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Pancreatic Neoplasms: HELP
Articles by Julien Taïeb
Based on 18 articles published since 2009
(Why 18 articles?)
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Between 2009 and 2019, J. Taieb wrote the following 18 articles about Pancreatic Neoplasms.
 
+ Citations + Abstracts
1 Guideline Guidelines for time-to-event end-point definitions in trials for pancreatic cancer. Results of the DATECAN initiative (Definition for the Assessment of Time-to-event End-points in CANcer trials). 2014

Bonnetain, Franck / Bonsing, Bert / Conroy, Thierry / Dousseau, Adelaide / Glimelius, Bengt / Haustermans, Karin / Lacaine, François / Van Laethem, Jean Luc / Aparicio, Thomas / Aust, Daniela / Bassi, Claudio / Berger, Virginie / Chamorey, Emmanuel / Chibaudel, Benoist / Dahan, Laeticia / De Gramont, Aimery / Delpero, Jean Robert / Dervenis, Christos / Ducreux, Michel / Gal, Jocelyn / Gerber, Erich / Ghaneh, Paula / Hammel, Pascal / Hendlisz, Alain / Jooste, Valérie / Labianca, Roberto / Latouche, Aurelien / Lutz, Manfred / Macarulla, Teresa / Malka, David / Mauer, Muriel / Mitry, Emmanuel / Neoptolemos, John / Pessaux, Patrick / Sauvanet, Alain / Tabernero, Josep / Taieb, Julien / van Tienhoven, Geertjan / Gourgou-Bourgade, Sophie / Bellera, Carine / Mathoulin-Pélissier, Simone / Collette, Laurence. ·Methodology and Quality of Life Unit in Cancer, EA 3181, University Hospital of Besançon and CTD-INCa Gercor, UNICNCER GERICO, Besançon, France. Electronic address: franck.bonnetain@univ-fcomte.fr. · Leiden University Medical Center, Leiden, Netherlands. · Department of Medical Oncology, Institut de Cancérologie de Lorraine, Vandoeuvre-les-Nancy, France. · Bordeaux Segalen University & CHRU, Bordeaux, France. · Department of Radiology, Oncology and Radiation Science, Uppsala University, Uppsala, Sweden. · Department of Radiation Oncology, Leuven, Belgium. · Digestive Surgical Department, Tenon hospital, Paris, France. · Gastro Intestinal Cancer Unit Erasme Hospital Brussels, Belgium. · Gastroenterology Department, Avicenne Hospital, Paris 13, Bobigny, France. · Institute for Pathology, University Hospital Carl-Gustav-Carus, Dresden, Germany. · Surgical and Gastroenterological Department, Endocrine and Pancreatic Unit, Hospital of 'G.B.Rossi', University of Verona, Italy. · Institut de Cancérologie de l'Ouest - Centre Paul Papin Centre de Lutte Contre le Cancer (CLCC), Angers, France. · Biostatistics Unit, Centre Antoine Lacassagne, Nice, France. · Oncology Department, Hôpital Saint-Antoine & CTD-INCa GERCOR, Assistance Publique des Hôpitaux de Paris, UPMC Paris VI, Paris, France. · Gastroenterology Department, Hopital la Timone, Assitance publique des Hopitaux de Marseille, Marseille, France. · Department of Surgery, Institut Paoli Calmettes, Marseille, France. · Department of Surgery, Agia Olga Hospital, Athens, Greece. · Department of Gastroenterology, Institut Gustave Roussy, Villejuif, France. · Biostatistician, Biostatistics Unit, Centre Antoine Lacassagne, Nice, France. · Department of Radiotherapy, Institut fuer Radioonkologie, Vienna, Austria. · Department of Surgical Oncology, Royal Liverpool Hospital, United Kingdom. · Department of Gastroenterology, Beaujon Hospital, Assistance Publique des Hôpitaux de Paris, Paris, France. · Digestive Oncology and Gastro-enterology Department, Jules Bordet Institute, Brussels, Belgium. · Digestive Cancer Registry, INSERM U866, Dijon, France. · Medical Oncology Unit, Ospedali Riuniti di Bergamo, Bergame, Italy. · Inserm, Centre for Research in Epidemiology and Population Health, U1018, Biostatistics Team, Villejuif, France. · Gastroenterology Department, Caritas Hospital, Saarbrücken, Germany. · Department of the Gastrointestinal Tumors and Phase I Unit, Vall d'Hebron University Hospital, Barcelona, Spain. · Statistics Department, EORTC, Brussels, Belgium. · Department of Medical Oncology, Institut Curie, Hôpital René Huguenin, Saint-Cloud, France. · Division of Surgery and Oncology at the University of Liverpool and Royal Liverpool University Hospital, Liverpool, United Kingdom. · Department of Digestive Surgery, Universitu Hospital Strasbourg, France. · Department of Hepato-pancreatic and Biliary Surgery, Beaujon Hospital, Assistance Publique des Hôpitaux de Paris, Paris, France. · Department of Hepato-gastroenterology and Digestive Oncology, Georges Pompidou European hospital, Paris, France. · Department of Radiation Oncology, Academisch Medisch Centrum, Amsterdam, The Netherlands. · Institut Du Cancer de Montpellier, Comprehensive Cancer Centre, and Data Center for Cancer Clinical Trials, CTD-INCa, Montpellier, France. · Clinical and Epidemiological Research Unit, Institut Bergonie, Comprehensive Cancer Centre, Bordeaux, France; Data Center for Cancer Clinical Trials, CTD-INCa, Bordeaux, France; INSERM, Centre d'Investigation Clinique - Épidémiologie Clinique CIC-EC 7, F-33000 Bordeaux, France. ·Eur J Cancer · Pubmed #25256896.

ABSTRACT: BACKGROUND: Using potential surrogate end-points for overall survival (OS) such as Disease-Free- (DFS) or Progression-Free Survival (PFS) is increasingly common in randomised controlled trials (RCTs). However, end-points are too often imprecisely defined which largely contributes to a lack of homogeneity across trials, hampering comparison between them. The aim of the DATECAN (Definition for the Assessment of Time-to-event End-points in CANcer trials)-Pancreas project is to provide guidelines for standardised definition of time-to-event end-points in RCTs for pancreatic cancer. METHODS: Time-to-event end-points currently used were identified from a literature review of pancreatic RCT trials (2006-2009). Academic research groups were contacted for participation in order to select clinicians and methodologists to participate in the pilot and scoring groups (>30 experts). A consensus was built after 2 rounds of the modified Delphi formal consensus approach with the Rand scoring methodology (range: 1-9). RESULTS: For pancreatic cancer, 14 time to event end-points and 25 distinct event types applied to two settings (detectable disease and/or no detectable disease) were considered relevant and included in the questionnaire sent to 52 selected experts. Thirty experts answered both scoring rounds. A total of 204 events distributed over the 14 end-points were scored. After the first round, consensus was reached for 25 items; after the second consensus was reached for 156 items; and after the face-to-face meeting for 203 items. CONCLUSION: The formal consensus approach reached the elaboration of guidelines for standardised definitions of time-to-event end-points allowing cross-comparison of RCTs in pancreatic cancer.

