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1. Nivolumab plus ipilimumab versus sunitinib for first-line treatment of advanced renal cell carcinoma: extended 8-year follow-up results of efficacy and safety from the phase III CheckMate 214 trial

Author

Tannir, N.M., Albigès, L., McDermott, D.F., Burotto, M., Choueiri, T.K., Hammers, H.J., Barthélémy, P., Plimack, E.R., Porta, C., George, S., Donskov, F., Atkins, M.B., Gurney, H., Kollmannsberger, C.K., Grimm, M.-O., Barrios, C., Tomita, Y., Castellano, D., Grünwald, V., Rini, B.I., Jiang, R., Desilva, H., Fedorov, V., Lee, C.-W., and Motzer, R.J.

Published
2024
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3. Subcutaneous versus intravenous nivolumab for renal cell carcinoma

Author

Albiges, L., Bourlon, M.T., Chacón, M., Cutuli, H.J., Chuken, Y.A.L., Żurawski, B., Mota, J.M., Magri, I., Burotto, M., Luz, M., de Menezes, J., Ruiz, E.P.Y., Fu, S., Richardet, M., Valderrama, B.P., Maruzzo, M., Bracarda, S., Breckenridge, M., Vezina, H.E., Rathod, D., Yu, Z., Zhao, Y., Dixon, M., Perumal, D., and George, S.

Published
2024
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4. IMscin001 Part 2: a randomised phase III, open-label, multicentre study examining the pharmacokinetics, efficacy, immunogenicity, and safety of atezolizumab subcutaneous versus intravenous administration in previously treated locally advanced or metastatic non-small-cell lung cancer and pharmacokinetics comparison with other approved indications

Author

Burotto, M., Zvirbule, Z., Mochalova, A., Runglodvatana, Y., Herraez-Baranda, L., Liu, S.N., Chan, P., Shearer-Kang, E., Liu, X., Tosti, N., Zanghi, J.A., Leutgeb, B., and Felip, E.

Published
2023
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5. Corrigendum to ‘IMscin001 Part 2: a randomised phase III, open-label, multicentre study examining the pharmacokinetics, efficacy, immunogenicity, and safety of atezolizumab subcutaneous versus intravenous administration in previously treated locally advanced or metastatic non-small-cell lung cancer and pharmacokinetics comparison with other approved indications’

Author

Burotto, M., primary, Zvirbule, Z., additional, Mochalova, A., additional, Runglodvatana, Y., additional, Herraez-Baranda, L., additional, Liu, S.N., additional, Chan, P., additional, Shearer-Kang, E., additional, Liu, X., additional, Tosti, N., additional, Zanghi, J.A., additional, Leutgeb, B., additional, and Felip, E., additional

Published
2024
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6. 64O Lenvatinib plus pembrolizumab, pemetrexed, and a platinum (len + pembro + chemo) as first-line therapy for metastatic non squamous non-small cell lung cancer (NSCLC): Phase III LEAP-006 study

Author

Herbst, R.S., primary, Cho, B.C., additional, Zhou, C., additional, Burotto, M., additional, Cobo Dols, M., additional, Sendur, M.A.N., additional, Moiseyenko, V., additional, Zurawski, B., additional, Casarini, I.A., additional, Nishio, M., additional, Hui, R., additional, Pons-Tostivint, E., additional, Dudnik, J., additional, Ahmed, S., additional, Okpara, C.E., additional, Yin, L., additional, Luo, Y., additional, Bhagwati, N., additional, and Rodriguez Abreu, D., additional

Published
2023
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7. 97P Efficacy and safety of the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection in patients with HER2-positive early breast cancer: Long-term data from the PHranceSCa study

Author

O'Shaughnessy, J., primary, Sousa, S.P., additional, Jurado, J. Cruz, additional, Fallowfield, L.J., additional, Auvinen, P., additional, Pulido, C., additional, Cvetanovic, A.S., additional, Wilks, S.T., additional, Ribeiro, L.A., additional, Burotto, M., additional, Boulet, T., additional, Revelant, V., additional, Theron, N., additional, Trask, P., additional, Wahyudi, L.A., additional, Machackova, Z., additional, and Stamatovic, L., additional

Published
2023
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8. 61MO IMscin001 (part 2: randomized phase III): Pharmacokinetics (PK), efficacy and safety of atezolizumab (atezo) subcutaneous (SC) vs intravenous (IV) in previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC)

Author

Burotto, M., primary, Zvirbule, Z., additional, Mochalova, A., additional, Runglodvatana, Y., additional, Herraez Baranda, L.A., additional, Liu, S., additional, Chan, P., additional, Shearer-Kang, E., additional, Shivhare, M., additional, Tosti, N., additional, Zanghi, J., additional, Leutgeb, B., additional, and Felip, E., additional

Published
2022
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9. LBA53 Nivolumab (NIVO) plus relatlimab with platinum-doublet chemotherapy (PDCT) vs NIVO + PDCT as first-line (1L) treatment (tx) for stage IV or recurrent NSCLC: Results from the randomized phase II RELATIVITY-104 study.

