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http://hdl.handle.net/2445/186251
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DC Field | Value | Language |
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dc.contributor.author | Grande, Enrique | - |
dc.contributor.author | Alonso Gordoa, Teresa | - |
dc.contributor.author | Reig Torras, Oscar | - |
dc.contributor.author | Esteban, E. | - |
dc.contributor.author | Castellano, D. | - |
dc.contributor.author | Garcia Del Muro, Xavier | - |
dc.contributor.author | Mendez, M.J. | - |
dc.contributor.author | García Donas, J. | - |
dc.contributor.author | González Rodríguez, M. | - |
dc.contributor.author | Arranz Arija, José Ángel | - |
dc.contributor.author | Lopez Criado, P. | - |
dc.contributor.author | Molina Cerrillo, J. | - |
dc.contributor.author | Mellado González, Begoña | - |
dc.contributor.author | Alvarez Fernandez, C. | - |
dc.contributor.author | Velasco, G. de | - |
dc.contributor.author | Cuéllar Rivas, M.A. | - |
dc.contributor.author | Rodríguez Alonso, R.M. | - |
dc.contributor.author | Rodríguez Moreno, J.F. | - |
dc.contributor.author | Suarez Rodriguez, C. | - |
dc.date.accessioned | 2022-06-02T08:57:44Z | - |
dc.date.available | 2022-06-02T08:57:44Z | - |
dc.date.issued | 2022-04-01 | - |
dc.identifier.issn | 2059-7029 | - |
dc.identifier.uri | http://hdl.handle.net/2445/186251 | - |
dc.description.abstract | Background: The INMUNOSUN trial had the objective of prospectively evaluating the efficacy and safety of sunitinib as a pure second-line treatment in patients with metastatic renal cell carcinoma (mRCC) who have progressed to first-line immune checkpoint inhibitor (ICI)-based therapies. Patients and methods: A multicenter, phase II, single-arm, open-label study was carried out in patients with a histologically confirmed diagnosis of mRCC with a clear-cell component who had progressed to a first-line regimen of ICI-based therapies. All patients received sunitinib 50 mg once daily orally for 4 weeks, followed by a 2-week rest period following package insert instructions. The primary outcome was the objective response rate. Results: Twenty-one assessable patients were included in the efficacy and safety analyses. Four patients [19.0%, 95% confidence interval (CI) 2.3% to 35.8%] showed an objective response (OR), and all of them had partial responses. Additionally, 14 (67%) patients showed a stable response, leading to clinical benefit in 18 patients (85.7%, 95% CI 70.7% to 100%). Among the four assessable patients who showed an OR, the median duration of the response was 7.1 months (interquartile range 4.2-12.0 months). The median progression-free survival (PFS) was 5.6 months (95% CI 3.1-8.0 months). The median overall survival (OS) was 23.5 months (95% CI 6.3-40.7 months). Patients who had better antitumor response to first-line ICI-based treatment showed a longer PFS and OS with sunitinib. The most frequent treatment-emergent adverse events were diarrhea (n = 11, 52%), dysgeusia (n = 8, 38%), palmar-plantar erythrodysesthesia (n = 8, 38%), and hypertension (n = 8, 38%). There was 1 patient who exhibited grade 5 pancytopenia, and 11 patients experienced grade 3 adverse events. Eight (38%) patients had serious adverse events, four of which were considered to be related to sunitinib. Conclusion: Although the INMUNOSUN trial did not reach the pre-specified endpoint, it demonstrated that sunitinib is active and can be safely used as a second-line option in patients with mRCC who progress to new standard ICI-based regimens. | - |
dc.format.extent | 9 p. | - |
dc.format.mimetype | application/pdf | - |
dc.language.iso | eng | - |
dc.publisher | Elsevier BV | - |
dc.relation.isformatof | Reproducció del document publicat a: https://doi.org/10.1016/j.esmoop.2022.100463 | - |
dc.relation.ispartof | ESMO Open, 2022, vol. 7, num. 2 | - |
dc.relation.uri | https://doi.org/10.1016/j.esmoop.2022.100463 | - |
dc.rights | cc by-nc-nd (c) Grande, Enrique et al, 2022 | - |
dc.rights.uri | http://creativecommons.org/licenses/by-nc-nd/3.0/es/ | * |
dc.source | Articles publicats en revistes (Ciències Clíniques) | - |
dc.subject.classification | Càncer de ronyó | - |
dc.subject.classification | Inhibidors enzimàtics | - |
dc.subject.other | Renal cancer | - |
dc.subject.other | Enzyme inhibitors | - |
dc.title | Results from the INMUNOSUN-SOGUG trial: a prospective phase II study of sunitinib as a second-line therapy in patients with metastatic renal cell carcinoma after immune checkpoint-based combination therapy | - |
dc.type | info:eu-repo/semantics/article | - |
dc.type | info:eu-repo/semantics/publishedVersion | - |
dc.identifier.idgrec | 732592 | - |
dc.date.updated | 2022-06-02T07:36:34Z | - |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | - |
dc.identifier.pmid | 35405437 | - |
Appears in Collections: | Articles publicats en revistes (Ciències Clíniques) Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) |
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PIIS2059702922000813.pdf | 421.52 kB | Adobe PDF | View/Open |
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