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

Volumn 32, Issue 12, 2014, Pages 1188-1194

  Raemaekers, John M M ^a   André, Marc P E ^d   Federico, Massimo ^g   Girinsky, Theodore ^m   Oumedaly, Reman ⁿ   Brusamolino, Ercole ^h   Brice, Pauline ^p   Fermé, Christophe ^m   Van Der Maazen, Richard ^a   Gotti, Manuel ⁱ   Bouabdallah, Reda ^q   Sebban, Catherine J ^r   Lievens, Yolande ^e   Re, Allessandro ^j   Stamatoullas, Aspasia ^s   Morschhauser, Frank ^t   Lugtenburg, Pieternella J ^b   Abruzzese, Elisabetta ^k   Olivier, Pierre ^u   Casasnovas, Rene Olivier ^v   Van Imhoff, Gustaaf ^c   Raveloarivahy, Tiana ^f   Bellei, Monica ^g   Van Der Borght, Thierry ^d   Bardet, Stephane ^o   Versari, Annibale ^l   Hutchings, Martin ^x   Meignan, Michel ^w   Fortpied, Catherine ^f   more..

^a RADBOUD UNIVERSITY MEDICAL CENTER   (Netherlands)

^b ERASMUS MEDICAL CENTER   (Netherlands)

^c UNIVERSITY MEDICAL CENTER GRONINGEN   (Netherlands)

^d UNIVERSITÉ CATHOLIQUE DE LOUVAIN   (Belgium)

^e GHENT UNIVERSITY HOSPITAL   (Belgium)

^f EORTC DATA CENTER   (Belgium)

^g UNIVERSITY OF MODENA AND REGGIO EMILIA   (Italy)

^h HUMANITAS CLINICAL AND RESEARCH CENTER   (Italy)

ⁱ FONDAZIONE IRCCS POLICLINICO SAN MATTEO   (Italy)

^j SPEDALI CIVILI   (Italy)

^k UNIVERSITY OF ROME TOR VERGATA   (Italy)

^l S MARIA NUOVA HOSPITAL   (Italy)

^m INSTITUT GUSTAVE ROUSSY   (France)

ⁿ CAEN UNIVERSITY HOSPITAL   (France)

^o CENTRE FRANÇOIS BACLESSE   (France)

^p SAINT LOUIS HOSPITAL   (France)

^q INSTITUT PAOLI CALMETTES   (France)

^r CENTRE LÉON BÉRARD   (France)

^s CENTRE HENRI BECQUEREL   (France)

^t LILLE UNIVERSITY HOSPITAL   (France)

^u UNIVERSITY HOSPITAL OF NANCY   (France)

^v DIJON UNIVERSITY HOSPITAL   (France)

^w HENRI MONDOR HOSPITAL   (France)

^x Rigshospitalet   (Denmark)

more..

Author keywords

[No Author keywords available]

Indexed keywords

BLEOMYCIN; DACARBAZINE; DOXORUBICIN; VINBLASTINE; ANTINEOPLASTIC AGENT; CYCLOPHOSPHAMIDE; ETOPOSIDE; PREDNISONE; PROCARBAZINE; VINCRISTINE;

ADOLESCENT; ADULT; AGED; ARTICLE; CANCER CHEMOTHERAPY; CANCER RADIOTHERAPY; CANCER RECURRENCE; CANCER RISK; CANCER STAGING; CANCER SURVIVAL; CONTROLLED STUDY; DRUG EFFICACY; EXPERIMENTAL THERAPY; FEMALE; HODGKIN DISEASE; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTIPLE CYCLE TREATMENT; OUTCOME ASSESSMENT; PHASE 3 CLINICAL TRIAL; POSITRON EMISSION TOMOGRAPHY; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME; CHEMORADIOTHERAPY; CONTROLLED CLINICAL TRIAL; DISEASE FREE SURVIVAL; METHODOLOGY; MIDDLE AGED; MULTICENTER STUDY; PATHOLOGY; PROSPECTIVE STUDY; SCINTISCANNING; TUMOR RECURRENCE; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BLEOMYCIN; CHEMORADIOTHERAPY; CYCLOPHOSPHAMIDE; DACARBAZINE; DISEASE-FREE SURVIVAL; DOXORUBICIN; ETOPOSIDE; FEMALE; HODGKIN DISEASE; HUMANS; MALE; MIDDLE AGED; NEOPLASM RECURRENCE, LOCAL; NEOPLASM STAGING; POSITRON-EMISSION TOMOGRAPHY; PREDNISONE; PROCARBAZINE; PROSPECTIVE STUDIES; VINBLASTINE; VINCRISTINE; YOUNG ADULT;

