Background
Mature 5-yr update of the phase III EORTC/LYSA/FIL H10 trial. Reports 5-yr PFS and OS for favorable (H10-F) and unfavorable (H10-U) cohorts comparing standard CMT vs experimental PET-adapted chemotherapy without RT in PET-negative patients.
Interventions and follow up
Arm A (standard CMT): ABVD x 3 (H10-F) or x 4 (H10-U) + involved-node RT 30 Gy
Arm B (experimental PET-adaptive): ABVD x 2; if PET-negative ABVD x 1-2 more, no RT; if PET-positive BEACOPP x 2 + involved-node RT 30 Gy
Primary endpoint: PFS at 5 yr
mFollow up: 5.4 yr
Arm B (experimental PET-adaptive): ABVD x 2; if PET-negative ABVD x 1-2 more, no RT; if PET-positive BEACOPP x 2 + involved-node RT 30 Gy
Primary endpoint: PFS at 5 yr
mFollow up: 5.4 yr
Results
5-yr PFS H10-F (standard vs experimental): 99.0% vs 87.1%, difference 11.9% (95% CI 5.6-18.2%), P<.0001
5-yr PFS H10-U (standard vs experimental): 92.1% vs 89.6%, difference 2.5% (95% CI -1.7 to 6.7%) — non-inferiority not met
5-yr OS H10-F: 98.7% vs 98.1% — no sig diff
5-yr OS H10-U: 94.5% vs 95.3% — no sig diff
Second malignancy: No significant difference at 5 yr
5-yr PFS H10-U (standard vs experimental): 92.1% vs 89.6%, difference 2.5% (95% CI -1.7 to 6.7%) — non-inferiority not met
5-yr OS H10-F: 98.7% vs 98.1% — no sig diff
5-yr OS H10-U: 94.5% vs 95.3% — no sig diff
Second malignancy: No significant difference at 5 yr
Adverse events
Safety signals: No new signals at extended follow-up
Second malignancy: Comparable between arms at 5 yr; longer follow-up needed to assess late solid-tumor risk from RT
Second malignancy: Comparable between arms at 5 yr; longer follow-up needed to assess late solid-tumor risk from RT
Conclusions
Mature 5-yr data confirm PET-guided RT omission in PET-negative early favorable HL yields significantly inferior PFS vs CMT, with no OS benefit from omitting RT. Standard CMT with involved-node RT remains the treatment of choice for early favorable HL.
Key Limitations
Despite the PFS difference, OS is identical, confirming chemotherapy-alone relapsers can be effectively salvaged. Whether cumulative late RT effects (cardiac, breast cancer risk in young women) outweigh the short-term PFS benefit is a patient-specific judgment not addressed. Second-malignancy data still immature at 5 yr.
Clinical Context
Reinforces CMT with ISRT as standard for early-stage HL where RT is appropriate (ESMO). RT omission is discussed in young women with mediastinal disease given lifetime breast cancer risk, but is not the standard recommendation based on H10 data.
References