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2. Erdafitinib versus pembrolizumab in pretreated patients with advanced or metastatic urothelial cancer with select FGFR alterations: cohort 2 of the randomized phase III THOR trial

Author

Bastick, Patricia, Sewak, Sanjeev, Tran, Ben, Pichler, Martin, Shariat, Shahrokh, Rottey, Sylvie, Schatteman, Peter, Schrijvers, Dirk, Verschaeve, Vincent, Vulsteke, Christof, Barros Leite Ferreira, Luiza Aleixo, de Santana Gomes Andrea Juliana, Pereira, Junior, Joao Antonio, Azevedo, Sergio, Bastos, Diogo, Borges, Giuliano, Dettino, Aldo, Antonio, Pires Luis, Luz, Murilo, Martins, Suelen, Mota, Jose Mauricio, Toledo, Joseane, Eigl, Bernhard, Finch, Daygen, Gingerich, Joel, Dong, Haiying, Huang, Jian, Jin, Jie, Pan, Hongming, Sun, Zhongquan, Tian, Ye, Wan, Ben, Wu, Bin, Xu, Ting, Xue, Wei, Zhou, Fangjian, Barthelemy, Philippe, Borchiellini, Delphine, Calcagno, Fabien, Carnot, Aurelien, Cornillon, Pierre, Delva, Remy, Emambux, Sheik, Houede, Nadine, Laguerre, Brigitte, Lauridant, Géraldine, Loriot, Yohann, Mahammedi, Hakim, Maillet, Denis, Pouessel, Damien, Roubaud, Guilhem, Schlurmann-Constans, Friederike, Tosi, Diego, Zanetta, Sylvie, Banek, Severine, Feyerabend, Susan, Kramer, Mario, Niegisch, Guenther, Nuhn, Philipp, Schnabel, Marco, Wuelfing, Christian, Baka, Sofia, Bamias, Aristotelis, Fountzilas, George, Kalofonos, Harabolos, Karalis, Konstantinos, Kotsakis, Athanasios, Timotheadou, Eleni, Landherr, Laszlo, Mangel, Laszlo, Pe’er, Avivit, Levratovsky, Meital, Basso, Umberto, Battelli, Nicola, Cavo, Alessia, De Giorgi, Ugo, Doni, Laura, Galli, Luca, Gigante, Maria Olga, Guadalupi, Valentina, Maio, Michele, Milesi, Laura, Nolè, Franco, Scagliotti, Giorgio, Tortora, Giampaolo, Fukasawa, Satoshi, Harabayashi, Toru, Kamiya, Naoto, Kawahara, Takashi, Kawakita, Mutsushi, Matsubara, Nobunaki, Matsumoto, Kazumasa, Nishimura, Kazuo, Rikiya, Taoka, Shimizu, Nobuaki, Tagaki, Toshio, Kang, Taek Won, Kim, Jwa Hoon, Kim, SeHyun, Lee, Hyo Jin, Lee, Yun-Gyoo, Rha, Sun Young, Seo, Ho Kyung, Los, Maartje, Zurawski, Bogdan, Cortes, Paulo, Faustino, Catia, Vau, Nuno Sineiro, da Luz, Ricardo, Atduev, Vagif, Kirtbaya, Dmitry, Kopyltsov, Evgeny, Lykov, Aleksandr, Marat, Urmantsev, Orlov, Sergey, Penkov, Konstantin, Pirmagomedov, Albert, Semenov, Andrey, Varlamov, Sergey, Anguera, Georgia, Domenech, Montserrat, Girones, Regina, Gonzalez del Alba, Aranzazu, Milagro, Nuria Lainez, Luque, Raquel, Ortega, Esther Martínez, Mellado, Begoña, Méndez Vidal, María Jose, Fernandez, Esteban Nogales, Valderrama, Begoña Perez, Marín, Alvaro Pinto, Santander, Carmen, Huang, Yi-Hsiu, Su, Wen-Pin, Wu, Hung-Chan, Wu, WenJeng, Yu, Kai-Jie, Bilici, Ahmet, Goker, Erdem, Gumus, Mahmut, Karaoglu, Aziz, Kefeli, Umut, Köse, Fatih, Ozguroglu, Mustafa, Tural, Deniz, Turk, Haci, Yalcin, Suayib, Bondarenko, Igor, Khareba, Gennadii, Kidik, Yana, Lychkovskyy, Oleksandr, Sakalo, Valerii, Shevnia, Serghii, Stakhovskyy, Eduard, Bahl, Amit, Crabb, Simon, Powles, Thomas, Sankey, Peter, Sarwar, Mohammad, Benedetto, Pasquale, Burgess, Earle, Dawson, Nancy, Doshi, Gurjyot, Fleming, Mark, Maly, Joseph, Parikh, Mamta, Waterhouse, David, Siefker-Radtke, A.O., Matsubara, N., Park, S.H., Huddart, R.A., Burgess, E.F., Özgüroğlu, M., Valderrama, B.P., Laguerre, B., Basso, U., Triantos, S., Akapame, S., Kean, Y., Deprince, K., Mukhopadhyay, S., and Loriot, Y.

Published
2024
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4. 1389P Two-year follow-up of KEYNOTE-365 cohort D: Pembrolizumab (pembro) plus abiraterone acetate (abi) and prednisone in patients with chemotherapy-naive metastatic castration-resistant prostate cancer (mCRPC)

Author

Linch, M., primary, Ferrario, C., additional, Stoeckle, M., additional, Laguerre, B., additional, Arranz Arija, J.A., additional, Todenhöfer, T., additional, Fong, P.C., additional, Piulats Rodriguez, J.M., additional, Berry, W., additional, Emmenegger, U., additional, Mourey, L., additional, Mar, N., additional, Appleman, L.J., additional, Joshua, A., additional, Conter, H.J., additional, Li, X.T., additional, Schloss, C., additional, Poehlein, C.H., additional, de Bono, J.S., additional, and Yu, E.Y., additional

Published
2022
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5. 1480P Baseline levels of proinflammatory cytokines according to body mass index (BMI) and BMI impact on clinical outcomes in metastatic renal cell carcinoma (mRCC) patients (pts) treated with nivolumab (NIVO) within the NIVOREN trial

