SUSTOL demonstrated superiority in the delayed phase of CINV vs ondansetron
- Modified Absorption of Granisetron In the Prevention of CINV.
- 2-sided hypothesis test. Significance level at α=0.05.1
- All patients were concomitantly administered intravenous dexamethasone.
- SUSTOL demonstrated superiority vs ondansetron IV in the prevention of delayed CINV in a trial of over 900 patients receiving HEC regimens encompassing AC, cisplatin, and other regimens1
- A prespecified subgroup analysis of the cisplatin and non-cisplatin strata demonstrated consistent treatment benefit compared to the overall study population. However, the study was not powered to show statistical significance within subset analyses1
- Due to the number of cisplatin-treated patients in SUSTOL Phase 3 clinical trials (n=358; 26% of HEC-treated patients), efficacy in this population has not been established1,2
- Data shown are not included in the SUSTOL Prescribing Information. SUSTOL is not indicated in patients treated with cisplatin
“This was the first published trial that compared a single dose of two different 5-HT3 antagonists when used in combination with dexamethasone and an NK1 RA.
“As a result, granisetron extended-release injection was the first FDA-approved 5-HT3 antagonist indicated for the prevention of delayed CINV associated with AC anticancer agents.”
|§||NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Antiemesis.|
- Schnadig et al. Future Oncol. 2016.
- Data on File [C2006-01]. Heron Therapeutics, Inc.
- NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Antiemesis V.1.2021. ©National Comprehensive Cancer Network, Inc. 2021. All rights reserved. Accessed January 26, 2021. To view the most recent and complete version of the guideline, go to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
- Zhou et al. Ther Clin Risk Manag. 2015.
- Data on File [C2013-01]. Heron Therapeutics, Inc., San Diego, CA.
- Aapro et al. Ann Oncol. 2006.
- SUSTOL [prescribing information]. Heron Therapeutics, Inc., 2017.