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A pooled analysis of quality of life measures and adverse events data in north central cancer treatment group lung cancer clinical trials
Version of Record online: 8 JAN 2007
Copyright © 2007 American Cancer Society
Volume 109, Issue 4, pages 787–795, 15 February 2007
How to Cite
Huschka, M. M., Mandrekar, S. J., Schaefer, P. L., Jett, J. R. and Sloan, J. A. (2007), A pooled analysis of quality of life measures and adverse events data in north central cancer treatment group lung cancer clinical trials. Cancer, 109: 787–795. doi: 10.1002/cncr.22444
- Issue online: 2 FEB 2007
- Version of Record online: 8 JAN 2007
- Manuscript Revised: 9 NOV 2006
- Manuscript Accepted: 9 NOV 2006
- Manuscript Received: 7 JUL 2006
- pooled analysis;
- quality of life;
- adverse events;
- lung cancer
In this pooled analysis, the authors examined correlations between single-item and multiple-item quality of life (QOL) measures and assessed the agreement between clinically significant changes in QOL and patient-reported adverse events (AE).
Data from 6 lung cancer clinical trials that involved 358 patients were pooled. All trials incorporated the Uniscale and 1 of 3 multiple-item assessments: the Functional Assessment for Cancer Therapy-Lung, the Lung Cancer Symptom Scale, or the Symptom Distress Scale. Spearman rank correlations and a Bland-Altman approach were used to assess agreement. Time-to-event analysis was performed using the Kaplan-Meier method.
Correlations between the Uniscale and multiple-item assessments were substantial (correlation coefficient = 0.49–0.66). At least 1 10-point decline was reported in the Uniscale and multiple-item assessments by 58% of patients and 39% of patients, respectively. At least 1 severe AE (grade ≥3) was reported in 35% of patients postbaseline. The percent agreement between experiencing a severe AE and a decline in QOL was 48% and 59% for the Uniscale and multiple-item assessments, respectively. The median time to the first 10-point decline in QOL for the Uniscale and multiple-item assessments was 67 days and 142 days, respectively, and the median time to the first occurrence of a severe AE was 304 days.
Information gleaned from the single-item Uniscale assessment was comparable to that gleaned from multiple-item global measures. There was moderate agreement between QOL and AE. A 10-point decline in QOL occurred earlier than Common Toxicity Criteria AE reporting. This suggests the need for inclusion of a QOL instrument in lung cancer clinical trials. Cancer 2007. © 2007 American Cancer Society.