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55. Abstracts

Author

Axon, A. T. R., Donnaym, Debongnej C, Tytgat, G. N. J., Bartelsman, J. F. W. M., René, E., Verdon, R., Rozé, C., Vallot, T., Matheron, S., Leport, C., Marche, C., Van Laethem, Y., Hermans, P., Clumeck, N., Van Laethem, J. L., Bourgeois, N., Gelin, M., Jacobs, F., Rickaert, F., Van De Stadt, J., Van Gossum, A., Vereerstraeten, P., Adler, M., McDonald, G. B., Silverstein, Fred, Berg, N. G., Delmotte, Ph., Petermans, J., Mutsers, A., Degrez Th., de Halleux J., Debongnie J. C., Fiasse R., Mainguet P., Thirapathi, Y., Korwin, J. D. de, Blech, M. F., Rossit, C., Conroy, M. C., Hartemann, P., Burdin, J. C., Schmitt, J., Van Avermaet, S., Debeuckelaere, S., Du Ville, L., Potvin, P., Devis, G., Urbain, D., Jeanmart, J., Lemone, M., Kiromera, A., Van Daele, D., Saikali, S., De Wit, S., Thys, O., Hoang, P., Jewell, D. P., Vandelli, A., Cariani, G., Bonora, G., Lenzi, T., Fontana, G., Wandall, J. H., Alnor-Hansen, D., Hage, E., Garcéa Reinoso C., Saez-Royuela F., Fernandez Guerrero M., Porres Cubero JC., González Campos C., Spiessens, C., Witte, P. de, Geboes, K., Lemli, J., de Baets, M. H., Cook, G. C., Debongne, J. C., Jouret, A., Haot, J., Russo, A., Aprile, G., Magnano, A., Delmée, M., ctors, N., De Vos, R., eboes, K., utgeerts, P., esmet, V., antrappen, G., Motte, S., Dumonceau, J. M., Deviere, J., Baize, M., Thys, J. P., Serruys, E., Cremer, M., De Koster, E, Nyst, JF, Glupczynski, Y, Deprez, C, Deltenre, M, Bechi, P., Dei, R., Amorosi, A., Pantalone, D., Pucciani, F., Napoli, A. Di, Petrino, R., Boero, M., Morgando, A., Piglia, R., Chiandussi, L., Bologna, E., Stroppiana, M., Peyre, S., Rizzi, R., Bangera, M., Sateqna-Buidetti, C., Ramdani, B., Lamy, V., Famerée, D., Cappelli, J., Moisse, R., de Korwin, J. D., Gobert, B., Bene, M. C., Conroy, M. C., Schmitt, J., Burdin, J. C., Faure, G., Benhamou, JP, De Koster, E, Nyst, JF, Deltenre, M, Wyatt, J I, Méqraud, F., Brassens-Rabbé, M. P., Albenque, M., Nejjari, C., Rathbone, B. J., Gasbarrini, G., Pretolani, S., Careddu, N., Cilia, D., Acampora, P., Brocchi, E., Bonvicini, F., Malfertheiner, P., Geboes, K., Ectors, N., Scarpignato, Carmelo, Deltenre M., Glupczynski Y., De Koster E., Nyst JF., Otero J., Dondelinger, R. F., Kurdziel, J. C., Goffette, P., Kurdziel, J. C., Dardenne, A. N., Pringot, J., Dondelinger, R. F., Van Gansbeke, P., Lalmand, B., Grassart, A., Gelin, M., Struyven, J., Valette, PJ, Brandtzaeg, P., Halstensen, T. S., Helgeland, L., Kett, K., Cuvelier, C., Jewell, P. P., van Deventer, Sander J. H., Radema, Sandra A., Tytgat, Guido N. J., de Reuck, M., Potvliege, R., Burette, A., Glupczynski, Y., Deprez, C., Glupczynski, Y., Van Den Borre, C., Goossens, H., Verhas, M., Bourdeaux, L., DeVos, D., Devreker, T., Glupczynski, Y., Goutier, S., Cpttone, C., Disclafani, G., Genova, G., Romeo, S., Bazan, P., Garcéa Reinoso C, Saez-Royuela F, González Campos C, Struelens, M. J., Nonhoff, C., Maas, A., Rost, F., Serruys, E., Adler, M., Delmée, M., Gay, G., and Delmotte, S.

