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

Author

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

Published
2017
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4. Evaluation in usual practice of the bevacizumab-FOLFIRI combination for the first-line treatment of patients with unresectable metastatic colorectal cancer treated in 2006: focus on resected patients and oncogeriatrics: AVASTIN OUEST cohort of the Observatory of Cancer of the Brittany and Pays de la Loire Areas (Observatoire dédié au Cancer Bretagne / Pays de la Loire)

Author

Metges, J. P., Lebot, M. A., Faroux, R., Riaud, F., Gamelin, E., Capitain, O., Guérin Meyer, V., Leynia, P., Douillard, J. Y., Senellart, H., Rochard, S., Louvigné, C., Campion, L., Dupuis, O., Grollier, C., Achour, N. A., Person, B., Raoul, J. L., Boucher, E., Bertrand, C., Ramée, J. F., Guivarch, L., Etienne, P. L., Roussel, S., Desclos, H., Julien, M. N., Labarre, M. I., Klein, V., Bessard, R., Stampfli, C., Royet, F., Faycal, J., Gouva, S., Le Bihan, G., Couturier, M., Gourlaouen, A., Bertholom, C., Porneuf, M., Jobard, E., Peguet, E., Grasset, D., Bouret, J. F., Bicheler, V., Ulvoas, A., Miglianico, L., Chouzenoux, C., Deguiral, P., Derenne, L., Martin, D., Langlet, P. Michel, Bodin, C., Rossi, V., Barré, S., Cojocarasu, O., Naveau Ploux, C., Vidal, A. M., Cumin, I., Egreteau, J., Brouard, A., Matysiak Budnik, T., Thomaré, P., Le Bris Michel, A. S., Piriou, G., Largeau, R., Elhannani, C., Crespeau, E., Suberville, F., Bourgeois, H., Riche, C., Lagadec, D. Déniel, Marhuenda, F., and Grudé, F.

Published
2014
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6. Safety and tolerability of subcutaneous trastuzumab for the adjuvant treatment of human epidermal growth factor receptor 2-positive early breast cancer: SafeHer phase III study's primary analysis of 2573 patients

