A Prospective Study of Olanzapine and Aprepitant for CINV in Cisplatin-HAIC for Hepatocellular Carcinoma (PROACT).

BACKGROUND/AIM: This study investigated the efficacy and safety of olanzapine and aprepitant in preventing chemotherapy-induced nausea and vomiting in patients with hepatocellular carcinoma (HCC) undergoing cisplatin-based hepatic arterial infusion chemotherapy (HAIC).

PATIENTS AND

METHODS

This single-center, non-randomized, prospective study included patients with HCC receiving cisplatin-HAIC between December 2020 and February 2023. In the first treatment session, patients without diabetes mellitus received granisetron and olanzapine (GRA+OLA), and those with diabetes received granisetron monotherapy (GRA). The primary endpoint was the complete response (CR, no vomiting or rescue medications) rate in the GRA+OLA group. In the second session, aprepitant was added if complete control (CC, CR plus no severe nausea) was not achieved during the first treatment. Secondary endpoints were rates of CC and total control (TC, CR plus no nausea), changes in liver function, and toxicity in each medication group.

RESULTS

The CR rate in the GRA+OLA group (n=7) was 85.7% (90% confidence interval=47.9-99.3%), which is numerically but not statistically significantly higher than the rate in the GRA group (n=9, 66.7%; p=0.59). Aprepitant was added in two cases, both of which achieved TC. No grade ≥3 treatment-related adverse events were observed.

CONCLUSION

Olanzapine and/or aprepitant with granisetron may be effective and safe as an antiemetic therapy in cisplatin-HAIC.