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1. Managing cancer patients during the COVID-19 pandemic: an ESMO multidisciplinary expert consensus

Author

Addeo, A., Albiges, L., Ascierto, P.A., Banerjee, S., Barlesi, F., Caldas, C., Cardoso, F., Cervantes, A., Chaberny, I.F., Cherny, N.I., Choueiri, T.K., Chua, M.L.K., Criscitiello, C., Curigliano, G., de Azambuja, E., De Ruysscher, D., de Vries, E., Dent, R., Douillard, J.Y., D’Ugo, D., Dziadziuszko, R., Faivre-Finn, C., Felip, E., Garassino, M., Garrido, P., Girard, N., Glynne-Jones, R., Golfinopoulos, V., Haanen, J., Hamilton, E., Jänne, P.A., Jordan, K., Kanesvaran, R., Kim, S.B., Liebert, U.G., Lordick, F., Machiels, J.P., Michielin, O., Mok, T.S.K., Morgan, G., Obermannova, R., Park, K., Passaro, A., Pentheroudakis, G., Peters, S., Reck, M., Salazar Soler, R., Scotté, F., Senan, S., Sessa, C., Smyth, E., Soo, R., Soria, J.C., Spicer, J., Strasser, F., Tabernero, J., Tan, D.S.W., Trapani, D., Van Cutsem, E., van Halteren, H., van Schil, P.E., Veronesi, G., Yang, J., and Garassino, M.C.

Published
2020
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2. Design and conduct of early clinical studies of immunotherapy agent combinations: recommendations from the task force on Methodology for the Development of Innovative Cancer Therapies

Author

Atkins, M., Banerji, U., Bates, S., Bogaerts, J., Calvo, E., De Braud, F., Douillard, J.Y., Giaccone, G., Keegan, P., Kumar, R., LoRusso, P., Marabelle, A., Perrone, A., Pignatti, F., Plummer, R., Seymour, L., Schwartz, G., Shalabi, A., Shapiro, G., Siu, L.L., Smoragiewicz, M., Tabernero, J., Therasse, P., and Yang, A.

Published
2018
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5. 2nd ESMO Consensus Conference on Lung Cancer: early-stage non-small-cell lung cancer consensus on diagnosis, treatment and follow-up

Author

Stahel, Rolf, Felip, Enriqueta, Peters, Solange, Kerr, Keith, Besse, Benjamin, Vansteenkiste, Johan, Eberhardt, Wilfried, Edelman, Martin, Mok, Tony, O'Byrne, Ken, Novello, Silvia, Bubendorf, Lukas, Marchetti, Antonio, Baas, Paul, Reck, Martin, Syrigos, Konstantinos, Paz-Ares, Luis, Smit, Egbert F., Meldgaard, Peter, Adjei, Alex, Nicolson, Marianne, Crinò, Lucio, Van Schil, Paul, Senan, Suresh, Faivre-Finn, Corinne, Rocco, Gaetano, Veronesi, Giulia, Douillard, Jean-Yves, Lim, Eric, Dooms, Christophe, Weder, Walter, De Ruysscher, Dirk, Le Pechoux, Cecile, De Leyn, Paul, Westeel, Virginie, Vansteenkiste, J., Crinò, L., Dooms, C., Douillard, J.Y., Faivre-Finn, C., Lim, E., Rocco, G., Senan, S., Van Schil, P., Veronesi, G., Stahel, R., Peters, S., and Felip, E.

Published
2014
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8. ESMO Consensus Guidelines for management of patients with colon and rectal cancer. A personalized approach to clinical decision making

Author

Schmoll, H.J., Van Cutsem, E., Stein, A., Valentini, V., Glimelius, B., Haustermans, K., Nordlinger, B., van de Velde, C.J., Balmana, J., Regula, J., Nagtegaal, I.D., Beets-Tan, R.G., Arnold, D., Ciardiello, F., Hoff, P., Kerr, D., Köhne, C.H., Labianca, R., Price, T., Scheithauer, W., Sobrero, A., Tabernero, J., Aderka, D., Barroso, S., Bodoky, G., Douillard, J.Y., El Ghazaly, H., Gallardo, J., Garin, A., Glynne-Jones, R., Jordan, K., Meshcheryakov, A., Papamichail, D., Pfeiffer, P., Souglakos, I., Turhal, S., and Cervantes, A.

