A multi-center, open label trial to evaluate the efficacy and tolerability of aprepitant (A) and palonosetron (P) for the prevention of chemotherapy-induced nausea and vomiting in colorectal cancer (CRC) patients receiving FOLFOX chemotherapy

Abstract

20684 Background: Colorectal cancer patients have seen significant recent advances in care with newly developed chemotherapeutic regimens. The risk of significant nausea/vomiting (N/V) with modern combination chemotherapy for CRC has not been well characterized, especially when evaluating newer classes of antiemetics have been used. The primary aim of this study is to test the ability of modern combination antiemetic therapy to control N/V and otherwise affect quality of life (QOL) both during and after FOLFOX. Methods: A, a neurokinin-1 antagonist, dexamethasone (D), and P were given prior to FOLFOX as follows: Patients received P 0.25 mg IV, D 12 mg PO and A 125 mg PO 1 hour prior to FOLFOX on Day 1 followed by A 80 mg daily days 2 and 3, and D 8 mg daily days 2–4. The primary aim of this study was to minimize N/V both during and after FOLFOX. Nausea, vomiting, rescue medication, and nutritional intake were evaluated Days 1–5. Responses were defined as complete (CR) = no emesis and no rescue medications, major (MR) = no emesis with nausea and/or rescue medication use, and Failure (F) = any emesis, all for the complete 5 day observation period. Results: First cycle responses for 32 patients are presented. Patient characteristics: Stage III/IV (28) vs. I/II (4), male/female 18/14, median 58 y/o (range 27–80). Clinically meaningful responses were seen in 29/32 (91%) of patients (CR 14/32 = 44% + MR 15/32 = 47%). Of the MR patients, 9/15 took rescue medication for their nausea. Three patients (9%) had an emetic event within 5 days of starting cycle 1 and were antiemetic failures. Adverse effects were mild with no grade 3 or 4 events in the first cycle. QOL endpoints evaluated showed improvements in patient appetite, nutritional intake, and decreased or stable nausea from baseline in the majority of patients. Conclusions: In this interim analysis, the ADP combination provided an emesis free chemotherapy experience in 91% of patients without undue toxicity, showing improvement over the 30–70% emesis rates seen historically with FOLFOX and standard antiemetic agents. Data on multiple cycles at the target accrual, plus additional QOL data will be available in June. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Merck Merck