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Pancreatic Neoplasms: HELP
Articles by Olivier Bouche
Based on 13 articles published since 2008
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Between 2008 and 2019, O. Bouché wrote the following 13 articles about Pancreatic Neoplasms.
 
+ Citations + Abstracts
1 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.

2 Review Pancreas cancer-associated polymyositis of the legs regressing after cephalic duodenopancreatectomy: case report and review of the literature. 2012

Amroun, Koceila Lamine / De Mestier, Louis / Deguelte-Lardiere, Sophie / Diebold, Marie-Danièle / Bouché, Olivier / Kianmanesh, Reza. ·Service of General, Digestive and Endocrine Surgery, Robert-Debré Hospital. Reims, France. lamroun@chu-reims.fr ·JOP · Pubmed #23183398.

ABSTRACT: CONTEXT: Inflammatory myopathy, such as polymyositis, has been widely reported as paraneoplastic syndrome associated with various malignancies. However, its association with pancreas adenocarcinoma is very uncommon. CASE REPORT: A case of a patient with paraneoplastic polymyositis of both legs associated with pancreatic adenocarcinoma is reported here. The diagnosis of polymyositis was highlighted by MRI and confirmed by histopathological examination. The surgical resection of the primary tumor led to the complete resolution of polymyositis with no further recurrence despite later metastases. CONCLUSION: The association between pancreatic cancer and paraneoplastic polymyositis is very uncommon and has to be recognized by clinicians.

3 Clinical Trial Retrospective Analysis of CA19-9 Decrease in Patients with Metastatic Pancreatic Carcinoma Treated with FOLFIRINOX or Gemcitabine in a Randomized Phase III Study (ACCORD11/PRODIGE4). 2017

Robert, Marie / Jarlier, Marta / Gourgou, Sophie / Desseigne, Françoise / Ychou, Marc / Bouché, Olivier / Juzyna, Beata / Conroy, Thierry / Bennouna, Jaafar. ·Department of Medical Oncology, Institut de Cancérologie de l'Ouest, St. Herblain, France. ·Oncology · Pubmed #28982109.

ABSTRACT: OBJECTIVES: Carbohydrate antigen 19-9 (CA19-9) is a sensitive and specific serum marker in pancreatic cancer. Our retrospective analysis aims to evaluate CA19-9 decrease in patients with metastatic pancreatic cancer treated in ACCORD11/PRODIGE4 (FOLFIRINOX vs. gemcitabine). METHODS: A total of 342 patients were treated. CA19-9 was measured at 8 weeks (±2) in 160 patients from a total of 282 with abnormal CA19-9 values at baseline (gemcitabine arm, n = 75; FOLFIRINOX arm, n = 85). In the present study, 8-week CA19-9 decrease or greater CA19-9 decrease according to the 20 and 90% thresholds were analyzed. Progression-free survival (PFS) and overall survival (OS) were estimated in each subgroup. RESULTS: In the FOLFIRINOX arm, patients with an 8-week CA19-9 decrease or greater CA19-9 decrease ≥20% showed improved median OS, PFS, and objective response rate. In the overall study population, median OS and PFS were significantly improved in patients with an 8-week CA19-9 decrease ≥20% (vs. <20%). The 8-week CA19-9 decrease was predictive of PFS (interaction test significant according to treatment arm; p = 0.006). CONCLUSION: An 8-week CA19-9 decrease ≥20% is a prognostic factor for OS and PFS. The 8-week CA19-9 decrease (20% threshold) is predictive of PFS. It could help to evaluate the efficacy of FOLFIRINOX and gemcitabine regimens.

4 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.

5 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.

6 Clinical Trial Impact of FOLFIRINOX compared with gemcitabine on quality of life in patients with metastatic pancreatic cancer: results from the PRODIGE 4/ACCORD 11 randomized trial. 2013

Gourgou-Bourgade, Sophie / Bascoul-Mollevi, Caroline / Desseigne, Françoise / Ychou, Marc / Bouché, Olivier / Guimbaud, Rosine / Bécouarn, Yves / Adenis, Antoine / Raoul, Jean-Luc / Boige, Valérie / Bérille, Jocelyne / Conroy, Thierry. ·Centre Léon Bérard, Lyon, France. ·J Clin Oncol · Pubmed #23213101.

