Axitinib versus placebo as an adjuvant treatment of renal cell carcinoma: results from the phase III, randomized ATLAS trialopen access
- Authors
- Gross-Goupil, M.[Gross-Goupil, M.]; Kwon, T.G.[Kwon, T.G.]; Eto, M.[Eto, M.]; Ye, D.[Ye, D.]; Miyake, H.[Miyake, H.]; Seo, S.I.[Seo, S.I.]; Byun, S.-S.[Byun, S.-S.]; Lee, J.L.[Lee, J.L.]; Master, V.[Master, V.]; Jin, J.[Jin, J.]; DeBenedetto, R.[DeBenedetto, R.]; Linke, R.[Linke, R.]; Casey, M.[Casey, M.]; Rosbrook, B.[Rosbrook, B.]; Lechuga, M.[Lechuga, M.]; Valota, O.[Valota, O.]; Grande, E.[Grande, E.]; Quinn, D.I.[Quinn, D.I.]
- Issue Date
- Dec-2018
- Publisher
- OXFORD UNIV PRESS
- Keywords
- adjuvant; axitinib; disease-free survival; overall survival; renal cell carcinoma; safety
- Citation
- Annals of oncology : official journal of the European Society for Medical Oncology, v.29, no.12, pp.2371 - 2378
- Journal Title
- Annals of oncology : official journal of the European Society for Medical Oncology
- Volume
- 29
- Number
- 12
- Start Page
- 2371
- End Page
- 2378
- URI
- https://scholarworks.bwise.kr/skku/handle/2021.sw.skku/23679
- DOI
- 10.1093/annonc/mdy454
- ISSN
- 0923-7534
- Abstract
- Background: The ATLAS trial compared axitinib versus placebo in patients with locoregional renal cell carcinoma (RCC) at risk of recurrence after nephrectomy. Patients and methods: In a phase III, randomized, double-blind trial, patients had >50% clear-cell RCC, had undergone nephrectomy, and had no evidence of macroscopic residual or metastatic disease [independent review committee (IRC) confirmed]. The intent-to-treat population included all randomized patients [≥pT2 and/or N+, any Fuhrman grade (FG), Eastern Cooperative Oncology Group status 0/1]. Patients (stratified by risk group/country) received (1 : 1) oral twice-daily axitinib 5 mg or placebo for ≤3 years, with a 1-year minimum unless recurrence, occurrence of second primary malignancy, significant toxicity, or consent withdrawal. The primary end point was disease-free survival (DFS) per IRC. A prespecified DFS analysis in the highest-risk subpopulation (pT3, FG ≥ 3 or pT4 and/or N+, any T, any FG) was conducted. Results: A total of 724 patients (363 versus 361, axitinib versus placebo) were randomized from 8 May 2012, to 1 July 2016. The trial was stopped due to futility at a preplanned interim analysis at 203 DFS events. There was no significant difference in DFS per IRC [hazard ratio (HR) = 0.870; 95% confidence interval (CI) : 0.660-1.147; P = 0.3211). In the highest-risk subpopulation, a 36% and 27% reduction in risk of a DFS event (HR; 95% CI) was observed per investigator (0.641; 0.468-0.879; P = 0.0051), and by IRC (0.735; 0.525-1.028; P = 0.0704), respectively. Overall survival data were not mature. Similar adverse events (AEs; 99% versus 92%) and serious AEs (19% versus 14%), but more grade 3/4 AEs (61% versus 30%) were reported for axitinib versus placebo. Conclusions: ATLAS did not meet its primary end point; however, improvement in DFS per investigator was seen in the highest-risk subpopulation. No new safety signals were reported. Trial registration number: NCT01599754.
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