Author

Girard, N., Burotto, M., Paz-Ares, L.G., Reck, M., Schenker, M., Lingua, A., Orlandi, F.J., Naidoo, J., Beardlsey, E.K., Velcheti, V., Martinengo, G.L., Felip, E., Zhang, Y., Kasbekar, P., Chowdhury, M., Spires, T., Tendolkar, A., and Cobo Dols, M.

Subjects
*NIVOLUMAB, *NON-small-cell lung carcinoma, *CANCER chemotherapy
Published
2024
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11. LBA8 Phase III study of cabozantinib (C) in combination with nivolumab (N) and ipilimumab (I) in previously untreated advanced renal cell carcinoma (aRCC) of IMDC intermediate or poor risk (COSMIC-313)

Author

Choueiri, T.K., primary, Powles, T.B., additional, Albiges, L., additional, Burotto, M., additional, Szczylik, C., additional, Zurawski, B., additional, Riuz, E. Yanez, additional, Maruzzo, M., additional, Zaizar, A. Suarez, additional, Fein, L.E., additional, Schutz, F.A. Barros, additional, Heng, D.Y.C., additional, Wang, F., additional, Mataveli, F., additional, Chang, Y-L., additional, van Kooten Losio, M., additional, Rodriguez, C. Suarez, additional, and Motzer, R.J., additional

Published
2022
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12. EP16.03-002 Mechanisms of Resistance to First-line Osimertinib in Hispanic Patients with EGFR mutant Non-Small Cell Lung Cancer (FRESTON-CLICaP∫)

Author

Chamorro, D.F., primary, Ruiz-Patiño, A., additional, Recondo, G., additional, Martín, C., additional, Raez, L., additional, Samtani, S., additional, Minata, J.N., additional, Blaquier, J.B., additional, Enrico, D., additional, Burotto, M., additional, Ordoñez-Reyes, C., additional, Garcia-Robledo, J.B., additional, Corrales, L., additional, Zatarain-Barrón, L., additional, Más, L., additional, Sotelo, C., additional, Ricaurte, L., additional, Santoyo, N., additional, Cuello, M., additional, Mejia, S., additional, Jaller, E., additional, Vargas, C., additional, Carranza, H., additional, Otero, J., additional, Rodríguez, J., additional, Archila, P., additional, Bermudez, M., additional, Gamez, T., additional, Cordeiro de Lima, V., additional, Freitas, H., additional, Russo, A., additional, Polo, C., additional, Malapelle, U., additional, de Miguel-Perez, D., additional, Rolfo, C., additional, Viola, L., additional, Rossell, R., additional, Arrieta, O., additional, and Cardona, A.F., additional

Published
2022
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13. LBA74 Final analysis of the phase III LITESPARK-005 study of belzutifan versus everolimus in participants (pts) with previously treated advanced clear cell renal cell carcinoma (ccRCC)

Author

Rini, B.I., Suarez Rodriguez, C., Albiges, L., Jalkanen, K., De Velasco Oria, G.A., Burotto, M., Ghatalia, P., Iacovelli, R., Lam, E.T., Verzoni, E., Gumus, M., Stadler, W., Kollmannsberger, C.K., Melichar, B., Venugopal, B., Lin, J., Perini, R., Vickery, D., Choueiri, T.K., and Powles, T.B.

Published
2024
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14. 1691P Subcutaneous nivolumab (NIVO SC) vs intravenous nivolumab (NIVO IV) in patients (pts) with previously treated advanced or metastatic clear cell renal cell carcinoma (ccRCC): Updated efficacy and safety results from CheckMate 67T

Author

Albiges, L., Bourlon de los Rios, M.T., Chacon, M., Cutuli, H.J., Lopez Chuken, Y.A., Mota, J., Magri, I., Burotto, M., Luz, M.D.A., Menezes, J., Yanez Ruiz, E.P., Maruzzo, M., Bracarda, S., Breckenridge, M., Rathod, D., Yu, Z., Vezina, H., and George, S.

Published
2024
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17. Nivolumab plus ipilimumab (NIVO+IPI) vs sunitinib (SUN) dans le traitement de première ligne (1L) du carcinome rénal avancé (CCRa) : données de suivi à long terme de l'étude de phase 3 CheckMate 214.

Author

Tannir, N.M., Mcdermott, D.F., Burotto, M., Choueiri, T.K., Hammers, H.J., Plimack, E.R., Porta, C., George, S., Powles, T., Donskov, F., Atkins, M.B., Kollmannsberger, C.K., Grimm, M.O., Tomita, Y., Rini, B.I., Jiang, R., Desilva, H., Lee, C.W., Barthélémy, P., and Motzer, R.J.

