Phase-II trial with M-CAVe-CEC as a salvage chemotherapeutic regimen for early relapsed or primary refractory Hodgkin's disease.

A substantial number of patients with Hodgkin's disease (HD) do not respond adequately to standard therapy. Patients who relapse later than 1 year after completion of treatment have a good chance of achieving a second complete remission (CR). The prognosis of patients with primary refractory HD or relapse within 1 year, however, is poor. The long-term results of autologous bone marrow transplantation (ABMT) in these patients have not yet been established. Therefore, we conducted a phase-II study among 15 patients with primary refractory or early relapsed HD, in which they were treated with a two-drug sequential regimen not cross-resistant with MOPP. The patients received two to six courses of methotrexate, cyclophosphamide, adriamycin, vinblastine, CCNU, etoposide, and chlorambucil (M-CAVe-CEC). Seven patients (47%) achieved a CR, including a patient with additional radiotherapy. Actuarial overall survival was 58 and 41%, respectively, and failure-free survival 38% at 2 and 5 years. Gastrointestinal toxicity was acceptable. Dose reductions were necessary in up to 60% of courses given. These preliminary results suggest that the M-CAVe-CEC regimen may be a more effective salvage regimen as compared with other regimens for primary refractory or early relapsed HD. Larger studies, possibly with hematopoietic growth factors, are required to determine its value in comparison to ABMT.