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Efficacy of rolapitant for prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with gastrointestinal and colorectal cancers

Date

09 Oct 2016

Session

Poster display

Presenters

Rudolph Navari

Citation

Annals of Oncology (2016) 27 (6): 497-521. 10.1093/annonc/mdw390

Authors

R. Navari1, K. Jordan2, B.L. Rapoport3, I. Schnadig4, M. Chasen5, S. Arora6, D. Powers7, L. Schwartzberg8

Author affiliations

  • 1 Department Of Medicine, Indiana University School of Medicine–South Bend, 46544 - South Bend/US
  • 2 Department Of Internal Medicine Iv, Hematology And Oncology, Martin-Luther-University Halle-Wittenberg, 06120 - Halle/DE
  • 3 Medical Oncology, The Medical Oncology Centre of Rosebank, 2196 - Johannesburg/ZA
  • 4 Pharmacy And Therapeutics, Compass Oncology, US Oncology Research, Tualatin/US
  • 5 Department Of Oncology, University of Ottawa, Ottawa/CA
  • 6 Biostatistics, TESARO, Inc., Waltham/US
  • 7 Medical Affairs, TESARO, Inc., Waltham/US
  • 8 Hematology & Oncology, The West Clinic, Memphis/US
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Resources

Background

Rolapitant (VARUBI®) is a selective, long-acting neurokinin-1 receptor antagonist (RA) for the prevention of chemotherapy-induced nausea and vomiting (CINV). Rolapitant effectively prevented CINV in phase 3 trials of patients (pts) receiving highly or moderately emetogenic chemotherapy (HEC, MEC). While MEC and HEC regimens are commonly used to treat pts with gastrointestinal and colorectal cancers (GI/CRC), very few studies have evaluated the effectiveness of a neurokinin-1 RA regimen in these pts. We assessed the incidence of CINV and efficacy of rolapitant in a subset of pts with GI/CRC.

Methods

This is a post hoc analysis of 3 similarly-designed, randomized, placebo-controlled trials. Pts with cancer of the esophagus, stomach, colon/rectum, or anus received a single oral dose of 180 mg oral rolapitant or placebo prior to HEC or MEC. All pts received a 5-hydroxytryptamine type 3 (5-HT3) RA and dexamethasone (active control). The HEC studies included cisplatin, and the MEC study carboplatin, oxaliplatin, irinotecan, epirubicin, and doxorubicin. Endpoints included complete response (CR; no emesis and no use of rescue medication), no emesis, no nausea (maximum visual analogue scale [VAS]

Results

Out of 188 GI/CRC pts, 101 pts received rolapitant and 87 received active control. Pts treated with rolapitant had significantly higher rates of CR, no nausea, no emesis, and CP in the overall phase (P 

Conclusions

Addition of rolapitant to 5-HT3 RA and dexamethasone therapy significantly improved CR,no nausea, no emesis, and CP in pts with GI/CRC receiving emetogenic chemotherapy.

Pooled HEC/MEC
Endpoint, % Rolapitant (n = 101) Control (n = 87) p-value
Overall phase
Complete response 73.3 48.3

Clinical trial identification

NCT01500226, NCT01499849, NCT01500213

Legal entity responsible for the study

TESARO, Inc.

Funding

TESARO, Inc.

Disclosure

K. Jordan: Consulting or Advisory Role: Merck, MSD, Helsinn Healthcare, Tesaro. B.L. Rapoport: Consulting or Advisory Role: Tesaro, Merck; Speakers' Bureau: Tesaro, Merck; Travel, Accommodations, Expenses: Tesaro, Merck; Honoraria: Tesaro, Merck. I. Schnadig: Advisory Board: Tesaro. S. Arora, D. Powers: Employment: Tesaro. L. Schwartzberg: Consulting or Advisory Role: Eisai, Teva, Amgen, Genentech, Bristol-Myers Squibb; Leadership: Vector Oncology; Speakers' Bureau: Genentech, Novartis, Bristol-Myers Squibb; Stock and Other Ownership Interests: Vector Oncology; Research Funding: Eisa. All other authors have declared no conflicts of interest.

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