Affiliations 

  • 1 Palliative Care, William Osler Health Services, 2100 Bovaird Drive East, Brampton, ON, L6R 3J7, Canada. martin.chasen@williamoslerhs.ca
  • 2 Matrahaza University Hospital, Mátraháza, Kékestető, 3233, Hungary
  • 3 Compass Oncology, US Oncology Research, Tualatin Office II, 12960 SW 65th Ave Ste. 435, Tualatin, OR, 97062, USA
  • 4 Medical Oncology Center of Rosebank, 129 Oxford Rd, Corner Northwold, Saxonwold, Johannesburg, 2196, South Africa
  • 5 TESARO, Inc, 1000 Winter St North, Suite 3300, Waltham, MA, 02451, USA
  • 6 Indiana University School of Medicine-South Bend, 202 Lincolnway East, Suite #105, Mishawaka, IN, 46544, USA
  • 7 West Clinic, Memphis, TN, 38120, USA
  • 8 Division of Medical Oncology, San Giuseppe Moscati Hospital, Condtrada Amoretta, 8, Avellino, 83100, Italy
Support Care Cancer, 2017 01;25(1):85-92.
PMID: 27557833

Abstract

PURPOSE: Addition of rolapitant to standard antiemetic therapy improved protection against chemotherapy-induced nausea and vomiting (CINV) in phase 3 trials of patients receiving highly emetogenic chemotherapy (HEC) or moderately emetogenic chemotherapy (MEC). Here, we assessed the impact of CINV on the daily lives of patients receiving HEC or MEC using the Functional Living Index-Emesis (FLIE).

METHODS: In three double-blind phase 3 studies, patients receiving HEC or MEC were randomized 1:1 to receive oral rolapitant 180 mg or placebo prior to chemotherapy plus 5-hydroxytryptamine type 3 receptor antagonist and dexamethasone therapy. Patients completed the FLIE questionnaire on day 6 of cycle 1. Endpoints included FLIE total score, nausea and vomiting domain scores, and the proportion of patients with no impact on daily life (total score >108 [range 18-126]). We performed a prespecified analysis of the MEC/anthracycline-cyclophosphamide (AC) study and a post hoc analysis of two pooled cisplatin-based HEC studies.

RESULTS: In the pooled HEC studies, rolapitant significantly improved the FLIE total score (114.5 vs 109.3, p 

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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