Abstract

Copyright of Proges en Urologie is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Published
2024
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18. CheckMate-9ER-Studie: Nivolumab + Cabozantinib im Vergleich zu Sunitinib bei fortgeschrittenem Nierenzellkarzinom - aktualisierte Ergebnisse mit verlängerter Nachbeobachtung und bei sarkomatoider Histologie

Author

Bedke, J., Choueiri, T., Powles, T., Burotto, M., Bourlon, M., Hsieh, J., Maruzzo, M., Shah, A., Suarez, C., Barrios, C., Richardet, M., Porta, C., Goh, J., Tomita, Y., Zhang, J., Simsek, B., Scheffold, C., Gupta, S., Apolo, A., and Motzer, R.

Subjects
ddc: 610, 610 Medical sciences, Medicine
Abstract

Hintergrund: In der CheckMate-9ER-Studie bei der Erstlinienbehandlung von Patienten mit fortgeschrittenem oder metastasierten Nierenzellkarzinom (aRCC, N=651) wurde mit Nivolumab + Cabozantinib (NIVO + CABO) im Vergleich zu Sunitinib eine Verbesserung des progressionsfreien Überlebens[zum vollständigen Text gelangen Sie über die oben angegebene URL], 61. Jahrestagung der Südwestdeutschen Gesellschaft für Urologie e.V.

Published
2021

19. Survie conditionnelle et suivi à 5 ans dans l’étude checkmate 214 : Nivolumab + Ipilimumab (N+I) versus Sunitinib (S) dans le traitement de première ligne du carcinome rénal avancé (ACCR)

Author

Escudier, B., primary, Tannir, N., additional, Mcdermott, D., additional, Burotto, M., additional, Choueiri, T., additional, Hammers, H., additional, Plimack, E., additional, Porta, C., additional, George, S., additional, Powles, T., additional, Donskov, F., additional, Gurney, H., additional, Kollmannsberger, C., additional, Grimm, M., additional, Tomita, Y., additional, Rini, B., additional, Mchenry, M., additional, Lee, C., additional, and Motzer, R., additional

Published
2021
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20. Nivolumab + Cabozantinib (N+C) vs Sunitinib (S) en première ligne (1L) de traitement chez des patients atteints d’un carcinome rénal avancé (ACCR) dans l’essai de phase III checkmate 9ER : analyse en sous-groupes basée sur l’absence ou présence de néphrectomie antérieure

Author

Escudier, B., primary, Porta, C., additional, Burotto, M., additional, Suarez, C., additional, Bourlon, M., additional, Hsieh, J., additional, Shah, A., additional, Hamzaj, A., additional, Bedke, J., additional, Pook, D., additional, Kessler, E., additional, Tomita, Y., additional, Drakaki, A., additional, Zhang, J., additional, Simsek, B., additional, Schwab, G., additional, Motzer, R., additional, Choueiri, T., additional, Apolo, A., additional, and Powles, T., additional

Published
2021
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21. 579MO CheckMate 9KD cohort A2 final analysis: Nivolumab (NIVO) + rucaparib for chemotherapy (CT)-naïve metastatic castration-resistant prostate cancer (mCRPC)

Author

Petrylak, D.P., primary, Perez-Gracia, J.L., additional, Lacombe, L., additional, Bastos, D.A., additional, Mahammedi, H., additional, Kwan, E.M., additional, Zschäbitz, S., additional, Armstrong, A.J., additional, Pachynski, R.K., additional, Goh, J.C., additional, Burotto, M., additional, Gravis, G., additional, McCune, S.L., additional, Vázquez Limón, J.C., additional, Retz, M., additional, Saad, F., additional, Amin, N.P., additional, Li, J., additional, Unsal-Kacmaz, K., additional, and Fizazi, K., additional

Published
2021
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22. 663P First-line nivolumab + cabozantinib vs sunitinib in patients (pts) with advanced renal cell carcinoma (aRCC) in subgroups based on prior nephrectomy in the CheckMate 9ER trial

Author

Porta, C.G., primary, Burotto, M., additional, Suarez Rodriguez, C., additional, Bourlon, M.T., additional, Hsieh, J., additional, Shah, A.Y., additional, Hamzaj, A., additional, Bedke, J., additional, Pook, D., additional, Kessler, E.R., additional, Tomita, Y., additional, Drakaki, A., additional, Zhang, J., additional, Simsek, B., additional, Schwab, G., additional, Escudier, B., additional, Motzer, R.J., additional, Choueiri, T.K., additional, Apolo, A.B., additional, and Powles, T.B., additional

Published
2021
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23. PCN53 Grade 3/4 Adverse Event (AE) Costs of Nivolumab Plus Ipilimumab (N+I) Versus Nivolumab Plus Cabozantinib (N+C) and Pembrolizumab Plus Axitinib (P+A) for Previously Untreated Advanced Renal Cell Carcinoma (aRCC)

Author

McGregor, B., primary, Geynisman, D., additional, Burotto, M., additional, Porta, C., additional, Suarez, C., additional, Bourlon, M.T., additional, Stwalley, B., additional, Du, E.X., additional, Gu, C., additional, Sendhil, S., additional, Betts, K.A., additional, Huo, S., additional, and Choueiri, T.K., additional

