First results of the EORTC-GELA H9 randomized trials: the H9-F trial (comparing 3 radiation dose levels) and H9-U trial (comparing 3 chemotherapy schemes) in patients with favorable of unfavorable early stage Hodgkin's lymphoma (HL)

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

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Presenter: E.M. Noordijk
Presenter's Affiliation: EORTC
Type of Session: Scientific

Background

  • Hodgkin's lymphoma (HL) has an excellent prognosis, yet optimal therapy has still yet to be found
  • Patients are treated based on known prognositc factors that can divide them into "favorable" and "unfavorable" groups
  • Goal is to maintain excellent outcomes while minimizing treatment and thereby decreasing toxicity
  • This presentation reported on two separate trials in HL-one for favorable patients and one for unfavorable patients

Materials and Methods

  • Favorable patients were defined as being less than 50 years old, without B symptoms and with ESR <50 or with B symptoms and ESR <30, 1-3 involved sites, and a mediastinal mass-thoracic ratio of <0.35.  Patients who did not have all of these characteristics were considered "Unfavorable".
  • Favorable patients all received EBVP chemotherapy for 6 cycles.  Those with a complete response (CR) were randomized to receive no further radiation, involved field (IF) radiation to 20Gy, or IF radiation to 36Gy.
  • Unfavorable patients were randomized to receive ABVD x 6 cycles + 30 Gy IF radiation vs. ABVD x 4 + 30 Gy IF radiation vs. BEACOPP chemotherapy x4 + 30Gy IF radiation
  • A total of 1591 patients with stage I-II HL were randomized into these studies

Results

Favorable study

  • 79% of patients had a CR after EBVP chemotherapy
  • 18% had a PR, and all received 36 Gy IF radiation
  • The arm with no radiation was closed after early stopping rules were met showing an increased failure rate.  This arm's failure free survival (FFS) was 70%
  • 4 yr event free survival (EFS) was 87% (36 Gy arm) vs. 84% (20 Gy arm)
  • 4 yr overall survival (OS) was 98% in all arms (including no radiation arm)

Unfavorable study

  • CR rate at end of chemotherapy was 74% (ABVDx6), 71% (ABVDx4), and 60% (BEACOPP)
  • 4 year EFS rates were 94% (ABVDx6), 89% (ABVDx4), and 91% (BEACOPP)
  • 4 year OS rates were 96%, 95%, and 93%, respectively
  • There were 36 total deaths-17 from HL and 12 treatment related deaths
  • Toxicity was higher in the BEACOPP arm: Antibiotic use 6% vs 13%, transfusion rate 2% vs. 9%, hospitalization rate 11% vs. 22%

 

Author's Conclusions

Favorable study

  • In terms of EFS/RFS, radiation cannot be eliminated.  However, with limited follow up, 20 Gy appears to be equally efficacious to 36 Gy

Unfavorable study

  • The dose of ABVD can be reduced to 4 cycles
  • BEACOPP has no advantage over ABVD, but with increased toxicities

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  • For both unfavorable and favorable patients, there should be continued investigation to minimizing treatment

Clinical/Scientific Implications
HL has an excellent prognosis.  However, because the vast majority of patients are cured of their disease and the majority of patients are young, reducing toxicity-both short term and long term-is crucial.  In the favorable study, it appears that radiation is still required, though the dose may be able to be reduced to 20 Gy.  This is promising, though caution was made by the presenter that there is too short of follow up to accept this at present.  In unfavorable patients, it appears that BEACOPP chemotherapy will no longer be used, given its similar efficacy but increased toxicity.  It should be noted that overall survival was similar between the groups, even when the no radiation arm was included.  This speaks to the excellent salvage rate in relapsed HL.  The presenter pointed out that there is no standard for salvage, though many go on to high dose chemotherapy with stem cell or bone marrow reconstitution.  This exposes the relapsed patient to much more toxicity than IF radiation would have. 


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