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6. Editorial

Author

Smith, Denis

Published
2018

8. Cooling it

Author

Smith, Denis

Published
2018

20. Atezolizumab plus modified docetaxel, cisplatin, and fluorouracil as first-line treatment for advanced anal cancer (SCARCE C17-02 PRODIGE 60): a randomised, non-comparative, phase 2 study

Author

Kim, Stefano, Ghiringhelli, Francois, de la Fouchardière, Christelle, Evesque, Ludovic, Smith, Denis, Badet, Nicolas, Samalin, Emmanuelle, Lopez-Trabada Ataz, Daniel, Parzy, Aurelie, Desramé, Jérôme, Baba Hamed, Nabil, Buecher, Bruno, Tougeron, David, Bouché, Olivier, Dahan, Laetitia, Chibaudel, Benoist, El Hajbi, Farid, Mineur, Laurent, Dubreuil, Olivier, Ben Abdelghani, Meher, Pecout, Solange, Bibeau, Frederic, Herfs, Michael, Garcia, Marie-Line, Meurisse, Aurelia, Vernerey, Dewi, Taïeb, Julien, and Borg, Christophe

Published
2024
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21. DCF versus doublet chemotherapy as first-line treatment of advanced squamous anal cell carcinoma: a multicenter propensity score-matching study

Author

Kim, Stefano, Vendrely, Véronique, Saint, Angélique, André, Thierry, Vaflard, Pauline, Samalin, Emmanuelle, Pernot, Simon, Bouché, Oliver, Zubir, Mustapha, Desrame, Jérôme, de la Fouchardière, Christelle, Smith, Denis, Ghiringhelli, François, Vienot, Angélique, Jacquin, Marion, Klajer, Elodie, Nguyen, Thierry, François, Éric, Taieb, Julien, Le Malicot, Karine, Vernerey, Dewi, Meurisse, Aurélia, and Borg, Christophe

Published
2023
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22. Hepatic arterial oxaliplatin plus intravenous 5-fluorouracil and cetuximab for first-line treatment of colorectal liver metastases: A multicenter phase II trial

Author

Malka, David, Verret, Benjamin, Faron, Matthieu, Guimbaud, Rosine, Caramella, Caroline, Edeline, Julien, Galais, Marie-Pierre, Bengrine-Lefevre, Leïla, Smith, Denis, Dupont-Bierre, Eric, De Baere, Thierry, Goéré, Diane, Dartigues, Peggy, Lacroix, Ludovic, Boige, Valérie, Gelli, Maximiliano, Pignon, Jean-Pierre, and Ducreux, Michel

Published
2023
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26. SOURCES

Author

Smith, Denis

Published
1988

27. INDEX

Author

Smith, Denis

Published
1988

29. NOTES

Author

Smith, Denis

Published
1988

35. Contents

Author

Smith, Denis

Published
1988

40. Lanreotide as maintenance therapy after first-line treatment in patients with non-resectable duodeno-pancreatic neuroendocrine tumours: An international double-blind, placebo-controlled randomised phase II trial – Prodige 31 REMINET: An FFCD study

Author

Lepage, Côme, Phelip, Jean-Marc, Lievre, Astrid, Le-Malicot, Karine, Dahan, Laetitia, Tougeron, David, Toumpanakis, Christos, Di-Fiore, Frédéric, Lombard-Bohas, Catherine, Borbath, Ivan, Coriat, Romain, Lecomte, Thierry, Guimbaud, Rosine, Petorin, Caroline, Legoux, Jean-Louis, Michel, Pierre, Scoazec, Jean-Yves, Smith, Denis, and Walter, Thomas

Published
2022
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41. FFCD 1709-SIRTCI phase II trial: Selective internal radiation therapy plus Xelox, Bevacizumab and Atezolizumab in liver-dominant metastatic colorectal cancer

Author

Randrian, Violaine, Pernot, Simon, Le Malicot, Karine, Catena, Vittorio, Baumgaertner, Isabelle, Tacher, Vania, Forestier, Julien, Hautefeuille, Vincent, Tabouret-Viaud, Claire, Gagnaire, Alice, Mitry, Emmanuel, Guiu, Boris, Aparicio, Thomas, Smith, Denis, Dhomps, Anthony, Tasu, Jean-Pierre, Perdrisot, Rémy, Edeline, Julien, Capron, Claude, Cheze-Le Rest, Catherine, Emile, Jean-François, Laurent-Puig, Pierre, Bejan-Angoulvant, Theodora, Sokol, Harry, Lepage, Come, Taieb, Julien, and Tougeron, David