Author

Gligorov, J, Ataseven, B, Verrill, M, de Laurentiis, M, Jung, K, Azim, H, Al-Sakaff, N, Lauer, S, Shing, M, Pivot, X, Koroveshi, D, Bouzid, K, Casalnuovo, M, Cascallar, D, Korbenfeld, E, Bastick, P, Beith, J, Colosimo, M, Friedlander, M, Ganju, V, Green, M, Patterson, K, Redfern, A, Richardson, G, Ceric, T, Gordana, K, Beato, C, Ferrari, M, Hegg, R, Helena, V, Ismael, G, Lessa, A, Mano, M, Morelle, A, Nogueira, J, Timcheva, K, Tomova, A, Tsakova, M, Zlatareva-Petrova, A, Asselah, J, Assi, H, Brezden-Masley, C, Chia, S, Freedman, O, Harb, M, Joy, A, Kulkarni, S, Prady, C, Gaete, A, Matamala, L, Torres, R, Yanez, E, Franco, S, Urrego, M, Gugic, D, Vrbanec, D, Melichar, B, Prausova, J, Vyzula, R, Pilarte, R, Leon, M, Munoz, R, Ramos, G, Azeem, H, Aziz, A, El Zawahry, H, Osegueda, F, Alexandre, J, Artignan, X, Barletta, H, Beguier, E, Berdah, J, Marty, C, Bollet, M, Bourgeois, H, Bressac, C, Burki, F, Campone, M, Coeffic, D, Cojocarasu, O, Dagada, C, Dalenc, F, Del Piano, F, Desauw, C, Desmoulins, I, Dohollou, N, Egreteau, J, Ferrero, J, Foa, C, Garidi, R, Gasnault, L, Guardiola, E, Hamizi, S, Jarcau, R, Jacquin, J, Jaubert, D, Jolimoy, G, Mineur, H, Largillier, R, Leduc, B, Martin, P, Melis, A, Monge, J, Moullet, I, Mousseau, M, Nguyen, S, Orfeuvre, H, Petit, T, Priou, F, Bach, I, Simon, H, Stefani, L, Uwer, L, Youssef, A, Aktas, B, von der Assen, A, Augustin, D, Balser, C, Bauer, L, Bechtner, C, Beyer, G, Brucker, C, Buckner, U, Busch, S, Christensen, B, Deryal, M, Farrokh, A, Faust, E, Friedrichs, K, Graf, H, Griesshammer, M, Grischke, E, Hanle, C, Heider, A, Henschen, S, Hesse, T, Jackisch, C, Kisro, J, Kohler, A, Kuemmel, S, Lampe, D, Lantzsch, T, Latos, K, Lex, B, Liedtke, C, Luedders, D, Maintz, C, Muller, V, Overkamp, F, Park-Simon, T, Paul, M, Prechtl, A, Ringsdorf, U, Runnebaum, I, Ruth, S, Salat, C, Scheffen, I, Schilling, J, Schmatloch, S, Schmidt, M, Schneeweiss, A, Schrader, I, Seipelt, G, Simon, E, Stefek, A, Stickeler, E, Thill, M, Tio, J, Tuczek, A, Warm, M, Weigel, M, Wischnik, A, Wojcinski, S, Ziegler-Lohr, K, Aravantinos, G, Ardavanis, A, Fountzilas, G, Gogas, H, Kakolyris, S, Mavroudis, D, Papadimitriou, C, Papandreou, C, Papazisis, K, Castro, H, Hernandez-Monroy, C, Ngan, R, Yeo, W, Bittner, N, Boer, K, Csejtei, A, Horvath, Z, Kocsis, J, Mangel, L, Mezei, K, Nagy, Z, Szanto, J, Atmakusuma, D, Fadjari, H, Kurnianda, D, Prayogo, N, Tanggo, E, Coate, L, Hennessy, B, Kelly, C, Martin, M, Nasim, S, O'Connor, M, Aieta, M, Allegrini, G, Amadori, D, Bidoli, P, Biti, G, Bordonaro, R, Bottini, A, Carterni, G, Cavanna, L, Cazzaniga, M, Cognetti, F, Contu, A, Cruciani, G, Donadio, M, Falcone, A, Farci, D, Forcignano, R, Frassoldati, A, Gaion, F, Gamucci, T, Giotta, F, Livi, L, Lorusso, V, Maiello, E, Marchetti, P, Mariani, G, Mion, M, Moscetti, L, Musolino, A, Pazzola, A, Pedrazzoli, P, Pigi, A, de Placido, S, Caremoli, E, Santoro, A, Tienghi, A, Ahn, J, Lee, K, Lee, S, Seo, J, Sohn, J, Cesas, A, Juozaityte, E, Cheah, N, Chong, F, Devi, B, Phua, V, Teoh, D, Ching, L, Yusof, M, Corona, J, Dominguez, A, Mendoza, R, Hernandez, C, Ramiro, A, Santos, J, Espinosa, P, Villarreal Garza, C, Errihani, H, Bakker, S, van den Berkmortel, F, Blaisse, R, Huinink, D, van den Bosch, J, Braun, J, Dercksen, M, Droogendijk, H, Erdkamp, F, Haringhuizen, A, de Jongh, F, Kok, T, Los, M, Madretsma, S, Terwogt, J, van der Padt, A, van Rossum-Schornagel, Q, Smilde, T, de Valk, B, van der Velden, A, van Warmerdam, L, van de Wouw, A, North, R, Kersten, C, Mjaaland, I, Wist, E, Aziz, Z, Masood, N, Rashid, K, Shah, M, Alcedo, J, Aleman, D, Neciosup, S, Reategui, R, Valdiviezo, N, Vera, L, Fernando, G, Roque, F, Strebel, H, Krzemieniecki, K, Litwiniuk, M, Mruk, A, Pienkowski, T, Sawrycki, P, Slomian, G, Tomczak, P, Afonso, N, Cardoso, F, Damasceno, M, Nave, M, Badulescu, F, Ciule, L, Curescu, S, Eniu, A, Filip, D, Grecea, D, Jinga, D, Lungulescu, D, Oprean, C, Stanculeanu, D, Turdean, M, Dvornichenko, V, Emelyanov, S, Lichinitser, M, Manikhas, A, Sakaeva, D, Shirinkin, V, Stroyakovskiy, D, Abulkhair, O, Zekri, J, Filipovic, S, Kovcin, V, Nedovic, J, Pesic, J, Vasovic, S, Ng, R, Bystricky, B, Leskova, J, Mardiak, J, Misurova, E, Wagnerova, M, Takac, I, Demetriou, G, Dreosti, L, Govender, P, Jordaan, J, Veersamy, P, Romero, J, Lopez, N, Arias, C, Chacon, J, Aramburo, A, Morales, L, Garcia, M, Estevez, L, Garcia-Palomo Perez, A, Garcia Saenz, J, Garcia Sanchis, L, Cubells, L, Cortijo, L, Santiago, S, De Aranguiz, B, Manas, J, Gallego, P, Cussac, A, Ferrandiz, C, Garrido, M, Alvarez, P, Vega, J, Del Prado, P, Janez, N, Murillo, S, Rosales, A, Jaso, L, Fernandez, I, Martorell, A, Carrion, R, Simon, S, Alcibar, A, Lorenzo, J, Garcia, V, Asensio, T, Maicas, M, Villanueva Silva, M, Killander, F, Svensson, J, Fehr, M, Hauser, N, Muller, A, Pagani, O, Passmann-Kegel, H, Popescu, R, Rabaglio, M, Rauch, D, Schlatter, C, Zaman, K, Chang, T, Huang, C, Wang, H, Yu, J, Bandidwattanawong, C, Maneechavakajorn, J, Seetalarom, K, Dejthevaporn, T, Somwangprasert, A, Vongsaisuwon, M, Akbulut, H, Altundag, K, Arican, A, Bozcuk, H, Eralp, Y, Idris, M, Isikdogan, A, Senol, C, Sevinc, A, Uygun, K, Yucel, E, Yucel, I, Yumuk, F, Shparyk, Y, Voitko, N, Jaloudi, M, Adams, J, Agrawal, R, Ahmed, S, Alhasso, A, Allerton, R, Anwar, S, Archer, C, Ashford, R, Barraclough, L, Bertelli, G, Bishop, J, Branson, T, Butt, M, Chakrabarti, A, Chakraborti, P, Churn, M, Crowley, C, Davis, R, Dhadda, A, Eldeeb, H, Fraser, J, Hall, J, Hickish, T, Hogg, M, Howe, T, Joffe, J, Kelleher, M, Kelly, S, Kendall, A, Kristeleit, H, Lumsden, G, Macmillan, C, Macpherson, I, Malik, Z, Mithal, N, Neal, A, Panwar, U, Proctor, A, Proctor, S, Raj, S, Rehman, S, Sandri, I, Scatchard, K, Sherwin, E, Sims, E, Singer, J, Smith, S, Tahir, S, Taylor, W, Tsalic, M, Wardley, A, Waters, S, Wheatley, D, Wright, K, Yuille, F, Alonso, I, Artagaveytia, N, Rodriguez, R, Arbona, E, Garcia, Y, Lion, L, Marcano, D, Van Thuan, T, Gligorov J., Ataseven B., Verrill M., de Laurentiis M., Jung K. H., Azim H. A., Al-Sakaff N., Lauer S., Shing M., Pivot X., Koroveshi D., Bouzid K., Casalnuovo M., Cascallar D., Korbenfeld E. P., Bastick P., Beith J., Colosimo M., Friedlander M., Ganju V., Green M., Patterson K., Redfern A., Richardson G., Ceric T., Gordana K., Beato C. A., Ferrari M., Hegg R., Helena V., Ismael G. F., Lessa A. E., Mano M., Morelle A., Nogueira J. A., Timcheva K., Tomova A., Tsakova M., Zlatareva-Petrova A., Asselah J., Assi H., Brezden-Masley C., Chia S., Freedman O., Harb M., Joy A. A., Kulkarni S., Prady C., Gaete A. A. A., Matamala L., Torres R., Yanez E., Franco S., Urrego M., Gugic D., Vrbanec D., Melichar B., Prausova J., Vyzula R., Pilarte R. G., Leon M. I., Munoz R., Ramos G., Azeem H. A., Aziz A. A., El Zawahry H., Osegueda F. R., Alexandre J., Artignan X., Barletta H., Beguier E., Berdah J. -F., Marty C. B., Bollet M., Bourgeois H., Bressac C., Burki F., Campone M., Coeffic D., Cojocarasu O. Z., Dagada C., Dalenc F., Del Piano F., Desauw C., Desmoulins I., Dohollou N., Egreteau J., Ferrero J. -M., Foa C., Garidi R., Gasnault L., Guardiola E., Hamizi S., Jarcau R., Jacquin J. -P., Jaubert D., Jolimoy G., Mineur H. L., Largillier R., Leduc B., Martin P., Melis A., Monge J., Moullet I., Mousseau M., Nguyen S., Orfeuvre H., Petit T., Priou F., Bach I. S., Simon H., Stefani L., Uwer L., Youssef A., Aktas B., von der Assen A., Augustin D., Balser C., Bauer L. -E., Bechtner C., Beyer G., Brucker C., Buckner U., Busch S., Christensen B., Deryal M., Farrokh A., Faust E., Friedrichs K., Graf H., Griesshammer M., Grischke E. -M., Hanle C., Heider A., Henschen S., Hesse T., Jackisch C., Kisro J., Kohler A., Kuemmel S., Lampe D., Lantzsch T., Latos K., Lex B., Liedtke C., Luedders D., Maintz C., Muller V., Overkamp F., Park-Simon T. -W., Paul M., Prechtl A., Ringsdorf U., Runnebaum I., Ruth S., Salat C., Scheffen I., Schilling J., Schmatloch S., Schmidt M., Schneeweiss A., Schrader I., Seipelt G., Simon E., Stefek A., Stickeler E., Thill M., Tio J., Tuczek A., Warm M., Weigel M., Wischnik A., Wojcinski S., Ziegler-Lohr K., Aravantinos G., Ardavanis A., Fountzilas G., Gogas H., Kakolyris S., Mavroudis D., Papadimitriou C., Papandreou C., Papazisis K., Castro H., Hernandez-Monroy C. E., Ngan R., Yeo W., Bittner N., Boer K., Csejtei A., Horvath Z., Kocsis J., Mangel L. C., Mezei K., Nagy Z., Szanto J., Atmakusuma D., Fadjari H., Kurnianda D., Prayogo N., Tanggo E. H., Coate L., Hennessy B., Kelly C., Martin M., Nasim S., O'Connor M., Aieta M., Allegrini G., Amadori D., Bidoli P., Biti G., Bordonaro R., Bottini A., Carterni G., Cavanna L., Cazzaniga M., Cognetti F., Contu A., Cruciani G., Donadio M., Falcone A., Farci D., Forcignano R. C., Frassoldati A., Gaion F., Gamucci T., Giotta F., Livi L., Lorusso V., Maiello E., Marchetti P., Mariani G., Mion M., Moscetti L., Musolino A., Pazzola A., Pedrazzoli P., Pigi A., de Placido S., Caremoli E. R., Santoro A., Tienghi A., Ahn J. -S., Lee K. S., Lee S. H., Seo J. H., Sohn J. -H., Cesas A., Juozaityte E., Cheah N. L. C., Chong F. L. T., Devi B. C. R., Phua V., Teoh D., Ching L. W., Yusof M., Corona J., Dominguez A., Mendoza R. L. G., Hernandez C. A., Ramiro A. J., Santos J. M., Espinosa P. M., Villarreal Garza C. M., Errihani H., Bakker S., van den Berkmortel F., Blaisse R. J. B., Huinink D. T. B., van den Bosch J., Braun J. J., Dercksen M. W., Droogendijk H., Erdkamp F., Haringhuizen A., de Jongh F. E., Kok T. C., Los M., Madretsma S., Terwogt J. M. M., van der Padt A., van Rossum-Schornagel Q. C., Smilde T. J., de Valk B., van der Velden A., van Warmerdam L., van de Wouw A. J., North R., Kersten C., Mjaaland I., Wist E., Aziz Z., Masood N., Rashid K., Shah M., Alcedo J. C., Aleman D., Neciosup S., Reategui R., Valdiviezo N., Vera L., Fernando G., Roque F., Strebel H. M., Krzemieniecki K., Litwiniuk M., Mruk A., Pienkowski T., Sawrycki P., Slomian G., Tomczak P., Afonso N., Cardoso F., Damasceno M., Nave M., Badulescu F., Ciule L., Curescu S., Eniu A., Filip D., Grecea D., Jinga D. -C., Lungulescu D., Oprean C. M., Stanculeanu D. L., Turdean M., Dvornichenko V., Emelyanov S., Lichinitser M., Manikhas A., Sakaeva D., Shirinkin V., Stroyakovskiy D., Abulkhair O., Zekri J., Filipovic S., Kovcin V., Nedovic J., Pesic J., Vasovic S., Ng R., Bystricky B., Leskova J., Mardiak J., Misurova E., Wagnerova M., Takac I., Demetriou G. S., Dreosti L., Govender P., Jordaan J. P., Veersamy P., Romero J. L. A., Lopez N. B., Arias C. C., Chacon J., Aramburo A. F., Morales L. A. F., Garcia M., Estevez L. G., Garcia-Palomo Perez A., Garcia Saenz J. A., Garcia Sanchis L., Cubells L. G., Cortijo L. G., Santiago S. G., De Aranguiz B. H. F., Manas J. J. I., Gallego P. J., Cussac A. L., Ferrandiz C. L., Garrido M. L., Alvarez P. L., Vega J. M. L., Del Prado P. M., Janez N. M., Murillo S. M., Rosales A. M., Jaso L. M., Fernandez I. P., Martorell A. P., Carrion R. P., Simon S. P., Alcibar A. P., Lorenzo J. P., Garcia V. Q., Asensio T. R. Y. C., Maicas M. D. T., Villanueva Silva M. J., Killander F., Svensson J. H., Fehr M., Hauser N., Muller A., Pagani O., Passmann-Kegel H., Popescu R., Rabaglio M., Rauch D., Schlatter C., Zaman K., Chang T. -W., Huang C. -S., Wang H. -C., Yu J. -C., Bandidwattanawong C., Maneechavakajorn J., Seetalarom K., Dejthevaporn T. S., Somwangprasert A., Vongsaisuwon M., Akbulut H., Altundag K., Arican A., Bozcuk H., Eralp Y., Idris M., Isikdogan A., Senol C. H., Sevinc A., Uygun K., Yucel E., Yucel I., Yumuk F., Shparyk Y., Voitko N., Jaloudi M., Adams J., Agrawal R., Ahmed S., Alhasso A., Allerton R., Anwar S., Archer C., Ashford R., Barraclough L., Bertelli G., Bishop J., Branson T., Butt M., Chakrabarti A., Chakraborti P., Churn M., Crowley C., Davis R., Dhadda A., Eldeeb H., Fraser J., Hall J., Hickish T., Hogg M., Howe T., Joffe J., Kelleher M., Kelly S., Kendall A., Kristeleit H., Lumsden G., Macmillan C., MacPherson I., Malik Z., Mithal N., Neal A., Panwar U., Proctor A., Proctor S. J., Raj S., Rehman S., Sandri I., Scatchard K., Sherwin E., Sims E., Singer J., Smith S., Tahir S., Taylor W., Tsalic M., Wardley A., Waters S., Wheatley D., Wright K., Yuille F., Alonso I., Artagaveytia N., Rodriguez R., Arbona E., Garcia Y., Lion L., Marcano D., Van Thuan T., Gligorov, J, Ataseven, B, Verrill, M, de Laurentiis, M, Jung, K, Azim, H, Al-Sakaff, N, Lauer, S, Shing, M, Pivot, X, Koroveshi, D, Bouzid, K, Casalnuovo, M, Cascallar, D, Korbenfeld, E, Bastick, P, Beith, J, Colosimo, M, Friedlander, M, Ganju, V, Green, M, Patterson, K, Redfern, A, Richardson, G, Ceric, T, Gordana, K, Beato, C, Ferrari, M, Hegg, R, Helena, V, Ismael, G, Lessa, A, Mano, M, Morelle, A, Nogueira, J, Timcheva, K, Tomova, A, Tsakova, M, Zlatareva-Petrova, A, Asselah, J, Assi, H, Brezden-Masley, C, Chia, S, Freedman, O, Harb, M, Joy, A, Kulkarni, S, Prady, C, Gaete, A, Matamala, L, Torres, R, Yanez, E, Franco, S, Urrego, M, Gugic, D, Vrbanec, D, Melichar, B, Prausova, J, Vyzula, R, Pilarte, R, Leon, M, Munoz, R, Ramos, G, Azeem, H, Aziz, A, El Zawahry, H, Osegueda, F, Alexandre, J, Artignan, X, Barletta, H, Beguier, E, Berdah, J, Marty, C, Bollet, M, Bourgeois, H, Bressac, C, Burki, F, Campone, M, Coeffic, D, Cojocarasu, O, Dagada, C, Dalenc, F, Del Piano, F, Desauw, C, Desmoulins, I, Dohollou, N, Egreteau, J, Ferrero, J, Foa, C, Garidi, R, Gasnault, L, Guardiola, E, Hamizi, S, Jarcau, R, Jacquin, J, Jaubert, D, Jolimoy, G, Mineur, H, Largillier, R, Leduc, B, Martin, P, Melis, A, Monge, J, Moullet, I, Mousseau, M, Nguyen, S, Orfeuvre, H, Petit, T, Priou, F, Bach, I, Simon, H, Stefani, L, Uwer, L, Youssef, A, Aktas, B, von der Assen, A, Augustin, D, Balser, C, Bauer, L, Bechtner, C, Beyer, G, Brucker, C, Buckner, U, Busch, S, Christensen, B, Deryal, M, Farrokh, A, Faust, E, Friedrichs, K, Graf, H, Griesshammer, M, Grischke, E, Hanle, C, Heider, A, Henschen, S, Hesse, T, Jackisch, C, Kisro, J, Kohler, A, Kuemmel, S, Lampe, D, Lantzsch, T, Latos, K, Lex, B, Liedtke, C, Luedders, D, Maintz, C, Muller, V, Overkamp, F, Park-Simon, T, Paul, M, Prechtl, A, Ringsdorf, U, Runnebaum, I, Ruth, S, Salat, C, Scheffen, I, Schilling, J, Schmatloch, S, Schmidt, M, Schneeweiss, A, Schrader, I, Seipelt, G, Simon, E, Stefek, A, Stickeler, E, Thill, M, Tio, J, Tuczek, A, Warm, M, Weigel, M, Wischnik, A, Wojcinski, S, Ziegler-Lohr, K, Aravantinos, G, Ardavanis, A, Fountzilas, G, Gogas, H, Kakolyris, S, Mavroudis, D, Papadimitriou, C, Papandreou, C, Papazisis, K, Castro, H, Hernandez-Monroy, C, Ngan, R, Yeo, W, Bittner, N, Boer, K, Csejtei, A, Horvath, Z, Kocsis, J, Mangel, L, Mezei, K, Nagy, Z, Szanto, J, Atmakusuma, D, Fadjari, H, Kurnianda, D, Prayogo, N, Tanggo, E, Coate, L, Hennessy, B, Kelly, C, Martin, M, Nasim, S, O'Connor, M, Aieta, M, Allegrini, G, Amadori, D, Bidoli, P, Biti, G, Bordonaro, R, Bottini, A, Carterni, G, Cavanna, L, Cazzaniga, M, Cognetti, F, Contu, A, Cruciani, G, Donadio, M, Falcone, A, Farci, D, Forcignano, R, Frassoldati, A, Gaion, F, Gamucci, T, Giotta, F, Livi, L, Lorusso, V, Maiello, E, Marchetti, P, Mariani, G, Mion, M, Moscetti, L, Musolino, A, Pazzola, A, Pedrazzoli, P, Pigi, A, de Placido, S, Caremoli, E, Santoro, A, Tienghi, A, Ahn, J, Lee, K, Lee, S, Seo, J, Sohn, J, Cesas, A, Juozaityte, E, Cheah, N, Chong, F, Devi, B, Phua, V, Teoh, D, Ching, L, Yusof, M, Corona, J, Dominguez, A, Mendoza, R, Hernandez, C, Ramiro, A, Santos, J, Espinosa, P, Villarreal Garza, C, Errihani, H, Bakker, S, van den Berkmortel, F, Blaisse, R, Huinink, D, van den Bosch, J, Braun, J, Dercksen, M, Droogendijk, H, Erdkamp, F, Haringhuizen, A, de Jongh, F, Kok, T, Los, M, Madretsma, S, Terwogt, J, van der Padt, A, van Rossum-Schornagel, Q, Smilde, T, de Valk, B, van der Velden, A, van Warmerdam, L, van de Wouw, A, North, R, Kersten, C, Mjaaland, I, Wist, E, Aziz, Z, Masood, N, Rashid, K, Shah, M, Alcedo, J, Aleman, D, Neciosup, S, Reategui, R, Valdiviezo, N, Vera, L, Fernando, G, Roque, F, Strebel, H, Krzemieniecki, K, Litwiniuk, M, Mruk, A, Pienkowski, T, Sawrycki, P, Slomian, G, Tomczak, P, Afonso, N, Cardoso, F, Damasceno, M, Nave, M, Badulescu, F, Ciule, L, Curescu, S, Eniu, A, Filip, D, Grecea, D, Jinga, D, Lungulescu, D, Oprean, C, Stanculeanu, D, Turdean, M, Dvornichenko, V, Emelyanov, S, Lichinitser, M, Manikhas, A, Sakaeva, D, Shirinkin, V, Stroyakovskiy, D, Abulkhair, O, Zekri, J, Filipovic, S, Kovcin, V, Nedovic, J, Pesic, J, Vasovic, S, Ng, R, Bystricky, B, Leskova, J, Mardiak, J, Misurova, E, Wagnerova, M, Takac, I, Demetriou, G, Dreosti, L, Govender, P, Jordaan, J, Veersamy, P, Romero, J, Lopez, N, Arias, C, Chacon, J, Aramburo, A, Morales, L, Garcia, M, Estevez, L, Garcia-Palomo Perez, A, Garcia Saenz, J, Garcia Sanchis, L, Cubells, L, Cortijo, L, Santiago, S, De Aranguiz, B, Manas, J, Gallego, P, Cussac, A, Ferrandiz, C, Garrido, M, Alvarez, P, Vega, J, Del Prado, P, Janez, N, Murillo, S, Rosales, A, Jaso, L, Fernandez, I, Martorell, A, Carrion, R, Simon, S, Alcibar, A, Lorenzo, J, Garcia, V, Asensio, T, Maicas, M, Villanueva Silva, M, Killander, F, Svensson, J, Fehr, M, Hauser, N, Muller, A, Pagani, O, Passmann-Kegel, H, Popescu, R, Rabaglio, M, Rauch, D, Schlatter, C, Zaman, K, Chang, T, Huang, C, Wang, H, Yu, J, Bandidwattanawong, C, Maneechavakajorn, J, Seetalarom, K, Dejthevaporn, T, Somwangprasert, A, Vongsaisuwon, M, Akbulut, H, Altundag, K, Arican, A, Bozcuk, H, Eralp, Y, Idris, M, Isikdogan, A, Senol, C, Sevinc, A, Uygun, K, Yucel, E, Yucel, I, Yumuk, F, Shparyk, Y, Voitko, N, Jaloudi, M, Adams, J, Agrawal, R, Ahmed, S, Alhasso, A, Allerton, R, Anwar, S, Archer, C, Ashford, R, Barraclough, L, Bertelli, G, Bishop, J, Branson, T, Butt, M, Chakrabarti, A, Chakraborti, P, Churn, M, Crowley, C, Davis, R, Dhadda, A, Eldeeb, H, Fraser, J, Hall, J, Hickish, T, Hogg, M, Howe, T, Joffe, J, Kelleher, M, Kelly, S, Kendall, A, Kristeleit, H, Lumsden, G, Macmillan, C, Macpherson, I, Malik, Z, Mithal, N, Neal, A, Panwar, U, Proctor, A, Proctor, S, Raj, S, Rehman, S, Sandri, I, Scatchard, K, Sherwin, E, 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H., Azim H. A., Al-Sakaff N., Lauer S., Shing M., Pivot X., Koroveshi D., Bouzid K., Casalnuovo M., Cascallar D., Korbenfeld E. P., Bastick P., Beith J., Colosimo M., Friedlander M., Ganju V., Green M., Patterson K., Redfern A., Richardson G., Ceric T., Gordana K., Beato C. A., Ferrari M., Hegg R., Helena V., Ismael G. F., Lessa A. E., Mano M., Morelle A., Nogueira J. A., Timcheva K., Tomova A., Tsakova M., Zlatareva-Petrova A., Asselah J., Assi H., Brezden-Masley C., Chia S., Freedman O., Harb M., Joy A. A., Kulkarni S., Prady C., Gaete A. A. A., Matamala L., Torres R., Yanez E., Franco S., Urrego M., Gugic D., Vrbanec D., Melichar B., Prausova J., Vyzula R., Pilarte R. G., Leon M. I., Munoz R., Ramos G., Azeem H. A., Aziz A. A., El Zawahry H., Osegueda F. R., Alexandre J., Artignan X., Barletta H., Beguier E., Berdah J. -F., Marty C. B., Bollet M., Bourgeois H., Bressac C., Burki F., Campone M., Coeffic D., Cojocarasu O. 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S., Simon H., Stefani L., Uwer L., Youssef A., Aktas B., von der Assen A., Augustin D., Balser C., Bauer L. -E., Bechtner C., Beyer G., Brucker C., Buckner U., Busch S., Christensen B., Deryal M., Farrokh A., Faust E., Friedrichs K., Graf H., Griesshammer M., Grischke E. -M., Hanle C., Heider A., Henschen S., Hesse T., Jackisch C., Kisro J., Kohler A., Kuemmel S., Lampe D., Lantzsch T., Latos K., Lex B., Liedtke C., Luedders D., Maintz C., Muller V., Overkamp F., Park-Simon T. -W., Paul M., Prechtl A., Ringsdorf U., Runnebaum I., Ruth S., Salat C., Scheffen I., Schilling J., Schmatloch S., Schmidt M., Schneeweiss A., Schrader I., Seipelt G., Simon E., Stefek A., Stickeler E., Thill M., Tio J., Tuczek A., Warm M., Weigel M., Wischnik A., Wojcinski S., Ziegler-Lohr K., Aravantinos G., Ardavanis A., Fountzilas G., Gogas H., Kakolyris S., Mavroudis D., Papadimitriou C., Papandreou C., Papazisis K., Castro H., Hernandez-Monroy C. 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M., Errihani H., Bakker S., van den Berkmortel F., Blaisse R. J. B., Huinink D. T. B., van den Bosch J., Braun J. J., Dercksen M. W., Droogendijk H., Erdkamp F., Haringhuizen A., de Jongh F. E., Kok T. C., Los M., Madretsma S., Terwogt J. M. M., van der Padt A., van Rossum-Schornagel Q. C., Smilde T. J., de Valk B., van der Velden A., van Warmerdam L., van de Wouw A. J., North R., Kersten C., Mjaaland I., Wist E., Aziz Z., Masood N., Rashid K., Shah M., Alcedo J. C., Aleman D., Neciosup S., Reategui R., Valdiviezo N., Vera L., Fernando G., Roque F., Strebel H. M., Krzemieniecki K., Litwiniuk M., Mruk A., Pienkowski T., Sawrycki P., Slomian G., Tomczak P., Afonso N., Cardoso F., Damasceno M., Nave M., Badulescu F., Ciule L., Curescu S., Eniu A., Filip D., Grecea D., Jinga D. -C., Lungulescu D., Oprean C. M., Stanculeanu D. 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H., Fehr M., Hauser N., Muller A., Pagani O., Passmann-Kegel H., Popescu R., Rabaglio M., Rauch D., Schlatter C., Zaman K., Chang T. -W., Huang C. -S., Wang H. -C., Yu J. -C., Bandidwattanawong C., Maneechavakajorn J., Seetalarom K., Dejthevaporn T. S., Somwangprasert A., Vongsaisuwon M., Akbulut H., Altundag K., Arican A., Bozcuk H., Eralp Y., Idris M., Isikdogan A., Senol C. H., Sevinc A., Uygun K., Yucel E., Yucel I., Yumuk F., Shparyk Y., Voitko N., Jaloudi M., Adams J., Agrawal R., Ahmed S., Alhasso A., Allerton R., Anwar S., Archer C., Ashford R., Barraclough L., Bertelli G., Bishop J., Branson T., Butt M., Chakrabarti A., Chakraborti P., Churn M., Crowley C., Davis R., Dhadda A., Eldeeb H., Fraser J., Hall J., Hickish T., Hogg M., Howe T., Joffe J., Kelleher M., Kelly S., Kendall A., Kristeleit H., Lumsden G., Macmillan C., MacPherson I., Malik Z., Mithal N., Neal A., Panwar U., Proctor A., Proctor S. J., Raj S., Rehman S., Sandri I., Scatchard K., Sherwin E., Sims E., Singer J., Smith S., Tahir S., Taylor W., Tsalic M., Wardley A., Waters S., Wheatley D., Wright K., Yuille F., Alonso I., Artagaveytia N., Rodriguez R., Arbona E., Garcia Y., Lion L., Marcano D., and Van Thuan T.