Published
2012
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10. Managing cancer patients during the COVID-19 pandemic: an ESMO multidisciplinary expert consensus

Author

Curigliano, G., Banerjee, S., Cervantes, A., Garassino, M.C., Garrido, P., Girard, N., Haanen, J., Jordan, K., Lordick, F., Machiels, J.P., Michielin, O., Peters, S., Tabernero, J., Douillard, J.Y., Pentheroudakis, G., Panel members, Addeo, A., Albiges, L., Ascierto, P.A., Banerjee, S., Barlesi, F., Caldas, C., Cardoso, F., Cervantes, A., Chaberny, I.F., Cherny, N.I., Choueiri, T.K., Chua, MLK, Criscitiello, C., Curigliano, G., de Azambuja, E., De Ruysscher, D., de Vries, E., Dent, R., Douillard, J.Y., D'Ugo, D., Dziadziuszko, R., Faivre-Finn, C., Felip, E., Garassino, M., Garrido, P., Girard, N., Glynne-Jones, R., Golfinopoulos, V., Haanen, J., Hamilton, E., Jänne, P.A., Jordan, K., Kanesvaran, R., Kim, S.B., Liebert, U.G., Lordick, F., Machiels, J.P., Michielin, O., Mok, TSK, Morgan, G., Obermannova, R., Park, K., Passaro, A., Pentheroudakis, G., Peters, S., Reck, M., Salazar Soler, R., Scotté, F., Senan, S., Sessa, C., Smyth, E., Soo, R., Soria, J.C., Spicer, J., Strasser, F., Tabernero, J., Tan, DSW, Trapani, D., Van Cutsem, E., van Halteren, H., van Schil, P.E., Veronesi, G., and Yang, J.

Subjects
Betacoronavirus, Consensus, Coronavirus Infections/epidemiology, Coronavirus Infections/immunology, Coronavirus Infections/therapy, Disease Management, Europe/epidemiology, Granulocyte Colony-Stimulating Factor/pharmacology, Granulocyte Colony-Stimulating Factor/therapeutic use, Humans, Medical Oncology/methods, Medical Oncology/standards, Neoplasms/epidemiology, Neoplasms/immunology, Neoplasms/therapy, Pandemics/prevention & control, Pneumonia, Viral/epidemiology, Pneumonia, Viral/immunology, Pneumonia, Viral/therapy, Real-Time Polymerase Chain Reaction/methods, Real-Time Polymerase Chain Reaction/standards, Societies, Medical/standards, T-Lymphocytes, Cytotoxic/drug effects, T-Lymphocytes, Cytotoxic/immunology, Telemedicine/methods, Telemedicine/standards, education
Abstract

We established an international consortium to review and discuss relevant clinical evidence in order to develop expert consensus statements related to cancer management during the severe acute respiratory syndrome coronavirus 2-related disease (COVID-19) pandemic. The steering committee prepared 10 working packages addressing significant clinical questions from diagnosis to surgery. During a virtual consensus meeting of 62 global experts and one patient advocate, led by the European Society for Medical Oncology, statements were discussed, amended and voted upon. When consensus could not be reached, the panel revised statements until a consensus was reached. Overall, the expert panel agreed on 28 consensus statements that can be used to overcome many of the clinical and technical areas of uncertainty ranging from diagnosis to therapeutic planning and treatment during the COVID-19 pandemic.

