A COOPERATIVE STUDY OF EPIRUBICIN WITH CYCLOPHOSPHAMIDE, VINCRISTINE AND PREDNISONE (CEOP) IN NON-HODGKINS-LYMPHOMA

Background. The purpose of our cooperative trial was to investigate wh ether epirubicin (EPI) at 90 mg/m(2) in a CHOP-like combination (calle d CEOP) could increase complete response (CR) and survival rates in no n-Hodgkin lymphoma (NHL) patients while maintaining a tolerable degree of toxicity. Methods. Between September 1986 and July 1992, 218 patie nts from 12 Centers in Lombardy entered the study. The inclusion crite ria were: a histological diagnosis of intermediate or diffuse large ce ll (DLC) NHL and no previous radio-chemotherapy, The patients in stage s IA and IIA (both intermediate and DLC) received four CEOP courses fo llowed by local/regional radiotherapy; those with intermediate NHL in stages IB, IIB, III A and B and IV A and B received six CEOP courses a nd, if they achieved CR, three further courses as consolidation. Resul ts. Among the 160 evaluable patients, CR was observed in 90% of the su bjects with DLC-NHL (stages IA and IIA) and in 59% of those with inter mediate-grade NHL (ah clinical stages). If the clinical stages are con sidered separately, the CR rates were 92% for stages IA, IIA and 53% f or stages IB, IIB, III A and B, IV A and B. Relapses occurred in 20% o f the patients treated with four CEOP courses plus radiotherapy and in 31% of those who received nine CEOP courses because of the advanced s tage of their disease. As of May 1994, the median follow-up was 42 mon ths. If all of the patients are considered together, the 7-year overal l survival (OS) probability was 64% and the 7-year disease-free surviv al (DFS) probability 67%. In comparison with stages III/IV, the patien ts in stages I-II had better DFS (l-year chance 77% vs 56%, p<0.03). H ematological toxicity was acceptable,and a delay in the administration of CEOP chemotherapy was required in only three patients. No life-thr eatening infections were recorded. Conclusions. Our cooperative study of the use of the CEOP combination in NHL patients shows that response rates and the length of DFS are equal to the best results obtained wi th CHOP and more intensive programs, although further confirmation mus t be provided by means of a longer follow-up and a more careful analys is of prognostic factors according to the recently proposed internatio nal index In our experience, an EPI dose of 90 mg/m(2) has negligible toxicity (particularly on bone marrow), even in elderly patients. Thes e findings are interesting since it is well known that myelotoxicity i s the principal Limiting factor for the majority of anthracycline-cont aining regimens used in the treatment of potentially curable NHL.