TY - JOUR
T1 - Patient-reported outcomes for axitinib vs sorafenib in metastatic renal cell carcinoma
T2 - Phase III (AXIS) trial
AU - Cella, D.
AU - Escudier, B.
AU - Rini, B.
AU - Chen, C.
AU - Bhattacharyya, H.
AU - Tarazi, J.
AU - Rosbrook, B.
AU - Kim, S.
AU - Motzer, R.
N1 - Funding Information:
This study was sponsored by Pfizer Inc. Medical writing support was provided by Dennis Revicki, PhD, at United Biosource Corporation and Helen Jones, PhD, at UBC Scientific Solutions and was funded by Pfizer Inc.
Funding Information:
DC has served as a consultant for and received research funding from Pfizer, AVEO, Bayer, GlaxoSmithKline, and Novartis. BE has received honoraria from AVEO, Bayer, GlaxoSmithKline, Novartis, and Pfizer. BRi has served as a consultant for and received research funding from Pfizer. CC, HB, JT, Bro, and SK are employees of and shareholders in Pfizer Inc. RM has served as a consultant for Pfizer.
Copyright:
Copyright 2013 Elsevier B.V., All rights reserved.
PY - 2013/4/30
Y1 - 2013/4/30
N2 - 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.
AB - 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.
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U2 - 10.1038/bjc.2013.145
DO - 10.1038/bjc.2013.145
M3 - Article
C2 - 23579211
AN - SCOPUS:84877010240
VL - 108
SP - 1571
EP - 1578
JO - British Journal of Cancer
JF - British Journal of Cancer
SN - 0007-0920
IS - 8
ER -