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. 2012 Feb 14;106(4):646-50.
doi: 10.1038/bjc.2011.589. Epub 2012 Jan 12.

Baseline quality of life as a prognostic survival tool in patients receiving sunitinib for metastatic renal cell carcinoma

D Cella  1 , A G Bushmakin, J C Cappelleri, C Charbonneau, M D Michaelson, R J Motzer
Affiliations

Baseline quality of life as a prognostic survival tool in patients receiving sunitinib for metastatic renal cell carcinoma

D Cella et al. Br J Cancer. .

Abstract

Background: In a randomized phase III trial of sunitinib vs interferon-alfa (IFN-α) in metastatic renal cell carcinoma (mRCC), better baseline quality of life (QoL) was predictive of longer survival. Using this dataset, we have developed a novel prognostic tool that establishes a relationship between baseline QoL scores and median survival time.

Methods: Baseline QoL was assessed using the FACT-Kidney Symptom Index-15 item (FKSI-15), its disease-related symptoms (FKSI-DRS) subscale, and the Functional Assessment of Cancer Therapy-General (FACT-G) scale. Weibull models estimated median progression-free survival (mPFS) and overall survival (mOS) as a function of baseline QoL.

Results: Longer PFS and OS were associated with higher baseline FKSI-15, FKSI-DRS, and FACT-G scores (P<0.05), and baseline FKSI-15 score was the best predictor of survival. For example, for a baseline FKSI-15 score of 60, the predicted mPFS was 67.9 weeks, and predicted mOS was 240.6 weeks. The magnitude of benefit was greater with sunitinib vs IFN-α for a given baseline QoL score.

Conclusion: This novel tool indicates that baseline FKSI-15 scores were linked to mPFS and mOS in a clear and interpretable way. The results support evaluation of patient-reported QoL symptoms at baseline as a prognostic indicator of survival in clinical research and practice.

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Figures

Figure 1
Figure 1
The Functional Assessment of Cancer Therapy–Kidney Symptom Index (FKSI)-15 item long form questionnaire 2007. Reprinted with permission, FACIT.org.
Figure 2
Figure 2
Predicted median (A) PFS and (B) OS as a function of baseline FKSI-15 scores in patients on sunitinib. Abbreviations: CI=confidence interval; FKSI-15=Functional Assessment of Cancer Therapy–Kidney Symptom Index–15 item; OS=overall survival; PFS=progression-free survival.
Figure 3
Figure 3
Between-treatment (sunitinib vs IFN-α) percentage differences in predicted median (A) PFS and (B) OS as a function of baseline FKSI-15 scores. Abbreviations: PFS=progression-free survival; OS=overall survival; CI=confidence interval; FKSI-15=Functional Assessment of Cancer Therapy–Kidney Symptom Index–15 item. Note: a two-sided 95% CI for the between-treatment difference that does not contain 0 indicates that the difference in the treatment arms was statistically significant.
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