Author

Colomba, E., primary, Carril Ajuria, L., additional, Dalban, C., additional, Derosa, L., additional, Alves Costa Silva, C., additional, Rassy, E., additional, Negrier, S., additional, Chevreau, C.M., additional, Gravis Mescam, G., additional, Oudard, S., additional, Laguerre, B., additional, Barthelemy, P., additional, Gross Goupil, M., additional, Geoffrois, L., additional, Thiery-Vuillemin, A., additional, Joly Lobbedez, F., additional, Ladoire, S., additional, Tantot, F., additional, Escudier, B., additional, and Albiges, L., additional

Published
2022
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7. 1710P Exposure-response (E/R) relationship of nivolumab (N) and ipilimumab (I) in patients (pts) with metastatic renal cell clear cell carcinoma (mRCC) from the randomised phase II BIONIKK study

Author

Blanchet, B., Puszkiel, A.A., Jouinot, A., Bennamoun, M., Maillet, D., Borchiellini, D., Laguerre, B., Pannier, D., Gross Goupil, M., Chevreau, C.M., Barthelemy, P., Tournigand, C., Coquan, E., Gravis, G., Kotti, S., Fridman, W-H., Sautes-Fridman, C., Oudard, S., Sun, C-M., and Vano, Y-A.

Published
2024
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8. 1700P Impact of sarcomatoid (S) and rhabdoid (R) components (comp.) on the efficacy of nivolumab (N) +/- ipilimumab (I) in the first-line (L1) treatment of metastatic clear cell renal cell carcinoma (mRCC) in the randomized phase II BIONIKK trial

Author

Vano, Y-A., Hernandez, I., Bennamoun, M., Verkarre, V., Chevreau, C.M., Gross Goupil, M., Tournigand, C., Borchiellini, D., Laguerre, B., Maillet, D., Barthelemy, P., Gravis, G., Coquan, E., Pannier, D., Houede, N., Kotti, S., Fridman, W-H., Sautes-Fridman, C., Sun, C-M., and Oudard, S.

Published
2024
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11. KEYNOTE-365 cohort D: Pembrolizumab (pembro) plus abiraterone acetate (abi) and prednisone in chemotherapy (chemo)–naive patients with metastatic castration-resistant prostate cancer (mCRPC)

Author

Todenhöfer, T., primary, Piulats, J.M., additional, Ferrario, C., additional, Linch, M.D., additional, Stoeckle, M., additional, Laguerre, B., additional, Arranz, J.A., additional, Fong, P.C.C., additional, Berry, W.R., additional, Emmenegger, U., additional, Mourey, L., additional, Mar, N., additional, Appleman, L.J., additional, Joshua, A.M., additional, Conter, H.J., additional, Li, X.T., additional, Schloss, C., additional, Poehlein, C.H., additional, De Bono, J.S., additional, and Yu, E.Y., additional

Published
2022
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12. Abiraterone plus prednisone added to androgen deprivation therapy and docetaxel in de novo metastatic castration-sensitive prostate cancer (PEACE-1): a multicentre, open-label, randomised, phase 3 study with a 2 x 2 factorial design

Author

Fizazi, K, Foulon, S, Carles, J, Roubaud, G, McDermott, R, Flechon, A, Tombal, B, Supiot, S, Berthold, D, Ronchin, P, Kacso, G, Gravis, G, Calabro, F, Berdah, JF, Hasbini, A, Silva, M, Thiery-Vuillemin, A, Latorzeff, I, Mourey, L, Laguerre, B, Abadie-Lacourtoisie, S, Martin, E, El Kouri, C, Escande, A, Rosello, A, Magne, N, Schlurmann, F, Priou, F, Chand-Fouche, ME, Freixa, SV, Jamaluddin, M, Rieger, I, and Bossi, A

Abstract

Background Current standard of care for metastatic castration-sensitive prostate cancer supplements androgen deprivation therapy with either docetaxel, second-generation hormonal therapy, or radiotherapy. We aimed to evaluate the efficacy and safety of abiraterone plus prednisone, with or without radiotherapy, in addition to standard of care. Methods We conducted an open-label, randomised, phase 3 study with a 2 x 2 factorial design (PEACE-1) at 77 hospitals across Belgium, France, Ireland, Italy, Romania, Spain, and Switzerland. Eligible patients were male, aged 18 years or older, with histologically confirmed or cytologically confirmed de novo metastatic prostate adenocarcinoma, and an Eastern Cooperative Oncology Group performance status of 0-1 (or 2 due to bone pain). Participants were randomly assigned (1: 1:1:1) to standard of care (androgen deprivation therapy alone or with intravenous docetaxel 75 mg/m(2) once every 3 weeks), standard of care plus radiotherapy, standard of care plus abiraterone (oral 1000 mg abiraterone once daily plus oral 5 mg prednisone twice daily), or standard of care plus radiotherapy plus abiraterone. Neither the investigators nor the patients were masked to treatment allocation. The coprimary endpoints were radiographic progression-free survival and overall survival. Abiraterone efficacy was first assessed in the overall population and then in the population who received androgen deprivation therapy with docetaxel as standard of care (population of interest). This study is ongoing and is registered with ClinicalTrials.gov, NCT01957436. Findings Between Nov 27, 2013, and Dec 20, 2018, 1173 patients were enrolled (one patient subsequently withdrew consent for analysis of his data) and assigned to receive standard of care (n=296), standard of care plus radiotherapy (n=293), standard of care plus abiraterone (n=292), or standard of care plus radiotherapy plus abiraterone (n=291). Median follow-up was 3.5 years (IQR 2.8-4.6) for radiographic progression-free survival and 4.4 years (3.5-5.4) for overall survival. Adjusted Cox regression modelling revealed no interaction between abiraterone and radiotherapy, enabling the pooled analysis of abiraterone efficacy. In the overall population, patients assigned to receive abiraterone (n=583) had longer radiographic progression-free survival (hazard ratio [HR] 0.54, 99.9% CI 0.41-0.71; p

