TY - JOUR
T1 - ABVD or BEACOPPbaseline along with involved-field radiotherapy in early-stage Hodgkin Lymphoma with risk factors
T2 - Results of the European Organisation for Research and Treatment of Cancer (EORTC)–Groupe d'Étude des Lymphomes de l'Adulte (GELA) H9-U intergroup randomised trial
AU - Fermé, Christophe
AU - Thomas, José
AU - Brice, Pauline
AU - Casasnovas, Olivier
AU - Vranovsky, Andrej
AU - Bologna, Serge
AU - Lugtenburg, Pieternella J
AU - Bouabdallah, Réda
AU - Carde, Patrice
AU - Sebban, Catherine
AU - Eghbali, Houchingue
AU - Salles, Gilles
AU - Van Imhoff, Gustaaf W.
AU - Thyss, Antoine
AU - Noordijk, Evert M.
AU - Reman, Oumédaly
AU - Lybeert, Marnix L.M.
AU - Janvier, Maud
AU - Spina, Michele
AU - Audhuy, Bruno
AU - Raemaekers, John M M
AU - Delarue, Richard
AU - Anglaret, Bruno
AU - de Weerdt, Okke
AU - Marjanovic, Zora
AU - Tersteeg, Robbert J.H.A.
AU - de Jong, Daphne
AU - Brière, Josette
AU - Henry-Amar, Michel
N1 - Funding Information:
The trial was supported by grants from the French Ministry of Health, Programme Hospitalier de Recherche Clinique 1998, and the French National League Against Cancer. The French Federation of Comprehensive Cancer centres (FNCLCC) sponsored the French participating centers.
Publisher Copyright:
© 2017 Elsevier Ltd
PY - 2017/8/1
Y1 - 2017/8/1
N2 - Purpose For early-stage Hodgkin lymphoma (HL), optimal chemotherapy regimen and the number of cycles to be delivered remain to settle down. The H9-U trial compared three modalities of chemotherapy followed by involved-field radiotherapy (IFRT) in patients with stage I-II HL and risk factors (NCT00005584). Patients and methods Patients aged 15–70 years with untreated supradiaphragmatic HL with at least one risk factor (age ≥ 50, involvement of 4–5 nodal areas, mediastinum/thoracic ratio ≥ 0.35, erythrocyte sedimentation rate (ESR) ≥ 50 without B-symptoms or ESR ≥ 30 and B-symptoms) were eligible for the randomised, open label, multicentre, non-inferiority H9-U trial. The limit of non-inferiority was set at 10% for the difference between 5-year event-free survival (EFS) estimates. From October 1998 to September 2002, 808 patients were randomised to receive either the control arm 6-ABVD-IFRT (n = 276), or one of the two experimental arms: 4-ABVD-IFRT (n = 277) or 4-BEACOPPbaseline-IFRT (n = 255). Results Results in the 4-ABVD-IFRT (5-year EFS, 85.9%) and the 4-BEACOPPbaseline-IFRT (5-year EFS, 88.8%) were not inferior to 6-ABVD-IFRT (5-year EFS, 89.9%): difference of 4.0% (90%CI, -0.7%–8.8%) and of 1.1% (90%CI,-3.5%–5.6%) respectively. The 5-year overall survival estimates were 94%, 93%, and 93%, respectively. Patients treated with combined modality treatment chemotherapeutic regimen comprising doxorubicin (Adriamycin), bleomycin, vincristine (Oncovin), cyclophosphamide, procarbazine, etoposide and prednisone (BEACOPP)baseline more often developed serious adverse events requiring supportive measures and hospitalisation compared with patients receiving the chemotherapeutic regimen comprising doxorubicin (Adriamycin), bleomycin, vinblastine and dacarbazine (ABVD). Conclusions The trial demonstrates that 4-ABVD followed by IFRT yields high disease control in patients with early-stage HL and risk factors responding to chemotherapy. Although non-inferior in terms of efficacy, four cycles of BEACOPPbaseline were more toxic than four or six cycles of ABVD.
AB - Purpose For early-stage Hodgkin lymphoma (HL), optimal chemotherapy regimen and the number of cycles to be delivered remain to settle down. The H9-U trial compared three modalities of chemotherapy followed by involved-field radiotherapy (IFRT) in patients with stage I-II HL and risk factors (NCT00005584). Patients and methods Patients aged 15–70 years with untreated supradiaphragmatic HL with at least one risk factor (age ≥ 50, involvement of 4–5 nodal areas, mediastinum/thoracic ratio ≥ 0.35, erythrocyte sedimentation rate (ESR) ≥ 50 without B-symptoms or ESR ≥ 30 and B-symptoms) were eligible for the randomised, open label, multicentre, non-inferiority H9-U trial. The limit of non-inferiority was set at 10% for the difference between 5-year event-free survival (EFS) estimates. From October 1998 to September 2002, 808 patients were randomised to receive either the control arm 6-ABVD-IFRT (n = 276), or one of the two experimental arms: 4-ABVD-IFRT (n = 277) or 4-BEACOPPbaseline-IFRT (n = 255). Results Results in the 4-ABVD-IFRT (5-year EFS, 85.9%) and the 4-BEACOPPbaseline-IFRT (5-year EFS, 88.8%) were not inferior to 6-ABVD-IFRT (5-year EFS, 89.9%): difference of 4.0% (90%CI, -0.7%–8.8%) and of 1.1% (90%CI,-3.5%–5.6%) respectively. The 5-year overall survival estimates were 94%, 93%, and 93%, respectively. Patients treated with combined modality treatment chemotherapeutic regimen comprising doxorubicin (Adriamycin), bleomycin, vincristine (Oncovin), cyclophosphamide, procarbazine, etoposide and prednisone (BEACOPP)baseline more often developed serious adverse events requiring supportive measures and hospitalisation compared with patients receiving the chemotherapeutic regimen comprising doxorubicin (Adriamycin), bleomycin, vinblastine and dacarbazine (ABVD). Conclusions The trial demonstrates that 4-ABVD followed by IFRT yields high disease control in patients with early-stage HL and risk factors responding to chemotherapy. Although non-inferior in terms of efficacy, four cycles of BEACOPPbaseline were more toxic than four or six cycles of ABVD.
KW - Chemotherapy
KW - Early stage
KW - Hodgkin lymphoma
KW - Radiotherapy
KW - Treatment efficacy
UR - https://www.scopus.com/pages/publications/85020316632
U2 - 10.1016/j.ejca.2017.05.005
DO - 10.1016/j.ejca.2017.05.005
M3 - Article
C2 - 28601705
AN - SCOPUS:85020316632
SN - 0959-8049
VL - 81
SP - 45
EP - 55
JO - European Journal of Cancer
JF - European Journal of Cancer
ER -