2 Review Pancreatic cancer: French clinical practice guidelines for diagnosis, treatment and follow-up (SNFGE, FFCD, GERCOR, UNICANCER, SFCD, SFED, SFRO, ACHBT, AFC). 2018

Neuzillet, Cindy / Gaujoux, Sébastien / Williet, Nicolas / Bachet, Jean-Baptiste / Bauguion, Lucile / Colson Durand, Laurianne / Conroy, Thierry / Dahan, Laetitia / Gilabert, Marine / Huguet, Florence / Marthey, Lysiane / Meilleroux, Julie / de Mestier, Louis / Napoléon, Bertrand / Portales, Fabienne / Sa Cunha, Antonio / Schwarz, Lilian / Taieb, Julien / Chibaudel, Benoist / Bouché, Olivier / Hammel, Pascal / Anonymous2561138 / Anonymous2571138 / Anonymous2581138 / Anonymous2591138 / Anonymous2601138 / Anonymous2611138 / Anonymous2621138 / Anonymous2631138 / Anonymous2641138 / Anonymous2651138. ·Department of Medical Oncology, Curie Institute, Versailles Saint-Quentin University (UVSQ), Saint-Cloud, France. Electronic address: cindy.neuzillet@gmail.com. · Department of Digestive, Hepato-Biliary and Pancreatic Surgery, Cochin Hospital, AP-HP, Paris Descartes Faculty of Medicine, Paris Descartes University, Sorbonne Paris Cité, Paris, France. · Hepato-Gastroenterology Department, University Hospital of Saint-Etienne, Saint Priest en Jarez, France. · Hepato-Gastroenterology Department, Pitié Salpétrière University Hospital, AP-HP, Paris Cedex 13, France. · Hepato-Gastroenterology Department, Departmental Hospital Center, La Roche sur Yon, France. · Department of Radiotherapy, Henri Mondor Hospital, AP-HP, Université Paris Est Creteil, Créteil, France. · Department of Medical Oncology, Lorraine Institute of Oncology and Lorraine University, Vandoeuvre-lès-Nancy Cedex, France. · Digestive Oncology Department, "DACCORD" (Digestif, Anatomie pathologique, Chirurgie, CISIH, Oncologie, Radiothérapie, Dermatologie) pole, CHU Timone, Marseille Cedex 05, France. · Paoli Calmettes Institute, Department of Medical Oncology and Cancer Research Center of Marseille (CRCM), INSERM U1068 Stress Cell, Aix-Marseille University, Marseille, France. · Department of Oncology and Radiotherapy, Tenon Hospital, East Paris University Hospitals, AP-HP, Paris Sorbonne University, Paris, France. · Gastroenterology Department, Béclère Hospital, AP-HP, Clamart, France. · Pathology Department, Toulouse University Hospital, Toulouse, France. · Department of Gastroenterology-Pancreatology, Beaujon Hospital, APHP, Paris 7 University, Clichy, France. · Jean Mermoz Private Hospital, Ramsay Générale de Santé, Lyon, France. · Digestive Oncology Department, Regional Institute of Cancer, Montpellier, France. · INSERM UMR 935, Paul Brousse Hospital, Hepatobiliary Center, AP-HP, Université Paris-Sud, Université Paris-Saclay, Villejuif, France. · Department of Digestive Surgery, Hôpital Charles Nicolle, Rouen University Hospital, Rouen, France and Genomic and Personalized Medicine in Cancer and Neurological Disorders, UMR 1245 INSERM, Rouen University, France. · Hepato-Gastroenterology and Digestive Oncology Department, Georges Pompidou European Hospital, AP-HP, Paris, France. · Department of Medical Oncology, Franco-British Institute, Levallois-Perret, France. · Hepato-Gastroenterology and Digestive Oncology Department, Robert Debré University Hospital, Avenue Général Koenig, 51092 Reims Cedex, France. · Department of Digestive Oncology, Beaujon University Hospital (AP-HP), Paris VII Diderot University, Clichy-la-Garenne, France. Electronic address: pascal.hammel@aphp.fr. ·Dig Liver Dis · Pubmed #30219670.

ABSTRACT: BACKGROUND: This document is a summary of the French intergroup guidelines regarding the management of pancreatic adenocarcinoma (PA), updated in July 2018. DESIGN: This collaborative work was produced under the auspices of all French medical and surgical societies involved in the management of PA. It is based on the previous guidelines, recent literature review and expert opinions. Recommendations were graded in three categories, according to the level of evidence. RESULTS: Over the last seven years, significant changes in PA management have been implemented in clinical practice. Imaging/staging: diffusion magnetic resonance imaging is useful before surgery to rule out small liver metastases. SURGERY: centralization of pancreatic surgery in expert centers is associated with a decreased postoperative mortality. Adjuvant chemotherapy: modified FOLFIRINOX in fit patients, or gemcitabine, or 5-FU, or gemcitabine plus capecitabine, to be discussed on a case-by-case basis. Locally advanced PA: no survival benefit of chemoradiotherapy. Metastatic PA: FOLFIRINOX and gemcitabine plus nab-paclitaxel combination are first-line standards in fit patients; second-line with 5FU/nal-IRI or 5FU/oxaliplatin combination after first-line gemcitabine. CONCLUSION: Guidelines for management of PA are continuously evolving and need to be regularly updated. This constant progress is made possible through clinical and translational research. However, as each individual case is particular, they cannot substitute to multidisciplinary tumor board discussion.

3 Review What treatment in 2017 for inoperable pancreatic cancers? 2017

Taieb, J / Pointet, A-L / Van Laethem, J L / Laquente, B / Pernot, S / Lordick, F / Reni, M. ·Hepatogastroenterology and GI Oncology Department, Sorbonne Paris Cité, Paris Descartes University, Georges Pompidou European Hospital, Paris, France. · Department of Gastroenterology and Digestive Oncology, Erasme University Hospital, ULB, Brussels, Belgium. · Medical Oncology Department, Catalan Institute of Oncology, L'Hospitalet, Barcelona, Spain. · University Cancer Center Leipzig (UCCL), University Medicine Leipzig, Leipzig, Germany. · Department of Medical Oncology, IRCCS Ospedale San Raffaele, Milan, Italy. ·Ann Oncol · Pubmed #28459988.

ABSTRACT: Pancreatic adenocarcinoma is a frequent and severe disease, either diagnosed as metastatic pancreatic adenocarcinoma (MPA) or as locally advanced pancreatic carcinoma (LAPC). Though no improvement in patients outcome have been made between 1996 and 2011, since 5 years new treatment options have become available to treat our patients. New standard first line regimens, such as FOLFIRINOX and gemcitabine combined with nab-paclitaxel, have improved overall survivals and second line treatments have been tested and validated. Other first-line treatments have failed, but research remains active and trials are ongoing with promising new anti-cancer agents. These new effective regimens used for MPA have yielded promising results in LAPC patients in open cohorts or phase II trials and a recent trial have failed to demonstrate the added value of classical external radiotherapy in this setting. Here, we review current standards of care in LAPC and MPA, consider the latest challenges and strategic questions, and examine what we may hope for in the future.

4 Review FOLFIRINOX for locally advanced pancreatic cancer: a systematic review and patient-level meta-analysis. 2016

Suker, Mustafa / Beumer, Berend R / Sadot, Eran / Marthey, Lysiane / Faris, Jason E / Mellon, Eric A / El-Rayes, Bassel F / Wang-Gillam, Andrea / Lacy, Jill / Hosein, Peter J / Moorcraft, Sing Yu / Conroy, Thierry / Hohla, Florian / Allen, Peter / Taieb, Julien / Hong, Theodore S / Shridhar, Ravi / Chau, Ian / van Eijck, Casper H / Koerkamp, Bas Groot. ·Department of Surgery, Erasmus University Medical Centre, Rotterdam, Netherlands. · Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA. · Department of Hepatogastroenterology, Antoine Beclère Hospital, Assistance publique-Hôpitaux de Paris, Paris Sud University, Clamart, France. · Department of Hematology-Oncology, Massachusetts General Hospital, Boston, MA, USA. · Department of Radiation Oncology, H Lee Moffitt Cancer Center & Research Institute, Tampa, FL, USA. · Department of Hematology and Medical Oncology, Emory University, Atlanta, GA, USA. · Department of Medicine, Washington University School of Medicine, Saint Louis, MO, USA. · Department of Medicine, Yale Cancer Center, Yale School of Medicine, New Haven, CT, USA. · Department of Medicine, Division of Medical Oncology, University of Kentucky-Markey Cancer Center, Lexington, KY, USA. · Department of Medicine, The Royal Marsden National Health Service Foundation Trust, London and Surrey, UK. · Department of Medical Oncology, Institut de Cancérologie de Lorraine and Lorraine University, Vandoeuvre-lès-Nancy, France. · Department of Hematology, Medical Oncology, Hemostasis, Rheumatology and Infectious Diseases, Paracelsus Medical University of Salzburg, Salzburg, Austria. · Department of Gastroenterology and Digestive Oncology, Georges Pompidou European Hospital, Assistance publique-Hôpitaux de Paris, Sorbonne Paris Cité, Paris Descartes University, Cancer Research Personalized Medicine (CARPEM), Paris, France. · Department of Radiation Oncology, Florida Hospital Cancer Institute, Orlando, FL, USA. · Department of Surgery, Erasmus University Medical Centre, Rotterdam, Netherlands. Electronic address: b.grootkoerkamp@erasmusmc.nl. ·Lancet Oncol · Pubmed #27160474.