Published
2022

14. Dose dense methotrexate, vinblastine, doxorubicin et cisplatin (DD-MVAC) versus gemcitabine et cisplatin (GC) comme chimiothérapie péri-opératoire dans le cancer de vessie localisé infiltrant le muscle. résultats de la phase III GETUG/AFU vesper V05

Author

Pfister, C., primary, Gravis, G., additional, Flechon, A., additional, Chevreau, C., additional, Mahammedi, H., additional, Laguerre, B., additional, Guillot, A., additional, Joly, F., additional, Soulié, M., additional, Allory, Y., additional, Harter, V., additional, and Culine, S., additional

Published
2021
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15. 670P Cabozantinib associated with concomitant radiotherapy or a bone targeted agent (multimodal approach, results from the CABOREAL study post-hoc analysis)

Author

Gross-Goupil, M., primary, Fléchon, A., additional, Mourey, L., additional, Topart, D., additional, Gravis, G., additional, Oudard, S.M., additional, Tourani, J-M., additional, Geoffrois, L., additional, Meriaux, E., additional, Thiery-Vuillemin, A., additional, Barthelemy, P., additional, Ladoire, S., additional, Laguerre, B., additional, Zara, L., additional, Perrot, V., additional, Escudier, B., additional, and Albiges, L., additional

Published
2021
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16. 697P Impact of β-blockers (BB) on outcomes of metastatic renal cell carcinoma (mRCC) patients treated with nivolumab (N)

Author

Alves Costa Silva, C., primary, Derosa, L., additional, Dalban, C., additional, Colomba, E., additional, Negrier, S., additional, Chevreau, C.M., additional, Gravis, G., additional, Oudard, S.M., additional, Laguerre, B., additional, Barthelemy, P., additional, Borchiellini, D., additional, Gross-Goupil, M., additional, Geoffrois, L., additional, Rolland, F., additional, Thiery-Vuillemin, A., additional, Joly, F., additional, Ladoire, S., additional, Tantot, F., additional, Escudier, B., additional, and Albiges, L., additional

Published
2021
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17. 657MO Antibiotic (ATB) therapy and outcome from nivolumab (N) in metastatic renal cell carcinoma (mRCC) patients (pts): Results of the GETUG-AFU 26 NIVOREN multicentric phase II study

Author

Derosa, L., primary, Alves Costa Silva, C., additional, Dalban, C., additional, Colomba, E., additional, Negrier, S., additional, Chevreau, C.M., additional, Gravis, G., additional, Oudard, S.M., additional, Laguerre, B., additional, Barthelemy, P., additional, Borchiellini, D., additional, Gross-Goupil, M., additional, Geoffrois, L., additional, Rolland, F., additional, Thiery-Vuillemin, A., additional, Joly, F., additional, Ladoire, S., additional, Tantot, F., additional, Escudier, B., additional, and Albiges, L., additional

Published
2021
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18. 686P Angiogenesis related blood biomarkers of response to checkpoint inhibitors (IO) and VEGFR-TKI in metastatic renal cell carcinoma (mRCC): Results from the BIONIKK prospective trial

Author

Mauge, L., primary, Galy-Fauroux, I., additional, Elaidi, R-T., additional, Ben Dhia, L., additional, Bertil, S., additional, Bennamoun, M., additional, Chevreau, C.M., additional, Borchiellini, D., additional, Pannier, D., additional, Maillet, D., additional, Gross-Goupil, M., additional, Tournigand, C., additional, Laguerre, B., additional, Barthelemy, P., additional, Joly, F., additional, Gravis, G., additional, Zucman-Rossi, J., additional, Oudard, S.M., additional, Vano, Y., additional, and Helley, D., additional

Published
2021
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19. 652O Dose-dense methotrexate, vinblastine, doxorubicin and cisplatin (dd-MVAC) or gemcitabine and cisplatin (GC) as perioperative chemotherapy for patients with muscle-invasive bladder cancer (MIBC): Results of the GETUG/AFU VESPER V05 phase III trial

Author

Pfister, C., primary, Gravis, G., additional, Flechon, A., additional, Chevreau, C.M., additional, Mahammedi, H., additional, Laguerre, B., additional, Guillot, A., additional, Joly, F., additional, Soulie, M., additional, Allory, Y., additional, Harter, V., additional, and Culine, S., additional

Published
2021
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20. 73P Association between homologous recombination repair mutations and response to pembrolizumab (pembro) plus olaparib (ola) in metastatic castration-resistant prostate cancer (mCRPC): KEYNOTE-365 Cohort A biomarker analysis

Author

Yu, E., primary, Piulats, J.M., additional, Gravis, G., additional, Fong, P., additional, Todenhöfer, T., additional, Laguerre, B., additional, Arranz, J., additional, Oudard, S., additional, Massard, C., additional, Stoeckle, M., additional, Nordquist, L.T., additional, Carles, J., additional, Huang, M., additional, Li, Y., additional, Qiu, P., additional, Poehlein, C.H., additional, Schloss, C., additional, and de Bono, J., additional

Published
2021
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21. 612P Pembrolizumab (pembro) plus olaparib in patients with docetaxel-pretreated metastatic castration-resistant prostate cancer (mCRPC): Update of KEYNOTE-365 cohort A with a minimum of 11 months of follow-up for all patients

Author

Yu, E., primary, Piulats, J.M., additional, Gravis, G., additional, Fong, P.C.C., additional, Todenhöfer, T., additional, Laguerre, B., additional, Arranz Arija, J.A., additional, Oudard, S., additional, Massard, C., additional, Stoeckle, M., additional, Nordquist, L.T., additional, Carles, J., additional, Kolinsky, M.P., additional, Augustin, M., additional, Gurney, H., additional, Tafreshi, A., additional, Li, X.T., additional, Poehlein, C.H., additional, Schloss, C., additional, and de Bono, J.S., additional

Published
2021
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24. Cetuximab, docetaxel, and cisplatin versus platinum, fluorouracil, and cetuximab as first-line treatment in patients with recurrent or metastatic head and neck squamous-cell carcinoma (GORTEC 2014-01 TPExtreme): a multicentre, open-label, randomised, phase 2 trial

