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"Quality of Life Promotional Claims: Methodological Issues and Potential Solutions"
Fabricated Promotional Claim II
TUMORSTOP® CAN MAINTAIN QUALITY OF LIFE
Study Report
Tumorstop (canceradicate) is indicated for the treatment of recurrent pancreatic cancer. In 2 phase 3 multi-center randomized clinical studies at 75 centers in Europe, Eastern Europe and South America, Tumorstop significantly improved overall survival at 6 months compared with best supportive care in 1,200 patients with recurrent pancreatic cancer. In addition to the primary endpoint of survival, health-related quality of life was evaluated periodically up to 6 month using the Short Form-36 (SF-36) the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-30 (QLQC-30) and patient self-assessment on the Visual Analog Scale - Tumor (VAS-T). In study 1, a multivariate analysis and uni-variate analyses of the individual subscales were performed and corrected for multivariate testing. In general, patients receiving Tumorstop reported significantly better results for the QLQC-30 and on the physical component score of the SF-36 at month 6. Mean change from baseline on the VAS-T showed significant superiority in patients treated with Tumorstop. In Study 2, similar analyses resulted in only significant differences in the EORTC cancer-specific measure. The pattern of correlation between the scores of the EORTC measure and SF-36 were consistent between Europe and Eastern Europe, but differed for South America.
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TUMORSTOP® CAN MAINTAIN QUALITY OF LIFE
SUPPORTING DATA SUMMARY
(Note: All data are fabricated to stimulate discussion)
| Study |
N |
Duration |
Primary Endpoints1 |
Death at:2 |
Discontinuations (not due to death) at:3 |
| |
|
|
Survival rate at 6 m. |
0-2 m |
2-6 m |
0-2 m |
2-6 m |
| 1 |
700 |
Up to 6 m. |
A=49%* |
A=70 |
A=109 |
A=6 |
A=13 |
| | | |
S=38% |
S=90 |
S=127 |
S=9 |
S=19 |
| |
|
|
|
|
|
|
|
|
2 |
500 |
Up to 6 m. |
A=54% |
A=30 |
A=85 |
A=3 |
A=9 |
| |
|
|
S=45% |
S=50 |
S=88 |
S=7 |
S=11 |
| 1. | Data summarized is overall percentage of patients surviving at 6 months. A = active (Tumorstop), S = supportive care. |
| 2. | Number of patients; A = active (Tumorstop), S = supportive care. |
| 3. | Number of patients; A = active (Tumorstop), S = supportive care; reasons for discontinuations include lost to follow up, side effect, disease progression, and patient decision. |
| * | p<0.05 compared to best supportive care group. |
| Study |
N |
Patient Population1 |
SF-36 Mental Component Summary Score2 (D) |
SF-36 Physical Component Summary Score2 (D) |
EORTC QLQC-303Global QoL |
VAS-T4 |
| 1 |
700 |
EU=27% |
3 |
7 |
15 |
17 |
| |
|
SA=40% |
p=0.06 |
p=0.01 |
p=0.03 |
p=0.001 |
| |
|
|
|
|
|
|
|
2 |
500 |
EU=31% |
2 |
4 |
13 |
9 |
| |
|
SA=39% |
p=0.11 |
p=0.13 |
p=0.04 |
p=0.19 |
| 1. | Patient populations are Europe (EU), Eastern Europe (EEU), South America (SA) |
| 2. | Short Form - 36 (SF-36) mental component summary scores and physical component summary scores are reported as difference from supportive care group. Primary time point of assessment for health-related quality of life was based on measurements collected at month 2, 4, and 6 or at discontinuation visit using longitudinal multivariate analysis of variance. SF-36 was translated and culturally validated in Europe and Eastern Europe. In South America, SF-36 was translated, but no cultural validation was done. Baseline value for SF-36 Mental Component is 42, for SF-36 Physical Component is 36. |
| 3. | European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-30 (QLQC-30) global quality of life are reported as difference from supportive care group. Primary time point of assessment for health-related quality of life was based on measurements collected at month 2, 4, and 6 or at discontinuation visit using longitudinal multivariate analysis of variance. QLQC-30 was translated and culturally validated in Europe and Eastern Europe. In South America, QLQC-30 was translated, but no cultural validation was done. Baseline for EORTC Global Quality of Life is 32. |
| 4. | Visual Analog Scale - Tumor (VAS-T) consists of a graphical rating scale used to record "quality of life". The instrument was designed by the study team who reached their determination having noted the use of visual analogue scale systems such as the LASA (Baum et al) and the EQ5Dvas (Brooks et al). The scale consists of a 10 cm line with endpoints of 0 and 100 on which the patient marks their own assessment of quality of life. The assumption made by the study team is that this "number" has cardinal properties. The instrument has no prior validation history. Baseline for VAS-T is 38. |
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