ABSTRACT: BACKGROUND: 35% of patients with pancreatic cancer have unresectable locally advanced disease at diagnosis. Several studies have examined systemic chemotherapy with FOLFIRINOX (leucovorin and fluorouracil plus irinotecan and oxaliplatin) in patients with locally advanced pancreatic cancer. We aimed to assess the effectiveness of FOLFIRINOX as first-line treatment in this patient population. METHODS: We systematically searched Embase, MEDLINE (OvidSP), Web of Science, Scopus, PubMed Publisher, Cochrane, and Google Scholar from July 1, 1994, to July 2, 2015, for studies of treatment-naive patients of any age who received FOLFIRINOX as first-line treatment of locally advanced pancreatic cancer. Our primary outcome was overall survival. Secondary outcomes were progression-free survival; rates of grade 3 or 4 adverse events; and the proportion of patients who underwent radiotherapy or chemoradiotherapy, surgical resection after FOLFIRINOX, and R0 resection. We evaluated survival outcomes with the Kaplan-Meier method with patient-level data. Grade 3 or 4 adverse events, and the proportion of patients who underwent subsequent radiotherapy or chemoradiotherapy or resection, were pooled in a random-effects model. FINDINGS: We included 13 studies comprising 689 patients, of whom 355 (52%) patients had locally advanced pancreatic cancer. 11 studies, comprising 315 patients with locally advanced disease, reported survival outcomes and were eligible for patient-level meta-analysis. Median overall survival from the start of FOLFIRINOX ranged from 10·0 months (95% CI 4·0-16·0) to 32·7 months (23·1-42·3) across studies with a pooled patient-level median overall survival of 24·2 months (95% CI 21·7-26·8). Median progression-free survival ranged from 3·0 months (95% CI not calculable) to 20·4 months (6·5-34·3) across studies with a patient-level median progression-free survival of 15·0 months (95% 13·8-16·2). In ten studies comprising 490 patients, 296 grade 3 or 4 adverse events were reported (60·4 events per 100 patients). No deaths were attributed to FOLFIRINOX toxicity. The proportion of patients who underwent radiotherapy or chemoradiotherapy ranged from 31% to 100% across studies. In eight studies, 154 (57%) of 271 patients received radiotherapy or chemoradiotherapy after FOLFIRINOX. The pooled proportion of patients who received any radiotherapy treatment was 63·5% (95% CI 43·3-81·6, I(2) 90%). The proportion of patients who underwent surgical resection for locally advanced pancreatic cancer ranged from 0% to 43%. The proportion of patients who had R0 resection of those who underwent resection ranged from 50% to 100% across studies. In 12 studies, 91 (28%) of 325 patients underwent resection after FOLFIRINOX. The pooled proportion of patients who had resection was 25·9% (95% CI 20·2-31·9, I(2) 24%). R0 resection was reported in 60 (74%) of 81 patients. The pooled proportion of patients who had R0 resection was 78·4% (95% CI 60·2-92·2, I(2) 64%). INTERPRETATION: Patients with locally advanced pancreatic cancer treated with FOLFIRINOX had a median overall survival of 24·2 months-longer than that reported with gemcitabine (6-13 months). Future research should assess these promising results in a randomised controlled trial, and should establish which patients might benefit from radiotherapy or chemoradiotherapy or resection after FOLFIRINOX. FUNDING: None.

5 Review Medical treatment of pancreatic cancer: new hopes after 10 years of gemcitabine. 2011

Trouilloud, Isabelle / Dubreuil, Olivier / Boussaha, Tarek / Lepère, Céline / Landi, Bruno / Zaanan, Aziz / Bachet, Jean-Baptiste / Taieb, Julien. ·Service d'oncologie digestive, hôpital européen Georges-Pompidou, AP-HP, université Paris V, 20, rue Leblanc, 75015 Paris, France. isabelle.trouilloud@egp.aphp.fr ·Clin Res Hepatol Gastroenterol · Pubmed #21435966.

ABSTRACT: Exocrine pancreatic cancer has a very poor prognosis. R0 resection of the tumor is to date the only potentially curative approach, but less than 20% of patients are eligible for a curative surgery at diagnosis. Until recently, gemcitabine was the standard treatment for advanced and metastatic pancreatic cancer patients, since it was shown more than a decade ago to induce clinical benefit and to improve survival when compared to weekly bolus 5-fluorouracil. In order to improve patients' outcome many trials have, during the last 10 years, explored the pharmacokinetic modulation of gemcitabine and combination therapies with gemcitabine and other anti-cancer agents with consistent negative results. It is finally a trial assessing the efficacy of a combination chemotherapy without gemcitabine: the FOLFIRINOX regimen, reported this year, that has shown for the first time a significant improvement in progression free and overall survivals. In parallel, many trials testing new targeted agents in these patients are currently ongoing. After 10 years without significant progress in the treatment of pancreatic cancer patients, the hope that a significant improvement in the outcome of these patients can be achieved has been raised.

6 Clinical Trial Nab-paclitaxel plus either gemcitabine or simplified leucovorin and fluorouracil as first-line therapy for metastatic pancreatic adenocarcinoma (AFUGEM GERCOR): a non-comparative, multicentre, open-label, randomised phase 2 trial. 2017

Bachet, Jean-Baptiste / Hammel, Pascal / Desramé, Jérôme / Meurisse, Aurélia / Chibaudel, Benoist / André, Thierry / Debourdeau, Philippe / Dauba, Jérome / Lecomte, Thierry / Seitz, Jean-François / Tournigand, Christophe / Aparicio, Thomas / Meyer, Véronique Guerin / Taieb, Julien / Volet, Julien / Monier, Amandine / Bonnetain, Franck / Louvet, Christophe. ·Sorbonne Universités, UPMC Univ Paris 06, Paris, France; Department of Hepato-Gastroenterology, Groupe hospitalier Pitié Salpêtrière, Paris, France. Electronic address: jean-baptiste.bachet@aphp.fr. · Department of Digestive Oncology, Hôpital Beaujon, Paris, France. · Department of Hepato-Gastroenterology, Hôpital Privé Jean Mermoz, Lyon, France. · Department of Methodology and Quality of Life in Oncology, INSERM UMR 1098, Hôpital Universitaire de Besancon, Paris, France. · Department of Oncology, Institut Franco-Britannique, Levallois-Perret, Paris, France. · Department of Oncology, Hôpital Saint Antoine, Paris, France. · Department of Oncology, Institut Saint Catherine, Avignon, France. · Department of Oncology, Hôpital Layne Mont de Marsan, Mont de Marsan, France. · Department of Hepato-Gastroenterology, Hôpital Trousseau, Tours, France. · CHU La Timone, Marseille, France. · Department of Oncology, CHU Henri Mondor, Créteil, France. · Department of Hepato-Gastroenterology, CHU Avicenne, Bobigny, France. · Department of Oncology, Institut de cancérologie de L'Ouest Paul Papin, Angers, France. · Department of Gastroenterology and Digestive Oncology, Hôpital Européen Georges Pompidou, Paris, France. · Department of Hepato-Gastroenterology, CHU Robert Debré, Reims, France. · GERCOR (Groupe Coopérateur Multidisciplinaire en Oncologie), Paris, France. · Department of Oncology, Institut Mutualiste Montsouris, Paris, France. ·Lancet Gastroenterol Hepatol · Pubmed #28397697.

