Pick Topic
Review Topic
List Experts
Examine Expert
Save Expert
  Site Guide ··   
Pancreatic Neoplasms: HELP
Articles by Thomas Aparicio
Based on 8 articles published since 2010
(Why 8 articles?)
||||

Between 2010 and 2020, T. Aparicio wrote the following 8 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 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.

3 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).

4 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.

5 Clinical Trial [Locally advanced unresectable pancreatic cancer: Induction chemoradiotherapy followed by maintenance gemcitabine versus gemcitabine alone: Definitive results of the 2000-2001 FFCD/SFRO phase III trial]. 2011

Barhoumi, M / Mornex, F / Bonnetain, F / Rougier, P / Mariette, C / Bouché, O / Bosset, J-F / Aparicio, T / Mineur, L / Azzedine, A / Hammel, P / Butel, J / Stremsdoerfer, N / Maingon, P / Bedenne, L / Chauffert, B. ·EA, département de radiothérapie-oncologie, centre hospitalier Lyon-Sud, Pierre-Bénite, France. barhoumi.maha@yahoo.fr ·Cancer Radiother · Pubmed #21315644.

ABSTRACT: PURPOSE: To compare chemoradiation with systemic chemotherapy to chemotherapy alone in locally advanced pancreatic cancer. PATIENTS AND METHODS: One hundred and nineteen patients with locally advanced pancreatic cancer, with World Health Organization performance status of zero to two were randomly assigned to either the induction chemoradiation group (60 Gy, 2 Gy/fraction; concomitant 5-fluoro-uracil infusion, 300 mg/m(2) per day, days 1-5 for 6 weeks; cisplatin, 20 mg/m(2) per day, days 1-5 during weeks 1 and 5) or the induction gemcitabine group (GEM: 1000 mg/m(2) weekly for 7 weeks). Maintenance gemcitabine (1000 mg/m(2) weekly, 3/4 weeks) was given in both arms until disease progression or toxicity. RESULTS: Overall survival was shorter in the chemoradiation than in the gemcitabine arm (median survival 8.6 [99% confidence interval 7.1-11.4] and 13 months [8,9,9-18], p=0.03). One-year survival was, respectively, 32 and 53%. These results were confirmed in a per-protocol analysis for patients who received 75% or more of the planned dose of radiotherapy. More overall grades 3-4 toxic effects were recorded in the chemoradiation arm, both during induction (36 versus 22%) and maintenance (32 versus 18%). CONCLUSION: This intensive induction schedule of chemoradiation was more toxic and less effective than gemcitabine alone.

6 Article Impact on health-related quality of life deterioration-free survival of a first-line therapy combining nab-paclitaxel plus either gemcitabine or simplified leucovorin and fluorouracil for patients with metastatic pancreatic cancer: Results of the randomized phase II AFUGEM GERCOR clinical trial. 2019

Charton, Emilie / Bachet, Jean-Baptiste / Hammel, Pascal / Desramé, Jérôme / Chibaudel, Benoist / Cohen, Romain / Debourdeau, Philippe / Dauba, Jérome / Lecomte, Thierry / Seitz, Jean-François / Tournigand, Christophe / Aparicio, Thomas / Guerin-Meyer, Véronique / Taieb, Julien / Volet, Julien / Louvet, Christophe / Anota, Amélie / Bonnetain, Franck. ·Methodology and Quality of Life Unit in Oncology, INSERM UMR 1098, University Hospital of Besançon, Besançon, France. · University Bourgogne Franche-Comté, INSERM, EFS BFC, UMR1098, Interactions Hôte-Greffon-Tumeur/Ingénierie Cellulaire et Génique, Besançon, France. · Department of Hepato-Gastroenterology, Groupe hospitalier Pitié Salpêtrière, Sorbonne University, UPMC University, Paris, France. · Department of Digestive Oncology, Hôpital Beaujon, Clichy, France. · Department of Hepato-Gastroenterology, Hôpital Privé Jean Mermoz, Lyon, France. · Department of Oncology, Institut Franco-Britannique, Levallois-Perret, France. · Department of Oncology, AP-HP, Hôpital Saint-Antoine, Sorbonne University, 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 Saint Louis, Paris, 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. · Department of Oncology, Institut Mutualiste Montsouris, Paris, France. · French National Platform of Quality of Life and Cancer, Besançon, France. ·Cancer Med · Pubmed #31314957.

