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: Results of the Korean South West Oncology Group (KSWOG) Study
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Purpose Data on the efficacy of olanzapine in patients receiving moderately emetogenic chemotherapy (MEC) are limited. This study aimed to evaluate and compare the efficacy of olanzapine versus placebo in controlling nausea and vomiting in patients receiving MEC. Materials and Methods We conducted a randomized, double-blind, placebo-controlled study to determine whether olanzapine can reduce the frequency of chemotherapy-induced nausea and vomiting (CINV) and improve the quality of life (QOL) in patients receiving palonosetron and dexamethasone as prophylaxis for MEC-induced nausea and vomiting. The primary end point was complete response for the acute phase (0-24 hours after chemotherapy). The secondary end points were complete response for the delayed (24-120 hours) and overall phase (0-120 hours), proportion of significant nausea (visual analogue scale 25 mm), use of rescue medications, and effect on QOL. Results Fifty-six patients were randomized to the olanzapine (n=29) and placebo (n=27) groups. Complete response rates were not significantly different between the olanzapine and placebo groups in the acute (96.5% vs. 88.0%, p=0.326), delayed (69.0% vs. 48.0%, p=0.118), and overall phases (69.0% vs. 48.0%, p=0.118). However, the percentage of patients with significant nausea (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 lower in the olanzapine group than in the placebo. Furthermore, the olanzapine group demonstrated better QOL (p=0.015). Conclusion Olanzapine combined with palonosetron and dexamethasone significantly improved QOL and vomiting control among previously untreated patients receiving MEC, although the efficacy was limited to the reduction of the frequency of CINV.
Abstract
Purpose Data on the efficacy of olanzapine in patients receiving moderately emetogenic chemotherapy (MEC) are limited. This study aimed to evaluate and compare the efficacy of olanzapine versus placebo in controlling nausea and vomiting in patients receiving MEC. Materials and Methods We conducted a randomized, double-blind, placebo-controlled study to determine whether olanzapine can reduce the frequency of chemotherapy-induced nausea and vomiting (CINV) and improve the quality of life (QOL) in patients receiving palonosetron and dexamethasone as prophylaxis for MEC-induced nausea and vomiting. The primary end point was complete response for the acute phase (0-24 hours after chemotherapy). The secondary end points were complete response for the delayed (24-120 hours) and overall phase (0-120 hours), proportion of significant nausea (visual analogue scale 25 mm), use of rescue medications, and effect on QOL. Results Fifty-six patients were randomized to the olanzapine (n=29) and placebo (n=27) groups. Complete response rates were not significantly different between the olanzapine and placebo groups in the acute (96.5% vs. 88.0%, p=0.326), delayed (69.0% vs. 48.0%, p=0.118), and overall phases (69.0% vs. 48.0%, p=0.118). However, the percentage of patients with significant nausea (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 lower in the olanzapine group than in the placebo. Furthermore, the olanzapine group demonstrated better QOL (p=0.015). Conclusion Olanzapine combined with palonosetron and dexamethasone significantly improved QOL and vomiting control among previously untreated patients receiving MEC, although the efficacy was limited to the reduction of the frequency of CINV.
참고문헌 (19)
- Ingle RJ, "Conditionability of cancer chemotherapy patients", Oncol Nurs Forum, 11, pp.97~102 (1984)
- Richardson JL, "The influence of symptoms of disease and side effects of treatment on compliance with cancer therapy", J Clin Oncol, 6, pp.1746~1752 (1988)
- Herrstedt J, "Antiemetics : an update and the MASCC guidelines applied in clinical practice", Nat Clin Pract Oncol, 5, pp.32~43 (2008)
- Hesketh PJ, "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, pp.354~360 (2006)
- Hesketh PJ, "Antiemetics : American Society of Clinical Oncology focused guideline update", J Clin Oncol, 34, pp.381~386 (2016)
- Herrstedt J, "2016 Updated MASCC", ESMO consensus recommendations : prevention of nausea and vomiting following high emetic risk chemotherapy, 2017, pp.25, 277~288
- Jordan K, "International antiemetic guidelines on chemotherapy induced nausea and vomiting(CINV) : content and implementation in daily routine practice", Eur J Pharmacol, 722, pp.197~202 (2014)
- Geling O, "Should 5-hydroxytryptamine-3 receptor antagonists be administered beyond 24 hours after chemotherapy to prevent delayed emesis? Systematic re-evaluation of clinical evidence and drug cost implications", J Clin Oncol, 23, pp.1289~1294 (2005)
- Bymaster FP, "Potent antagonism of 5-HT(3)and 5-HT(6)receptors by olanzapine", Eur J Pharmacol, 430, pp.341~349 (2001)
- Navari RM, "Olanzapine for the prevention of chemotherapy-induced nausea and vomiting", N Engl J Med, 375, pp.134~142 (2016)
- Navari RM, "Olanzapine versus aprepitant for the prevention of chemotherapy-induced nausea and vomiting : a randomized phase III trial", J Support Oncol, 9, pp.188~195 (2011)
- Mizukami N, "Olanzapine for the prevention of chemotherapy-induced nausea and vomiting in patients receiving highly or moderately emetogenic chemotherapy : a randomized, double-blind, placebo-controlled study", J Pain Symptom Manage, 47, pp.542~550 (2014)
- Borjeson S, "Similarities and differences in assessing nausea on a verbal category scale and a visual analogue scale", Cancer Nurs, 20, pp.260~266 (1997)
- Martin AR, "Assessing the impact of chemotherapy-induced nausea and vomiting on patients' daily lives : a modified version of the Functional Living Index-Emesis(FLIE)with 5-day recall", Support Care Cancer, 11, pp.522~527 (2003)
- Hesketh PJ, "Antiemetics : American Society of Clinical Oncology clinical practice guideline update", J Clin Oncol, 35, pp.3240~3261 (2017)
- Berger MJ, "NCCN guidelines insights: antiemesis, version 2.2017", J Natl Compr Canc Netw, 15, pp.883~893 (2017)
- Chiu L, "Efficacy of olanzapine for the prophylaxis and rescue of chemotherapy-induced nausea and vomiting(CINV) : a systematic review and meta-analysis", Support Care Cancer, 24, pp.2381~2392 (2016)
- Navari RM, "A phase II trial of olanzapine for the prevention of chemotherapy-induced nausea and vomiting : a Hoosier Oncology Group study", Support Care Cancer, 13, pp.529~534 (2005)
- Tan L, "Clinical research of olanzapine for prevention of chemotherapyinduced nausea and vomiting", J Exp Clin Cancer Res, 28, pp.131~ (2009)