ABSTRACT: BACKGROUND: Nab-paclitaxel plus gemcitabine has become a standard treatment regimen in patients with metastatic pancreatic adenocarcinoma; however, retrospective data suggest that gemcitabine might be inefficient in 50-60% of patients and thus not an optimum regimen in combination with nab-paclitaxel. We did a phase 2 trial to assess the activity and safety of a new regimen of nab-paclitaxel plus simplified leucovorin and fluorouracil. METHODS: We did a non-comparative, multicentre, open-label, randomised phase 2 trial in 15 hospitals and institutions in France. Eligible participants were previously untreated patients with metastatic pancreatic adenocarcinoma (previous adjuvant chemotherapy after curative intent resection was allowed if the interval between the end of chemotherapy and relapse was more than 12 months). Patients had to have at least one measurable lesion assessed by CT scan or MRI and an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less. We randomly assigned participants (1:2) centrally to 28-day cycles of either gemcitabine plus nab-paclitaxel or simplified leucovorin and fluorouracil plus nab-paclitaxel. The randomisation was by minimisation, stratified by centre and ECOG performance status. Drugs were administered in each cycle as follows: nab-paclitaxel (125 mg/m FINDINGS: Between Dec 12, 2013, and Oct 31, 2014, we randomly assigned 114 patients to treatment: 75 patients to the leucovorin and fluorouracil group and 39 to the gemcitabine group. One patient in the leucovorin and fluorouracil group did not have a 4-month assessment, and was thus excluded from the modified ITT analysis. Median follow-up was 13·1 months (95% CI 12·5-14·1). At 4 months, 40 (56%, 90% CI 45-66) of 72 patients in the leucovorin and fluorouracil group were alive and free from disease progression (21 [54%, 40-68] of 39 patients in the gemcitabine group were also alive and progression-free at 4 months). Grade 3-4 adverse events occurred in 33 (87%) of 38 patients in the gemcitabine group and in 56 (77%) of 73 patients in the leucovorin and fluorouracil group, with different toxicity profiles. The most common grade 3-4 adverse events in the leucovorin and fluorouracil group were neutropenia without fever (17 [23%]), fatigue (16 [22%]), paraesthesia (14 [19%]), diarrhoea (nine [12%]), and mucositis (seven [10%]); in the gemcitabine group they were neutropenia without fever (12 [32%]), thrombocytopenia (seven [18%]), fatigue (eight [21%]), anaemia (five [13%]), increased alanine aminotransferase and aspartate aminotransferase concentrations (five [13%] for both), and paraesthesia (four [11%]). Two participants died; one in the leucovorin and fluorouracil group from septic shock, and one in the gemcitabine group from diabetes compensation with acidosis; these deaths were deemed to be not related to treatment. Treatment-related serious adverse events occurred in 28 (38%) of 73 patients in the leucovorin and fluorouracil group and in 14 (37%) of 38 in the gemcitabine group. INTERPRETATION: Nab-paclitaxel plus simplified leucovorin and fluorouracil fulfilled the primary endpoint in that more than the required 50% of our study population were progression-free at 4 months, with a tolerable toxicity profile. This regimen thus deserves further assessment in a phase 3 trial. FUNDING: GERCOR (Groupe Coopérateur Multidisciplinaire en Oncologie) and Celgene through grants to GERCOR.

7 Clinical Trial Prognostic value of health-related quality of life in patients with metastatic pancreatic adenocarcinoma: a random forest methodology. 2016

Diouf, Momar / Filleron, Thomas / Pointet, Anne-Laure / Dupont-Gossard, Anne-Claire / Malka, David / Artru, Pascal / Gauthier, Mélanie / Lecomte, Thierry / Aparicio, Thomas / Thirot-Bidault, Anne / Lobry, Céline / Fein, Francine / Dubreuil, Olivier / Landi, Bruno / Zaanan, Aziz / Taieb, Julien / Bonnetain, Franck. ·Clinical Research and Innovation Directorate, Amiens University Hospital, Amiens, France. diouf.momar@chu-amiens.fr. · Methodology and Quality of Life in Oncology Unit, EA 3181 CHU Besançon and the Qualité de Vie et Cancer Clinical Research Platform, Besançon, France. diouf.momar@chu-amiens.fr. · Biostatistics Unit, Claudius Régaud Institute, Toulouse, France. · Hepatogastroenterology and Digestive Oncology Department, Hôpital Européen Georges Pompidou, Université Paris Descartes, Paris, France. · CHU Jean Minjoz, Besançon, France. · Gustave Roussy, Villejuif, France. · Hôpital Privé Jean Mermoz, Lyon, France. · Centre Georges-François Leclerc, Dijon, France. · CHU de Tours-Hôpital Trousseau, Chambray-Les-Tours, France. · CHU Avicenne, Université Paris 13, Sorbonne Paris Cité, Bobigny, France. · CHU Bicêtre, Le Kremlin-Bicêtre, France. · CHU Bichat-Claude Bernard, Paris, France. · Hepatogastroenterology and Digestive Oncology Department, Hôpital Européen Georges Pompidou, Université Paris Descartes, Paris, France. julien.taieb@egp.aphp.fr. · Methodology and Quality of Life in Oncology Unit, EA 3181 CHU Besançon and the Qualité de Vie et Cancer Clinical Research Platform, Besançon, France. ·Qual Life Res · Pubmed #26615615.

ABSTRACT: PURPOSE: Eastern Cooperative Oncology Group Performance Status (ECOG-PS) is currently an important parameter in the choice of treatment strategy for metastatic pancreatic adenocarcinoma (mPA) patients. However, previous research has shown that patients' self-reported health-related quality of life (HRQOL) scales provided additional prognostic information in homogeneous groups of patients with respect to ECOG-PS. The aim of this study was to identify HRQOL scales with independent prognostic value in mPA and to propose prognostic groups for these patients. METHODS: We analysed data from 98 chemotherapy-naive patients with histologically proven mPA recruited from 2007 to 2011 in the FIRGEM phase II study which aimed to compare the effectiveness of two chemotherapy regimen. HRQOL data were assessed with the European Organization for Research and Treatment of Cancer QLQ-C30 questionnaire. A random survival forest methodology was used to impute missing data and to identify major prognostic factors for overall survival. RESULTS: Baseline HRQOL assessment was completed by 60 % of patients (59/98). Twelve prognostic variables were identified. The three most important prognostic variables were fatigue, appetite loss, and role functioning, followed by three laboratory variables. The model's discriminative power assessed by Harrell's C statistic was 0.65. Fatigue score explained almost all the survival variability. CONCLUSION: HRQOL scores have prognostic value for mPA patients with good ECOG-PS. Moreover, the patient's fatigue, appetite loss, and self-perception of daily activities were more reliable prognostic indicators than clinical and laboratory variables. These HRQOL scores, especially the fatigue symptom, should be urgently included for prognostic assessment of mPA patients (with good ECOG-PS).

8 Clinical Trial Sequential FOLFIRI.3 + Gemcitabine Improves Health-Related Quality of Life Deterioration-Free Survival of Patients with Metastatic Pancreatic Adenocarcinoma: A Randomized Phase II Trial. 2015

Anota, Amélie / Mouillet, Guillaume / Trouilloud, Isabelle / Dupont-Gossart, Anne-Claire / Artru, Pascal / Lecomte, Thierry / Zaanan, Aziz / Gauthier, Mélanie / Fein, Francine / Dubreuil, Olivier / Paget-Bailly, Sophie / Taieb, Julien / Bonnetain, Franck. ·National Quality of Life in Oncology Platform, Besançon, France; Methodological and Quality of Life in Oncology Unit (EA 3181), University Hospital of Besançon, Besançon, France. · Methodological and Quality of Life in Oncology Unit (EA 3181), University Hospital of Besançon, Besançon, France. · Department of Gastroenterology and Digestive Oncology, Georges Pompidou European Hospital, University of Paris Descartes, Paris, France. · Department of Gastroenterology, University Hospital of Besançon, Besançon, France. · Hepato-Gastro-Enterology and Digestive Oncology Department, Hospital Jean Mermoz, Lyon, France. · Department of Gastroenterology and Digestive Oncology, University Hospital of Tours- Trousseau Hospital, Chambray-Les-Tours, France. · Biostatistics and Quality of Life Unit, Centre Georges François Leclerc, Dijon, France. ·PLoS One · Pubmed #26010884.

