Combination chemotherapy for advanced diffuse large cell lymphoma. The adverse effects of bone marrow invasion,...

Thirty-nine adults with clinical stage III or IV diffuse large cell lymphoma were prospectively randomised to receive etoposide with doxorubicin (Group 1: n = 17), the same schedule of etoposide with carminomycin (Group 2: n = 8), or BACOP (Group 3: n = 14). The complete remission rates were respectively 24%, 25% and 28%, and further good partial remissions were 41%, 25% and 14%. The incidence of adverse prognostic factors was examined with the first two groups combined for comparison to patients receiving BACOP. The low complete remission rates were attributable to bone marrow invasion in 64% (16/25) of patients in groups 1 and 2, and 64% (9/14) in group 3; to extensive gastrointestinal tract involvement in 24% (6/25) of patients in groups 1 and 2, and 36% (5/14) in group 3; and to high bulk disease in 24% (6/25) of patients in groups 1 and 2, and 36% (5/14) in group 3. Actuarially predicted survival has not been reached for group 1, is 12 months for group 2, and 8 months for group 3; these different trends are not statistically significant. The trial was discontinued when it became clear that there was no difference between the two- and five-drug treatment regimens and that unacceptably low remission rates were obtained in patients having a high incidence of these poor prognostic factors, particularly when compared with results being reported in regimens that contain high or intermediate doses of methotrexate.