Published
2021
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24. PCN92 Temporal Trends in Grade 3/4 Adverse Events and Associated Costs of Nivolumab Plus Cabozantinib (N+C) Versus Sunitinib (S) for Previously Untreated Advanced Renal Cell Carcinoma (aRCC)

Author

Geynisman, D., primary, McGregor, B., additional, Burotto, M., additional, Porta, C., additional, Suarez, C., additional, Bourlon, M.T., additional, Stwalley, B., additional, Du, E.X., additional, Gu, C., additional, Yang, X., additional, Betts, K.A., additional, Huo, S., additional, and Choueiri, T.K., additional

Published
2021
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25. 579MO CheckMate 9KD cohort A2 final analysis: Nivolumab (NIVO) + rucaparib for chemotherapy (CT)-naive metastatic castration-resistant prostate cancer (mCRPC).

Author

Petrylak D.P., Perez-Gracia J.L., Lacombe L., Bastos D.A., Mahammedi H., Kwan E.M., Zschabitz S., Armstrong A.J., Pachynski R.K., Goh J.C., Burotto M., Gravis G., McCune S.L., Vazquez Limon J.C., Retz M., Saad F., Amin N.P., Li J., Unsal-Kacmaz K., Fizazi K., Petrylak D.P., Perez-Gracia J.L., Lacombe L., Bastos D.A., Mahammedi H., Kwan E.M., Zschabitz S., Armstrong A.J., Pachynski R.K., Goh J.C., Burotto M., Gravis G., McCune S.L., Vazquez Limon J.C., Retz M., Saad F., Amin N.P., Li J., Unsal-Kacmaz K., and Fizazi K.

Abstract

Background: CheckMate 9KD is a phase II, multi-cohort trial of NIVO (anti-PD-1) combined with rucaparib, docetaxel, or enzalutamide for mCRPC. We report results for cohort A2, assessing NIVO + rucaparib for CT-naive mCRPC. Method(s): In cohort A2, unselected patients (pts) with CT-naive mCRPC, ongoing ADT, prior abiraterone and/or enzalutamide for mCRPC, and no prior PARP inhibitors received NIVO 480 mg Q4W + rucaparib 600 mg BID until disease progression/unacceptable toxicity (NIVO dosing <= 2 y). Coprimary endpoints were objective response rate (ORR) per PCWG3 criteria and prostate-specific antigen response rate (PSA-RR) in all treated pts and pts with homologous recombination deficiency positive (HRD+) tumors; HRD status was determined before enrollment. Secondary endpoints included radiographic progression-free survival (rPFS), overall survival (OS), and safety. Result(s): Of 71 treated pts, median age 73 y (range, 51-87 y), 23.9% had visceral metastases and 54.9% had measurable disease. Median treatment duration was 4.6 mo for NIVO and 5.5 mo for rucaparib; median follow-up was 17.5 mo. The table summarizes efficacy results, and shows better outcomes for HRD+ vs HRD-/not evaluable tumors. Any-grade treatment-related AEs (TRAEs) occurred in 90.1% of pts, most commonly nausea (40.8%) and anemia (32.4%). Grade >= 3 TRAEs occurred in 50.7% of pts, most commonly anemia (14.1%) and increased ALT (12.7%). TRAEs led to discontinuation in...Copyright © 2021 European Society for Medical Oncology

Published
2021

26. CheckMate-9ER-Studie: Nivolumab + Cabozantinib im Vergleich zu Sunitinib bei fortgeschrittenem Nierenzellkarzinom - aktualisierte Ergebnisse mit verlängerter Nachbeobachtung und bei sarkomatoider Histologie

Author

Bedke, J, Choueiri, T, Powles, T, Burotto, M, Bourlon, M, Hsieh, J, Maruzzo, M, Shah, A, Suarez, C, Barrios, C, Richardet, M, Porta, C, Goh, J, Tomita, Y, Zhang, J, Simsek, B, Scheffold, C, Gupta, S, Apolo, A, Motzer, R, Bedke, J, Choueiri, T, Powles, T, Burotto, M, Bourlon, M, Hsieh, J, Maruzzo, M, Shah, A, Suarez, C, Barrios, C, Richardet, M, Porta, C, Goh, J, Tomita, Y, Zhang, J, Simsek, B, Scheffold, C, Gupta, S, Apolo, A, and Motzer, R

Published
2021

27. LBA7 Nivolumab plus gemcitabine-cisplatin versus gemcitabine-cisplatin alone for previously untreated unresectable or metastatic urothelial carcinoma: Results from the phase III CheckMate 901 trial

Author

van der Heijden, M.S., Sonpavde, G.P., Powles, T.B., Necchi, A., Burotto, M., Schenker, M., Sade, J.P., Bamias, A., Beuzeboc, P., Bedke, J., Oldenburg, J., Urun, Y., Ye, D., He, Z., Perez Valderrama, B., Tomita, Y., Filian, J., Purcea, D., Nasroulah, F., and Galsky, M.D.