Published
2020

11. Managing cancer patients during the COVID-19 pandemic: an ESMO multidisciplinary expert consensus

Author

Curigliano, G., primary, Banerjee, S., additional, Cervantes, A., additional, Garassino, M.C., additional, Garrido, P., additional, Girard, N., additional, Haanen, J., additional, Jordan, K., additional, Lordick, F., additional, Machiels, J.P., additional, Michielin, O., additional, Peters, S., additional, Tabernero, J., additional, Douillard, J.Y., additional, Pentheroudakis, G., additional, Addeo, A., additional, Albiges, L., additional, Ascierto, P.A., additional, Barlesi, F., additional, Caldas, C., additional, Cardoso, F., additional, Chaberny, I.F., additional, Cherny, N.I., additional, Choueiri, T.K., additional, Chua, M.L.K., additional, Criscitiello, C., additional, Curigliano, G., additional, de Azambuja, E., additional, De Ruysscher, D., additional, de Vries, E., additional, Dent, R., additional, D’Ugo, D., additional, Dziadziuszko, R., additional, Faivre-Finn, C., additional, Felip, E., additional, Garassino, M., additional, Glynne-Jones, R., additional, Golfinopoulos, V., additional, Hamilton, E., additional, Jänne, P.A., additional, Kanesvaran, R., additional, Kim, S.B., additional, Liebert, U.G., additional, Mok, T.S.K., additional, Morgan, G., additional, Obermannova, R., additional, Park, K., additional, Passaro, A., additional, Reck, M., additional, Salazar Soler, R., additional, Scotté, F., additional, Senan, S., additional, Sessa, C., additional, Smyth, E., additional, Soo, R., additional, Soria, J.C., additional, Spicer, J., additional, Strasser, F., additional, Tan, D.S.W., additional, Trapani, D., additional, Van Cutsem, E., additional, van Halteren, H., additional, van Schil, P.E., additional, Veronesi, G., additional, and Yang, J., additional

Published
2020
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13. ESMO recommendations on microsatellite instability testing for immunotherapy in cancer, and its relationship with PD-1/PD-L1 expression and tumour mutational burden: a systematic review-based approach

Author

Luchini, C., Bibeau, F., Ligtenberg, M.J.L., Singh, N., Nottegar, A., Bosse, T., Miller, R., Riaz, N., Douillard, J.Y., Andre, F., Scarpa, A., Luchini, C., Bibeau, F., Ligtenberg, M.J.L., Singh, N., Nottegar, A., Bosse, T., Miller, R., Riaz, N., Douillard, J.Y., Andre, F., and Scarpa, A.

Abstract

Contains fulltext : 215605.pdf (publisher's version ) (Closed access), BACKGROUND: Cancers with a defective DNA mismatch repair (dMMR) system contain thousands of mutations most frequently located in monomorphic microsatellites and are thereby defined as having microsatellite instability (MSI). Therefore, MSI is a marker of dMMR. MSI/dMMR can be identified using immunohistochemistry to detect loss of MMR proteins and/or molecular tests to show microsatellite alterations. Together with tumour mutational burden (TMB) and PD-1/PD-L1 expression, it plays a role as a predictive biomarker for immunotherapy. METHODS: To define best practices to implement the detection of dMMR tumours in clinical practice, the ESMO Translational Research and Precision Medicine Working Group launched a collaborative project, based on a systematic review-approach, to generate consensus recommendations on the: (i) definitions related to the concept of MSI/dMMR; (ii) methods of MSI/dMMR testing and (iii) relationships between MSI, TMB and PD-1/PD-L1 expression. RESULTS: The MSI-related definitions, for which a consensus frame-work was used to establish definitions, included: 'microsatellites', 'MSI', 'DNA mismatch repair' and 'features of MSI tumour'. This consensus also provides recommendations on MSI testing; immunohistochemistry for the mismatch repair proteins MLH1, MSH2, MSH6 and PMS2 represents the first action to assess MSI/dMMR (consensus with strong agreement); the second method of MSI/dMMR testing is represented by polymerase chain reaction (PCR)-based assessment of microsatellite alterations using five microsatellite markers including at least BAT-25 and BAT-26 (strong agreement). Next-generation sequencing, coupling MSI and TMB analysis, may represent a decisive tool for selecting patients for immunotherapy, for common or rare cancers not belonging to the spectrum of Lynch syndrome (very strong agreement). The relationships between MSI, TMB and PD-1/PD-L1 expression are complex, and differ according to tumour types. CONCLUSIONS: This ESMO initiative is

