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. 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

Ian D Schnadig  1 , Richy Agajanian  2 , Christopher Dakhil  3 , Nashat Gabrail  4 , Jeffrey Vacirca  5 , Charles Taylor  6 , Sharon Wilks  7 , Eduardo Braun  8 , Michael C Mosier  9 , Robert B Geller  10 , Lee Schwartzberg  11 , Nicholas Vogelzang  12
Affiliations

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

Ian D Schnadig et al. Cancer Manag Res. .

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).

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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.

Figures

Figure 1
Figure 1
MAGIC trial AC subgroup CONSORT diagram. Abbreviations: AC, anthracycline + cyclophosphamide; MAGIC, Modified Absorption of Granisetron In the prevention of CINV; mITT, modified intent-to-treat.
See this image and copyright information in PMC

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