TY - JOUR
T1 - 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
T2 - A Prospective Study
AU - Fukuta, Fumimasa
AU - Kitamura, Hiroshi
AU - Hotta, Hiroshi
AU - Itoh, Naoki
AU - Okada, Manabu
AU - Shindo, Tetsuya
AU - Kyoda, Yuki
AU - Hashimoto, Kohei
AU - Kobayashi, Ko
AU - Tanaka, Toshiaki
AU - Masumori, Naoya
N1 - Publisher Copyright:
© 2024 Fumimasa Fukuta et al.
PY - 2024
Y1 - 2024
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85199918639&partnerID=8YFLogxK
U2 - 10.1155/2024/8838889
DO - 10.1155/2024/8838889
M3 - 学術論文
AN - SCOPUS:85199918639
SN - 0961-5423
VL - 2024
JO - European Journal of Cancer Care
JF - European Journal of Cancer Care
M1 - 8838889
ER -