Early positron emission tomography response-adapted treatment in stage I and II hodgkin lymphoma: Final results of the randomized EORTC/LYSA/FIL H10 trial

Marc P.E. André; Théodore Girinsky; Massimo Federico; Oumédaly Reman; Catherine Fortpied; Manuel Gotti; Olivier Casasnovas; Pauline Brice; Richard Van Der Maazen; Alessandro Re; Véronique Edeline; Christophe Fermé; Gustaaf Van Imhoff; Francesco Merli; Réda Bouabdallah; Catherine Sebban; Lena Specht; Aspasia Stamatoullas; Richard Delarue; Valeria Fiaccadori; Monica Bellei; Tiana Raveloarivahy; Annibale Versari; Martin Hutchings; Michel Meignan; John Raemaekers

doi:10.1200/JCO.2016.68.6394

Early positron emission tomography response-adapted treatment in stage I and II hodgkin lymphoma: Final results of the randomized EORTC/LYSA/FIL H10 trial

Marc P.E. André, Théodore Girinsky, Massimo Federico, Oumédaly Reman, Catherine Fortpied, Manuel Gotti, Olivier Casasnovas, Pauline Brice, Richard Van Der Maazen, Alessandro Re, Véronique Edeline, Christophe Fermé, Gustaaf Van Imhoff, Francesco Merli, Réda Bouabdallah, Catherine Sebban, Lena Specht, Aspasia Stamatoullas, Richard Delarue, Valeria FiaccadoriMonica Bellei, Tiana Raveloarivahy, Annibale Versari, Martin Hutchings, Michel Meignan, John Raemaekers^*

^*Corresponding author af dette arbejde

Institut for Klinisk Medicin

209 Citationer (Scopus)

Abstract

Purpose Patients who receive combined modality treatment for stage I and II Hodgkin lymphoma (HL) have an excellent outcome. Early response evaluation with positron emission tomography (PET) scan may improve selection of patients who need reduced or more intensive treatments. Methods We performed a randomized trial to evaluate treatment adaptation on the basis of early PET (ePET) after two cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) in previously untreated—according to European Organisation for Research and Treatment of Cancer criteria favorable (F) and unfavorable (U)—stage I and II HL. The standard arm consisted of ABVD followed by involved-node radiotherapy (INRT), regardless of ePET result. In the experimental arm, ePET-negative patients received ABVD only (noninferiority design), whereas ePET-positive patients switched to two cycles of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPPesc) and INRT (superiority design). Primary end point was progression-free survival (PFS). Results Of 1,950 randomly assigned patients, 1,925 received an ePET—361 patients (18.8%) were positive. In ePET-positive patients, 5-year PFS improved from 77.4% for standard ABVD + INRT to 90.6% for intensification to BEACOPPesc + INRT (hazard ratio [HR], 0.42; 95% CI, 0.23 to 0.74; P = .002). In ePET-negative patients, 5-year PFS rates in the F group were 99.0% versus 87.1% (HR, 15.8; 95% CI, 3.8 to 66.1) in favor of ABVD + INRT; the U group, 92.1% versus 89.6% (HR, 1.45; 95% CI, 0.8 to 2.5) in favor of ABVD + INRT. For both F and U groups, noninferiority of ABVD only compared with combined modality treatment could not be demonstrated. Conclusion In stage I and II HL, PET response after two cycles of ABVD allows for early treatment adaptation. When ePET is positive after two cycles of ABVD, switching to BEACOPPesc + INRT significantly improved 5-year PFS. In ePET-negative patients, noninferiority of ABVD only could not be demonstrated: risk of relapse is increased when INRT is omitted, especially in patients in the F group.

Originalsprog	Engelsk
Tidsskrift	Journal of Clinical Oncology
Vol/bind	35
Udgave nummer	16
Sider (fra-til)	1786-1796
Antal sider	11
ISSN	0732-183X
DOI	https://doi.org/10.1200/JCO.2016.68.6394
Status	Udgivet - 1 jun. 2017

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10.1200/JCO.2016.68.6394

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André, M. P. E., Girinsky, T., Federico, M., Reman, O., Fortpied, C., Gotti, M., Casasnovas, O., Brice, P., Van Der Maazen, R., Re, A., Edeline, V., Fermé, C., Van Imhoff, G., Merli, F., Bouabdallah, R., Sebban, C., Specht, L., Stamatoullas, A., Delarue, R., ... Raemaekers, J. (2017). Early positron emission tomography response-adapted treatment in stage I and II hodgkin lymphoma: Final results of the randomized EORTC/LYSA/FIL H10 trial. Journal of Clinical Oncology, 35(16), 1786-1796. https://doi.org/10.1200/JCO.2016.68.6394

Early positron emission tomography response-adapted treatment in stage I and II hodgkin lymphoma : Final results of the randomized EORTC/LYSA/FIL H10 trial. / André, Marc P.E.; Girinsky, Théodore; Federico, Massimo et al.