ABSTRACT: PURPOSE: To compare the quality of life (QoL) of patients receiving oxaliplatin, irinotecan, fluorouracil, and leucovorin (FOLFIRINOX) or gemcitabine as first-line chemotherapy and to assess whether pretreatment QoL predicts survival in patients with metastatic pancreatic cancer. PATIENTS AND METHODS: Three hundred forty-two patients with performance status 0 or 1 were randomly assigned to receive FOLFIRINOX (oxaliplatin, 85 mg/m(2); irinotecan, 180 mg/m(2); leucovorin, 400 mg/m(2); and fluorouracil, 400 mg/m(2) bolus followed by 2,400 mg/m(2) 46-hour continuous infusion, once every 2 weeks) or gemcitabine 1,000 mg/m(2) weekly for 7 of 8 weeks and then weekly for 3 of 4 weeks. QoL was assessed using European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire C30 every 2 weeks. RESULTS: Improvement in global health status (GHS; P < .001) was observed in the FOLFIRINOX arm and improvement in emotional functioning (P < .001) was observed in both arms, along with a decrease in pain, insomnia, anorexia, and constipation in both arms. A significant increase in diarrhea was observed in the FOLFIRINOX arm during the first 2 months of chemotherapy. Time until definitive deterioration ≥ 20 points was significantly longer for FOLFIRINOX compared with gemcitabine for GHS, physical, role, cognitive, and social functioning, and six symptom domains (fatigue, nausea/vomiting, pain, dyspnea, anorexia, and constipation). Physical functioning, constipation, and dyspnea were independent significant prognostic factors for survival with treatment arm, age older than 65 years, and low serum albumin. CONCLUSION: FOLFIRINOX significantly reduces QoL impairment compared with gemcitabine in patients with metastatic pancreatic cancer. Furthermore, baseline QoL scores improved estimation of survival probability when added to baseline clinical and demographic variables.

7 Clinical Trial FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. 2011

Conroy, Thierry / Desseigne, Françoise / Ychou, Marc / Bouché, Olivier / Guimbaud, Rosine / Bécouarn, Yves / Adenis, Antoine / Raoul, Jean-Luc / Gourgou-Bourgade, Sophie / de la Fouchardière, Christelle / Bennouna, Jaafar / Bachet, Jean-Baptiste / Khemissa-Akouz, Faiza / Péré-Vergé, Denis / Delbaldo, Catherine / Assenat, Eric / Chauffert, Bruno / Michel, Pierre / Montoto-Grillot, Christine / Ducreux, Michel / Anonymous1530694 / Anonymous1540694. ·Nancy University and Department of Medical Oncology, Centre Alexis Vautrin, Nancy, France. t.conroy@nancy.fnclcc.fr ·N Engl J Med · Pubmed #21561347.