Published
2019

14. Design and conduct of early clinical studies of immunotherapy agent combinations: recommendations from the task force on Methodology for the Development of Innovative Cancer Therapies

Author

Smoragiewicz, M., primary, Bogaerts, J., additional, Calvo, E., additional, Marabelle, A., additional, Perrone, A., additional, Seymour, L., additional, Shalabi, A., additional, Siu, L.L., additional, Tabernero, J., additional, Giaccone, G., additional, Atkins, M., additional, Banerji, U., additional, Bates, S., additional, De Braud, F., additional, Douillard, J.Y., additional, Keegan, P., additional, Kumar, R., additional, LoRusso, P., additional, Pignatti, F., additional, Plummer, R., additional, Schwartz, G., additional, Shapiro, G., additional, Smoragiewicz, M., additional, Therasse, P., additional, and Yang, A., additional

Published
2018
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15. Career opportunities and benefits for young oncologists in the European Society for Medical Oncology (ESMO)

Author

Morgan, G., Lambertini, M., Kourie, H.R., Amaral, T., Argiles, G., Banerjee, S., Cardone, C., Corral, J., De Mattos-Arruda, L., Öztürk, A., Petrova, M., Poulsen, L., Strijbos, M., Tyulyandina, A., Vidra, R., Califano, R., de Azambuja, E., Garrido Lopez, P., Guarneri, V., Reck, M., Moiseyenko, V., Martinelli, E., Douillard, J.Y., Stahel, R., Voest, E., Arnold, D., Cardoso, F., Casali, P., Cervantes, A., Eggermont, A.M., Eniu, A., Jassem, J., Pentheroudakis, G., Peters, S., McGregor, K., Rauh, S., Zielinski, C.C., Ciardiello, F., Tabernero, J., and Preusser, M.

Abstract

The European Society for Medical Oncology (ESMO) is one of the leading societies of oncology professionals in the world. Approximately 30% of the 13 000 ESMO members are below the age of 40 and thus meet the society's definition of young oncologists (YOs). ESMO has identified the training and development of YOs as a priority and has therefore established a comprehensive career development programme. This includes a leadership development programme to help identify and develop the future leaders in oncology. Well-trained and highly motivated future generations of multidisciplinary oncologists are essential to ensure the optimal evolution of the field of oncology with the ultimate goal of providing the best possible care to patients with cancer. ESMO's career development portfolio is managed and continuously optimised by several dedicated committees composed of ESMO officers and is directly supervised by the ESMO Executive Board and the ESMO President. It offers unique resources for YOs at all stages of training and includes a broad variety of fellowship opportunities, educational courses, scientific meetings, publications and resources. In this article, we provide an overview of the activities and career development opportunities provided by ESMO to the next generation of oncologists.

Published
2016

16. How health-related quality of life assessment should be used in advanced colorectal cancer clinical trials

Author

Bonnetain, F., primary, Borg, C., additional, Adams, R.R., additional, Ajani, J.A., additional, Benson, A., additional, Bleiberg, H., additional, Chibaudel, B., additional, Diaz-Rubio, E., additional, Douillard, J.Y., additional, Fuchs, C.S., additional, Giantonio, B.J., additional, Goldberg, R., additional, Heinemann, V., additional, Koopman, M., additional, Labianca, R., additional, Larsen, A.K., additional, Maughan, T., additional, Mitchell, E., additional, Peeters, M., additional, Punt, C.J.A., additional, Schmoll, H.J., additional, Tournigand, C., additional, and de Gramont, A., additional

Published
2017
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17. Clinical validation of a prognostic tool in a population of outpatients treated for incurable cancer undergoing anticancer therapy: PRONOPALL study

