TY - JOUR
T1 - Cytoreductive nephrectomy and exposure to sunitinib – a post hoc analysis of the Immediate Surgery or Surgery After Sunitinib Malate in Treating Patients With Metastatic Kidney Cancer (SURTIME) trial
AU - Abu-Ghanem, Yasmin
AU - van Thienen, Johannes V.
AU - Blank, Christian
AU - Aarts, Maureen J. B.
AU - Jewett, Michael
AU - de Jong, Igle Jan
AU - Lattouf, Jean-Baptiste
AU - van Melick, Harm H. E.
AU - Wood, Lori
AU - Mulders, Peter
AU - Rottey, Sylvie
AU - Wagstaff, John
AU - Zondervan, Patricia
AU - Powles, Tom
AU - Neven, Anouk
AU - Collette, Laurence
AU - Tombal, Bertrand
AU - Haanen, John
AU - Bex, Axel
N1 - Funding Information: Prof Bex reported serving as a member of the medical steering committee of the International Kidney Cancer Coalition and the Kidney Cancer Association. Dr Blank reported receiving personal fees for advisory roles for BMS, MSD, Roche, GlaxoSmithKline, Eli Lilly and Company, Novartis, and Pfizer and grants from Novartis and BMS outside the submitted work. Dr Jewett reported receiving honoraria from Pfizer, Ipsen, Olympus, and Theralase Therapeutics. Dr Lattouf reported receiving honoraria from Janssen and Bayer for participation in advisory boards outside the submitted work. Dr Powles reported receiving grants from AstraZeneca and Roche and personal fees from AstraZeneca, Roche, Pfizer, Novartis, Merck & Co, and BMS outside the submitted work. Dr Tombal reported receiving grants from Amgen, Myovant, Astellas, Janssen, Bayer Sanofi, Ferring. No other disclosures were reported. Funding Information: The study was supported by a restricted educational grant from Pfizer. This publication was also supported by a donation from the Kankerbestrijding/KWF from the Netherlands through the EORTC Cancer Research Fund. Publisher Copyright: © 2021 The Authors BJU International © 2021 BJU International
PY - 2021
Y1 - 2021
N2 - Objective: To analyse if exposure to sunitinib in the Immediate Surgery or Surgery After Sunitinib Malate in Treating Patients With Metastatic Kidney Cancer (SURTIME) trial, which investigated opposite sequences of cytoreductive nephrectomy (CN) and systemic therapy, is associated with the overall survival (OS) benefit observed in the deferred CN arm. Patients and Methods: A post hoc analysis of SURTIME trial data. Variables analysed included number of patients receiving sunitinib, time from randomisation to start sunitinib, overall response rate by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1, and duration of drug exposure and dose in the intention-to-treat population of the immediate and deferred arm. Descriptive methods and 95% confidence-intervals (CI) were used. Results: In the deferred arm, 97.7% (95% CI 89.3–99.6%; n = 48) received sunitinib vs 80% (95% CI 66.9–88.7%, n = 40) in the immediate arm. Following immediate CN, 19.6% progressed 4 weeks after CN and the median time to start sunitinib was 39.5 vs 4.5 days in the deferred arm. At week 16, 46.0% had progressed at metastatic sites in the immediate CN arm vs 32.7% in the deferred arm. Sunitinib dose reductions, escalations and interruptions were not statistically significantly different between arms. Among patients who received sunitinib in the immediate or deferred arm the median total sunitinib treatment duration was 172.5 vs 248 days. Reduction of target lesions was more profound in the deferred arm. Conclusions: In comparison to the deferred CN approach, immediate CN impairs administration, onset, and duration of sunitinib. Starting with systemic therapy leads to early and more profound disease control and identification of progression prior to planned CN, which may have contributed to the observed OS benefit.
AB - Objective: To analyse if exposure to sunitinib in the Immediate Surgery or Surgery After Sunitinib Malate in Treating Patients With Metastatic Kidney Cancer (SURTIME) trial, which investigated opposite sequences of cytoreductive nephrectomy (CN) and systemic therapy, is associated with the overall survival (OS) benefit observed in the deferred CN arm. Patients and Methods: A post hoc analysis of SURTIME trial data. Variables analysed included number of patients receiving sunitinib, time from randomisation to start sunitinib, overall response rate by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1, and duration of drug exposure and dose in the intention-to-treat population of the immediate and deferred arm. Descriptive methods and 95% confidence-intervals (CI) were used. Results: In the deferred arm, 97.7% (95% CI 89.3–99.6%; n = 48) received sunitinib vs 80% (95% CI 66.9–88.7%, n = 40) in the immediate arm. Following immediate CN, 19.6% progressed 4 weeks after CN and the median time to start sunitinib was 39.5 vs 4.5 days in the deferred arm. At week 16, 46.0% had progressed at metastatic sites in the immediate CN arm vs 32.7% in the deferred arm. Sunitinib dose reductions, escalations and interruptions were not statistically significantly different between arms. Among patients who received sunitinib in the immediate or deferred arm the median total sunitinib treatment duration was 172.5 vs 248 days. Reduction of target lesions was more profound in the deferred arm. Conclusions: In comparison to the deferred CN approach, immediate CN impairs administration, onset, and duration of sunitinib. Starting with systemic therapy leads to early and more profound disease control and identification of progression prior to planned CN, which may have contributed to the observed OS benefit.
KW - #KidneyCancer
KW - #kcsm
KW - #uroonc
KW - cytoreductive nephrectomy
KW - deferred
KW - immediate
KW - renal cell carcinoma
KW - sunitinib
KW - survival
UR - http://www.scopus.com/inward/record.url?scp=85120573848&partnerID=8YFLogxK
U2 - https://doi.org/10.1111/bju.15625
DO - https://doi.org/10.1111/bju.15625
M3 - Article
C2 - 34706141
SN - 1464-4096
JO - BJU international
JF - BJU international
ER -