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A Pooled Analysis of Treatment-Free Survival in Advanced Renal Cell Carcinoma. | LitMetric

AI Article Synopsis

  • The study aimed to assess treatment-free survival (TFS) in patients with advanced renal cell carcinoma (aRCC) undergoing immune-oncology (IO) and VEGF tyrosine kinase inhibitor (TKI) combination therapies compared to TKI alone.
  • The analysis pooled data from three randomized trials involving over 2,300 patients, evaluating outcomes like overall survival (OS), TFS with and without toxicity across a 30-month period.
  • Results indicated that both treatment groups experienced similar TFS durations, with slightly different rates of being free from severe toxicity, suggesting the treatment protocols influenced the observed outcomes.

Article Abstract

Purpose: A clinically meaningful attribute of some immune-oncology (IO) regimens is potential durable clinical benefit during a treatment-free interval. We characterize treatment-free survival (TFS) with and without ongoing toxicity in trials of frontline IO-VEGF tyrosine kinase inhibitor (TKI) combinations in patients with advanced renal cell carcinoma (aRCC).

Experimental Design: Individual patient data were pooled by treatment arm from randomized trials submitted to the FDA evaluating IO-TKI combination in treatment-naïve aRCC with at least 30 months of median follow-up. OS, TFS, TFS with and without toxicity, and time to all protocol therapy cessation were assessed. TFS was estimated by 30-month restricted mean times, defined as area between Kaplan-Meier curves for two time-to-event endpoints originating at randomization: time to all protocol therapy cessation and time to subsequent systemic therapy initiation or death.

Results: Three trials met criteria for analysis; 1,183 patients received IO-TKI versus 1,184 on control arms receiving TKI alone (sunitinib, SUN). IO-TKI and SUN groups spent 9% {2.7 months [95% confidence interval (CI), 1.8-3.5]} and 10% [2.9 months (95% CI, 2.1-3.8)] of the 30-month period alive and treatment-free, respectively. Mean TFS without grade ≥3 toxicity was 1.7 and 2.3 months in IO-TKI and SUN groups, respectively.

Conclusions: In this post hoc partitioned survival analysis, TFS and TFS without toxicity appeared similar in the IO-TKI group compared with the SUN group. These findings may reflect contin-uation of TKI until progression per protocol design in all trials and discontinuation of IO after 2 years in two trials. See related commentary by Stadler and Karrison, p. 3098.

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Source
http://dx.doi.org/10.1158/1078-0432.CCR-23-3719DOI Listing

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