Multicenter, placebo-controlled, double-blind, randomized study of fosnetupitant in combination with palonosetron for the prevention of chemotherapy-induced nausea and vomiting in patients receiving highly emetogenic chemotherapy
© 2019 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society..
BACKGROUND: The current randomized, double-blind, phase 2 study assessed the efficacy and safety profile of a single intravenous administration of fosnetupitant, a neurokinin 1 receptor antagonist prodrug, for the prevention of chemotherapy-induced nausea and vomiting in Japanese patients receiving cisplatin-based chemotherapy.
METHODS: Patients scheduled to receive cisplatin (at a dose of ≥70 mg/m2 )-based regimens were randomly assigned to receive fosnetupitant at a dose of 81 mg or 235 mg or placebo in combination with palonosetron at a dose of 0.75 mg and dexamethasone. The primary endpoint was complete response (CR; no vomiting and no rescue medication) during the overall phase (0-120 hours). The overall CR rate was compared between each dose of fosnetupitant and the placebo group adjusting for the stratification factors of sex and age class (age <55 years vs age ≥55 years). Safety was assessed, with special attention given to events that potentially were suggestive of infusion site reactions.
RESULTS: A total of 594 patients were randomized. Of these, 194 patients, 195 patients, and 195 patients, respectively, in the placebo and fosnetupitant 81-mg and 235-mg dose groups were evaluable for efficacy. The overall CR rate was 54.7% for the placebo group, 63.8% for the fosnetupitant 81-mg dose group (adjusted difference, 9.1%; 95% CI, -0.4% to 18.6% [P = .061]), and 76.8% for the fosnetupitant 235-mg dose group (adjusted difference, 22.0%; 97.5% CI, 11.7% to 32.3% [P < .001]). Safety profiles were comparable between the 3 groups. The incidence of infusion site reactions related to fosnetupitant was ≤1% in each dose group.
CONCLUSIONS: Fosnetupitant at a dose of 235 mg provided superior prevention of chemotherapy-induced nausea and vomiting among patients receiving cisplatin-based chemotherapy compared with the control group, and with a satisfactory safety profile.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2019 |
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| Erschienen: |
2019 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:125 |
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| Enthalten in: |
Cancer - 125(2019), 22 vom: 15. Nov., Seite 4076-4083 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Sugawara, Shunichi [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 26.05.2020 Date Revised 10.12.2020 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1002/cncr.32429 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| 100 | 1 | |a Sugawara, Shunichi |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Multicenter, placebo-controlled, double-blind, randomized study of fosnetupitant in combination with palonosetron for the prevention of chemotherapy-induced nausea and vomiting in patients receiving highly emetogenic chemotherapy |
| 264 | 1 | |c 2019 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 26.05.2020 | ||
| 500 | |a Date Revised 10.12.2020 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2019 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society. | ||
| 520 | |a BACKGROUND: The current randomized, double-blind, phase 2 study assessed the efficacy and safety profile of a single intravenous administration of fosnetupitant, a neurokinin 1 receptor antagonist prodrug, for the prevention of chemotherapy-induced nausea and vomiting in Japanese patients receiving cisplatin-based chemotherapy | ||
| 520 | |a METHODS: Patients scheduled to receive cisplatin (at a dose of ≥70 mg/m2 )-based regimens were randomly assigned to receive fosnetupitant at a dose of 81 mg or 235 mg or placebo in combination with palonosetron at a dose of 0.75 mg and dexamethasone. The primary endpoint was complete response (CR; no vomiting and no rescue medication) during the overall phase (0-120 hours). The overall CR rate was compared between each dose of fosnetupitant and the placebo group adjusting for the stratification factors of sex and age class (age <55 years vs age ≥55 years). Safety was assessed, with special attention given to events that potentially were suggestive of infusion site reactions | ||
| 520 | |a RESULTS: A total of 594 patients were randomized. Of these, 194 patients, 195 patients, and 195 patients, respectively, in the placebo and fosnetupitant 81-mg and 235-mg dose groups were evaluable for efficacy. The overall CR rate was 54.7% for the placebo group, 63.8% for the fosnetupitant 81-mg dose group (adjusted difference, 9.1%; 95% CI, -0.4% to 18.6% [P = .061]), and 76.8% for the fosnetupitant 235-mg dose group (adjusted difference, 22.0%; 97.5% CI, 11.7% to 32.3% [P < .001]). Safety profiles were comparable between the 3 groups. The incidence of infusion site reactions related to fosnetupitant was ≤1% in each dose group | ||
| 520 | |a CONCLUSIONS: Fosnetupitant at a dose of 235 mg provided superior prevention of chemotherapy-induced nausea and vomiting among patients receiving cisplatin-based chemotherapy compared with the control group, and with a satisfactory safety profile | ||
| 650 | 4 | |a Clinical Trial, Phase II | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Pragmatic Clinical Trial | |
| 650 | 4 | |a chemotherapy-induced nausea and vomiting | |
| 650 | 4 | |a fosnetupitant | |
| 650 | 4 | |a highly emetogenic chemotherapy | |
| 650 | 4 | |a injection site reaction | |
| 650 | 4 | |a neurokinin 1 receptor antagonist | |
| 650 | 4 | |a phase 2 | |
| 650 | 7 | |a Antiemetics |2 NLM | |
| 650 | 7 | |a Antineoplastic Agents |2 NLM | |
| 650 | 7 | |a Drug Combinations |2 NLM | |
| 650 | 7 | |a Isoquinolines |2 NLM | |
| 650 | 7 | |a Pyridines |2 NLM | |
| 650 | 7 | |a Quinuclidines |2 NLM | |
| 650 | 7 | |a netupitant, palosentron drug combination |2 NLM | |
| 700 | 1 | |a Inui, Naoki |e verfasserin |4 aut | |
| 700 | 1 | |a Kanehara, Masashi |e verfasserin |4 aut | |
| 700 | 1 | |a Morise, Masahiro |e verfasserin |4 aut | |
| 700 | 1 | |a Yoshimori, Kozo |e verfasserin |4 aut | |
| 700 | 1 | |a Kumagai, Toru |e verfasserin |4 aut | |
| 700 | 1 | |a Fukui, Tomoya |e verfasserin |4 aut | |
| 700 | 1 | |a Minato, Koichi |e verfasserin |4 aut | |
| 700 | 1 | |a Iwashima, Akira |e verfasserin |4 aut | |
| 700 | 1 | |a Takeda, Yuichiro |e verfasserin |4 aut | |
| 700 | 1 | |a Kubota, Kaoru |e verfasserin |4 aut | |
| 700 | 1 | |a Saeki, Toshiaki |e verfasserin |4 aut | |
| 700 | 1 | |a Tamura, Tomohide |e verfasserin |4 aut | |
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