Published
2023
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28. LBA88 Belzutifan versus everolimus in participants (pts) with previously treated advanced clear cell renal cell carcinoma (ccRCC): Randomized open-label phase III LITESPARK-005 study

Author

Albiges, L., Rini, B.I., Peltola, K., De Velasco Oria, G.A., Burotto, M., Suarez Rodriguez, C., Ghatalia, P., Iacovelli, R., Lam, E.T., Verzoni, E., Gumus, M., Stadler, W.M., Kollmannsberger, C.K., Melichar, B., Venugopal, B., Wang, A., Perini, R., Vickery, D., Powles, T.B., and Choueiri, T.K.

Published
2023
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29. 1771MO Pembrolizumab (pembro) plus enzalutamide (enza) for patients (pts) with metastatic castration-resistant prostate cancer (mCRPC): Randomized double-blind phase III KEYNOTE-641 study

Author

Graff, J.N., Burotto, M., Fong, P.C., Pook, D., Zurawski, B., Manneh Kopp, R., Salinas, J.E., Bylow, K., Kramer, G., Ratta, R., Kwiatkowski, M., Retz, M., Kwak, C., Arranz Arija, J.A., Gurney, H.P., Matsubara, N., Liang, L.W., Todoric, J., Imai, K., and Stenzl, A.

Published
2023
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30. 1447P IMscin001 part 2 updated results: Efficacy, safety, immunogenicity and patient-reported outcomes (PROs) from the randomised phase III study of atezolizumab (atezo) subcutaneous (SC) vs intravenous (IV) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)

Author

Burotto, M., Zvirbule, Z., Alvarez, R., Chewaskulyong, B., Herraez Baranda, L.A., Shearer-Kang, E., Liu, X., Tosti, N., Castro Sanchez, A.Y., Zanghi, J., and Felip, E.

Published
2023
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31. Recommendations for detection, prioritization, and treatment of thoracic oncology patients during the COVID-19 pandemic: the THOCOoP cooperative group

Author

Arrieta, O, Cardona, AF, Lara-Mejia, L, Heredia, D, Barron, F, Zatarain-Barron, ZL, Lozano, F, de Lima, VC, Maldonado, F, Corona-Cruz, F, Ramos, M, Cabrera, L, Martin, C, Corrales, L, Cuello, M, Arroyo-Hernandez, M, Aman, E, Bacon, L, Baez, R, Benitez, S, Botero, A, Burotto, M, Caglevic, C, Ferraris, G, Freitas, H, Kaen, DL, Lamot, S, Lyons, G, Mas, L, Mata, A, Mathias, C, Munoz, A, Patane, AK, Oblitas, G, Pino, L, Raez, LE, Remon, J, Rojas, L, Rolfo, C, Ruiz-Patino, A, Samtani, S, Viola, L, Viteri, S, and Rosell, R

Subjects
Health systems, Personal protective equipment, COVID-19, Thoracic oncology, Lung cancer, Recommendations
Abstract

The world currently faces a pandemic due to SARS-CoV-2. Relevant information has emerged regarding the higher risk of poor outcomes in lung cancer patients. As such, lung cancer patients must be prioritized in terms of prevention, detection and treatment. On May 7th, 45 experts in thoracic cancers from 11 different countries were invited to participate. A core panel of experts regarding thoracic oncology care amidst the pandemic gathered virtually, and a total of 60 initial recommendations were drafted based on available evidence, 2 questions were deleted due to conflicting evidence. By May 16th, 44 experts had agreed to participate, and voted on each of the 58 recommendation using a Delphi panel on a live voting event. Consensus was reached regarding the recommendations (> 66 % strongly agree/agree) for 56 questions. Strong consensus (> 80 % strongly agree/agree) was reached for 44 questions. Patients with lung cancer represent a particularly vulnerable population during this time. Special care must be taken to maintain treatment while avoiding exposure.

Published
2020

32. 696O_PR Nivolumab + cabozantinib vs sunitinib in first-line treatment for advanced renal cell carcinoma: First results from the randomized phase III CheckMate 9ER trial

Author

Choueiri, T.K., Powles, T., Burotto, M., Bourlon, M.T., Zurawski, B., Oyervides Juárez, Víctor Manuel, Hsieh, J.J., Basso, U., Shah, A.Y., Suarez, C., Hamzaj, A., Barrios, C.H., Richardet, M., Pook, D., Tomita, Y., Escudier, B., Zhang, J., Simsek, B., Apolo, A.B., Motzer, R.J., Choueiri, T.K., Powles, T., Burotto, M., Bourlon, M.T., Zurawski, B., Oyervides Juárez, Víctor Manuel, Hsieh, J.J., Basso, U., Shah, A.Y., Suarez, C., Hamzaj, A., Barrios, C.H., Richardet, M., Pook, D., Tomita, Y., Escudier, B., Zhang, J., Simsek, B., Apolo, A.B., and Motzer, R.J.