Abstract

Aim To assess the safety and tolerability of adjuvant subcutaneous trastuzumab (Herceptin® SC, H SC), delivered from an H SC Vial via hand-held syringe (Cohort A) or single-use injection device (Cohort B), with or without chemotherapy, for human epidermal growth factor receptor 2 (HER2)-positive stage I to IIIC early breast cancer (EBC) in the phase III SafeHer study (NCT01566721). Methods Patients received 600 mg fixed-dose H SC every 3 weeks for 18 cycles. The chemotherapy partner was at the investigators' discretion (H SC monotherapy was limited to ≤10% of the population). Data from the first H SC dose until 28 days (plus a 5-day window) after the last dose are presented. Results are descriptive. Results In the overall population, 2282/2573 patients (88.7%) experienced adverse events (AEs). Of the above, 128 (5.0%) patients experienced AEs leading to study drug discontinuation; 596 (23.2%) experienced grade ≥ 3 AEs and 326 (12.7%) experienced serious AEs. Grade ≥ 3 cardiac disorders were reported in 24 patients (0.9%), including congestive heart failure in eight (0.3%). As expected, the AE rates varied according to the timing of chemotherapy in both cohorts, with higher rates in concurrent versus sequential chemotherapy subgroups. In the concurrent chemotherapy subgroup, AEs were more common during the actual period of concurrent chemotherapy compared with the period when patients did not receive concurrent chemotherapy. Conclusion SafeHer confirms the safety and tolerability of the H SC 600 mg fixed dose for 1 year (every 3 weeks for 18 cycles) as adjuvant therapy with concurrent or sequential chemotherapy for HER2-positive EBC. These primary analysis results are consistent with the known safety profile for intravenous H and H SC.

