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Cancer Manag Res. 2017 May 19;9:179-187. doi: 10.2147/CMAR.S129059. eCollection 2017.

APF530 versus ondansetron, each in a guideline-recommended three-drug regimen, for the prevention of chemotherapy-induced nausea and vomiting due to anthracycline plus cyclophosphamide-based highly emetogenic chemotherapy regimens: a post hoc subgroup analysis of the Phase III randomized MAGIC trial.

Author information

1
Compass Oncology, US Oncology Research, Tualatin, OR.
2
The Oncology Institute of Hope and Innovation, Whittier, CA.
3
Cancer Center of Kansas, Wichita, KS.
4
Gabrail Cancer Center, Canton, OH.
5
North Shore Hematology Oncology, East Setauket, NY.
6
Tulsa Cancer Institute, Tulsa, OK.
7
Cancer Care Centers of South Texas, San Antonio, TX.
8
Michiana Hematology Oncology, Westville, IN.
9
Biostatistics, EMB Statistical Solutions, LLC, Overland Park, KS.
10
Medical Affairs, Heron Therapeutics, Inc., San Diego, CA.
11
West Cancer Center, Germantown, TN.
12
Comprehensive Cancer Centers of Nevada, Las Vegas, NV, USA.

Abstract

BACKGROUND:

APF530, a novel extended-release granisetron injection, was superior to ondansetron in a guideline-recommended three-drug regimen in preventing delayed-phase chemotherapy-induced nausea and vomiting (CINV) among patients receiving highly emetogenic chemotherapy (HEC) in the double-blind Phase III Modified Absorption of Granisetron In the prevention of CINV (MAGIC) trial.

PATIENTS AND METHODS:

This MAGIC post hoc analysis evaluated CINV prevention efficacy and safety of APF530 versus ondansetron, each with fosaprepitant and dexamethasone, in patient subgroup receiving an anthracycline plus cyclophosphamide (AC) regimen. Patients were randomized 1:1 to APF530 500 mg subcutaneously (granisetron 10 mg) or ondansetron 0.15 mg/kg intravenously (IV) (≤16 mg); stratification was by planned cisplatin ≥50 mg/m2 (yes/no). Patients were to receive fosaprepitant 150 mg IV and dexamethasone 12 mg IV on day 1, then dexamethasone 8 mg orally once daily on day 2 and twice daily on days 3 and 4. Patients were mostly younger females (APF530 arm, mean age 54.1 years, female, 99.3%; ondansetron arm, 53.8 years, female 98.3%). The primary end point was delayed-phase (>24-120 hours) complete response (CR).

RESULTS:

APF530 versus ondansetron regimens achieved numerically better CINV control in delayed and overall (0-120 hours) phases for CR, complete control, total response, rescue medication use, and proportion with no nausea. APF530 trends are consistent with the overall population, although not statistically superior given the underpowered AC subgroup analysis. The APF530 regimen in this population was generally well tolerated, with safety comparable to that of the overall population.

CONCLUSION:

APF530 plus fosaprepitant and dexamethasone effectively prevented CINV among patients receiving AC-based HEC, a large subgroup in whom CINV control has traditionally been challenging.

KEYWORDS:

APF530; anthracycline; chemotherapy-induced nausea and vomiting (CINV); cyclophosphamide; extended release granisetron; highly emetogenic chemotherapy (HEC)

Conflict of interest statement

Disclosure IDS, LS, and NV have acted in consultant/advisory roles for Heron Therapeutics, Inc. EB has received research funding and honoraria from Heron Therapeutics, Inc. MCM has received honoraria from EMB Statistical Solutions, LLC. RBG is employed by and has ownership interests in Heron Therapeutics, Inc. The other authors report no conflicts of interest in this work.

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