Περίληψη:
Introduction: During the last few years epirubicin (E) and mitoxantrone
(M) (Novantrone) have been used in the treatment of non-Hodgkin’s
lymphoma (NHL), because of their favorable principal profile. In
particular, M has less severe non-hematological toxicity. Patients and
methods: A randomized multicenter phase III study was conducted in order
to compare the efficacy and toxicity of CEOP (arm A) consisted of
cyclophosphamide 1000 mg m(-2), vincristine 2 mg, E 70 mg m(-2) on day 1
and prednisone 60 mg on days 1-7. The CNOP regimen (arm B) General
Hospital, Athens, Greece was identical to CEOP except for replacement of
E by M at a dose of 12 Mg m(-2). Randomization was stratified according
to stages I-IV. From September 1993 to March 1999, 249 patients
registered for the trial. Patient characteristics were equally
distributed in the two arms, except for age and International Prognostic
Index (IPI) groups. Results: There were no significant differences
between the two groups in the rates of complete (CR) and partial
response (PR). The overall response rate was 78% in arm A (57% CR, 2 1
% PR) and 82% in arm B (60% CR, 22% PR). With a median follow-up
time of 47.3 months, the median survival was not reached in arm A, while
it was 39.5 months in arm B (P=0.09). Three-year survival rates were
62.5% for CEOP and 51.5% for CNOP. There was no significant difference
regarding the time to progression between the two groups (29.7 vs. 18.5
months); furthermore the median duration of CRs was 71.6 and 49 months
for CEOP and CNOP, respectively (P = 0.07). The therapeutic efficacies
of both regimens were equivalent among the four IPI groups. More
alopecia was observed in arm A. WHO grade >2 neutropenia was more
frequent in arm B. Supportive treatment with G-CSF was given to 22 and
24 patients respectively. Conclusion: There were no significant
differences in terms of CEOP, CNOP overall response rates, overall
survival and time to progression between CEOP and CNOP in the treatment
of intermediate- and high-grade NHL.Patients with low or low
intermediate IPI risk treated with either Hospital, Athens 106 76,
Greece CEOP or CNOP showed significantly better survival, response rates
and time to progressionthan those with high intermediate or high IPI
risk. Therefore, new improved therapeutic approaches should be developed
for the treatment of high IPI risk patients.
Συγγραφείς:
Economopoulos, T
Dimopoulos, MA
Mellou, S
Pavlidis, N and
Samantas, E
Nicolaides, C
Tsatalas, C
Papadopoulos, A and
Papageorgriou, E
Papasavvas, P
Fountzilas, G