Published
2017

7. Predictive factors for early progression during induction chemotherapy (IC) and chemotherapy-free interval (CFI): Analysis from PRODIGE 9 trial

Author

Aparicio, T., primary, Bennouna, J., additional, Le Malicot, K., additional, Boige, V., additional, Taieb, J., additional, Bouche, O., additional, Francois, E., additional, Phelip, J-M., additional, Borel, C., additional, Faroux, R., additional, Dahan, L., additional, Bachet, J-B., additional, Egreteau, J., additional, Kaminsky-Forrett, M-C., additional, Gornet, J-M., additional, Cojocarasu, O., additional, Gasmi, M., additional, Guerin-Meyer, V., additional, Ghiringhelli, F., additional, and Lepage, C., additional

Published
2017
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8. Non pegylated liposomal doxorubicin (npld, myocettm) + carboplatin (cb) in patients (pts) with ovarian cancer in late relapse (oclr): a phase 2 gineco study

Author

You, B., primary, Joly, F., additional, Ray-Coquard, I.L., additional, El Kouri, C., additional, Mercier-Blas, A., additional, Berton-Rigaud, D., additional, Kalbacher, E., additional, Cojocarasu, O., additional, Fabbro, M., additional, Cretin, J., additional, Zannetti, A., additional, Abadie-Lacourtoisie, S., additional, Mollon, D., additional, Hardy-Bessard, A.-C., additional, Provansal, M., additional, and Freyer, G., additional

Published
2016
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10. Évaluation en pratique courante de l’association bevacizumab-FOLFIRI en première ligne chez des patients atteints d’un cancer colorectal métastatique non résécable traités en 2006: focus sur patients réséqués et oncogériatrie

Author

Metges, J. P., primary, Lebot, M. A., additional, Faroux, R., additional, Riaud, F., additional, Gamelin, E., additional, Capitain, O., additional, Guérin Meyer, V., additional, Leynia, P., additional, Douillard, J. Y., additional, Senellart, H., additional, Rochard, S., additional, Louvigné, C., additional, Campion, L., additional, Dupuis, O., additional, Grollier, C., additional, Achour, N. A., additional, Person, B., additional, Raoul, J. L., additional, Boucher, E., additional, Bertrand, C., additional, Ramée, J. F., additional, Guivarch, L., additional, Etienne, P. L., additional, Roussel, S., additional, Desclos, H., additional, Julien, M. N., additional, Labarre, M. I., additional, Klein, V., additional, Bessard, R., additional, Stampfli, C., additional, Royet, F., additional, Faycal, J., additional, Gouva, S., additional, Le Bihan, G., additional, Couturier, M., additional, Gourlaouen, A., additional, Bertholom, C., additional, Porneuf, M., additional, Jobard, E., additional, Peguet, E., additional, Grasset, D., additional, Bouret, J. F., additional, Bicheler, V., additional, Ulvoas, A., additional, Miglianico, L., additional, Chouzenoux, C., additional, Deguiral, P., additional, Derenne, L., additional, Martin, D., additional, Langlet, P. Michel, additional, Bodin, C., additional, Rossi, V., additional, Barré, S., additional, Cojocarasu, O., additional, Naveau Ploux, C., additional, Vidal, A. M., additional, Cumin, I., additional, Egreteau, J., additional, Brouard, A., additional, Matysiak Budnik, T., additional, Thomaré, P., additional, Le Bris Michel, A. S., additional, Piriou, G., additional, Largeau, R., additional, Elhannani, C., additional, Crespeau, E., additional, Suberville, F., additional, Bourgeois, H., additional, Riche, C., additional, Lagadec, D. Déniel, additional, Marhuenda, F., additional, and Grudé, F., additional

Published
2014
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16. Safety and tolerability of subcutaneous trastuzumab for the adjuvant treatment of human epidermal growth factor receptor 2-positive early breast cancer: SafeHer phase III study's primary analysis of 2573 patients

