Hideaki Yahata1, Hiroaki Kobayashi2, Kenzo Sonoda1, Mototsugu Shimokawa3, Tatsuhiro Ohgami4, Toshiaki Saito5, Shinji Ogawa6, Kunihiro Sakai7, Akimasa Ichinoe8, Yousuke Ueoka9, Yasuyuki Hasuo10, Makoto Nishida11, Satohiro Masuda12, Kiyoko Kato1. 1. Department of Obstetrics and Gynecology, Kyushu University Hospital, Fukuoka, Japan. 2. Department of Obstetrics and Gynecology, Faculty of Medicine, Kagoshima University Hospital, Kagoshima, Japan. hirokoba@m2.kufm.kagoshima-u.ac.jp. 3. Center of Clinical Research, National Kyushu Cancer Center, Fukuoka, Japan. 4. Department of Obstetrics and Gynecology, Miyazaki Prefectural Hospital, Miyazaki, Japan. 5. Gynecology Service, National Kyushu Cancer Center, Fukuoka, Japan. 6. Department of Obstetrics and Gynecology, Kyushu Hospital, Kitakyushu, Japan. 7. Department of Obstetrics and Gynecology, Saiseikai Fukuoka Hospital, Fukuoka, Japan. 8. Department of Obstetrics and Gynecology, Kitakyushu Municipal Medical Center, Kitakyushu, Japan. 9. Department of Obstetrics and Gynecology, Hamanomachi Hospital, Fukuoka, Japan. 10. Department of Obstetrics and Gynecology, National Kyushu Medical Center, Fukuoka, Japan. 11. Department of Obstetrics and Gynecology, Fukuoka Red Cross Hospital, Fukuoka, Japan. 12. Department of Pharmacy, Kyushu University Hospital, Fukuoka, Japan.
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 receivedTC 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.
RCT Entities:
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 cancerpatients receiving TC combination chemotherapy.
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