Journal of Clinical Oncology, Vol 15, 2652-2658, Copyright © 1997 by American Society of Clinical Oncology
Randomized trial of CVPP for three versus six cycles in favorable- prognosis and CVPP versus AOPE plus radiotherapy in intermediate- prognosis untreated Hodgkin's disease
S Pavlovsky, E Schvartzman, F Lastiri, H Magnasco, C Corrado, E Raslawski, ME Cancela, MC Ardaiz, I Cerutti, A Rosso, S Bruno, PN Aranguren, A Salvarezza, H Donato, E Dibar and S Zirone
Fundaleu, Centro de Internacion e Investigacion Clinica Angelica Ocampo, Buenos Aires, Argentina. fundaleu@datamarkets.com.ar
PURPOSE: To evaluate in a randomized trial the impact of three versus six
cycles of cyclophosphamide, vinblastine, procarbazine, and prednisone
(CVPP) chemotherapy in favorable-prognosis and CVPP versus doxorubicin,
vincristine, prednisone, and etoposide (AOPE) plus involved-field
radiotherapy (RT) in intermediate-prognosis previously untreated Hodgkin's
disease. PATIENTS AND METHODS: Of 256 patients evaluated, 80 with a
favorable 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 risk 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 consisted of
intravenous (I.V.) cyclophosphamide and vinblastine on days 1 and 8, and
oral procarbazine and prednisone on days 1 to 14, every 28 days. AOPE
consisted of I.V. doxorubicin and vincristine on day 1, oral prednisone on
days 1 to 5, and I.V. etoposide on days 1 and 3, every 28 days. RESULTS:
Complete remission was obtained in 39 of 41 (95%) patients treated with
three cycles of CVPP and 36 of 39 (92%) treated with 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 complete 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 the 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 rate was 95% versus 87% respectively (P
= .157). CONCLUSION: Three cycles of CVPP without RT are equally effective
as six cycles in the favorable-risk group. However, in the
intermediate-group, CVPP plus RT is superior to AOPE plus RT, with
significantly fewer events before and after induction (P = .009), without a
difference in overall survival.
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