Author

Jose Chacon, Katja Ziegler-Löhr, Kamran Rashid, Stanley Madretsma, Hortense Laharie Mineur, Soo Hyeon Lee, Bohuslav Melichar, Jasna Pesic, Julia Hall, Jörg Schilling, Paola Morales Espinosa, Wendy Taylor, Francesco Cognetti, Doris Augustin, Ines Sandri, Laura Murillo Jaso, Alejandro Juarez Ramiro, Nora Artagaveytia, Rocio Reategui, Nataliia Voitko, Teresa Gamucci, Lisa H Barraclough, Jérôme Alexandre, Mohammed Butt, Frank Priou, A.J. van de Wouw, Cristina Marinela Oprean, Isabel Alonso, Suzana Vasovic, Fernando Roque, Marc Thill, Viktoria Dvornichenko, K. Bouzid, Idris Yucel, Andrea Stefek, Jose Manuel Lopez Vega, Daniil Stroyakovskiy, R. Chiara Forcignanò, Mohammed Harb, Andrzej Mruk, Jana Prausová, Lydia Dreosti, Prabir Chakraborti, Armando Santoro, Lee Wei Ching, Anna Tuczek, Jane Beith, Larisa Ciule, Hakan Bozcuk, Antonino Musolino, Hartmut Kristeleit, Clare Crowley, T.C. Kok, Dhurata Koroveshi, Natasha Mithal, Laura Garcia Sanchis, Stephan Henschen, Carmen Cañabate Arias, A. Contu, Antoaneta Tomova, Alper Sevinc, Helga Droogendijk, Gustavo Fernando Ismael, Konstantinos Papazisis, Laurent Gasnault, Sandra Bakker, Judit Kocsis, Bernd Christensen, Stephen Kelly, Rosana Jarcau, Christian Jackisch, George Fountzilas, Cyril Foa, Annebeth W. Haringhuizen, Silvia Neciosup, Juan Matos Santos, Finlander Rosales Osegueda, Robinson Rodriguez, Marcus Schmidt, Bart de Valk, Kathryn Wright, A.S. Dhadda, Elizabeth Sherwin, Sabino De Placido, Luigi Cavanna, Joelle Egreteau, Shazza Rehman, Giacomo Allegrini, Doerte Luedders, Poovandren Govender, Hugues Barletta, Iztok Takač, Yuraima Garcia, Michael Green, Geneviève Jolimoy, Marcela Urrego, Chanyoot Bandidwattanawong, Vito Lorusso, Annette van der Velden, Rene Muñoz, Djumhana Atmakusuma, Christos Papandreou, Craig Macmillan, Hassan Errihani, Iris Schrader, Isabelle Desmoulins, Jean-Marc Ferrero, Mohamed Idris, B. Ataseven, Andre Farrokh, Isabelle Moullet, Iain R. Macpherson, N. Al-Sakaff, Stephen Chia, Blanca Hernando Fernandez De Aranguiz, Lorena Lion, Alexandros Ardavanis, Ani Zlatareva-Petrova, Ernesto Pablo Korbenfeld, Hugo Castro, Mirta Garcia, Heike Passmann-Kegel, Lionel Uwer, Gary Richardson, Marion Paul, Georgia Demetriou, Andreas Köhler, V. Kovcin, Eliot Sims, Gerasimos Aravantinos, Adriana Dominguez, Daniel Rauch, Greta Beyer, Laurence J. C. van Warmerdam, Roberto Bordonaro, Raymond Ng, David Coeffic, Rostislav Vyzula, Bernard Leduc, Jozef Mardiak, Andrea Pigi, Ingo Runnebaum, Jose Angel Garcia Saenz, Areewan Somwangprasert, Cristina Llorca Ferrandiz, Coskun Hasan Senol, Martin Griesshammer, Friedrich Overkamp, Suzanne Nguyen, Maria Turdean, Udaiveer Panwar, Zsuzsanna Nagy, Francesco Giotta, Andreas Schneeweiss, Teresa Ramon y Cajal Asensio, Jae Hong Seo, Joohyuk Sohn, Jean-Philippe Jacquin, Daniela Grecea, Jasmina Nedovic, Arrate Plazaola Alcibar, Tadeusz Pienkowski, Jetske M. Meerum Terwogt, Elmar Stickeler, Hazem I. Assi, Vadim Shirinkin, Grzegorz Slomian, Etela Mišurová, Roberto Hegg, K. Friedrichs, Corinne Dagada, Jean-François Berdah, Fulden Yumuk, Alexandru Eniu, Amit Chakrabarti, Mathias Fehr, Christoph Salat, Dan Lungulescu, Heinrik Martin Strebel, Antonio Llombart Cussac, Rémy Largillier, Stefan Curescu, Albert von der Assen, Emmanuel Guardiola, Andras Csejtei, Tamas Hickish, Krzysztof Krzemieniecki, Yaroslav Shparyk, Ramon Perez Carrion, Michela Donadio, Purificacion Martinez del Prado, Sandra Franco, J.J. Braun, Michael Friedlander, Suhail Anwar, Thierry Petit, Sarah Smith, Rafael Gutierrez Pilarte, Laia Garrigos Cubells, Frans L. G. Erdkamp, Jedzada Maneechavakajorn, Mastura Yusof, Jocelyn Adams, Diana Cascallar, Luis Antonio Fernandez Morales, Max S. Mano, Simon Waters, Carlos Beato, Philippe Martin, Martin Hogg, Isabelle Sillet Bach, Monica Casalnuovo, Klara Mezei, Alexey Manikhas, Margarida Damasceno, Sergey Emelyanov, Gabriella Mariani, Kecman Gordana, Gianfilippo Bertelli, Ignacio Pelaez Fernandez, Damir Vrbanec, Maria Wagnerova, Johannes Petrus Jordaan, Marina Cazzaniga, Mustafa Deryal, Ruth Davis, Abdurrahman Isikdogan, Sanjay Raj, José Juan Illarramendi Mañas, Vinod Ganju, Maria Dolores Torregrosa Maicas, Glenda Ramos, Nugroho Prayogo, H. Orfeuvre, Filipovic S, Joke Tio, Andrew Redfern, M. Shing, Eduardo Yanez, Khalil Zaman, Jin-Seok Ahn, Dino Amadori, Bahriye Aktas, Miriam O'Connor, Uta Ringsdorf, Christophe Desauw, J. Gligorov, Jorge Corona, Michele De Laurentiis, Arthur Wischnik, Paolo Pedrazzoli, Katalin Boér, Caroline Archer, Anne Kendall, Ori Freedman, Maya Tsakova, Dana Lucia Stanculeanu, Kevin Patterson, Cathy Kelly, Nellie Lay Chin Cheah, X. Artignan, Anil A. Joy, Steffi Busch, Monica Nave, Bryan Hennessy, Lorenzo Livi, X. Pivot, R.J.B. Blaisse, Adolfo Murias Rosales, Juan Carlos Alcedo, Dalila Marcano, Emmanuel Beguier, Andreas Müller, László Csaba Mangel, Christina Schlatter, Fernando Gaion, Tjoung-Won Park-Simon, Sebastian Wojcinski, Ute Bückner, Florinel Badulescu, Cynthia Mayte Villarreal Garza, Rozenn Allerton, Mikhail Lichinitser, Damir Gugić, Manuela Rabaglio, Jens Kisro, Iris Scheffen, Vincent Phua, Marc A. Bollet, Giampaolo Biti, M. Verrill, Adrien Melis, Andrew M Wardley, Ali Arican, Hamdy A. Azim, Lelia-Eveline Bauer, Tsai-Wang Chang, Nik Hauser, René Lazaro González Mendoza, Dominique Jaubert, Samreen Ahmed, Mazhar Shah, János Szántó, Kunibert Latos, Xavier Pivot, Helen Gogas, Elona Juozaityte, Luca Moscetti, Helene Simon, Giacomo Carterni, Dan-Corneliu Jinga, Olivia Pagani, Elena Rota Caremoli, Esther Arbona, Cornelia Liedtke, Stylianos Kakolyris, Abdulla Alhasso, Omalkhair Abulkhair, Jose Ponce Lorenzo, Julian Singer, Tony Branson, Claudia Hänle, Ingvild Mjaaland, Chiun-Sheng Huang, Heri Fadjari, Jonathan Joffe, Laetitia Stefani, Dieter Lampe, Franck Burki, S. Lauer, Sabine Schmatloch, Gracieux Fernando, Dina Sakaeva, Christina Balser, Michael Martin, Nora Bittner, Andrea Heider, Antonio Frassoldati, Serafin Morales Murillo, Hakan Akbulut, Saad Tahir, Tilmann Lantzsch, Christine Brezden-Masley, Vanessa Helena, Tran Van Thuan, F.E. de Jongh, Roger K.C. Ngan, Elke Faust, Hugues Bourgeois, Flora Li Tze Chong, Nehal Masood, Keun Seok Lee, J. Bishop, Mathias Warm, Dimitris Mavroudis, Petrosian Veersamy, Judith Fraser, Andres Garcia-Palomo Perez, Heiko Graf, Vanesa Quiroga Garcia, Jyh-Cherng Yu, Maria Jose Villanueva Silva, Elke Simon, Diana Aleman, Kazim Uygun, Cosima Brucker, Michael Weigel, Volkmar Müller, Djohan Kurnianda, Duncan Wheatley, Amr Abdel Aziz, Benno Lex, Laura G. Estévez, Darren Teoh, María Isabel León, Noemia Afonso, Frances Yuille, Amelia Tienghi, Gernot Seipelt, Jose Alberto Nogueira, Dumitru Filip, Zafar Malik, Fatima Cardoso, Giorgio Cruciani, Winnie Yeo, Luis Vera, Santiago Gonzalez Santiago, Richard North, M.W. Dercksen, Zsolt Horváth, Noelia Martinez Jañez, Marta Mion, Marcela Ferrari, Natalia Valdiviezo, Oana Zveltlana Cojocarasu, Alessandra Morelle, Medy Tsalic, Sonia Pernas Simon, Christoph Maintz, Daniele Farci, Alvaro Edson Lessa, Jeremy Monge, Joseph Gligorov, Anthony Neal, Norberto Batista Lopez, Piotr Tomczak, Yesim Eralp, Kasan Seetalarom, Thitiya (Sirisinha) Dejthevaporn, Jamal Zekri, Steven John Proctor, Saira Nasim, Muireann Kelleher, Eftal Yucel, Quirine Clementine van Rossum-Schornagel, Linda Coate, Paolo Marchetti, Theresa Howe, Carlos Alberto Hernandez, Roberto Torres, Konstanta Timcheva, Evaristo Maiello, Anita Prechtl, Jamil Asselah, Branislav Bystricky, Kate Scatchard, Zeba Aziz, Jaroslava Leskova, Sherko Kuemmel, Paolo Bidoli, Richard Ashford, Piotr Sawrycki, Claude Bressac, Alberto Bottini, Pilar Lopez Alvarez, Nadine Dohollou, Alejandro Andres Acevedo Gaete, M. De Laurentiis, T.J. Smilde, Andrew Proctor, Catherine Prady, Michele Aieta, Jan Henry Svensson, Reda Garidi, Erik Wist, Antonia Perello Martorell, Mohammed Jaloudi, Graeme Lumsden, Eva-Maria Grischke, Ali Youssef, Annemieke van der Padt, Kadri Altundag, Christina Bechtner, Mireille Mousseau, Heba El Zawahry, Maartje Los, Alvydas Česas, Alfredo Falcone, Salima Hamizi, Franchette W P J van den Berkmortel, Cesar Estuardo Hernandez-Monroy, K.H. Jung, Swati Kulkarni, R.K. Agrawal, Hwei Chung Wang, Hany Eldeeb, Fredrika Killander, Jose Luis Alonso Romero, Antonio Pazzola, Daan ten Bokkel Huinink, Mario Campone, Beena C.R. Devi, Florence Dalenc, Pedro Jimenez Gallego, Mawin Vongsaisuwon, Timur Ceric, Chantal Bernard Marty, R. A. Popescu, J. van den Bosch, Luis Matamala, Sylvia Ruth, Maria Litwiniuk, Maria Lomas Garrido, Mark Churn, Christian Kersten, Francesco Del Piano, Eddie Herman Tanggo, Antonio Fernandez Aramburo, Kyung Hae Jung, Christos Papadimitriou, Hamdy Abdel Azeem, Patricia Bastick, Tobias Hesse, Maree Colosimo, Lucia Gonzalez Cortijo, Mark Verrill, Gligorov, J, Ataseven, B, Verrill, M, De Laurentiis, M, Jung, K. H, Azim, H. A, Al-sakaff, N, Lauer, S, Shing, M, Pivot, X., de Laurentiis, M, Jung, K, Azim, H, Al-Sakaff, N, Pivot, X, Koroveshi, D, Bouzid, K, Casalnuovo, M, Cascallar, D, Korbenfeld, E, Bastick, P, Beith, J, Colosimo, M, Friedlander, M, Ganju, V, Green, M, Patterson, K, Redfern, A, Richardson, G, Ceric, T, Gordana, K, Beato, C, Ferrari, M, Hegg, R, Helena, V, Ismael, G, Lessa, A, Mano, M, Morelle, A, Nogueira, J, Timcheva, K, Tomova, A, Tsakova, M, Zlatareva-Petrova, A, Asselah, J, Assi, H, Brezden-Masley, C, Chia, S, Freedman, O, Harb, M, Joy, A, Kulkarni, S, Prady, C, Gaete, A, Matamala, L, Torres, R, Yanez, E, Franco, S, Urrego, M, Gugic, D, Vrbanec, D, Melichar, B, Prausova, J, Vyzula, R, Pilarte, R, Leon, M, Munoz, R, Ramos, G, Azeem, H, Aziz, A, El Zawahry, H, Osegueda, F, Alexandre, J, Artignan, X, Barletta, H, Beguier, E, Berdah, J, Marty, C, Bollet, M, Bourgeois, H, Bressac, C, Burki, F, Campone, M, Coeffic, D, Cojocarasu, O, Dagada, C, Dalenc, F, Del Piano, F, Desauw, C, Desmoulins, I, Dohollou, N, Egreteau, J, Ferrero, J, Foa, C, Garidi, R, Gasnault, L, Guardiola, E, Hamizi, S, Jarcau, R, Jacquin, J, Jaubert, D, Jolimoy, G, Mineur, H, Largillier, R, Leduc, B, Martin, P, Melis, A, Monge, J, Moullet, I, Mousseau, M, Nguyen, S, Orfeuvre, H, Petit, T, Priou, F, Bach, I, Simon, H, Stefani, L, Uwer, L, Youssef, A, Aktas, B, von der Assen, A, Augustin, D, Balser, C, Bauer, L, Bechtner, C, Beyer, G, Brucker, C, Buckner, U, Busch, S, Christensen, B, Deryal, M, Farrokh, A, Faust, E, Friedrichs, K, Graf, H, Griesshammer, M, Grischke, E, Hanle, C, Heider, A, Henschen, S, Hesse, T, Jackisch, C, Kisro, J, Kohler, A, Kuemmel, S, Lampe, D, Lantzsch, T, Latos, K, Lex, B, Liedtke, C, Luedders, D, Maintz, C, Muller, V, Overkamp, F, Park-Simon, T, Paul, M, Prechtl, A, Ringsdorf, U, Runnebaum, I, Ruth, S, Salat, C, Scheffen, I, Schilling, J, Schmatloch, S, Schmidt, M, Schneeweiss, A, Schrader, I, Seipelt, G, Simon, E, Stefek, A, Stickeler, E, Thill, M, Tio, J, Tuczek, A, Warm, M, Weigel, M, Wischnik, A, Wojcinski, S, Ziegler-Lohr, K, Aravantinos, G, Ardavanis, A, Fountzilas, G, Gogas, H, Kakolyris, S, Mavroudis, D, Papadimitriou, C, Papandreou, C, Papazisis, K, Castro, H, Hernandez-Monroy, C, Ngan, R, Yeo, W, Bittner, N, Boer, K, Csejtei, A, Horvath, Z, Kocsis, J, Mangel, L, Mezei, K, Nagy, Z, Szanto, J, Atmakusuma, D, Fadjari, H, Kurnianda, D, Prayogo, N, Tanggo, E, Coate, L, Hennessy, B, Kelly, C, Martin, M, Nasim, S, O'Connor, M, Aieta, M, Allegrini, G, Amadori, D, Bidoli, P, Biti, G, Bordonaro, R, Bottini, A, Carterni, G, Cavanna, L, Cazzaniga, M, Cognetti, F, Contu, A, Cruciani, G, Donadio, M, Falcone, A, Farci, D, Forcignano, R, Frassoldati, A, Gaion, F, Gamucci, T, Giotta, F, Livi, L, Lorusso, V, Maiello, E, Marchetti, P, Mariani, G, Mion, M, Moscetti, L, Musolino, A, Pazzola, A, Pedrazzoli, P, Pigi, A, de Placido, S, Caremoli, E, Santoro, A, Tienghi, A, Ahn, J, Lee, K, Lee, S, Seo, J, Sohn, J, Cesas, A, Juozaityte, E, Cheah, N, Chong, F, Devi, B, Phua, V, Teoh, D, Ching, L, Yusof, M, Corona, J, Dominguez, A, Mendoza, R, Hernandez, C, Ramiro, A, Santos, J, Espinosa, P, Villarreal Garza, C, Errihani, H, Bakker, S, van den Berkmortel, F, Blaisse, R, Huinink, D, van den Bosch, J, Braun, J, Dercksen, M, Droogendijk, H, Erdkamp, F, Haringhuizen, A, de Jongh, F, Kok, T, Los, M, Madretsma, S, Terwogt, J, van der Padt, A, van Rossum-Schornagel, Q, Smilde, T, de Valk, B, van der Velden, A, van Warmerdam, L, van de Wouw, A, North, R, Kersten, C, Mjaaland, I, Wist, E, Aziz, Z, Masood, N, Rashid, K, Shah, M, Alcedo, J, Aleman, D, Neciosup, S, Reategui, R, Valdiviezo, N, Vera, L, Fernando, G, Roque, F, Strebel, H, Krzemieniecki, K, Litwiniuk, M, Mruk, A, Pienkowski, T, Sawrycki, P, Slomian, G, Tomczak, P, Afonso, N, Cardoso, F, Damasceno, M, Nave, M, Badulescu, F, Ciule, L, Curescu, S, Eniu, A, Filip, D, Grecea, D, Jinga, D, Lungulescu, D, Oprean, C, Stanculeanu, D, Turdean, M, Dvornichenko, V, Emelyanov, S, Lichinitser, M, Manikhas, A, Sakaeva, D, Shirinkin, V, Stroyakovskiy, D, Abulkhair, O, Zekri, J, Filipovic, S, Kovcin, V, Nedovic, J, Pesic, J, Vasovic, S, Ng, R, Bystricky, B, Leskova, J, Mardiak, J, Misurova, E, Wagnerova, M, Takac, I, Demetriou, G, Dreosti, L, Govender, P, Jordaan, J, Veersamy, P, Romero, J, Lopez, N, Arias, C, Chacon, J, Aramburo, A, Morales, L, Garcia, M, Estevez, L, Garcia-Palomo Perez, A, Garcia Saenz, J, Garcia Sanchis, L, Cubells, L, Cortijo, L, Santiago, S, De Aranguiz, B, Manas, J, Gallego, P, Cussac, A, Ferrandiz, C, Garrido, M, Alvarez, P, Vega, J, Del Prado, P, Janez, N, Murillo, S, Rosales, A, Jaso, L, Fernandez, I, Martorell, A, Carrion, R, Simon, S, Alcibar, A, Lorenzo, J, Garcia, V, Asensio, T, Maicas, M, Villanueva Silva, M, Killander, F, Svensson, J, Fehr, M, Hauser, N, Muller, A, Pagani, O, Passmann-Kegel, H, Popescu, R, Rabaglio, M, Rauch, D, Schlatter, C, Zaman, K, Chang, T, Huang, C, Wang, H, Yu, J, Bandidwattanawong, C, Maneechavakajorn, J, Seetalarom, K, Dejthevaporn, T, Somwangprasert, A, Vongsaisuwon, M, Akbulut, H, Altundag, K, Arican, A, Bozcuk, H, Eralp, Y, Idris, M, Isikdogan, A, Senol, C, Sevinc, A, Uygun, K, Yucel, E, Yucel, I, Yumuk, F, Shparyk, Y, Voitko, N, Jaloudi, M, Adams, J, Agrawal, R, Ahmed, S, Alhasso, A, Allerton, R, Anwar, S, Archer, C, Ashford, R, Barraclough, L, Bertelli, G, Bishop, J, Branson, T, Butt, M, Chakrabarti, A, Chakraborti, P, Churn, M, Crowley, C, Davis, R, Dhadda, A, Eldeeb, H, Fraser, J, Hall, J, Hickish, T, Hogg, M, Howe, T, Joffe, J, Kelleher, M, Kelly, S, Kendall, A, Kristeleit, H, Lumsden, G, Macmillan, C, Macpherson, I, Malik, Z, Mithal, N, Neal, A, Panwar, U, Proctor, A, Proctor, S, Raj, S, Rehman, S, Sandri, I, Scatchard, K, Sherwin, E, Sims, E, Singer, J, Smith, S, Tahir, S, Taylor, W, Tsalic, M, Wardley, A, Waters, S, Wheatley, D, Wright, K, Yuille, F, Alonso, I, Artagaveytia, N, Rodriguez, R, Arbona, E, Garcia, Y, Lion, L, Marcano, D, and Van Thuan, T

