Health-related quality of life during treatment for renal cell carcinoma: results from a phase II study of axitinib.
BACKGROUND
Patients with metastatic renal cell carcinoma (RCC) are often treated with cytokine therapy, although the effect is modest and second-line therapy is often warranted. Relatively little is known regarding the impact on health-related quality of life (HRQOL) in cytokine-refractory patients. This study examined the HRQOL of patients with metastatic RCC treated with axitinib, a new targeted therapy that affects the vessels supplying blood to the tumor.


METHODS
Patients with metastatic RCC and progression following first-line cytokine therapy were enrolled into a single-arm, open-label multicenter phase II trial. Axitinib was administered orally twice daily until disease progression or intolerance. The primary endpoint was objective response rate, with secondary endpoints being time to progression, overall survival, safety and HRQOL. The longitudinal analyses of the HRQOL data through 144 weeks of treatment, as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30, are presented here.


RESULTS
Fifty-two patients completed baseline HRQOL assessments. Statistically significant baseline-post-treatment changes were observed on the role, cognitive and social functioning scales as well as on the nausea and vomiting, pain and diarrhea symptoms. All of the changes were less than one-quarter of the category, with diarrhea being the exception at less than half a category, suggesting that the changes as reported by patients were not meaningful.


CONCLUSIONS
Treatment of metastatic RCC with axitinib demonstrated acceptable disruption in HRQOL functioning and symptoms when compared to baseline levels. From a patient-reported perspective, treatment with axitinib appears to be well tolerated.
Global Outcomes Research, Pfizer Inc., New London, CT 06320, USA. Peter.C.Trask@Pfizer.com
Peter C
PC
Trask
Andrew G
AG
Bushmakin
Joseph C
JC
Cappelleri
Paul
P
Bycott
Katherine
K
Liau
Sinil
S
Kim
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D020533:Angiogenesis Inhibitors / Q000627:therapeutic use*; D000077784:Axitinib; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D018450:Disease Progression; D005260:Female; D006801:Humans; D007093:Imidazoles / Q000627:therapeutic use*; D007191:Indazoles / Q000627:therapeutic use*; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D011795:Surveys and Questionnaires
D020533:Angiogenesis Inhibitors; D007093:Imidazoles; D007191:Indazoles; D000077784:Axitinib