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.
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.


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).


CONCLUSIONS
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.
Department of Onco-Hematology, Archet Hospital, Nice mounier.n@chu-nice.fr.
N
N
Mounier
Department of Hematology, Saint-Louis Hospital, Paris.
P
P
Brice
Department of Hematology, Nancy Hospital.
S
S
Bologna
Department of Hematology, Saint-Louis Hospital, Paris.
J
J
Briere
Department of Hematology, Henri Mondor Hospital, Creteil.
I
I
Gaillard
Department of Hematology, Besancon Hospital.
M
M
Heczko
Department of Hematology, la Pitié-Salpétrière Hospital, Paris.
J
J
Gabarre
Department of Hematology, CHU de Dijon Hospital, Dijon.
O
O
Casasnovas
Department of Hematology, St Etienne Hospital, St Etienne.
J
J
Jaubert
Department of Hematology, Courlancy Cancer Institute, Reims.
P
P
Colin
Department of Hematology, Reims Hospital, Reims.
A
A
Delmer
Department of Hematology, Corbeil Hospital, Corbeil Essonnes.
A
A
Devidas
Department of Hematology, Lyon Sud Hospital, Pierre Benite.
E
E
Bachy
Department of Hematology, Leon Berard Cancer Center, Lyon.
E
E
Nicolas-Virelizier
Department of Hematology, St Antoine Hospital, Paris.
A
A
Aoudjhane
Department of Hematology, Colmar Hospital, Colmar, France.
C
C
Humbrecht
Department of Hematology, Mont Godine Hospital, Yvoire, Belgium.
M
M
Andre
Department of Hematology, Gustave Roussy Institute, Villejuif, France.
P
P
Carde
D000293:Adolescent; D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001761:Bleomycin / Q000627:therapeutic use; D003520:Cyclophosphamide / Q000627:therapeutic use; D003606:Dacarbazine / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D004317:Doxorubicin / Q000627:therapeutic use; D005047:Etoposide / Q000627:therapeutic use; D005260:Female; D006689:Hodgkin Disease / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011241:Prednisone / Q000627:therapeutic use; D011344:Procarbazine / Q000627:therapeutic use; D016019:Survival Analysis; D016896:Treatment Outcome; D014747:Vinblastine / Q000627:therapeutic use; D014750:Vincristine / Q000627:therapeutic use; D055815:Young Adult
D001761:Bleomycin; D011344:Procarbazine; D014750:Vincristine; D014747:Vinblastine; D005047:Etoposide; D003606:Dacarbazine; D004317:Doxorubicin; D003520:Cyclophosphamide; D011241:Prednisone
Hodgkin lymphoma; intensive chemotherapy; phase 3 trial; prognostic factors; secondary malignancy