Author

Guigay, J, Auperin, A, Fayette, J, Saada-Bouzid, E, Lafond, C, Taberna, M, Geoffrois, L, Martin, L, Capitain, O, Cupissol, D, Castanie, H, Vansteene, D, Schafhausen, P, Johnson, A, Even, C, Sire, C, Duplomb, S, Evrard, C, Delord, JP, Laguerre, B, Zanetta, S, Chevassus-Clement, C, Fraslin, A, Louat, F, Sinigaglia, L, Keilholz, U, Bourhis, J, Mesia, R, Gallego, O, López Pousa A., and Vazquez Fernandez, Silvia

Abstract

Background Results from a phase 2 trial of the TPEx chemotherapy regimen (docetaxel-platinum-cetuximab) showed promising results, with a median overall survival of 14.0 months in first-line recurrent or metastatic head and neck squamous-cell carcinoma (HNSCC). We therefore aimed to compare the efficacy and safety of the TPEx regimen with the standard of care EXTREME regimen (platinum-fluorouracil-cetuximab) in this setting. Methods This was a multicentre, open-label, randomised, phase 2 trial, done in 68 centres (cancer centres, university and general hospitals, and private clinics) in France, Spain, and Germany. Eligible patients were aged 18-70 years with histologically confirmed recurrent or metastatic HNSCC unsuitable for curative treatment; had at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1; and had an Eastern Cooperative Oncology Group (ECOG) performance status of 1 or less. Participants were randomly assigned (1:1) using the TenAlea website by investigators or delegated clinical research associates to the TPEx regimen or the EXTREME regimen, with minimisation by ECOG performance status, type of disease evolution, previous cetuximab treatment, and country. The TPEx regimen consisted of docetaxel 75 mg/m(2) and cisplatin 75 mg/m(2), both intravenously on day 1, and cetuximab on days 1, 8, and 15 (intravenously 400 mg/m(2) on day 1 of cycle 1 and 250 mg/m(2) weekly subsequently). Four cycles were repeated every 21 days with systematic granulocyte colony-stimulating factor (G-CSF) support at each cycle. In case of disease control after four cycles, intravenous cetuximab 500 mg/m(2) was continued every 2 weeks as maintenance therapy until progression or unacceptable toxicity. The EXTREME regimen consisted of fluorouracil 4000 mg/m(2) on day 1-4, cisplatin 100 mg/m(2) on day 1, and cetuximab on days 1, 8, and 15 (400 mg/m(2) on day 1 of cycle 1 and 250 mg/m(2) weekly subsequently) all delivered intravenously. Six cycles were delivered every 21 days followed by weekly 250 mg/m(2) cetuximab as maintenance therapy in case of disease control. G-CSF support was not mandatory per the protocol in the EXTREME regimen. The primary endpoint was overall survival in the intention-to-treat population; safety was analysed in all patients who received at least one dose of chemotherapy or cetuximab. Enrolment is closed and this is the final analysis. This study is registered at ClinicalTrials.gov, NCT02268695. Findings Between Oct 10, 2014, and Nov 29, 2017, 541 patients were enrolled and randomly assigned to the two treatment regimens (271 to TPEx, 270 to EXTREME). Two patients in the TPEx group had major deviations in consent forms and were not included in the final analysis. Median follow-up was 34.4 months (IQR 26.6-44.8) in the TPEx group and 30.2 months (25.5-45.3) in the EXTREME group. At data cutoff, 209 patients had died in the TPEx group and 218 had died in the EXTREME group. Overall survival did not differ significantly between the groups (median 14.5 months [95% CI 12.5-15.7] in the TPEx group and 13.4 months [12.2-15.4] in the EXTREME group; hazard ratio 0.89 [95% CI 0.74-1.08]; p=0.23). 214 (81%) of 263 patients in the TPEx group versus 246 (93%) of 265 patients in the EXTREME group had grade 3 or worse adverse events during chemotherapy (p

Published
2021

25. 2364MO Durvalumab (D) +/- tremelimumab (T) in combination with dose-dense MVAC (ddMVAC) as neoadjuvant treatment in patients with muscle-invasive bladder carcinoma (MIBC): Results of NEMIO, a randomized phase I-II trial

Author

Thibault, C., Bennamoun, M., Flechon, A., Gravis, G., Pouessel, D., Combe, P-F., Borchiellini, D., Loriot, Y., Laguerre, B., Barthelemy, P., Gross Goupil, M., Helissey, C., Huillard, O., Cancel, M., Campedel, L., Audenet, F., Belhouari, H., Kotti, S., Tran, Y., and Oudard, S.

Published
2023
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27. Design of a randomized controlled phase III study of dose dense methotrexate, vinblastine, doxorubicin and cisplatin (dd-MVAC) or gemcitabine and cisplatin (GC) as peri-operative chemotherapy for patients with locally advanced transitional cell cancer of the bladder. The French GETUG/AFU V05 VESPER trial

Author

Grawis, G., Pignot, G., Flechon, A., Fendler, J.P., Chevreau, C., Soulie, M., Mahammedi, H., Guy, L., Laguerre, B., Verhoest, G., Guillot, A., Mottet, N., Joly, F., Doerfler, A., Abadie-Lacourtoisie, S., Azzouzi, A.R., Mongiat, P., Geoffrois, L., Eschwege, P., Di Fiore, F., Roubaud, G., Hoepffner, J.L., Barthelemy, P., Lang, H., Voog, E., Mandron, E., Tourani, J.M., Serrrate, C., Colau, A., Saldana, C., de La Taille, A., Nguyen, T., Kleinclauss, F., Loriot, Y., Irani, J., Eymard, J.C., Larre, S., Huillard, O., Zerbib, M., Rolland, F., Rigaud, J., Houede, N., Droupy, S., Malouf, G., Roupret, M., El Demery, M., Legon, C., Vieillot, S., Letang, N., Lharidon, T., Gaschignard, N., Hilgers, W., Davin, J.L., Pfister, Christian, Harter, Valentin, Allory, Yves, Radvanyi, François, and Culine, Stéphane

Published
2020
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28. Re: Androgen-Deprivation Therapy Alone or with Docetaxel in Non-Castrate Metastatic Prostate Cancer (GETUG-AFU 15): A Randomised, Open-Label, Phase 3 Trial

Author

Gravis, G., Fizazi, K., Joly, F., Oudard, S., Priou, F., Esterni, B., Latorzeff, I., Delva, R., Krakowski, I., Laguerre, B., Rolland, F., Théodore, C., Deplanque, G., Ferrero, J. M., Pouessel, D., Mourey, L., Beuzeboc, P., Zanetta, S., Habibian, M., Berdah, J. F., Dauba, J., Baciuchka, M., Platini, C., Linassier, C., Labourey, J. L., Machiels, J. P., El Kouri, C., Ravaud, A., Suc, E., Eymard, J. C., Hasbini, A., Bousquet, G., and Soulie, M.

