- Standard of care radiotherapy (RT) was omitted in patients with early-stage unfavorable Hodgkin lymphoma (HL) responsive to chemotherapy (CT) without loss of treatment efficacy.
- Positron emission tomography (PET) assessment of CT response in these patients guided the decision to omit RT.
Why this matters
- Routine use of RT puts these typically younger patients at a risk for long-term side effects, including an increased risk for secondary cancers.
- Phase 3 international randomized controlled prospective trial of 1100 patients aged 18-60 years with newly diagnosed unfavorable HL.
- Patients were assigned to combined modality treatment (CMT): 4 cycles of CT followed by 30 Gy involved-field RT or PET-guided treatment, which omitted RT in patients with Deauville score (DS)
- Funding: Deutsche Krebshilfe, German Cancer Aid.
- 979 patients had confirmed PET results: 66.5% were PET-negative, 24.3% had DS3, and 9.2% DS4.
- Overall 5-year progression-free survival (PFS):
- CMT group (n=428): 97.3%.
- PET-guided treatment (n=477): 95.1%.
- Difference: −2.2% (95% CI, −5.3% to 0.9%), excluding prespecified lower noninferiority margin of −8%.
- 5-year PFS in PET-negative patients:
- CMT group, with RT: 97.7%.
- PET-guided group, no RT: 95.9%.
- PET-positivity was confirmed as a significant risk factor for disease progression.
- Low number of fatal events.
- Dr Borchmann, who presented these findings commented that “PET-guided 2+2 chemotherapy is the new GHSG [German Hodgkin Study Group] standard of care,” and that “Most patients with this disease will not need radiotherapy any longer.”