Author

Bourgeois, H., primary, Grudé, F., additional, Solal-Céligny, P., additional, Dupuis, O., additional, Voog, E., additional, Ganem, G., additional, Denis, F., additional, Zinger, M., additional, Juhel-Voog, L., additional, Lafond, C., additional, Maillart, P., additional, Capitain, O., additional, Delva, R., additional, Soulié, P., additional, Abadie-Lacourtoisie, S., additional, Guérin-Meyer, V., additional, Morin-Meschin, M.E., additional, Commer, J.M., additional, Gangler, A., additional, d’Aillières, B., additional, Zannetti, A., additional, Bourbouloux, E., additional, Berton-Rigault, D., additional, Lebouvier-Sadot, S., additional, Kaassis, M., additional, Baudon, J., additional, Lam, Y.H., additional, Bizieux, A., additional, Marcq, M., additional, Edeline, J., additional, Le Du, F., additional, Lefeuvre, C., additional, Deguiral, P., additional, Delecroix, V., additional, Blot, E., additional, Egreteau, J., additional, Goudier, M.J., additional, Lamy, R., additional, Ferec, M., additional, Artignan, X., additional, Corbinais, S., additional, Morel, H., additional, Hardy-Bessard, A.C., additional, Alleaume, C., additional, Naudeix, E., additional, Cojocarasu, O., additional, Metges, J.P., additional, Riché, C., additional, Gamelin, E., additional, Déniel-Lagadec, D., additional, Marhuenda, F., additional, Ingrand, P., additional, and Douillard, J.Y., additional

Published
2017
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19. ESMO consensus guidelines for the management of patients with metastatic colorectal cancer

Author

Cutsem, E. Van, Cervantes, A., Adam, R., Sobrero, A., Krieken, J.H.J.M. van, Aderka, D., Aranda Aguilar, E., Bardelli, A., Benson, A., Bodoky, G., Ciardiello, F., D'Hoore, A., Diaz-Rubio, E., Douillard, J.Y., Ducreux, M., Falcone, A., Grothey, A., Gruenberger, T., Haustermans, K., Heinemann, V., Hoff, P., Kohne, C.H., Labianca, R., Laurent-Puig, P., Ma, B., Maughan, T., Muro, K., Normanno, N., Osterlund, P., Oyen, W.J.G., Papamichael, D., Pentheroudakis, G., Pfeiffer, P., Price, T.J., Punt, C., Ricke, J., Roth, A., Salazar, R., Scheithauer, W., Schmoll, H.J., Tabernero, J., Taieb, J., Tejpar, S., Wasan, H., Yoshino, T., Zaanan, A., Arnold, D., Cutsem, E. Van, Cervantes, A., Adam, R., Sobrero, A., Krieken, J.H.J.M. van, Aderka, D., Aranda Aguilar, E., Bardelli, A., Benson, A., Bodoky, G., Ciardiello, F., D'Hoore, A., Diaz-Rubio, E., Douillard, J.Y., Ducreux, M., Falcone, A., Grothey, A., Gruenberger, T., Haustermans, K., Heinemann, V., Hoff, P., Kohne, C.H., Labianca, R., Laurent-Puig, P., Ma, B., Maughan, T., Muro, K., Normanno, N., Osterlund, P., Oyen, W.J.G., Papamichael, D., Pentheroudakis, G., Pfeiffer, P., Price, T.J., Punt, C., Ricke, J., Roth, A., Salazar, R., Scheithauer, W., Schmoll, H.J., Tabernero, J., Taieb, J., Tejpar, S., Wasan, H., Yoshino, T., Zaanan, A., and Arnold, D.

Abstract

Contains fulltext : 165965.pdf (publisher's version ) (Closed access), Colorectal cancer (CRC) is one of the most common malignancies in Western countries. Over the last 20 years, and the last decade in particular, the clinical outcome for patients with metastatic CRC (mCRC) has improved greatly due not only to an increase in the number of patients being referred for and undergoing surgical resection of their localised metastatic disease but also to a more strategic approach to the delivery of systemic therapy and an expansion in the use of ablative techniques. This reflects the increase in the number of patients that are being managed within a multidisciplinary team environment and specialist cancer centres, and the emergence over the same time period not only of improved imaging techniques but also prognostic and predictive molecular markers. Treatment decisions for patients with mCRC must be evidence-based. Thus, these ESMO consensus guidelines have been developed based on the current available evidence to provide a series of evidence-based recommendations to assist in the treatment and management of patients with mCRC in this rapidly evolving treatment setting.

