PHASE I II STUDY OF CYCLOPHOSPHAMIDE, CARBOPLATIN, AND ETOPOSIDE AND AUTOLOGOUS HEMATOPOIETIC STEM-CELL TRANSPLANTATION WITH POSTTRANSPLANTINTERFERON ALFA-2B FOR PATIENTS WITH LYMPHOMA AND HODGKINS-DISEASE/

Purpose: To evaluate the safety and toxicity of interferon alfa-2b (IF N) following an intensive preparative transplantation regimen in patie nts with relapsed Hodgkin's disease (HD) and non-Hodgkin's lymphoma (N HL). Patients and Methods: Thirty-two patients with NHL or HD underwen t autologous transplantation following cyclophosphamide 7,200 mg/m(2), carboplatin 1,600 mg/m(2), and etoposide 1,600 mg/m(2) (CCV). Fourtee n patients received an escalating dose of IFN. IFN was started at 1 x 10(6) U/m(2) subcutaneously (SC) three times per week with a monthly d ose escalation to a maximum of 3 x 10(6) U/m(2) SC three times per wee k. IFN was continued for a total of 6 months. Results: The preparative regimen was well tolerated. Renal dysfunction was noted more frequent ly in patients with a history of pretransplant cisplatin treatment, an d cardiac dysfunction was responsible for the single transplant-relate d death (3%). IFN wets well tolerated with no serious complications. T ransient neutropenia and thrombocytopenia were noted in several patien ts. The mean maximal-dose IFN achieved was 2 x 10(6) IU/m(2). The medi an duration of treatment with IFN was 5.2 months. The overall probabil ity of survival (OS) and event-free survival (EFS) at 36 months, with a median follow-up duration of 18 months, was 42% OS and 14% EFS in an and 70% OS and 56% EFS in NHL. The EFS at 36 months was 73% for all N HL patients who received IFN and 50% for patients who refused IFN trea tment (P = .12), with OS estimates of 100% in the IFN group and 35% in the untreated group (P = .0002). Conclusion: CCV is a safe, effective conditioning regimen in patients with NHL or an. Posttransplant IFN c an be safely administered at 2.0 x 10(6) U/m(2) three times per week f or 6 months and may have a meaningful antitumor effect.