HD10: Investigating reduction of combined modality treatment intensity in early stage Hodgkin's Lymphoma.  Interim analysis of a randomized trial of the German Hodgkin's Study Group (GHSG)

Reviewer: Ryan Smith , MD
OncoLink
Last Modified: May 14, 2005

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Presenter: V. Diehl
Presenter's Affiliation: German Hodgkin's Study Group
Type of Session: Scientific

Background

  • Patients with early stage Hodgkin's lymphoma (HL) have an excellent prognosis
  • This is especially true in patients without risk factors, defined by this group as a large mediastinal mass, high ESR, 3 or more areas involved, or extranodal disease
  • The current thrust of research in HL is to reduce the amount of therapy these patients require, in attempts to reduce toxicity
  • This study investigates less intensive treatment in patients with clinical stage I-II HL without risk factors

Materials and Methods

  • 1131 patients were randomized in a 2x2 factorial design between ABVD x2 vs. ABVD x4 and involved field radiation (IF-RT) to 20 Gy vs. 30 Gy
  • Patients were equally balanced with respect to age, gender, performance status, and stage
  • Median follow up was 28 months
 

Results

  • There was more toxicity in the group that received 4 cycles of ABVD, with respect to hair loss, leukopenia, and infection, though none of these reached statistical significance
  • There was no increase in second malignancies in any arm
  • Complete responses were seen in 98% of patients in all arms
  • Progression free survival was similar in all arms (96%)
  • Overall survival was similar in all arms (98%)
  • There were 13 deaths, with 5 from HL and 5 from treatment-many from bleomycin induced pulmonary toxicity
  • There have been 10 second malignancies: 5 solid malignancies, 4 NHL, 1 AML
 

Author's Conclusions

  • This trial confirms the excellent results from the HD7 trial, looking at ABVDx4 + low dose radiation
  • There is no difference in PFS or OS between the arms with reduced treatment
  • There may be a reduced toxicity with less chemotherapy.  It is logical that the same will be true for reduced radiation, though it could not be proven from this data

Clinical/Scientific Implications

HL is usually readily curable, though the toxicity of therapy can be detrimental in these young patients.  It appears that ABVDx2 cycles is as efficacious to 4 cycles and that 20 Gy is equivalent to 30 Gy.  However, with a median follow up of just over two years, this cannot be accepted as standard just yet.  What may be most interesting is that this study serves as the impetus for the German group's next study, which is using PET scans after treatment to dictate further treatment.  Using functional imaging such as this may lead to the individual treatment design that has long been awaited in HL.
 
 



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