Efficacy of aprepitant for the prevention of chemotherapy-induced nausea and vomiting with a moderately emetogenic chemotherapy regimen: a multicenter, placebo-controlled, double-blind, randomized study in patients with gynecologic cancer receiving paclitaxel and carboplatin

Hideaki Yahata, Hiroaki Kobayashi, Kenzo Sonoda, Mototsugu Shimokawa, Tatsuhiro Ohgami, Toshiaki Saito, Shinji Ogawa, Kunihiro Sakai, Akimasa Ichinoe, Yousuke Ueoka, Yasuyuki Hasuo, Makoto Nishida, Satohiro Masuda, Kiyoko Kato

研究成果: ジャーナルへの寄稿記事

35 引用 (Scopus)

抄録

Background: Substance P contributes to the hypersensitivity reaction (HSR) to paclitaxel in a rat model. Aprepitant acts as an inhibitor of the binding of substance P to the neurokinin-1 receptor and, consequently, may reduce the frequency of paclitaxel-induced HSR. While aprepitant has a prophylactic effect against vomiting caused by high-dose cisplatin, the benefits of aprepitant have not been clearly demonstrated in patients receiving paclitaxel and carboplatin (TC) combination chemotherapy. Methods: We conducted a multicenter, placebo-controlled, double-blind, randomized study in Japanese patients with gynecologic cancer who received TC combination chemotherapy. Patients received aprepitant or placebo together with both a 5-HT3 receptor antagonist and dexamethasone prior to chemotherapy. The primary endpoint was the proportion of patients with HSR, and the secondary endpoints were the proportion of patients with “no vomiting”, “no significant nausea”, and complete response, respectively. Results: Of the 324 randomized patients, 297 (151 in the aprepitant group; 146 in the placebo group) were evaluated. The percentage of patients with HSR (9.2 vs. 7.5 %, respectively; P = 0.339) was not significantly different between the groups. The percentage of “no vomiting” patients (78.2 vs. 54.8 %; P < 0.0001), “no significant nausea” patients (85.4 vs. 74.7 %; P = 0.014), and patients showing complete response (61.6 vs. 47.3 %, P = 0.0073) was significantly higher in the aprepitant group than in the placebo group. Conclusion: The administration of aprepitant did not have a prophylactic effect on the HSR but was effective in reducing nausea and vomiting in gynecologic cancer patients receiving TC combination chemotherapy.

元の言語英語
ページ(範囲)491-497
ページ数7
ジャーナルInternational Journal of Clinical Oncology
21
発行部数3
DOI
出版物ステータス出版済み - 6 1 2016

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aprepitant
Carboplatin
Paclitaxel
Double-Blind Method
Nausea
Vomiting
Placebos
Drug Therapy
Neoplasms
Hypersensitivity
Combination Drug Therapy
Substance P
Serotonin 5-HT3 Receptor Antagonists
Neurokinin-1 Receptors
Receptors, Serotonin, 5-HT3

All Science Journal Classification (ASJC) codes

  • Surgery
  • Hematology
  • Oncology

これを引用

Efficacy of aprepitant for the prevention of chemotherapy-induced nausea and vomiting with a moderately emetogenic chemotherapy regimen : a multicenter, placebo-controlled, double-blind, randomized study in patients with gynecologic cancer receiving paclitaxel and carboplatin. / Yahata, Hideaki; Kobayashi, Hiroaki; Sonoda, Kenzo; Shimokawa, Mototsugu; Ohgami, Tatsuhiro; Saito, Toshiaki; Ogawa, Shinji; Sakai, Kunihiro; Ichinoe, Akimasa; Ueoka, Yousuke; Hasuo, Yasuyuki; Nishida, Makoto; Masuda, Satohiro; Kato, Kiyoko.

:: International Journal of Clinical Oncology, 巻 21, 番号 3, 01.06.2016, p. 491-497.

研究成果: ジャーナルへの寄稿記事

Yahata, Hideaki ; Kobayashi, Hiroaki ; Sonoda, Kenzo ; Shimokawa, Mototsugu ; Ohgami, Tatsuhiro ; Saito, Toshiaki ; Ogawa, Shinji ; Sakai, Kunihiro ; Ichinoe, Akimasa ; Ueoka, Yousuke ; Hasuo, Yasuyuki ; Nishida, Makoto ; Masuda, Satohiro ; Kato, Kiyoko. / Efficacy of aprepitant for the prevention of chemotherapy-induced nausea and vomiting with a moderately emetogenic chemotherapy regimen : a multicenter, placebo-controlled, double-blind, randomized study in patients with gynecologic cancer receiving paclitaxel and carboplatin. :: International Journal of Clinical Oncology. 2016 ; 巻 21, 番号 3. pp. 491-497.
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title = "Efficacy of aprepitant for the prevention of chemotherapy-induced nausea and vomiting with a moderately emetogenic chemotherapy regimen: a multicenter, placebo-controlled, double-blind, randomized study in patients with gynecologic cancer receiving paclitaxel and carboplatin",
abstract = "Background: Substance P contributes to the hypersensitivity reaction (HSR) to paclitaxel in a rat model. Aprepitant acts as an inhibitor of the binding of substance P to the neurokinin-1 receptor and, consequently, may reduce the frequency of paclitaxel-induced HSR. While aprepitant has a prophylactic effect against vomiting caused by high-dose cisplatin, the benefits of aprepitant have not been clearly demonstrated in patients receiving paclitaxel and carboplatin (TC) combination chemotherapy. Methods: We conducted a multicenter, placebo-controlled, double-blind, randomized study in Japanese patients with gynecologic cancer who received TC combination chemotherapy. Patients received aprepitant or placebo together with both a 5-HT3 receptor antagonist and dexamethasone prior to chemotherapy. The primary endpoint was the proportion of patients with HSR, and the secondary endpoints were the proportion of patients with “no vomiting”, “no significant nausea”, and complete response, respectively. Results: Of the 324 randomized patients, 297 (151 in the aprepitant group; 146 in the placebo group) were evaluated. The percentage of patients with HSR (9.2 vs. 7.5 {\%}, respectively; P = 0.339) was not significantly different between the groups. The percentage of “no vomiting” patients (78.2 vs. 54.8 {\%}; P < 0.0001), “no significant nausea” patients (85.4 vs. 74.7 {\%}; P = 0.014), and patients showing complete response (61.6 vs. 47.3 {\%}, P = 0.0073) was significantly higher in the aprepitant group than in the placebo group. Conclusion: The administration of aprepitant did not have a prophylactic effect on the HSR but was effective in reducing nausea and vomiting in gynecologic cancer patients receiving TC combination chemotherapy.",
author = "Hideaki Yahata and Hiroaki Kobayashi and Kenzo Sonoda and Mototsugu Shimokawa and Tatsuhiro Ohgami and Toshiaki Saito and Shinji Ogawa and Kunihiro Sakai and Akimasa Ichinoe and Yousuke Ueoka and Yasuyuki Hasuo and Makoto Nishida and Satohiro Masuda and Kiyoko Kato",
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T1 - Efficacy of aprepitant for the prevention of chemotherapy-induced nausea and vomiting with a moderately emetogenic chemotherapy regimen

