A multicenter, single-arm evaluation of palonosetron for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients who have experienced CINV during the previous cycle of low emetogenic chemotherapy (LEC).

Abstract

e19587 Background: Patients receiving LEC agents have a 10-30% probability of developing CINV without prophylaxis. Current guidelines recommend one antiemetic agent (generally dexamethasone) for patients (pts) receiving LEC, with a lack of scientific evidence supporting antiemetic use in this population. PALO is a safe and effective antiemetic for pts receiving MEC or HEC, but has not been evaluated in pts receiving LEC. Methods: We conducted a multi-center, single-arm study to evaluate the efficacy of PALO 0.25mg in preventing CINV in pts with confirmed malignant disease who previously experienced either vomiting and/or at least moderate nausea during their last cycle of LEC. PALO was administered prior to the initiation of chemotherapy. Efficacy and safety–including episodes of nausea, retching, and/or vomiting, and use of rescue medication–was assessed from Days 1-6 in patient diaries. The primary outcome was complete response (CR), defined as no emetic episode and no rescue medication for 0-24hrs (acute), >24-120hrs (delayed), and 0-120hrs (overall). Results: A total of 36 pts were enrolled, with 35 pts completing the 5-day study. Patients were mostly female (25, 69.4%), Caucasian (30, 83.3%), with a mean age of 65.0±13.27yrs, and a Karnofsky Performance Status of 82.8±13.86. One patient did not complete verifiable efficacy assessments, with efficacy analysis based on 34 pts. A CR in the acute period (0-24hrs) was noted in 30 pts (88.2%) with no emetic episodes in 31 pts (91.2%). For CINV during the delayed (>24-120hrs) and overall (>0-120hrs) period, 23 pts (67.6%) demonstrated a CR, with no emetic episodes in 27 pts (79.4%). Adverse events (AEs) were seen in 13 pts (36.1%); TEAEs in 12 pts (33.3%)-including decreased appetite, fatigue, headache, and pyrexia (each 2 pts, 5.6%). Conclusions: In patients who experienced CINV on their prior cycle of LEC, palonosetron provided improved CINV prophylaxis in the acute (88% CR) and overall (68% CR) periods, with a safety profile similar to previous trials. Larger studies are warranted to confirm these findings.