LONG-TERM RESULTS OF THE EORTC RANDOMIZED STUDY OF IRRADIATION AND VINBLASTINE IN CLINICAL STAGES-I AND STAGES-II OF HODGKINS-DISEASE

Two hundred and ninety five patients with clinical stages I and II of Hodgkin's disease were randomized between 1964 and 1970 for a controlled clinical trial. The patients were staged after clinical and radiological examination. No laparotomy was performed. Radiotherapy was carried out using the mantle field or inverted Y technique. The patients were assigned at random to two groups: (a) no further treatment, and (b) a weekly injection of vinblastine for 2 yr. Fourteen hospital centers participated: 6 in France, 5 in Holland and 3 in Belgium. The proportion of relapse-free patients is significantly higher amongst those who received long-term adjuvant chemotherapy. The incidence of relapses in liver, spleen, lung and irradiated areas does not differ between the two groups, but the incidence of relapse in non-irradiated lymph node areas is significantly higher in the group of patients who did not receive chemotherapy. This suggests that only small aggregates of neoplastic cells, which were not visible at pretreatment lymphangiogram, were sterilised by the chemotherapy. No significant difference in survival between the two groups was observed. A few prognostic factors significantly influence the rates of relapse and survival. For patients with good prognostic indicators, the incidence of relapses was low and not reduced significantly by adjuvant chemotherapy. © 1979.