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Pancreatic Neoplasms: HELP
Articles by Pascal Artru
Based on 11 articles published since 2009
(Why 11 articles?)
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Between 2009 and 2019, P. Artru wrote the following 11 articles about Pancreatic Neoplasms.
 
+ Citations + Abstracts
1 Clinical Trial FOLFIRINOX or Gemcitabine as Adjuvant Therapy for Pancreatic Cancer. 2018

Conroy, Thierry / Hammel, Pascal / Hebbar, Mohamed / Ben Abdelghani, Meher / Wei, Alice C / Raoul, Jean-Luc / Choné, Laurence / Francois, Eric / Artru, Pascal / Biagi, James J / Lecomte, Thierry / Assenat, Eric / Faroux, Roger / Ychou, Marc / Volet, Julien / Sauvanet, Alain / Breysacher, Gilles / Di Fiore, Frédéric / Cripps, Christine / Kavan, Petr / Texereau, Patrick / Bouhier-Leporrier, Karine / Khemissa-Akouz, Faiza / Legoux, Jean-Louis / Juzyna, Béata / Gourgou, Sophie / O'Callaghan, Christopher J / Jouffroy-Zeller, Claire / Rat, Patrick / Malka, David / Castan, Florence / Bachet, Jean-Baptiste / Anonymous2681306. ·From the Institut de Cancérologie de Lorraine and Université de Lorraine (T.C.) and Centre Hospitalier Universitaire (L.C.), Nancy, Hôpital Beaujon and University Paris VII, Clichy (P.H., A.S.), Hôpital Huriez, Lille (M.H.), Centre Paul Strauss, Strasbourg (M.B.A.), Institut Paoli-Calmettes, Marseille (J.-L.R.), Centre Antoine-Lacassagne, Nice (E.F.), Hôpital Jean-Mermoz, Lyon (P.A.), Hôpital Trousseau, Tours (T.L.), Centre Hospitalier Universitaire de Saint-Eloi (E.A.) and Institut du Cancer de Montpellier-Val d'Aurelle, Université de Montpellier (M.Y., S.G., F.C.), Montpellier, Centre Hospitalier Départemental Vendée, La Roche-sur-Yon (R.F.), Centre Hospitalier Universitaire Robert Debré, Reims (J.V.), Hôpital Louis Pasteur, Colmar (G.B.), Normandie University, Rouen University Hospital, Rouen (F.D.F.), Hôpital Layné, Mont-de-Marsan (P.T.), Centre Hospitalier Universitaire Côte de Nacre, Caen (K.B.-L.), Hôpital Saint-Jean, Perpignan (F.K.-A.), Centre Hospitalier Régional, Orléans (J.-L.L.), R&D Unicancer (B.J., C.J.-Z.) and Sorbonne Université, Hôpitaux Universitaires Pitié-Salpétrière, Assistance Publique-Hôpitaux de Paris (J.-B.B.), Paris, Gustave Roussy, Université Paris-Saclay, Villejuif (D.M.), and Centre Hospitalier Universitaire, Dijon (P.R.) - all in France · and the Princess Margaret Cancer Centre, Toronto (A.C.W.), Kingston General Hospital (J.J.B.) and the Canadian Cancer Trials Group, Queen's University (C.J.O.), Kingston, ON, the Ottawa Health Research Institute, Ottawa (C.C.), and Segal Cancer Centre, Jewish General Hospital, Montreal (P.K.) - all in Canada. ·N Engl J Med · Pubmed #30575490.

