Junichi Nishimura1, Taroh Satoh2, Mutsumi Fukunaga3, Hiroyoshi Takemoto3, Ken Nakata3, Yoshihito Ide4, Takayuki Fukuzaki5, Toshihiro Kudo2, Yasuhiro Miyake6, Masayoshi Yasui7, Shunji Morita8, Daisuke Sakai2, Mamoru Uemura9, Taishi Hata9, Ichiro Takemasa9, Tsunekazu Mizushima9, Yuko Ohno10, Hirofumi Yamamoto9, Mitsugu Sekimoto11, Riichiro Nezu12, Yuichiro Doki9, Masaki Mori9. 1. Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Yamadaoka 2-2, Suita, Osaka, Japan. Electronic address: jnishimura@gesurg.med.osaka-u.ac.jp. 2. Department of Frontier-Science for Cancer and Chemotherapy, Graduate School of Medicine, Yamadaoka 2-2, Suita, Osaka, Japan. 3. Department of Surgery, Sakai City Hospital, Sakai-Ward Minami Yasui-cho 1-1-1, Sakai, Osaka, Japan. 4. Department of Surgery, Yao Municipal Hospital, Ryugecho 1-3-1, Yao, Osaka, Japan. 5. Department of Surgery, Ikeda Municipal Hospital, Jyounan 3-1-18, Ikeda, Osaka, Japan. 6. Department of Surgery, Minoh City Hospital, Kayano 5-7-1, Minoh, Osaka, Japan. 7. Department of Surgery, Kaizuka City Hospital, Hori 3-10-20, Kaizuka, Osaka, Japan. 8. Department of Surgery, Toyonaka Municipal Hospital, Shibahara 4-14-1, Toyonaka, Osaka, Japan. 9. Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Yamadaoka 2-2, Suita, Osaka, Japan. 10. Department of Mathematical Health Science, Graduate School of Medicine, Osaka University, Yamadaoka 1-7, Suita, Osaka, Japan. 11. Department of Surgery, National Hospital Organization, Osaka National Hospital, Hoenzakka 2-1-14, Osaka, Osaka, Japan. 12. Department of Surgery, Nishinomiya Municipal Hospital, Hayashidacho 8-24, Nishinomiya, Hyogo, Japan.
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. Little is known about the feasibility and safety of aprepitant in patients treated with oxaliplatin. METHODS: In this multicentre, open label, randomised, phase 3 trial, we recruited patients with colorectal cancer who underwent anoxaliplatin-based chemotherapy. Patients were centrally randomised 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 end-point was the proportion of patients with no emesis. RESULTS: A total of 413 patients entered this clinical trial from 25 centres in Japan. Significantly more patients in the aprepitant group achieved no vomiting overall and delayed phase than those in the control group (95.7% versus 83.6%, and 95.7% versus 84.7%, respectively). The aprepitant group also had statistically significantly higher percentages of no significant nausea, complete response and complete protection than the control group overall. In the control group, the percentages of no vomiting were higher in the second cycle than in the first cycle. The incidence of vomiting occurred day 7 or later was significantly higher in the control group compared with the aprepitant group. Other adverse events were not significant between the groups. CONCLUSION: The aprepitant therapy was more effective than the control therapy for prevention of CINV in colorectal cancer patients receiving anoxaliplatin-based regimen.
RCT Entities:
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. Little is known about the feasibility and safety of aprepitant in patients treated with oxaliplatin. METHODS: In this multicentre, open label, randomised, phase 3 trial, we recruited patients with colorectal cancer who underwent an oxaliplatin-based chemotherapy. Patients were centrally randomised 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 end-point was the proportion of patients with no emesis. RESULTS: A total of 413 patients entered this clinical trial from 25 centres in Japan. Significantly more patients in the aprepitant group achieved no vomiting overall and delayed phase than those in the control group (95.7% versus 83.6%, and 95.7% versus 84.7%, respectively). The aprepitant group also had statistically significantly higher percentages of no significant nausea, complete response and complete protection than the control group overall. In the control group, the percentages of no vomiting were higher in the second cycle than in the first cycle. The incidence of vomiting occurred day 7 or later was significantly higher in the control group compared with the aprepitant group. Other adverse events were not significant between the groups. CONCLUSION: The aprepitant therapy was more effective than the control therapy for prevention of CINV in colorectal cancerpatients receiving an oxaliplatin-based regimen.
Authors: Joseph S Bubalo; Jon D Herrington; Marc Takemoto; Patricia Willman; Michael S Edwards; Casey Williams; Alan Fisher; Alison Palumbo; Eric Chen; Charles Blanke; Charles D Lopez Journal: Support Care Cancer Date: 2017-10-31 Impact factor: 3.603
Authors: Marziyeh Ghorbani; Mehdi Dehghani; Noushin Fahimfar; Soha Namazi; Ali Dehshahri Journal: Support Care Cancer Date: 2022-01-17 Impact factor: 3.603
Authors: Karin Jordan; Luisa Blättermann; Axel Hinke; Carsten Müller-Tidow; Franziska Jahn Journal: Support Care Cancer Date: 2017-08-31 Impact factor: 3.603
Authors: Fausto Roila; David Warr; Paul J Hesketh; Richard Gralla; Jorn Herrstedt; Karin Jordan; Matti Aapro; Enzo Ballatori; Bernardo Rapoport Journal: Support Care Cancer Date: 2016-08-11 Impact factor: 3.603