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Randomized Controlled Trial
. 2022 Jul;130(1):68-75.
doi: 10.1111/bju.15625. Epub 2021 Nov 24.

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

Yasmin Abu-Ghanem  1 , Johannes V van Thienen  2 , Christian Blank  2 , Maureen J B Aarts  3 , Michael Jewett  4 , Igle Jan de Jong  5 , Jean-Baptiste Lattouf  6 , Harm H E van Melick  7 , Lori Wood  8 , Peter Mulders  9 , Sylvie Rottey  10 , John Wagstaff  11 , Patricia Zondervan  12 , Tom Powles  13 , Anouk Neven  14 , Laurence Collette  14 , Bertrand Tombal  14   15 , John Haanen  2 , Axel Bex  1   2
Affiliations
Randomized Controlled Trial

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

Yasmin Abu-Ghanem et al. BJU Int. 2022 Jul.

Abstract

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.

Keywords: #KidneyCancer; #kcsm; #uroonc; cytoreductive nephrectomy; deferred; immediate; renal cell carcinoma; sunitinib; survival.

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