At 3 months post-study enrollment, 11 patients in the supportive care group who showed no improvement became eligible and were crossed over to receive Atgam therapy. Efficacy was evaluated as sustained improvement in peripheral blood counts within 3 months of entry into the study. A statistically significant (p<) difference was observed between the two treatment groups in hematological improvement based on the investigator's evaluation; 11 of 21 (52%) patients in the Atgam group responded, compared with no patients (0 of 20) in the control group. Six of the 11 crossover patients from the control group showed improvement after 3 months of therapy. Overall, of 32 patients in both the Atgam group and the control group who crossed over to receive Atgam, 17 patients (53%) had a hematological improvement. Estimated 1-year survival rate was 62% for all 32 patients treated with Atgam. The 2-year survival rate was 100% among the Atgam responders [17 of the 32 patients (53%) compared to 14% for the nonresponders].
Oxymetholone (also known as anapolon or anadrol) is a very drastic synthetic steroid, 17-alpha-alkylated modification of dihydrotestosterone. It was developed for the treatment of osteoporosis and anaemia, as well as to stimulate muscle gain in malnourished and debilitated patients. Oxymetholone has been approved by the American Food and Drug Administration (FDA) for use in humans. Later there where created non-steroidal drugs that effectively could treat anaemia and osteoporosis; because of this anapolon lost his popularity and by 1993 Syntex decided to cease the production of the drug, as well as other manufacturers did.