Published
2020

33. Nivolumab + ipilimumab (N + I) vs sunitinib (S) dans le traitement de première ligne du carcinome rénal avancé (aRCC) dans l’étude CheckMate 214 : suivi à 4 ans et analyse en sous-groupe des patients (pts) non néphrectomisés

Author

Albiges, L., primary, Tannir, N., additional, Burotto, M., additional, Mcdermott, D., additional, Plimack, E., additional, Barthélémy, P., additional, Porta, C., additional, Powles, T., additional, Donskov, F., additional, George, S., additional, Kollmannsberger, C., additional, Gurney, H., additional, Grimm, M., additional, Tomita, Y., additional, Castellano, D., additional, Rini, B., additional, Choueiri, T., additional, Shally Saggi, S., additional, Mchenry, M., additional, and Motzer, R., additional

Published
2020
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34. 711P Nivolumab + ipilimumab (N+I) vs sunitinib (S) for first-line treatment of advanced renal cell carcinoma (aRCC) in CheckMate 214: 4-year follow-up and subgroup analysis of patients (pts) without nephrectomy

Author

Albiges, L., primary, Tannir, N., additional, Burotto, M., additional, McDermott, D.F., additional, Plimack, E.R., additional, Barthélémy, P., additional, Porta, C.G., additional, Powles, T.B., additional, Donskov, F., additional, George, S., additional, Kollmannsberger, C., additional, Gurney, H., additional, Grimm, M-O., additional, Tomita, Y., additional, Castellano Gauna, D., additional, Rini, B.I., additional, Choueiri, T.K., additional, Saggi, S.S., additional, McHenry, M.B., additional, and Motzer, R.J., additional

Published
2020
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35. 696O_PR Nivolumab + cabozantinib vs sunitinib in first-line treatment for advanced renal cell carcinoma: First results from the randomized phase III CheckMate 9ER trial

Author

Choueiri, T.K., primary, Powles, T., additional, Burotto, M., additional, Bourlon, M.T., additional, Zurawski, B., additional, Oyervides Juárez, V.M., additional, Hsieh, J.J., additional, Basso, U., additional, Shah, A.Y., additional, Suarez, C., additional, Hamzaj, A., additional, Barrios, C.H., additional, Richardet, M., additional, Pook, D., additional, Tomita, Y., additional, Escudier, B., additional, Zhang, J., additional, Simsek, B., additional, Apolo, A.B., additional, and Motzer, R.J., additional

Published
2020
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37. 165MO Patient (pt) preference for the pertuzumab-trastuzumab fixed-dose combination for subcutaneous use (PH FDC SC) in HER2-positive early breast cancer (EBC): Primary analysis of the open-label, randomised crossover PHranceSCa study

Author

O'Shaughnessy, J., primary, Sousa, S., additional, Cruz, J., additional, Fallowfield, L., additional, Auvinen, P., additional, Pulido, C., additional, Cvetanovic, A., additional, Wilks, S., additional, Ribeiro, L., additional, Burotto, M., additional, Klingbiel, D., additional, Messeri, D., additional, Alexandrou, A., additional, Trask, P., additional, Fredriksson, J., additional, Machackova, Z., additional, and Stamatovic, L., additional

Published
2020
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38. 718P A phase II study of patients with advanced or metastatic renal cell carcinoma (mRCC) receiving pazopanib after previous checkpoint inhibitor treatment

Author

Powles, T.B., primary, Oudard, S., additional, Grünwald, V., additional, Calvo, E., additional, Michaelson, M.D., additional, Burotto, M., additional, Melichar, B., additional, Tyagi, R., additional, Hilmi, F., additional, Gaur, A., additional, Hirschberg, Y., additional, and Heng, D., additional

Published
2020
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39. 80O Patient (pt) preference and satisfaction with the subcutaneous fixed-dose combination of pertuzumab (P) and trastuzumab (H) in pts with HER2-positive early breast cancer (HER2+ eBC): Interim analysis of the open-label, randomised cross-over PHranceSCa study

Author

O'Shaughnessy, J., primary, Sousa, S.P., additional, Cruz, J., additional, Fallowfield, L.J., additional, Auvinen, P., additional, Pulido, C., additional, Cvetanovic, A., additional, Wilks, S., additional, Ribeiro, L., additional, Burotto, M., additional, Klingbiel, D., additional, Messeri, D., additional, Alexandrou, A., additional, Trask, P., additional, Fredriksson, J., additional, and Stamatovic, L., additional

Published
2020
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45. ANG1005 for breast cancer brain metastases: correlation between F-FLT-PET after first cycle and MRI in response assessment.

Author

O'Sullivan, C., Lindenberg, M., Bryla, C., Patronas, N., Peer, C., Amiri-Kordestani, L., Davarpanah, N., Gonzalez, E., Burotto, M., Choyke, P., Steinberg, S., Liewehr, D., Figg, W., Fojo, T., Balasubramaniam, S., and Bates, S.

