Daiki Tsuji1, Kenichi Suzuki2, Yohei Kawasaki3, Koichi Goto4, Reiko Matsui5, Nobuhiko Seki6, Hironobu Hashimoto7, Toshihiro Hama2, Takeharu Yamanaka8, Nobuyuki Yamamoto9, Kunihiko Itoh10. 1. Department of Clinical Pharmacology & Genetics, University of Shizuoka, 52-1, Yada, Surugaku, Shizuoka, 422-8526, Japan. d-tsuji@u-shizuoka-ken.ac.jp. 2. Department of Pharmacy, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan. 3. Clinical Research Center, Chiba University Hospital, Chiba, Japan. 4. Department of Thoracic Oncology, National Cancer Center Hospital East, Tokyo, Japan. 5. Department of Pharmacy, National Cancer Center Hospital East, Tokyo, Japan. 6. Division of Medical Oncology, Teikyo University School of Medicine, Tokyo, Japan. 7. Department of Pharmacy, National Cancer Center Hospital, Tokyo, Japan. 8. Department of Biostatistics, Yokohama City University School of Medicine, Yokohama, Japan. 9. Third Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan. 10. Department of Clinical Pharmacology & Genetics, University of Shizuoka, 52-1, Yada, Surugaku, Shizuoka, 422-8526, Japan.
Abstract
PURPOSE: The triplet antiemetic regimen is recommended for cisplatin-based highly emetogenic chemotherapy, in the current guidelines for antiemetic prophylaxis. Although risk factors related to chemotherapy-induced nausea and vomiting (CINV) have been identified by several prior studies, there are only few studies evaluating risk factors associated with the prophylactic triplet antiemetic therapy, particularly in palonosetron use. The present study aimed to reveal the risk factors related to CINV development in patients receivingcisplatin and to compare CINV risk factors between palonosetron and granisetron use. METHODS: In total, 825 patients in a phase III trial receiving palonosetron with graniestron were evaluated. Multivariate logistic regression models were used to predict risk factors associated with CINV development. Additionally, risk factors associated with CINV development were separately evaluated in each treatment group. RESULTS: Multivariate analysis of the entire study group revealed that sex, age, cisplatin dose, and granisetron use were significant and independent factors affecting CINV development in the overall phase. Similarly, sex and age were risk factors for CINV in both treatment groups. Kaplan-Meier curves classified by each treatment group showed no significant difference between the groups among patients without any risk factors for CINV (P = 0.353). Conversely, complete response rates for patients with at least one risk factor were higher in patients receivingpalonosetron (P = 0.049). CONCLUSIONS: This analysis revealed the importance of previously reported CINV risk factors when using triplet antiemetics. Palonosetron might be preferred for patients with at least one risk factor.
RCT Entities:
PURPOSE: The triplet antiemetic regimen is recommended for cisplatin-based highly emetogenic chemotherapy, in the current guidelines for antiemetic prophylaxis. Although risk factors related to chemotherapy-induced nausea and vomiting (CINV) have been identified by several prior studies, there are only few studies evaluating risk factors associated with the prophylactic triplet antiemetic therapy, particularly in palonosetron use. The present study aimed to reveal the risk factors related to CINV development in patients receiving cisplatin and to compare CINV risk factors between palonosetron and granisetron use. METHODS: In total, 825 patients in a phase III trial receiving palonosetron with graniestron were evaluated. Multivariate logistic regression models were used to predict risk factors associated with CINV development. Additionally, risk factors associated with CINV development were separately evaluated in each treatment group. RESULTS: Multivariate analysis of the entire study group revealed that sex, age, cisplatin dose, and granisetron use were significant and independent factors affecting CINV development in the overall phase. Similarly, sex and age were risk factors for CINV in both treatment groups. Kaplan-Meier curves classified by each treatment group showed no significant difference between the groups among patients without any risk factors for CINV (P = 0.353). Conversely, complete response rates for patients with at least one risk factor were higher in patients receiving palonosetron (P = 0.049). CONCLUSIONS: This analysis revealed the importance of previously reported CINV risk factors when using triplet antiemetics. Palonosetron might be preferred for patients with at least one risk factor.