To assess the clinical efficacy of programmed death 1 (PD-1) inhibitors plus split-course radiotherapy in the first-line treatment of advanced kidney cancer.
In this prospective, randomized, single-blinded, controlled trial, 44 patients with advanced kidney cancer initially treated in our hospital from January 2017 to December 2018 were recruited. They were concurrently and randomly assigned at a ratio of 1 : 1 to the control group and the study group, with 22 cases in each group. The control group received PD-1 inhibitor nivolumab combined with ipilimumab, and the study group received split-course radiotherapy plus. The primary endpoint is clinical efficacy, and the secondary endpoints are progression-free survival (PFS), overall survival (OS), and adverse events (AEs).
Nivolumab plus split-course radiotherapy was associated with an objective remission rate (ORR) of 59.09% versus nivolumab alone with an ORR of 27.27%. The median PFS was 21.5 months (95% CI: 14.1-NA) after single nivolumab therapy and 28.1 months (95% CI: 24.5-NA) after nivolumab plus split-course radiotherapy, with an HR of 1.875 (95% CI: 0.877-4.011). The median OS was 27.1 months (95% CI: 20.7-NA) after single nivolumab therapy and not reached after nivolumab plus split-course radiotherapy and an HR of 2.56 (95% CI: 1.081-6.06). Nivolumab was associated with significantly better OS plus split-course radiotherapy versus nivolumab alone.
Nivolumab plus split-course radiotherapy in patients with advanced renal cell carcinoma significantly improves ORR and prolongs overall survival with a good safety profile.
Journal of oncology. 2022 Jul 30*** epublish ***
Weiping Li, Zhigang Cao, Pengcheng Chang, Bin Zhang, Fudong Li, Dehui Chang
Department of Urology, The First Hospital of Lanzhou University, Lanzhou 730030, China., Department of Urology, The 940 Hospital of Joint Logistics Support Force of Chinese PLA, Lanzhou 730050, China.