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Randomized, placebo-controlled, phase III trial of fosaprepitant, ondansetron, dexamethasone (FOND) versus FOND plus olanzapine (FOND-O) for the prevention of chemotherapy-induced nausea and vomiting in patients with hematologic malignancies receiving highly emetogenic chemotherapy and hematopoietic cell transplantation regimens: the FOND-O Trial.

08:00 EDT 12th June 2018 | BioPortfolio

Summary of "Randomized, placebo-controlled, phase III trial of fosaprepitant, ondansetron, dexamethasone (FOND) versus FOND plus olanzapine (FOND-O) for the prevention of chemotherapy-induced nausea and vomiting in patients with hematologic malignancies receiving highly emetogenic chemotherapy and hematopoietic cell transplantation regimens: the FOND-O Trial."

Evidence supports olanzapine for prophylaxis of chemotherapy-induced nausea/vomiting (CINV) for highly emetogenic chemotherapy (HEC); however, most studies focus on solid malignancies and single day regimens. A randomized, double-blinded, placebo-controlled trial was conducted to compare addition of olanzapine to triplet therapy (fosaprepitant, ondansetron, dexamethasone; FOND-O) versus triplet therapy alone (FOND) in preventing CINV in hematology patients receiving single and multi-day HEC and hematopoietic cell transplant (HCT) regimens (NCT02635984). Primary objective of this study is to compare complete response (
CR:
no emesis and minimal nausea, <25mm on 100mm visual analog scale) during overall assessment period (chemotherapy days plus 5 days after). Secondary objectives of number emesis, number rescue medications, percent achieving minimal nausea, and percent achieving complete protection (
CP:
no emesis, rescue antiemetic, or significant nausea), all of which are reported as acute (chemotherapy days), delayed (5 days after chemotherapy), and overall phases. Olanzapine 10 mg or matching placebo were given on each chemotherapy day and three days after. Adults with hematologic malignancy receiving HCT regimens of Melphalan, BEAM, BuCy, BuFlu, BuMel, FluCy, FluCy-TBI, Etoposide-TBI as well as the ICE or 7+3 chemotherapy regimens were included. An estimated 98 patients were required using alpha 0.05 and 80% power. No significant differences existed in baseline characteristics between FOND-O (n=51) and FOND (n=50) arms. Mean duration of olanzapine was 7.7 days (4-11 days). Discontinuation for possible adverse event occurred in 3 placebo and 0 olanzapine patients. CR was significantly higher for FOND-O in overall (55% vs. 26%, p=0.003) and delayed (60.8% vs. 30%, p=0.001) but not acute (p=0.13) phases. Significantly more patients receiving FOND-O achieved no more than minimal nausea in overall (p=0.001) and delayed phase (p=0.0002) as well as fewer overall mean emesis counts (p=0.005). CP rates were not different in any assessment phase (p≥0.05 each). Within the HCT subgroup (n=64), the CR, CP, and no significant nausea rates were significantly better for FONDO-O in overall and delayed phases (all p<0.05). Analysis within the HCT subgroup revealed significant improvement in outcomes in delayed and overall phases with FOND-O in the autologous but not allogeneic cohort. Addition of olanzapine to NK1-based triplet antiemetic regimen significantly improves clinically relevant outcomes in the HCT population.

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Journal Details

This article was published in the following journal.

Name: Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation
ISSN: 1523-6536
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