Randomized comparison of interferon-alpha with busulfan and hydroxyurea in chronic myelogenous leukemia (German CML Study Group)
Phase 3N = 513
- Population
- Philadelphia chromosome-positive CML; 513 patients randomized.
- Design
- Randomized multicenter study of the influence of interferon-alpha versus busulfan or hydroxyurea on survival.
- Arms
- Busulfan (control, n = 186): Busulfan
- Hydroxyurea (control, n = 194): Hydroxyurea
- Interferon-alpha (experimental, n = 133): Interferon-alpha
- People
- Hehlmann R, senior author Heinze B, German CML Study Group
Δ median OS+1.7 yearsΔ 60-month OS+27 points
Show the numbers
| Endpoint | Analysis | Interferon-alpha | Busulfan / Hydroxyurea | Effect |
|---|---|---|---|---|
| OSRandomized Philadelphia chromosome-positive patients (513) | primaryHehlmann 1994 | median 5.5 years; 59% at 5 y (48–70%) | median 3.8 years; 32% at 5 y (24–40%) | P=Interferon vs busulfan .008; interferon vs hydroxyurea .44The abstract does not name the analysis population; entered as published for the 513 randomized Philadelphia chromosome-positive patients. |
| Endpoint | Analysis | Interferon-alpha | Busulfan / Hydroxyurea | Effect |
|---|---|---|---|---|
| OSRandomized Philadelphia chromosome-positive patients (513) | primaryHehlmann 1994 | median 5.5 years; 59% at 5 y (48–70%) | median 3.8 years; 32% at 5 y (24–40%) | P=Interferon vs busulfan .008; interferon vs hydroxyurea .44The abstract does not name the analysis population; entered as published for the 513 randomized Philadelphia chromosome-positive patients. |
- Busulfan (control)
- Hydroxyurea (control)
- Interferon-alpha (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 | Interferon-alpha |
|---|---|---|---|
| 0 | 100.0% | 100.0% | 100.0% |
| 41 | 53.6% | 60.4% | 65.0% |
| 83 | 28.3% | 36.1% | 41.8% |
| 124 | 15.2% | 21.8% | 27.2% |
| 165 | 8.1% | 13.2% | 17.7% |
Appears in
Sources
Hehlmann R, Heimpel H, Hasford J, Kolb HJ, Pralle H, Hossfeld DK, et al. Randomized comparison of interferon-alpha with busulfan and hydroxyurea in chronic myelogenous leukemia. The German CML Study Group. Blood. 1994;84(12):4064-77.