Published
2013
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29. Erratum to ‘Clinical progression is associated with poor prognosis whatever the treatment line in metastatic castration-resistant prostate cancer: The CATS international database’ [European Journal of Cancer, Volume 125 (January 2020) Pages 153–163] (European Journal of Cancer (2020) 125 (153–163), (S0959804919308020), (10.1016/j.ejca.2019.10.030))

Author

Delanoy, N. Hardy-Bessard, A.-C. Efstathiou, E. Moulec, S.L. Basso, U. Birtle, A. Thomson, A. Krainer, M. Guillot, A. Giorgi, U.D. Hasbini, A. Daugaard, G. Bahl, A. Chowdhury, S. Caffo, O. Beuzeboc, P. Spaeth, D. Eymard, J.-C. Fléchon, A. Alexandre, J. Helissey, C. Butt, M. Priou, F. Lechevallier, E. Deville, J.-L. Gross-Goupil, M. Morales, R. Thiery-Vuillemin, A. Gavrikova, T. Barthélémy, P. Sella, A. Fizazi, K. Ferrero, J.-M. Laguerre, B. Thibault, C. Hans, S. Oudard, S.

Abstract

The publisher regrets that the following corrections were missed during the publication of this article. Figure 2 legend is missing from the published article and should appear as follows: Figure 2: Overall survival from initiation of each life-extending therapy in accordance with the type of progression in 661 patients with mCRPC. (A) OS from first life-extending therapy (LET) initiation (all arms combined), (B) OS from second LET initiation (all arms combined), and (C) OS from third LET initiation (all arms combined). Referring to Table 3, ‘Median OS (all arms combined) in months’, the 1st LET entry for the Clin-p column should appear as 30.7 [27.5; 32.9]. Referring to Figure 2A, median Clin-p should appear as 30.7 [27.5; 32.9]. The correct Figure is included here The publisher would like to apologise for any inconvenience caused. [Figure presented] © 2020 Elsevier Ltd

Published
2020

30. Kidney ccRCC immune classification (KIC) enhances the predictive value of T effector (Teff) and angiogenesis (Angio) signatures in response to nivolumab (N)

Author

Meylan, M., Beuselinck, B, Dalban, C., Vano, Y., Leclercq, N. Rioux, Sautès-Fridman, C., Roussel, E., Verbiest, A, Chaput, N., Terry, S., Chevreau, C., Gross-Goupil, M., Flechon, A, Laguerre, B., Chabaud, S., Tantot, F., Lambrechts, D., Escudier, B., Fridman, W.-H., Albiges, L., Centre de Recherche des Cordeliers (CRC (UMR_S_1138 / U1138)), École pratique des hautes études (EPHE), Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Université de Paris (UP), University Hospitals Leuven [Leuven], Centre Léon Bérard [Lyon], Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Institut de recherche en santé, environnement et travail (Irset), Université d'Angers (UA)-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-École des Hautes Études en Santé Publique [EHESP] (EHESP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), CHU Pontchaillou [Rennes], Institut Gustave Roussy (IGR), Analyse moléculaire, modélisation et imagerie de la maladie cancéreuse (AMMICa), Institut Gustave Roussy (IGR)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay-Centre National de la Recherche Scientifique (CNRS), Université Paris-Saclay, Institut Claudius Regaud, CHU Bordeaux [Bordeaux], Centre Eugène Marquis (CRLCC), AP-HP Hôpital Bicêtre (Le Kremlin-Bicêtre), UNICANCER, Leuven Center for Cancer Biology (VIB-KU-CCB), Catholic University of Leuven - Katholieke Universiteit Leuven (KU Leuven)-Vlaams Instituut voor Biotechnologie [Ghent, Belgique] (VIB), Institut National du CancerInstitut National du Cancer (INCA) France, Bristol-Myers SquibbBristol-Myers Squibb, École Pratique des Hautes Études (EPHE), Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Université Paris Cité (UPCité), and Université d'Angers (UA)-Université de Rennes (UR)-École des Hautes Études en Santé Publique [EHESP] (EHESP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique )

Subjects
[SDV]Life Sciences [q-bio], ComputingMilieux_MISCELLANEOUS
Abstract

International audience

Published
2020

31. Ramucirumab plus docetaxel versus placebo plus docetaxel in patients with locally advanced or metastatic urothelial carcinoma after platinum-based therapy (RANGE): overall survival and updated results of a randomised, double-blind, phase 3 trial