ABSTRACT: BACKGROUND: Among patients with metastatic pancreatic cancer, combination chemotherapy with fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX) leads to longer overall survival than gemcitabine therapy. We compared the efficacy and safety of a modified FOLFIRINOX regimen with gemcitabine as adjuvant therapy in patients with resected pancreatic cancer. METHODS: We randomly assigned 493 patients with resected pancreatic ductal adenocarcinoma to receive a modified FOLFIRINOX regimen (oxaliplatin [85 mg per square meter of body-surface area], irinotecan [180 mg per square meter, reduced to 150 mg per square meter after a protocol-specified safety analysis], leucovorin [400 mg per square meter], and fluorouracil [2400 mg per square meter] every 2 weeks) or gemcitabine (1000 mg per square meter on days 1, 8, and 15 every 4 weeks) for 24 weeks. The primary end point was disease-free survival. Secondary end points included overall survival and safety. RESULTS: At a median follow-up of 33.6 months, the median disease-free survival was 21.6 months in the modified-FOLFIRINOX group and 12.8 months in the gemcitabine group (stratified hazard ratio for cancer-related event, second cancer, or death, 0.58; 95% confidence interval [CI], 0.46 to 0.73; P<0.001). The disease-free survival rate at 3 years was 39.7% in the modified-FOLFIRINOX group and 21.4% in the gemcitabine group. The median overall survival was 54.4 months in the modified-FOLFIRINOX group and 35.0 months in the gemcitabine group (stratified hazard ratio for death, 0.64; 95% CI, 0.48 to 0.86; P=0.003). The overall survival rate at 3 years was 63.4% in the modified-FOLFIRINOX group and 48.6% in the gemcitabine group. Adverse events of grade 3 or 4 occurred in 75.9% of the patients in the modified-FOLFIRINOX group and in 52.9% of those in the gemcitabine group. One patient in the gemcitabine group died from toxic effects (interstitial pneumonitis). CONCLUSIONS: Adjuvant therapy with a modified FOLFIRINOX regimen led to significantly longer survival than gemcitabine among patients with resected pancreatic cancer, at the expense of a higher incidence of toxic effects. (Funded by R&D Unicancer and others; ClinicalTrials.gov number, NCT01526135 ; EudraCT number, 2011-002026-52 .).

2 Clinical Trial Prognostic nomogram and score to predict overall survival in locally advanced untreated pancreatic cancer (PROLAP). 2016

Vernerey, Dewi / Huguet, Florence / Vienot, Angélique / Goldstein, David / Paget-Bailly, Sophie / Van Laethem, Jean-Luc / Glimelius, Bengt / Artru, Pascal / Moore, Malcolm J / André, Thierry / Mineur, Laurent / Chibaudel, Benoist / Benetkiewicz, Magdalena / Louvet, Christophe / Hammel, Pascal / Bonnetain, Franck. ·Methodological and Quality of Life in Oncology Unit, EA 3181, University Hospital of Besançon, 3 Boulevard Alexandre Fleming, Besançon 25030, France. · Oncology Multidisciplinary Research Group (GERCOR), 151 rue du Faubourg Saint Antoine, Paris 75011, France. · Department of Radiotherapy, Tenon Hospital (AP-HP), 4 rue de la Chine, Paris 75020, France. · Department of Gastroenterology, University Hospital of Besançon, 3 Boulevard Alexandre Fleming, Besançon 25030, France. · Department of Medical Oncology, Prince of Wales hospital and Prince of Wales Clinical school, UNSW, Sydney, New South Wales 2031, Australia. · AGITG (Australasian Gastrointestinal Trials Group), 119-143 Missenden Rd, Camperdown, New South Wales 2050, Australia. · Department of Gastroenterology, Erasme University Hospital, Route de Lennik 808, Brussels 1070, Belgium. · Department of Radiology, Oncology and Radiation Science, University of Uppsala, Uppsala 75105, Sweden. · Department of Gastroenterology, Jean Mermoz Hospital, 55 avenue Mermoz, Lyon 69008, France. · Department of Medical Oncology, Princess Margaret Hospital, 610 University Avenue, Toronto, Ontario M5G 2M9, Canada. · Department of Medical Oncology, Saint-Antoine Hospital (AP-HP), 184 rue du Faubourg Saint Antoine, Paris 75011, France. · Department of Radiotherapy and Medical Oncology, Sainte-Catherine Institute, 250 Chemin de Baigne Pieds, Avignon 84918, France. · Department of Medical Oncology, Franco-British Hospital Institute, 3 Rue Barbès, Levallois-Perret 92300, France. · Department of Medical Oncology, Institute Mutualiste Montsouris, 42 Boulevard Jourdan, Paris 75014, France. · Department of Digestive Oncology, Beaujon Hospital (AP-HP), 100 boulevard du General Leclerc, Clichy 92110, France. ·Br J Cancer · Pubmed #27404456.

