Fosnetupitant for long-delayed chemotherapy-induced nausea and vomiting in oxaliplatin-based regimens: a prospective observational study (LODEC-N)

PURPOSE: Although previous standard antiemetic trials evaluated chemotherapy-induced nausea and vomiting (CINV) up to 120 h, recent evidence suggests that symptoms can persist well beyond this timeframe. However, the preventive efficacy of a triplet regimen including fosnetupitant (FosNTP) during the long-delayed phase (120-336 h) remains unclear in patients undergoing moderately emetogenic chemotherapy. This study aimed to prospectively evaluate the efficacy of FosNTP in preventing CINV during this extended long-delayed window. METHODS: This single-center, single-arm, prospective observational study recruited patients scheduled to receive oxaliplatin-based chemotherapy. The primary endpoint was the long-delayed (120-336 h) complete control (CC) rate. Key secondary endpoints included the long-delayed complete response (CR) rate and the overall (0-336 h) CC, CR, and total control (TC) rates. Relative risks for emetogenic events were assessed using a logistic regression model. RESULTS: The analysis included 100 patients. Most eligible patients received CapeOX (oxaliplatin + capecitabine) (92.0%). The long-delayed CC rate was 76.3%. The long-delayed CR and TC rates were 84.7% and 75.4%, respectively. Risk factors for CINV in participants who did not achieve CC during the long-delayed phase included age (odds ratio 0.954 [95% confidence interval 0.909-0.998]), female sex (8.808 [2.446-41.992]), and history of motion sickness (5.050 [1.118-27.548]). CONCLUSION: The triplet regimen involving FosNTP showed promising results and potential utility for managing long-delayed CINV in patients receiving oxaliplatin-based chemotherapy. However, given the single-arm study design, further comparative trials are warranted to confirm these findings. Participants with high emetic risk factors-such as younger age, female sex, or a history of motion sickness-continued to experience suboptimal control. TRIAL REGISTRATION NUMBER AND DATE OF REGISTRATION: jRCT1030230130.