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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

(2014) JOURNAL OF CLINICAL ONCOLOGY. 32(12). p.1188-1194
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Abstract
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.
Keywords
PHYSICIAN-ASSISTED SUICIDE, PALLIATIVE CARE, NATIONAL-SURVEY, UNITED-STATES, NONMALIGNANT DISEASE, NONCANCER PATIENTS, MEDICAL-PRACTICE, BELGIUM, EUTHANASIA, FLANDERS

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Citation

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MLA
Raemaekers, John MM, Marc PE Andre, Massimo Federico, et al. “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.” JOURNAL OF CLINICAL ONCOLOGY 32.12 (2014): 1188–1194. Print.
APA
Raemaekers, J. M., Andre, M. P., Federico, M., Girinsky, T., Oumedaly, R., Brusamolino, E., Brice, P., et al. (2014). 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. JOURNAL OF CLINICAL ONCOLOGY, 32(12), 1188–1194.
Chicago author-date
Raemaekers, John MM, Marc PE Andre, Massimo Federico, Theodore Girinsky, Reman Oumedaly, Ercole Brusamolino, Pauline Brice, et al. 2014. “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.” Journal of Clinical Oncology 32 (12): 1188–1194.
Chicago author-date (all authors)
Raemaekers, John MM, Marc PE Andre, Massimo Federico, Theodore Girinsky, Reman Oumedaly, Ercole Brusamolino, Pauline Brice, Christophe Ferme, 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. 2014. “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.” Journal of Clinical Oncology 32 (12): 1188–1194.
Vancouver
1.
Raemaekers JM, Andre MP, Federico M, Girinsky T, Oumedaly R, Brusamolino E, et al. 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. JOURNAL OF CLINICAL ONCOLOGY. 2014;32(12):1188–94.
IEEE
[1]
J. M. Raemaekers et al., “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,” JOURNAL OF CLINICAL ONCOLOGY, vol. 32, no. 12, pp. 1188–1194, 2014.
@article{4430146,
  abstract     = {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.},
  author       = {Raemaekers, John MM and Andre, Marc PE and Federico, Massimo and Girinsky, Theodore and Oumedaly, Reman and Brusamolino, Ercole and Brice, Pauline and Ferme, Christophe and van der Maazen, Richard and Gotti, Manuel and Bouabdallah, Reda and Sebban, Catherine J and Lievens, Yolande and Re, Allessandro and Stamatoullas, Aspasia and Morschhauser, Frank and Lugtenburg, Pieternella J and Abruzzese, Elisabetta and Olivier, Pierre and Casasnovas, Rene-Olivier and van Imhoff, Gustaaf and Raveloarivahy, Tiana and Bellei, Monica and van der Borght, Thierry and Bardet, Stephane and Versari, Annibale and Hutchings, Martin and Meignan, Michel and Fortpied, Catherine},
  issn         = {0732-183X},
  journal      = {JOURNAL OF CLINICAL ONCOLOGY},
  keywords     = {PHYSICIAN-ASSISTED SUICIDE,PALLIATIVE CARE,NATIONAL-SURVEY,UNITED-STATES,NONMALIGNANT DISEASE,NONCANCER PATIENTS,MEDICAL-PRACTICE,BELGIUM,EUTHANASIA,FLANDERS},
  language     = {eng},
  number       = {12},
  pages        = {1188--1194},
  title        = {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},
  url          = {http://dx.doi.org/10.1200/JCO.2013.51.9298},
  volume       = {32},
  year         = {2014},
}

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