ABSTRACT: BACKGROUND: Data are lacking on the efficacy and safety of a combination chemotherapy regimen consisting of oxaliplatin, irinotecan, fluorouracil, and leucovorin (FOLFIRINOX) as compared with gemcitabine as first-line therapy in patients with metastatic pancreatic cancer. METHODS: We randomly assigned 342 patients with an Eastern Cooperative Oncology Group performance status score of 0 or 1 (on a scale of 0 to 5, with higher scores indicating a greater severity of illness) to receive FOLFIRINOX (oxaliplatin, 85 mg per square meter of body-surface area; irinotecan, 180 mg per square meter; leucovorin, 400 mg per square meter; and fluorouracil, 400 mg per square meter given as a bolus followed by 2400 mg per square meter given as a 46-hour continuous infusion, every 2 weeks) or gemcitabine at a dose of 1000 mg per square meter weekly for 7 of 8 weeks and then weekly for 3 of 4 weeks. Six months of chemotherapy were recommended in both groups in patients who had a response. The primary end point was overall survival. RESULTS: The median overall survival was 11.1 months in the FOLFIRINOX group as compared with 6.8 months in the gemcitabine group (hazard ratio for death, 0.57; 95% confidence interval [CI], 0.45 to 0.73; P<0.001). Median progression-free survival was 6.4 months in the FOLFIRINOX group and 3.3 months in the gemcitabine group (hazard ratio for disease progression, 0.47; 95% CI, 0.37 to 0.59; P<0.001). The objective response rate was 31.6% in the FOLFIRINOX group versus 9.4% in the gemcitabine group (P<0.001). More adverse events were noted in the FOLFIRINOX group; 5.4% of patients in this group had febrile neutropenia. At 6 months, 31% of the patients in the FOLFIRINOX group had a definitive degradation of the quality of life versus 66% in the gemcitabine group (hazard ratio, 0.47; 95% CI, 0.30 to 0.70; P<0.001). CONCLUSIONS: As compared with gemcitabine, FOLFIRINOX was associated with a survival advantage and had increased toxicity. FOLFIRINOX is an option for the treatment of patients with metastatic pancreatic cancer and good performance status. (Funded by the French government and others; ClinicalTrials.gov number, NCT00112658.).

8 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.

9 Clinical Trial Phase III trial comparing intensive induction chemoradiotherapy (60 Gy, infusional 5-FU and intermittent cisplatin) followed by maintenance gemcitabine with gemcitabine alone for locally advanced unresectable pancreatic cancer. Definitive results of the 2000-01 FFCD/SFRO study. 2008

Chauffert, B / 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. ·Department of Oncology, Anticancer Center G.F. Leclerc, Dijon, France. ·Ann Oncol · Pubmed #18467316.

ABSTRACT: BACKGROUND: The role of chemoradiation with systemic chemotherapy compared with chemotherapy alone in locally advanced pancreatic cancer (LAPC) is uncertain. PATIENTS AND METHODS: One hundred and nineteen patients with LAPC, World Health Organization performance status of zero to two were randomly assigned to either the induction CHRT group (60 Gy, 2 Gy/fraction; concomitant 5-fluorouracil infusion, 300 mg/m(2)/day, days 1-5 for 6 weeks; cisplatin, 20 mg/m(2)/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 CHRT than in GEM arm [median survival 8.6 (99% confidence interval 7.1-11.4) and 13 months (8.7-18.1), 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 CHRT arm, both during induction (36 versus 22%) and maintenance (32 versus 18%). CONCLUSION: This intensive induction schedule of CHRT was more toxic and less effective than gemcitabine alone.

10 Article Overall Survival Prediction and Usefulness of Second-Line Chemotherapy in Advanced Pancreatic Adenocarcinoma. 2017

Vienot, Angélique / Beinse, Guillaume / Louvet, Christophe / de Mestier, Louis / Meurisse, Aurélia / Fein, Francine / Heyd, Bruno / Cleau, Denis / d'Engremont, Christelle / Dupont-Gossart, Anne-Claire / Lakkis, Zaher / Tournigand, Christophe / Bouché, Olivier / Rousseau, Benoît / Neuzillet, Cindy / Bonnetain, Franck / Borg, Christophe / Vernerey, Dewi. ·Department of Gastroenterology, Methodological and Quality of Life in Oncology Unit, EA 3181, Department of Digestive Surgery and Liver Transplantation, and Department of Medical Oncology, Besançon University Hospital, Besançon, France; Department of Medical Oncology, Henri Mondor University Hospital, Assistance Publique-Hôpitaux de Paris, Paris Est Créteil University (UPEC), Créteil, France; Department of Medical Oncology, Institute Mutualiste Montsouris, Paris, France; Department of Hepato-Gastroenterology, Reims University Hospital, Reims, France; INSERM, Unit 1098, and Clinical Investigation Center 1431, University of Bourgogne-Franche-Comté, Besançon, France; Department of Gastroenterology, Vesoul Hospital, Vesoul, France. ·J Natl Cancer Inst · Pubmed #28383673.