T2 - a multicenter, placebo-controlled, double-blind, randomized study in patients with gynecologic cancer receiving paclitaxel and carboplatin

AU - Yahata, Hideaki

AU - Kobayashi, Hiroaki

AU - Sonoda, Kenzo

AU - Shimokawa, Mototsugu

AU - Ohgami, Tatsuhiro

AU - Saito, Toshiaki

AU - Ogawa, Shinji

AU - Sakai, Kunihiro

AU - Ichinoe, Akimasa

AU - Ueoka, Yousuke

AU - Hasuo, Yasuyuki

AU - Nishida, Makoto

AU - Masuda, Satohiro

AU - Kato, Kiyoko

PY - 2016/6/1

Y1 - 2016/6/1

N2 - Background: Substance P contributes to the hypersensitivity reaction (HSR) to paclitaxel in a rat model. Aprepitant acts as an inhibitor of the binding of substance P to the neurokinin-1 receptor and, consequently, may reduce the frequency of paclitaxel-induced HSR. While aprepitant has a prophylactic effect against vomiting caused by high-dose cisplatin, the benefits of aprepitant have not been clearly demonstrated in patients receiving paclitaxel and carboplatin (TC) combination chemotherapy. Methods: We conducted a multicenter, placebo-controlled, double-blind, randomized study in Japanese patients with gynecologic cancer who received TC combination chemotherapy. Patients received aprepitant or placebo together with both a 5-HT3 receptor antagonist and dexamethasone prior to chemotherapy. The primary endpoint was the proportion of patients with HSR, and the secondary endpoints were the proportion of patients with “no vomiting”, “no significant nausea”, and complete response, respectively. Results: Of the 324 randomized patients, 297 (151 in the aprepitant group; 146 in the placebo group) were evaluated. The percentage of patients with HSR (9.2 vs. 7.5 %, respectively; P = 0.339) was not significantly different between the groups. The percentage of “no vomiting” patients (78.2 vs. 54.8 %; P < 0.0001), “no significant nausea” patients (85.4 vs. 74.7 %; P = 0.014), and patients showing complete response (61.6 vs. 47.3 %, P = 0.0073) was significantly higher in the aprepitant group than in the placebo group. Conclusion: The administration of aprepitant did not have a prophylactic effect on the HSR but was effective in reducing nausea and vomiting in gynecologic cancer patients receiving TC combination chemotherapy.

AB - Background: Substance P contributes to the hypersensitivity reaction (HSR) to paclitaxel in a rat model. Aprepitant acts as an inhibitor of the binding of substance P to the neurokinin-1 receptor and, consequently, may reduce the frequency of paclitaxel-induced HSR. While aprepitant has a prophylactic effect against vomiting caused by high-dose cisplatin, the benefits of aprepitant have not been clearly demonstrated in patients receiving paclitaxel and carboplatin (TC) combination chemotherapy. Methods: We conducted a multicenter, placebo-controlled, double-blind, randomized study in Japanese patients with gynecologic cancer who received TC combination chemotherapy. Patients received aprepitant or placebo together with both a 5-HT3 receptor antagonist and dexamethasone prior to chemotherapy. The primary endpoint was the proportion of patients with HSR, and the secondary endpoints were the proportion of patients with “no vomiting”, “no significant nausea”, and complete response, respectively. Results: Of the 324 randomized patients, 297 (151 in the aprepitant group; 146 in the placebo group) were evaluated. The percentage of patients with HSR (9.2 vs. 7.5 %, respectively; P = 0.339) was not significantly different between the groups. The percentage of “no vomiting” patients (78.2 vs. 54.8 %; P < 0.0001), “no significant nausea” patients (85.4 vs. 74.7 %; P = 0.014), and patients showing complete response (61.6 vs. 47.3 %, P = 0.0073) was significantly higher in the aprepitant group than in the placebo group. Conclusion: The administration of aprepitant did not have a prophylactic effect on the HSR but was effective in reducing nausea and vomiting in gynecologic cancer patients receiving TC combination chemotherapy.

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