Subjects
0301 basic medicine, Oncology, Cancer Research, Receptor, ErbB-2, medicine.medical_treatment, Medizin, Antineoplastic Agent, 0302 clinical medicine, Breast cancer, Trastuzumab, Adjuvant, Aged, 80 and over, education.field_of_study, Middle Aged, HER2/neu, Tolerability, Chemotherapy, Adjuvant, 030220 oncology & carcinogenesis, Herceptin, Subcutaneous, subcutaneous, Female, Survival Analysi, Breast Neoplasm, medicine.drug, Human, Adult, medicine.medical_specialty, Injections, Subcutaneous, Population, Socio-culturale, Antineoplastic Agents, Breast Neoplasms, Injections, Subcutaneou, 03 medical and health sciences, Young Adult, Internal medicine, medicine, Adjuvant therapy, Humans, Subcutaneou, education, Adverse effect, Aged, Chemotherapy, Adjuvant, breast cancer, HER2/neu, herceptin, trastuzumab, business.industry, medicine.disease, Survival Analysis, Surgery, Discontinuation, 030104 developmental biology, business
Abstract

Aim To assess the safety and tolerability of adjuvant subcutaneous trastuzumab (Herceptin ® SC, H SC), delivered from an H SC Vial via hand-held syringe (Cohort A) or single-use injection device (Cohort B), with or without chemotherapy, for human epidermal growth factor receptor 2 (HER2)-positive stage I to IIIC early breast cancer (EBC) in the phase III SafeHer study (NCT01566721). Methods Patients received 600 mg fixed-dose H SC every 3 weeks for 18 cycles. The chemotherapy partner was at the investigators' discretion (H SC monotherapy was limited to ≤10% of the population). Data from the first H SC dose until 28 days (plus a 5-day window) after the last dose are presented. Results are descriptive. Results In the overall population, 2282/2573 patients (88.7%) experienced adverse events (AEs). Of the above, 128 (5.0%) patients experienced AEs leading to study drug discontinuation; 596 (23.2%) experienced grade ≥ 3 AEs and 326 (12.7%) experienced serious AEs. Grade ≥ 3 cardiac disorders were reported in 24 patients (0.9%), including congestive heart failure in eight (0.3%). As expected, the AE rates varied according to the timing of chemotherapy in both cohorts, with higher rates in concurrent versus sequential chemotherapy subgroups. In the concurrent chemotherapy subgroup, AEs were more common during the actual period of concurrent chemotherapy compared with the period when patients did not receive concurrent chemotherapy. Conclusion SafeHer confirms the safety and tolerability of the H SC 600 mg fixed dose for 1 year (every 3 weeks for 18 cycles) as adjuvant therapy with concurrent or sequential chemotherapy for HER2-positive EBC. These primary analysis results are consistent with the known safety profile for intravenous H and H SC.

Published
2017

17. The place of the relative at the time of the announcement of cancer progression: BABEL - a mixed-methods study.

Author

Ingrand I, Laurent E, Lecomte T, Cojocarasu O, Egreteau J, Aleba A, Hureaux J, Colombat P, Gyan E, and Bourgeois H

Abstract

Objectives: This study aims to explore the place of the relative in these triadic consultations and how this influences communication., Methods: A mixed-methods research strategy was used. Triadic consultations for the announcement of cancer progression were recorded and following the 3 participants completed questionnaires comprising mirror-items. Recordings and answers were further investigated in a few semi-structured interviews. Comparison of quantitative responses (questionnaires) used Wilcoxon's test for matched series. Qualitative analyses (consultations, interviews) used grounded theory. Patients were over 18, followed for cancer in palliative phase, excluding brain tumors and malignant hemopathies, and presented renewed disease progression. Relatives were over 18 and authorized by the patient to participate., Results: 47 consultations (audio-recordings, answers to questionnaires) and 12 interviews conducted separately with 4 triads were collected. Half the relatives, while remaining in the background, nevertheless contributed to the discussion. For patients, the presence of a relative was considered beneficial and for oncologists it facilitated the announcement. However, symptoms perceived as intimate or private appeared difficult to express for some patients, and for relatives, prognosis was a difficult subject to broach. Although their relationship with time and their expectations may differ, patients and relatives found consultations positive. Oncologists appeared to underestimate the patient's level of understanding ( P <0.001) and perceptions of the seriousness of the disease ( P =0.009) but not those of relatives. They did not evaluate the relative's state of health and check what the dyad had retained., Significance of Results: Training via simulation sessions should be adapted to communication involving relatives.

Published
2023
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18. Perioperative Cetuximab with Cisplatin and 5-Fluorouracil in Esogastric Adenocarcinoma: A Phase II Study.

Author

Gronnier C, Mariette C, Lepage C, Monterymard C, Jary M, Ferru A, Baconnier M, Adhoute X, Tavan D, Perrier H, Guerin-Meyer V, Lecaille C, Bonichon-Lamichhane N, Pillon D, Cojocarasu O, Egreteau J, D'journo XB, Dahan L, Locher C, Texereau P, Collet D, Michel P, Ben Abdelghani M, Guimbaud R, Muller M, Bouché O, and Piessen G

Abstract

Purpose: While perioperative chemotherapy provides a survival benefit over surgery alone in gastric and gastroesophageal junction (G/GEJ) adenocarcinomas, the results need to be improved. This study aimed to evaluate the efficacy and safety of perioperative cetuximab combined with 5-fluorouracil and cisplatin., Patients and Methods: Patients received six cycles of cetuximab, cisplatin, and simplified LV5FU2 before and after surgery. The primary objective was a combined evaluation of the tumor objective response (TOR), assessed by computed tomography, and the absence of major toxicities resulting in discontinuation of neoadjuvant chemotherapy (NCT) (45% and 90%, respectively)., Results: From 2011 to 2013, 65 patients were enrolled. From 64 patients evaluable for the primary endpoint, 19 (29.7%) had a morphological TOR and 61 (95.3%) did not stop NCT prematurely due to major toxicity. Sixty patients (92.3%) underwent resection. Sixteen patients (/56 available, 28.5%) had histological responses (Mandard tumor regression grade ≤3). After a median follow-up of 44.5 months, median disease-free and overall survival were 24.4 [95% CI: 16.4-39.4] and 40.3 months [95% CI: 27.5-NA], respectively., Conclusion: Adding cetuximab to the NCT regimen in operable G/GEJ adenocarcinomas is safe, but did not show enough efficacy in the present study to meet the primary endpoint (NCT01360086).

Published
2023
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19. Geriatric Assessment Implementation before Chemotherapy in MEtastatic Prostate Cancer, Results from the Real-Life Study GAMERS.

Author

Gluszak C, Campion L, Seegers V, Cojocarasu O, Commer JM, Priou F, Rolland F, Terret C, and Abadie-Lacourtoisie S

Abstract

Geriatric assessment (GA) can predict and improve treatment tolerance and estimate overall survival in older patients with cancer. Several international organizations promote GA; however, data related to its implementation in daily clinical practice are still limited. We aimed to describe GA implementation in patients over 75 years old with metastatic prostate cancer treated with docetaxel as first-line treatment, and with positive G8 screening test or frailty criteria. This retrospective real-world study included 224 patients treated from 2014 to 2021 in four French centers, including 131 patients with a theoretical indication of GA. Among the latter, 51 (38.9%) patients had GA. The main barriers to GA were the lack of systematic screening (32/80, 40.0%), unavailability of geriatric physician (20/80, 25.0%), and absence of referral despite a positive screening test (12/80, 15.0%). With GA performed in only one-third of the patients with a theoretical indication in daily clinical practice, mostly due to an absence of screening test, the use of GA is currently sub-optimal.

Published
2023
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20. Efficacy and safety of panitumumab in a cohort of patients with metastatic colorectal cancer in France: PANI OUEST, a post-EMA-approval descriptive study with a geriatric oncology focus.

Author

Metges JP, Douillard JY, Ramée JF, Dupuis O, Senellart H, Porneuf M, Deguiral P, Achour NE, Edeline J, Cumin I, Artignan X, Faroux R, Stampfli C, Cojocarasu O, Gourlaouen A, Bideau K, Meyer VG, Fichet A, Klein V, Touchefeu Y, Besson D, Desclos H, Barraya R, Alavi Z, Campion L, Lagadec DD, Marhuenda F, and Grudé F

Subjects
Adult, Aged, Aged, 80 and over, Colorectal Neoplasms genetics, Female, France, Geriatrics, Humans, Male, Medical Oncology, Middle Aged, Progression-Free Survival, Proto-Oncogene Proteins p21(ras) metabolism, Treatment Outcome, Antineoplastic Agents, Immunological therapeutic use, Colorectal Neoplasms drug therapy, Panitumumab therapeutic use, Product Surveillance, Postmarketing
Abstract

Background/aims: The Bretagne-Pays de la Loire cancer observatory, an oncology network created by the French Ministry of Health, is specifically dedicated to assess the use of new targeted anticancer therapies in routine practice. In line with the French National Cancer III program, our cancer network set up a real-life cohort, which is independent of the pharmaceutical industry, for patients with colorectal cancer to monitor patient safety and quality of care and promote pharmacovigilance., Materials and Methods: Panitumumab monotherapy was assessed in 243 patients with wild-type Kirsten rat sarcoma who were treated for metastatic colorectal cancer (mCRC) between July 2008 and December 2010 after prior chemotherapy using oxaliplatine and irinotecan. This was a post-European medicine agency marketing (EMA-M) study Results: This study shed light on the best practices, strategic adaptations, clinical results (treatment objective responses, 13%; progression free survival, 2.99 months [2.73-3.15]; and overall survival, 6.8 months [5.49-8.38]) as well as expected or unexpected (grade 3 or 4: 11.5%) secondary effects in the phase IV panitumumab treatment of mCRC., Conclusion: Our results are similar to those by Amado whose phase III study led to obtaining EMA-M for panitumumab and tend to confirm the antitumor activity of this antiepidermal growth factor receptor antibody in the treatment of mCRC. In addition, our results opened avenues to further assessment of panitumumab use as monotherapy as well as its benefit-risk ratio while taking into account the patients' general and clinical characteristics. In 2012, the French National Authority for Health appended these data to the panitumumab transparency committee report.

Published
2020
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21. Artificial intelligence-guided tissue analysis combined with immune infiltrate assessment predicts stage III colon cancer outcomes in PETACC08 study.

