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Ann Oncol. 2014 Aug;25(8):1622-8. doi: 10.1093/annonc/mdu189. Epub 2014 May 14.

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.

Author information

1
Department of Onco-Hematology, Archet Hospital, Nice mounier.n@chu-nice.fr.
2
Department of Hematology, Saint-Louis Hospital, Paris.
3
Department of Hematology, Nancy Hospital.
4
Department of Hematology, Henri Mondor Hospital, Creteil.
5
Department of Hematology, Besancon Hospital.
6
Department of Hematology, la Pitié-Salpétrière Hospital, Paris.
7
Department of Hematology, CHU de Dijon Hospital, Dijon.
8
Department of Hematology, St Etienne Hospital, St Etienne.
9
Department of Hematology, Courlancy Cancer Institute, Reims.
10
Department of Hematology, Reims Hospital, Reims.
11
Department of Hematology, Corbeil Hospital, Corbeil Essonnes.
12
Department of Hematology, Lyon Sud Hospital, Pierre Benite.
13
Department of Hematology, Leon Berard Cancer Center, Lyon.
14
Department of Hematology, St Antoine Hospital, Paris.
15
Department of Hematology, Colmar Hospital, Colmar, France.
16
Department of Hematology, Mont Godine Hospital, Yvoire, Belgium.
17
Department of Hematology, Gustave Roussy Institute, Villejuif, France.

Abstract

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.

KEYWORDS:

Hodgkin lymphoma; intensive chemotherapy; phase 3 trial; prognostic factors; secondary malignancy

PMID:
24827123
DOI:
10.1093/annonc/mdu189
[Indexed for MEDLINE]

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