ABSTRACT: BACKGROUND: A randomized multicenter phase II trial was conducted to assess the sequential treatment strategy using FOLFIRI.3 and gemcitabine alternately (Arm 2) compared to gemcitabine alone (Arm 1) in patients with metastatic non pre-treated pancreatic adenocarcinoma. The primary endpoint was the progression-free survival (PFS) rate at 6 months. It concludes that the sequential treatment strategy appears to be feasible and effective with a PFS rate of 43.5% in Arm 2 at 6 months (26.1% in Arm 1). This paper reports the results of the longitudinal analysis of the health-related quality of life (HRQoL) as a secondary endpoint of this study. METHODS: HRQoL was evaluated using the EORTC QLQ-C30 at baseline and every two months until the end of the study or death. HRQoL deterioration-free survival (QFS) was defined as the time from randomization to a first significant deterioration as compared to the baseline score with no further significant improvement, or death. A propensity score was estimated comparing characteristics of partial and complete responders. Analyses were repeated with inverse probability weighting method using the propensity score. Multivariate Cox regression analyses were performed to identify independent factors influencing QFS. RESULTS: 98 patients were included between 2007 and 2011. Adjusting on the propensity score, patients of Arm 2 presented a longer QFS of Global Health Status (Hazard Ratio: 0.52 [0.31-0.85]), emotional functioning (0.35 [0.21-0.59]) and pain (0.50 [0.31-0.81]) than those of Arm 1. CONCLUSION: Patients of Arm 2 presented a better HRQoL with a longer QFS than those of Arm 1. Moreover, the propensity score method allows to take into account the missing data depending on patients' characteristics. TRIAL REGISTRATION INFORMATION: Eudract N° 2006-005703-34. (Name of the Trial: FIRGEM).

9 Clinical Trial Fixed-dose rate gemcitabine alone or alternating with FOLFIRI.3 (irinotecan, leucovorin and fluorouracil) in the first-line treatment of patients with metastatic pancreatic adenocarcinoma: an AGEO randomised phase II study (FIRGEM). 2014

Trouilloud, Isabelle / Dupont-Gossard, Anne-Claire / Malka, David / Artru, Pascal / Gauthier, Mélanie / Lecomte, Thierry / Aparicio, Thomas / Thirot-Bidault, Anne / Lobry, Céline / Asnacios, Amani / Manet-Lacombe, Sophie / Fein, Francine / Dubreuil, Olivier / Landi, Bruno / Zaanan, Aziz / Bonnetain, Franck / Taïeb, Julien. ·Hôpital Européen Georges Pompidou, Université Paris Descartes, Paris, France. · CHU Jean Minjoz, Besançon, France. · Gustave Roussy, Villejuif, France. · Hôpital Privé Jean Mermoz, Lyon, France. · Centre Georges-François Leclerc, Dijon, France. · CHU de Tours-Hôpital Trousseau, Chambray-Les-Tours, France. · CHU Avicenne, Université Paris 13, Sorbonne Paris Cité, Bobigny, France. · CHU Bicêtre, Le Kremlin-Bicêtre, France. · CHU Bichat-Claude Bernard, Paris, France. · CHU Antoine Béclère, Clamart, France. · Centre Hospitalier René Dubos, Cergy-Pontoise, France. · Hôpital Européen Georges Pompidou, Université Paris Descartes, Paris, France. Electronic address: julien.taieb@egp.aphp.fr. ·Eur J Cancer · Pubmed #25454414.

ABSTRACT: BACKGROUND: Fluorouracil and irinotecan-based, and gemcitabine-based regimens, are the standard of care in the first-line treatment of patients with metastatic pancreatic cancer. New approaches are needed to improve survival and quality of life. Whether a sequential approach alternating irinotecan, fluorouracil and gemcitabine may be effective and tolerable in patients with metastatic pancreatic cancer is unknown. METHODS: In this randomised, multicentre, open-label, phase 2 trial, patients with metastatic pancreatic adenocarcinoma, World Health Organisation (WHO) performance status 0-1, and bilirubin levels <1.5 upper limit of normal values (ULN) were randomised 1:1 to receive as first-line treatment either FOLFIRI.3 (irinotecan, leucovorin and fluorouracil) alternating with fixed-dose rate gemcitabine as 2-month periods (FIRGEM, arm A), or fixed-dose rate gemcitabine alone (arm B). Treatment was continued until disease progression or limiting toxicity. The primary end-point was the crude progression-free survival (PFS) rate at 6 months. The study is registered with EudraCT (N° 2006-005703-34). RESULTS: Between October 2007 and March 2011, 98 patients were enroled. The observed 6-month PFS rate was 43.5% (95% confidence interval (CI), [28.6-58.4%]) in arm A reaching the Fleming decision rules criteria to reject H0 and 26.1% (95% CI [12.9-39.3%]) in arm B. Objective response rates were 37% (23-51%) in arm A and 10% (1-19%) in arm B. Median PFS (5.0 versus 3.4 months, hazard ratio (HR)=0.59 [0.38-0.90]) and overall survival (11.0 versus 8.2 months, HR=0.71 [0.46-1.10]) were higher in arm A compared to arm B. The most frequent grade 3-4 toxicities were neutropenia (49%/24%; febrile neutropenia, 4%/0% in arms A/B), diarrhoea (arm A, 12% and arm B, 0%), and nausea/vomiting (8%/4%). No toxic deaths occurred. CONCLUSION: The FIRGEM strategy appears to be effective and feasible in patients with metastatic pancreatic cancer.

10 Article How Does Chemoradiotherapy Following Induction FOLFIRINOX Improve the Results in Resected Borderline or Locally Advanced Pancreatic Adenocarcinoma? An AGEO-FRENCH Multicentric Cohort. 2019

Pietrasz, Daniel / Turrini, Olivier / Vendrely, Véronique / Simon, Jean-Marc / Hentic, Olivia / Coriat, Romain / Portales, Fabienne / Le Roy, Bertrand / Taieb, Julien / Regenet, Nicolas / Goere, Diane / Artru, Pascal / Vaillant, Jean-Christophe / Huguet, Florence / Laurent, Christophe / Sauvanet, Alain / Delpero, Jean-Robert / Bachet, Jean Baptiste / Sa Cunha, Antonio. ·Department of Hepato-Bilio-Pancreatic Surgery, Liver Transplant Center, Paul Brousse Hospital, Université Paris-Sud, Université Paris-Saclay, Villejuif, France. daniel.pietrasz@wanadoo.fr. · Department of Digestive and Hepatobiliary Surgery, Pitié-Salpêtrière Hospital, Sorbonne University, UPMC University, Paris 06, France. daniel.pietrasz@wanadoo.fr. · Surgical Oncology Department, Institut Paoli Calmette, Marseille, France. · Departement of Radiotherapy, Hopital Haut Lévêque, CHU de Bordeaux, Pessac, France. · Radiation Oncology, Pitié-Salpêtrière Hospital, Paris, France. · Pancreato-Gastroenterology Department, Beaujon Hospital, Clichy, France. · Gastroenterology Unit, Cochin Hospital, Paris, France. · Institut du Cancer de Montpellier, Montpellier, France. · CHU Estaing, Service de Chirurgie Digestive, Université Clermont Auvergne, Clermont-Ferrand, France. · Hepatogastroenterology and Digestive Oncology Department, Georges Pompidou Hospital, Paris, France. · Department of Digestive Surgery, Nantes Hospital, Nantes, France. · Surgical Oncology Department, Gustave Roussy, Villejuif, France. · Department of Gastroenterology, Hôpital Privé Jean Mermoz, Lyon, France. · Department of Digestive and Hepatobiliary Surgery, Pitié-Salpêtrière Hospital, Sorbonne University, UPMC University, Paris 06, France. · Department of Radiation Oncology, Tenon Hospital, Hôpitaux Universitaires Est Parisien, Assistance Publique-Hôpitaux de Paris, Paris, France. · Department of Hepatobiliopancreatic Surgery and Liver Transplantation, Hôpital Haut Lévêque, CHU de Bordeaux, Pessac, France. · Department of Digestive Surgery and Transplantation, Beaujon Hospital, Clichy, France. · Gastroenterology and Digestive Oncology Department, Pitié-Salpêtrière Hospital, Sorbonne University, UPMC University, Paris, France. · Department of Hepato-Bilio-Pancreatic Surgery, Liver Transplant Center, Paul Brousse Hospital, Université Paris-Sud, Université Paris-Saclay, Villejuif, France. ·Ann Surg Oncol · Pubmed #30362063.