Abstract

Purpose: Improved therapies and imaging modalities are needed for the treatment of breast cancer brain metastases (BCBM). ANG1005 is a drug conjugate consisting of paclitaxel covalently linked to Angiopep-2, designed to cross the blood-brain barrier. We conducted a biomarker substudy to evaluate F-FLT-PET for response assessment. Methods: Ten patients with measurable BCBM received ANG1005 at a dose of 550 mg/m IV every 21 days. Before and after cycle 1, patients underwent PET imaging with F-FLT, a thymidine analog, retention of which reflects cellular proliferation, for comparison with gadolinium-contrast magnetic resonance imaging (Gd-MRI) in brain metastases detection and response assessment. A 20 % change in uptake after one cycle of ANG1005 was deemed significant. Results: Thirty-two target and twenty non-target metastatic brain lesions were analyzed. The median tumor reduction by MRI after cycle 1 was −17.5 % ( n = 10 patients, lower, upper quartiles: −25.5, −4.8 %) in target lesion size compared with baseline. Fifteen of twenty-nine target lesions (52 %) and 12/20 nontarget lesions (60 %) showed a ≥20 % decrease post-therapy in FLT-PET SUV change (odds ratio 0.71, 95 % CI: 0.19, 2.61). The median percentage change in SUV was −20.9 % ( n = 29 lesions; lower, upper quartiles: −42.4, 2.0 %), and the median percentage change in SUV was also −20.9 % ( n = 29; lower, upper quartiles: −49.0, 0.0 %). Two patients had confirmed partial responses by PET and MRI lasting 6 and 18 cycles, respectively. Seven patients had stable disease, receiving a median of six cycles. Conclusions: ANG1005 warrants further study in BCBM. Results demonstrated a moderately strong association between MRI and F-FLT-PET imaging. [ABSTRACT FROM AUTHOR]

Published
2016
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46. Nivolumab + ipilimumab (N+I) vs sunitinib (S) dans le traitement de première ligne du carcinome rénal avancé (aRCC) dans l’étude CheckMate 214 : suivi à 4 ans et analyse en sous-groupe des patients (pts) non néphrectomisés

Author

Albiges, L., Tannir, N., Burotto, M., Mcdermott, D., Plimack, E., Barthélémy, P., Porta, C., Powles, T., Donskov, F., George, S., Kollmannsberger, C., Gurney, H., Grimm, M., Tomita, Y., Castellano, D., Rini, B., Choueiri, T., Shally Saggi, S., Mchenry, M., and Motzer, R.

Abstract

Dans la CheckMate 214, N+I était supérieur à S chez les pts de pronostic intermédiaire/défavorable (IP) et chez les pts en ITT. Nous rapportons ici la survie, la réponse selon un comité de revue des examens radiologiques indépendant (IRRC) et la tolérance après 4 ans minimum de suivi, et une analyse exploratoire post-hoc dans un sous-groupe de pts sans néphrectomie préalable présentant une lésion cible au niveau du rein.

Published
2020
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48. Survie conditionnelle et suivi à 5 ans dans l’étude checkmate 214 : Nivolumab+Ipilimumab (N+I) versus Sunitinib (S) dans le traitement de première ligne du carcinome rénal avancé (ACCR)

Author

Escudier, B., Tannir, N., Mcdermott, D., Burotto, M., Choueiri, T., Hammers, H., Plimack, E., Porta, C., George, S., Powles, T., Donskov, F., Gurney, H., Kollmannsberger, C., Grimm, M., Tomita, Y., Rini, B., Mchenry, M., Lee, C., and Motzer, R.

Abstract

La survie conditionnelle (SC), indicateur utilisé pour prédire le bénéfice durable d’un traitement, tient compte du temps écoulé depuis le début du traitement et fournit des informations sur l’évolution du pronostic à des points de repère temporel. Dans l’étude CheckMate 214, la SC des patients atteints d’un aCCR a été évaluée avec un suivi minimum de 5 ans (suivi médian de 67,7 mois).

Published
2021
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49. Belzutifan versus Everolimus for Advanced Renal-Cell Carcinoma.

Author

Choueiri, T. K., Powles, T., Peltola, K., de Velasco, G., Burotto, M., Suarez, C., Ghatalia, P., Iacovelli, R., Lam, E. T., Verzoni, E., Gümüş, M., Stadler, W. M., Kollmannsberger, C., Melichar, B., Venugopal, B., Gross-Goupil, M., Poprach, A., De Santis, M., Schutz, F. A., and Park, S. H.

