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Observational Study
. 2023 Jun;21(3):e166-e174.
doi: 10.1016/j.clgc.2022.11.021. Epub 2022 Dec 5.

Long-term Clinical Outcomes of a Spanish Cohort of Metastatic Renal Cell Carcinoma Patients with a Complete Response to Sunitinib

Guillermo de Velasco  1 , Teresa Alonso-Gordoa  2 , Alejo Rodríguez-Vida  3 , Georgia Anguera  4 , Marc Campayo  5 , Álvaro Pinto  6 , Esther Martínez Ortega  7 , Enrique Gallardo  8 , Natalia Fernández Núñez  9 , Iciar García-Carbonero  10 , Oscar Reig  11 , María José Méndez-Vidal  12 , Ovidio Fernández-Calvo  13 , Natalia Vidal Cassinello  14 , Dolores Torregrosa  15 , Ana López-Martín  16 , Adriana Rosero  17 , Patricia G Valiente  18 , Carmen Garcías de España  19 , Miguel A Climent  20 , Montserrat Domenech Santasusana  21 , Ángel Rodríguez Sánchez  22 , Isabel Chirivella González  23 , Ruth Afonso  24 , Xavier García Del Muro  25 , Javier Casinello  26 , Eva M Fernández-Parra  27 , Lourdes García Sánchez  28 , Javier Afonso  29 , Susana Hernando Polo  30 , Úrsula Asensio  31
Affiliations
Observational Study

Long-term Clinical Outcomes of a Spanish Cohort of Metastatic Renal Cell Carcinoma Patients with a Complete Response to Sunitinib

Guillermo de Velasco et al. Clin Genitourin Cancer. 2023 Jun.

Abstract

Introduction: The long-term clinical outcomes of patients with metastatic renal cell carcinoma (mRCC) and a complete response (CR) to the tyrosine kinase inhibitor (TKI) sunitinib are poorly known. The characteristics of these patients could reveal previously undetected associations with clinical variables.

Patients and methods: This observational, retrospective study (ATILA) used data from a registry of patients with mRCC who had received first-line sunitinib and had achieved CR from 2007 to 2018 in Spain.

Results: Sixty-two patients with CR were included; 48 patients (77.4%) received sunitinib in monotherapy and 14 (22.6%) combined with or followed by local treatment. Median age was 58.5 years (range, 32-81). Most patients (79.0%) had clear cell histology and had undergone previous nephrectomy (90.3%). The majority (70.2%) had an intermediate IMDC prognosis, 23% favorable and 7.0% poor. The median time on treatment with sunitinib was 28.2 months (IQR, 16.7-41.0) and the median time to CR was 10.9 months (IQR, 7.2-19.3). After a median follow-up of 8 years (range, 3-13 years), the median PFS was not reached. The overall median duration of complete response was 64.1 months (IQR, 32.2-99.4). The tolerance and safety profile of sunitinib was consistent with previous reports.

Conclusion: Durable CR to sunitinib was observed in patients regardless the prognosis group, metastasis site or histology type, with 75% of patients remaining in CR after 10 years.

Clinicaltrials: gov: NCT03916458.

Keywords: Complete response; Metastatic renal cell carcinoma; Renal cell carcinoma; Sunitinib; Tyrosine kinase inhibitor.

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Conflict of interest statement

