Top

Published in:

01-03-2020 | Nausea | Review Article

Efficacy of olanzapine, neurokinin-1 receptor antagonists, and thalidomide in combination with palonosetron plus dexamethasone in preventing highly emetogenic chemotherapy-induced nausea and vomiting: a Bayesian network meta-analysis

Authors: Abdullah A. Alhifany, Ali McBride, Abdulaali R. Almutairi, Ejaz Cheema, Alaa Shahbar, Yasser Alatawi, Adnan S. Alharbi, Hani Babiker, Karen MacDonald, Matti Aapro, Ivo Abraham

Published in: Supportive Care in Cancer | Issue 3/2020

Abstract

Background

Olanzapine, neurokinin-1-receptor-antagonists (NK-1-RA), and thalidomide added to palonosetron + dexamethasone (PALO-DEX) have been evaluated in separate studies as prophylaxis for chemotherapy-induced nausea and vomiting (CINV) due to highly emetogenic chemotherapy (HEC). We conducted a Bayesian network meta-analysis to compare the prophylactic efficacy of these agents in combination with PALO-DEX.

Methods

PubMed, Medline/Ovid, Embase, and Clinicaltrials.gov were searched from inception through 22 Mar 2018. Study quality was assessed using the Cochrane methodology. A Bayesian network meta-analysis using random-effects models was used to asses complete response (CR) and rate of no nausea (RNN) in acute, delayed, and overall phases and were expressed as odds ratios (OR) and 95% credible interval (95% CrI). Ranking probabilities of treatments were calculated using the surface under the cumulative ranking curve (SUCRA) to identify the probability of a given treatment as the best option against the worst option.

Results

Nine RCTs involving two thousand nine hundred fifty-nine patients were included. The olanzapine-based regimen showed greater CR in the acute, delayed, and overall-phases versus the PALO-DEX regimen (OR = 3.97, 95% CrI = 1.02–19.13; OR = 5.62, 95% CrI = 1.66–28.58; OR = 4.79, 95% CrI = 1.40–24.02, respectively). Additionally, it showed greater RNN than the NK-1-RA-based and the PALO-DEX regimens in the delayed phase only (OR = 2.90, 95% CrI = 1.34–5.15; OR = 4.53, 95% CrI = 1.89–10.55, respectively). Olanzapine-, NK-1-RA-, and thalidomide-based regimens did not differ in CR in the three phases. SUCRA probabilities ranked the olanzapine-based regimen as the best option in terms of CR and RNN, while ranking the NK-1-RA-based regimens as the second best option in terms of CR throughout the three phases.

Conclusion

Based on the data included in the analyses, there is insufficient evidence to support adding thalidomide or NK-1-RA to PALO-DEX in preventing CINV induced by HEC. However, adding olanzapine to PALO-DEX achieves better CR and RNN. Olanzapine side-effects and the absence of direct comparisons explain why some guidelines are cautious in suggesting the use of olanzapine.

Available only for authorised users

Navari RM, Aapro M (2016) Antiemetic prophylaxis for chemotherapy-induced nausea and vomiting. N Engl J Med 374(14):1356–1367. https://doi.org/10.1056/NEJMra1515442 CrossRefPubMed

Aapro MS, Grunberg SM, Manikhas GM, Olivares G, Suarez T, Tjulandin SA, Bertoli LF, Yunus F, Morrica B, Lordick F, Macciocchi A (2006) A phase III, double-blind, randomized trial of palonosetron compared with ondansetron in preventing chemotherapy-induced nausea and vomiting following highly emetogenic chemotherapy. Ann Oncol 17(9):1441–1449. https://doi.org/10.1093/annonc/mdl137 CrossRefPubMed

Eisenberg P, Figueroa-Vadillo J, Zamora R, Charu V, Hajdenberg J, Cartmell A, Macciocchi A, Grunberg S (2003) Improved prevention of moderately emetogenic chemotherapy-induced nausea and vomiting with palonosetron, a pharmacologically novel 5-HT3 receptor antagonist: results of a phase III, single-dose trial versus dolasetron. Cancer 98(11):2473–2482. https://doi.org/10.1002/cncr.11817 CrossRefPubMed

Gralla R, Lichinitser M, Van Der Vegt S, Sleeboom H, Mezger J, Peschel C, Tonini G, Labianca R, Macciocchi A, Aapro M (2003) Palonosetron improves prevention of chemotherapy-induced nausea and vomiting following moderately emetogenic chemotherapy: results of a double-blind randomized phase III trial comparing single doses of palonosetron with ondansetron. Ann Oncol 14(10):1570–1577CrossRef