Author

Petrylak, D.P. de Wit, R. Chi, K.N. Drakaki, A. Sternberg, C.N. Nishiyama, H. Castellano, D. Hussain, S.A. Fléchon, A. Bamias, A. Yu, E.Y. van der Heijden, M.S. Matsubara, N. Alekseev, B. Necchi, A. Géczi, L. Ou, Y.-C. Coskun, H.S. Su, W.-P. Bedke, J. Gakis, G. Percent, I.J. Lee, J.-L. Tucci, M. Semenov, A. Laestadius, F. Peer, A. Tortora, G. Safina, S. Garcia del Muro, X. Rodriguez-Vida, A. Cicin, I. Harputluoglu, H. Tagawa, S.T. Vaishampayan, U. Aragon-Ching, J.B. Hamid, O. Liepa, A.M. Wijayawardana, S. Russo, F. Walgren, R.A. Zimmermann, A.H. Hozak, R.R. Bell-McGuinn, K.M. Powles, T. Wong, S.-L.S. Tan, T.H. Hovey, E.J. Clay, T.D. Wan Ng, S.S. Rutten, A. Machiels, J.-P. Dumez, H. Cheng, S.Y.-S. Ferrario, C. Sengeloev, L. Jensen, N.V. Thibault, C. Laguerre, B. Joly, F. Culine, S. Becht, C. Niegisch, G. Stöckle, M. Grimm, M.-O. Schwentner, C.A. Schultze-Seemann, W. Kalofonos, H. Mavroudis, D. Papandreou, C. Karavasilis, V. Révész, J. Rosenbaum, E. Leibowitz-Amit, R. Kejzman, D. Sarid, D. Scagliotti, G.V. Bracarda, S. Massari, F. Osawa, T. Miyajima, N. Shinohara, N. Fukuta, F. Ohyama, C. Obara, W. Yamashita, S. Tomita, Y. Kawai, K. Fukasawa, S. Oyama, M. Yonese, J. Nagata, M. Uemura, M. Nishimura, K. Kawakita, M. Tsunemori, H. Hashine, K. Inokuchi, J. Yokomizo, A. Nagamori, S. Lee, H.J. Park, S.H. Rha, S.Y. Kim, Y.J. Lee, Y.-G. Vazquez Cortés, L. Lorena Urzua Flores, C. Blaisse, R.J.B. Erdkamp, F.L.G. Aarts, M.J.B. Wojcik-Tomaszewska, J. Tomczak, P. Sikora-Kupis, B. Schenker, M. Herzal, A.A. Udrea, A.A. Karlov, P. Fomkin, R. Gajate Borau, P. Grande, E. Delgado Mignorance, J.I. Su, Y.-L. Li, J.-R. Lin, C.-L. Lin, C.-C. Yeh, S.-P. Erman, M. Urun, Y. Golovko, Y. Bondarenko, I. Sinielnikov, I. Crabb, S.J. Syndikus, I. Huddart, R. Sundar, S. Chowdhury, S. Sarwar, N. Flaig, T.W. Pan, C.X. Schwarz, J.K. Cultrera, J.L. Acs, P.I. Hainsworth, J.D. Herms, B.T. Lawler, W.E. Lowe, T.E.

Abstract

Background: Ramucirumab—an IgG1 vascular endothelial growth factor receptor 2 antagonist—plus docetaxel was previously reported to improve progression-free survival in platinum-refractory, advanced urothelial carcinoma. Here, we report the secondary endpoint of overall survival results for the RANGE trial. Methods: We did a randomised, double-blind, phase 3 trial in patients with advanced or metastatic urothelial carcinoma who progressed during or after platinum-based chemotherapy. Patients were enrolled from 124 investigative sites (hospitals, clinics, and academic centres) in 23 countries. Previous treatment with one immune checkpoint inhibitor was permitted. Patients were randomly assigned (1:1) using an interactive web response system to receive intravenous ramucirumab 10 mg/kg or placebo 10 mg/kg volume equivalent followed by intravenous docetaxel 75 mg/m2 (60 mg/m2 in Korea, Taiwan, and Japan) on day 1 of a 21-day cycle. Treatment continued until disease progression, unacceptable toxicity, or other discontinuation criteria were met. Randomisation was stratified by geographical region, Eastern Cooperative Oncology Group performance status at baseline, and visceral metastasis. Progression-free survival (the primary endpoint) and overall survival (a key secondary endpoint) were assessed in the intention-to-treat population. The study is registered with ClinicalTrials.gov, NCT02426125; patient enrolment is complete and the last patient on treatment is being followed up for safety issues. Findings: Between July 20, 2015, and April 4, 2017, 530 patients were randomly allocated to ramucirumab plus docetaxel (n=263) or placebo plus docetaxel (n=267) and comprised the intention-to-treat population. At database lock (March 21, 2018) for the final overall survival analysis, median follow-up was 7·4 months (IQR 3·5–13·9). In our sensitivity analysis of investigator-assessed progression-free survival at the overall survival database lock, median progression-free survival remained significantly improved with ramucirumab compared with placebo (4·1 months [95% CI 3·3–4·8] vs 2·8 months [2·6–2·9]; HR 0·696 [95% CI 0·573–0·845]; p=0·0002). Median overall survival was 9·4 months (95% CI 7·9–11·4) in the ramucirumab group versus 7·9 months (7·0–9·3) in the placebo group (stratified HR 0·887 [95% CI 0·724–1·086]; p=0·25). Grade 3 or worse treatment-related treatment-emergent adverse events in 5% or more of patients and with an incidence more than 2% higher with ramucirumab than with placebo were febrile neutropenia (24 [9%] of 258 patients in the ramucirumab group vs 16 [6%] of 265 patients in the placebo group) and neutropenia (17 [7%] of 258 vs six [2%] of 265). Serious adverse events were similar between groups (112 [43%] of 258 patients in the ramucirumab group vs 107 [40%] of 265 patients in the placebo group). Adverse events related to study treatment and leading to death occurred in eight (3%) patients in the ramucirumab group versus five (2%) patients in the placebo group. Interpretation: Additional follow-up supports that ramucirumab plus docetaxel significantly improves progression-free survival, without a significant improvement in overall survival, for patients with platinum-refractory advanced urothelial carcinoma. Clinically meaningful benefit might be restricted in an unselected population. Funding: Eli Lilly and Company. © 2020 Elsevier Ltd

Published
2020

32. Corrigendum to 'Clinical progression is associated with poor prognosis whatever the treatment line in metastatic castration resistant prostate cancer: The CATS international database' [Eur J Canc 125, (January 2020) 153–163] (European Journal of Cancer (2020) 125 (153–163), (S0959804919308020), (10.1016/j.ejca.2019.10.030))

Author

Delanoy, N. Hardy-Bessard, A.-C. Efstathiou, E. Le Moulec, S. Basso, U. Birtle, A. Thomson, A. Krainer, M. Guillot, A. De Giorgi, U. Hasbini, A. Daugaard, G. Bahl, A. Chowdhury, S. Caffo, O. Beuzeboc, P. Spaeth, D. Eymard, J.-C. Fléchon, A. Alexandre, J. Helissey, C. Butt, M. Priou, F. Lechevallier, E. Deville, J.-L. Gross-Goupil, M. Morales, R. Thiery-Vuillemin, A. Gavrikova, T. Barthélémy, P. Sella, A. Fizazi, K. Ferrero, J.-M. Laguerre, B. Thibault, C. Hans, S. Oudard, S.