Published
2016

20. Early-stage non-small-cell lung cancer consensus on diagnosis, treatment and follow-up : 2nd ESMO Consensus Conference on Lung Cancer

Author

Vansteenkiste, J., Crinò, L., Dooms, C., Douillard, J.Y., Faivre-Finn, C., Lim, E., Rocco, G., Senan, S., Van Schil, P., Veronesi, G., Stahel, R., Peters, S., Felip, E., Panel Members, Stahel, R., Felip, E., Peters, S., Kerr, K., Besse, B., Vansteenkiste, J., Eberhardt, W., Edelman, M., Mok, T., O'Byrne, K., Novello, S., Bubendorf, L., Marchetti, A., Baas, P., Reck, M., Syrigos, K., Paz-Ares, L., Smit, EF., Meldgaard, P., Adjei, A., Nicolson, M., Crinò, L., Van Schil, P., Senan, S., Faivre-Finn, C., Rocco, G., Veronesi, G., Douillard, JY., Lim, E., Dooms, C., Weder, W., De Ruysscher, D., Le Pechoux, C., De Leyn, P., and Westeel, V.

Abstract

To complement the existing treatment guidelines for all tumour types, ESMO organises consensus conferences to focus on specific issues in each type of tumour. The 2nd ESMO Consensus Conference on Lung Cancer was held on 11-12 May 2013 in Lugano. A total of 35 experts met to address several questions on non-small-cell lung cancer (NSCLC) in each of four areas: pathology and molecular biomarkers, first-line/second and further lines in advanced disease, early-stage disease and locally advanced disease. For each question, recommendations were made including reference to the grade of recommendation and level of evidence. This consensus paper focuses on early-stage disease.

Published
2014

21. Phase III study of regorafenib versus placebo as maintenance therapy in RAS wild type metastatic colorectal cancer (RAVELLO trial)

Author

Martinelli, E., primary, Troiani, T., additional, Venturini, F., additional, Cervantes Rupierez, A., additional, Douillard, J.Y., additional, Falcone, A., additional, Folprecht, G., additional, Kohne, C., additional, Taieb, J., additional, Tabernero, J., additional, Cardone, C., additional, Sforza, V., additional, Martini, G., additional, Napolitano, S., additional, Capuano, A., additional, Auricchio, F., additional, and Ciardiello, F., additional

Published
2015
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24. 2nd ESMO Consensus Conference on Lung Cancer: early-stage non-small-cell lung cancer consensus on diagnosis, treatment and follow-up

Author

Vansteenkiste, J., primary, Crinò, L., additional, Dooms, C., additional, Douillard, J.Y., additional, Faivre-Finn, C., additional, Lim, E., additional, Rocco, G., additional, Senan, S., additional, Van Schil, P., additional, Veronesi, G., additional, Stahel, R., additional, Peters, S., additional, Felip, E., additional, Stahel, Rolf, additional, Felip, Enriqueta, additional, Peters, Solange, additional, Kerr, Keith, additional, Besse, Benjamin, additional, Vansteenkiste, Johan, additional, Eberhardt, Wilfried, additional, Edelman, Martin, additional, Mok, Tony, additional, O'Byrne, Ken, additional, Novello, Silvia, additional, Bubendorf, Lukas, additional, Marchetti, Antonio, additional, Baas, Paul, additional, Reck, Martin, additional, Syrigos, Konstantinos, additional, Paz-Ares, Luis, additional, Smit, Egbert F., additional, Meldgaard, Peter, additional, Adjei, Alex, additional, Nicolson, Marianne, additional, Crinò, Lucio, additional, Van Schil, Paul, additional, Senan, Suresh, additional, Faivre-Finn, Corinne, additional, Rocco, Gaetano, additional, Veronesi, Giulia, additional, Douillard, Jean-Yves, additional, Lim, Eric, additional, Dooms, Christophe, additional, Weder, Walter, additional, De Ruysscher, Dirk, additional, Le Pechoux, Cecile, additional, De Leyn, Paul, additional, and Westeel, Virginie, additional