Saito M, Aogi K, Sekine I, Yoshizawa H, Yanagita Y, Sakai H, Inoue K, Kitagawa C, Ogura T, Mitsuhashi S (2009) Palonosetron plus dexamethasone versus granisetron plus dexamethasone for prevention of nausea and vomiting during chemotherapy: a double-blind, double-dummy, randomised, comparative phase III trial. Lancet Oncol 10(2):115–124. https://doi.org/10.1016/s1470-2045(08)70313-9 CrossRefPubMed

Tricco AC, Blondal E, Veroniki AA, Soobiah C, Vafaei A, Ivory J, Strifler L, Cardoso R, Reynen E, Nincic V, Ashoor H, Ho J, Ng C, Johnson C, Lillie E, Antony J, Roberts DJ, Hemmelgarn BR, Straus SE (2016) Comparative safety and effectiveness of serotonin receptor antagonists in patients undergoing chemotherapy: a systematic review and network meta-analysis. BMC Med 14(1):216. https://doi.org/10.1186/s12916-016-0761-9 CrossRefPubMedPubMedCentral

Grunberg SM, Koeller JM (2003) Palonosetron: a unique 5-HT3-receptor antagonist for the prevention of chemotherapy-induced emesis. Expert Opin Pharmacother 4(12):2297–2303. https://doi.org/10.1517/14656566.4.12.2297 CrossRefPubMed

Janelsins MC, Tejani MA, Kamen C, Peoples AR, Mustian KM, Morrow GR (2013) Current pharmacotherapy for chemotherapy-induced nausea and vomiting in cancer patients. Expert Opin Pharmacother 14(6):757–766. https://doi.org/10.1517/14656566.2013.776541 CrossRefPubMedPubMedCentral

Rojas C, Raje M, Tsukamoto T, Slusher BS (2014) Molecular mechanisms of 5-HT(3) and NK(1) receptor antagonists in prevention of emesis. Eur J Pharmacol 722:26–37. https://doi.org/10.1016/j.ejphar.2013.08.049 CrossRefPubMed

10.

Aapro M, Fabi A, Nole F, Medici M, Steger G, Bachmann C, Roncoroni S, Roila F (2010) Double-blind, randomised, controlled study of the efficacy and tolerability of palonosetron plus dexamethasone for 1 day with or without dexamethasone on days 2 and 3 in the prevention of nausea and vomiting induced by moderately emetogenic chemotherapy. Ann Oncol 21(5):1083–1088. https://doi.org/10.1093/annonc/mdp584 CrossRefPubMed

11.

Aapro M, Rugo H, Rossi G, Rizzi G, Borroni ME, Bondarenko I, Sarosiek T, Oprean C, Cardona-Huerta S, Lorusso V, Karthaus M, Schwartzberg L, Grunberg S (2014) A randomized phase III study evaluating the efficacy and safety of NEPA, a fixed-dose combination of netupitant and palonosetron, for prevention of chemotherapy-induced nausea and vomiting following moderately emetogenic chemotherapy. Ann Oncol 25(7):1328–1333. https://doi.org/10.1093/annonc/mdu101 CrossRefPubMedPubMedCentral

12.

Navari RM, Gray SE, Kerr AC (2011) Olanzapine versus aprepitant for the prevention of chemotherapy-induced nausea and vomiting: a randomized phase III trial. J Support Oncol 9(5):188–195. https://doi.org/10.1016/j.suponc.2011.05.002 CrossRefPubMed

13.

Zhang L, Qu X, Teng Y, Shi J, Yu P, Sun T, Wang J, Zhu Z, Zhang X, Zhao M, Liu J, Jin B, Luo Y, Teng Z, Dong Y, Wen F, An Y, Yuan C, Chen T, Zhou L, Chen Y, Zhang J, Wang Z, Qu J, Jin F, Zhang J, Jin X, Xie X, Wang J, Man L, Fu L, Liu Y (2017) Efficacy of thalidomide in preventing delayed nausea and vomiting induced by highly emetogenic chemotherapy: a randomized, multicenter, double-blind, placebo-controlled phase III trial (CLOG1302 study). J Clin Oncol 35(31):3558–3565. https://doi.org/10.1200/jco.2017.72.2538 CrossRefPubMed

14.

NCCN (2018) National comprehensive cancer network. Antiemesis: clinical practice guidelines in oncology, v 1.2018. Retrieved from www.nccn.org.

15.

