Do androgens enhance the response to antithymocyte globulin in patients
with aplastic anemia? A prospective randomized trial
RE Champlin, WG Ho, SA Feig, DJ Winston, C Lenarsky and RP Gale
We analyzed the effect of antithymocyte globulin (ATG) with or without
androgens in 121 patients with aplastic anemia. Fifty-three patients with
moderate to severe aplastic anemia were prospectively randomized to receive
ATG with or without oral androgens. Eleven of 26 patients (42%) receiving
ATG plus androgen responded, including three complete and eight partial
responses. Twelve of 27 patients (44%) receiving ATG plus placebo
responded, including five complete and seven partial responses. The
difference in response rates was not significant (P greater than .9).
Survival was also comparable in the two groups; for patients with severe
aplastic anemia, actuarial survival at two years was 55% +/- 24% (95%
confidence interval) in patients receiving ATG plus androgen compared with
50% +/- 24% in the ATG plus placebo group (P = .65). Furthermore, results
in both groups were indistinguishable from those obtained in 68 historical
controls receiving ATG without androgens. These data indicate that
androgens are not required in order to respond to antithymocyte globulin
and the addition of androgens, as used in this trial, did not significantly
improve response rates to ATG treatment.
Volume 66,
Issue 1,
pp. 184-188,
07/01/1985
Copyright © 1985 by The American Society of Hematology
