• John M M Raemaekers, Marc P E André, Massimo Federico, Theodore Girinsky, Reman Oumedaly, Ercole Brusamolino, Pauline Brice, Christophe Fermé, Richard van der Maazen, Manuel Gotti, Reda Bouabdallah, Catherine J Sebban, Yolande Lievens, Allessandro Re, Aspasia Stamatoullas, Frank Morschhauser, Pieternella J Lugtenburg, Elisabetta Abruzzese, Pierre Olivier, Rene-Olivier Casasnovas, Gustaaf van Imhoff, Tiana Raveloarivahy, Monica Bellei, Thierry van der Borght, Stephane Bardet, Annibale Versari, Martin Hutchings, Michel Meignan, and Catherine Fortpied.
• John M.M. Raemaekers and Richard van der Maazen, Radboud University Medical Center, Nijmegen; Pieternella J. Lugtenburg, Erasmus University Medical Center, Rotterdam; Gustaaf van Imhoff, University Medical Centre Groningen, Groningen, the Netherlands; Marc P.E. André and Thierry van der Borght, Centre Hospitalier Universitaire (CHU) L'Université Catholique de Louvain Mont Godinne, Yvoir; Yolande Lievens, Ghent University Hospital, Ghent; Tiana Raveloarivahy and Catherine Fortpied, European Organisation for Research and Treatment of Cancer, Brussels, Belgium; Massimo Federico and Monica Bellei, University of Modena and Reggio Emilia, Modena; Ercole Brusamolino, Istituto Clinico Humanitas, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Milan; Manuel Gotti, Fondazione IRCCS Policlinico San Matteo, Pavia; Allessandro Re, Spedali Civili Hospital, Brescia; Elisabetta Abruzzese, San Eugenio Hospital, Tor Vergata University, Rome; Annibale Versari, Arcispedale Santa Maria Nuova, IRCCS di Reggio Emilia, Reggio Emilia, Italy; Theodore Girinsky and Christophe Fermé, Institut Gustave Roussy, Villejuif; Reman Oumedaly, CHU Caen; Stephane Bardet, Centre Francois Baclesse, Caen; Pauline Brice, Hôpital Saint-Louis, Paris; Reda Bouabdallah, Institut Paoli Calmette, Marseille; Catherine J. Sebban, Centre Léon Bérard, Lyon; Aspasia Stamatoullas, Centre Henri Becquerel, Rouen; Frank Morschhauser, CHU de Lille, Lille; Pierre Olivier, CHU Nancy, Nancy; Rene-Olivier Casasnovas, CHU de Dijon, Dijon; Michel Meignan, Hôpital Henri Mondor, Creteil, France; and Martin Hutchings, Rigshospitalet, Kopenhagen, Denmark.
• J. Clin. Oncol. 2014 Apr 20; 32 (12): 1188-94.

PurposeCombined-modality treatment is standard treatment for patients with clinical stage I/II Hodgkin lymphoma (HL). We hypothesized that an early positron emission tomography (PET) scan could be used to adapt treatment. Therefore, we started the randomized EORTC/LYSA/FIL Intergroup H10 trial evaluating whether involved-node radiotherapy (IN-RT) could be omitted without compromising progression-free survival in patients attaining a negative early PET scan after two cycles of ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine) as compared with standard combined-modality treatment.Patients And MethodsPatients age 15 to 70 years with untreated clinical stage I/II HL were eligible. Here we report the clinical outcome of the preplanned interim futility analysis scheduled to occur after documentation of 34 events in the early PET-negative group. Because testing for futility in this noninferiority trial corresponds to testing the hypothesis of no difference, a one-sided superiority test was conducted.ResultsThe analysis included 1,137 patients. In the favorable subgroup, 85.8% had a negative early PET scan (standard arm, one event v experimental arm, nine events). In the unfavorable subgroup, 74.8% had a negative early PET scan (standard arm, seven events v experimental arm, 16 events). The independent data monitoring committee concluded it was unlikely that we would show noninferiority in the final results for the experimental arm and advised stopping random assignment for early PET-negative patients.ConclusionOn the basis of this analysis, combined-modality treatment resulted in fewer early progressions in clinical stage I/II HL, although early outcome was excellent in both arms. The final analysis will reveal whether this finding is maintained over time.

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