The aim of this pilot study is to determine if addition of Aprepitant to Ondansetrone and dexamethasone can prevent acute and delayed CINV of highly emetogenic regimen given over 4 days.
This is a prospective cross over pilot study designed to assess the benefit and toxicity of addition of Aprepitant to standard antiemetic prophylaxis regimen used in patients with relapsed/refractory Non-Hodgkin lymohoma planned to receive ESHAP regimen.ESHAP is administered as follows: Etoposide 40 mg/m2/day as a 1 h intravenous infusion from day 1 to 4; Cisplatin 25 mg/m2/day as a continuous infusion from day 1 to 4; Solumedrol 500 mg/day as a 15 min intravenous infusion from day 1 to day 5, Cytarabine 2 g/m2 given as a 2 h intravenous infusion on day 5.Group A patients were given triple combinations of antiemetic therapy consisting of Aprepitant, Ondansetrone and dexamethasone for the first 2 cycles then without Aprepitant in the 3rd and 4th cycle. While Group B was given the first 2 cycles without Aprepitant then Aprepitant was added in Cycle 3 &4.Each patient was asked to fill questionnaire assessing occurrence of nausea or vomiting as well as its degree and duration.
During the period from January to June 2015, 13 patients with refractory/relapsed NHL receive ESHAP were enrolled in pilot study. All had good performance status, 7 males and 6 females with median age 45 years (38–56). Each patient received 4 cycles with a total of 48 cycles given During the 24 cycles received with Aprepitant, nausea was recorded in 3 cycles (12.5%) compared to 14 times in the cycles without (58.3%) (p < 0.05). The median duration was same between the 2 groups (2days, range 1-4). Patients receiving Aprepitant in the first 2 cycles (Group A) recorded less nausea in subsequent cycles given without Aprepitant compared to Group B. vomiting, it was recorded once during the cycles with Aprepitant while it was recorded twice (8.3%) compared to 10 times (41.6%) during cycles without Aprepitant (p < 0.05).
Addition of Emend to Ondansetrone significantly decrease CINV in patients receiving multiday highly emetogenic chemotherapy regimen with good control even at day 4. However, a larger study is needed to confirm these observations.
Clinical trial identification
All authors have declared no conflicts of interest.