ABVD or BEACOPPbaseline along with involved-field radiotherapy in early-stage Hodgkin Lymphoma with risk factors: 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

Christophe Fermé, José Thomas, Pauline Brice, Olivier Casasnovas, Andrej Vranovsky, Serge Bologna, Pieternella J. Lugtenburg, Réda Bouabdallah, Patrice Carde, Catherine Sebban, Houchingue Eghbali, Gilles Salles, Gustaaf W. van Imhoff, Antoine Thyss, Evert M. Noordijk, Oumédaly Reman, Marnix L.M. Lybeert, Maud Janvier, Michele Spina, Bruno AudhuyJohn M.M. Raemaekers, Richard Delarue, Bruno Anglaret, Okke de Weerdt, Zora Marjanovic, Robbert J.H.A. Tersteeg, Daphne de Jong, Josette Brière, Michel Henry-Amar, for the European Organisation for Research and Treatment of Cancer Lymphoma Group, and, the Groupe d'Étude des Lymphomes de l'Adulte

Research output: Contribution to journalArticle

7 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)45-55
Number of pages11
JournalEuropean Journal of Cancer
Volume81
DOIs
Publication statusPublished - Aug 1 2017

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Dacarbazine
Vinblastine
Bleomycin
Hodgkin Disease
Doxorubicin
Radiotherapy
Disease-Free Survival
Blood Sedimentation
Vincristine
Drug Therapy
Arm
Procarbazine
Poisons
Mediastinum
Etoposide
Prednisone
Cyclophosphamide
Hospitalization
Thorax

Keywords

  • Chemotherapy
  • Early stage
  • Hodgkin lymphoma
  • Radiotherapy
  • Treatment efficacy

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

ABVD or BEACOPPbaseline along with involved-field radiotherapy in early-stage Hodgkin Lymphoma with risk factors : 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. / Fermé, Christophe; Thomas, José; Brice, Pauline; Casasnovas, Olivier; Vranovsky, Andrej; Bologna, Serge; Lugtenburg, Pieternella J.; Bouabdallah, Réda; Carde, Patrice; Sebban, Catherine; Eghbali, Houchingue; Salles, Gilles; van Imhoff, Gustaaf W.; Thyss, Antoine; Noordijk, Evert M.; Reman, Oumédaly; Lybeert, Marnix L.M.; Janvier, Maud; Spina, Michele; Audhuy, Bruno; Raemaekers, John M.M.; Delarue, Richard; Anglaret, Bruno; de Weerdt, Okke; Marjanovic, Zora; Tersteeg, Robbert J.H.A.; de Jong, Daphne; Brière, Josette; Henry-Amar, Michel; for the European Organisation for Research and Treatment of Cancer Lymphoma Group, and; the Groupe d'Étude des Lymphomes de l'Adulte.

In: European Journal of Cancer, Vol. 81, 01.08.2017, p. 45-55.

Research output: Contribution to journalArticle

Fermé, C, Thomas, J, Brice, P, Casasnovas, O, Vranovsky, A, Bologna, S, Lugtenburg, PJ, Bouabdallah, R, Carde, P, Sebban, C, Eghbali, H, Salles, G, van Imhoff, GW, Thyss, A, Noordijk, EM, Reman, O, Lybeert, MLM, Janvier, M, Spina, M, Audhuy, B, Raemaekers, JMM, Delarue, R, Anglaret, B, de Weerdt, O, Marjanovic, Z, Tersteeg, RJHA, de Jong, D, Brière, J, Henry-Amar, M, for the European Organisation for Research and Treatment of Cancer Lymphoma Group, and & the Groupe d'Étude des Lymphomes de l'Adulte 2017, 'ABVD or BEACOPPbaseline along with involved-field radiotherapy in early-stage Hodgkin Lymphoma with risk factors: 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', European Journal of Cancer, vol. 81, pp. 45-55. https://doi.org/10.1016/j.ejca.2017.05.005
Fermé, Christophe ; Thomas, José ; Brice, Pauline ; Casasnovas, Olivier ; Vranovsky, Andrej ; Bologna, Serge ; Lugtenburg, Pieternella J. ; Bouabdallah, Réda ; Carde, Patrice ; Sebban, Catherine ; Eghbali, Houchingue ; Salles, Gilles ; van Imhoff, Gustaaf W. ; Thyss, Antoine ; Noordijk, Evert M. ; Reman, Oumédaly ; Lybeert, Marnix L.M. ; Janvier, Maud ; Spina, Michele ; Audhuy, Bruno ; Raemaekers, John M.M. ; Delarue, Richard ; Anglaret, Bruno ; de Weerdt, Okke ; Marjanovic, Zora ; Tersteeg, Robbert J.H.A. ; de Jong, Daphne ; Brière, Josette ; Henry-Amar, Michel ; for the European Organisation for Research and Treatment of Cancer Lymphoma Group, and ; the Groupe d'Étude des Lymphomes de l'Adulte. / ABVD or BEACOPPbaseline along with involved-field radiotherapy in early-stage Hodgkin Lymphoma with risk factors : 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. In: European Journal of Cancer. 2017 ; Vol. 81. pp. 45-55.
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abstract = "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.",
keywords = "Chemotherapy, Early stage, Hodgkin lymphoma, Radiotherapy, Treatment efficacy",
author = "Christophe Ferm{\'e} and Jos{\'e} Thomas and Pauline Brice and Olivier Casasnovas and Andrej Vranovsky and Serge Bologna and Lugtenburg, {Pieternella J.} and R{\'e}da Bouabdallah and Patrice Carde and Catherine Sebban and Houchingue Eghbali and Gilles Salles and {van Imhoff}, {Gustaaf W.} and Antoine Thyss and Noordijk, {Evert M.} and Oum{\'e}daly Reman and Lybeert, {Marnix L.M.} and Maud Janvier and Michele Spina and Bruno Audhuy and Raemaekers, {John M.M.} and Richard Delarue and Bruno Anglaret and {de Weerdt}, Okke and Zora Marjanovic and Tersteeg, {Robbert J.H.A.} and {de Jong}, Daphne and Josette Bri{\`e}re and Michel Henry-Amar and {for the European Organisation for Research and Treatment of Cancer Lymphoma Group, and} and {the Groupe d'{\'E}tude des Lymphomes de l'Adulte}",
year = "2017",
month = "8",
day = "1",
doi = "10.1016/j.ejca.2017.05.005",
language = "English",
volume = "81",
pages = "45--55",
journal = "European Journal of Cancer",
issn = "0959-8049",
publisher = "Elsevier Ltd",

}

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

AU - for the European Organisation for Research and Treatment of Cancer Lymphoma Group, and

AU - the Groupe d'Étude des Lymphomes de l'Adulte

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

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