EID: 84904810169     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2013.51.9298     Document Type: Article

References (29)

1. Fermé C, Eghbali H, Meerwaldt JH, et al: Chemotherapy plus involved-field radiation in earlystage Hodgkin's disease. N Engl J Med 357:1916-1927, 2007 (Pubitemid 350074687)
2. Engert A, Plütschow A, Eich HT, et al: Reduced treatment intensity in patients with early-stage Hodgkin's lymphoma. N Engl J Med 363:640-652, 2010
3. Girinsky T, van der Maazen R, Specht L, et al: Involved-node radiotherapy (INRT) in patients with early Hodgkin lymphoma: Concepts and guidelines. Radiother Oncol 79:270-277, 2006 (Pubitemid 44109907)
4. Aleman BM, van den Belt-Dusebout AW, Klokman WJ, et al: Long-term cause-specific mortality of patients treated for Hodgkin's disease. J Clin Oncol 21:3431-3439, 2003 (Pubitemid 46603515)
5. Meyer RM, Gospodarowicz MK, Connors JM, et al: ABVD alone versus radiation-based therapy in limited-stage Hodgkin's lymphoma. N Engl J Med 366:399-408, 2012
6. Herbst C, Rehan FA, Skoetz N, et al: Chemotherapy alone versus chemotherapy plus radiotherapy for early stage Hodgkin lymphoma. Cochrane Database Syst Rev 2:CD007110, 2011
7. Thomas J, Fermé C, Noordijk E, et al: Results of the EORTC-GELA H9 randomized trials: The H9-F trial (comparing 3 radiation dose levels) and H9-U trial (comparing 3 chemotherapy schemes) in patients with favorable or unfavorable early stage Hodgkin's lymphoma. Haematologica 92, 2007 (abstr C010)
8. Yahalom J: Don't throw out the baby with the bathwater: On optimizing cure and reducing toxicity in Hodgkin's lymphoma. J Clin Oncol 24:544-548, 2006
9. van der Maazen RW, Raemaekers JM: Chemotherapy and radiotherapy in Hodgkin's lymphoma: Joining in or splitting up? Curr Opin Oncol 18:660-666, 2006
10. Straus DJ: Chemotherapy only for localized Hodgkin lymphoma. J Intern Med 270:197-205, 2011
11. Younes A: Early-stage Hodgkin's lymphoma: In pursuit of perfection. J Clin Oncol 30:895-896, 2012
12. Brusamolino E, Baio A, Orlandi E, et al: Long-term events in adult patients with clinical stage IA-IIA nonbulky Hodgkin's lymphoma treated with four cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine and adjuvant radiotherapy: A single-institution 15-year follow-up. Clin Cancer Res 12: 6487-6493, 2006 (Pubitemid 44799722)
13. Hutchings M, Mikhaeel NG, Fields PA, et al: Prognostic value of interim FDG-PET after two or three cycles of chemotherapy in Hodgkin lymphoma. Ann Oncol 16:1160-1168, 2005 (Pubitemid 41418320)
14. Gallamini A, Rigacci L, Merli F, et al: The predictive value of positron emission tomography scanning performed after two courses of standard therapy on treatment outcome in advanced stage Hodgkin's disease. Haematologica 91:475-481, 2006
15. Hutchings M, Loft A, Hansen M, et al: FDG-PET after two cycles of chemotherapy predicts treatment failure and progression-free survival in Hodgkin lymphoma. Blood 107:52-59, 2006 (Pubitemid 43053523)
16. von Tresckow B, Plütschow A, Fuchs M, et al: Dose-intensification in early unfavorable Hodgkin's lymphoma: Final analysis of the German Hodgkin Study Group HD14 trial. J Clin Oncol 30:907-913, 2012