Published
1990
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62. Exploratory analysis based on tumor location of REACHIN, a randomized, double-blinded, placebo-controlled phase 2 trial of regorafenib after failure of gemcitabine and platinum-based chemotherapy for advanced/metastatic biliary tract tumors

Author

Demols, A., primary, Borbath, I., additional, Van den Eynde, M., additional, Houbiers, G., additional, Peeters, M., additional, Marechal, R., additional, Delaunoit, T., additional, Goeminne, J., additional, Laurent, S., additional, Holbrechts, S., additional, Paesmans, M., additional, and Van Laethem, J., additional

Published
2019
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71. Effect of oral magnesium supplementation on the kinetics of magnesium wasting induced by EGFR targeted antibody therapy for colorectal carcinoma (MAGNET trial)

Author

Piessevaux, H., primary, Demey, W., additional, Bols, A., additional, Janssens, J., additional, Polus, M., additional, Rezaei Kalantari, H., additional, Laurent, S., additional, Demols, A., additional, Humblet, Y., additional, Deboever, G., additional, Kargar Samani, K., additional, Ferrante, M., additional, Monsaert, E., additional, Rondou, T., additional, van Laethem, J.-L., additional, and Tejpar, S., additional

Published
2018
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72. Final results of a phase II quality of life (QOL) randomized, cross-over (CO) study with gemcitabine (Gem) and nab-paclitaxel (n-P) in locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC): QOLINPAC

Author

Chiritescu, G., primary, Dumon, K., additional, Verslype, C., additional, Houbiers, G., additional, Peeters, M., additional, Janssens, J., additional, van Daele, D., additional, Laurent, S., additional, Arts, J., additional, Hendrickx, K., additional, Borbath, I., additional, Ferrante, M., additional, Bastin, F.M., additional, Goeminne, J.-C., additional, van Laethem, J.-L., additional, Vanderstraeten, E., additional, Decaestecker, J., additional, van Vaerenbergh, W., additional, Delhougne, B., additional, and Van Cutsem, E., additional

Published
2018
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74. Gemcitabine with nab-paclitaxel in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC): A quality of life randomized cross-over study (QOLINPAC)

Author

Chiritescu, G., primary, Dumon, K., additional, Verslype, C., additional, Prenen, H., additional, Houbiers, G., additional, Peeters, M., additional, Janssens, J., additional, Van Daele, D., additional, Laurent, S., additional, Arts, J., additional, Hendrickx, K., additional, Borbath, I., additional, Ferrante, M., additional, Bastin, F., additional, Goeminne, J., additional, Van Laethem, J., additional, Vanderstraeten, E., additional, Decaestecker, J., additional, Van Vaerenbergh, W., additional, Delhougne, B., additional, and Van Cutsem, E., additional

Published
2018
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75. A two arm phase II study of FOLFIRI in combination with standard or escalating dose of cetuximab as first line treatment for metastatic colorectal cancer: Everest 2 final results

Author

Chiritescu, G., primary, Dumon, K., additional, Mercadé, T. Macarulla, additional, Lang, I., additional, Vivas, C. Santos, additional, Papai, Z., additional, Janssens, J., additional, Hendrickx, K., additional, Pracht, M., additional, Van den Eynde, M., additional, Taïeb, J., additional, Moons, V., additional, Geboes, K., additional, Van Laethem, J., additional, Greil, R., additional, Cervantes, A., additional, Vergauwe, P., additional, Ferrante, M., additional, Vanderstraeten, E., additional, Fridrik, M., additional, Wöll, E., additional, Limón, M., additional, Rivera, F., additional, Sagaert, X., additional, Tejpar, S., additional, and Van Cutsem, E., additional

Published
2018
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76. Safety and antitumor activity of pembrolizumab in patients with advanced microsatellite instability–high (MSI-H) colorectal cancer: KEYNOTE-164

Author

Le, D., primary, Kavan, P., additional, Kim, T., additional, Burge, M., additional, Van Cutsem, E., additional, Hara, H., additional, Boland, P., additional, Van Laethem, J., additional, Geva, R., additional, Taniguchi, H., additional, Crocenzi, T., additional, Sharma, M., additional, Atreya, C., additional, Diaz, L., additional, Liang, L., additional, Marinello, P., additional, Dai, T., additional, and O’Neill, B., additional

