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

Purpose An exploratory analysis of the phase III CONSOLE study indicated that the triplet antiemetic regimen including fosnetupitant (FosNTP) may be effective across extended overall period (0–168 h) for highly emetogenic chemotherapy-induced nausea and vomiting (CINV); however, its impact during the long-delayed phase (> 168 h) remains unclear. This study aimed to prospectively explore the benefits of FosNTPs in preventing CINV beyond 168 h in patients undergoing oxaliplatin-based chemotherapy. 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 demonstrated sufficient efficacy in preventing CINV in patients receiving oxaliplatin-based chemotherapy, including during the long-delayed phase. However, 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