ABSTRACT: Background: In advanced pancreatic ductal adenocarcinoma (aPDAC), there is no consensual strategy for second-line chemotherapy (L2). Better discrimination of overall survival (OS) may help clinical decision-making. We aimed to predict OS from the beginning of L2 and to assess the benefit from chemotherapy among the identified risk groups. Methods: Analyses were derived from all consecutive aPDAC patients treated at Besancon University Hospital, Besancon, France, between January 2003 and December 2013 (n = 462). The association of 50 parameters with OS was evaluated using univariate and multivariable Cox analyses. Based on the final model, a prognostic nomogram and score were developed and externally validated. Patients in the external validation cohort who received L2 (n = 163) were treated at three French institutions between January 2010 and April 2016. All statistical tests were two-sided. Results: In the development cohort, 395 patients (85.5%) were eligible for L2, of which 261 (66.1%) were treated. Age, smoking status, liver metastases, performance status, pain, jaundice, ascites, duration of first-line, and type of L2 regimen were identified as independent prognostic factors for OS in L2. The score determined three groups with median OS of 11.3 months (95% confidence interval [CI] = 9.1 to 12.9 months), 3.6 months (95% CI = 2.6 to 4.7 months), and 1.4 months (95% CI = 1.2 to 1.7 months), for low-, intermediate-, and high-risk groups, respectively ( P < .001). By applying the score in the population eligible for L2 but untreated, the chemotherapy benefit was statistically significant across all groups, but with a magnitude of the effect decreased statistically significantly from low- to high-risk groups ( P = .001 for treatment and risk groups interaction term). The ability of the score to discriminate OS was confirmed in the external validation cohort. Conclusions: This prognostic nomogram and score in patients with aPDAC can accurately predict OS before administration of L2 and may help clinicians in their therapeutic decisions.

11 Article Safety and efficacy of FOLFIRINOX in elderly patients with metastatic or locally advanced pancreatic adenocarcinoma: A retrospective analysis. 2017

Baldini, C / Escande, A / Bouché, O / El Hajbi, F / Volet, J / Bourgeois, V / Renaut Vantroys, T / Ploquin, A / Desauw, C / Hebbar, M. ·Department of Medical Oncology, Hospital Huriez, University Lille Nord de France, Lille, France; Department of Digestive-Oncology, Oscar Lambret Cancer Center, Lille, France. Electronic address: capucine.baldini@chru-lille.fr. · Department of Medical Oncology, Hospital Huriez, University Lille Nord de France, Lille, France. · Department of Medical Oncology, University Hospital, Reims, France. · Department of Digestive-Oncology, Oscar Lambret Cancer Center, Lille, France. · Department of Medical Oncology, Boulogne-sur-mer Hospital, France. · Department of Medical Oncology, Valenciennes Hospital, France. ·Pancreatology · Pubmed #28040425.

ABSTRACT: BACKGROUND: FOLFIRINOX is a polychemotherapy regimen currently used to treat inoperable pancreatic cancer in patients with a good performance status (PS). FOLFIRINOX lengthens overall survival time (OS), but no specific data are available in elderly patients. METHODS: All cases of inoperable pancreatic adenocarcinoma in patients over 70 years old treated with FOLFIRINOX were retrospectively reviewed between 2008 and 2015 in five institutions in France. The primary objective was to evaluate the safety and efficacy of FOLFIRINOX in the elderly. RESULTS: Forty-two patients with a median age of 73 years (range: 70-79) and a median PS of 1 (range: 0-2) were included. 88% of patients treated with FOLFIRINOX were enrolled between 2012 and 2015. 24 patients (57%) needed a primary dose reduction but this did not impact OS (median OS 11.7 months (6.9-16.4) compared to 16.6 months (0.37-32.8) without dose reduction, p = 0.69). Twelve patients (29%) experienced grade 3 toxicity. Sensory neuropathy occurred most often (56%). Primary prophylaxis with granulocyte colony stimulating factor (GCSF) was administered to 14 patients (33%). One treatment-related death occurred (septic shock), although this patient had not had primary prophylaxis with GCSF. Median follow-up was 86 months. Median OS was 11.6 months (95%CI: 8.9-14.3). CONCLUSION: Median OS observed in the elderly was similar to OS previously reported in younger patients in the ACCORD 11 trial. FOLFIRINOX is effective in selected, fit elderly patients but with greater grade 3 neurotoxicity. Primary dose reduction and primary GCSF prophylaxis may control tolerance.

