PracticeUpdate: Oncology - Winter 2018

ASCO 2018 27

Mirtazapine Prevents Delayed Nausea and Vomiting in Highly Emetogenic Chemotherapy Adverse effects were reported to be mild to moderate

By the PracticeUpdate Editorial Team M irtazapine is effective in reduc- ing the occurrence of nausea and vomiting during chemotherapy with agents apt to cause these miseries, according to results of a study presented at ASCO 2018. Nausea and vomiting that develop during highly emetogenic chemotherapy (HEC) of breast cancer is miserable for the patient and can result in interruption or alteration of chemotherapy. Preventing these adverse effects of HEC is desirable. In seeking a solution, the researchers from Fudan University Shanghai Cancer Center honed in on mirtazapine. The drug is an antagonist of a number of adrenergic and serotonin receptors. Its wide-ranging effects include lessening of symptoms of depression, and relief of insomnia and emesis. Concerning the latter, not much is known of the drug’s effect on the relief of delayed nausea and vomiting. Establishing a benefit would be worthwhile because the drug is available as a generic and thus is less expensive to use. To approach this issue, the researchers enrolled patients in a phase III, open-label study. The patients were undergoing

than those in the control group, with signifi- cantly better rates of delayed CR (76.1% vs. 49.0%; P = .006) and overall CR (58.7% vs. 34.7%; P = .019). The good news held, with delayed CR rates of 88.2% versus 55.0% (P = .010) in the third cycle of HEC (P = .010) in the second cycle for both delayed CR (of acute CR [67.4% vs. 51.0%; P = .006]). CC rates also significantly favored the mirtazap- ine group in all 3 cycles of HEC. Adverse effects were mild to moderate and were not as burdensome to patients in the mirtazapine group, who reported better night-time sleep and weight gain. “Mirtazapine with aprepitant, a 5-HT3 receptor antagonist, and dexametha- sone significantly improved HEC-induced delayed nausea and vomiting preven- tion in patients with breast cancer who experienced delayed emesis in the same chemotherapy previously,” concluded Dr. Cao and colleagues. A limitation of the trial was the patient number. Originally intended to enroll 212 patients, enrollment was slow and was closed at 95 patients. www.practiceupdate.com/c/69127

treatment for breast cancer and had experienced delayed nausea and vomiting during treatment with cisplatin-containing chemotherapy or combined adriamycin and cyclophosphamide therapy and agreed to at least 3 cycles of the same regimen. Of the95patients in the trial (NCT02336750), 46 were randomly assigned to receive mirtazapine (15 mg on days 2–4 of each chemotherapy cycle). The remaining 49 patients did not receive the drug. Both the experimental and control groups received the serotonin type 3 antagonist aprepitant along with dexamethasone (7.5 mg, also on days 2–4). The primary response was a complete response (CR), defined as the lack of vom- iting without the use of rescue drugs in the delayed period of treatment from 25 to 120 hours. Secondary endpoints included CR during the acute phase of treatment (0–24 hr) and for the full 120 hours and complete control (CC), defined as the lack of vomit- ing, no use of rescue medications, and, if it occurred, only mild nausea. In the first cycle of chemotherapy, those receivingmirtazapinemade out much better

© ASCO/Scott Morgan 2018

VOL. 2 • NO. 3 • 2018