Author

Reichling C, Taieb J, Derangere V, Klopfenstein Q, Le Malicot K, Gornet JM, Becheur H, Fein F, Cojocarasu O, Kaminsky MC, Lagasse JP, Luet D, Nguyen S, Etienne PL, Gasmi M, Vanoli A, Perrier H, Puig PL, Emile JF, Lepage C, and Ghiringhelli F

Subjects
Adenocarcinoma drug therapy, Adenocarcinoma mortality, Antineoplastic Combined Chemotherapy Protocols, Colonic Neoplasms drug therapy, Colonic Neoplasms mortality, Disease-Free Survival, Humans, Lymphocytes, Tumor-Infiltrating, Neoplasm Invasiveness, Neoplasm Staging, Prognosis, Adenocarcinoma pathology, Artificial Intelligence, Colonic Neoplasms pathology, Image Interpretation, Computer-Assisted
Abstract

Objective: Diagnostic tests, such as Immunoscore, predict prognosis in patients with colon cancer. However, additional prognostic markers could be detected on pathological slides using artificial intelligence tools., Design: We have developed a software to detect colon tumour, healthy mucosa, stroma and immune cells on CD3 and CD8 stained slides. The lymphocyte density and surface area were quantified automatically in the tumour core (TC) and invasive margin (IM). Using a LASSO algorithm, DGMate (DiGital tuMor pArameTErs), we detected digital parameters within the tumour cells related to patient outcomes., Results: Within the dataset of 1018 patients, we observed that a poorer relapse-free survival (RFS) was associated with high IM stromal area (HR 5.65; 95% CI 2.34 to 13.67; p<0.0001) and high DGMate (HR 2.72; 95% CI 1.92 to 3.85; p<0.001). Higher CD3+ TC, CD3+ IM and CD8+ TC densities were significantly associated with a longer RFS. Analysis of variance showed that CD3+ TC yielded a similar prognostic value to the classical CD3/CD8 Immunoscore (p=0.44). A combination of the IM stromal area, DGMate and CD3, designated 'DGMuneS', outperformed Immunoscore when used in estimating patients' prognosis (C-index=0.601 vs 0.578, p=0.04) and was independently associated with patient outcomes following Cox multivariate analysis. A predictive nomogram based on DGMuneS and clinical variables identified a group of patients with less than 10% relapse risk and another group with a 50% relapse risk., Conclusion: These findings suggest that artificial intelligence can potentially improve patient care by assisting pathologists in better defining stage III colon cancer patients' prognosis., Competing Interests: Competing interests: JPL served on external advisory board or Sanofi Avantis France; received fee for travel from Ipsen, Novartis, Amgen, Roche; received fee for communication from Novartis and funding for research was provided by Merck Serono, Roche and MSD. DL received fee for travel from Merck Serono and Amgen. CL receives speakers bureau honoraria from Amgen, Novartis and Bayer and is a consultant/advisory board member for Novartis and Halio-DX. P-LP is a consultant/advisory board member for Merck Serono, Amgen, Boerhinger Ingelheim, Biocartis, Roche, Bristol-Myers Squibb and MSD. JT has received honoraria for speaker or advisory role from Sanofi, Roche, Merck, Amgen, Sirtex, Servier, Lilly, Celgene and MSD. FG served on external advisory boards for Roche. Research funding received from Roche, Genentech, Amgen, Enterome and Servier. Received funding for clinical trial from Astra Zeneca; received fee for communication from Amgen, Astra Zeneca, BMS, Sanofi, Merck-Serono and Servier and received fee for travel from Roche and Servier., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Published
2020
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22. Long survival of patients with metastatic clear cell renal cell carcinoma. Results of real life study of 344 patients.

Author

Voog E, Campillo-Gimenez B, Elkouri C, Priou F, Rolland F, Laguerre B, Elhannani C, Merrer J, Pfister C, Sevin E, L'Haridon T, Hasbini A, Moise L, Le Rol A, Malhaire JP, Delva R, Vauléon E, Cojocarasu O, Deguiral P, Cumin I, Cheneau C, Schlürmann F, Delecroix V, Boughalem E, Mollon D, Ligeza-Poisson C, Abadie-Lacourtoisie S, Monpetit E, Chatellier T, Desclos H, Coquan E, Joly F, Tessereau JY, Dupuy S, Déniel Lagadec D, Marhuenda F, and Grudé F

Subjects
Adult, Aged, Aged, 80 and over, Bevacizumab therapeutic use, Carcinoma, Renal Cell mortality, Everolimus therapeutic use, Female, France epidemiology, Humans, Kidney Neoplasms mortality, Male, Middle Aged, Molecular Targeted Therapy adverse effects, Molecular Targeted Therapy methods, Patient Selection, Prognosis, Prospective Studies, Risk Factors, Survival Analysis, Time Factors, Angiogenesis Inhibitors therapeutic use, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Carcinoma, Renal Cell drug therapy, Kidney Neoplasms drug therapy, Protein Kinase Inhibitors therapeutic use
Abstract

The treatment landscape in metastatic renal cell carcinoma has changed fundamentally over the last decade by the development of antiangiogenic agents, mammalian target of rapamycin inhibitors and immunotherapy. Outside of the context of a clinical trial, the treatments are used sequentially. We describe results under real-life conditions of a sequential treatment strategy, before the era of immunotherapy. All patients were treated according to their prognostic score (either Memorial Sloan Kettering Cancer Center or International Metastatic Renal Cell Carcinoma Database Consortium) for advanced renal cell carcinoma. A treatment strategy involving 1 to 4 lines was determined including a rechallenge criterion for the repeat use of a treatment class. Three hundred forty-four patients were included over 3 years. Overall survival was 57 months in patients with good or intermediate prognosis and 19 months in patients with poor prognosis. In the former group, the proportions of patients treated with 2 to 4 treatment lines were 70%, 38% and 16%, respectively. The best objective response rates for lines 1 to 4 were 46%, 36%, 16% and 17%, respectively. Grade III/IV toxicity did not appear to be cumulative. The recommended strategy was followed in 68% of patients. A large proportion of patients with good or intermediate prognosis who progress after two lines of treatment still have a performance status good enough to receive a systemic treatment, which justifies such a strategy. Overall survival of patients with good and intermediate prognosis was long, suggesting a benefit from the applied approach. These results might be used as selection criterion for the treatment of patients in the era of immune checkpoint inhibitors., (© 2019 UICC.)

Published
2020
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23. Predictive factors for early progression during induction chemotherapy and chemotherapy-free interval: analysis from PRODIGE 9 trial.

Author

Aparicio T, Bennouna J, Le Malicot K, Boige V, Taieb J, Bouché O, Phelip JM, François E, Borel C, Faroux R, Dahan L, Bachet JB, Egreteau J, Kaminsky MC, Gornet JM, Cojocarasu O, Gasmi M, Guerin-Meyer V, Lepage C, and Ghiringhelli F

Subjects
Aged, Disease Progression, Female, Humans, Male, Colorectal Neoplasms drug therapy, Induction Chemotherapy methods
Abstract

Background: Identifying patients with metastatic colorectal cancer who will have an early disease progression during induction chemotherapy (IC) and identifying patients who may have a chemotherapy-free interval (CFI) after IC are two major challenges., Methods: A logistic model was used to identify factors associated with early progression during IC and with short duration of the first CFI in 488 patients enrolled in the PRODIGE 9 trial. Independent factors were defined with a threshold 0.10., Results: In multivariate analysis, baseline leukocytes >10 × 10 9 /L (OR = 1.98 [1.02-3.8], p = 0.04), and stable or increasing CEA at 2 months (OR = 3.61 [1.68-7.75], p = 0.01) were independent factors associated with progression during IC. Male gender (OR = 1.725 [0.92-3.325], p = 0.09) and no tumour response at first evaluation (OR = 1.90 [0.96-3.76], p = 0.07) were significantly associated with a short CFI. The presence of BRAF V600E mutation was also associated with short CFI (OR = 4.59 [0.95; 22.3], p = 0.058)., Conclusion: High baseline leukocyte count and the lack of CEA decrease level at first evaluation were associated with early progression, and could be in favour of early chemotherapy intensification. Male gender, no tumour response at first evaluation and BRAF mutation are associated with a short CFI, and may be considered for maintenance chemotherapy after IC., Clinical Trial Number: NCT00952029.

Published
2020
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24. Non-pegylated liposomal doxorubicin (NPLD, Myocet®) + carboplatin in patients with platinum sensitive ovarian cancers: A ARCAGY-GINECO phase IB-II trial.

Author

Romeo C, Joly F, Ray-Coquard I, El Kouri C, Mercier-Blas A, Berton-Rigaud D, Kalbacher E, Cojocarasu O, Fabbro M, Cretin J, Zannetti A, Abadie-Lacourtoisie S, Mollon D, Hardy-Bessard AC, Provansal M, Blot E, Delbaldo C, Lesoin A, Freyer G, and You B

Subjects
Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols adverse effects, Carboplatin administration & dosage, Doxorubicin administration & dosage, Doxorubicin analogs & derivatives, Female, Humans, Middle Aged, Ovarian Neoplasms mortality, Polyethylene Glycols administration & dosage, Prospective Studies, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Ovarian Neoplasms drug therapy
Abstract

Background: Carboplatin and pegylated liposomal doxorubicin combination is a standard regimen in platinum-sensitive recurrent ovarian cancer patients. The pegylated liposomal doxorubicin shortage from 2011 to 2013 urged assessment of the efficacy and tolerance of non-pegylated liposomal doxorubicin in combination with carboplatin., Methods: MYCA was a multicenter 2-step phase Ib-II single arm trial meant to assess the safety and efficacy of carboplatin AUC 5 mg/min.mL combined with non-pegylated liposomal (dose escalation from 40 to 50 mg/m 2 during phase Ib step; and 50 mg/m2 during phase II step), every 4 weeks in patients with platinum-sensitive relapse. The primary objective was disease control rate (DCR) at 12 months., Results: From 2012 to 2014, 87 patients were enrolled. They were treated as second (78%) or third line (22%) treatment. Total of 67 patients (78%) completed 6 cycles. G-CSF support was prescribed to 58% patients. The DCR at 12 months was 30.0% (95% CI, 20.3-39.7); the median PFS was 10.0 months (95% CI, 8.6-11.0). The median overall survival was 28.1 months (95% CI, 22.3-32.5); and the objective response rate was 58% (95% CI, 47-68). Grade 3-4 neutropenia, anemia and thrombocytopenia were observed in 17%, 13% and 1%, respectively; febrile neutropenia in 6%. One patient who did not receive GCSF support died from febrile neutropenia., Conclusion: Non-pegylated liposomal doxorubicin-carboplatin combination exhibits an acceptable safety profile, with GCSF prophylaxis. Acknowledging the lack of direct comparison, efficacy in terms of 12 month DCR was comparable with standard treatments., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Published
2019
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25. Assessment of the prognostic role of a 94-single nucleotide polymorphisms risk score in early breast cancer in the SIGNAL/PHARE prospective cohort: no correlation with clinico-pathological characteristics and outcomes.

Author

Curtit E, Pivot X, Henriques J, Paget-Bailly S, Fumoleau P, Rios M, Bonnefoi H, Bachelot T, Soulié P, Jouannaud C, Bourgeois H, Petit T, Tennevet I, Assouline D, Mathieu MC, Jacquin JP, Lavau-Denes S, Darut-Jouve A, Ferrero JM, Tarpin C, Lévy C, Delecroix V, Trillet-Lenoir V, Cojocarasu O, Meunier J, Pierga JY, Kerbrat P, Faure-Mercier C, Blanché H, Sahbatou M, Boland A, Bacq D, Besse C, Thomas G, Deleuze JF, Pauporté I, Romieu G, and Cox DG

Subjects
Adult, Aged, Aged, 80 and over, Alleles, Biomarkers, Tumor, Breast Neoplasms pathology, Clinical Trials, Phase III as Topic, Cohort Studies, Female, Genotype, Humans, Middle Aged, Neoplasm Grading, Neoplasm Metastasis, Neoplasm Staging, Prognosis, Randomized Controlled Trials as Topic, Survival Analysis, Tumor Burden, Young Adult, Breast Neoplasms genetics, Breast Neoplasms mortality, Genetic Association Studies, Genetic Predisposition to Disease, Polymorphism, Single Nucleotide
Abstract

Background: Genome-wide association studies (GWAS) have to date identified 94 genetic variants (single nucleotide polymorphisms (SNPs)) associated with risk of developing breast cancer. A score based on the combined effect of the 94 risk alleles can be calculated to measure the global risk of breast cancer. We aimed to test the hypothesis that the 94-SNP-based risk score is associated with clinico-pathological characteristics, breast cancer subtypes and outcomes in early breast cancer., Methods: A 94-SNP risk score was calculated in 8703 patients in the PHARE and SIGNAL prospective case cohorts. This score is the total number of inherited risk alleles based on 94 selected SNPs. Clinical data and outcomes were prospectively registered. Genotyping was obtained from a GWAS., Results: The median 94-SNP risk score in 8703 patients with early breast cancer was 77.5 (range: 58.1-97.6). The risk score was not associated with usual prognostic and predictive factors (age; tumor, node, metastasis (TNM) status; Scarff-Bloom-Richardson grade; inflammatory features; estrogen receptor status; progesterone receptor status; human epidermal growth factor receptor 2 (HER2) status) and did not correlate with breast cancer subtypes. The 94-SNP risk score did not predict outcomes represented by overall survival or disease-free survival., Conclusions: In a prospective case cohort of 8703 patients, a risk score based on 94 SNPs was not associated with breast cancer characteristics, cancer subtypes, or patients' outcomes. If we hypothesize that prognosis and subtypes of breast cancer are determined by constitutional genetic factors, our results suggest that a score based on breast cancer risk-associated SNPs is not associated with prognosis., Trial Registration: PHARE cohort: NCT00381901 , Sept. 26, 2006 - SIGNAL cohort: INCa RECF1098, Jan. 28, 2009.

