Grande, EAlonso-Gordoa, TReig, OEsteban, ECastellano, DGarcia-Del-Muro, XMendez, M JGarcia-Donas, JGonzalez Rodriguez, MArranz-Arija, J ALopez-Criado, PMolina-Cerrillo, JMellado, BAlvarez-Fernandez, CDe Velasco, GCuellar-Rivas, M ARodriguez-Alonso, R MRodriguez-Moreno, J FSuarez-Rodriguez, C2023-05-032023-05-032022-04-08Grande E, Alonso-Gordoa T, Reig O, Esteban E, Castellano D, Garcia-Del-Muro X, et al. 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. ESMO Open. 2022 Apr;7(2):100463http://hdl.handle.net/10668/22214The 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. 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. 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. 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.enAttribution-NonCommercial-NoDerivatives 4.0 Internationalhttp://creativecommons.org/licenses/by-nc-nd/4.0/Immune checkpoint inhibitorsMetastatic renal carcinomaSecond-line treatmentSunitinibCarcinoma, Renal CellFemaleHumansIndolesKidney NeoplasmsMaleProspective StudiesSunitinibresearch article35405437open accessCarcinoma de celulas renalesEstudios prospectivosFemeninoHumanosIndolesMasculinoNeoplasias renalesSunitinib10.1016/j.esmoop.2022.1004632059-7029PMC9058923http://www.esmoopen.com/article/S2059702922000813/pdfhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC9058923/pdf