Are experimental treatments for cancer in children superior to established treatments? Observational study of randomised controlled trials by the Children's Oncology Group
BMJ 2005; doi: https://doi.org/10.1136/bmj.38628.561123.7C (Published 18 November 2005) Cite this as: BMJ 2005;:bmj;bmj.38628.561123.7Cv1
Data supplement
Description of studies included in analysis
Description of studies included in analysis
Variable
% (No)
Disease:
Acute lymphoblastic leukaemia
43 (65)
Acute myeloblastic leukaemia
8 (12)
Hodgkin’s disease
3 (5)
Lymphoma
10 (15)
Rhabdomyosarcoma
6 (10)
Wilm’s tumour
8 (12)
Others
22 (33)
Type of treatment:
Neo- adjuvant
3 (4)
Adjuvant
24 (36)
Induction
7 (11)
Consolidation
7 (10)
Maintenance
39 (60)
Supportive
2 (3)
Definitive*
17 (26)
Other
1 (2)
Type of intervention:
Chemotherapy
59 (89)
Radiation therapy
2 (3)
Chemotherapy and radiation therapy
31 (48)
Others
8 (12)
Study design:
Parallel
97 (147)
Cross over
3 (5)
No masking:
100 (152)
Expected difference in outcomes, and sample size prespecified:
Yes
78 (119)
No
9 (14)
Missing data
13 (19)
α and β error prespecified:
Yes
76 (116)
No
11 (17)
Missing data
13 (19)
Type of comparison:
Active
91 (138)
Placebo or no therapy
9 (14)
Primary endpoint:
Survival
43 (65)
Event free survival
39 (60)
Others
18 (27)
Adequate allocation concealment:
Yes
93 (142)
No
7 (10)
Intention to treat analysis:
Yes
93 (142)
No or unclear
7 (10)
Description of drop outs:
Yes
93 (141)
No
7 (11)
*With intent to prolong survival or achieve cure.
Fig A Summary analyses according to publication status
Figure A [As supplied by authors]
Fig B Distribution of outcomes according to investigator’s judgment and achievement of statistical significance (126 trials involved 152 comparisons; there were missing data for 7% of studies regarding statistical significance. However, survival data from these studies were available for meta-analysis).
Figure B [As supplied by authors]
Fig C Children’s Oncology Group - Forest Plot of all trials included in the analysis – Overall SurvivalFig C [As supplied by authors] Children’s Oncology Group - Forest Plot of all trials included in the analysis – Overall Survival
Random-effect analysis: Meta-Analysis
Fig D Summary analyses according to the methodological quality of trials and the choice of comparator. Notation same as in fig 2. The results were not affected by any of these methodological factors. ‡ Diff=difference; Calc=calculation.
Figure D [As supplied by authors]
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