Published
2017
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26. In reply.

Author

Boisdron-Celle M, Capitain O, Faroux R, Borg C, Philippe Metges J, Galais MP, Kaassis M, Bennouna J, Bouhier-Leporrier K, Francois E, Baumgaertner I, Guerin-Meyer V, Cojocarasu O, Roemer-Becuwe C, Stampfli C, Rosenfeld L, Lecompte T, Berger V, Morel A, and Gamelin E

Subjects
Fluorouracil, Humans, Dihydropyrimidine Dehydrogenase Deficiency
Published
2017
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27. Constitutional variants are not associated with HER2-positive breast cancer: results from the SIGNAL/PHARE clinical cohort.

Author

Pivot X, Romieu G, Fumoleau P, Rios M, Bonnefoi H, Bachelot T, Soulié P, Jouannaud C, Bourgeois H, Petit T, Tennevet I, Assouline D, Mathieu MC, Jacquin JP, Lavau-Denes S, Darut-Jouve A, Ferrero JM, Tarpin C, Lévy C, Delecroix V, Trillet-Lenoir V, Cojocarasu O, Meunier J, Pierga JY, Agostini C, Kerbrat P, Faure-Mercier C, Blanché H, Sahbatou M, Boland A, Bacq D, Besse C, Calvo F, Renaud A, Deleuze JF, Pauporté I, Thomas G, and Cox DG

Abstract

Human epidermal growth factor receptor 2-positive breast cancer is a subtype of interest regarding its outcome and the impressive impact of human epidermal growth factor receptor 2 targeted therapy. Constitutional variants may be involved in the aetiology of human epidermal growth factor receptor 2-positive breast cancer, and we propose a case-case study to test the hypothesis that single nucleotide polymorphisms may be associated with human epidermal growth factor receptor 2 status. A Genome-Wide Association Study was used in a cohort of 9836 patients from the SIGNAL/PHARE study (NCT00381901-RECF1098). The main goal was to identify variants specifically related to human epidermal growth factor receptor 2-positive breast cancer. A two-staged genotyping strategy was carried out to cover as large a proportion of the genome as possible. All subjects were genotyped using the Illumina HumanCore Exome chip set. Principal Components Analysis and k -means were then used to characterize the ancestry of the participants. A random sample of subjects from the main "European" cluster was genotyped with the Omni5 chip set. These data were then used to impute missing genotypes from the remaining subjects genotyped only using the HumanCore Exome array. From the 9836 patients, a total of 8703 cases including 3230 patients with human epidermal growth factor receptor 2-positive breast cancer were analyzed. Despite having 80% power to detect an odds ratio of 1.23 in this population, no variant achieved genome-wide significance for association with the occurrence of human epidermal growth factor receptor 2-positive breast cancer vs. any other subtype of breast tumour. Our study was unable to identify constitutional polymorphisms that are strongly associated with human epidermal growth factor receptor 2-positive status among breast cancer patients.

Published
2017
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28. Prevention of 5-fluorouracil-induced early severe toxicity by pre-therapeutic dihydropyrimidine dehydrogenase deficiency screening: Assessment of a multiparametric approach.

Author

Boisdron-Celle M, Capitain O, Faroux R, Borg C, Metges JP, Galais MP, Kaassis M, Bennouna J, Bouhier-Leporrier K, Francois E, Baumgaertner I, Guerin-Meyer V, Cojocarasu O, Roemer-Becuwe C, Stampfli C, Rosenfeld L, Lecompte T, Berger V, Morel A, and Gamelin E

Subjects
Adult, Aged, Aged, 80 and over, Cohort Studies, Dihydrouracil Dehydrogenase (NADP) genetics, Genotype, Humans, Middle Aged, Polymorphism, Single Nucleotide, Prospective Studies, Antimetabolites, Antineoplastic toxicity, Dihydropyrimidine Dehydrogenase Deficiency diagnosis, Fluorouracil toxicity
Abstract

5-Fluorouracil (5-FU)-based treatments can lead to early-onset severe (4%-5%) even fatal (0.3%) toxicities in patients with dihydropyrimidine dehydrogenase (DPD) deficiency. This multicenter prospective cohort study aimed to assess the clinical benefit of pretherapeutic screening for DPD deficiency using a multiparametric approach. Two parallel cohorts of patients treated with 5-FU-based chemotherapy for colorectal carcinoma were compared in a prospective nonrandomized study. In arm A, patients had DPD deficiency screening before treatment, whereas in arm B no pretherapy screening was performed. Dosing was based on 5-FU administration guidelines of each institution. DPD deficiency screening was performed using a combined multiparametric approach (5-FU ODPM Tox ). The frequency of early grade 4-5 toxic events potentially induced by 5-FU was compared in the two groups. At total of 1,142 patients (n = 1,116 evaluable) were enrolled. In arm A, out of 718 evaluable patients, nine grade 4 early toxicities potentially related to 5-FU were reported in nine patients (1.2%) with no toxic death despite one complete DPD deficiency and 24 partial deficiencies. The 24 patients with partial deficiency had safe pharmacokinetics (PK)-monitored 5-FU. In arm B, among 398 evaluable patients, 17 grade 4-5 toxic early events potentially related to 5-FU were reported in 12 patients (4.2%). The incidence of early severe toxicity was significantly higher in arm B (P = .0019), confirming the positive impact of pretherapeutic DPD assessment. The percent of patients with a toxicity grade 3 or higher observed in arm A was 10.8% (n = 78) compared to 17.55% (n = 69)  in arm B (P = .0497). The percentage of death was reduced from 2.5/1,000 in arm B to 0 in arm A. The time to occurrence of all grade ≥3 toxicities was determined in both arms and the difference between the two arms was significant (P = .047). Overall, one patient with complete DPD deficiency confirmed retrospectively died within 13 days from grade 5 multivisceral toxicity. Enrollment was prematurely closed after external experts' decision. In conclusion, multiparametric pretherapeutic DPD deficiency screening significantly lowered the risk of early severe toxicity and avoided an early toxic death. This approach should be used for safe administration of 5-FU-based treatments., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Published
2017
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29. GWAS in the SIGNAL/PHARE clinical cohort restricts the association between the FGFR2 locus and estrogen receptor status to HER2-negative breast cancer patients.

Author

Cox DG, Curtit E, Romieu G, Fumoleau P, Rios M, Bonnefoi H, Bachelot T, Soulié P, Jouannaud C, Bourgeois H, Petit T, Tennevet I, Assouline D, Mathieu MC, Jacquin JP, Lavau-Denes S, Darut-Jouve A, Ferrero JM, Tarpin C, Lévy C, Delecroix V, Trillet-Lenoir V, Cojocarasu O, Meunier J, Pierga JY, Faure-Mercier C, Blanché H, Sahbatou M, Boland A, Bacq D, Besse C, Deleuze JF, Pauporté I, Thomas G, and Pivot X

Subjects
Clinical Trials, Phase III as Topic, Cohort Studies, Female, Genetic Predisposition to Disease, Humans, Polymorphism, Single Nucleotide, Randomized Controlled Trials as Topic, Receptors, Estrogen genetics, Biomarkers, Tumor, Breast Neoplasms genetics, Genome-Wide Association Study, Receptor, ErbB-2 genetics, Receptor, Fibroblast Growth Factor, Type 2 genetics
Abstract

Genetic polymorphisms are associated with breast cancer risk. Clinical and epidemiological observations suggest that clinical characteristics of breast cancer, such as estrogen receptor or HER2 status, are also influenced by hereditary factors. To identify genetic variants associated with pathological characteristics of breast cancer patients, a Genome Wide Association Study was performed in a cohort of 9365 women from the French nationwide SIGNAL/PHARE studies (NCT00381901/RECF1098). Strong association between the FGFR2 locus and ER status of breast cancer patients was observed (ER-positive n=6211, ER-negative n=2516; rs3135718 OR=1.34 p=5.46×10-12). This association was limited to patients with HER2-negative tumors (ER-positive n=4267, ER-negative n=1185; rs3135724 OR=1.85 p=1.16×10-11). The FGFR2 locus is known to be associated with breast cancer risk. This study provides sound evidence for an association between variants in the FGFR2 locus and ER status among breast cancer patients, particularly among patients with HER2-negative disease. This refinement of the association between FGFR2 variants and ER-status to HER2-negative disease provides novel insight to potential biological and clinical influence of genetic polymorphisms on breast tumors.

Published
2016
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30. Clinical benefits of non-taxane chemotherapies in unselected patients with symptomatic metastatic castration-resistant prostate cancer after docetaxel: the GETUG-P02 study.

Author

Joly F, Delva R, Mourey L, Sevin E, Bompas E, Vedrine L, Ravaud A, Eymard JC, Tubiana-Mathieu N, Linassier C, Houede N, Guillot A, Ringensen F, Cojocarasu O, Valenza B, Leconte A, Lheureux S, Clarisse B, and Oudard S

Subjects
Age Factors, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols adverse effects, Docetaxel, Etoposide administration & dosage, Etoposide adverse effects, Humans, Male, Middle Aged, Mitoxantrone administration & dosage, Mitoxantrone adverse effects, Neoplasm Metastasis, Palliative Care, Prednisone administration & dosage, Prednisone adverse effects, Prostatic Neoplasms, Castration-Resistant pathology, Taxoids administration & dosage, Taxoids adverse effects, Vinblastine administration & dosage, Vinblastine adverse effects, Vinblastine analogs & derivatives, Vinorelbine, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Prostatic Neoplasms, Castration-Resistant drug therapy
Abstract

Objective: To evaluate the overall benefits of non-taxane chemotherapies in a non-selected population including unfit patients presenting with symptoms and pain., Patients and Methods: This randomized phase II study reports data from 92 patients (52% >70 years old; 40% with a performance score of 2) previously treated with taxane-based chemotherapy, collected from 15 centres in France. Patients received i.v. mitoxantrone (MTX), oral vinorelbine, or oral etoposide, together with oral prednisone. Palliative benefit (pain response without progression of the disease), biological and tumoural responses, and toxicity profile as well as geriatric assessment (in elderly population) were analysed on an intention-to-treat basis., Results: The palliative response rate was 17% for the whole population, and reached 29% when considering the MTX arm. Pain control was achieved in 40% of the patients. The median overall survival was 10.4 months, and was longer in palliative responders. Few grade 3-4 toxicities were observed. The subgroup analysis of elderly patients showed similar results regarding the number and dose intensity of treatments, efficacy and safety., Conclusion: In a population including frail and/or elderly patients, who are poorly represented in most clinical studies, non-taxane chemotherapy may remain a relevant option for metastatic prostate cancer having relapsed after a docetaxel-based regimen. Although new treatment options are now approved, the decision-making process should take into account their expected benefit/risk ratio based on the patient status., (© 2013 The Authors. BJU International © 2013 BJU International.)

Published
2015
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