Published
2022
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42. Observational Study in a Real-World Setting of Targeted Therapy in the Systemic Treatment of Progressive Unresectable or Metastatic Well-Differentiated Pancreatic Neuroendocrine Tumors (pNETs) in France: OPALINE Study

Author

Smith, Denis, Lepage, Côme, Vicaut, Eric, Dominguez, Sophie, Coriat, Romain, Dubreuil, Olivier, Lecomte, Thierry, Baudin, Eric, Venat Bouvet, Laurence, Samalin, Emmanuelle, Santos, Alexandre, Borie, Odile, Bisot-Locard, Ségolène, Goichot, Bernard, and Lombard-Bohas, Catherine

Published
2022
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43. Pembrolizumab versus chemotherapy for microsatellite instability-high or mismatch repair-deficient metastatic colorectal cancer (KEYNOTE-177): final analysis of a randomised, open-label, phase 3 study

Author

Diaz, Luis A, Jr, Shiu, Kai-Keen, Kim, Tae-Won, Jensen, Benny Vittrup, Jensen, Lars Henrik, Punt, Cornelis, Smith, Denis, Garcia-Carbonero, Rocio, Benavides, Manuel, Gibbs, Peter, de la Fourchardiere, Christelle, Rivera, Fernando, Elez, Elena, Le, Dung T, Yoshino, Takayuki, Zhong, Wen Yan, Fogelman, David, Marinello, Patricia, and Andre, Thierry

Published
2022
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44. SUNLAND: a randomized, double-blinded phase II GERCOR trial of sunitinib versus placebo and lanreotide in patients with advanced progressive midgut neuroendocrine tumors.

Author

Hammel, Pascal, Smith, Denis, Afchain, Pauline, Dominguez-Tinajero, Sophie, Seitz, Jean-François, Lievre, Astrid, Van Cutsem, Eric, Assenat, Eric, Di Fiore, Frédéric, Peeters, Marc, Sobhani, Iradj, Raymond, Eric, Charton, Emilie, Vernerey, Dewi, De Mestier, Louis, and Lombard-Bohas, Catherine

