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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.

AbstractBACKGROUND:
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.
AuthorsHideaki 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
JournalInternational journal of clinical oncology (Int J Clin Oncol) Vol. 21 Issue 3 Pg. 491-7 (Jun 2016) ISSN: 1437-7772 [Electronic] Japan
PMID26662632 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
Chemical References
  • Antiemetics
  • Morpholines
  • Serotonin 5-HT3 Receptor Antagonists
  • Aprepitant
  • Dexamethasone
  • Carboplatin
  • Paclitaxel
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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