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 - European Organisation for Research and Treatment of Cancer Lymphoma Group, and
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
PY - 2017/8
Y1 - 2017/8
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 - Adolescent
KW - Adult
KW - Aged
KW - Antineoplastic Combined Chemotherapy Protocols
KW - Bleomycin
KW - Combined Modality Therapy
KW - Cyclophosphamide
KW - Dacarbazine
KW - Doxorubicin
KW - Etoposide
KW - Female
KW - Hodgkin Disease
KW - Humans
KW - Journal Article
KW - Male
KW - Middle Aged
KW - Prednisone
KW - Procarbazine
KW - Radiotherapy
KW - Randomized Controlled Trial
KW - Research Support, Non-U.S. Gov't
KW - Risk Factors
KW - Survival Analysis
KW - Vinblastine
KW - Vincristine
KW - Young Adult
U2 - https://doi.org/10.1016/j.ejca.2017.05.005
DO - https://doi.org/10.1016/j.ejca.2017.05.005
M3 - Article
C2 - 28601705
SN - 0959-8049
VL - 81
SP - 45
EP - 55
JO - European Journal of Cancer
JF - European Journal of Cancer
ER -