ABSTRACT: BACKGROUND: The phase II AFUGEM GERCOR trial aimed to assess the efficacy of a first-line therapy combining nab-paclitaxel plus either gemcitabine (gemcitabine group) or simplified leucovorin and fluorouracil (sLV5FU2 group) in patients with previously untreated metastatic pancreatic cancer. Results of progression-free survival at 4 months (primary endpoint) were in favor of the sLV5FU2 group. This paper presents health-related quality of life (HRQoL) data as a secondary endpoint. METHODS: HRQoL was assessed using the EORTC QLQ-C30 questionnaire at baseline and at each chemotherapy cycle until the end of treatment. The HRQoL deterioration-free survival (QFS) was used as a modality of longitudinal analysis. QFS was defined as the time between randomization and the first definitive HRQoL score deterioration as compared to the baseline score, or death. Sensitivity analysis was performed excluding death as an event. Univariate Cox models were used to estimate hazard ratios (HRs) and 90% confidence intervals (CIs) of the treatment effect. RESULTS: Between 2013 and 2014, 114 patients were randomized in a 1:2 ratio (39 in the gemcitabine group and 75 in the sLV5FU2 group). Patients in the sLV5FU2 group seemed to present longer QFS than those of the gemcitabine group for 14 out of 15 dimensions, with HRs < 1. Results of the sensitivity analysis excluding death as an event were significantly in favor of the sLV5FU2 group for physical functioning (HR = 0.51 [90% CI 0.27-0.97]) and pain (HR = 0.26 [90% CI 0.09-0.74]). CONCLUSION: The nab-paclitaxel plus simplified leucovorin and fluorouracil combination had no negative impact in exploratory HRQoL analyses.

7 Article Poorly differentiated gastro-entero-pancreatic neuroendocrine carcinomas: Are they really heterogeneous? Insights from the FFCD-GTE national cohort. 2017

Walter, T / Tougeron, D / Baudin, E / Le Malicot, K / Lecomte, T / Malka, D / Hentic, O / Manfredi, S / Bonnet, I / Guimbaud, R / Coriat, R / Lepère, C / Desauw, C / Thirot-Bidault, A / Dahan, L / Roquin, G / Aparicio, T / Legoux, J-L / Lombard-Bohas, C / Scoazec, J-Y / Lepage, C / Cadiot, G / Anonymous2580906. ·University Hospital, Lyon, France. Electronic address: thomas.walter@chu-lyon.fr. · University Hospital, Poitiers, France. · Gustave Roussy Institute, Villejuif, France. · FFCD, Dijon, France. · Trousseau Hospital, Tours, France. · Beaujon Hospital, Clichy, France. · University Hospital, Rennes, France. · Valenciennes Hospital, Valenciennes, France. · University Hospital, Toulouse, France. · Cochin Hospital, University Paris Descartes, Paris, France. · Georges Pompidou European Hospital, University Paris-V, Paris, France. · University Hospital, Lille, France. · Hôpitalde Bicêtre, Le Kremlin Bicêtre, France. · La Timone Hospital, Marseille, France. · University Hospital, Angers, France. · Avicenne Hospital, Bobigny, France. · Hôpital de la Source, Orléans, France. · University Hospital, Lyon, France. · FFCD, Dijon, France; University Hospital, Dijon, France. · University Hospital, Reims, France. ·Eur J Cancer · Pubmed #28501762.

ABSTRACT: BACKGROUND: Diagnosis and management of poorly differentiated gastro-entero-pancreatic (GEP) neuroendocrine carcinomas (NECs) remain challenging. Recent studies suggest prognostic heterogeneity. We designed within the French Group of Endocrine Tumours a prospective cohort to gain insight in the prognostic stratification and treatment of GEP-NEC. PATIENTS AND METHODS: All patients with a diagnosis of GEP-NEC between 1st January 2010 and 31st December 2013 could be included in this national cohort. Adenoneuroendocrine tumours were excluded. RESULTS: 253 patients from 49 centres were included. Median age was 66 years. Main primary locations were pancreas (21%), colorectal (27%), oesophagus-stomach (18%); primary location was unknown in 20%. Tumours were metastatic at diagnosis in 78% of cases. Performance status (PS) at diagnosis was 0-1 in 79% of patients. Among the 147 (58%) cases reviewed by an expert pathological network, 39% were classified as small cell NEC and 61% as large cell NEC. Median Ki67 index was 75% (range, 20-100). Median overall survival was 15.6 (13.6-17.0) months. Significant adverse prognostic factors in univariate analysis were PS > 1 (hazard ratio [HR] = 2.5), metastatic disease (HR = 1.6), NSE>2 upper limit of normal [ULN]; HR = 3.2), CgA>2 ULN (HR = 1.7) and lactate dehydrogenase >2 ULN (HR = 2.1). After first-line palliative chemotherapy (CT1) with platinum-etoposide (n = 152), objective response, progression-free survival and overall survival were 50%, 6.2 and 11.6 months; they were 24%, 2.9 and 5.9, respectively, after post-CT1 FOLFIRI regimen (n = 72). CONCLUSIONS: We report a large prospective series of GEP-NEC which show the predominance of large cell type and advanced stage at diagnosis. Prognosis was found more homogeneous than previously reported, mainly impacted by PS and tumour burden.

8 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.