I: Journal of Clinical Oncology, Bind 35, Nr. 16, 01.06.2017, s. 1786-1796.

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review

André, MPE, Girinsky, T, Federico, M, Reman, O, Fortpied, C, Gotti, M, Casasnovas, O, Brice, P, Van Der Maazen, R, Re, A, Edeline, V, Fermé, C, Van Imhoff, G, Merli, F, Bouabdallah, R, Sebban, C, Specht, L, Stamatoullas, A, Delarue, R, Fiaccadori, V, Bellei, M, Raveloarivahy, T, Versari, A, Hutchings, M, Meignan, M & Raemaekers, J 2017, 'Early positron emission tomography response-adapted treatment in stage I and II hodgkin lymphoma: Final results of the randomized EORTC/LYSA/FIL H10 trial', Journal of Clinical Oncology, bind 35, nr. 16, s. 1786-1796. https://doi.org/10.1200/JCO.2016.68.6394

@article{f50495a9a5964f9a89522a3ea4cdbd7d,

title = "Early positron emission tomography response-adapted treatment in stage I and II hodgkin lymphoma: Final results of the randomized EORTC/LYSA/FIL H10 trial",

abstract = "Purpose Patients who receive combined modality treatment for stage I and II Hodgkin lymphoma (HL) have an excellent outcome. Early response evaluation with positron emission tomography (PET) scan may improve selection of patients who need reduced or more intensive treatments. Methods We performed a randomized trial to evaluate treatment adaptation on the basis of early PET (ePET) after two cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) in previously untreated—according to European Organisation for Research and Treatment of Cancer criteria favorable (F) and unfavorable (U)—stage I and II HL. The standard arm consisted of ABVD followed by involved-node radiotherapy (INRT), regardless of ePET result. In the experimental arm, ePET-negative patients received ABVD only (noninferiority design), whereas ePET-positive patients switched to two cycles of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPPesc) and INRT (superiority design). Primary end point was progression-free survival (PFS). Results Of 1,950 randomly assigned patients, 1,925 received an ePET—361 patients (18.8%) were positive. In ePET-positive patients, 5-year PFS improved from 77.4% for standard ABVD + INRT to 90.6% for intensification to BEACOPPesc + INRT (hazard ratio [HR], 0.42; 95% CI, 0.23 to 0.74; P = .002). In ePET-negative patients, 5-year PFS rates in the F group were 99.0% versus 87.1% (HR, 15.8; 95% CI, 3.8 to 66.1) in favor of ABVD + INRT; the U group, 92.1% versus 89.6% (HR, 1.45; 95% CI, 0.8 to 2.5) in favor of ABVD + INRT. For both F and U groups, noninferiority of ABVD only compared with combined modality treatment could not be demonstrated. Conclusion In stage I and II HL, PET response after two cycles of ABVD allows for early treatment adaptation. When ePET is positive after two cycles of ABVD, switching to BEACOPPesc + INRT significantly improved 5-year PFS. In ePET-negative patients, noninferiority of ABVD only could not be demonstrated: risk of relapse is increased when INRT is omitted, especially in patients in the F group.",

author = "Andr{\'e}, {Marc P.E.} and Th{\'e}odore Girinsky and Massimo Federico and Oum{\'e}daly Reman and Catherine Fortpied and Manuel Gotti and Olivier Casasnovas and Pauline Brice and {Van Der Maazen}, Richard and Alessandro Re and V{\'e}ronique Edeline and Christophe Ferm{\'e} and {Van Imhoff}, Gustaaf and Francesco Merli and R{\'e}da Bouabdallah and Catherine Sebban and Lena Specht and Aspasia Stamatoullas and Richard Delarue and Valeria Fiaccadori and Monica Bellei and Tiana Raveloarivahy and Annibale Versari and Martin Hutchings and Michel Meignan and John Raemaekers",

year = "2017",

month = jun,

day = "1",

doi = "10.1200/JCO.2016.68.6394",

language = "English",

volume = "35",

pages = "1786--1796",

journal = "Journal of Clinical Oncology",

issn = "0732-183X",

publisher = "American Society of Clinical Oncology",

number = "16",

}

TY - JOUR

T1 - Early positron emission tomography response-adapted treatment in stage I and II hodgkin lymphoma

T2 - Final results of the randomized EORTC/LYSA/FIL H10 trial

AU - André, Marc P.E.