ABSTRACT: BACKGROUND: The management of locally advanced pancreatic cancer (LAPC) patients remains controversial. Better discrimination for overall survival (OS) at diagnosis is needed. We address this issue by developing and validating a prognostic nomogram and a score for OS in LAPC (PROLAP). METHODS: Analyses were derived from 442 LAPC patients enrolled in the LAP07 trial. The prognostic ability of 30 baseline parameters was evaluated using univariate and multivariate Cox regression analyses. Performance assessment and internal validation of the final model were done with Harrell's C-index, calibration plot and bootstrap sample procedures. On the basis of the final model, a prognostic nomogram and a score were developed, and externally validated in 106 consecutive LAPC patients treated in Besançon Hospital, France. RESULTS: Age, pain, tumour size, albumin and CA 19-9 were independent prognostic factors for OS. The final model had good calibration, acceptable discrimination (C-index=0.60) and robust internal validity. The PROLAP score has the potential to delineate three different prognosis groups with median OS of 15.4, 11.7 and 8.5 months (log-rank P<0.0001). The score ability to discriminate OS was externally confirmed in 63 (59%) patients with complete clinical data derived from a data set of 106 consecutive LAPC patients; median OS of 18.3, 14.1 and 7.6 months for the three groups (log-rank P<0.0001). CONCLUSIONS: The PROLAP nomogram and score can accurately predict OS before initiation of induction chemotherapy in LAPC-untreated patients. They may help to optimise clinical trials design and might offer the opportunity to define risk-adapted strategies for LAPC management in the future.

3 Clinical Trial Effect of Chemoradiotherapy vs Chemotherapy on Survival in Patients With Locally Advanced Pancreatic Cancer Controlled After 4 Months of Gemcitabine With or Without Erlotinib: The LAP07 Randomized Clinical Trial. 2016

Hammel, Pascal / Huguet, Florence / van Laethem, Jean-Luc / Goldstein, David / Glimelius, Bengt / Artru, Pascal / Borbath, Ivan / Bouché, Olivier / Shannon, Jenny / André, Thierry / Mineur, Laurent / Chibaudel, Benoist / Bonnetain, Franck / Louvet, Christophe / Anonymous6180866. ·Department of Digestive Oncology, Beaujon Hospital (AP-HP), Clichy, France. · Department of Radiotherapy, Tenon Hospital (AP-HP), Paris, France. · Department of Gastroenterology, Erasme University Hospital, Brussels, Belgium. · Department of Medical Oncology, Prince of Wales Hospital, Sydney, Australia5Australasian Gastrointestinal Trials Group (AGITG), Camperdown, Australia6Prince of Wales Clinical School, University of New South Wales, Sydney, Australia. · Department of Radiology, Oncology, and Radiation Science, University of Uppsala, Uppsala, Sweden. · Department of Gastroenterology, Jean Mermoz Hospital, Lyon, France. · Department of Gastroenterology, Saint-Luc University Clinics, Brussels, Belgium. · Department of Gastroenterology, Robert Debré Hospital, Reims, France. · Australasian Gastrointestinal Trials Group (AGITG), Camperdown, Australia6Prince of Wales Clinical School, University of New South Wales, Sydney, Australia11Department of Medical Oncology, Nepean Hospital NSW, Sydney, Australia. · Department of Medical Oncology, Saint-Antoine Hospital (AP-HP), Paris, France. · Department of Radiotherapy and Medical Oncology, Sainte-Catherine Institute, Avignon, France. · Department of Medical Oncology, Franco-British Hospital Institute, Levallois-Perret, France15Oncology Multidisciplinary Research Group (GERCOR), Paris, France. · Department of Methodology and Quality of Life in Oncology, Hospital Minjoz, Besançon, France. · Department of Medical Oncology, Institute Mutualiste Montsouris, Paris, France. ·JAMA · Pubmed #27139057.

