Final Results of European Intergroup Trial of Early PET-Adapted Treatment in Hodgkin Lymphoma
Final results of the phase III EORTC/LYSA/FIL H10 trial confirm the benefits of early positron-emission tomography (PET)-adapted treatment in patients with stage I or II Hodgkin lymphoma. The results were reported by André et al in the Journal of Clinical Oncology.
Study Details
The randomized trial, which enrolled 1,950 patients with previously untreated European Organisation for Research and Treatment of Cancer (EORTC) criteria favorable and unfavorable stage I and II disease between November 2006 and June 2011, investigated the effects of modifying treatment on the basis of early PET after 2 cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD).
Among 754 patients with favorable disease, 371 were randomized to receive standard treatment and 376, experimental treatment; among the 1,196 patients with unfavorable disease, 583 were randomized to receive standard treatment and 595, to experimental treatment.
The standard treatment group received ABVD followed by involved-node radiotherapy irrespective of early PET results. In the experimental group, early PET-negative patients received ABVD alone (noninferiority design), and early PET-positive patients switched to two cycles of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPPesc) and involved-node radiotherapy (superiority design). The primary endpoint was progression-free survival.
Progression-Free Survival
Of the 1,950 randomized patients, 1,925 received early PET and 361 patients (18.8%) were PET-positive. Among PET-positive patients, 5-year progression-free survival was 90.6% with BEACOPPesc plus involved-node radiotherapy vs 77.4% for ABVD plus involved-node radiotherapy (hazard ratio [HR] = 0.42, P = .002).
Among PET-negative patients with favorable disease, 5-year progression-free survival was 99.0% with ABVD plus involved-node radiotherapy vs 87.1% with ABVD alone (HR = 15.8, 95% confidence interval [CI] = 3.8–66.1); noninferiority of ABVD was not established, since the upper bound of the 95% confidence interval exceeded the noninferiority margin of 3.2. Among those with unfavorable disease, 5-year progression-free survival was 92.1% vs 89.6% (HR = 1.45, 95% CI = 0.8–2.5), with the upper bound of the 95% confidence interval exceeding the noninferiority margin of 2.10.
The investigators concluded: “In stage I and II [Hodgkin lymphoma], PET response after two cycles of ABVD allows for early treatment adaptation. When [early] PET is positive after two cycles of ABVD, switching to BEACOPPesc [plus involved-node radiotherapy] significantly improved 5-year [progression-free survival]. In [early] PET-negative patients, noninferiority of ABVD only could not be demonstrated: risk of relapse is increased when [involved-node radiotherapy] is omitted, especially in patients in the [favorable] group.”
The study was supported by the EORTC (Belgium), LYmphoma Study Association (France), Fondazione Italiana Limfomi (Italy), Fondation Belge contre le Cancer (Belgium), Dutch Cancer Society (the Netherlands), Institut National du Cancer (France), Assistance Publique des Hopitaux de Paris (France), Societe Française de Medecine Nucleaire et Imagerie Moleculaire (France), Associazone Angela Serra (Italy), van Vlissingen Lymfoom Fonds (the Netherlands), and Chugai Pharmaceutical (Japan).
John Raemaekers, MD, PhD, of the Radboud University Medical Center, Nijmegen, the Netherlands, is the corresponding author of the Journal of Clinical Oncology article.
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