H10
The H10 EORTC/GELA/IIL Randomized Intergroup Trial on Early FDG-PET Scan Guided Treatment Adaptation Versus Standard Combined Modality Treatment in Patients With Supradiaphragmatic Stage I/II Hodgkin's Lymphoma
Phase 3N = 1,950NCT00433433
- Population
- Previously untreated clinical stage I or II Hodgkin lymphoma, age 15 to 70 years; 1950 randomly assigned, 1925 received an ePET scan (361 positive, 18.8%). The 2014 interim analysis included 1,137 patients.
- Design
- Randomised trial of treatment adaptation on early PET (ePET) after two cycles of ABVD, separately in EORTC-defined favourable (F) and unfavourable (U) groups. Standard arm: ABVD followed by involved-node radiotherapy (INRT) regardless of ePET result. Experimental arm: ePET-negative patients received ABVD only (noninferiority design); ePET-positive patients switched to two cycles of BEACOPPesc and INRT (superiority design). Primary end point PFS. The 2014 report is the preplanned interim futility analysis after 34 events in the ePET-negative group, tested with a one-sided superiority test.
- Primary endpoint
- PFS
- Arms
- Standard: ABVD + INRT (control): ABVD followed by involved-node radiotherapy regardless of early PET result
- ePET-negative: ABVD only (experimental): ABVD only (no radiotherapy) after a negative early PET scan following two cycles of ABVD
- ePET-positive: BEACOPPesc + INRT (experimental): Two cycles of BEACOPPesc followed by involved-node radiotherapy after a positive early PET scan following two cycles of ABVD
- People
- Raemaekers JM, senior author Fortpied C, EORTC/LYSA/FIL Intergroup
PFSHR 0.42 (95% CI 0.23–0.74)Δ 60-month PFS+13.2 pointsPFSHR 15.8 (95% CI 3.8–66.1)Δ 60-month PFS−11.9 pointsPFSHR 1.45 (95% CI 0.8–2.5)Δ 60-month PFS−2.5 points
Show the numbers
| Endpoint | Analysis | ePET-negative: ABVD only / ePET-positive: BEACOPPesc + INRT | Standard: ABVD + INRT | Effect |
|---|---|---|---|---|
| PFSePET-positive patients (superiority comparison) | finalAndré 2017 | 90.6% at 5 y | 77.4% at 5 y | HR 0.42 (95% CI 0.23–0.74)P=.002Hazard ratio is for BEACOPPesc + INRT relative to standard ABVD + INRT in ePET-positive patients, as worded in the abstract ('improved from ... to ...'). |
| PFSePET-negative patients in the favourable (F) group (noninferiority comparison) | finalAndré 2017 | 87.1% at 5 y | 99% at 5 y | HR 15.8 (95% CI 3.8–66.1)Abstract wording: 99.0% versus 87.1% (HR 15.8; 95% CI 3.8 to 66.1) 'in favor of ABVD + INRT'; each percentage is paired with an arm by that wording (corroborated by the open-access 10-year report, Federico 2024, PMID 37967311, which lists the favourable-group rates as 'ABVD + INRT and ABVD-only arms, respectively'). The 2017 abstract does not state the direction of the hazard ratio. Noninferiority of ABVD only could not be demonstrated. |
| PFSePET-negative patients in the unfavourable (U) group (noninferiority comparison) | finalAndré 2017 | 89.6% at 5 y | 92.1% at 5 y | HR 1.45 (95% CI 0.8–2.5)Abstract wording: 92.1% versus 89.6% (HR 1.45; 95% CI 0.8 to 2.5) 'in favor of ABVD + INRT'; each percentage is paired with an arm by that wording (same convention as the open-access 10-year report, Federico 2024, PMID 37967311). The 2017 abstract does not state the direction of the hazard ratio. Noninferiority of ABVD only could not be demonstrated. |
| Endpoint | Analysis | ePET-negative: ABVD only / ePET-positive: BEACOPPesc + INRT | Standard: ABVD + INRT | Effect |
|---|---|---|---|---|
| PFSePET-positive patients (superiority comparison) | finalAndré 2017 | 90.6% at 5 y | 77.4% at 5 y | HR 0.42 (95% CI 0.23–0.74)P=.002Hazard ratio is for BEACOPPesc + INRT relative to standard ABVD + INRT in ePET-positive patients, as worded in the abstract ('improved from ... to ...'). |
| PFSePET-negative patients in the favourable (F) group (noninferiority comparison) | finalAndré 2017 | 87.1% at 5 y | 99% at 5 y | HR 15.8 (95% CI 3.8–66.1)Abstract wording: 99.0% versus 87.1% (HR 15.8; 95% CI 3.8 to 66.1) 'in favor of ABVD + INRT'; each percentage is paired with an arm by that wording (corroborated by the open-access 10-year report, Federico 2024, PMID 37967311, which lists the favourable-group rates as 'ABVD + INRT and ABVD-only arms, respectively'). The 2017 abstract does not state the direction of the hazard ratio. Noninferiority of ABVD only could not be demonstrated. |
| PFSePET-negative patients in the unfavourable (U) group (noninferiority comparison) | finalAndré 2017 | 89.6% at 5 y | 92.1% at 5 y | HR 1.45 (95% CI 0.8–2.5)Abstract wording: 92.1% versus 89.6% (HR 1.45; 95% CI 0.8 to 2.5) 'in favor of ABVD + INRT'; each percentage is paired with an arm by that wording (same convention as the open-access 10-year report, Federico 2024, PMID 37967311). The 2017 abstract does not state the direction of the hazard ratio. Noninferiority of ABVD only could not be demonstrated. |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| PFS | 0.42 | 0.23–0.74 |
| PFS | 15.8 | 3.8–66.1 |
| PFS | 1.45 | 0.8–2.5 |
Appears in
Sources
Raemaekers JM, André MP, Federico M, Girinsky T, Oumedaly R, Brusamolino E, et al. Omitting radiotherapy in early positron emission tomography-negative stage I/II Hodgkin lymphoma is associated with an increased risk of early relapse: Clinical results of the preplanned interim analysis of the randomized EORTC/LYSA/FIL H10 trial. J Clin Oncol. 2014;32(12):1188-94.
André MPE, Girinsky T, Federico M, Reman O, Fortpied C, Gotti M, et al. Early Positron Emission Tomography Response-Adapted Treatment in Stage I and II Hodgkin Lymphoma: Final Results of the Randomized EORTC/LYSA/FIL H10 Trial. J Clin Oncol. 2017;35(16):1786-1794.