O-001 - A phase III trial of aprepitant in colorectal cancer patients receiving oxaliplatin-based chemotherapy (SENRI Trial)

Date 04 July 2015
Event WorldGI 2015
Session Oral and LBA abstracts
Topics Anti-Cancer Agents & Biologic Therapy
Supportive Care
Colon Cancer
Rectal Cancer
Presenter J. Nishimura
Citation Annals of Oncology (2015) 26 (suppl_4): 108-116. 10.1093/annonc/mdv235
Authors J. Nishimura1, T. Mizushima1, M. Fukunaga2, T. Fukuzaki3, T. Hata1, I. Takemasa1, H. Yamamoto1, M. Sekimoto4, R. Nezu1, Y. Doki1, M. Mori1, T. Satoh1, H. Takemoto5, K. Nakata6, Y. Ide7, T. Kudo1, Y. Miyake1, M. Yasui8, S. Morita9, D. Sakai1, M. Uemura1, Y. Ohno1
  • 1Osaka University Graduate School of Medicine, Suita/JP
  • 2Hyogo Prefectural Nishinomiya Hospital, Nishinomiya/JP
  • 3Saiseikai Senri Hospital, Suita/JP
  • 4Osaka National Hospital, Osaka/JP
  • 5Kinki Central Hospital of the Mutual Aid Association of Public School Teachers, Itami/JP
  • 6Sakai City Hospital, Sakai/JP
  • 7Yao Municipal Hospital, Yao/JP
  • 8Kaizuka City Hospital, Kaizuka/JP
  • 9Toyonaka Municipal Hospital, Toyonaka/JP

Abstract

Introduction

The oral neurokinin-1 antagonist aprepitant is recommended in several guidelines for preventing chemotherapy-induced nausea & vomiting (CINV) due to highly emetogenic cancer chemotherapy. In recent guidelines, FOLFOX and XELOX therapies are classified as having moderate emetogenic risk. However, in the phase III study of oxaliplatin-based chemotherapy in patients with metastatic colorectal cancer, the rates of nausea and vomiting ranged from 60.5% to 73.7% and 47.2% to 44.2%, respectively. It is very important to control and minimize nausea and vomiting to enable continuation of cancer chemotherapy. In this study, we conducted a multicenter, randomized phase III study to evaluate the usefulness of the combined use of aprepitant in colorectal cancer patients treated with oxaliplatin.

Methods

In this multicenter, open label, randomized, phase 3 trial, we recruited patients with colorectal cancer who underwent an oxaliplatin-based chemotherapy. Patients were centrally randomized in a 1:1 ratio to the control group (5-HT3-receptor antagonist + dexamethasone) or aprepitant group (5-HT3-receptor antagonist + dexamethasone + aprepitant or fosaprepitant) in the first course. All patients were treated with aprepitant/fosaprepitant therapy in the second course. The primary endpoint was the rate of patients with no emesis. We also analyzed the potential effect of gender on treatment response.

Results

A total of 413 patients entered this clinical trial from 25 centers in Japan. Significantly more patients in the aprepitant group achieved no vomiting overall and delayed phase than those in the control group (95.7% vs. 83.6% and 95.7% vs. 84.7%, respectively). There was no significant difference in adverse events between the groups. In the control group, 64% of women had overall complete response compared with 81% of men. In the aprepitant group, 78% of women had overall complete response compared with 90% of men. In women, the rates of no nausea and complete protection were significantly higher in the aprepitant group compared with the control group.

Conclusion

In colorectal cancer patients receiving oxaliplatin-based chemotherapy, the aprepitant therapy during chemotherapy improved antiemetic control compared with the control therapy. The addition of aprepitant might be more effective in female gender.