Published
2018
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77. A two arm phase II study of FOLFIRI in combination with standard or escalating dose of cetuximab as first line treatment for metastatic colorectal cancer: Everest 2 final results

Author

UCL - SSS/IREC/MIRO - Pôle d'imagerie moléculaire, radiothérapie et oncologie, UCL - (SLuc) Unité d'oncologie médicale, Chiritescu, G, Dumon, K, Mercadé, T Macarulla, Lang, I, Vivas, C Santos, Papai, Z, Janssens, J, Hendrickx, K, Pracht, M, Van den Eynde, Marc, Taïeb, J, Moons, V, Geboes, K, Van Laethem, J, Greil, R, Cervantes, A, Vergauwe, P, Ferrante, M, Vanderstraeten, E, Fridrik, M, Wöll, E, Limón, M, Rivera, F, Sagaert, X, Tejpar, S, Van Cutsem, E, ESMO 20th World Congress on Gastrointestinal Cancer, UCL - SSS/IREC/MIRO - Pôle d'imagerie moléculaire, radiothérapie et oncologie, UCL - (SLuc) Unité d'oncologie médicale, Chiritescu, G, Dumon, K, Mercadé, T Macarulla, Lang, I, Vivas, C Santos, Papai, Z, Janssens, J, Hendrickx, K, Pracht, M, Van den Eynde, Marc, Taïeb, J, Moons, V, Geboes, K, Van Laethem, J, Greil, R, Cervantes, A, Vergauwe, P, Ferrante, M, Vanderstraeten, E, Fridrik, M, Wöll, E, Limón, M, Rivera, F, Sagaert, X, Tejpar, S, Van Cutsem, E, and ESMO 20th World Congress on Gastrointestinal Cancer

Published
2018

80. Prognostic value of methylator phenotype in stage III colon cancer treated with oxaliplatin-based adjuvant chemotherapy

Author

Gallois, C., primary, Taieb, J., additional, Le Corre, D., additional, Le Malicot, K., additional, Tabernero, J., additional, Mulot, C., additional, Seitz, J.-F., additional, Aparicio, T., additional, Folprecht, G., additional, Lepage, C., additional, Mini, E., additional, Van Laethem, J.-L., additional, Emile, J.F., additional, and Laurent-Puig, P., additional

Published
2017
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81. Positron emission tomography response evaluation from a randomized phase III trial of weekly nab-paclitaxel plus gemcitabine versus gemcitabine alone for patients with metastatic adenocarcinoma of the pancreas

Author

Ramanathan, R. K., Goldstein, D., Korn, R. L., Arena, F. P, Moore, M., Siena, S., Teixeira, L., Tabernero, Josep, Van Laethem, J.-L., Liu, H., McGovern, D., Lu, B., Von Hoff, D. D., and Universitat Autònoma de Barcelona

Subjects
0301 basic medicine, Oncology, Male, positron emission tomography, endocrine system diseases, pancreatic cancer, metabolic response, Deoxycytidine, nab-paclitaxel, chemistry.chemical_compound, 0302 clinical medicine, Antineoplastic Combined Chemotherapy Protocols, Neoplasm Metastasis, Aged, 80 and over, medicine.diagnostic_test, Hematology, Middle Aged, medicine.anatomical_structure, Treatment Outcome, Paclitaxel, Positron emission tomography, Response Evaluation Criteria in Solid Tumors, 030220 oncology & carcinogenesis, Adenocarcinoma, Female, Pancreas, medicine.drug, Adult, medicine.medical_specialty, Nab-paclitaxel, Disease-Free Survival, Drug Administration Schedule, Nab -paclitaxel, 03 medical and health sciences, Internal medicine, Pancreatic cancer, Albumins, Gastrointestinal Tumors, medicine, Humans, Letters to the Editor, Aged, business.industry, Metabolic response, Original Articles, medicine.disease, Gemcitabine, Cancérologie, Pancreatic Neoplasms, 030104 developmental biology, chemistry, Positron-Emission Tomography, business, Hématologie
Abstract

