Rolapitant improves quality of life of patients receiving highly or moderately emetogenic chemotherapy

Martin Chasen, Laszlo Urban, Ian Schnadig, Bernardo Rapoport, Dan Powers, Sujata Arora, Rudolph Navari, Lee Schwartzberg, Cesare Gridelli

Research output: Contribution to journalArticle

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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 < 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). Conclusions: Compared with control, rolapitant improved quality of life in patients receiving HEC or MEC.

Original languageEnglish (US)
Pages (from-to)85-92
Number of pages8
JournalSupportive Care in Cancer
Volume25
Issue number1
DOIs
StatePublished - Jan 1 2017

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Quality of Life
Drug Therapy
Vomiting
Nausea
Anthracyclines
Cyclophosphamide
8-((1-(3,5-bis(trifluoromethyl)phenyl)ethoxy)methyl)-8-phenyl-1,7-diazaspiro(4,5)decan-2-one
Receptors, Serotonin, 5-HT3
Antiemetics
Dexamethasone
Cisplatin
Placebos

All Science Journal Classification (ASJC) codes

  • Oncology

Cite this

Chasen, M., Urban, L., Schnadig, I., Rapoport, B., Powers, D., Arora, S., ... Gridelli, C. (2017). Rolapitant improves quality of life of patients receiving highly or moderately emetogenic chemotherapy. Supportive Care in Cancer, 25(1), 85-92. https://doi.org/10.1007/s00520-016-3388-7

Rolapitant improves quality of life of patients receiving highly or moderately emetogenic chemotherapy. / Chasen, Martin; Urban, Laszlo; Schnadig, Ian; Rapoport, Bernardo; Powers, Dan; Arora, Sujata; Navari, Rudolph; Schwartzberg, Lee; Gridelli, Cesare.

In: Supportive Care in Cancer, Vol. 25, No. 1, 01.01.2017, p. 85-92.

Research output: Contribution to journalArticle

Chasen, M, Urban, L, Schnadig, I, Rapoport, B, Powers, D, Arora, S, Navari, R, Schwartzberg, L & Gridelli, C 2017, 'Rolapitant improves quality of life of patients receiving highly or moderately emetogenic chemotherapy', Supportive Care in Cancer, vol. 25, no. 1, pp. 85-92. https://doi.org/10.1007/s00520-016-3388-7
Chasen, Martin ; Urban, Laszlo ; Schnadig, Ian ; Rapoport, Bernardo ; Powers, Dan ; Arora, Sujata ; Navari, Rudolph ; Schwartzberg, Lee ; Gridelli, Cesare. / Rolapitant improves quality of life of patients receiving highly or moderately emetogenic chemotherapy. In: Supportive Care in Cancer. 2017 ; Vol. 25, No. 1. pp. 85-92.
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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 < 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). Conclusions: Compared with control, rolapitant improved quality of life in patients receiving HEC or MEC.",
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AU - Chasen, Martin

AU - Urban, Laszlo

AU - Schnadig, Ian

AU - Rapoport, Bernardo

AU - Powers, Dan

AU - Arora, Sujata

AU - Navari, Rudolph

AU - Schwartzberg, Lee

AU - Gridelli, Cesare

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N2 - 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 < 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). Conclusions: Compared with control, rolapitant improved quality of life in patients receiving HEC or MEC.

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