Disclosures G.d.V. received research grants from Pfizer, Roche, and Ipsen; consulting or honoraria fees from Ipsen, Pfizer, Roche, Bayer, Astellas, BMS, MSD and Merck. T.A.G. received research grants from Pfizer, Roche, and Ipsen; consulting fees from Ipsen, Pfizer, Roche, Sanofi, Bayer, Astellas, Janssen-Cilag, BMS, and EISAI; payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from Ipsen, Pfizer, Eisai, and Merck; and support for attending meetings and/or travel from Pfizer, Sanofi, BMS, and IPSEN. A.R.-V. served in advisory boards for MSD, Pfizer, BMS, Astellas, Janssen, Bayer, Clovis and Roche; received honoraria or travel expenses from Pfizer, MSD, Astellas, BMS, Janssen, Astra Zeneca, Roche, Bayer, and Sanofi Aventis; and research funding from Takeda, Pfizer, and Merck. G.A.P. served in speaker bureaus for Ipsen, BMS, Roche, and Janssen. M.C. served in advisory or consultancy roles for AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, EUSA Pharma, Lilly, Roche; received honoraria for lectures for Abbot, Bristol-Myers Squibb, EUSA Pharma, Ipsen, Novartis, Pfizer, Pierre Fabre, Roche; holds institutional financial interests in Astra Zeneca, Merck, Pfizer, Roche, and received travel expenses from Ipsen, Lilly, Merck, Pfizer, and Pierre Fabre. A.P. received research grants from Pfizer and BMS; advisory boards/speaker fees from Pfizer, BMS, Ipsen, Roche, Merck, MSD, Janssen, Astellas, Bayer, Sanofi; and travel expenses from Pfizer, BMS, Janssen and Roche. E.G. received grant support from Astellas, Janssen, Sanofi, Bayer, Ipsen, Ferrer, Pfizer, Roche, GSK and BMS; consulting fees from Sanofi, Janssen, Astellas, Bayer, Ipsen, Pfizer, Roche, Novartis, Eisai, EUSA Pharma, BMS, AstraZeneca, Merck, Rovi, Daiichi Sankyo and Techdow; payment or honoraria for lectures, presentations, speakers’ bureaus, man-uscript writing, or educational events from Astellas, Janssen, Sanofi, Bayer, Ipsen, Pfizer, Roche, BMS, Rovi, Daiichi Sankyo, Leo Pharma, Menarini, Eisai, MSD, Boehringer Ingelheim, Merck, EUSA Pharma and Novartis; support for attending meetings and/or travel from As-tellas, Janssen, Sanofi, BMS, Bayer, Ipsen, Roche, Novartis, Pierre Fabre, Pfizer and Eisai. N.F.N. received support from Roche, BMS, Boehringuer, Sanofi, Bayer, Astra Zeneca, Janssen, MSD, Lilly, Pfizer and IPSEN. I.C.-G. participated in advisory boards of Pfizer, EISAI and BMS. O.R. had consulting or advisory roles with BMS, EISAI, Ipsen; received travel and accommodations support from Ipsen and Pfizer. M.J.M. received honoraria and /or travel support from Janssen-Cilag, Bayer healthcare, Sanofi Aventis, Astellas Medivation, Roche, Ipsen, EISAI, Novartis and Pfizer; advisory boards and speaking for: Pfizer, Astellas, Roche, Ipsen, BMS, Eusa Pharma, Sanofi, Novartis, Janssen andPierre Fabre. N.V.C. received consultant fees from Janssen; speaking fees from Sanofi, Astra Zeneca, Astellas, Janssen, Roche, MSD, Ipsen; and travel support from Pfizer, Pierre Fabre, BMS. A.L.M. received support for attending meetings from Roche and MSD. C.G.d.E. has held consultant or advisory roles with Janssen, Sanofi, Bayer, Astellas; speaking roles from Janssen, Sanofi, Bayer, Astellas, Roche, Ipsen, Pfizer; and other support from Janssen, Sanofi and Roche. M.A.C. has held consulting or advisory role with BMS, MSD, Bayer, EUNSA, Pfizer, Roche, Janssen, Pierre Fabre, Ipsen; received travel expenses from Janssen, Astellas, Roche, Ipsen, and MSD. A.R.S. held consulting or advisory roles for Roche, Bristol, Sanofi, Merck, Ipsen and Eisai. I.C.G. has served as consultant or advisory board to Pzifer, Bristol-Myers Squibb, Ipsen, Roche and EusaPharma; has served as speaker to Pfizer, Bristol-Myers Squibb and Ipsen; and received travel and/or accommodation grants from Pfizer. R.A. has participated in advisory boards for Pfizer, Roche, Sanofi and Servier. X.G.d.M. has participated in advisory boards or as invited speaker for Astellas, BMS, Ipsen, Roche, Eusa Pharma, Eisai, Pfizer and Pharmamar. J.C. reports support from Janssen, Roche, AstraZéneca, Astellas, BMS, Pfizer, Sanofi, and Novartis. J.A. received advisory boards/speaker fees from Novartis, Pfizer, Merck, Roche, BMS; and travel and accommodations from AstraZeneca, BMS, Pfizer, Astellas and Sanofi. S.H.P. participated in advisory boards and as speaker for GSK, Clovis, Astra-Zeneca/MSD and Pfizer. Ú.A. is an employee of Pfizer. All other authors report no conflicts of interests.

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