Induction, consolidation, and maintenance therapies with arsenic as a single agent for acute promyelocytic leukaemia in a 11-year follow-up.

The aim of this study was to evaluate the effect of arsenic trioxide as a single agent in acute promyelocytic leukaemia cases for induction, consolidation, and maintenance therapy in a long-term, 11-year follow-up. We studied 60 patients with acute promyelocytic leukaemia. Sixty percent of the patients were aged between 12 and 24 years. Arsenic trioxide was infused at a 0.15 mg/kg daily dose until complete remission was achieved. After 2 weeks of rest, arsenic trioxide was infused daily for 28 days as a consolidation therapy. Then, arsenic infusions were given every 3-4 months for 14 days for 2 years, and the patients were followed until relapse or death. The rates of complete remission, disease-free survival, overall survival, and drug toxicity were evaluated. The morphologic complete remission was observed in 55 out of the 60 patients. The most common causes of a remission failure were early mortality because of the APL differentiation syndrome and the lack of response to arsenic treatment. The mean follow-up was 90 months. The primary outcomes for males and females were a mean disease-free survival of 101 and 97 months, respectively, and a mean overall survival of 103 and 101 months, respectively. From the 55 cases with remission, three patients died (late mortality). Of the 60 patients, 85% are still alive. Arsenic trioxide was generally well tolerated. The long-term follow-up of patients with APL, treated with arsenic alone as induction, consolidation, and maintenance therapy, shows high cure rates and excellent outcomes.