S A Giralt1, K F Mangan2, R T Maziarz3, J S Bubalo3, R Beveridge4, D D Hurd5, F L Mendoza6, E B Rubenstein7, T J DeGroot7, M W Schuster8. 1. Adult BMT Service, Memorial Sloan Kettering Cancer Center, New York. Electronic address: GiraltS@mskcc.org. 2. Fox Chase Temple BMT Program, Philadelphia. 3. Oregon Health and Science University, Portland. 4. Fairfax-Northern Virginia Hematology-Oncology P.C., Fairfax. 5. Wake Forest University School of Medicine, Winston-Salem. 6. Adult BMT Service, Memorial Sloan Kettering Cancer Center, New York. 7. Medical & Scientific Affairs, Eisai Inc., Woodcliff Lake. 8. Hematopoietic Stem Cell Transplantation Program, Stony Brook University, Stony Brook, USA.
Abstract
BACKGROUND: Explore safety and efficacy of three palonosetron-containing regimens for emesis prevention over 7 days in multiple myeloma (MM) patients receiving melphalan (100 mg/m(2)) and hematopoietic stem cell transplantation (HSCT). PATIENTS AND METHODS: Randomized, double-blind pilot study in MM patients (n=73) receiving 1, 2, or 3 days of 0.25 mgpalonosetron (30-s i.v. bolus) 30 min before melphalan (days -2 and -1) and HSCT (day 0). Patients received dexamethasone (20 mg i.v., days -2 and -1) immediately before or after study drug/placebo. Daily diaries recorded emesis, rescue medication, nausea duration, and adverse events (AEs). RESULTS: Seven-day complete protection (no emesis) occurred in 41.7% [95% confidence interval (CI) 22.1% to 63.4%], 41.7% (95% CI 22.1% to 63.4%), and 44.0% (95% CI 24.2% to 65.1%) of patients receiving 1, 2, or 3 days of palonosetron, respectively (P=0.43). Complete response (emesis free without rescue medication) occurred in 8.3%, 20.8%, and 20.0% (P=0.14). Common AEs (≥10%) were mild-to-moderate diarrhea, constipation, headache, insomnia, and flatulence. No serious AEs occurred. CONCLUSIONS:Palonosetron with dexamethasone was safe and effective in preventing emesis in MM patients receivingmelphalan and HSCT. This pilot study with a limited number of patients suggests that multiple doses of palonosetron could be more effective than a single dose in making patients emesis free without need for rescue medication. However, even multiple doses of palonosetron resulted in only 20% of patients being emesis free without rescue medication, suggesting that further improvement will require development of more effective combination antiemetic therapy.
RCT Entities:
BACKGROUND: Explore safety and efficacy of three palonosetron-containing regimens for emesis prevention over 7 days in multiple myeloma (MM) patients receiving melphalan (100 mg/m(2)) and hematopoietic stem cell transplantation (HSCT). PATIENTS AND METHODS: Randomized, double-blind pilot study in MMpatients (n=73) receiving 1, 2, or 3 days of 0.25 mg palonosetron (30-s i.v. bolus) 30 min before melphalan (days -2 and -1) and HSCT (day 0). Patients received dexamethasone (20 mg i.v., days -2 and -1) immediately before or after study drug/placebo. Daily diaries recorded emesis, rescue medication, nausea duration, and adverse events (AEs). RESULTS: Seven-day complete protection (no emesis) occurred in 41.7% [95% confidence interval (CI) 22.1% to 63.4%], 41.7% (95% CI 22.1% to 63.4%), and 44.0% (95% CI 24.2% to 65.1%) of patients receiving 1, 2, or 3 days of palonosetron, respectively (P=0.43). Complete response (emesis free without rescue medication) occurred in 8.3%, 20.8%, and 20.0% (P=0.14). Common AEs (≥10%) were mild-to-moderate diarrhea, constipation, headache, insomnia, and flatulence. No serious AEs occurred. CONCLUSIONS:Palonosetron with dexamethasone was safe and effective in preventing emesis in MMpatients receiving melphalan and HSCT. This pilot study with a limited number of patients suggests that multiple doses of palonosetron could be more effective than a single dose in making patientsemesis free without need for rescue medication. However, even multiple doses of palonosetron resulted in only 20% of patients being emesis free without rescue medication, suggesting that further improvement will require development of more effective combination antiemetic therapy.
Authors: Midori Nakagaki; Michael Barras; Cameron Curley; Jason P Butler; Glen A Kennedy Journal: Support Care Cancer Date: 2016-10-13 Impact factor: 3.603
Authors: Lawrence H Einhorn; Bernardo Rapoport; Rudolph M Navari; Jørn Herrstedt; Mary J Brames Journal: Support Care Cancer Date: 2016-11-04 Impact factor: 3.603