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.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 1571-1578 |
| Number of pages | 8 |
| Journal | British Journal of Cancer |
| Volume | 108 |
| Issue number | 8 |
| DOIs | |
| State | Published - Apr 30 2013 |
Funding
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. 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.
ASJC Scopus subject areas
- Oncology
- Cancer Research