ABSTRACT: BACKGROUND: Patients with borderline (BR) or locally advanced (LA) pancreatic adenocarcinoma (PAC) are often treated with induction FOLFIRINOX (FLX). However, the role of additional preoperative chemoradiotherapy (CRT) is controversial. The aim of this study is to evaluate its impact in patients who underwent resection after induction FLX. PATIENTS AND METHODS: Retrospective analysis of prospective consecutive surgical BR or LA PAC patients after induction FLX in 23 French centers between November 2010 and December 2015, treated with or without preoperative additional CRT (FLX vs FLX + CRT groups). RESULTS: Two hundred three patients were included (106 BR, 97 LA PAC). Median number of FLX cycles was 6 (range 1-30); 50% (n = 102) of patients received additional CRT. Median duration between diagnosis and surgery was 5.4 and 8.7 months (P = 0.001) in the FLX and FLX + CRT group, respectively. The 90-day mortality, major complications, and pancreatic fistula rates were 4.4%, 17.7%, and 5.4%, respectively. After 45.1 months follow-up, overall survival (OS) and disease-free survival were 45.4 months and 16.2 months, respectively. Patients with additional CRT had higher R0 resection rate (89.2% vs 76.3%; P = 0.017), ypN0 rate (76.2% vs 48.5%; P < 0.001), and higher rate of pathologic major response (33.3% vs 12.9%; P = 0.001). In the FLX + CRT group, patients had lower rate of locoregional relapse (28.3% vs 50.7%; P = 0.004). Patients with additional CRT had longer OS than those receiving FLX alone (57.8 vs 35.5 months; P = 0.007). CONCLUSIONS: Pathological results and survival data argue for interest in additional CRT. Prospective studies on an intention-to-treat basis are needed to confirm these results.

11 Article Additive value of pre-operative and one-month post-operative lymphocyte count for death-risk stratification in patients with resectable pancreatic cancer: a multicentric study. 2016

d'Engremont, Christelle / Vernerey, Dewi / Pointet, Anne-Laure / Simone, Gaël / Fein, Francine / Heyd, Bruno / Koch, Stéphane / Vuitton, Lucine / Kim, Stefano / Jary, Marine / Lamfichek, Najib / Turco, Celia / Lakkis, Zaher / Berger, Anne / Bonnetain, Franck / Taieb, Julien / Bachellier, Philippe / Borg, Christophe. ·Department of Gastroenterology, University Hospital of Besançon, Besançon, France. · Methodology and Quality of Life in Oncology Unit, University Hospital of Besançon, Besançon, France. · Department of Gastroenterology and GI oncology, Paris Descartes University, Georges Pompidou European Hospital, Paris, France. · Department of Digestive Surgery and Liver Transplantation, University hospital of Strasbourg, Strasbourg, France. · Department of Digestive Surgery and Liver Transplantation, University Hospital of Besançon, Besançon, France. · Department of Medical Oncology, University Hospital of Besançon, Besançon, France. · Department of Digestive Surgery, Hospital of Belfort-Montbeliard, Montbeliard, France. · Department of GI Surgery, Paris Descartes University, Georges Pompidou European Hospital, Paris, France. · Department of Medical Oncology, University Hospital of Besançon, Besançon, France. christophe.borg@efs.sante.fr. · Centre investigation Clinique en biothérapie, CIC-1431, Besançon, France. christophe.borg@efs.sante.fr. · UMR1098 INSERM/Université de Franche Comté/Etablissement Français du Sang, Besançon, France. christophe.borg@efs.sante.fr. · Department of Oncology, University Hospital of Besançon, 3 Boulevard Alexander Fleming, Besancon, F-25030, France. christophe.borg@efs.sante.fr. ·BMC Cancer · Pubmed #27782813.

ABSTRACT: BACKGROUND: Pancreatic adenocarcinoma (PDAC) incidence is increasing worldwide. Several studies have shown that lymphopenia was correlated with a poor prognosis but the potential interest to measure lymphopenia in the pre and post-operative setting as well as its added value among conventional prognostic factors was never investigated. METHODS: Data from two independent cohorts in whom patients underwent resection for pancreatic carcinoma were retrospectively recorded. We examined the association between perioperative findings, pre and post-operative lymphocyte counts and overall survival (OS) in univariate and multivariate analyses. Performance assessment and internal validation of the final model were evaluated with Harrell's C-index, calibration plot and bootstrap sample procedures. RESULTS: Three hundred ninety patients were included in the analysis between 2000 and 2011. Pre and post-operative lymphocyte counts were independent prognostic factors associated with OS in multivariate analysis (p = 0.0128 and p = 0.0764, respectively). The addition of lymphocyte count variable to the conventional parameters identified in multivariate analysis (metastatic lymph node ratio, veinous emboli and adjuvant chemotherapy) significantly improved the model discrimination capacity (bootstrap mean difference = 0.04; 95 % CI, 0.01-0.06). The use of a threshold and combining the categorical (≥1000; <1000) information in pre and post lymphocyte counts permitted the identification of 4 subgroups of patients with different prognosis (p < 0.0001). Finally, the description of patients in long-term remission showed that only 3 of 65 (4.6 %) patients with post-operative lymphocyte count under 1000/mm CONCLUSION: Pre and post-operative lymphopenia are independent prognostic factors for OS and they have an additive value regarding conventional prognostic factors for death-risk stratification and to predict long-term survival. Lymphopenia should be included as stratification factors in future clinical trial assessing overall survival in pancreatic cancer patients.

12 Article Reply to the comment on 'Nab-paclitaxel plus gemcitabine for metastatic pancreatic adenocarcinoma after Folfirinox failure: an AGEO prospective multicentre cohort'. 2016

Pernot, Simon / Bachet, Jean-Baptiste / Portal, Alix / Taieb, Julien. ·Department of Gastroenterology and Digestive Oncology, Georges Pompidou European Hospital, Assistance Publique-Hôpitaux de Paris (AP-HP), Paris Descartes University, Paris 75015, France. · Department of Gastroenterology, La Pitié-Salpétrière Hospital, Assistance Publique-Hôpitaux de Paris (AP-HP), Sorbonne University, UPMC University, Paris 75013, France. ·Br J Cancer · Pubmed #27124338.

