics to risk-stratify IPMN patients. If these findings are supported by larger validation studies, they might enable more rational decision-making in clinical management of IPMN patients in conjunction with clinical guidelines. [ABSTRACT FROM AUTHOR]

Published
2021
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44. Association of genetic polymorphisms with survival of pancreatic ductal adenocarcinoma patients

Author

Rizzato, Cosmeri, primary, Campa, Daniele, additional, Talar-Wojnarowska, Renata, additional, Halloran, Christopher, additional, Kupcinskas, Juozas, additional, Butturini, Giovanni, additional, Mohelníková-Duchoňová, Beatrice, additional, Sperti, Cosimo, additional, Tjaden, Christine, additional, Ghaneh, Paula, additional, Hackert, Thilo, additional, Funel, Niccola, additional, Giese, Nathalia, additional, Tavano, Francesca, additional, Pezzilli, Raffaele, additional, Pedata, Mariangela, additional, Pasquali, Claudio, additional, Gazouli, Maria, additional, Mambrini, Andrea, additional, Souček, Pavel, additional, di Sebastiano, Pierluigi, additional, Capurso, Gabriele, additional, Cantore, Maurizio, additional, Oliverius, Martin, additional, Offringa, Rienk, additional, Małecka-Panas, Ewa, additional, Strobel, Oliver, additional, Scarpa, Aldo, additional, and Canzian, Federico, additional

Published
2016
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49. Toward the blood-borne miRNome of human diseases

Author

Keller, Andreas, primary, Leidinger, Petra, additional, Bauer, Andrea, additional, ElSharawy, Abdou, additional, Haas, Jan, additional, Backes, Christina, additional, Wendschlag, Anke, additional, Giese, Nathalia, additional, Tjaden, Christine, additional, Ott, Katja, additional, Werner, Jens, additional, Hackert, Thilo, additional, Ruprecht, Klemens, additional, Huwer, Hanno, additional, Huebers, Junko, additional, Jacobs, Gunnar, additional, Rosenstiel, Philip, additional, Dommisch, Henrik, additional, Schaefer, Arne, additional, Müller-Quernheim, Joachim, additional, Wullich, Bernd, additional, Keck, Bastian, additional, Graf, Norbert, additional, Reichrath, Joerg, additional, Vogel, Britta, additional, Nebel, Almut, additional, Jager, Sven U, additional, Staehler, Peer, additional, Amarantos, Ioannis, additional, Boisguerin, Valesca, additional, Staehler, Cord, additional, Beier, Markus, additional, Scheffler, Matthias, additional, Büchler, Markus W, additional, Wischhusen, Joerg, additional, Haeusler, Sebastian F M, additional, Dietl, Johannes, additional, Hofmann, Sylvia, additional, Lenhof, Hans-Peter, additional, Schreiber, Stefan, additional, Katus, Hugo A, additional, Rottbauer, Wolfgang, additional, Meder, Benjamin, additional, Hoheisel, Joerg D, additional, Franke, Andre, additional, and Meese, Eckart, additional

Published
2011
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50. Randomized controlled phase I/II study to investigate immune stimulatory effects by low dose radiotherapy in primarily operable pancreatic cancer

Author

Timke, Carmen, primary, Winnenthal, Hubertus Schmitz, additional, Klug, Felix, additional, Roeder, Falk FF, additional, Bonertz, Andreas, additional, Reissfelder, Christoph, additional, Rochet, Nathalie, additional, Koch, Moritz, additional, Tjaden, Christine, additional, Buechler, Markus W, additional, Debus, Juergen, additional, Werner, Jens, additional, Beckhove, Philipp, additional, Weitz, Jürgen, additional, and Huber, Peter E, additional

Published
2011
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