Abstract
Background
We previously reported in the SENRI trial on the usefulness of aprepitant for the prevention of chemotherapy-induced nausea and vomiting (CINV) in colorectal cancer patients receiving an oxaliplatin-based regimen which is classified as moderately emetogenic cancer chemotherapy. In the present subgroup analysis of the SENRI trial, we assessed the risk factors for CINV in colorectal cancer patients who received oxaliplatin-based chemotherapy.
Methods
Multivariate logistic regression models were used to assess the impact of aprepitant use and patient characteristics on vomiting and nausea. We also assessed the proportion of CINV in patients by gender.
Results
Female gender and aprepitant use were associated with the incidence of vomiting and no significant nausea. Significantly more men achieved no vomiting than women (92.9 vs 84.5 % in men and women, respectively; P = 0.0001). The rate of no nausea, complete response, complete protection, and total control was also higher in men. The rate rescue therapy use was significantly higher in women than men. We compared the rate of CINV between aprepitant and control groups and found a significant difference in male patients who achieved no vomiting and complete protection in the overall phase. In women, the rate of no nausea, no vomiting, and total control was higher in the aprepitant group than in the control group.
Conclusions
Gender and aprepitant use were risk factors for CINV in colorectal patients who received oxaliplatin-based chemotherapy. Aprepitant therapy was more effective for women than for men in the prevention of CINV in colorectal cancer patients receiving an oxaliplatin-based regimen.
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References
Network NCCN (2016) NCCN clinical practice guidelines in oncology: antiemesis
Roila F, Herrstedt J, Aapro M et al (2010) Guideline update for MASCC and ESMO in the prevention of chemotherapy- and radiotherapy-induced nausea and vomiting: results of the Perugia consensus conference. Ann Oncol 21(Suppl 5):v232–v243
Basch E, Prestrud AA, Hesketh PJ et al (2011) Antiemetics: American Society of Clinical Oncology clinical practice guideline update. J Clin Oncol 29:4189–4198
Oncology JSoC (2010) Guideline: appropriate use of antiemetics. Kanehara & Co., Ltd, Tokyo (in Japanese)
Nishimura J, Satoh T, Fukunaga M et al (2015) Combination antiemetic therapy with aprepitant/fosaprepitant in patients with colorectal cancer receiving oxaliplatin-based chemotherapy (SENRI trial): a multicentre, randomised, controlled phase 3 trial. Eur J Cancer 51:1274–1282
Hesketh PJ, Aapro M, Street JC et al (2010) Evaluation of risk factors predictive of nausea and vomiting with current standard-of-care antiemetic treatment: analysis of two phase III trials of aprepitant in patients receiving cisplatin-based chemotherapy. Support Care Cancer 18:1171–1177
Hesketh PJ, Grunberg SM, Herrstedt J et al (2006) Combined data from two phase III trials of the NK1 antagonist aprepitant plus a 5HT 3 antagonist and a corticosteroid for prevention of chemotherapy-induced nausea and vomiting: effect of gender on treatment response. Support Care Cancer 14:354–360
Poon KS, Un MK, Low XH et al (2013) Impact of cancer-related fatigue on chemotherapy-induced nausea and vomiting in Asian cancer patients. Pharmacoepidemiol Drug Saf 22:1345–1351
Roila F, Tonato M, Basurto C et al (1989) Protection from nausea and vomiting in cisplatin-treated patients: high-dose metoclopramide combined with methylprednisolone versus metoclopramide combined with dexamethasone and diphenhydramine: a study of the Italian Oncology Group for Clinical Research. J Clin Oncol 7:1693–1700
Sekine I, Segawa Y, Kubota K et al (2013) Risk factors of chemotherapy-induced nausea and vomiting: index for personalized antiemetic prophylaxis. Cancer Sci 104:711–717
Tamura K, Aiba K, Saeki T et al (2015) Testing the effectiveness of antiemetic guidelines: results of a prospective registry by the CINV Study Group of Japan. Int J Clin Oncol 20:855–865
