Randomized comparison of busulfan and hydroxyurea in chronic myelogenous leukemia: prolongation of survival by hydroxyurea (German CML Study Group)
Phase 3N = 441
- Population
- People with CML in chronic phase; 90.7 percent were Philadelphia chromosome-positive.
- Design
- Randomized multicenter study, July 1983 to January 1991, hydroxyurea versus busulfan; patients resistant before blast crisis could cross over to the other drug.
- Arms
- Busulfan (control): Busulfan
- Hydroxyurea (experimental): Hydroxyurea
- People
- Hehlmann R, senior author Georgii A, German CML Study Group
Δ median OS+12.8 months
Show the numbers
| Endpoint | Analysis | Hydroxyurea | Busulfan | Effect |
|---|---|---|---|---|
| OSPhiladelphia chromosome-positive patients | primaryHehlmann 1993 | median 58.2 months | median 45.4 months | P=.008The abstract reports this comparison for Philadelphia-positive patients only; the numbers of patients per arm are not given in the abstract. |
| Endpoint | Analysis | Hydroxyurea | Busulfan | Effect |
|---|---|---|---|---|
| OSPhiladelphia chromosome-positive patients | primaryHehlmann 1993 | median 58.2 months | median 45.4 months | P=.008The abstract reports this comparison for Philadelphia-positive patients only; the numbers of patients per arm are not given in the abstract. |
- Busulfan (control)
- Hydroxyurea (experimental)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Busulfan | Hydroxyurea |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 36 | 57.7% | 65.1% |
| 73 | 32.8% | 41.9% |
| 109 | 18.9% | 27.3% |
| 146 | 10.8% | 17.6% |
Appears in
Sources
Hehlmann R, Heimpel H, Hasford J, Kolb HJ, Pralle H, Hossfeld DK, et al. Randomized comparison of busulfan and hydroxyurea in chronic myelogenous leukemia: prolongation of survival by hydroxyurea. The German CML Study Group. Blood. 1993;82(2):398-407.