Popovic M, Warr DG, Deangelis C, Tsao M, Chan KK, Poon M, Yip C, Pulenzas N, Lam H, Zhang L, Chow E (2014) Efficacy and safety of palonosetron for the prophylaxis of chemotherapy-induced nausea and vomiting (CINV): a systematic review and meta-analysis of randomized controlled trials. Support Care Cancer 22(6):1685–1697. https://doi.org/10.1007/s00520-014-2175-6 CrossRefPubMed

16.

Roila F, Molassiotis A, Herrstedt J, Aapro M, Gralla RJ, Bruera E, Clark-Snow RA, Dupuis LL, Einhorn LH, Feyer P, Hesketh PJ, Jordan K, Olver I, Rapoport BL, Roscoe J, Ruhlmann CH, Walsh D, Warr D, van der Wetering M (2016) 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 27(suppl 5):v119–v133. https://doi.org/10.1093/annonc/mdw270 CrossRefPubMed

17.

Zhang Y, Yang Y, Zhang Z, Fang W, Kang S, Luo Y, Sheng J, Zhan J, Hong S, Huang Y, Zhou N, Zhao H, Zhang L (2017) Neurokinin-1 receptor antagonist-based triple regimens in preventing chemotherapy-induced nausea and vomiting: a network meta-analysis. J Natl Cancer Inst 109(2). https://doi.org/10.1093/jnci/djw217 CrossRef

18.

Zhang Z, Zhang Y, Chen G, Hong S, Yang Y, Fang W, Luo F, Chen X, Ma Y, Zhao Y, Zhan J, Xue C, Hou X, Zhou T, Ma S, Gao F, Huang Y, Chen L, Zhou N, Zhao H, Zhang L (2018) Olanzapine-based triple regimens versus neurokinin-1 receptor antagonist-based triple regimens in preventing chemotherapy-induced nausea and vomiting associated with highly emetogenic chemotherapy: a network meta-analysis. Oncologist. https://doi.org/10.1634/theoncologist.2017-0378 CrossRef

19.

Moher D, Liberati A, Tetzlaff J, Altman DG (2010) Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Int J Surg (London, England) 8(5):336–341. https://doi.org/10.1016/j.ijsu.2010.02.007 CrossRef

20.

Turner RM, Davey J, Clarke MJ, Thompson SG, Higgins JP (2012) Predicting the extent of heterogeneity in meta-analysis, using empirical data from the Cochrane database of systematic reviews. Int J Epidemiol 41(3):818–827. https://doi.org/10.1093/ije/dys041 CrossRefPubMedPubMedCentral

21.

Herrington JD, Jaskiewicz AD, Song J (2008) Randomized, placebo-controlled, pilot study evaluating aprepitant single dose plus palonosetron and dexamethasone for the prevention of acute and delayed chemotherapy-induced nausea and vomiting. Cancer 112(9):2080–2087. https://doi.org/10.1002/cncr.23364 CrossRefPubMed

22.

Hesketh PJ, Rossi G, Rizzi G, Palmas M, Alyasova A, Bondarenko I, Lisyanskaya A, Gralla RJ (2014) Efficacy and safety of NEPA, an oral combination of netupitant and palonosetron, for prevention of chemotherapy-induced nausea and vomiting following highly emetogenic chemotherapy: a randomized dose-ranging pivotal study. Ann Oncol 25(7):1340–1346. https://doi.org/10.1093/annonc/mdu110 CrossRefPubMedPubMedCentral

23.

Mukhopadhyay S, Kwatra G, Alice KP, Badyal D (2017) Role of olanzapine in chemotherapy-induced nausea and vomiting on platinum-based chemotherapy patients: a randomized controlled study. Support Care Cancer 25(1):145–154. https://doi.org/10.1007/s00520-016-3386-9 CrossRefPubMed

24.

Babu G, Saldanha SC, Kuntegowdanahalli Chinnagiriyappa L, Jacob LA, Mallekavu SB, Dasappa L, Kiran PR, Sreevatsa A, Appachu S, Unnikrishnan V, Arroju V (2016) The efficacy, safety, and cost benefit of olanzapine versus aprepitant in highly emetogenic chemotherapy: a pilot study from South India. Chemother Res Pract 2016:3439707. https://doi.org/10.1155/2016/3439707 CrossRefPubMedPubMedCentral

25.

Navari RM, Nagy CK, Le-Rademacher J, Loprinzi CL (2016) Olanzapine versus fosaprepitant for the prevention of concurrent chemotherapy radiotherapy-induced nausea and vomiting. J Commun Support Oncol 14(4):141–147. https://doi.org/10.12788/jcso.0245 CrossRef

26.

