title: Rolapitant improves quality of life of patients receiving highly or moderately emetogenic chemotherapy.
abstract: 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).
  
  
  
  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.
  
  
  
  In the pooled HEC studies, rolapitant significantly improved the FLIE total score (114.5 vs 109.3, p < 0.001), nausea score (55.3 vs 53.5, p < 0.05), and vomiting score (59.2 vs 55.8, p < 0.001) versus control; similar results were observed in the MEC/AC study for FLIE total score (112.7 vs 108.6, p < 0.001), nausea score (54.1 vs 52.3, p < 0.05), and vomiting score (58.6 vs 56.3, p < 0.001). A higher proportion of patients reported no impact on daily life with rolapitant than with control in the MEC/AC study (73.2 vs 67.4, p = 0.027).
  
  
  
  Compared with control, rolapitant improved quality of life in patients receiving HEC or MEC.
authors.affiliation: Palliative Care, William Osler Health Services, 2100 Bovaird Drive East, Brampton, ON, L6R 3J7, Canada. martin.chasen@williamoslerhs.ca.
authors.forename: Martin
authors.initials: M
authors.lastname: Chasen
authors.affiliation: Matrahaza University Hospital, Mátraháza, Kékestető, 3233, Hungary.
authors.forename: Laszlo
authors.initials: L
authors.lastname: Urban
authors.affiliation: Compass Oncology, US Oncology Research, Tualatin Office II, 12960 SW 65th Ave Ste. 435, Tualatin, OR, 97062, USA.
authors.forename: Ian
authors.initials: I
authors.lastname: Schnadig
authors.affiliation: Medical Oncology Center of Rosebank, 129 Oxford Rd, Corner Northwold, Saxonwold, Johannesburg, 2196, South Africa.
authors.forename: Bernardo
authors.initials: B
authors.lastname: Rapoport
authors.affiliation: TESARO, Inc, 1000 Winter St North, Suite 3300, Waltham, MA, 02451, USA.
authors.forename: Dan
authors.initials: D
authors.lastname: Powers
authors.affiliation: TESARO, Inc, 1000 Winter St North, Suite 3300, Waltham, MA, 02451, USA.
authors.forename: Sujata
authors.initials: S
authors.lastname: Arora
authors.affiliation: Indiana University School of Medicine-South Bend, 202 Lincolnway East, Suite #105, Mishawaka, IN, 46544, USA.
authors.forename: Rudolph
authors.initials: R
authors.lastname: Navari
authors.affiliation: West Clinic, Memphis, TN, 38120, USA.
authors.forename: Lee
authors.initials: L
authors.lastname: Schwartzberg
authors.affiliation: Division of Medical Oncology, San Giuseppe Moscati Hospital, Condtrada Amoretta, 8, Avellino, 83100, Italy.
authors.forename: Cesare
authors.initials: C
authors.lastname: Gridelli
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018943:Anthracyclines / Q000008:administration & dosage / Q000009:adverse effects; D000932:Antiemetics / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000009:adverse effects; D003907:Dexamethasone / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced / Q000517:prevention & control*; D009369:Neoplasms / Q000188:drug therapy; D064729:Neurokinin-1 Receptor Antagonists / Q000627:therapeutic use; D011788:Quality of Life; D013141:Spiro Compounds / Q000627:therapeutic use*; D014839:Vomiting / Q000139:chemically induced / Q000517:prevention & control*; D055815:Young Adult
chemical_list: D018943:Anthracyclines; D000932:Antiemetics; D064729:Neurokinin-1 Receptor Antagonists; D013141:Spiro Compounds; D003907:Dexamethasone; D003520:Cyclophosphamide; C578834:rolapitant; D002945:Cisplatin
keywords: Antiemetic; Chemotherapy-induced nausea and vomiting (CINV); Functional Living Index-Emesis; Neurokinin-1 receptor antagonist; Quality of life; Rolapitant