Abstract
4573 Background: The ATLAS trial compared axitinib vs placebo in patients (pts) with locoregional RCC at risk of recurrence after nephrectomy. ATLAS was stopped due to futility at a pre-planned interim analysis; results showed no difference in disease-free survival (DFS) between the treatment arms. We explored whether pts treated longer with axitinib achieved better outcomes and the impact of axitinib dose reduction or increase on DFS – the trial required dose reduction for toxicity and allowed dose escalation in the event of no or minimal toxicity. Methods: Pts in ATLAS received a maximum of 3 y of study treatment. A landmark analysis was conducted comparing pts treated with axitinib ≤1 y vs > 1 y. Pts who recurred or censored prior to 1 y were excluded. An analysis of daily dose characteristics was undertaken to compare patients whose dose was reduced and whose dose was increased to those with a stable dose of axitinib. Cox proportional hazard model was used for DFS analysis. Toxicity analysis using a 90-day landmark was also conducted. Results: Overall, 264 axitinib-treated pts were included in this analysis. Of these 42 pts were treated for ≤1 y and 222 pts for > 1 y. Pts remaining on axitinib > 1 y vs ≤1 y did not have different DFS (hazard ratio [HR] = 0.572, 95% confidence interval [CI]: 0.247–1.327, P= 0.1874). Pts with dose reduction had longer DFS than those with a stable dose (HR = 0.458, CI: 0.305–0.687, P= 0.0001). Pts with dose increase did not have DFS different to stable dose pts (HR = 1.936, CI: 0.937–3.997, P= 0.0685). No difference in DFS in pts experiencing grade ≥2 adverse events (AEs) vs grade < 2 AEs within 90 d of start of treatment was observed (HR = 0.885, CI: 0.419–1.869, P= 0.7488). Pts experiencing grade ≥3 AEs within 90 d of start of treatment had shorter DFS compared to those that did not (HR = 1.643, CI: 0.963–2.801, P= 0.0653). Conclusions: DFS did not vary based on duration of axitinib treatment, however, pts with dose reductions had longer DFS vs pts with stable dose or dose increases. This difference suggests that there is a relation between axitinib exposure and DFS as seen with sunitinib in the advanced setting and pazopanib in the PROTECT study.
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