ABSTRACT: -- No abstract --

13 Article Nab-paclitaxel plus gemcitabine for metastatic pancreatic adenocarcinoma after Folfirinox failure: an AGEO prospective multicentre cohort. 2015

Portal, Alix / Pernot, Simon / Tougeron, David / Arbaud, Claire / Bidault, Anne Thirot / de la Fouchardière, Christelle / Hammel, Pascal / Lecomte, Thierry / Dréanic, Johann / Coriat, Romain / Bachet, Jean-Baptiste / Dubreuil, Olivier / Marthey, Lysiane / Dahan, Laetitia / Tchoundjeu, Belinda / Locher, Christophe / Lepère, Céline / Bonnetain, Franck / Taieb, Julien. ·Department of Gastroenterology and Digestive Oncology, Georges Pompidou European Hospital, Assistance Publique-Hôpitaux de Paris (AP-HP), Paris Descartes University, Paris, France. · Department of Gastroenterology, Poitiers University Hospital, Poitiers, France. · Methodological and Quality of Life Unit in Oncology, Quality of Life and Cancer Clinical Research Platform, Besançon University Hospital, Besançon, France. · Department of Gastroenterology, Kremlin Bicêtre Hospital, Assistance Publique-Hôpitaux de Paris (AP-HP), Paris Sud University, Le Kremlin Bicêtre, France. · Department of Medical Oncology, Anticancer Center Leon Berard, Lyon I university, Lyon, France. · Department of Digestive Oncology, Hospital Beaujon, Assistance Publique-Hôpitaux de Paris (AP-HP), Paris Denis Diderot University, Clichy, France. · Department of Hepato-Gastroenterology and Digestive Oncology, University Hospital of Tours, UMR CNRS 7192, François-Rabelais University, Tours, France. · Gastroenterology and Endoscopy Unit, Cochin Hospital, Assistance Publique-Hôpitaux de Paris (AP-HP), Paris Descartes University, Sorbonne Paris Cité, Paris, France. · Department of Gastroenterology, La Pitié-Salpétrière Hospital, Assistance Publique-Hôpitaux de Paris (AP-HP), Sorbonne University, UPMC University Paris 06, Paris, France. · Department of Hepatogastroenterology and Nutrition, Antoine-Béclère Hospital, Assistance publique-Hôpitaux de Paris (AP-HP), DHU Hepatinov, Clamart, France. · Department of Gastroenterology, University Hospital La Timone, Aix-Marseille University, Marseille, France. · Department of Gastroenterology and Digestive Oncology, Orleans Regional Hospital (CHRO), Orleans, France. · Department of Gastroenterology, Meaux Hospital, Meaux, France. ·Br J Cancer · Pubmed #26372701.

ABSTRACT: BACKGROUND: There is currently no standard second-line treatment for metastatic pancreatic adenocarcinoma (MPA), and progression-free survival is consistently <4 months in this setting. The aim of this study was to evaluate the efficacy and tolerability of Nab-paclitaxel plus gemcitabine (A+G) after Folfirinox failure in MPA. METHODS: From February 2013 to July 2014, all consecutive patients treated with A+G for histologically proven MPA after Folfirinox failure were prospectively enrolled in 12 French centres. A+G was delivered as described in the MPACT trial, until disease progression, patient refusal or unacceptable toxicity. RESULTS: Fifty-seven patients were treated with Nab-paclitaxel plus gemcitabine, for a median of 4 cycles (range 1-12). The disease control rate was 58%, with a 17.5% objective response rate. Median overall survival (OS) was 8.8 months (95% CI: 6.2-9.7) and median progression-free survival was 5.1 months (95% CI: 3.2-6.2). Since the start of first-line chemotherapy, median OS was 18 months (95% CI: 16-21). No toxic deaths occurred. Grade 3-4 toxicities were reported in 40% of patients, consisting of neutropenia (12.5%), neurotoxicity (12.5%), asthenia (9%) and thrombocytopenia (6.5%). CONCLUSIONS: A+G seems to be effective, with a manageable toxicity profile, after Folfirinox failure in patients with MPA.

14 Article Pathologic Major Response After FOLFIRINOX is Prognostic for Patients Secondary Resected for Borderline or Locally Advanced Pancreatic Adenocarcinoma: An AGEO-FRENCH, Prospective, Multicentric Cohort. 2015

Pietrasz, Daniel / Marthey, Lysiane / Wagner, Mathilde / Blanc, Jean-Frédéric / Laurent, Christophe / Turrini, Olivier / Raoul, Jean Luc / Terrebonne, Eric / Hentic, Olivia / Trouilloud, Isabelle / Coriat, Romain / Regenet, Nicolas / Innominato, Pasquale / Taieb, Julien / Cunha, Antonio Sa / Bachet, Jean Baptiste. ·Department of Digestive and Hepatobiliary Surgery, Pitié-Salpêtrière Hospital, Sorbonne University, UPMC University, Paris, France. · Hepatogastroenterology Department, Antoine Béclère Hospital, Clamart, France. · Department of Radiology, Pitié-Salpêtrière Hospital, Sorbonne University, UPMC University, Paris, France. · Hepato-Gastroenterology Department, Saint-André Hospital, Bordeaux, France. · Department of Visceral and Transplant Surgery, Saint-André Hospital, Bordeaux, France. · Surgical Oncology Department, Institut Paoli Calmette, Marseille, France. · Oncology Department, Institut Paoli Calmette, Marseille, France. · Gastroenterology and Digestive Oncology Department, Bordeaux South Hospital, Bordeaux, France. · Pancreato-Gastroenterology Department, Beaujon Hospital, Clichy, France. · Hepatogastroenterology and Digestive Oncology Department, Georges Pompidou Hospital, Paris, France. · Gastroenterology Unit, Cochin Hospital, Paris, France. · Department of Digestive Surgery, Nantes Hospital, Nantes, France. · Hematology-Oncology Department, Paul Brousse Hospital, Villejuif, France. · Liver Transplant Center, Paul Brousse Hospital, Villejuif, France. · Gastroenterology and Digestive Oncology Department, Pitié-Salpêtrière Hospital, Sorbonne University, UPMC University, Paris, France. jean-baptiste.bachet@aphp.fr. ·Ann Surg Oncol · Pubmed #26271395.

ABSTRACT: PURPOSE: In view of increased response rates and survivals in patients with metastatic pancreatic adenocarcinoma (PAC) with FOLFIRINOX, many centers proposed this regimen as induction chemotherapy for borderline (BR) or locally advanced (LA) PAC. The aim of this study was to assess surgical and oncological outcomes of patients who underwent resection after induction FOLFIRINOX therapy. METHODS: We prospectively identified surgical consecutive BR or LA PAC patients after induction FOLFIRINOX in 20 observational French centers between November 2010 and December 2013. Two independent experts retrospectively evaluated initial CT scan for central review. RESULTS: Eighty patients were included, 47 had BR and 33 had LA PAC. Median number of FOLFIRINOX cycles was 6 (range 1-30) and 65 % of patients received chemoradiation. The 30-day-mortality, major complications, and symptomatic pancreatic fistula rates were 2.5, 22.5, and 4 %, respectively. R0 resection was achieved in 84 %. After a median follow-up of 38.2 months since diagnosis, disease-free survival (DFS) was 17.16 months. The overall survival rates at 12 and 24 months were 92 and 81 %, respectively. A 26 % (n = 21) pathologic major response (pMR) rate was reached. In univariate and multivariate analysis, pMR was a prognostic factor for DFS (hazard ratio 0.33; P = 0.01 and hazard ratio 0.38; P = 0.035). CONCLUSIONS: Resection after induction FOLFIRINOX is safe and associated with similar or better outcomes as upfront surgery in patients with PAC. A pMR was observed in 26 % of cases and was prognostic of DFS. This therapeutic design should be investigated in prospective studies.

15 Article FOLFIRINOX for locally advanced pancreatic adenocarcinoma: results of an AGEO multicenter prospective observational cohort. 2015

Marthey, L / Sa-Cunha, A / Blanc, J F / Gauthier, M / Cueff, A / Francois, E / Trouilloud, I / Malka, D / Bachet, J B / Coriat, R / Terrebonne, E / De La Fouchardière, C / Manfredi, S / Solub, D / Lécaille, C / Thirot Bidault, A / Carbonnel, F / Taieb, J. ·Department of Gastroenterology, Kremlin Bicêtre Hospital, Assistance publique-Hôpitaux de Paris (AP-HP), Paris Sud University, Le Kremlin Bicêtre, France. ·Ann Surg Oncol · Pubmed #25037971.