Shumway NM, Terrazzino SE, Jones CB (2009) A randomized pilot study comparing aprepitant to olanzapine for treatment of chemotherapy-induced nausea and vomiting. J Clin Oncol 27(suppl15):9633

27.

Chiu L, Chow R, Popovic M, Navari RM, Shumway NM, Chiu N, Lam H, Milakovic M, Pasetka M, Vuong S, Chow E, DeAngelis C (2016) 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(5):2381–2392. https://doi.org/10.1007/s00520-016-3075-8 CrossRefPubMed

28.

Chow R, Chiu L, Navari R, Passik S, Chiu N, Popovic M, Lam H, Pasetka M, Chow E, DeAngelis C (2016) 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 24(2):1001–1008. https://doi.org/10.1007/s00520-015-3000-6 CrossRefPubMed

29.

Franca MS, Uson Junior PL, Antunes YP, Prado BL, Donnarumma Cdel C, Mutao TS, Rodrigues HV, Giglio A (2015) Assessment of adherence to the guidelines for the management of nausea and vomiting induced by chemotherapy. Einstein (Sao Paulo, Brazil) 13(2):221–225. https://doi.org/10.1590/s1679-45082015ao3097 CrossRef

30.

US Food and Drug Administration (2005) Safety alerts for human medical products. Varubi (rolapitant) injectable emulsion: health care provider letter—anaphylaxis and other serious hypersensitivity reactions. Silver Spring, MD: Office of the Commissioner, US Food & Drug Administration. https://www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm592592.htm. Accessed 6 December 2005

31.

Aapro M, Molassiotis A, Dicato M, Pelaez I, Rodriguez-Lescure A, Pastorelli D, Ma L, Burke T, Gu A, Gascon P, Roila F (2012) The effect of guideline-consistent antiemetic therapy on chemotherapy-induced nausea and vomiting (CINV): the Pan European Emesis registry (PEER). Ann Oncol 23(8):1986–1992. https://doi.org/10.1093/annonc/mds021 CrossRefPubMed

32.

Feyer P, Jordan K (2011) Update and new trends in antiemetic therapy: the continuing need for novel therapies. Ann Oncol 22(1):30–38. https://doi.org/10.1093/annonc/mdq600 CrossRefPubMed

Title: Efficacy of olanzapine, neurokinin-1 receptor antagonists, and thalidomide in combination with palonosetron plus dexamethasone in preventing highly emetogenic chemotherapy-induced nausea and vomiting: a Bayesian network meta-analysis
Authors: Abdullah A. Alhifany
Ali McBride
Abdulaali R. Almutairi
Ejaz Cheema
Alaa Shahbar
Yasser Alatawi
Adnan S. Alharbi
Hani Babiker
Karen MacDonald
Matti Aapro
Ivo Abraham
Publication date: 01-03-2020
Publisher: Springer Berlin Heidelberg
Keywords: Nausea
Vomiting
Olanzapine
Dexamethasone
Cytostatic Therapy
Published in: Supportive Care in Cancer / Issue 3/2020
Print ISSN: 0941-4355
Electronic ISSN: 1433-7339
DOI: https://doi.org/10.1007/s00520-019-05210-4

Webinar | 19-02-2024 | 17:30 (CET)

Keynote webinar | Spotlight on antibody–drug conjugates in cancer

Watch now

Antibody–drug conjugates (ADCs) are novel agents that have shown promise across multiple tumor types. Explore the current landscape of ADCs in breast and lung cancer with our experts, and gain insights into the mechanism of action, key clinical trials data, existing challenges, and future directions.

Dr. Véronique Diéras

Prof. Fabrice Barlesi

Developed by: Springer Medicine

At a glance: The STEP trials

Springer Medicine

Abstract

Background

Methods

Results

Conclusion

Please log in to get access to this content

Other articles of this Issue 3/2020

Pilot randomized trial of an electronic symptom monitoring and reporting intervention for hospitalized adults undergoing hematopoietic stem cell transplantation

Palliative care needs of advanced cancer patients in the emergency department at the end of life: an observational cohort study

The burden of low anterior resection syndrome on quality of life in patients with mid or low rectal cancer

Meal planning values impacted by the cancer experience in families with school-aged survivors—a qualitative exploration and recommendations for intervention development

Changes in taste and food preferences in breast cancer patients receiving chemotherapy: a pilot study

Mind-body medicine use by women diagnosed with breast cancer: results of a nationally representative survey

Keynote webinar | Spotlight on antibody–drug conjugates in cancer