Steroid-free regimen with aprepitant in preventing chemotherapy-induced nausea and vomiting in patients with colorectal cancer receiving FOLFOX chemotherapy: A randomized phase III trial.

Abstract

TPS820 Background: Addition of aprepitant, an NK1 receptor antagonist to a 5-HT3 receptor antagonist and dexamethasone regimen was shown to be effective for prevention of chemotherapy-induced nausea and vomiting (CINV) with moderately emetogenic chemotherapy (MEC). Little is known about the efficacy of aprepitant when used without dexamethasone. Dexamethasone is widely used to prevent both acute and delayed nausea and vomiting induced by chemotherapy. However, multi-period use of dexamethasone could be associated with side effect, such as hyperglycemia, dyspepsia and insomnia. This randomized phase III trial studies antiemetic therapy with aprepitant and tropisetron to see how well they work compared to dexamethasone plus tropisetron in preventing chemotherapy-induced nausea and vomiting in patients with colorectal cancer receiving FOLFOX (oxaliplatin, leucovorin and 5-fluorouracil) chemotherapy. Methods: This trial is an open-label, single-center, randomized phase 2 study. Eligibility criteria include histologically confirmed colorectal cancer, no prior chemotherapy and scheduled to receive FOLFOX, Age ≥ 18 years, ECOG Performance Status 0, 1 or 2. Up to 298 patient will be enrolled and randomized 1:1 to receive aprepitant (125 mg orally on day 1 and 80 mg orally on days 2 and 3) plus tropisetron (5mg IV of day1) or dexamethasone (10 mg IV on day 1 and 5 mg IV on days 2, 3) plus Tropisetron (5mg IV of day1). The primary objective of this study is complete response defined as no emetic episodes and no use of rescue medication. The second objectives include nausea score, time to first vomiting episode or use of rescue medication, frequency of rescue medication and functional Living Index -Emesis (FLIE). Clinical trial information: NCT02909478.