PMID- 24637998
OWN - NLM
STAT- MEDLINE
DCOM- 20140723
LR  - 20220316
IS  - 1527-7755 (Electronic)
IS  - 0732-183X (Linking)
VI  - 32
IP  - 12
DP  - 2014 Apr 20
TI  - Omitting radiotherapy in early positron emission tomography-negative stage I/II 
      Hodgkin lymphoma is associated with an increased risk of early relapse: Clinical 
      results of the preplanned interim analysis of the randomized EORTC/LYSA/FIL H10 
      trial.
PG  - 1188-94
LID - 10.1200/JCO.2013.51.9298 [doi]
AB  - PURPOSE: Combined-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 METHODS: 
      Patients 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. RESULTS: The 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. CONCLUSION: On 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.
FAU - Raemaekers, John M M
AU  - Raemaekers JM
AD  - 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. Andre and Thierry van der Borght, Centre Hospitalier 
      Universitaire (CHU) L'Universite 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 Ferme, 
      Institut Gustave Roussy, Villejuif; Reman Oumedaly, CHU Caen; Stephane Bardet, 
      Centre Francois Baclesse, Caen; Pauline Brice, Hopital Saint-Louis, Paris; Reda 
      Bouabdallah, Institut Paoli Calmette, Marseille; Catherine J. Sebban, Centre Leon 
      Berard, 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, Hopital Henri Mondor, Creteil, 
      France; and Martin Hutchings, Rigshospitalet, Kopenhagen, Denmark.
FAU - Andre, Marc P E
AU  - Andre MP
FAU - Federico, Massimo
AU  - Federico M
FAU - Girinsky, Theodore
AU  - Girinsky T
FAU - Oumedaly, Reman
AU  - Oumedaly R
FAU - Brusamolino, Ercole
AU  - Brusamolino E
FAU - Brice, Pauline
AU  - Brice P
FAU - Ferme, Christophe
AU  - Ferme C
FAU - van der Maazen, Richard
AU  - van der Maazen R
FAU - Gotti, Manuel
AU  - Gotti M
FAU - Bouabdallah, Reda
AU  - Bouabdallah R
FAU - Sebban, Catherine J
AU  - Sebban CJ
FAU - Lievens, Yolande
AU  - Lievens Y
FAU - Re, Allessandro
AU  - Re A
FAU - Stamatoullas, Aspasia
AU  - Stamatoullas A
FAU - Morschhauser, Frank
AU  - Morschhauser F
FAU - Lugtenburg, Pieternella J
AU  - Lugtenburg PJ
FAU - Abruzzese, Elisabetta
AU  - Abruzzese E
FAU - Olivier, Pierre
AU  - Olivier P
FAU - Casasnovas, Rene-Olivier
AU  - Casasnovas RO
FAU - van Imhoff, Gustaaf
AU  - van Imhoff G
FAU - Raveloarivahy, Tiana
AU  - Raveloarivahy T
FAU - Bellei, Monica
AU  - Bellei M
FAU - van der Borght, Thierry
AU  - van der Borght T
FAU - Bardet, Stephane
AU  - Bardet S
FAU - Versari, Annibale
AU  - Versari A
FAU - Hutchings, Martin
AU  - Hutchings M
FAU - Meignan, Michel
AU  - Meignan M
FAU - Fortpied, Catherine
AU  - Fortpied C
LA  - eng
SI  - ClinicalTrials.gov/NCT00433433
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20140317
PL  - United States
TA  - J Clin Oncol
JT  - Journal of clinical oncology : official journal of the American Society of 
      Clinical Oncology
JID - 8309333
RN  - 11056-06-7 (Bleomycin)
RN  - 35S93Y190K (Procarbazine)
RN  - 5J49Q6B70F (Vincristine)
RN  - 5V9KLZ54CY (Vinblastine)
RN  - 6PLQ3CP4P3 (Etoposide)
RN  - 7GR28W0FJI (Dacarbazine)
RN  - 80168379AG (Doxorubicin)
RN  - 8N3DW7272P (Cyclophosphamide)
RN  - VB0R961HZT (Prednisone)
RN  - ABVD protocol
RN  - BEACOPP protocol
SB  - IM
CIN - J Clin Oncol. 2014 Apr 20;32(12):1180-2. PMID: 24638010
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Antineoplastic Combined Chemotherapy Protocols/administration & 
      dosage/*therapeutic use
MH  - Bleomycin/administration & dosage
MH  - Chemoradiotherapy
MH  - Cyclophosphamide/administration & dosage
MH  - Dacarbazine/administration & dosage
MH  - Disease-Free Survival
MH  - Doxorubicin/administration & dosage
MH  - Etoposide/administration & dosage
MH  - Female
MH  - Hodgkin Disease/diagnostic imaging/*drug therapy/pathology/*radiotherapy
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Recurrence, Local/pathology
MH  - Neoplasm Staging
MH  - Positron-Emission Tomography/methods
MH  - Prednisone/administration & dosage
MH  - Procarbazine/administration & dosage
MH  - Prospective Studies
MH  - Vinblastine/administration & dosage
MH  - Vincristine/administration & dosage
MH  - Young Adult
EDAT- 2014/03/19 06:00
MHDA- 2014/07/24 06:00
CRDT- 2014/03/19 06:00
PHST- 2014/03/19 06:00 [entrez]
PHST- 2014/03/19 06:00 [pubmed]
PHST- 2014/07/24 06:00 [medline]
AID - JCO.2013.51.9298 [pii]
AID - 10.1200/JCO.2013.51.9298 [doi]
PST - ppublish
SO  - J Clin Oncol. 2014 Apr 20;32(12):1188-94. doi: 10.1200/JCO.2013.51.9298. Epub 
      2014 Mar 17.