In the phase III MPACT trial, nab-paclitaxel plus gemcitabine (nab-P + Gem) demonstrated superior efficacyversus Gem alone for patients with metastatic pancreatic cancer. We sought to examine the feasibility of positron emissiontomography (PET) and to compare metabolic response rates and associated correlations with efficacy in the MPACT trial.Patients and methods: Patients with previously untreated metastatic adenocarcinoma of the pancreas were randomized1:1 to receive nab-P + Gem or Gem alone. Treatment continued until disease progression by RECIST or unacceptable toxicity.Results: PET scans were carried out on the first 257 patients enrolled at PET-equipped centers (PET cohort). Most patients(252 of 257) had ≥ 2 PET-avid lesions, and median maximum standardized uptake values at baseline were 4.6 and 4.5 in thenab-P + Gem and Gem-alone arms, respectively. In a pooled treatment arm analysis, a metabolic response by PET (best responseat any time during study) was associated with longer overall survival (OS) (median 11.3 versus 6.9 months; HR, 0.56;P < 0.001). Efficacy results within each treatment arm appeared better for patients with a metabolic response. The metabolicresponse rate (best response and week 8 response) was higher for nab-P + Gem (best response: 72% versus 53%,P = 0.002; week 8: 67% versus 51%; P = 0.014). Efficacy in the PET cohort was greater for nab-P + Gem versus Gem alone,including for OS (median 10.5 versus 8.4 months; hazard ratio [HR], 0.71; P = 0.009) and ORR by RECIST (31% versus 11%;P < 0.001).Conclusion: Pancreatic lesions were PET avid at baseline, and the rate of metabolic response was significantly higher fornab-P + Gem versus Gem alone at week 8 and for best response during study. Having a metabolic response was associatedwith longer survival, and more patients experienced a metabolic response than a RECIST-defined response.ClinicalTrials.gov: NCT00844649., SCOPUS: ar.j, info:eu-repo/semantics/published

Published
2015

83. 3rd St. Gallen EORTC Gastrointestinal Cancer Conference: Consensus recommendations on controversial issues in the primary treatment of pancreatic cancer

Author

Lutz, M.P. (Manfred P.), Zalcberg, J. (John), Ducreux, M. (Michel), Aust, G. (Gabriela), Bruno, M.J. (Marco), Buchler, M.W. (M.), Delpero, J.-R. (Jean-Robert), Gloor, B. (Beat), Glynne-Jones, R., Hartwig, W. (Werner), Huguet, F. (Florence), Laurent-Puig, P. (Pierre), Lordick, F. (Florian), Maisonneuve, P. (Patrick), Mayerle, J. (Julia), Martignoni, M. (Marc), Neoptolemos, J.P. (John), Rhim, A.D. (Andrew D.), Schmied, B.M. (Bruno M.), Seufferlein, T. (Thomas), Werner, J. (Jens), van Laethem, J.-L. (Jean-Luc), Otto, F. (Florian), Lutz, M.P. (Manfred P.), Zalcberg, J. (John), Ducreux, M. (Michel), Aust, G. (Gabriela), Bruno, M.J. (Marco), Buchler, M.W. (M.), Delpero, J.-R. (Jean-Robert), Gloor, B. (Beat), Glynne-Jones, R., Hartwig, W. (Werner), Huguet, F. (Florence), Laurent-Puig, P. (Pierre), Lordick, F. (Florian), Maisonneuve, P. (Patrick), Mayerle, J. (Julia), Martignoni, M. (Marc), Neoptolemos, J.P. (John), Rhim, A.D. (Andrew D.), Schmied, B.M. (Bruno M.), Seufferlein, T. (Thomas), Werner, J. (Jens), van Laethem, J.-L. (Jean-Luc), and Otto, F. (Florian)

Abstract

The primary treatment of pancreatic cancer was the topic of the 3rd St. Gallen Conference 2016. A multidisciplinary panel reviewed the current evidence and discussed controversial issues in a moderated consensus session. Here we report on the key expert recommendations. It was generally accepted that radical surgical resection followed by adjuvant chemotherapy offers the only evidence-based treatment with a chance for cure. Initial staging should classify

Published
2017
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84. The management of pancreatic cancer. Current expert opinion and recommendations derived from the 8th World Congress on Gastrointestinal Cancer, Barcelona, 2006

