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 of Treatment
Supportive Care
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

Abstract

Aim

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.

Methods

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.

Results

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.

Conclusions

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.

Disclosure

All authors have declared no conflicts of interest.