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Toward comprehensive management tailored to prognostic factors of patients
with clinical stages I and II in Hodgkin's disease. The EORTC Lymphoma
Group controlled clinical trials: 1964-1987
M Tubiana, M Henry-Amar, P Carde, JM Burgers, M Hayat, E Van der Schueren, EM Noordijk, A Tanguy, JH Meerwaldt and J Thomas
Institut Gustave-Roussy, Villejuif, France.
From 1964 to 1987, the EORTC Lymphoma Group conducted four consecutive
controlled clinical trials on clinical stages I and II Hodgkin's disease in
which 1,579 patients were entered. From the onset the main aim of these
trials was to identify the subsets of patients who could be treated safely
by regional radiotherapy (RT). Therefore, several prognostic indicators
were prospectively registered and progressively used in the trial protocols
for the delineation of the favorable and unfavorable subgroups as soon as
they were recognized of high predictive value. In the H2 trial (1972 to
1976), the histologic subtype was the only variable taken into account for
the therapeutic strategy and the staging laparotomy findings were found to
be of prognostic value only in patients with favorable prognostic
indicators. In the H5 trial (1977 to 1982), patients were subdivided into
two subgroups according to six prognostic indicators. Patients with
favorable features were submitted to a staging laparotomy (lap); lap
negative patients were randomized between mantle field RT and mantle field
plus paraaortic RT. Disease free survival (DFS) and total survival (S) were
similar in the two arms. Among patients with unfavorable features, DFS and
S were significantly higher in the arm treated by combination of
mechlorethamine, vincristine, procarbazine, prednisone (MOPP) chemotherapy
(CT) and RT than in the arm treated by total nodal irradiation.
Nevertheless, in patients below the age of 40, the overall survival rates
were equivalent in the two arms. In the H6 trial, the delineation of the
favorable subgroup was based on (a) absence of systemic symptoms and
elevated ESR, (b) no more than one or two lymph node areas involved. The
aim of the study was to assess the impact on survival of a therapeutic
strategy including staging laparotomy. At a 4-year follow-up, no difference
in survival was evidenced. In patients with unfavorable prognostic
indicators, 3 MOPP- RT-3 MOPP were compared with 3 ABVD-RT-3 ABVD. From H1
to H5 trials, the proportion of patients having received CT during the
course of the disease gradually decreased; the data suggest that a further
reduction in the proportion of patients aggressively treated is
conceptually possible. On the basis of the prognostic factors identified,
one can delineate three subsets of patients and modulate toxic cost of the
initial treatment according to the characteristics of these subsets. In the
most favorable subgroup, RT alone produces high survival and CT is not
justified.(ABSTRACT TRUNCATED AT 400 WORDS)
Volume 73,
Issue 1,
pp. 47-56,
01/01/1989
Copyright © 1989 by The American Society of Hematology
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