Author

Verslype, C., Van Cutsem, E., Dicato, M., Cascinu, S., Cunningham, D., Diaz-Rubio, E., Glimelius, B., Haller, D., Haustermans, K., Heinemann, V., Hoff, P., Johnston, PG, Kerr, D., Labianca, R., Louvet, C., Minsky, B., Moore, M., Nordlinger, B., Pedrazzoli, S., Roth, A., Rothenberg, M., Rougier, P., Schmoll, H-J, Tabernero, J., Tempero, M., van de Velde, C., Van Laethem, J-L, Zalcberg, J., Verslype, C., Van Cutsem, E., Dicato, M., Cascinu, S., Cunningham, D., Diaz-Rubio, E., Glimelius, B., Haller, D., Haustermans, K., Heinemann, V., Hoff, P., Johnston, PG, Kerr, D., Labianca, R., Louvet, C., Minsky, B., Moore, M., Nordlinger, B., Pedrazzoli, S., Roth, A., Rothenberg, M., Rougier, P., Schmoll, H-J, Tabernero, J., Tempero, M., van de Velde, C., Van Laethem, J-L, and Zalcberg, J.

Abstract

This article summarizes the expert discussion on the management of pancreatic cancer, which took place during the 8th World Congress on Gastrointestinal Cancer in June 2006 in Barcelona. A multidisciplinary approach to a patient with pancreatic cancer is essential, in order to guarantee an optimal staging, surgery, selection of the appropriate (neo-)adjuvant strategy and chemotherapeutic choice management. Moreover, optimal symptomatic management requires a dedicated team of health care professionals. Quality control of surgery and pathology is especially important in this disease with a high locoregional failure rate. There is now solid evidence in favour of chemotherapy in both the adjuvant and palliative setting, and gemcitabine combined with erlotinib, capecitabine or platinum compounds seems to be slightly more active than gemcitabine alone in advanced pancreatic cancer. There is a place for chemoradiotherapy in selected patients with locally advanced disease, while the role in the adjuvant setting remains controversial. Those involved in the care for patients with pancreatic cancer should be encouraged to participate in well-designed clinical trials, in order to increase the evidence-based knowledge and to make further progress

Published
2017

85. Prospective validation of a lymphocyte infiltration prognostic test in stage III colon cancer patients treated with adjuvant FOLFOX

Author

Emile, J, Julie, C, Le Malicot, K, Lepage, C, Tabernero, J, Mini, E, Folprecht, G, Van Laethem, J, Dimet, S, Boulagnon-Rombi, C, Allard, M, Penault-Llorca, F, Bennouna, J, Laurent-Puig, P, Taieb, J, Bidoli, P, Emile, JF, Van Laethem, JL, Allard, MA, Emile, J, Julie, C, Le Malicot, K, Lepage, C, Tabernero, J, Mini, E, Folprecht, G, Van Laethem, J, Dimet, S, Boulagnon-Rombi, C, Allard, M, Penault-Llorca, F, Bennouna, J, Laurent-Puig, P, Taieb, J, Bidoli, P, Emile, JF, Van Laethem, JL, and Allard, MA

Abstract

Background The prognostic value of lymphocyte infiltration (LI) of colorectal carcinoma (CC) has been demonstrated by several groups. However, no validated test is currently available for clinical practice. We previously described an automated and reproducible method for testing LI and aimed to validate it for clinical use. Patients and methods According to National Institutes of Health criteria, we designed a prospective validation of this biomarker in patients included in the PETACC8 phase III study. Primary objective was to compare percentage of patients alive and without recurrence at 2 years in patients with high versus low LI (#NCT02364024). Associations of LI with patient recurrence and survival were analysed, and multivariable models were adjusted for treatment and relevant factors. Automated testing of LI was performed on virtual slides without access to clinical data. Results Among the 1220 CC patients enrolled, LI was high, low and not evaluable in 241 (19.8%), 790 (64.8%) and 189 (15.5%), respectively. Primary objective was met with a 2-year recurrence rate of 14.4% versus 21.1% in patients with high and low LI, respectively (p = 0.02). Patients with high LI also had better disease free survival (DFS) and overall survival (OS). Tumour stage, grade, RAS status and BRAF status were with LI the only prognostic markers in multivariable analysis for OS. Subgroup analyses revealed that high LI had better DFS and OS in mismatch repair (MMR) proficient patients, and in patients without RAS mutation, but not in MMR deficient and RAS mutated patients. Conclusion Although this is the first validation with high level of evidence (IIB) of the prognostic value of a LI test in colon cancers, it still needs to be confirmed in independent series of colon cancer patients. © 2017 Elsevier Ltd

