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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

Thomas, J., Ferme, C., Noordijk, E. M., Morschhauser, F., Girinsky, T., Gaillard, I., Lugtenburg, P. J., Andre, M., Lybeert, M. L. M., Stamatoullas, A., Beijert, M., Helias, P., Eghbali, H., Gabarre, J., van der Maazen, R. W. M., Jaubert, J., Bouabdallah, K., Boulat, O., Roesink, J. M., Christian, B., Ong, F., Bordessoule, D., Tertian, G., Gonzalez, H., Vranovsky, A., Quittet, P., Tirelli, U., de Jong, D., Audouin, J., Aleman, B. M. P., Henry-Amar, M., European Org Res Treatment Canc & Grp Etude Lymphomes Adulte, 1-Apr-2018, In : International Journal of Radiation Oncology Biology Physics. 100, 5, p. 1133-1145 13 p.

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  • Comparison of 36 Gy, 20 Gy, or No Radiation Therapy

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DOI

  • Jose Thomas
  • Christophe Ferme
  • Evert M. Noordijk
  • Franck Morschhauser
  • Theodore Girinsky
  • Isabelle Gaillard
  • Pieternella J. Lugtenburg
  • Marc Andre
  • Marnix L. M. Lybeert
  • Aspasia Stamatoullas
  • Max Beijert
  • Philippe Helias
  • Houchingue Eghbali
  • Jean Gabarre
  • Richard W. M. van der Maazen
  • Jerome Jaubert
  • Krimo Bouabdallah
  • Olivier Boulat
  • Judith M. Roesink
  • Bernard Christian
  • Francisca Ong
  • Dominique Bordessoule
  • Gerard Tertian
  • Hugo Gonzalez
  • Andrej Vranovsky
  • Philippe Quittet
  • Umberto Tirelli
  • Daphne de Jong
  • Josee Audouin
  • Berthe M. P. Aleman
  • Michel Henry-Amar
  • European Org Res Treatment Canc
  • Grp Etude Lymphomes Adulte

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-RTarm 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

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. (C) 2017 Elsevier Inc. All rights reserved.

Original languageEnglish
Pages (from-to)1133-1145
Number of pages13
JournalInternational Journal of Radiation Oncology Biology Physics
Volume100
Issue number5
Publication statusPublished - 1-Apr-2018

    Keywords

  • INVOLVED-FIELD RADIOTHERAPY, DISEASE, VINBLASTINE, DOXORUBICIN, BLEOMYCIN, CANCER

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