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A randomized comparison of methotrexate dose and the addition of bleomycin to chop therapy for diffuse large cell lymphoma and other non‐Hodgkin's lymphomas cancer and leukemia group B study 7851
Author(s) -
Gottlieb Arlan J.,
Anderson James R.,
Ginsberg Sandra J.,
Bloomfield Clara D.,
Norton Larry,
Barcos Maurice,
Peterson Bruce A.,
Nissen Nis,
Henderson Edward S.,
Holland James F.
Publication year - 1990
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/1097-0142(19901101)66:9<1888::aid-cncr2820660906>3.0.co;2-k
Subject(s) - medicine , vincristine , bleomycin , chop , prednisone , methotrexate , lymphoma , gastroenterology , cyclophosphamide , surgery , chemotherapy , oncology
In 1978, Cancer and Leukemia Group B initiated a randomized study to determine the usefulness of the addition of bleomycin and/or high‐dose methotrexate to standard therapy for the treatment of certain adult non‐Hodgkin's lymphomas. Between 1978 and 1985, 177 patients with diffuse large cell lymphoma (DLCL) and 97 patients with other intermediate‐grade non‐Hodgkin's lymphoma were randomized to receive therapy with three courses of cyclophosphamide, adriamycin, vincristine, and prednisone (CHOP) every 3 weeks with or without low‐dose bleomycin by continuous IV infusion. Responders after three courses were further randomized to 3 weeks of therapy with either high‐dose methotrexate (3 gm/m 2 /week intravenously with leucovorin rescue) or standard‐dose methotrexate (30 mg/m 2 /week orally without rescue). Therapy was concluded with three additional courses of CHOP. Neither the addition of low‐dose infusion bleomycin nor the use of high‐dose rather than low‐dose methotrexate had significant effects on response for patients with DLCL; complete response rates for the four treatment programs ranged from 47% to 51%. Median failure‐free survival (FFS) for the entire group of DLCL patients was 12 months; 5‐year FFS was 27%. There was no significant effect on FFS from the addition of either low‐dose bleomycin to CHOP (5‐year FFS: CHOP, 28%; CHOP‐B, 26%, P = 0.81), or from the use of different doses of methotrexate (5‐year FFS: high‐dose, 34%; standard‐dose, 33%, P = 0.51). Patients with follicular large cell lymphoma, with or without diffuse areas, had a better FFS (5‐year FFS, 47%) than patients with DLCL (5‐year FFS, 27%), while the patients with the other histopathologic subtypes of diffuse lymphomas had the poorest FFS (5‐year FFS, 16%).