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Clinical Trial
. 2013 Apr 30;108(8):1571-8.
doi: 10.1038/bjc.2013.145. Epub 2013 Apr 11.

Patient-reported outcomes for axitinib vs sorafenib in metastatic renal cell carcinoma: phase III (AXIS) trial

D Cella  1 , B Escudier, B Rini, C Chen, H Bhattacharyya, J Tarazi, B Rosbrook, S Kim, R Motzer
Affiliations
Clinical Trial

Patient-reported outcomes for axitinib vs sorafenib in metastatic renal cell carcinoma: phase III (AXIS) trial

D Cella et al. Br J Cancer. .

Abstract

Background: Axitinib demonstrated greater progression-free survival vs sorafenib in a phase III study of previously treated patients with metastatic renal cell carcinoma. Here, we report patient-reported kidney-specific symptoms and health status, measured by the Functional Assessment of Cancer Therapy (FACT) Kidney Cancer Symptom Index (FKSI) and the European Quality of Life self-report questionnaire (EQ-5D).

Methods: In all, 723 patients received axitinib (starting dose 5 mg twice daily (b.i.d.)) or sorafenib (400 mg b.i.d.). The FKSI-15, including the disease-related symptoms (FKSI-DRS) subscale, was administered on day 1 before dosing, every 4 weeks and at end of treatment (EOT)/withdrawal. Statistical methods included a mixed-effects repeated-measures model.

Results: At baseline, patients in both arms had relatively high mean FSKI-15 and FKSI-DRS scores, comparable to the general US population. Subsequent on-treatment overall mean scores were similar between axitinib and sorafenib, and there was no substantial decline during treatment. Scores substantially worsened at EOT, mainly due to disease progression.

Conclusion: Patient-reported outcomes were comparable for second-line axitinib and sorafenib and were maintained at relatively high levels while on treatment, but worsened at EOT. As duration of treatment was longer with axitinib than sorafenib, time to worsening of symptoms can be delayed longer with axitinib.

Trial registration: ClinicalTrials.gov NCT00678392.

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Figures

Figure 1
Figure 1
Mean FKSI-15 scores over the course of the study. Dotted line represents US population mean. Point estimates for end of treatment scores for axitinib and sorafenib arms are virtually identical and therefore indistinguishable. FKSI-15, Functional Assessment of Cancer Therapy Kidney Symptom Index-15; s.e., standard error.
Figure 2
Figure 2
Mean FKSI-DRS scores over the course of the study. Dotted line represents US population mean. FKSI-DRS, Functional Assessment of Cancer Therapy–Kidney Cancer Symptom Index-disease-related symptoms subscale; s.e., standard error.
Figure 3
Figure 3
Response to individual FKSI question, ‘I am bothered by side effects of treatment.' EOT, end of treatment; FKSI, Functional Assessment of Cancer Therapy–Kidney Cancer Symptom Index.
See this image and copyright information in PMC

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References

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