Important group differences on the Functional Assessment of Cancer Therapy–Kidney Symptom Index Disease-Related Symptoms in patients with metastatic renal cell carcinoma Journal Article
| Authors: | Cella, D.; Motzer, R. J.; Rini, B. I.; Cappelleri, J. C.; Ramaswamy, K.; Hariharan, S.; Arondekar, B.; Bushmakin, A. G. |
| Article Title: | Important group differences on the Functional Assessment of Cancer Therapy–Kidney Symptom Index Disease-Related Symptoms in patients with metastatic renal cell carcinoma |
| Abstract: | Background: The Functional Assessment of Cancer Therapy–Kidney Symptom Index Disease-Related Symptoms (FKSI-DRS) is important to gauge clinical benefit in metastatic renal cell carcinoma (mRCC). Objectives: To estimate important difference (ID) in FKSI-DRS scores that is considered to be meaningful when comparing treatment effect between groups, using mRCC trial data. Methods: Data were derived from two pivotal phase III mRCC trials comparing sunitinib versus interferon alfa (N = 750) in first-line mRCC, and axitinib versus sorafenib (N = 723) in second-line mRCC. The change from baseline in FKSI-DRS score was examined as a function of a set of anchors using the repeated-measures model. Several anchors were evaluated: FKSI item “I am bothered by side effects of treatment,” EuroQol five-dimensional questionnaire utility score, and adverse events. Results: When the “I am bothered by side effects of treatment” score was used as an anchor, the ID ranged between 1.2 and 1.3 points. When change in the EuroQol five-dimensional questionnaire utility score was used as an anchor, the FKSI-DRS ID ranged between 0.62 and 0.63 points. Selecting the adverse events that corresponded to a maximum worsening in the FKSI-DRS score in either trial, the ID ranged between 0.62 and 0.74 points. Conclusions: Among patients undergoing treatment for mRCC, between-group differences in FKSI-DRS scores as low as 1 point might be meaningful. © 2018 ISPOR–The Professional Society for Health Economics and Outcomes Research |
| Keywords: | adult; middle aged; major clinical study; fatigue; sorafenib; sunitinib; diarrhea; hypertension; side effect; alpha interferon; anorexia; nausea; vomiting; cancer therapy; renal cell carcinoma; arthralgia; asthenia; rash; questionnaire; scoring system; intermethod comparison; targeted therapy; therapy effect; health-related quality of life; axitinib; dyspepsia; hand foot syndrome; kidney metastasis; dysgeusia; clinical assessment tool; decreased appetite; phase 3 clinical trial (topic); body weight loss; human; male; female; priority journal; article; clinically important difference; functional assessment inventory; functional assessment of cancer therapy kidney symptom index disease related symptom; important group difference; minimal clinically important difference |
| Journal Title: | Value in Health |
| Volume: | 21 |
| Issue: | 12 |
| ISSN: | 1098-3015 |
| Publisher: | Elsevier Science, Inc. |
| Date Published: | 2018-12-01 |
| Start Page: | 1413 |
| End Page: | 1418 |
| Language: | English |
| DOI: | 10.1016/j.jval.2018.04.1371 |
| PROVIDER: | scopus |
| PUBMED: | 30502785 |
| PMCID: | PMC6788639 |
| DOI/URL: | |
| Notes: | Value Health -- Export Date: 2 January 2019 -- Article -- CODEN: VIHLF C2 - 30502785 -- Source: Scopus |
