Arsenic trioxide [ARS1]

Arsenic trioxide for treating newly diagnosed low to intermediate risk acute promyelocytic leukaemia in ADULTS where all the following criteria are met:

  1. An application is made by and the start of systemic anti-cancer therapy with arsenic trioxide will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy
  2. The patient is an ADULT and has a confirmed diagnosis of acute promyelocytic leukaemia characterised by the presence of the t(15;17) translocation and/or the presence of the Pro-Myelocytic Leukaemia/Retinoic-Acid-Receptor- alpha (PML/RAR-alpha) gene
  3. The patient is newly diagnosed with acute promyelocytic leukaemia
  4. The patient has low to intermediate risk acute promyelocytic leukaemia (white cell count ≤10 x 10⁹/L) and has not received any chemotherapy for this. Patients with high risk acute promyelocytic leukaemia are not funded for treatment with arsenic trioxide
  5. The patient will be treated with induction treatment of arsenic trioxide in combination with all-trans-retinoic acid (ATRA)
  6. Induction treatment with arsenic trioxide will be continued until complete remission is achieved but if complete remission is not achieved by day 60, arsenic trioxide will be discontinued
  7. As consolidation therapy, a maximum of 4 cycles of arsenic trioxide will be prescribed, each cycle being 4 weeks on treatment followed by 4 weeks off therapy
  8. The dosing and schedule of administration of arsenic trioxide will be either in accordance with that described in the Summary of Product Characteristics (SPC) or that used in the UK NCRI AML17 trial as reported in Lancet Oncology 2015; 16:1295-1305. If the AML17 dosing and schedule is used, hospital Trust policy regarding unlicensed treatments should be followed
  9. The treating team is aware of the risk of and the treatment for * APL differentiation syndrome * QT interval prolongation and the need for monitoring of electrolytes * Liver toxicity The use of arsenic trioxide is excluded from the NHS England Treatment Break Policy
  10. Arsenic trioxide is to be otherwise used as set out in its SPC

[NHS funded]{.badge .rounded-pill .bg-success} From: 11 September 2018

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NICE Technology Appraisal: TA526 (13 June 2018)

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