Short-course olanzapine to prevent delayed emesis following carboplatin/paclitaxel for gynecologic cancer: a randomised study

Abstract

Purpose:

To explore efficacy of short-course olanzapine with or without low-dose dexamethasone for prevention of delayed emesis in gynecologic cancer patients receiving carboplatin/paclitaxel.

Methods:

This was a prospective study in 81 chemo-naive patients receiving 0.25 mg intravenous palonosetron, 16 mg dexamethasone, and 10 mg oral olanzapine before chemotherapy. On days 2 and 3, patients randomly received 10 mg olanzapine (arm A; n=27), 10 mg olanzapine plus 4 mg dexamethasone (arm B; n=27), or 8 mg dexamethasone (reference arm C; n=27). The primary endpoint was total control (TC; no vomiting, no rescue antiemetics, and no nausea) on days 2–5, using a diary. Secondary endpoints included proportion of patients with no emesis impact on daily life using the Functional Living Index–Emesis (FLIE) questionnaire, and patient’s satisfaction with antiemetic coverage.

Results:

Fifty-two percent of patients in arm A (P=0.406), 59% in arm B (P=0.779), and 67% in arm C had a delayed TC. Secondary analyses showed no significant difference across arms in any efficacy endpoint. FLIE scores as well as mean satisfaction scores were similar across arms.

Conclusions:

In this exploratory study with a small sample size, we did not find any clue about better control of delayed emesis with either olanzapine regimen in gynecologic cancer patients treated with carboplatin/paclitaxel and receiving the same prophylaxis for acute emesis.

Keywords

Carboplatin CINV emesis olanzapine palonosetron

Get full access to this article

View all access options for this article.

References

Jordan

Jahn

Aapro

Recent developments in the prevention of chemotherapy-induced nausea and vomiting (CINV): a comprehensive review. Ann Oncol 2015; 26: 1081–1090.

Hesketh

PJ.

Chemotherapy-induced nausea and vomiting. N Engl J Med 2008; 358: 2482–2494.

Roila

Herrstedt

Aapro

et al . 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 2010; 21 (suppl 5): v232–v243.

Basch

Prestrud

Hesketh

et al . Antiemetics: American Society of Clinical Oncology clinical practice guideline update. J Clin Oncol 2011; 29: 4189–4198.

Furukawa

Akasaka

Shigemitsu

et al . Evaluation of the relation between patient characteristics and the state of chemotherapy-induced nausea and vomiting in patients with gynecologic cancer receiving paclitaxel and carboplatin. Arch Gynecol Obstet 2014; 289: 859–864.

Navari

RM.

Management of chemotherapy-induced nausea and vomiting. Drugs 2013; 73: 249–262.

Chow

Chiu

Navari

et al . Efficacy and safety of olanzapine for the prophylaxis of chemotherapy-induced nausea and vomiting (CINV) as reported in phase I and II studies: a systematic review. Support Care Cancer 2016; 24: 1001–1008.

Chiu

Chow

Popovic

et al . Efficacy of olanzapine for the prophylaxis and rescue of chemotherapy-induced nausea and vomiting (CINV): a systematic review and meta-analysis. Support Care Cancer 2016; 24: 2381–2392.

Navari

Gray

Kerr

AC.

Olanzapine versus aprepitant for the prevention of chemotherapy-induced nausea and vomiting: a randomized phase III trial. J Support Oncol 2011; 9: 188–195.

10.

Bloechl-Daum

Deuson

Mavros

Hansen

Herrstedt

Delayed nausea and vomiting continue to reduce patient’s quality of life after highly and moderately emetogenic chemotherapy despite antiemetic treatment. J Clin Oncol 2006; 24: 4472–4478.

11.

Decker

DeMeyer

Kisko

DL.

Measuring the maintenance of daily life activities using the Functional Living Index–Emesis (FLIE) in patients receiving moderately emetogenic chemotherapy. J Support Oncol 2006; 4: 35–41.

12.

Mizukami

Yamauchi

Koike

et al . 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 2014; 47: 542–550.

13.

Tanioka

Kitao

Matsumoto

et al . A randomised, placebo-controlled, double-blind study of aprepitant in nondrinking women younger than 70 years receiving moderately emetogenic chemotherapy. Br J Cancer 2013; 109: 859–865.

14.

Vardy

Chiew

Galica

Pond

Tannock

IF.

Side effects associated with the use of dexamethasone for prophylaxis of delayed emesis after moderately emetogenic chemotherapy. Br J Cancer 2006; 94: 1011–1015.

15.

Navari

Qin

Ruddy

et al . Olanzapine for the prevention of chemotherapy-induced nausea and vomiting. N Engl J Med 2016; 375: 134–142.

16.

Roila

Ruggeri

Ballatori

Del Favero

Tonato

Aprepitant versus dexamethasone for preventing chemotherapy-induced delayed emesis in patients with breast cancer: a randomized double-blind study. J Clin Oncol 2014; 32: 101–106.

17.

Hernandez Torres

Mazzarello

et al . Defining optimal control of chemotherapy-induced nausea and vomiting: based on patients’ experience. Support Care Cancer 2015; 23: 3341–3359.

18.

Roila

Molassiotis

Herrstedt

et al . 2016 MASCC and ESMO guideline update for the prevention of chemotherapy- and radiotherapy-induced nausea and vomiting and of nausea and vomiting in advanced cancer patients. Ann Oncol 2016; 27 (suppl 5): v119–v133.

19.

Hesketh

Kris

Basch

et al . Antiemetics: American Society of Clinical Oncology clinical practice update. J Clin Oncol 2017; 35: 3240–3261.

20.

Yahata

Kobayashi

Sonoda

et al . Efficacy of aprepitant for the prevention of chemotherapy-induced nausea and vomiting with a moderately emetogenic chemotherapy regimen: a multicenter, placebo-controlled, double-blind, randomized study in patients with gynecologic cancer receiving paclitaxel and carboplatin. Int J Clin Oncol 2016; 21: 491–497.

21.

Mizuno

Hiura

Kikkawa

et al . A prospective observational study on chemotherapy-induced nausea and vomiting (CINV) in patients with gynecologic cancer by the CINV Study Group of Japan. Gynecol Oncol 2016; 140: 559–564.

Supplementary Material

Please find the following supplemental material available below.

For Open Access articles published under a Creative Commons License, all supplemental material carries the same license as the article it is associated with.

For non-Open Access articles published, all supplemental material carries a non-exclusive license, and permission requests for re-use of supplemental material or any part of supplemental material shall be sent directly to the copyright owner as specified in the copyright notice associated with the article.

0.00 MB

0.01 MB