Published
2017

86. The management of metastatic pancreatic cancer: expert discussion and recommendations from the 14th ESMO/World Congress on Gastrointestinal Cancer, Barcelona, 2012

Author

Verslype, C., Van Cutsem, E., Dicato, M., Arber, N., Berlin, J. D., Büchler, M. W., Cervantes, A., Ciardiello, F., Ducreux, M., Douillard, J. Y., Grothey, A., Haller, D., Haustermans, K., Heinemann, V., Hidalgo, M., Labianca, R., Li, J., Marshall, J. L., Nordlinger, B., O'Reilly, E. M., Roth, A., Rougier, P., Ryan, D., Schmiegel, W., Seufferlein, T., Schmoll, H. J., Sobrero, A., Tabernero, J., Tempero, M., Van Laethem, J. L., Ychou, M., Zalcberg, J., Verslype, C., Van Cutsem, E., Dicato, M., Arber, N., Berlin, J. D., Büchler, M. W., Cervantes, A., Ciardiello, F., Ducreux, M., Douillard, J. Y., Grothey, A., Haller, D., Haustermans, K., Heinemann, V., Hidalgo, M., Labianca, R., Li, J., Marshall, J. L., Nordlinger, B., O'Reilly, E. M., Roth, A., Rougier, P., Ryan, D., Schmiegel, W., Seufferlein, T., Schmoll, H. J., Sobrero, A., Tabernero, J., Tempero, M., Van Laethem, J. L., Ychou, M., and Zalcberg, J.

Published
2017

90. ERBB2 alterations a new prognostic biomarker in stage III colon cancer from a FOLFOX based adjuvant trial (PETACC8)

Author

Laurent-Puig, P., primary, Balogoun, R., additional, Cayre, A., additional, Le Malicot, K., additional, Tabernero, J., additional, Mini, E., additional, Folprecht, G., additional, van Laethem, J.-L., additional, Thaler, J., additional, Petersen, L. Nørgård, additional, Sanchez, E., additional, Bridgewater, J., additional, Ellis, S., additional, Locher, C., additional, Lagorce, C., additional, Ramé, J.-F., additional, Lepage, C., additional, Penault-Llorca, F., additional, and Taieb, J., additional

Published
2016
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91. Prognostic value of the neutrophil-to-lymphocyte ratio in advanced hepatocellular carcinoma: An exploratory analysis from the ARQ197-215 study

Author

Personeni, N., primary, Giordano, L., additional, Abbadessa, G., additional, Porta, C., additional, Borbath, I., additional, Daniele, B., additional, Salvagni, S., additional, van Laethem, J.-L., additional, Van Vlierberghe, H., additional, Trojan, J., additional, Weiss, A., additional, Gasbarrini, A., additional, Shuster, D., additional, De Toni, E.N., additional, Lencioni, M., additional, Miles, S., additional, Lamar, M.E., additional, Schwartz, B., additional, Santoro, A., additional, and Rimassa, L., additional

Published
2016
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92. Adjuvant FOLFOX+ cetuximab vs FOLFOX in full RAS and BRAF wild type stage III colon cancer patients: Results from the PETACC8 trial

Author

Taieb, J., primary, Le Malicot, K., additional, Balogoum, R., additional, Tabernero, J., additional, Mini, E., additional, Folprecht, G., additional, van Laethem, J.-L., additional, Emile, J.-F., additional, Mulot, C., additional, Fratté, S., additional, Levaché, C.-B., additional, Saban-Roche, L., additional, Thaler, J., additional, Petersen, L. Nørgård, additional, Sanchez, E., additional, Bridgewater, J., additional, Perkins, G., additional, Lepage, C., additional, Zaanan, A., additional, and Laurent-Puig, P., additional

Published
2016
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94. 740P - Final results of a phase II quality of life (QOL) randomized, cross-over (CO) study with gemcitabine (Gem) and nab-paclitaxel (n-P) in locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC): QOLINPAC

Author

Chiritescu, G., Dumon, K., Verslype, C., Houbiers, G., Peeters, M., Janssens, J., van Daele, D., Laurent, S., Arts, J., Hendrickx, K., Borbath, I., Ferrante, M., Bastin, F.M., Goeminne, J.-C., van Laethem, J.-L., Vanderstraeten, E., Decaestecker, J., van Vaerenbergh, W., Delhougne, B., and Van Cutsem, E.