Abstract

Background: Sunitinib, a multitarget tyrosine kinase inhibitor, showed encouraging antitumor activity and manageable toxicity in patients with advanced midgut neuroendocrine tumors (NETs) in earlier results from phase I and II trials. Patients and methods: In this phase II trial, patients with a nonresectable grade 1 or 2 midgut progressive NET and Eastern Cooperative Oncology Group performance status 0–1 were randomly assigned 1:1 to receive 37.5 mg sunitinib or a placebo, combined with 120 mg lanreotide autogel every 28 days. The planned sample size was 104 patients. The primary outcome was investigator-assessed progression-free survival (PFS). Results: The study was stopped early because of insufficient patient recruitment. Between January 2013 and December 2016, 44 patients were enrolled and received sunitinib (n = 22) or placebo (n = 22). The median age was 63.7 years (Q 1– Q 3 range, 56.6–68.1) and 26 patients (59.1%) were male. The main localization was ileum (N = 37, 84.1%) and the majority were grade 2 (n = 25, 56.8%). The median follow-up was 36.7 months (95% confidence interval (CI) 34.6–48.2). The median PFS was 9.84 months (95% CI 6.8–23.3) with sunitinib and 11.47 months (95% CI 5.4–15.3) with placebo (hazard ratio (HR) = 0.80, 95% CI 0.41–1.56, p = 0.51). There was no difference in overall survival between treatment arms (HR = 0.81, (95% CI 0.32–2.01), p = 0.64). The objective response rate was 9.1% with sunitinib and 0.0% with placebo, and 19 patients (86.4%) had stable disease. Thirty-nine patients (88.6%) completed the baseline QLQ-C30 questionnaire. Baseline health-related quality of life level was similar between treatment arms, except for physical and emotional functioning which were higher (p = 0.089) and lower (p = 0.023) in the sunitinib arm, respectively. Trends toward longer time until a definitive deterioration in favor of the sunitinib arm were observed for 10 out of 15 dimensions (HRs < 1), with a significant result for financial difficulties (HR = 0.31, (90% CI 0.10–0.94)). Twenty-seven patients (61.4%) had at least one adverse event grade ⩾3 (sunitinib: 72.7%, placebo: 50.0%), with only one patient grade 4 for hypertension and vomiting. Eleven deaths non-related to treatment occurred (sunitinib arm: n = 5, placebo arm: n = 6). Conclusion: Our study does not provide enough evidence to conclude the role of sunitinib in advanced midgut NETs, primarily due to a lower-than-expected number of enrolled patients. While we cannot entirely rule out the efficacy of sunitinib, lanreotide alone may play a significant role. Trial registration: EudraCT: 2012-001098-94. Plain language summary: SUNLAND: a randomized, double-blind phase II GERCOR trial of sunitinib versus placebo and lanreotide in patients with advanced progressive midgut neuroendocrine tumors Neuroendocrine tumours of the small intestine are a rare condition with a very different prognosis and treatment from the more "classic" tumours (known as intestinal adenocarcinomas). A wide variety of treatments can be proposed, depending on the extent of the disease, the specific characteristics of the tumour (degree of proliferation) and how far it has progressed. Treatments may include surgical removal of tumours, administration of hormones (somatostatin analogues), "conventional" chemotherapy agents (cytotoxics), targeted systemic treatments, embolisation/chemotherapy applied directly to liver metastases, radioactive agents (PPRT), etc. Sunitinib is a drug that prevents the synthesis of vessels by certain tumours, thereby preventing them from feeding and proliferating. We compared this drug with a placebo, in combination with a somatostatin analog named lanreotide (phase II study). The main objectives studied were the rate and duration of tumor control (named progression free survival or PFS, corresponding to the length of time during the treatment of a tumour that a patient lives with the disease but it does not get worse. In a clinical trials, this is one classical way to see how well a new treatment works) and the quality of life parameters. The full recruitment of 104 patients planned for this study performed in 11 French center could not be reached, no doubt because of the rarity of this disease and the existence, at the same time, of therapeutic trials with other treatments. Despite some favourable trends for sunitinib on quality of life, the study was not conclusive, partly due to the use of octreotide in all patients, which may have interfered with the experimental treatment. [ABSTRACT FROM AUTHOR]

Published
2024
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45. Phase III randomized trial comparing systemic versus intra-arterial oxaliplatin, combined with LV5FU2 +/- irinotecan and a targeted therapy, in the first-line treatment of metastatic colorectal cancer restricted to the liver (OSCAR): PRODIGE 49

Author

Pernot, Simon, Pellerin, Olivier, Mineur, Laurent, Monterymard, Carole, Smith, Denis, Lapuyade, Bruno, Gallois, Claire, Khemissa Akouz, Faiza, De Baere, Thierry, Tougeron, David, Thirot-Bidault, Anne, Audemar, Franck, Simon, Mireille, Lecaille, Cedric, Louafi, Sami, Lepage, Come, Ducreux, Michel, and Taieb, Julien

Published
2022
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46. NESC Multicenter Phase II Trial in the Preoperative Treatment of Gastric Adenocarcinoma with Chemotherapy (Docetaxel-Cisplatin-5FU+Lenograstim) Followed by Chemoradiation Based 5FU and Oxaliplatin and Surgery

Author

Mineur, Laurent, primary, Plat, Frederi, additional, Desseigne, Françoise, additional, Deplanque, Gael, additional, Belkacemi, Mohamed, additional, Moureau-Zabotto, Laurence, additional, Beyrne, Carlos D., additional, Jalali, Khadija, additional, Obled, Stéphane, additional, Smith, Denis, additional, Vazquez, Léa, additional, and Boustany, Rania, additional

Published
2024
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49. Health-related quality of life in patients with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer treated with first-line pembrolizumab versus chemotherapy (KEYNOTE-177): an open-label, randomised, phase 3 trial

Author

Andre, Thierry, Amonkar, Mayur, Norquist, Josephine M, Shiu, Kai-Keen, Kim, Tae Won, Jensen, Benny Vittrup, Jensen, Lars Henrik, Punt, Cornelis J A, Smith, Denis, Garcia-Carbonero, Rocio, Sevilla, Isabel, De La Fouchardiere, Christelle, Rivera, Fernando, Elez, Elena, Diaz, Luis A, Jr, Yoshino, Takayuki, Van Cutsem, Eric, Yang, Ping, Farooqui, Mohammed, and Le, Dung T

Published
2021
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