Five-year results of the E.O.R.T.C. randomized study of splenectomy and spleen irradiation in clinical stages I and II of Hodgkin's disease

A controlled clinical trial was carried out on patients with clinical stages I and II of Hodgkin's disease by the E.O.R.T.C. from 1972 to 1976. Three hundred patients with supradiaphragmatic presentation were assigned at random into two groups, one treated by spleen irradiation, the other by splenectomy. All patients received a mantle field irradiation as well as a para-aortic lymph node irradiation. The actuarial survival rates and relapse-free survival rates at five years were, respectively, 90 and 62% in the group treated by spleen irradiation and 90 and 67% in the group splenectomized. The efficiency of the two treatments is therefore identical. In the group submitted to staging laparotomy, all patients received the same treatment without taking into account the results of the splenectomy and of the lymph node biopsy. Of 107 patients without spleen or lymph node involvement 18 relapsed (17%); of 33 patients with spleen involvement 14 relapsed (42%). Relapse in non-irradiated lymph node territories (iliac and inguinal areas) were fifteen-fold more frequent in patients with spleen involvement, whereas extra nodal relapses were about twice as frequent in patients with spleen involvement than in patients without spleen involvement. Patients with mixed cellularity or lymphoid depletion histological types received long term adjuvant chemotherapy either by Vinblastine + Procarbazine or by Vinblastine alone. The 5-year relapse rate was 12% with both chemotherapeutic regimens.