TY - JOUR
T1 - 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
T2 - Results of the EORT-GELA H9-F Intergroup Randomized Trial
AU - Thomas, José
AU - Fermé, Christophe
AU - Noordijk, Evert M.
AU - Morschhauser, Franck
AU - Girinsky, Théodore
AU - Gaillard, Isabelle
AU - Lugtenburg, Pieternella J.
AU - André, Marc
AU - Lybeert, Marnix L.M.
AU - Stamatoullas, Aspasia
AU - Beijert, Max
AU - Hélias, Philippe
AU - Eghbali, Houchingue
AU - Gabarre, Jean
AU - van der Maazen, Richard W.M.
AU - Jaubert, Jérôme
AU - Bouabdallah, Krimo
AU - Boulat, Olivier
AU - Roesink, Judith M.
AU - Christian, Bernard
AU - Ong, Francisca
AU - Bordessoule, Dominique
AU - Tertian, Gérard
AU - Gonzalez, Hugo
AU - Vranovsky, Andrej
AU - Quittet, Philippe
AU - Tirelli, Umberto
AU - de Jong, Daphne
AU - Audouin, Josée
AU - Aleman, Berthe M.P.
AU - Henry-Amar, Michel
N1 - Funding Information:
This trial was supported by grants from the French Ministry of Health, Programme Hospitalier de Recherche Clinique 1998, and French National League Against Cancer. The French Federation of Comprehensive Cancer Centers sponsored the French participating centers.
Publisher Copyright:
© 2017 Elsevier Inc.
PY - 2018/4/1
Y1 - 2018/4/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85043573155&partnerID=8YFLogxK
U2 - 10.1016/j.ijrobp.2017.10.015
DO - 10.1016/j.ijrobp.2017.10.015
M3 - Article
C2 - 29229324
AN - SCOPUS:85043573155
SN - 0360-3016
VL - 100
SP - 1133
EP - 1145
JO - International Journal of Radiation Oncology Biology Physics
JF - International Journal of Radiation Oncology Biology Physics
IS - 5
ER -