RANDOMIZED TRIAL OF CVPP FOR 3-CYCLES VERSUS 6-CYCLES IN FAVORABLE-PROGNOSIS AND CVPP VERSUS AOPE PLUS RADIOTHERAPY IN INTERMEDIATE-PROGNOSIS UNTREATED HODGKINS-DISEASE

Purpose: To evaluate in a randomized trial the impact versus six cycle s of cyclophosphamide, vinblastine, procarbazine, and prednisone (CVPP ) chemotherapy in favorable-prognosis and CVPP versus doxorubicin, vin cristine, prednisone, and etoposide (AOPE) plus involved-field radioth erapy (RT) in intermediate-prognosis previously untreated Hodgkin's di sease, Patients and Methods: Of 256 patients evaluated, 80 with a favo rable prognosis according to a prognostic index designed by the Grupo Argentina de Tratamiento de Leucemia Aguda (GATLA) were randomized to three versus six cycles of CVPP without RT and 176 with intermediate r isk to CVPP versus AOPE, both for six cycles with RT between the third and fourth cycles of 30 Gy to the involved areas at diagnosis, CVPP c onsisted of intravenous (IV) cyclophosphamide and vinblastine on days 1 and 8, and oral procarbazine and prednisone on days 1 to 14, every 2 8 days. AOPE consisted of IV doxorubicin and vincristine on day 1, ora l prednisone on days 1 to 5, and IV etoposide on days 1 and 3, every 2 8 days. Results: Complete remission was obtained in 39 of 41 (95%) pat ients treated with three cycles of CVPP and 36 of 39 (92%) treated wit h six cycles in the favorable-risk group (difference not significant [ NS]). In the intermediate-risk group, 89 of 92 (97%) treated with CVPP plus RT versus 75 of 84 (89%) treated with AOPE plus RT achieved a co mplete remission (P=.05). At 60 months, the event-free survival (EFS) and overall survival rates in the favorable-risk group were 80% and 91 % for CVPP x 3 and 84% and 97% for CVPP x 6, respectively (P=NS). In t he intermediate-risk group, 60-month EFS rate for CVPP plus RT was 85% , compared with 66% for AOPE plus RT (P=.009). The overall survival ra te was 95% versus 87% respectively (P=.157). Conclusion: Three cycles of CVPP without RT ore equally effective as six cycles in the favorabl e-risk group. However, in the intermediate-group, CVPP plus RT is supe rior to AOPE plus RT, with significantly fewer events before and after induction (P=.009), without a difference in overall survival. (C) 199 7 by American Society of Clinical Oncology.