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

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
Pages (from-to)1786-1796
Number of pages11
JournalJournal of Clinical Oncology
Volume35
Issue number16
DOIs
Publication statusPublished - Jun 1 2017

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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