12 Article Optical diagnosis of peritoneal metastases by infrared microscopic imaging. 2009

Untereiner, Valérie / Piot, Olivier / Diebold, Marie-Danielle / Bouché, Olivier / Scaglia, Elodie / Manfait, Michel. ·Unité MéDIAN, CNRS UMR 6237 MEDyC, IFR53, UFR Pharmacie, Université de Reims Champagne-Ardenne, 51 rue Cognacq Jay, 51096, Reims Cedex, France. ·Anal Bioanal Chem · Pubmed #19219424.

ABSTRACT: Fourier transform infrared (FTIR) spectroscopy is nowadays widely accepted as a technique with high potential for diagnosis of cancerous tissues. This study presents an example of the investigation of peritoneal metastases by FTIR microimaging. Peritoneal malignancies are generally secondary localizations of primary visceral cancers such as ovarian, stomach or colon cancers. By analysing simultaneously both formalin-fixed paraffin-embedded and frozen specimens, we examined malignant and non-malignant (i.e. fibrotic and cicatricial) peritoneal lesions. Paraffin-embedded tissues were analysed without any previous dewaxing. Multivariate statistical approaches, based on the classification of infrared data by hierarchical cluster analysis, allowed the discrimination of these various samples. Microimaging also permits the revelation of the heterogeneity of the tissue: it was possible to localize precisely the cancerous areas, and to distinguish, on the basis of their spectral signatures, the peritumoral neighbouring connective tissue close to the carcinomatous areas from the connective tissue distant from the cancerous areas. These spectral differences could be useful as complementary information to study molecular changes associated with the malignancy.

13 Article Patient-reported outcomes as a component of the primary endpoint in a double-blind, placebo-controlled trial in advanced pancreatic cancer. 2009

Eckhardt, S Gail / De Porre, Peter / Smith, David / Maurel, Joan / Steward, William P / Bouche, Olivier / van de Velde, Helgi / Michiels, Bart / Bugat, Roland. ·Developmental Therapeutics and GI Malignancies, University of Colorado Health Sciences Center, Aurora, Colorado 80045, USA. Gail.Eckhardt@UCHSC.edu ·J Pain Symptom Manage · Pubmed #18723314.

ABSTRACT: In this randomized, double-blind, placebo-controlled study comparing gemcitabine+tipifarnib (G+t) or gemcitabine+placebo (G+p) in patients with pancreatic cancer, the primary endpoint of time to deterioration (TTD) was based primarily on patient-reported outcomes. Deterioration was defined as death or worsening of disease-related symptoms, based on patient-reported outcomes of pain intensity and analgesic use in a daily diary, plus investigator-rated weekly performance status. Secondary endpoints included survival and safety. Two hundred and forty-four patients were treated for a total of 4780 weeks, during which the diary was completed daily. Overall, the completion of the diary was found to be feasible: patients completed approximately 95% of scheduled diary entries. Baseline characteristics were well balanced between the two treatment arms. The primary endpoint of TTD was not significantly different between the G+t arm (69 days) and the G+p arm (91 days, P=0.40). Survival was not significantly different between the G+t arm (202 days) and the G+p arm (221 days, P=0.66). The combination of G+t had an acceptable toxicity profile, with primarily neutropenia and thrombocytopenia. Methodologically, measurement of patient-reported outcomes is feasible and useful in assessing the effect of anti-cancer therapy in pancreatic cancer if comprehensive initial and ongoing training is provided to all people involved, including not only the patients but also the study personnel.