Comparison of 36 Gy, 20 Gy, or No Radiation Therapy After 6 Cycles of EBVP Chemotherapy and Complete Remission in Early-Stage Hodgkin Lymphoma Without Risk Factors: Results of the EORT-GELA H9-F Intergroup Randomized Trial

José Thomas, Christophe Fermé, Evert M Noordijk, Franck Morschhauser, Théodore Girinsky, Isabelle Gaillard, Pieternella J Lugtenburg, Marc André, Marnix L M Lybeert, Aspasia Stamatoullas, Max Beijert, Philippe Hélias, Houchingue Eghbali, Jean Gabarre, Richard W M van der Maazen, Jérôme Jaubert, Krimo Bouabdallah, Olivier Boulat, Judith M Roesink, Bernard ChristianFrancisca Ong, Dominique Bordessoule, Gérard Tertian, Hugo Gonzalez, Andrej Vranovsky, Philippe Quittet, Umberto Tirelli, Daphne de Jong, Josée Audouin, Berthe M P Aleman, Michel Henry-Amar

Research output: Contribution to journalArticleAcademicpeer-review


PURPOSE: While patients with early-stage Hodgkin lymphoma (HL) have an excellent outcome with combined treatment, the radiation therapy (RT) dose and treatment with chemotherapy alone remain questionable. This noninferiority trial evaluates the feasibility of reducing the dose or omitting RT after chemotherapy.

METHODS AND MATERIALS: Patients with untreated supradiaphragmatic HL without risk factors (age ≥ 50 years, 4 to 5 nodal areas involved, mediastinum-thoracic ratio ≥ 0.35, and erythrocyte sedimentation rate ≥ 50 mm in first hour without B symptoms or erythrocyte sedimentation rate ≥ 30 mm in first hour with B symptoms) were eligible for the trial. Patients in complete remission after chemotherapy were randomized to no RT, low-dose RT (20 Gy in 10 fractions), or standard-dose involved-field RT (36 Gy in 18 fractions). The limit of noninferiority was 10% for the difference between 5-year relapse-free survival (RFS) estimates. From September 1998 to May 2004, 783 patients received 6 cycles of epirubicin, bleomycin, vinblastine, and prednisone; 592 achieved complete remission or unconfirmed complete remission, of whom 578 were randomized to receive 36 Gy (n=239), 20 Gy of involved-field RT (n=209), or no RT (n=130).

RESULTS: Randomization to the no-RT arm was prematurely stopped (≥20% rate of inacceptable events: toxicity, treatment modification, early relapse, or death). Results in the 20-Gy arm (5-year RFS, 84.2%) were not inferior to those in the 36-Gy arm (5-year RFS, 88.6%) (difference, 4.4%; 90% confidence interval [CI] -1.2% to 9.9%). A difference of 16.5% (90% CI 8.0%-25.0%) in 5-year RFS estimates was observed between the no-RT arm (69.8%) and the 36-Gy arm (86.3%); the hazard ratio was 2.55 (95% CI 1.44-4.53; P<.001). The 5-year overall survival estimates ranged from 97% to 99%.

CONCLUSIONS: In adult patients with early-stage HL without risk factors in complete remission after epirubicin, bleomycin, vinblastine, and prednisone chemotherapy, the RT dose may be limited to 20 Gy without compromising disease control. Omitting RT in these patients may jeopardize the treatment outcome.

Original languageEnglish
Pages (from-to)1133-1145
Number of pages13
JournalInternational journal of radiation oncology, biology, physics
Issue number5
Early online date27 Oct 2017
Publication statusPublished - 1 Apr 2018

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