GHSG HD7

Background

Phase III RCT (GHSG HD7). 650 patients with early favorable Hodgkin lymphoma (stage I–IIA, no unfavorable risk factors). Compared extended-field RT (EFRT) alone vs 2 cycles ABVD + EFRT. First GHSG trial using ABVD-based CMT. Median follow-up 7 years.

Interventions and follow up

Arm A: 2 cycles ABVD + extended-field radiotherapy (EFRT) 30 Gy (n=326)
Arm B: Extended-field radiotherapy (EFRT) 30 Gy alone (n=324)
Primary endpoint: Freedom from treatment failure (FFTF)
mFollow up: 7 year

Results

FFTF at 7 years: 88% (CMT) vs 67% (RT alone), P<.0001
OS at 7 years: 97% (CMT) vs 96% (RT alone) — not significantly different
Relapse rate: 12% (CMT) vs 33% (RT alone)

Adverse events

Main adverse events: CMT arm had higher acute hematologic toxicity (ABVD). Grade 3–4 neutropenia in ~30% with ABVD. Late toxicity: pulmonary toxicity from bleomycin reported; RT-related cardiovascular effects expected with mantle fields.

Conclusions

Adding 2 cycles of ABVD to extended-field RT dramatically improved freedom from treatment failure (88% vs 67%) in early favorable Hodgkin lymphoma, confirming CMT superiority over RT alone. Despite the improvement in disease control, OS was not significantly different due to effective salvage therapy.

Key Limitations

Key Limitations: EFRT (mantle + para-aortic + spleen) is no longer used as standard RT; modern practice uses IFRT or ISRT, substantially reducing radiation toxicity. This trial does not answer whether ABVD + IFRT (modern approach) is superior to ABVD + IFRT without extended fields. OS equivalence despite FFTF benefit reflects effectiveness of salvage therapies.

Clinical Context

HD7 firmly established CMT as superior to RT alone for early favorable HL, completing the shift away from radiation-alone approaches. Combined with HD10 (which defined minimal effective therapy as 2 cycles ABVD + 20 Gy IFRT), HD7 forms the rationale for current 2-cycle ABVD + 20 Gy ISRT standard.

References

References: Engert A et al, JCO 2007 (GHSG HD7)