Abstract

The authors regret that the affiliation details for Ugo De Giorgi were incomplete in the original publication. The full affiliation is k Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy The authors would like to apologise for any inconvenience caused. © 2020 Elsevier Ltd

Published
2020

33. Carcinome à cellules claire métastatique : la radiomique comme biomarqueur prédictif de la survie des patients traités par nivolumab

Author

Khene, Z., primary, Brassier, M., additional, Kokorian, R., additional, Mathieu, R., additional, Peyronnet, B., additional, Gasmi, A., additional, Rioux-Leclercq, N., additional, Kammerer-Jacquet, S., additional, Shariat, S., additional, Pradere, B., additional, Laguerre, B., additional, and Bensalah, K., additional

Published
2020
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34. L’apprentissage machine peut prédire la réponse tumorale chez les patients traités par nivolumab pour un carcinome rénal métastatique – Un concept d’intelligence artificielle

Author

Khene, Z., primary, Brassier, M., additional, Mathieu, R., additional, Kokorian, R., additional, Gasmi, A., additional, Peyronnet, B., additional, Khene, F., additional, Rioux-Leclercq, N., additional, Shariat, S., additional, Laguerre, B., additional, and Bensalah, K., additional

Published
2020
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35. Essai GETUG/AFU-V05 VESPER phase III randomisée de chimiothérapie périopératoire (schéma MVAC dose-dense ou GC) dans le cancer de vessie infiltrant localisé. Résultats sur la toxicité de la chimiothérapie et la réponse histologique

Author

Pfister, C., primary, Gravis, G., additional, Flechon, A., additional, Soulie, M., additional, Guy, L., additional, Laguerre, B., additional, Mottet, N., additional, Joly, F., additional, Allory, Y., additional, Harter, V., additional, and Culine, S., additional

Published
2020
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36. 712P Primary tumour response in patients treated with nivolumab for metastatic renal cell carcinoma (mRCC): Results of the GETUG-AFU 26 NIVOREN trial

Author

Courcier, J., primary, Dalban, C., additional, Laguerre, B., additional, Ladoire, S., additional, Barthélémy, P., additional, Oudard, S., additional, Joly, F., additional, Gravis Mescam, G., additional, Chevreau, C.M., additional, Geoffrois, L., additional, Deluche, E., additional, Rolland, F., additional, Topart, D., additional, Culine, S., additional, Négrier, S., additional, Mahammedi, H., additional, Tantot, F., additional, Escudier, B., additional, Flippot, R., additional, and Albiges, L., additional

Published
2020
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37. 722P Cabozantinib in elderly patients: Results from a subanalysis of the CABOREAL study

Author

Gross-Goupil, M., primary, Fléchon, A., additional, Mourey, L., additional, Topart, D., additional, Gravis, G., additional, Oudard, S., additional, Tourani, J.M., additional, Geoffrois, L., additional, Meriaux, E., additional, Thiery-Vuillemin, A., additional, Barthélémy, P., additional, Ladoire, S., additional, Laguerre, B., additional, Bourouina, R., additional, Perrot, V., additional, Escudier, B., additional, and Albiges, L., additional

Published
2020
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38. 735P Metastatic renal medullary and collecting duct carcinoma in the era of antiangiogenic and immune checkpoint inhibitors: A multicentric retrospective study

Author

Guillaume, Z., primary, Colomba-Blameble, E., additional, Barthélémy, P., additional, Saldana, C., additional, Dumont, C., additional, Laguerre, B., additional, Maillet, D., additional, Vicier, C., additional, Rolland, F., additional, Borchiellini, D., additional, Thouvenin, J., additional, Albiges, L., additional, Auclin, E., additional, Oudard, S., additional, and Thibault, C., additional

Published
2020
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39. 732P Cabozantinib in non-clear cell metastatic renal cell carcinoma and sarcomatoid renal cell carcinoma: Real-world data from the CABOREAL study

Author

Fléchon, A., primary, Chevreau, C.M., additional, Topart, D., additional, Gravis, G., additional, Oudard, S., additional, Tourani, J.M., additional, Geoffrois, L., additional, Meriaux, E., additional, Thiery-Vuillemin, A., additional, Barthélémy, P., additional, Ladoire, S., additional, Laguerre, B., additional, Bourouina, R., additional, Perrot, V., additional, Escudier, B., additional, Gross-Goupil, M., additional, and Albiges, L., additional

Published
2020
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40. 724P A prospective phase II study of gemcitabine plus platinum in combination with bevacizumab for metastatic renal medullary and collecting duct carcinoma (GETUG-AFU 24, BEVABEL trial)

Author

Thibault, C., primary, Elaidi, R.T., additional, Fléchon, A., additional, Albiges, L., additional, Joly, C., additional, Barthélémy, P., additional, Gross Goupil, M., additional, Chevreau, C.M., additional, Joly, F., additional, Rolland, F., additional, Laguerre, B., additional, Gravis, G., additional, Brihoum, M., additional, Timsit, M-O., additional, Pecuchet, N., additional, Allory, Y., additional, and Oudard, S., additional

Published
2020
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41. 621P Pembrolizumab (pembro) plus olaparib in patients (pts) with docetaxel-pretreated metastatic castration-resistant prostate cancer (mCRPC): KEYNOTE-365 Cohort A update

Author

Arranz Arija, J.A., primary, Yu, E.Y., additional, Piulats, J.M., additional, Gravis, G., additional, Laguerre, B., additional, Oudard, S., additional, Fong, P.C., additional, Kolinsky, M.P., additional, Augustin, M., additional, Todenhöfer, T., additional, Kam, A.E., additional, Gurney, H., additional, Tafreshi, A., additional, Retz, M., additional, Berry, W.R., additional, Mar, N., additional, Wu, H., additional, Qiu, P., additional, Schloss, C., additional, and de Bono, J.S., additional

Published
2020
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42. 625P Pembrolizumab (pembro) plus enzalutamide (enza) in patients with abiraterone acetate (abi)-pretreated metastatic castration-resistant prostate cancer (mCRPC): KEYNOTE-365 Cohort C update

