Publication-only abstracts (abstract number preceded by an "e"), published in conjunction with the 2017 ASCO Annual Meeting but not presented at the Meeting, can be found online only.
A randomized, double-blind, placebo-controlled study of the safety and efficacy of olanzapine for the prevention of chemotherapy-induced nausea and vomiting in patients receiving moderately emetogenic chemotherapy.
Symptom Management/Supportive Care/Palliative Care
Patient and Survivor Care
2017 ASCO Annual Meeting
J Clin Oncol 35, 2017 (suppl; abstr e21699)
Author(s): So Yeon Jeon, Hye Sook Han, Woo Kyun Bae, Moo-Rim Park, Sang-Cheol Lee, Se-Il Go, Hwan Jung Yun, Hyewon Ryu, Yong-Jin Im, Eun-Kee Song; Department of Internal Medicine, Chonbuk National University Medical School, Jeonju, Republic of Korea; Chungbuk National University Hospital, Cheongju, South Korea; Department of Medical Oncology, Chonnam National University Hwasun Hospital, Hwasun, Republic of Korea; Department of Internal Medicine, Wonkwang University Hospital, Iksan, South Korea; Soonchunhyang University Hospital Seoul, Seoul, South Korea; Division of Hematology/Oncology, Department of Internal Medicine, Gyeongsang National University Hospital, Gyeongsang National University School of Medicine, Jinju, South Korea; Chungnam National University Hospital, Daejeon, South Korea; Chungnam National University Hospital, Deajeon, Republic of Korea; Center for Clinical Pharmacology and Biomedical Research Institute, Chonbuk National University Hospital, Jeonju, Republic of Korea; Chonbuk National University Medical School, Jeonbuk, Korea South
Background: Olanzapine was found to be effective for preventing acute and delayed emesis in patients receiving highly emetogenic chemotherapy by randomized phase 3 study. However, there is limited data for the efficacy of olanzapine combined with palonosetron and dexamethasone in patients receiving moderately emetogenic chemotherapy (MEC). Methods: We conducted randomized, double-blind, placebo-controlled study to determine whether olanzapine could reduce the frequency of CINV and improve quality of life (QOL) in patients receiving palonosetron and dexamethasone for the prophylaxis of MEC induced nausea and vomiting. Two groups received either 10 mg of olanzapine orally or matching placebo daily on days 1 through 4. The primary end point was the complete response (no emesis and no use of rescue medication) for the acute phase (0-24 hours after chemotherapy). Secondary end points included the complete responses for the delayed (24-120 hours) and overall phase (0-120 hours), proportion of significant emesis (VAS ≥ 25 mm) for overall phase, use of rescue medications, and effect on QOL by Functional Living Index-Emesis (FLIE) questionnaire. Results: Fifty-six patients were randomized and fifty-four patients were evaluable (29 assigned to olanzapine, and 25 to placebo). The complete response rate was not significant between olanzapine and placebo group in the acute (96.5% vs. 88.0%, P = 0.326), delayed (69.0% vs. 48.0%, P = 0.118), and overall phase (69.0% vs. 48.0%, P = 0.118). However, the percentage of patients with significant emesis (17.2% vs. 44.0%, P = 0.032) and the use of rescue medications (0.03±0.19 vs. 1.88±2.88, P = 0.002) were significantly lower with olanzapine than with placebo in the overall phase. Furthermore, olanzapine group experienced a better QOL than the placebo group, as reported on the FLIE questionnaire (P = 0.015). Conclusions: Olanzapine in addition to palonosetron and dexamethasone significantly improved the management of emesis and QOL among previously untreated patients receiving MEC, although the efficacy was limited to reduce the frequency of CINV. Clinical trial information: NCT02400866
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