Antiemetic Efficacy and Safety of Palonosetron on Days 1 and 5 with Aprepitant and Dexamethasone during Bleomycin, Etoposide, and Cisplatin Chemotherapy in Patients with Germ Cell Tumor: A Prospective Study

Abstract

Objective. BEP (bleomycin, etoposide, and cisplatin) chemotherapy is a standard regimen for germ cell tumors (GCTs); however, their high emetogenicity is problematic. The control of chemotherapy-induced nausea and vomiting (CINV) is crucial to complete the treatment. We conducted this study to explore the efficacy and safety of antiemetic therapy with dexamethasone and aprepitant for 5 days in combination with palonosetron 0.75 mg on days 1 and 5 in BEP. Methods. This open-label single-arm study was prospectively conducted in 4 hospitals. Chemotherapy-naïve men with GCT who were scheduled to receive the BEP regimen were eligible. The primary endpoint was the complete response (CR) rate of CINV. Results. A total of 19 patients were enrolled. Overall, 16 (84.2%) patients experienced some nausea, whereas only 4 (21.1%) patients had grade 1 emetic events. Overall CR of CINV was achieved in 9 (47.4%) patients. Although 14 (73.7%) patients experienced 22 adverse events after palonosetron administration, severe adverse events (grade 3 or more) attributable to it did not occur. Conclusion. The results suggest that aprepitant, palonosetron, and dexamethasone antiemetic therapy for patients with GCT receiving BEP is safe, whereas the efficacy of additional palonosetron administration on day 5 for prevention of delayed CINV remains unclear. This trial is registered with UMIN000008110.