Long term results of a randomized study performed by Intergruppo Italiano Linfomi comparing Mini-CEOP vs P-VEBEC in elderly patients with diffuse large B-cell lymphoma.
The Intergruppo Italiano Linfomi started, in 1996, a randomized trial for the initial treatment of elderly patients (older than 65 years) with Diffuse Large B-Cell Lymphoma (B-DLCL) comparing 6 courses of Mini-CEOP vs 8 weeks of P-VEBEC chemotherapy. Study objectives were survival, response and Quality of Life (QoL). Two hundred and thirty-two patients were evaluable for final analysis. Complete Response (CR) and Overall Response Rates (ORR) were 54% vs 66% (p = 0.107) and 90% vs 78% (p = 0.021) for P-VEBEC and Mini-CEOP, respectively. With a median follow-up of 72 months, the 5-year Overall Survival (OS), Relapse Free Survival (RFS), and Failure Free Survival (FFS) were 32%, 52%, and 21%, respectively. Subjects achieving a CR showed improvement of QoL regardless of treatment arm. Both Mini-CEOP and P-VEBEC determined a similar outcome for elderly patients with B-DLCL, with a third of patients alive after more than 6 years of follow-up. Both regimens can be considered equally for combination treatment with anti-CD20 monoclonal antibody.
Merli
F
F
Unità Operativa di Ematologia, A.O. S. Maria Nuova, Reggio Emilia, Italy. merli.francesco@asmn.re.it
Bertini
M
M
Luminari
S
S
Mozzana
R
R
Botto
B
B
Liberati
A M
AM
Baldini
L
L
Cabras
G
G
Di Vito
F
F
Orsucci
L
L
Naglieri
E
E
Polimeno
G
G
Marcheselli
L
L
Pennese
E
E
Vitolo
U
U
Federico
M
M
Gallo
E
E
D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001761:Bleomycin / Q000627:therapeutic use; D003520:Cyclophosphamide / Q000627:therapeutic use; D018572:Disease-Free Survival; D015251:Epirubicin / Q000627:therapeutic use; D005047:Etoposide / Q000627:therapeutic use; D005260:Female; D006801:Humans; D016393:Lymphoma, B-Cell / Q000188:drug therapy*; D016403:Lymphoma, Large B-Cell, Diffuse / Q000188:drug therapy*; D008297:Male; D011241:Prednisone / Q000627:therapeutic use; D011788:Quality of Life; D015996:Survival Rate; D013997:Time Factors; D016896:Treatment Outcome; D014747:Vinblastine / Q000627:therapeutic use; D014750:Vincristine / Q000627:therapeutic use
D001761:Bleomycin; D015251:Epirubicin; D014750:Vincristine; D014747:Vinblastine; D005047:Etoposide; D003520:Cyclophosphamide; D011241:Prednisone