Axitinib versus sorafenib in advanced renal cell carcinoma: subanalyses by prior therapy from a randomised phase III trial

B Escudier, M D Michaelson, R J Motzer, T E Hutson, J I Clark, H Y Lim, E Porfiri, P Zalewski, G Kannourakis, M Staehler, J Tarazi, B Rosbrook, L Cisar, S Hariharan, S Kim, B I Rini, B Escudier, M D Michaelson, R J Motzer, T E Hutson, J I Clark, H Y Lim, E Porfiri, P Zalewski, G Kannourakis, M Staehler, J Tarazi, B Rosbrook, L Cisar, S Hariharan, S Kim, B I Rini

Abstract

Background: In the AXIS trial, axitinib prolonged progression-free survival (PFS) vs sorafenib in patients with advanced renal cell carcinoma (RCC) previously treated with sunitinib or cytokines.

Methods: In post hoc analyses, patients were grouped by objective response to prior therapy (yes vs no), prior therapy duration (< vs ⩾median), and tumour burden (baseline sum of the longest diameter < vs ⩾median). PFS and overall survival (OS), and safety by type and duration of prior therapy were evaluated.

Results: Response to prior therapy did not influence outcome with second-line axitinib or sorafenib. PFS was significantly longer in axitinib-treated patients who received longer prior cytokine treatment and sorafenib-treated patients with smaller tumour burden following sunitinib. Overall survival with the second-line therapy was longer in patients who received longer duration of prior therapy, although not significant in the sunitinib-to-axitinib sequence subgroup; OS was also longer in patients with smaller tumour burden, but not significant in the cytokine-to-axitinib sequence subgroup. Safety profiles differed modestly by type and duration of prior therapy.

Conclusions: AXIS data suggest that longer duration of the first-line therapy generally yields better outcome with the second-line therapy and that lack of response to first-line therapy does not preclude positive clinical outcomes with a second-line vascular endothelial growth factor-targeted agent in patients with advanced RCC.

Trial registration: ClinicalTrials.gov NCT00678392.

Figures

Figure 1
Figure 1
Kaplan–Meier estimates of overall survival with second-line (A and B) axitinib or (C and D) sorafenib by duration of prior therapy with (A and C) sunitinib or (B and D) cytokines. *P-value based on two-sided unstratified log-rank test and not adjusted for multiplicity. Abbreviations: CI=confidence interval; mo=months; mOS=median overall survival; NE=not estimable.
Figure 2
Figure 2
Kaplan–Meier estimates of overall survival with second-line (A and B) axitinib or (C and D) sorafenib by baseline SLD following prior therapy with (A and C) sunitinib or (B and D) cytokines. *P-value based on two-sided unstratified log-rank test and not adjusted for multiplicity. Abbreviations: CI=confidence interval; mo=months; mOS=median overall survival; NE=not estimable; SLD=sum of the longest diameters.

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Source: PubMed

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