Production time assessment of a VYXEOS® cycle versus “3+7” regimen in the induction treatment for acute myeloid leukemia

Introduction
The standard of care in acute myeloid leukemia is composed of 3 days of daunorubicin and 7 days of cytarabine by syringe pump (“3+7” regimen). Their stabilities allow a two-step production of the 10 preparations: at D1 (D1 to D3) and at D4 (D4 to D7). VYXEOS^® (V) is an innovative pharmaceutical form of liposomes of daunorubicin 44mg and cytarabine 100mg administered at D1-D3-D5. The aim of the study is to compare the production time of both regimens.

Materials and methods
Prospective observational monocentric study – performed by a pharmacist, timed in minutes (mn) – of the production stages of each preparation: pharmaceutical validation, manufacturing sheets printing, component picking, waiting for an airlock release, decontamination, handling, waiting for preparation release, pharmaceutical release.
“3+7” regimen: production of 6 preparations at D1 and 4 at D4.
V regimen: production of one bag a day at D1, D3 and D5.
Global production time assessment by cycle: all steps accumulated, including decontamination and waiting times.
Effective working time assessment by cycle, excluding steps without human intervention.
Comparison of averages for global production time and effective working time between both regimen and for each stage, using a two-tailed Student’s t-test.

Results
Discussion/Conclusion
This study shows a significant difference on global production time with of shorter duration for “3+7” regimen. Production time for V is longer due to handling obligations: 30 mn rest at room temperature before handling and 15 mn rest after reconstitution. Those waiting times are minimum times and are not offset by shorter steps in the V production. However, as human intervention is not required during waiting times, others activities can be performed. Moreover, the 5h30mn stability of V is an organisational obstacle. On the other hand, “3+7” regimen production is already optimized with only two days of production in our unit.
Our study does not show any significant difference between the regimens in terms of effective working time.
Pharmaceutical time of the “3+7” regimen is more advantageous in our optimised production unit but to assess the whole circuit, delivery time and administration time by nurses (probably in favour of V) still have to be evaluated.

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