Published
2018
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97. O-015 - A two arm phase II study of FOLFIRI in combination with standard or escalating dose of cetuximab as first line treatment for metastatic colorectal cancer: Everest 2 final results

Author

Chiritescu, G., Dumon, K., Mercadé, T. Macarulla, Lang, I., Vivas, C. Santos, Papai, Z., Janssens, J., Hendrickx, K., Pracht, M., Van den Eynde, M., Taïeb, J., Moons, V., Geboes, K., Van Laethem, J., Greil, R., Cervantes, A., Vergauwe, P., Ferrante, M., Vanderstraeten, E., Fridrik, M., Wöll, E., Limón, M., Rivera, F., Sagaert, X., Tejpar, S., and Van Cutsem, E.

Published
2018
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98. O-003 - Gemcitabine with nab-paclitaxel in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC): A quality of life randomized cross-over study (QOLINPAC)

Author

Chiritescu, G., Dumon, K., Verslype, C., Prenen, H., Houbiers, G., Peeters, M., Janssens, J., Van Daele, D., Laurent, S., Arts, J., Hendrickx, K., Borbath, I., Ferrante, M., Bastin, F., Goeminne, J., Van Laethem, J., Vanderstraeten, E., Decaestecker, J., Van Vaerenbergh, W., Delhougne, B., and Van Cutsem, E.

Published
2018
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99. Nab-paclitaxel plus gemcitabine for metastatic pancreatic cancer: Long-term survival from a phase III trial

Author

Goldstein, D., El-Maraghi, R. H., Hammel, P., Heinemann, V., Kunzmann, V., Sastre, J., Scheithauer, W., Siena, S., Tabernero, J., Teixeira, L., Tortora, Giampaolo, Van Laethem, J. -L., Young, R., Penenberg, D. N., Lu, B., Romano, A., Von Hoff, D. D., Tortora G. (ORCID:0000-0002-1378-4962), Goldstein, D., El-Maraghi, R. H., Hammel, P., Heinemann, V., Kunzmann, V., Sastre, J., Scheithauer, W., Siena, S., Tabernero, J., Teixeira, L., Tortora, Giampaolo, Van Laethem, J. -L., Young, R., Penenberg, D. N., Lu, B., Romano, A., Von Hoff, D. D., and Tortora G. (ORCID:0000-0002-1378-4962)

Abstract

Background: Positive findings from the phase III MPACT trial led to the regulatory approval of nab-paclitaxel plus gemcitabine as a treatment option for patients with metastatic pancreatic cancer. This report is an update of overall survival (OS) based on longer follow-up. Methods: Patients (n = 861) with metastatic pancreatic cancer and a Karnofsky performance status of 70 or greater were randomly assigned one to one to receive nab-paclitaxel + gemcitabine or gemcitabine alone. Efficacy data for this post hoc analysis were collected through May 9, 2013. Exploratory analyses of carbohydrate antigen 19-9 (CA19-9) and neutrophil-to-lymphocyte ratio (NLR) were conducted. The primary efficacy endpoint was OS, which was analyzed for all randomly assigned patients by the Kaplan-Meier method. All statistical tests were two-sided. Results: The median OS was statistically significantly longer for nab-paclitaxel plus gemcitabine vs gemcitabine alone (8.7 vs 6.6 months, hazard ratio [HR] = 0.72, 95% confidence interval [CI] = 0.62 to 0.83, P <. 001). Long-term (>three-year) survivors were identified in the nab-paclitaxel plus gemcitabine arm only (4%). In pooled treatment arm analyses, higher CA19-9 level and NLR at baseline were statistically significantly associated with worse OS. There appeared to be a treatment effect for OS favoring nab-paclitaxel plus gemcitabine over gemcitabine alone in poor-prognosis subgroups defined by these factors (HR = 0.612, P <. 001 for CA19-9 level ≥ median and HR = 0.81, P =. 079 for NLR > 5). Conclusions: These data confirm and extend the primary report of OS, supporting the superior efficacy of nab-paclitaxel plus gemcitabine over gemcitabine alone. Subgroup analyses support the relevance of CA 19-9 and NLR as prognostic markers in metastatic pancreatic cancer.

Published
2015

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