TY - JOUR
T1 - Omitting Radiotherapy in Early Positron Emission Tomography-Negative Stage I/II Hodgkin Lymphoma Is Associated With an Increased Risk of Early Relapse
T2 - Clinical Results of the Preplanned Interim Analysis of the Randomized EORTC/LYSA/FIL H10 Trial
AU - Raemaekers, John M. M.
AU - Andre, Marc P. E.
AU - Federico, Massimo
AU - Girinsky, Theodore
AU - Oumedaly, Reman
AU - Brusamolino, Ercole
AU - Brice, Pauline
AU - Ferme, Christophe
AU - van der Maazen, Richard
AU - Gotti, Manuel
AU - Bouabdallah, Reda
AU - Sebban, Catherine J.
AU - Lievens, Yolande
AU - Re, Allessandro
AU - Stamatoullas, Aspasia
AU - Morschhauser, Frank
AU - Lugtenburg, Pieternella J.
AU - Abruzzese, Elisabetta
AU - Olivier, Pierre
AU - Casasnovas, Rene-Olivier
AU - van Imhoff, Gustaaf
AU - Raveloarivahy, Tiana
AU - Bellei, Monica
AU - van der Borght, Thierry
AU - Bardet, Stephane
AU - Versari, Annibale
AU - Hutchings, Martin
AU - Meignan, Michel
AU - Fortpied, Catherine
PY - 2014/4/20
Y1 - 2014/4/20
N2 - 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.
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.
KW - FDG-PET
KW - CHEMOTHERAPY
KW - DISEASE
KW - THERAPY
KW - CYCLES
KW - RADIATION
KW - SURVIVAL
KW - FUTILITY
U2 - 10.1200/JCO.2013.51.9298
DO - 10.1200/JCO.2013.51.9298
M3 - Article
SN - 0732-183X
VL - 32
SP - 1188
EP - 1194
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 12
ER -