Tonato M, Roila F, Del Favero A (1991) Methodology of antiemetic trials: a review. Ann Oncol 2:107–114
Rapoport BL (2014) Efficacy of a triple antiemetic regimen with aprepitant for the prevention of chemotherapy-induced nausea and vomiting: effects of gender, age, and region. Curr Med Res Opin 30:1875–1881
Celio L, Denaro A, Agustoni F et al (2012) Palonosetron plus 1-day dexamethasone for the prevention of nausea and vomiting due to moderately emetogenic chemotherapy: effect of established risk factors on treatment outcome in a phase III trial. J Support Oncol 10:65–71
Hesketh PJ, Younger J, Sanz-Altamira P et al (2009) Aprepitant as salvage antiemetic therapy in breast cancer patients receiving doxorubicin and cyclophosphamide. Support Care Cancer 17:1065–1070
Hickok JT, Roscoe JA, Morrow GR et al (2005) 5-Hydroxytryptamine-receptor antagonists versus prochlorperazine for control of delayed nausea caused by doxorubicin: a URCC CCOP randomised controlled trial. Lancet Oncol 6:765–772
Sullivan JR, Leyden MJ, Bell R (1983) Decreased cisplatin-induced nausea and vomiting with chronic alcohol ingestion. N Engl J Med 309:796
Warr DG, Hesketh PJ, Gralla RJ et al (2005) Efficacy and tolerability of aprepitant for the prevention of chemotherapy-induced nausea and vomiting in patients with breast cancer after moderately emetogenic chemotherapy. J Clin Oncol 23:2822–2830
Oechsle K, Muller MR, Hartmann JT et al (2006) Aprepitant as salvage therapy in patients with chemotherapy-induced nausea and emesis refractory to prophylaxis with 5-HT(3) antagonists and dexamethasone. Onkologie 29:557–561
Wu CE, Liaw CC (2012) Using aprepitant as secondary antiemetic prophylaxis for cancer patients with cisplatin-induced emesis. Support Care Cancer 20:2357–2361
Acknowledgments
This study is supported by a grant from The Supporting Center for Clinical Research and Education (Osaka, Japan), a nonprofit foundation. We thank the patients for their participation in this study, the study management team and staff at individual study sites. Participating institusions included Hannan Chuo Hospital, Higashiosaka City General Hospital, Hyogo Prefectural Nishinomiya Hospital, Ikeda Municipal Hospital, Iseikai Hospital, Japan Community Health care Organization Osaka Hospital, Japan Community Health care Organization Osaka Minato Central Hospital, Kaizuka City Hospital, Kansai Rosai Hospital, Kawasaki hospital, Kindai University Nara Hospital, Kinki Central Hospital, Minoh City Hospital, National Hospital Organization Kure Medical Center and Chugoku Cancer Center, National Hospital Organization Osaka National Hospital, Nippon Telegraph and Telephone West Corporation Osaka Hospital, Nishinomiya Municipal Hospital, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka University Hospital, Rinku General Medical Center, Saiseikai Senri Hospital, Sakai city hospital, Suita Municipal Hospital, Toyonaka Municipal Hospital, Yao Municipal Hospital.
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TS has received consulting fees from Eli Lilly, Daiici Sankyo, Ono Pharmaceutical, Merck Serono Co. Ltd, Bayer Pharmaceutical Co. Ltd, and Chugai Pharmaceutical Co. Ltd; honoraria from Chugai Pharmaceutical Co. Ltd, Merck Serono Co. Ltd, Bristol-Myers K.K., Taiho Pharmaceutical Co. Ltd, Bayer Pharmaceutical Co.Ltd and Takeda Pharmaceutical Co. Ltd; and departmental research grants from Chugai Pharmaceutical Co. Ltd and Yakult Honsha Co. Ltd. All other authors have declared no conflict of interest.
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Hiroyoshi Takemoto and Junichi Nishimura are joint first authors.
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Takemoto, H., Nishimura, J., Komori, T. et al. Combination antiemetic therapy with aprepitant/fosaprepitant in patients with colorectal cancer receiving oxaliplatin-based chemotherapy in the SENRI trial: analysis of risk factors for vomiting and nausea. Int J Clin Oncol 22, 88–95 (2017). https://doi.org/10.1007/s10147-016-1022-9
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DOI: https://doi.org/10.1007/s10147-016-1022-9