Published
2014
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26. Gefitinib versus docetaxel in previously treated non-small-cell lung cancer (INTEREST): a randomised phase III trial

Author

Kim, E.S., Hirsh, V., Mok, T., Socinski, M.A., Gervais, R., Wu, Y.L., Li, L.Y., Watkins, C.L., Sellers, M.V., Lowe, E.S., Sun, Y., Liao, M.L., Reck, M., Armour, A.A., Shepherd, F.A., Lippman, S.M., Douillard, J.Y., Østerlind, Kell, Kim, E.S., Hirsh, V., Mok, T., Socinski, M.A., Gervais, R., Wu, Y.L., Li, L.Y., Watkins, C.L., Sellers, M.V., Lowe, E.S., Sun, Y., Liao, M.L., Reck, M., Armour, A.A., Shepherd, F.A., Lippman, S.M., Douillard, J.Y., and Østerlind, Kell

Abstract

BACKGROUND: Two phase II trials in patients with previously-treated advanced non-small-cell lung cancer suggested that gefitinib was efficacious and less toxic than was chemotherapy. We compared gefitinib with docetaxel in patients with locally advanced or metastatic non-small-cell lung cancer who had been pretreated with platinum-based chemotherapy. METHODS: We undertook an open-label phase III study with recruitment between March 1, 2004, and Feb 17, 2006, at 149 centres in 24 countries. 1466 patients with pretreated (>/=one platinum-based regimen) advanced non-small-cell lung cancer were randomly assigned with dynamic balancing to receive gefitinib (250 mg per day orally; n=733) or docetaxel (75 mg/m(2) intravenously in 1-h infusion every 3 weeks; n=733). The primary objective was to compare overall survival between the groups with co-primary analyses to assess non-inferiority in the overall per-protocol population and superiority in patients with high epidermal growth factor receptor (EGFR)-gene-copy number in the intention-to-treat population. This study is registered with ClinicalTrials.gov, number NCT00076388. FINDINGS: 1433 patients were analysed per protocol (723 in gefitinib group and 710 in docetaxel group). Non-inferiority of gefitinib compared with docetaxel was confirmed for overall survival (593 vs 576 events; hazard ratio [HR] 1.020, 96% CI 0.905-1.150, meeting the predefined non-inferiority criterion; median survival 7.6 vs 8.0 months). Superiority of gefitinib in patients with high EGFR-gene-copy number (85 vs 89 patients) was not proven (72 vs 71 events; HR 1.09, 95% CI 0.78-1.51; p=0.62; median survival 8.4 vs 7.5 months). In the gefitinib group, the most common adverse events were rash or acne (360 [49%] vs 73 [10%]) and diarrhoea (255 [35%] vs 177 [25%]); whereas in the docetaxel group, neutropenia (35 [5%] vs 514 [74%]), asthenic disorders (182 [25%] vs 334 [47%]), and alopecia (23 [3%] vs 254 [36%]) were most common. INTERPRETATION: INTERE

Published
2008

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

Author

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

Published
2013
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29. Endpoints in adjuvant treatment trials: a systematic review of the literature in colon cancer and proposed definitions for future trials.

Author

Punt, C.J.A., Buyse, M., Kohne, C.H., Hohenberger, P., Labianca, R., Schmoll, H.J., Pahlman, L., Sobrero, A., Douillard, J.Y., Punt, C.J.A., Buyse, M., Kohne, C.H., Hohenberger, P., Labianca, R., Schmoll, H.J., Pahlman, L., Sobrero, A., and Douillard, J.Y.