AU - Girinsky, Théodore

AU - Federico, Massimo

AU - Reman, Oumédaly

AU - Fortpied, Catherine

AU - Gotti, Manuel

AU - Casasnovas, Olivier

AU - Brice, Pauline

AU - Van Der Maazen, Richard

AU - Re, Alessandro

AU - Edeline, Véronique

AU - Fermé, Christophe

AU - Van Imhoff, Gustaaf

AU - Merli, Francesco

AU - Bouabdallah, Réda

AU - Sebban, Catherine

AU - Specht, Lena

AU - Stamatoullas, Aspasia

AU - Delarue, Richard

AU - Fiaccadori, Valeria

AU - Bellei, Monica

AU - Raveloarivahy, Tiana

AU - Versari, Annibale

AU - Hutchings, Martin

AU - Meignan, Michel

AU - Raemaekers, John

PY - 2017/6/1

Y1 - 2017/6/1

N2 - Purpose Patients who receive combined modality treatment for stage I and II Hodgkin lymphoma (HL) have an excellent outcome. Early response evaluation with positron emission tomography (PET) scan may improve selection of patients who need reduced or more intensive treatments. Methods We performed a randomized trial to evaluate treatment adaptation on the basis of early PET (ePET) after two cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) in previously untreated—according to European Organisation for Research and Treatment of Cancer criteria favorable (F) and unfavorable (U)—stage I and II HL. The standard arm consisted of ABVD followed by involved-node radiotherapy (INRT), regardless of ePET result. In the experimental arm, ePET-negative patients received ABVD only (noninferiority design), whereas ePET-positive patients switched to two cycles of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPPesc) and INRT (superiority design). Primary end point was progression-free survival (PFS). Results Of 1,950 randomly assigned patients, 1,925 received an ePET—361 patients (18.8%) were positive. In ePET-positive patients, 5-year PFS improved from 77.4% for standard ABVD + INRT to 90.6% for intensification to BEACOPPesc + INRT (hazard ratio [HR], 0.42; 95% CI, 0.23 to 0.74; P = .002). In ePET-negative patients, 5-year PFS rates in the F group were 99.0% versus 87.1% (HR, 15.8; 95% CI, 3.8 to 66.1) in favor of ABVD + INRT; the U group, 92.1% versus 89.6% (HR, 1.45; 95% CI, 0.8 to 2.5) in favor of ABVD + INRT. For both F and U groups, noninferiority of ABVD only compared with combined modality treatment could not be demonstrated. Conclusion In stage I and II HL, PET response after two cycles of ABVD allows for early treatment adaptation. When ePET is positive after two cycles of ABVD, switching to BEACOPPesc + INRT significantly improved 5-year PFS. In ePET-negative patients, noninferiority of ABVD only could not be demonstrated: risk of relapse is increased when INRT is omitted, especially in patients in the F group.

AB - Purpose Patients who receive combined modality treatment for stage I and II Hodgkin lymphoma (HL) have an excellent outcome. Early response evaluation with positron emission tomography (PET) scan may improve selection of patients who need reduced or more intensive treatments. Methods We performed a randomized trial to evaluate treatment adaptation on the basis of early PET (ePET) after two cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) in previously untreated—according to European Organisation for Research and Treatment of Cancer criteria favorable (F) and unfavorable (U)—stage I and II HL. The standard arm consisted of ABVD followed by involved-node radiotherapy (INRT), regardless of ePET result. In the experimental arm, ePET-negative patients received ABVD only (noninferiority design), whereas ePET-positive patients switched to two cycles of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPPesc) and INRT (superiority design). Primary end point was progression-free survival (PFS). Results Of 1,950 randomly assigned patients, 1,925 received an ePET—361 patients (18.8%) were positive. In ePET-positive patients, 5-year PFS improved from 77.4% for standard ABVD + INRT to 90.6% for intensification to BEACOPPesc + INRT (hazard ratio [HR], 0.42; 95% CI, 0.23 to 0.74; P = .002). In ePET-negative patients, 5-year PFS rates in the F group were 99.0% versus 87.1% (HR, 15.8; 95% CI, 3.8 to 66.1) in favor of ABVD + INRT; the U group, 92.1% versus 89.6% (HR, 1.45; 95% CI, 0.8 to 2.5) in favor of ABVD + INRT. For both F and U groups, noninferiority of ABVD only compared with combined modality treatment could not be demonstrated. Conclusion In stage I and II HL, PET response after two cycles of ABVD allows for early treatment adaptation. When ePET is positive after two cycles of ABVD, switching to BEACOPPesc + INRT significantly improved 5-year PFS. In ePET-negative patients, noninferiority of ABVD only could not be demonstrated: risk of relapse is increased when INRT is omitted, especially in patients in the F group.

U2 - 10.1200/JCO.2016.68.6394

DO - 10.1200/JCO.2016.68.6394

M3 - Journal article

C2 - 28291393

AN - SCOPUS:85020260335

SN - 0732-183X

VL - 35

SP - 1786

EP - 1796

JO - Journal of Clinical Oncology

JF - Journal of Clinical Oncology

IS - 16

ER -

Early positron emission tomography response-adapted treatment in stage I and II hodgkin lymphoma: Final results of the randomized EORTC/LYSA/FIL H10 trial

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