Author

Mourey, L., primary, Conter, H.J., additional, Shore, N., additional, Berry, W.R., additional, Fong, P.C., additional, Piulats, J.M., additional, Appleman, L.J., additional, Todenhöfer, T., additional, Gravis, G., additional, Laguerre, B., additional, Gurney, H., additional, Retz, M., additional, Romano, E., additional, de Bono, J.S., additional, Kam, A.E., additional, Emmenegger, U., additional, Wu, H., additional, Qiu, P., additional, Schloss, C., additional, and Yu, E.Y., additional

Published
2020
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43. 700O Kidney ccRCC immune classification (KIC) enhances the predictive value of T effector (Teff) and angiogenesis (Angio) signatures in response to nivolumab (N)

Author

Meylan, M., primary, Beuselinck, B., additional, Dalban, C., additional, Vano, Y., additional, Rioux Leclercq, N., additional, Sautès-Fridman, C., additional, Roussel, E., additional, Verbiest, A., additional, Chaput, N., additional, Terry, S., additional, Chevreau, C., additional, Gross-Goupil, M., additional, Fléchon, A., additional, Laguerre, B., additional, Chabaud, S., additional, Tantot, F., additional, Lambrechts, D., additional, Escudier, B., additional, Fridman, W-H., additional, and Albiges, L., additional

Published
2020
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44. LBA25 Results from the phase II biomarker driven trial with nivolumab (N) and ipilimumab or VEGFR tyrosine kinase inhibitor (TKI) in naïve metastatic kidney cancer (m-ccRCC) patients (pts): The BIONIKK trial

Author

Vano, Y., primary, Elaidi, R.T., additional, Bennamoun, M., additional, Chevreau, C.M., additional, Borchiellini, D., additional, Pannier, D., additional, Maillet, D., additional, Gross-Goupil, M., additional, Tournigand, C., additional, Laguerre, B., additional, Barthélémy, P., additional, Joly, F., additional, Gravis, G., additional, Caruso, S., additional, Sun, C-M., additional, Verkarre, V., additional, Fridman, W-H., additional, Zucman-Rossi, J., additional, Sautès-Fridman, C., additional, and Oudard, S., additional

Published
2020
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45. 620P Pembrolizumab (pembro) plus docetaxel and prednisone in patients with abiraterone acetate (abi)- or enzalutamide (enza)–pretreated metastatic castration-resistant prostate cancer (mCRPC): KEYNOTE-365 cohort B update

Author

Romano, E., primary, Sridhar, S.S., additional, Kolinsky, M.P., additional, Gravis, G., additional, Mourey, L., additional, Piulats, J.M., additional, Berry, W.R., additional, Gurney, H., additional, Retz, M., additional, Appleman, L.J., additional, Boegemann, M., additional, de Bono, J.S., additional, Joshua, A.M., additional, Emmenegger, U., additional, Conter, H.J., additional, Laguerre, B., additional, Wu, H., additional, Qiu, P., additional, Schloss, C., additional, and Yu, E.Y., additional

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2020
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46. 723P Response to systemic therapy in fumarate hydratase (FH) mutated papillary renal cell carcinoma (pRCC): Is there a winner?

Author

Carril, L., primary, Colomba-Blameble, E., additional, Cerbone, L., additional, Crouzet, L., additional, Laguerre, B., additional, Thibault, C., additional, Vicier, C., additional, de Velasco, G., additional, Fléchon, A., additional, Saldana, C., additional, Richard, S., additional, Caron, O., additional, Escudier, B., additional, and Albiges, L., additional

Published
2020
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47. KEYNOTE-365 cohort c updated results: Pembrolizumab (pembro) plus enzalutamide (enza) in abiraterone (abi)-pretreated patients with metastatic Castration-Resistant Prostate Cancer (mCRPC)

Author

Feyerabend, S., primary, Berry, W., additional, Fong, P., additional, Piulats, J.M., additional, Appleman, L., additional, Conter, H., additional, Shore, N., additional, Gravis, G., additional, Laguerre, B., additional, Gurney, H., additional, Retz, M., additional, Romano, E., additional, Mourey, L., additional, De Bono, J., additional, Kam, A., additional, Emmenegger, U., additional, Wu, H., additional, Schloss, C., additional, Poehlein, C., additional, and Yu, E.Y., additional

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2020
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48. Metastatic clear-cell renal cell carcinoma: Computed tomography texture analysis as predictive biomarkers of survival in patients treated with Nivolumab: NivoMics 01-Study

Author

Khene, Z-E., primary, Kokorian, R., additional, Peyronnet, B., additional, Edeline, J., additional, Decrevoisier, R., additional, Crouzet, L., additional, Rioux-Leclercq, N., additional, Laguerre, B., additional, Pracht, M., additional, Mathieu, R., additional, and Bensalah, K., additional

Published
2020
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49. Pembrolizumab (pembro) plus olaparib in docetaxel-pretreated patients (pts) with metastatic castration-resistant prostate cancer (mCRPC): KEYNOTE-365 cohort A updated results

Author

Piulats, J.M., primary, Yu, E., additional, Gravis, G., additional, Laguerre, B., additional, Arranz, J., additional, Oudard, S., additional, Fong, P., additional, Kolinsky, M., additional, Augustin, M., additional, Feyerabend, S., additional, Kam, A.., additional, Gurney, H., additional, Tafreshi, A., additional, Retz, M., additional, Berry, W., additional, Mar, N., additional, Wu, H., additional, Schloss, C., additional, Poehlein, C., additional, and De Bono, J., additional

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2020
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50. Randomized phase III trial of dose-dense MVAC or GC as perioperative chemotherapy for muscle-invasive urothelial bladder cancer (MIUBC): Preliminary results of the GETUG/AFU V05 VESPER trial on toxicity and pathological responses

Author

Pfister, C., primary, Gravis, G., additional, Flechon, A., additional, Soulie, M., additional, Guy, L., additional, Laguerre, B., additional, Mottet, N., additional, Joly, F., additional, Allory, Y., additional, Harter, V., additional, and Culine, S., additional

Published
2020
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