Ibritumomab consolidation after 3 cycles of CHOP plus radiotherapy in high-risk limited-stage aggressive B-cell lymphoma: SWOG S0313.
In the S0313 trial, we evaluated the impact of adding ibritumomab tiuxetan consolidation to 3 cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy plus involved field radiotherapy (IFRT) in patients with limited-stage aggressive B-cell non-Hodgkin lymphoma (LD-NHL). Patients with at least 1 stage-modified adverse risk factor (nonbulky stage II, age >60 years, elevated lactate dehydrogenase, or World Health Organization performance status of 2) were treated with CHOP on days 1, 22, and 43, followed 3 weeks later by 40 to 50 Gy of IFRT. An ibritumomab tiuxetan regimen was initiated 3 to 6 weeks following IFRT. Forty-six patients were registered and eligible, with median follow-up of 7.3 years. The progression-free survival estimate is 89% at 2 years, 82% at 5 years, and 75% at 7 years. The overall survival estimate is 91% at 2 years, 87% at 5 years, and 82% at 7 years. Grade 4 adverse events occurring more than once included neutropenia (8), leukopenia (5), and lymphopenia (2). Febrile neutropenia was observed in 4 patients. No cases of treatment-related myeloid neoplasms were noted. In conclusion, patients with high-risk LD-NHL treated with 3 cycles of CHOP plus IFRT followed by ibritumomab tiuxetan consolidation had outcomes that compare favorably to our historical experience. The clinical trial was registered at www.clinicaltrials.gov as #NCT00070018.
University of Arizona Cancer Center, University of Arizona, Tucson, AZ;
Daniel O
DO
Persky
University of Arizona Cancer Center, University of Arizona, Tucson, AZ;
Thomas P
TP
Miller
SWOG Statistical Center, Fred Hutchinson Cancer Research Center, Seattle, WA;
Joseph M
JM
Unger
Department of Pathology, University of Arizona, Tucson, AZ;
Catherine M
CM
Spier
University of Arizona Cancer Center, University of Arizona, Tucson, AZ;
Soham
S
Puvvada
University of Arizona Cancer Center, University of Arizona, Tucson, AZ;
B Dino
BD
Stea
Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA;
Oliver W
OW
Press
James P. Wilmot Cancer Center, University of Rochester, Rochester, NY;
Louis S
LS
Constine
Loyola University Medical Center, Maywood IL; and.
Kevin P
KP
Barton
James P. Wilmot Cancer Center, University of Rochester, Rochester, NY;
Jonathan W
JW
Friedberg
SWOG Statistical Center, Fred Hutchinson Cancer Research Center, Seattle, WA;
Michael
M
LeBlanc
Fox Chase Cancer Center-Temple Health, Philadelphia, PA.
Richard I
RI
Fisher
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use; D059248:Chemoradiotherapy / Q000379:methods; D060830:Consolidation Chemotherapy / Q000379:methods*; D003520:Cyclophosphamide / Q000008:administration & dosage; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D016393:Lymphoma, B-Cell / Q000188:drug therapy* / Q000401:mortality / Q000532:radiotherapy; D008297:Male; D008875:Middle Aged; D011241:Prednisone / Q000008:administration & dosage; D014750:Vincristine / Q000008:administration & dosage; D055815:Young Adult
D000911:Antibodies, Monoclonal; C422802:ibritumomab tiuxetan; D014750:Vincristine; D004317:Doxorubicin; D003520:Cyclophosphamide; D011241:Prednisone