Subjects
*EVEROLIMUS, *POISONS, *OVERALL survival, *PROGRESSION-free survival, *IMMUNE checkpoint proteins
Abstract

Background: Belzutifan, a hypoxia-inducible factor 2a inhibitor, showed clinical activity in clear-cell renal-cell carcinoma in early-phase studies. Methods: In a phase 3, multicenter, open-label, active-controlled trial, we enrolled participants with advanced clear-cell renal-cell carcinoma who had previously received immune checkpoint and antiangiogenic therapies and randomly assigned them, in a 1:1 ratio, to receive 120 mg of belzutifan or 10 mg of everolimus orally once daily until disease progression or unacceptable toxic effects occurred. The dual primary end points were progression-free survival and overall survival. The key secondary end point was the occurrence of an objective response (a confirmed complete or partial response). Results: A total of 374 participants were assigned to belzutifan, and 372 to everolimus. At the first interim analysis (median follow-up, 18.4 months), the median progression-free survival was 5.6 months in both groups; at 18 months, 24.0% of the participants in the belzutifan group and 8.3% in the everolimus group were alive and free of progression (two-sided P = 0.002, which met the prespecified significance criterion). A confirmed objective response occurred in 21.9% of the participants (95% confidence interval [CI], 17.8 to 26.5) in the belzutifan group and in 3.5% (95% CI, 1.9 to 5.9) in the everolimus group (P<0.001, which met the prespecified significance criterion). At the second interim analysis (median follow-up, 25.7 months), the median overall survival was 21.4 months in the belzutifan group and 18.1 months in the everolimus group; at 18 months, 55.2% and 50.6% of the participants, respectively, were alive (hazard ratio for death, 0.88; 95% CI, 0.73 to 1.07; two-sided P = 0.20, which did not meet the prespecified significance criterion). Grade 3 or higher adverse events of any cause occurred in 61.8% of the participants in the belzutifan group (grade 5 in 3.5%) and in 62.5% in the everolimus group (grade 5 in 5.3%). Adverse events led to discontinuation of treatment in 5.9% and 14.7% of the participants, respectively. Conclusions: Belzutifan showed a significant benefit over everolimus with respect to progression-free survival and objective response in participants with advanced clear-cell renal-cell carcinoma who had previously received immune checkpoint and antiangiogenic therapies. Belzutifan was associated with no new safety signals. (Funded by Merck Sharp and Dohme, a subsidiary of Merck; LITESPARK-005 ClinicalTrials.gov number, NCT04195750.). [ABSTRACT FROM AUTHOR]

Published
2024
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50. Nivolumab plus Cabozantinib versus Sunitinib for Advanced Renal-Cell Carcinoma.

Author

Choueiri, T. K., Powles, T., Burotto, M., Escudier, B., Bourlon, M. T., Zurawski, B., Judrez, V. M. Oyervides, Hsieh, J J, Basso, U., Shah, A. Y., Sudrez, C., Hamzaj, A., Goh, J. C., Barrios, C., Richardet, M., Porta, C., kowalyszyn, R., Feregrino, J. P., Zotnierek, J., and Pook, D.

Subjects
*DRUG side effects, *DRUG efficacy, *QUALITY of life, *PROGRESSION-free survival, *CARCINOMA
Abstract

BACKGROUND The efficacy and safety of nivolumab plus cabozantinib as compared with those of sunitinib in the treatment of previously untreated advanced renal-cell carcinoma are not known. METHODS In this phase 3, randomized, open-label trial, we randomly assigned adults with previously untreated clear-cell, advanced renal-cell carcinoma to receive either nivolumab (240 mg every 2 weeks) plus cabozantinib (40 mg once daily) or sunitinib (50 mg once daily for 4 weeks of each 6-week cycle). The primary end point was progression-free survival, as determined by blinded independent central review. Secondary end points included overall survival, objective response as determined by independent. review, and safety. Health-related quality of life was an exploratory end point. RESULTS Overall, 651 patients were assigned to receive nivolumab plus cabozantinib (323 N patients) or sunitinib (328 patients). At a median follow-up of 18.1 months for c overall survival, the median progression-free survival was 16.6 months (95% confidence interval [CI], 12.5 to 24.9) with nivolumab plus cabozantinib and 8.3 months (95% CI, 7.0 to 9.7) with sunitinib (hazard ratio for disease progression or death, 0.51; 95% CI, 0.41 to 0.64; P<0.001). The probability of overall survival at 12 months was 85.7% (95% CI, 81.3 to 89.1) with nivolumab plus cabozantinib and 75.6% (95% CI, 70.5 to 80.0) with sunitinib (hazard ratio for death, 0.60; 98.89% CI, 0.40 to 0.89; P=0,001). An objective response occurred in 55.7% of the patients receiving nivolumab plus cabozantinib and in 27.1% of those receiving sunitinib (P<0.001). Efficacy benefits with nivolumab plus cabozantinib were consistent across subgroups. Adverse events of any cause of grade 3 or higher occurred in 75.3% of the 320 patients receiving nivolumab plus cabozantinib and in 70.6% of the 320 patients receiving sunitinib. Overall, 19.7% of the patients in the combination group discontinued at least one of the trial drugs owing to adverse events, and 5.6% discontinued both. Patients reported better health-related quality of life with nivolumab plus cabozantinib than with sunitinib. CONCLUSIONS Nivolumab plus cabozantinib had significant benefits over sunitinib with respect to progression-free survival, overall survival, and likelihood of response in patients with previously untreated advanced renal-cell carcinoma. [ABSTRACT FROM AUTHOR]

Published
2021
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