PMID- 24827123 OWN - NLM STAT- MEDLINE DCOM- 20151116 LR - 20220330 IS - 1569-8041 (Electronic) IS - 0923-7534 (Linking) VI - 25 IP - 8 DP - 2014 Aug TI - ABVD (8 cycles) versus BEACOPP (4 escalated cycles >/= 4 baseline): final results in stage III-IV low-risk Hodgkin lymphoma (IPS 0-2) of the LYSA H34 randomized trial. PG - 1622-8 LID - 10.1093/annonc/mdu189 [doi] AB - BACKGROUND: Treatment with escalated BEACOPP achieved a superior time to treatment failure over ABVD in patients with disseminated Hodgkin lymphoma. However, recent clinical trials have failed to confirm BEACOPP overall survival (OS) superiority over ABVD. In addition, the gain in low-risk patients is still a matter of debate. PATIENTS AND METHODS: We randomly compared ABVD (8 cycles) with BEACOPP (escalated 4 cycles >/= baseline 4 cycles) in low-risk patients with an International Prognostic Score (IPS) of 0-2. The primary end point was event-free survival (EFS). This parallel group, open-label phase 3 trial was registered under #RECF0219 at French National Cancer Institute. RESULTS: One hundred and fifty patients were randomized in this trial (ABVD 80, BEACOPP 70): 28 years was the median age, 50% were male and IPS was 0-1 for 64%. Complete remission rate was 85% for ABVD and 90% for BEACOPP. Progression or relapses were more frequent in the ABVD patients than in the BEACOPP patients (17 versus 5 patients). With a median follow-up period of 5.5 years, seven patients died: six in the ABVD arm and one in the BEACOPP arm (HL 3 and 0, 2nd cancer 2 and 1, accident 1 and 0). The EFS at 5 years was estimated at 62% for ABVD versus 77%, for BEACOPP [hazards ratio (HR) = 0.6, P = 0.07]. The progression-free survival (PFS) at 5 years was 75% versus 93% (HR = 0.3, P = 0.007). The OS at 5 years was 92% versus 99% (HR = 0.18, P = 0.06). CONCLUSION: Fewer progressions/relapses were observed with BEACOPP, demonstrating the high efficacy of the more intensive regimen, even in low-risk patients. However, additional considerations, balancing treatment-related toxicity and late morbidity due to salvage may help with decision-making with regard to treatment with ABVD or BEACOPP. CI - (c) The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com. FAU - Mounier, N AU - Mounier N AD - Department of Onco-Hematology, Archet Hospital, Nice mounier.n@chu-nice.fr. FAU - Brice, P AU - Brice P AD - Department of Hematology, Saint-Louis Hospital, Paris. FAU - Bologna, S AU - Bologna S AD - Department of Hematology, Nancy Hospital. FAU - Briere, J AU - Briere J AD - Department of Hematology, Saint-Louis Hospital, Paris. FAU - Gaillard, I AU - Gaillard I AD - Department of Hematology, Henri Mondor Hospital, Creteil. FAU - Heczko, M AU - Heczko M AD - Department of Hematology, Besancon Hospital. FAU - Gabarre, J AU - Gabarre J AD - Department of Hematology, la Pitie-Salpetriere Hospital, Paris. FAU - Casasnovas, O AU - Casasnovas O AD - Department of Hematology, CHU de Dijon Hospital, Dijon. FAU - Jaubert, J AU - Jaubert J AD - Department of Hematology, St Etienne Hospital, St Etienne. FAU - Colin, P AU - Colin P AD - Department of Hematology, Courlancy Cancer Institute, Reims. FAU - Delmer, A AU - Delmer A AD - Department of Hematology, Reims Hospital, Reims. FAU - Devidas, A AU - Devidas A AD - Department of Hematology, Corbeil Hospital, Corbeil