ABSTRACT: BACKGROUND: First-line treatment with FOLFIRINOX significantly increases overall survival (OS) in patients with metastatic pancreatic adenocarcinoma (PA) compared with gemcitabine. The aim of this observational cohort was to evaluate the tolerability and efficacy of this regimen in unresectable locally advanced PA (LAPA). PATIENTS AND METHODS: From February 2010 to February 2012, all consecutive patients from 11 French centers treated by FOLFIRINOX for a histologically proven LAPA were prospectively enrolled. Unresectability was defined independently by each center's multidisciplinary staff at diagnosis. Absence of metastatic disease was confirmed by chest-abdomen-pelvis computed tomography scan. FOLFIRINOX was delivered every 2 weeks as previously reported until progressive disease, major toxicity, or consolidation treatment by radiotherapy and/or surgery. RESULTS: Seventy-seven patients were enrolled. They received a median number of five cycles (1-30). Grade 3-4 toxicities were neutropenia (11 %), nausea (9 %), diarrhea (6 %), fatigue (6 %), and anemia (1 %). Grade 2-3 sensory neuropathy occurred in 25 % of patients. No toxic death was reported and only 6 % of patients had to stop treatment because of toxicity. Disease control rate was 84 with 28 % of objective response (Response Evaluation Criteria in Solid Tumors). Seventy-five percent of patients received a consolidation therapy: 70 % had radiotherapy and 36 % underwent a surgical resection, with a curative intent. Within the whole cohort, 1-year OS rate was 77 % (95 % CI 65-86) and 1-year progression-free survival rate was 59 % (95 % CI 46-70). CONCLUSION: First-line FOLFIRINOX for LAPA seems to be effective and have a manageable toxicity profile. These promising results will have to be confirmed in a phase III randomized trial.

16 Article FOLFOX as second-line chemotherapy in patients with pretreated metastatic pancreatic cancer from the FIRGEM study. 2014

Zaanan, Aziz / Trouilloud, Isabelle / Markoutsaki, Theofano / Gauthier, Mélanie / Dupont-Gossart, Anne-Claire / Lecomte, Thierry / Aparicio, Thomas / Artru, Pascal / Thirot-Bidault, Anne / Joubert, Fanny / Fanica, Daniella / Taieb, Julien. ·Department of Gastroenterology and Digestive Oncology, Georges Pompidou European Hospital, AP-HP, 20 rue Leblanc, 75015 Paris, France. julien.taieb@egp.aphp.fr. ·BMC Cancer · Pubmed #24929865.

ABSTRACT: BACKGROUND: FOLFOX second-line treatment seems to be a validated option for patients with pancreatic cancer (PC) progressing after gemcitabine chemotherapy. However, other therapeutics strategy has developed in first-line therapy, as the FIRGEM phase II study that evaluated gemcitabine alone versus FOLFIRI.3 alternating with gemcitabine every two months. The present study assessed the efficacy and safety of FOLFOX after failure of the first-line therapy used in the FIRGEM study. METHODS: In this prospective observational cohort study, we analysed all consecutive patients who received second-line chemotherapy with FOLFOX among 98 patients with metastatic PC included in the FIRGEM study. Progression-free survival (PFS) and overall survival (OS) were estimated from the start of second-line chemotherapy using the Kaplan-Meier method. RESULTS: Among 46 patients who received second-line chemotherapy, 27 patients (male, 55%; median age, 61 years; performance status (PS) 0-1, 44%) were treated with FOLFOX after progression to first-line gemcitabine alone (n = 20) or FOLFIRI.3 alternating with gemcitabine (n = 7). Grade 3 toxicity was observed in 33% of patients (no grade 4 toxicity). At the end of follow-up, all patients had progressed and 25 had died. No objective response was observed, and disease control rate was 36%. Median PFS and OS were 1.7 and 4.3 months, respectively. In multivariate analysis, PS was the only independent prognostic factor. For patients PS 0-1 versus 2-3, median PFS was 3.0 versus 1.2 months (log rank, p = 0.002), and median OS was 5.9 versus 2.6 months (log rank, p = 0.001). CONCLUSIONS: This study suggests that FOLFOX second-line therapy offered interesting efficacy results with an acceptable toxicity profile in metastatic PC patients with a good PS.

17 Article Sustained response with gemcitabine plus Nab-paclitaxel after folfirinox failure in metastatic pancreatic cancer: report of an effective new strategy. 2014

Portal, Alix / Pernot, Simon / Siauve, Nathalie / Landi, Bruno / Lepère, Céline / Colussi, Orianne / Rougier, Philippe / Zaanan, Aziz / Verrière, Benjamin / Taieb, Julien. ·Service d'hépatogastro-entérologie et d'oncologie digestive, université Paris Descartes, Sorbonne Paris-Cité, hôpital européen Georges-Pompidou, 20, rue Leblanc, 75015 Paris, France. · Service de radiologie, université Paris Descartes, Sorbonne Paris-Cité, hôpital européen Georges-Pompidou, Paris, France. · Service de pharmacie, université Paris Descartes, Sorbonne Paris-Cité, hôpital européen Georges-Pompidou, Paris, France. · Service d'hépatogastro-entérologie et d'oncologie digestive, université Paris Descartes, Sorbonne Paris-Cité, hôpital européen Georges-Pompidou, 20, rue Leblanc, 75015 Paris, France. Electronic address: julien.taieb@egp.aphp.fr. ·Clin Res Hepatol Gastroenterol · Pubmed #24559766.

ABSTRACT: INTRODUCTION: Folfirinox has shown a benefit in terms of survival and quality of life in first line treatment of metastatic pancreatic cancer. However, efficacy of second line chemotherapy after folfirinox is still limited. Gemcitabine plus Nab-paclitaxel have been recently validated as first line treatment with an increased overall survival compared to gemcitabine. This combination has never been studied as second-line after folfirinox. CASE REPORT: A metastatic pancreatic cancer was diagnosed in a 60-year-old patient with a performance status of 0. After 10 cycles of folfirinox, and an initial objective response, we objectively noted progressive disease according to the RECIST 1.1 criteria together with an increased carbohydrate antigen 19-9. The multidisciplinary team decided to use gemcitabine plus Nab-paclitaxel as second line palliative chemotherapy. After 2 months, we obtained an objective response. After 6 months, this response was maintained with an acceptable tolerability. CONCLUSION: Gemcitabine plus Nab-paclitaxel, as second line palliative chemotherapy, after failure of folfirinox, could be a good strategy for patients with a performance status of 0 and 1. Obviously, this data has to be confirmed in larger patients series and in future comparative clinical studies.

18 Article Double pancreatic and gastric adenocarcinomas: a rare association. 2013

Kourie, Hampig Raphael / Markoutsaki, Nina / Roussel, Hélène / Rahmi, Gabriel / Van der Stiegel, Muriel / Palazzo, Laurent / Fabre, Monique / Cuenod, Charles A / Dubreuil, Olivier / Landi, Bruno / Rougier, Philippe / Taieb, Julien. ·Hôtel-Dieu De France, Hemato-Oncology department, Beirut, Lebanon. Electronic address: hampig.kourie@hotmail.com. ·Clin Res Hepatol Gastroenterol · Pubmed #23158953.

ABSTRACT: Synchronous gastric and pancreatic cancers represent a very rare association. The role of tomodensitometry, endoscopic ultrasound and histology is primordial to differentiate between double tumors, local extension or metastasis. We report in our paper two cases of synchronous gastric and pancreatic cancers treated with Folforinox. Then, we discuss the risk factors, the diagnostic methods, the treatment modalities and the prognosis of these rare double cancers.