Efficacy and safety of rolapitant for prevention of chemotherapy-induced nausea and vomiting (CINV) in moderately emetogenic therapy (MEC).

Authors

null

Paul Joseph Hesketh

Lahey Hosp and Med Ctr, Burlington, MA

Paul Joseph Hesketh , Lee Steven Schwartzberg , Manuel R. Modiano , Sujata Arora , Allen Poma , Ian D. Schnadig

Organizations

Lahey Hosp and Med Ctr, Burlington, MA, University of Tennessee Health Science Center, Memphis, TN, ACRC/Arizona Clinical Research Center and Arizona Oncology, Tucson, AZ, TESARO, Inc., Waltham, MA, Tesaro, Inc., Waltham, MA, Compass Onc, Tualatin, OR

Research Funding

Pharmaceutical/Biotech Company

Background: Rolapitant, a novel NK-1 receptor antagonist, showed efficacy for prevention of CINV in patients (pts) receiving MEC (anthracycline/cyclophosphamide (A/C) and other regimens) in a global phase 3 trial. Recent anti-emetic guidelines consider A/C based regimens to be highly emetogenic. In this post hoc analysis, the efficacy and safety of rolapitant was assessed during Cycle 1 in pts receiving non-AC MEC. Methods: In a double-blind, active-controlled study, pts were randomized to oral rolapitant 200 mg or placebo 1–2 hours before MEC. All pts received granisetron 2 mg oral on days 1-3 and oral dexamethasone 20 mg on day 1. Pt subgroups were carboplatin-based MEC and Other MEC (OM; non-AC, non-carboplatin). Complete response (CR=no emesis and no use of rescue medication), no emesis, and no nausea were assessed during overall (0-120 h), acute (0-24 h), and delayed (>24-120 h) phases. Results: CR was significantly (P<0.05) higher with rolapitant than active control for overall and delayed phases in the carboplatin subset and for acute and overall phases in the OM subset (Table). No emesis rates were significantly (p<0.05) higher with rolapitant in carboplatin and OM subsets in the overall phase. No nausea rates were significantly higher with rolapitant during the overall (p= 0.023) and delayed (p=0.034) phases in carboplatin-based MEC. Incidences of treatment-related AEs in Cycle 1 with rolapitant vs. active control were 11.3% vs. 6.7% in carboplatin-based and 9.2% vs. 6.0% in OM-based therapy. Most common AEs with rolapitant and active control were constipation, fatigue, and headache. Conclusions: Rolapitant was superior to active control in preventing CINV in pt subgroups receiving either carboplatin or other non-AC MEC regimens. Rolapitant was well tolerated with low incidence of AEs. Clinical trial information: NCT01500226

Complete response rates (%)Carboplatin
(N = 401)
Other MEC (OM)
(N = 228)
Rolapitant
(N = 192)
Active control
(N = 209)
Rolapitant
(N = 130)
Active control
(N = 98)
Delayed phase (>24–120 h)82.3%65.6%66.9%60.2%
p-valuea<0.0010.296
Acute phase (0–24 h)91.7%88.0%89.2%76.5%
p-valuea0.2310.010
Overall phase (0–120 h)80.2%64.6%66.9%54.1%
p-valuea<0.0010.049

aunstratified CMH test.

Disclaimer

This material on this page is ©2024 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org

Abstract Details

Meeting

2015 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Patient and Survivor Care

Track

Patient and Survivor Care

Sub Track

Symptom Management/Supportive Care

Clinical Trial Registration Number

NCT01500226

Citation

J Clin Oncol 33, 2015 (suppl; abstr 9622)

DOI

10.1200/jco.2015.33.15_suppl.9622

Abstract #

9622

Poster Bd #

281

Abstract Disclosures