ABSTRACT: IMPORTANCE: In locally advanced pancreatic cancer, the role of chemoradiotherapy is controversial and the efficacy of erlotinib is unknown. OBJECTIVES: To assess whether chemoradiotherapy improves overall survival of patients with locally advanced pancreatic cancer controlled after 4 months of gemcitabine-based induction chemotherapy and to assess the effect of erlotinib on survival. DESIGN, SETTING, AND PARTICIPANTS: In LAP07, an international, open-label, phase 3 randomized trial, 449 patients were enrolled between 2008 and 2011. Follow-up ended in February 2013. INTERVENTIONS: In the first randomization, 223 patients received 1000 mg/m2 weekly of gemcitabine alone and 219 patients received 1000 mg/m2 of gemcitabine plus 100 mg/d of erlotinib. In the second randomization involving patients with progression-free disease after 4 months, 136 patients received 2 months of the same chemotherapy and 133 underwent chemoradiotherapy (54 Gy plus capecitabine). MAIN OUTCOMES AND MEASURES: The primary outcome was overall survival from the date of the first randomization. Secondary outcomes were the effect of erlotinib and quality assurance of radiotherapy on overall survival, progression-free survival of gemcitabine-erlotinib and erlotinib maintenance with gemcitabine alone at the second randomization, and toxic effects. RESULTS: A total of 442 of the 449 patients (232 men; median age, 63.3 years) enrolled underwent the first randomization. Of these, 269 underwent the second randomization. Interim analysis was performed when 221 patients died (109 in the chemoradiotherapy group and 112 in the chemotherapy group), reaching the early stopping boundaries for futility. With a median follow-up of 36.7 months, the median overall survival from the date of the first randomization was not significantly different between chemotherapy at 16.5 months (95% CI, 14.5-18.5 months) and chemoradiotherapy at 15.2 months (95% CI, 13.9-17.3 months; hazard ratio [HR], 1.03; 95% CI, 0.79-1.34; P = .83). Median overall survival from the date of the first randomization for the 223 patients receiving gemcitabine was 13.6 months (95% CI, 12.3-15.3 months) and was 11.9 months (95% CI, 10.4-13.5 months) for the 219 patients receiving gemcitabine plus erlotinib (HR, 1.19; 95% CI, 0.97-1.45; P = .09; 188 deaths vs 191 deaths). Chemoradiotherapy was associated with decreased local progression (32% vs 46%, P = .03) and no increase in grade 3 to 4 toxicity, except for nausea. CONCLUSIONS AND RELEVANCE: In this open-label, randomized trial involving patients with locally advanced pancreatic cancer with disease controlled after 4 months of induction chemotherapy, there was no significant difference in overall survival with chemoradiotherapy compared with chemotherapy alone and there was no significant difference in overall survival with gemcitabine compared with gemcitabine plus erlotinib used as maintenance therapy. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00634725.

4 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).

5 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).

6 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.

7 Clinical Trial Circulating tumor cells in locally advanced pancreatic adenocarcinoma: the ancillary CirCe 07 study to the LAP 07 trial. 2013

Bidard, F C / Huguet, F / Louvet, C / Mineur, L / Bouché, O / Chibaudel, B / Artru, P / Desseigne, F / Bachet, J B / Mathiot, C / Pierga, J Y / Hammel, P. ·Department of Medical Oncology, Institut Curie, Paris, France. fcbidard@curie.fr ·Ann Oncol · Pubmed #23676420.

ABSTRACT: BACKGROUND: Pancreatic carcinoma is one of the leading causes of cancer-related mortality. At the time of diagnosis, 30% of patients present with a locally advanced pancreatic carcinoma (LAPC). As circulating tumor cells (CTCs) count may be a surrogate of the cancer metastatic abilities, CTC detection rates and prognostic value were studied in a prospective cohort of LAPC patients. PATIENTS AND METHODS: An LAP07 international multicenter randomized study assesses in patients whose LAPC is controlled after 4 months of chemotherapy whether chemoradiotherapy could increase survival versus continuation of chemotherapy. A subgroup of patients included in the LAP07 trial was screened for CTCs (CellSearch®) before the start of the chemotherapy and after 2 months of treatment. Patient characteristics and survival were obtained prospectively and were correlated with CTC detection. RESULTS: Seventy-nine patients were included. One or more CTCs/7.5 ml were detected in 5% of patients before treatment and in 9% of patients after 2 months of treatment (overall detection rate: 11% of patients). CTC positivity was associated with poor tumor differentiation (P = 0.04), and with shorter overall survival (OS) in multivariable analysis (RR = 2.5, P = 0.01), together with anemia. CONCLUSIONS: The evaluation of micrometastatic disease using CTC detection appears as a promising prognostic tool in LAPC patients.

8 Clinical Trial First-line simplified GEMOX (S-GemOx) versus classical GEMOX in metastatic pancreatic cancer (MPA): results of a GERCOR randomized phase II study. 2009

Afchain, P / Chibaudel, B / Lledo, G / Selle, F / Bengrine-Lefevre, L / Nguyen, S / Paitel, J-F / Mineur, L / Artru, P / André, T / Louvet, C. ·Service d'Oncologie, Hôpital Saint-Antoine, Assistance Publique des Hôpitaux de Paris, Paris, France. ·Bull Cancer · Pubmed #19435690.

