Efficacy and safety of Single-agent Arsenic trioxide (ATO) as an Induction regimen in the treatment of newly diagnosed Acute promyelocytic leukemia...

Date 24 November 2018
Event ESMO Asia 2018 Congress
Session Poster display - Cocktail
Topics Leukaemia
Presenter putluru simha
Citation Annals of Oncology (2018) 29 (suppl_9): ix87-ix93. 10.1093/annonc/mdy437
Authors P.V. simha, D. Lokanatha, K. Govind Babu, L.A. Jacob, M.C. Suresh Babu, K..N. Lokesh, A.H. Rudresha, L.K. Rajeev, S.C. Smitha, G.V. Giri
  • Medical Oncology, Kidwai Cancer Institute., 560029 - Bengaluru/IN



Arsenic trioxide (ATO), as a single agent, has proven efficacy in inducing molecular remission in patients with relapsed acute promyelocytic leukemia (APL) but paucity of data as an induction regimen in the management of newly diagnosed cases of APL. In the present study, we focus on the use of single agent ATO for the induction of remission in APL.


24 newly diagnosed cases of APL were treated with single-agent ATO from May 2017 to May 2018 at Kidwai Cancer Institute, Bengaluru, India. The primary endpoint was Complete Response (CR) at the end of induction whereas toxicity profile was secondary endpoint.


We enrolled 24 patients, CR was achieved in 18 (75%) patients. Median time to achieve complete remission was 37.5 days (30-45 days). Mortality was seen in 6 (25%) patients, in 2 (8.3%) patients it was due to intracranial hemorrhage and in 4 (16.7%) patients it was due to differentiation syndrome. Median time of death following initiation of treatment with ATO was 12.5 days (4-21days). Both All-transretinoic acid (ATRA) & ATO were used in consolidation phase. Till June 2018, 10 (41.7%) patients were in consolidation & 8 (33.3%) patients were in maintenance phase. No patient relapsed so far. Toxicity profile in terms of electrolyte disturbances were observed in 18 (75%) patients & QTc prolongation in 12 (50%) patients. Differentiation syndrome was seen in 12 (50%) patients. The mean time to onset of differentiation syndrome following initiation of induction was 12.5 days (4-21 days). The mean leukocyte count at onset of differentiation syndrome was 20 × 109/L (4-36× 109/L).


Single agent ATO, as an induction regimen in newly diagnosed cases of Acute promyelocytic leukemia, is efficacious and well tolerated.

Editorial acknowledgement

Clinical trial identification

Legal entity responsible for the study

Kidwai Cancer Institute, Bengaluru, India; Kidwai Memorial Institute of Oncology, Banglore, India.


Has not received any funding.


All authors have declared no conflicts of interest.