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
| Autor: | E, Grande, T, Alonso-Gordoa, O, Reig, E, Esteban, D, Castellano, X, Garcia-Del-Muro, M J, Mendez, J, García-Donas, M, González Rodríguez, J A, Arranz-Arija, P, Lopez-Criado, J, Molina-Cerrillo, B, Mellado, C, Alvarez-Fernandez, G, De Velasco, M A, Cuéllar-Rivas, R M, Rodríguez-Alonso, J F, Rodríguez-Moreno, C, Suarez-Rodriguez |
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| Přispěvatelé: | Institut Català de la Salut, [Grande E] Medical Oncology, MD Anderson Cancer Center Madrid, Madrid, Spain. [Alonso-Gordoa T] Medical Oncology, Hospital Universitario Ramón y Cajal, Madrid, Spain. [Reig O] Medical Oncology, Hospital Clinic and Translational Genomics and Targeted Therapies in Solid Tumors Group, August Pi I Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain. [Esteban E] Medical Oncology, Hospital Universitario Central de Asturias, Oviedo, Spain. [Castellano D] Medical Oncology, Hospital Universitario 12 de Octubre, Madrid, Spain. [Garcia-Del-Muro X] Medical Oncology, Institut Català d’Oncologia (ICO Bellvitge) Idibell, University of Barcelona, Barcelona, Spain. [González Rodríguez M] Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. Servei d’Oncologia Mèdica, Vall d’Hebron Hospital Universitari, Barcelona, Spain, Vall d'Hebron Barcelona Hospital Campus |
| Rok vydání: | 2022 |
| Předmět: |
Male
Cancer Research Indoles compuestos heterocíclicos::compuestos heterocíclicos con anillos de fusión::compuestos heterocíclicos de 2 anillos::indoles [COMPUESTOS QUÍMICOS Y DROGAS] sunitinib neoplasias::neoplasias::neoplasias por localización::neoplasias urogenitales::neoplasias urológicas::neoplasias renales::carcinoma de células renales [ENFERMEDADES] Ronyons - Càncer - Tractamemt Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores] Other subheadings::Other subheadings::/drug therapy [Other subheadings] Càncer de ronyó immune checkpoint inhibitors Sunitinib Humans Prospective Studies Other subheadings::/therapeutic use [Other subheadings] Carcinoma Renal Cell Otros calificadores::/uso terapéutico [Otros calificadores] diagnóstico::pronóstico::resultado del tratamiento [TÉCNICAS Y EQUIPOS ANALÍTICOS DIAGNÓSTICOS Y TERAPÉUTICOS] Enzyme inhibitors metastatic renal carcinoma Diagnosis::Prognosis::Treatment Outcome [ANALYTICAL DIAGNOSTIC AND THERAPEUTIC TECHNIQUES AND EQUIPMENT] Kidney Neoplasms Renal cancer Oncology Inhibidors enzimàtics second-line treatment Neoplasms::Neoplasms::Neoplasms by Site::Urogenital Neoplasms::Urologic Neoplasms::Kidney Neoplasms::Carcinoma Renal Cell [DISEASES] Avaluació de resultats (Assistència sanitària) Female Heterocyclic Compounds::Heterocyclic Compounds Fused-Ring::Heterocyclic Compounds 2-Ring::Indoles [CHEMICALS AND DRUGS] |
| Zdroj: | Dipòsit Digital de la UB Universidad de Barcelona Scientia |
| Popis: | Immune checkpoint inhibitors; Metastatic renal carcinoma; Second-line treatment Inhibidors del punt de control immunitari; Carcinoma renal metastàtic; Tractament de segona línia Inhibidores del punto de control inmunitario; Carcinoma renal metastásico; Tratamiento de segunda línea 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. This work was supported by Pfizer, S.L.U. (Madrid, Spain). Pfizer, S.L.U. provided an unrestricted research grant with drug funding and drug supply to conduct the study (no grant number). |
| Databáze: | OpenAIRE |
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