62 P - CIP regimen as consolidation therapy after P-VABEC in aggressive NHL of the elderly

Previous studies ( Martelli et al. J. Clin. Oncol. 1993. Caracciolo et al. Leukemia & Lymphoma 1993, Hematol. Oncol. 1994 ) have shown the efficacy and tolerability of a weekly multidrug protocol (P-VABEC) in elderly patients with NHL. This study preliminarly evaluates the results of a consolidation therapy with Cisplatin, Idarubicin and Prednisolone in unselected patients. Patients at the time of this analysis (December 1995) we have enrolled in this study 62 consecutive patients affected by aggressive NHL (D, E, F, G, H of WF). The first 46 patients have been treated with P-VABEC only, while the other 16 patients have been treated with P-VABEC/CIP. P-VABEC Etoposide 100 mg/m2, Adriamicyn 30 mg/m 2 , Cyclophosphamide 350 mg/m 2 days 1, 14, 28, 42; Vincristine 1.2 mg/m 2 , Bleomycin 5 mg/m 2 days 7, 21, 35 days 7, 21, 35, 49; Prednisolone 50 mg/die os weeks 1->8. CIP Cisplatin 40 mg on day 1, Idarubicin 15 mg/m 2 on day 8, Prednisolone 50 mg/die os days 1->15 - every 21 days for 3 times. Results Induction therapy with, P-VABEC: 87% of patients achieved complete remission, 13% had a partial response and 6% of patients were non responder. EFS at 36 months was 39% (P-VABEC) and 65% (P-VABEC/CIP), and OS at 43 months was 40% and 75% respectively. The tolerability of the regimen has been good. All patients were treated on an out-patient basis, and in the majority of patients was not observed a significative haematological toxicity. These results, very preliminary, seem to show a therapeutical advantage of the therapy of consolidation with CIP. Particularly the incidence of early relapse seems reduced (P-VABEC; EFS 50% at 16 months; P-VABEC + CIP: median net reached). To confirm the data of this preliminary study is necessary an adequate follow-up period in a randomised study. This work was partially supported by an A.J.R.C. grant .