ABSTRACT: PURPOSE: GemOx was defined as a D1-D2 schedule, based on preclinical data. In order to improve convenience for patients, we evaluated a simplified D1-D1 GemOx regimen (S-GemOx) in MPA. PATIENTS AND METHODS: Patients (pts) with MPA were 2:1 randomly assigned for first-line treatment to S-GemOx (gemcitabine 1,000 mg/m(2), 100-minute infusion D1 immediately followed by oxaliplatin 100 mg/m(2), 120-minute infusion) or to GemOx (Gem D1 and ox D2). Treatment was repeated in each arm every 2 weeks until disease progression. Stratification was performed on center and PS. RESULTS: Fifty-seven pts were enrolled, S-GemOx = 37 (PS 2: 22%), GemOx = 20 (PS 2: 20%). Populations were well balanced for age (64.9 vs 66.6 years); gender (57 vs 65% male), location of primary tumor (pancreas head: 49 vs 50%), and metastatic sites (liver 76 vs 85%; peritoneum 24 vs 20%; lung 16 vs 10%; lymph nodes 14 vs 15%; other 5 vs 5%). Tumor differentiation significantly differed between the 2 groups (S-GemOx: 8% poorly differentiated vs GemOx: 36%). Response rate was 27% (95% CI: 12-42) in arm S-GemOx and 10% (95% CI: 0-23) in GemOx. Median PFS was 4.0 and 2.5 months in S-GemOx and GemOx, respectively. Median OS was 7.6 and 3.2 months in S-GemOx and GemOx, respectively. Since more cycles were administered in S-GemOx (8.5 [1-29] vs 5.8 [2-12]), grade 3 oxaliplatin-induced neuropathy was higher in S-GemOx [21.6 vs 0%]). CONCLUSIONS: Activity and tolerance of S-GemOx are in the same range as compared to our previous experiences of classical GemOx in metastatic pancreatic cancer. The very bad outcome of patients randomized in GemOx arm could at least be in part explained by the high-rate of poorly differentiated tumors.

9 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.

10 Article Gemcitabine as second-line chemotherapy after Folfirinox failure in advanced pancreatic adenocarcinoma: A retrospective study. 2017

Viaud, Juliette / Brac, Clémence / Artru, Pascal / Le Pabic, Estelle / Leconte, Bérengère / Bodère, Anaïs / Pracht, Marc / Le Sourd, Samuel / Edeline, Julien / Lièvre, Astrid. ·Department of Hepato-Gastroenterology, CHU Rennes, Rennes, France. · Department of Medical Oncology, Centre Eugène Marquis, Rennes, France. · Department of Hepato-Gastroenterology, Jean Mermoz Hospital, Lyon, France. · Department of Clinical Pharmacology, CHU Rennes, Rennes, France; Clinical Investigation Centre, Inserm 1414, Rennes 1 University, Rennes, France. · Department of Medical Oncology, Centre Eugène Marquis, Rennes, France; Rennes 1 University, Rennes , France. · Department of Hepato-Gastroenterology, CHU Rennes, Rennes, France; Rennes 1 University, Rennes , France; Inserm ER440 Oncogenesis, Stress & Signaling, Rennes, France. Electronic address: astrid.lievre@chu-rennes.fr. ·Dig Liver Dis · Pubmed #28256401.

ABSTRACT: BACKGROUND: Pancreatic adenocarcinoma (PA) is diagnosed in most cases at an advanced stage requiring chemotherapy. Folfirinox is the standard first-line treatment. After Folfirinox failure, gemcitabine alone is routinely used as second-line therapy without data supporting this attitude. AIM: Determine the response rate and outcome of patients with advanced PA treated with gemcitabine after Folfirinox failure. METHODS: We retrospectively analyzed all consecutive patients treated with gemcitabine after Folfirinox failure for a locally advanced or metastatic PA between 2009 and 2015. Progression-free survival (PFS) and overall survival (OS) were calculated using the Kaplan-Meier method. Response rate, control rate and tolerability were assessed. RESULTS: 96 patients were included (male, 51%; median age, 62; performance status (PS) 0-1, 47%). Median duration on gemcitabine was 2.1 months. The overall disease control rate was 40%. Median OS was 3.7 months (95%CI: 2.5-5.2) and median PFS was 2.1 months (95%CI: 2.0-2.6). Reasons for treatment discontinuation were mostly progression (51%). Age at diagnosis and PS were independently associated with OS in multivariate analysis (HR of 1.86; p=0.0055 and 2.42; p<0.0001 respectively). 34 patients experienced a grade 3 adverse event. CONCLUSIONS: This study suggests that gemcitabine is not beneficial to all patients failing on Folfirinox first-line therapy and should be restricted to young patients with good PS.

11 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.