Abstract | BACKGROUND: 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:
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Authors | 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 |
Journal | International journal of clinical oncology
(Int J Clin Oncol)
Vol. 21
Issue 3
Pg. 491-7
(Jun 2016)
ISSN: 1437-7772 [Electronic] Japan |
PMID | 26662632
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
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Chemical References |
- Antiemetics
- Morpholines
- Serotonin 5-HT3 Receptor Antagonists
- Aprepitant
- Dexamethasone
- Carboplatin
- Paclitaxel
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Topics |
- Adult
- Aged
- Antiemetics
(therapeutic use)
- Antineoplastic Combined Chemotherapy Protocols
(adverse effects)
- Aprepitant
- Carboplatin
(administration & dosage, adverse effects)
- Dexamethasone
(therapeutic use)
- Double-Blind Method
- Drug Hypersensitivity
(etiology, prevention & control)
- Drug Therapy, Combination
- Female
- Genital Neoplasms, Female
(drug therapy)
- Humans
- Middle Aged
- Morpholines
(therapeutic use)
- Nausea
(chemically induced, prevention & control)
- Paclitaxel
(administration & dosage, adverse effects)
- Remission Induction
- Serotonin 5-HT3 Receptor Antagonists
(therapeutic use)
- Vomiting
(chemically induced, prevention & control)
- Young Adult
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