1481PD - Aprepitant for the prevention of chemotherapy-induced nausea and vomiting with a moderately emetogenic chemotherapy: A multicenter, placebo-control...

Date 29 September 2014
Event ESMO 2014
Session Supportive and palliative care
Topics Complications/Toxicities of Treatment
Supportive Measures
Presenter Hideaki Yahata
Citation Annals of Oncology (2014) 25 (suppl_4): iv517-iv541. 10.1093/annonc/mdu356
Authors H. Yahata1, K. Sonoda1, H. Kobayashi2, M. Shimokawa3, T. Ohgami4, T. Saito5, S. Ogawa6, K. Sakai7, A. Ichinoe8, Y. Ueoka9, Y. Hasuo10, M. Nishida11, R. Oishi12, K. Kato1
  • 1Obstetrics And Gynecology, Kyushu University Hospital, 812-8582 - Fukuoka/JP
  • 2Obstetrics And Gynecology, Kagoshima University, 890-8520 - Kagoshima/JP
  • 3Clinical Research, kyushu Cancer Center, Fukuoka/JP
  • 4Obstetrics And Gynecology, Miyazaki Prefectural Hospital, Miyazaki/JP
  • 5Gynecology, National Kyushu Cancer Center, Fukuoka/JP
  • 6Obstetrics And Gynecology, Kyushu Hospital, Kitakyushu/JP
  • 7Obstetrics And Gynecology, Saiseikai Fukuoka Hospital, Fukuoka/JP
  • 8Obstetrics And Gynecology, Kitakyushu Municipal Medical Center, Kitakyushu/JP
  • 9Obstetrics And Gynecology, Hamanomachi Hospital, Fukuoka/JP
  • 10Obstetrics And Gynecology, National Kyushu Medical Center, Fukuoka/JP
  • 11Obstetrics And Gynecology, Fukuoka Red Cross Hospital, Fukuoka/JP
  • 12Pharmacy, Kyushu University Hospital, Fukuoka/JP



Aprepitant is a new neurokinin-1 receptor antagonist developed as a treatment for chemotherapy-induced nausea and vomiting (CINV). Several reports have shown that aprepitant is very effective for the prevention of CINV with highly emetogenic chemotherapy (HEC) in cisplatin-based regimens. However the efficacy of aprepitant for moderately emetogenic chemotherapy (MEC), such as paclitaxel plus carboplatin (TC), is still unclear. We conducted a multicenter, placebo-controlled, double-blind, randomized study in Japanese gynecologic patients who received a TC regimen.


This phase III, randomized, double-blind study enrolled patients from nine institutions with a diagnosis of ovarian, endometrial, or cervical cancer who were scheduled to receive paclitaxel (175-180mg/m2) and carboplatin (AUC=5-6) for the first time. Patients received aprepitant or placebo with a 5-HT3 antagonist (except palonosetron) and dexamethasone before chemotherapy. Patients recorded nausea and vomiting episodes in a diary. Endpoints were proportions of patients with no vomiting, no significant nausea and complete response ( no vomiting and no rescue medication) for five days after chemotherapy.


Of 324 randomized patients, 297 patients (151 in the aprepitant group; 146 in the placebo group) were evaluable for efficacy and toxicity. The percentages of patients with no vomiting (84.8% vs 61.6%, p < 0.0001), with no significant nausea (85.4% vs 74.7%, p = 0.014) and complete response (61.6% vs 47.3%, p = 0.0073) were significantly higher in the aprepitant group than in the placebo group, respectively. None of the patients discontinued the study because of adverse events with aprepitant.


The combination of aprepitant, a 5-HT3 antagonist, and dexamethasone demonstrated efficacy for CINV prevention with MEC in patients with gynecologic cancer receiving a TC regimen.


All authors have declared no conflicts of interest.