Chemotherapy using cyclophosphamide, doxorubicin, etoposide, cytarabin
e, bleomycin, vincristine, methotrexate with leucovorin, and prednison
e (ProMACE-CytaBOM) for patients with intermediate or high grade non-H
odgkin lymphomas (G, H and K according to the Working Formulation), wa
s tested by the Gruppo Cooperative Lombardo to confirm the activity of
the regimen and to test the feasibility and safety of administering t
hird-generation drug regimen in a cooperative group setting. Among 64
previously untreated patients, aged between 20 and 71 years, 7 had sta
ge IB-IIB, 12 had stage IIIA-B, 45 (67%) had stage IVA-B. There were 4
4 complete remissions (CRs) (69%) and 14 partial remissions (22%); the
difference between patients in stage I-II-III (84% complete remission
s) and those in stage IV (62% complete remissions) was statistically s
ignificant. The median length of follow up was 20 months (range 1-60 m
onths), with 56% of patients alive at 60 months and 53% of CRs patient
s free of disease at 60 months. Patients in stage I-II-III have the be
st survival and disease free survival compared to stage IV, 87% versus
42% and 72% versus 32% respectively (both with high statistical signi
ficance). Grade 3-4 (WHO) haematological toxicity was observed in 39%
of patients, with 3 septic deaths. Two more patients died with chemoth
erapy related toxicity (1 stroke and 1 acute renal insufficiency). Adm
inistration of ProMACE-CytaBOM is a feasible and safe regimen although
it presents moderate toxicity. ProMACE-CytaBOM may represent improved
treatment for aggressive lymphomas, in terms of duration of response
and survival, but a longer follow up is needed.