17. André M, Reman O, Federico M, et al: First report on the H10 EORTC/GELA/IIL randomized intergroup trial on early FDG-PET scan guided treatment adaptation versus standard combined modality treatment in patients with supradiaphragmatic stage I/II Hodgkin's lymphoma, for the Groupe d'Etude des Lymphomes de l'Adulte (GELA), European Organisation for the Research and Treatment of Cancer (EORTC) Lymphoma Group and the Intergruppo Italiano Linfomi (IIL). Blood 114, 2009 (abstr 97)
18. Tubiana M, Henry-Amar M, van der Werf-Messing B, et al: A multivariate analysis of prognostic factors in early stage Hodgkin's disease. Int J Radiat Oncol Biol Phys 11:23-30, 1985 (Pubitemid 15169348)
19. Noordijk EM, Carde P, Dupouy N, et al: Combined-modality therapy for clinical stage I or II Hodgkin's lymphoma: Long-term results of the European Organisation for Research and Treatment of Cancer H7 randomized controlled trials. J Clin Oncol 24:3128-3135, 2006 (Pubitemid 46638951)
20. 18F] fluorodeoxyglucose PET scan-guided therapy or standard therapy in treating patients with previously untreated stage I or stage II Hodgkin's lymphoma. http://clinicaltrials.gov/show/NCT00433433
21. Meignan M, Itti E, Bardet S, et al: Development and application of a real-time on-line blinded independent central review of interim PET scans to determine treatment allocation in lymphoma trials. J Clin Oncol 27:2739-2741, 2009
22. Juweid ME, Stroobants S, Hoekstra OS, et al: Use of positron emission tomography for response assessment of lymphoma: Consensus of the Imaging Subcommittee of International Harmonisation Project in Lymphoma. J Clin Oncol 25:571-578, 2007 (Pubitemid 350002965)
23. Meignan M, Gallamini A, Haioun C, et al: Report on the Second International Workshop on Interim Positron Emission Tomography in Lymphoma held in Menton, France, 8-9 April 2010. Leuk Lymphoma 51:2171-2180, 2010
24. Demets DL: Futility approaches to interim monitoring by data monitoring committees. Clin Trials 3:522-529, 2006
25. Snapinn S, Chen MG, Jiang Q, et al: Assessment of futility in clinical trials. Pharm Stat 5:273-281, 2006 (Pubitemid 46023756)
26. Cairns JA, Wittes J, Wyse DG, et al: Monitoring the ACTIVE-W trial: Some issues in monitoring a noninferiority trial. Am Heart J 155:33-41, 2008 (Pubitemid 350234783)
27. Herbst C, Rehan FA, Brillant C, et al: Combined modality treatment improves tumor control and overall survival in patients with early stage Hodgkin's lymphoma: A systematic review. Haematologica 95:494-500, 2010
28. Koshy M, Rich SE, Mahmood U, et al: Declining use of radiotherapy in stage I and II Hodgkin's disease and its effect on survival and secondary malignancies. Int J Radiat Oncol Biol Phys 82:619-625, 2012
29. Radford J, Barrington S, Counsell N, et al: Involved field radiotherapy versus no further treatment in patients with clinical stage IA and IIA Hodgkin lymphoma and a negative PET scan after 3 cycles of ABVD: Results of the UK NCRI RAPID trial. Blood 120, 2012 (abstr 547)