HD17
HD17 for Intermediate Stages - Treatment Optimization Trial in the First-Line Treatment of Intermediate Stage Hodgkin Lymphoma
Phase 3N = 1,100NCT01356680
- Population
- Newly diagnosed early-stage unfavourable Hodgkin lymphoma (all histologies), age 18 to 60 years, ECOG performance status 2 or less.
- Design
- Multicentre, open-label, randomised phase 3 trial (224 hospitals and practices in Germany, Switzerland, Austria and the Netherlands), enrolment 13 January 2012 to 21 March 2017. Standard combined-modality treatment: two cycles of eBEACOPP then two cycles of ABVD (2 + 2) followed by 30 Gy involved-field radiotherapy, versus PET4-guided treatment: the 2 + 2 regimen followed by 30 Gy involved-node radiotherapy only if PET after four cycles was positive. Primary objective: non-inferiority of the PET4-guided strategy in a per-protocol analysis of the primary endpoint PFS, with non-inferiority defined as an absolute difference of 8% in 5-year PFS estimates.
- Primary endpoint
- PFS
- Arms
- Standard combined-modality treatment (control, n = 548): 2 + 2 (two cycles of eBEACOPP then two cycles of ABVD) followed by 30 Gy involved-field radiotherapy
- PET4-guided treatment (experimental, n = 552): 2 + 2 (two cycles of eBEACOPP then two cycles of ABVD), then 30 Gy involved-node radiotherapy only in patients with positive PET after four cycles
- People
- Borchmann P, senior author Engert A, German Hodgkin Study Group
PFSHR 0.523 (95% CI 0.226–1.211)Δ 60-month PFS−2.2 points
Show the numbers
| Endpoint | Analysis | PET4-guided treatment | Standard combined-modality treatment | Effect |
|---|---|---|---|---|
| PFSAnalysis population of the quoted estimates not labelled in the abstract (non-inferiority assessed in the per-protocol population) | primarymedian follow-up 46.2 monthsBorchmann 2021 | 95.1% at 5 y (92–97%) | 97.3% at 5 y (94.5–98.7%) | HR 0.523 (95% CI 0.226–1.211)Between-group difference 2.2% (95% CI -0.9 to 5.3) against a non-inferiority margin of 8%; the abstract states that this difference excluded the margin. Median follow-up 46.2 months (IQR 32.7 to 61.2). The abstract does not state the direction of the hazard ratio (0.523 is below 1 while the standard group has the higher 5-year PFS) or the population of the quoted estimates; non-inferiority was assessed in the per-protocol population. 548 and 552 patients were randomly assigned; two patients in each group were ineligible. |
| Endpoint | Analysis | PET4-guided treatment | Standard combined-modality treatment | Effect |
|---|---|---|---|---|
| PFSAnalysis population of the quoted estimates not labelled in the abstract (non-inferiority assessed in the per-protocol population) | primarymedian follow-up 46.2 monthsBorchmann 2021 | 95.1% at 5 y (92–97%) | 97.3% at 5 y (94.5–98.7%) | HR 0.523 (95% CI 0.226–1.211)Between-group difference 2.2% (95% CI -0.9 to 5.3) against a non-inferiority margin of 8%; the abstract states that this difference excluded the margin. Median follow-up 46.2 months (IQR 32.7 to 61.2). The abstract does not state the direction of the hazard ratio (0.523 is below 1 while the standard group has the higher 5-year PFS) or the population of the quoted estimates; non-inferiority was assessed in the per-protocol population. 548 and 552 patients were randomly assigned; two patients in each group were ineligible. |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| PFS | 0.523 | 0.226–1.211 |