A phase II open-label study of aprepitant as anti-emetic prophylaxis in patients with acute myeloid leukemia (AML) undergoing induction chemotherapy

Despite the widespread use of 5-HT 3 antagonists as anti-emetic prophylaxis in patients with acute myeloid leukemia (AML) receiving induction chemotherapy, nausea and vomiting persist in many cases. We performed a Phase II single-arm study evaluating the use of aprepitant on days 1–5, in combination...

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Bibliographic Details
Published in:Supportive care in cancer 2019-06, Vol.27 (6), p.2295-2300
Main Authors: Brandwein, Joseph M., Seki, Jack T., Atenafu, Eshetu G., Rostom, Amr, Lutynski, Andrzej, Rydlewski, Anna, Schimmer, Aaron D., Schuh, Andre C., Gupta, Vikas, Yee, Karen W. L.
Format: Article
Language:English
Subjects:
Antiemetics
Cancer
Chemotherapy
Drug therapy
Gastrointestinal agents
Leukemia
Medicine
Medicine & Public Health
Nausea
Nursing
Nursing Research
Oncology
Oncology, Experimental
Original Article
Pain Medicine
Rehabilitation Medicine
Vomiting
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Summary:Despite the widespread use of 5-HT 3 antagonists as anti-emetic prophylaxis in patients with acute myeloid leukemia (AML) receiving induction chemotherapy, nausea and vomiting persist in many cases. We performed a Phase II single-arm study evaluating the use of aprepitant on days 1–5, in combination with a 5-HT antagonist on days 1–3, in AML patients undergoing induction chemotherapy with daunorubicin on days 1–3 plus cytarabine, given as a continuous infusion, on days 1–7. This was compared to a retrospective cohort of AML patients that received the same chemotherapy regimen with a 5-HT antagonist but without aprepitant. The cumulative incidence of vomiting/retching by the end of day 5 was significantly lower in the aprepitant vs. the control group (26.3 vs. 52.8%, p  = 0.013). The cumulative incidence of nausea by the end of day 5 was 61% in the aprepitant group vs. 75% in the control group. The total use of supplemental anti-emetics on days 2–5 was also significantly lower in the aprepitant group ( p  = 0.01). In contrast, the cumulative incidence of vomiting/retching by the end of day 8, the incidence of vomiting/retching on days 6–8, and the use of anti-emetics on days 6–8, were not significantly different between the two groups. The results suggest that the use of aprepitant may be associated with a lower rate of emesis during aprepitant dosing days, but not afterward. However, this requires confirmation in a randomized trial.
ISSN:0941-4355
1433-7339
DOI:10.1007/s00520-018-4515-4