Publication-only abstracts (abstract number preceded by an "e"), published in conjunction with the 2019 ASCO Annual Meeting but not presented at the Meeting, can be found online only.
Preliminary result of phase II study of megestrol combined with 5-hydroxytryptamine 3 inhibitor and dexamethasone for the prevention of nausea and vomiting induced by high emetogenic chemotherapy.
Symptoms and Survivorship
2019 ASCO Annual Meeting
J Clin Oncol 37, 2019 (suppl; abstr e23049)
Author(s): Qiong Wu, Suxia Luo, Ning Li, Wenying Deng, Yijie Ma, Xinyi Yang; Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China; Department of Medical Oncology, Henan Cancer Hospital, Zhengzhou, China; Henan Cancer Hospital, Zhengzhou, China
Background: Chemotherapy-induced nausea and vomiting (CINV) is one of the most distressing treatment-related side effects and have a strong impact on treatment adherence. A triplet antiemetic regimen, which is composed of neurokinin-1 receptor antagonist (NK1 RA), 5-hydroxytryptamine 3 (5-HT3) inhibitor and dexamethasone, is recommended by current antiemetic guidelines. However, NK1 RA is not available in hospital and more expensive for Chinese patients. Megestrol is currently known as more effective appetite stimulants in patients with cachexia or loss of appetite, but its antiemetic properties are less well known. Therefore, the aim of this study was to further evaluate the efficacy and safety of megestrol for the prevention of CINV. Methods: Patients treated with high emetogenic chemotherapy (HEC) were randomly divided into experimental group and control group. The antiemetic regimen of control group: 5-HT3 inhibitor 5mg/d, dexamethasone 12mg/d1, 8mg/d2-4. The regimen of experimental group: the use of 5-HT3 inhibitor and dexamethasone was the same as that of control group, and each patient took megestrol 160mg orally from the first day of chemotherapy for 10 days. Digestive tract reactions were daily evaluated after beginning of HEC. Primary end point was rate of complete response to vomiting and nausea. Results: From September 7 to December 31, 2018, 60 patients were enrolled and randomized in the study. The delayed nausea and vomiting rates were significantly lower in experimental group than control group (nausea: 63.3% vs 83.3%; vomiting: 13.3% vs 33.3%; p< 0.00). The control group was significantly higher rate of Grade 3-4 vomiting than that of the experimental group (20% vs 0%, p< 0.01). Conclusions: Megestrol, combined with dexamethasone and 5-HT3 inhibitor, has been shown to be able to successfully control CINV and no increase side effects during HEC. Clinical trial information: ChiCTR1800017953.
|Group||Number||Delayed vomiting rate (%)||Delayed nausea rate (%)||3-4 grade vomiting rate (%)|
|P-value||< 0.00||< 0.00||< 0.01|