Essonnes. FAU - Bachy, E AU - Bachy E AD - Department of Hematology, Lyon Sud Hospital, Pierre Benite. FAU - Nicolas-Virelizier, E AU - Nicolas-Virelizier E AD - Department of Hematology, Leon Berard Cancer Center, Lyon. FAU - Aoudjhane, A AU - Aoudjhane A AD - Department of Hematology, St Antoine Hospital, Paris. FAU - Humbrecht, C AU - Humbrecht C AD - Department of Hematology, Colmar Hospital, Colmar, France. FAU - Andre, M AU - Andre M AD - Department of Hematology, Mont Godine Hospital, Yvoire, Belgium. FAU - Carde, P AU - Carde P AD - Department of Hematology, Gustave Roussy Institute, Villejuif, France. CN - Lymphoma Study Association (LYSA) LA - eng PT - Clinical Trial, Phase III PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20140514 PL - England TA - Ann Oncol JT - Annals of oncology : official journal of the European Society for Medical Oncology JID - 9007735 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 MH - Adolescent MH - Adult MH - Antineoplastic Combined Chemotherapy Protocols/*therapeutic use MH - Bleomycin/therapeutic use MH - Cyclophosphamide/therapeutic use MH - Dacarbazine/therapeutic use MH - Dose-Response Relationship, Drug MH - Doxorubicin/therapeutic use MH - Etoposide/therapeutic use MH - Female MH - Hodgkin Disease/*drug therapy/mortality/pathology MH - Humans MH - Male MH - Middle Aged MH - Neoplasm Staging MH - Prednisone/therapeutic use MH - Procarbazine/therapeutic use MH - Survival Analysis MH - Treatment Outcome MH - Vinblastine/therapeutic use MH - Vincristine/therapeutic use MH - Young Adult OTO - NOTNLM OT - Hodgkin lymphoma OT - intensive chemotherapy OT - phase 3 trial OT - prognostic factors OT - secondary malignancy FIR - Divine, M IR - Divine M FIR - Fenaux, P IR - Fenaux P FIR - Coiffier, B IR - Coiffier B FIR - Reman, O IR - Reman O FIR - Aoudjhane, M IR - Aoudjhane M FIR - Blaise, A M IR - Blaise AM FIR - Bordessoule, D IR - Bordessoule D FIR - Bosly, A IR - Bosly A FIR - Morschhauser, F IR - Morschhauser F FIR - Caillot, D IR - Caillot D FIR - Gonzalez, H IR - Gonzalez H FIR - Lederlin, P IR - Lederlin P FIR - Bouabdallah, R IR - Bouabdallah R FIR - Van Hoof, A IR - Van Hoof A FIR - Boulat, O IR - Boulat O FIR - Bauduer, F IR - Bauduer F FIR - Tournilhac, O IR - Tournilhac O FIR - Decaudin, D IR - Decaudin D FIR - Sebban, C IR - Sebban C FIR - Janvier, M IR - Janvier M FIR - Kentos, A IR - Kentos A FIR - Voillat, L IR - Voillat L FIR - Fabbro, M IR - Fabbro M FIR - Eisenmann, J C IR - Eisenmann JC FIR - Martin, C IR - Martin C FIR - Christian, B IR - Christian B FIR - Ferrant, A IR - Ferrant A FIR - Salanoubat, C IR - Salanoubat C FIR - Varet, B IR - Varet B FIR - Bouabdallah, K IR - Bouabdallah K FIR - De Prijck, B IR - De Prijck B FIR - Levaltier, X IR - Levaltier X FIR - Castaigne, S IR - Castaigne S FIR - Audhuy, B IR - Audhuy B FIR - Frenkiel, N IR - Frenkiel N FIR - Rose, C IR - Rose C FIR - Fitoussi, O IR - Fitoussi O FIR - Orfeuvre, H IR - Orfeuvre H FIR - Pignon, J M IR - Pignon JM EDAT- 2014/05/16 06:00 MHDA- 2015/11/17 06:00 CRDT- 2014/05/16 06:00 PHST- 2014/05/16 06:00 [entrez] PHST- 2014/05/16 06:00 [pubmed] PHST- 2015/11/17 06:00 [medline] AID - S0923-7534(19)34825-2 [pii] AID - 10.1093/annonc/mdu189 [doi] PST - ppublish SO - Ann Oncol. 2014 Aug;25(8):1622-8. doi: 10.1093/annonc/mdu189. Epub 2014 May 14.