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.

Abstract

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/m2/week intravenously with leucovorin rescue) or standard-dose methotrexate (30 mg/m2/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%).

• Authors: A J Gottlieb, J R Anderson, S J Ginsberg, C D Bloomfield, L Norton, M Barcos, B A Peterson, N Nissen, E S Henderson, J F Holland
• Journal: Cancer (Cancer) Vol. 66 Issue 9 Pg. 1888-96 (Nov 01 1990) ISSN: 0008-543X [Print] United States
• PMID: 1699653 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S.)

Chemical References

• Bleomycin
• Vincristine
• Doxorubicin
• Cyclophosphamide
• Prednisone
• Methotrexate

Topics

• Aged
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use, toxicity)
• Bleomycin (administration & dosage, toxicity)
• Cyclophosphamide (administration & dosage, toxicity)
• Dose-Response Relationship, Drug
• Doxorubicin (administration & dosage, toxicity)
• Female
• Humans
• Infusions, Intravenous
• Lymphoma, Large B-Cell, Diffuse (drug therapy, mortality)
• Lymphoma, Non-Hodgkin (drug therapy, mortality)
• Male
• Methotrexate (administration & dosage, toxicity)
• Middle Aged
• Prednisone (administration & dosage, toxicity)
• Vincristine (administration & dosage, toxicity)