K Suzuki1, T Yamanaka2, H Hashimoto3, Y Shimada4, K Arata5, R Matsui6, K Goto7, T Takiguchi8, F Ohyanagi9, Y Kogure6, N Nogami10, M Nakao6, K Takeda11, K Azuma6, S Nagase12, T Hayashi13, K Fujiwara14, T Shimada6, N Seki15, N Yamamoto16. 1. Department of Pharmacy, Shizuoka Cancer Center, Shizuoka Department of Pharmacy, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo. 2. Department of Biostatistics, Yokohama City University School of Medicine, Yokohama. 3. Division of Pharmacy. 4. Division of Gastrointestinal Oncology, National Cancer Center Hospital, Tokyo. 5. Department of Pharmacy, Shizuoka Cancer Center, Shizuoka. 6. Department of Pharmacy. 7. Department of Thoracic Oncology, National Cancer Center Hospital East, Chiba. 8. Department of Pharmacy, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo. 9. Department of Thoracic Medical Oncology, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo. 10. Department of Thoracic Oncology, NHO Shikoku Cancer Center, Ehime. 11. Department of Clinical Oncology, Osaka City General Hospital, Osaka. 12. Department of Thoracic Surgery, Tokyo Medical University Hospital, Tokyo. 13. Department of Pharmacy, NHO Kyushu Cancer Center, Fukuoka. 14. Department of Pharmacy, Kindai University Hospital, Osaka. 15. Division of Medical Oncology, Teikyo University Hospital, Tokyo. 16. Department of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka Third Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan nbyamamo@wakayama-med.ac.jp.
Abstract
BACKGROUND: There has been no phase III study of comparing the efficacy of first- and second-generation 5-HT3 receptor antagonists in the triplet regimen with dexamethasone and aprepitant for preventing chemotherapy-induced nausea and vomiting after highly emetogenic chemotherapy (HEC). PATIENTS AND METHODS: Patients with a malignant solid tumor who would receive HEC containing 50 mg/m(2) or morecisplatin were randomly assigned to either palonosetron (0.75 mg) arm (Arm P) or granisetron (1 mg) arm (Arm G), on day 1, both arms with dexamethasone (12 mg on day 1 and 8 mg on days 2-4) and aprepitant (125 mg on day 1 and 80 mg on days 2-3). The primary end point was complete response (CR; no vomiting/retching and no rescue medication) at the 0-120 h period and secondary end points included complete control (CC; no vomiting/retching, no rescue medication, and no more than mild nausea) and total control (TC; no vomiting/retching, no rescue medication, and no nausea). RESULTS:Between July 2011 and June 2012, 842 patients were enrolled. Of 827 evaluable, 272 of 414 patients (65.7%) in Arm P had a CR at the 0-120 h period when compared with 244 of 413 (59.1%) in Arm G (P = 0.0539). Both arms had the same CR rate of 91.8% at the acute (0-24 h) period, while at the delayed (24-120 h) period, Arm P had a significantly higher CR rate than Arm G (67.2% versus 59.1%; P = 0.0142). In secondary end points, Arm P had significantly higher rates than Arm G at the 0-120 h period (CC rate: 63.8% versus 55.9%, P = 0.0234; TC rate: 47.6% versus 40.7%, P = 0.0369) and delayed periods (CC rate: 65.2% versus 55.9%, P = 0.0053; TC rate: 48.6% versus 41.4%, P = 0.0369). CONCLUSION: The present study did not show the superiority of palonosetron when compared with granisetron in the triplet regimen regarding the primary end point. CLINICAL TRIAL REGISTRY IDENTIFIER: UMIN000004863.
RCT Entities:
BACKGROUND: There has been no phase III study of comparing the efficacy of first- and second-generation 5-HT3 receptor antagonists in the triplet regimen with dexamethasone and aprepitant for preventing chemotherapy-induced nausea and vomiting after highly emetogenic chemotherapy (HEC). PATIENTS AND METHODS: Patients with a malignant solid tumor who would receive HEC containing 50 mg/m(2) or more cisplatin were randomly assigned to either palonosetron (0.75 mg) arm (Arm P) or granisetron (1 mg) arm (Arm G), on day 1, both arms with dexamethasone (12 mg on day 1 and 8 mg on days 2-4) and aprepitant (125 mg on day 1 and 80 mg on days 2-3). The primary end point was complete response (CR; no vomiting/retching and no rescue medication) at the 0-120 h period and secondary end points included complete control (CC; no vomiting/retching, no rescue medication, and no more than mild nausea) and total control (TC; no vomiting/retching, no rescue medication, and no nausea). RESULTS: Between July 2011 and June 2012, 842 patients were enrolled. Of 827 evaluable, 272 of 414 patients (65.7%) in Arm P had a CR at the 0-120 h period when compared with 244 of 413 (59.1%) in Arm G (P = 0.0539). Both arms had the same CR rate of 91.8% at the acute (0-24 h) period, while at the delayed (24-120 h) period, Arm P had a significantly higher CR rate than Arm G (67.2% versus 59.1%; P = 0.0142). In secondary end points, Arm P had significantly higher rates than Arm G at the 0-120 h period (CC rate: 63.8% versus 55.9%, P = 0.0234; TC rate: 47.6% versus 40.7%, P = 0.0369) and delayed periods (CC rate: 65.2% versus 55.9%, P = 0.0053; TC rate: 48.6% versus 41.4%, P = 0.0369). CONCLUSION: The present study did not show the superiority of palonosetron when compared with granisetron in the triplet regimen regarding the primary end point. CLINICAL TRIAL REGISTRY IDENTIFIER: UMIN000004863.
Authors: Ronald Chow; David G Warr; Rudolph M Navari; May Tsao; Marko Popovic; Leonard Chiu; Milica Milakovic; Henry Lam; Carlo DeAngelis Journal: Support Care Cancer Date: 2018-05-23 Impact factor: 3.603