Abstract

Item does not contain fulltext, Disease-free survival is increasingly being used as the primary endpoint of most trials testing adjuvant treatments in cancer. Other frequently used endpoints include overall survival, recurrence-free survival, and time to recurrence. These endpoints are often defined differently in different trials in the same type of cancer, leading to a lack of comparability among trials. In this Commentary, we used adjuvant studies in colon cancer as a model to address this issue. In a systematic review of the literature, we identified 52 studies of adjuvant treatment in colon cancer published in 1997-2006 that used eight other endpoints in addition to overall survival. Both the definition of these endpoints and the starting point for measuring time to the events that constituted these endpoints varied widely. A panel of experts on clinical research on colorectal cancer then reached consensus on the definition of each endpoint. Disease-free survival--defined as the time from randomization to any event, irrespective of cause--was considered to be the most informative endpoint for assessing the effect of treatment and therefore the most relevant to clinical practice. The proposed guidelines may add to the quality and cross-comparability of future studies of adjuvant treatments for cancer.

Published
2007

31. Edrecolomab alone or in combination with fluorouracil and folinic acid in the adjuvant treatment of stage III colon cancer: a randomised study.

Author

Punt, C.J.A., Nagy, A., Douillard, J.Y., Figer, A., Skovsgaard, T., Monson, J., Barone, C., Fountzilas, G., Riess, H., Moylan, E., Jones, D., Dethling, J., Colman, J., Coward, L., MacGregor, S., Punt, C.J.A., Nagy, A., Douillard, J.Y., Figer, A., Skovsgaard, T., Monson, J., Barone, C., Fountzilas, G., Riess, H., Moylan, E., Jones, D., Dethling, J., Colman, J., Coward, L., and MacGregor, S.

Abstract

Item does not contain fulltext, BACKGROUND: Edrecolomab is a murine monoclonal antibody to the cell-surface glycoprotein 17-1A, which is expressed on epithelial tissues and on various carcinomas. Preliminary data suggested that it might be of use in the adjuvant treatment of patients with resected stage III colon cancer. We did a randomised trial in 27 countries to determine the effect of adding edrecolomab to the combination of fluorouracil and folinic acid in these patients. METHODS: After surgery, 2761 patients were randomly assigned edrecolomab plus fluorouracil-folinic acid (combination therapy [n=912]); fluorouracil-folinic acid alone (chemotherapy [n=927]); or edrecolomab alone (edrecolomab monotherapy [n=922]). Patients were assessed for survival and disease recurrence after surgery. The primary endpoint tested the hypothesis that combination therapy improved overall survival relative to chemotherapy. The key secondary endpoint was to test whether edrecolomab monotherapy was non-inferior to chemotherapy in terms of disease-free survival. Analysis was by intention to treat. FINDINGS: Median follow-up time was 26 months (IQR 20-36). 3-year overall survival on combination therapy was no different from that on chemotherapy (74.7% vs 76.1%, hazard ratio 0.94 [95% CI 0.76-1.15], p=0.53). Disease-free survival was significantly lower on edrecolomab monotherapy than on chemotherapy (53.0% vs 65.5%, 0.62 [0.53-0.73], p<0.0001). Hypersensitivity reactions occurred in 452 (25%) patients receiving edrecolomab, causing treatment discontinuation in 71 (4%). The addition of edrecolomab to chemotherapy did not increase neutropenia, diarrhoea, or mucositis. INTERPRETATION: The addition of edrecolomab to fluorouracil and folinic acid in the adjuvant treatment of resected stage III colon cancer does not improve overall or disease-free survival, and edrecolomab monotherapy is associated with significantly shorter overall and disease-free survival than fluorouracil and folinic acid and is therefore an inferior

Published
2002

34. Hepatic arterial infusion using pirarubicin combined with systemic chemotherapy: a phase II study in patients with nonresectable liver metastases from colorectal cancer

Author

Fallik, D., primary, Ychou, M., additional, Jacob, J., additional, Colin, P., additional, Seitz, J.F., additional, Baulieux, J., additional, Adenis, A., additional, Douillard, J.Y., additional, Couzigou, P., additional, Mahjoubi, R., additional, Ducreux, M., additional, Mahjoubi, M., additional, and Rougier, P., additional

Published
2003
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