Patient-perceived symptomatic benefits of olanzapine treatment for nausea and vomiting in patients with advanced cancer who received palliative care through consultation teams: a multicenter prospective observational study.
Cancer
Nausea
Olanzapine, Japan
Palliative care
Vomiting
Journal
Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer
ISSN: 1433-7339
Titre abrégé: Support Care Cancer
Pays: Germany
ID NLM: 9302957
Informations de publication
Date de publication:
Oct 2021
Oct 2021
Historique:
received:
12
10
2020
accepted:
09
02
2021
pubmed:
21
3
2021
medline:
16
10
2021
entrez:
20
3
2021
Statut:
ppublish
Résumé
To examine the safety, effectiveness, and patient-perceived benefit of treatment with olanzapine for nausea and vomiting (N/V) in patients with advanced cancer. We conducted a multicenter prospective observational study in a tertiary care setting (Trial registration number: UMIN000020493, date of registration: 2016/1/12). We measured the following: average nausea in the last 24 h using a Numeric Rating Scale (NRS: range 0-10) at baseline and day 2, patient-perceived treatment benefit (based on a 5-point verbal scale), and adverse events (AEs; using the Common Terminology Criteria for Adverse Events version 4). The 85 participants (45% men) had a mean age of 58.7±15.8 years. Major causes of N/V were opioids (44%) and chemotherapy (34%). All patients received a daily dose of olanzapine of 5 mg or less as first-line treatment (N=35) or second- or later-line treatment (N=50). Nausea NRS decreased from 6.1±2.2 to 1.8±2.0 (differences: -4.3, 95% CI -3.7 to -4.9, p<0.001). The proportion of patients who did not experience vomiting episodes in the last 24 h increased from 40-89%. Mean decrease in nausea NRS by patient-perceived treatment benefit were as follows: -0.8 for "none" (n=4, 5%); -2.8 for "slight" (n=17, 20%); -3.3 for "moderate" (n=14, 16%); -4.7 for "lots" (n=25, 29%); and -6.1 for "complete" (n=25, 29%; p-for-trend<0.001). The most prevalent AE was somnolence (n=15, 18%). Short-term and relatively low-dose olanzapine treatment was effective for multifactorial N/V. Confirmatory studies with longer observation periods are needed to clarify the duration of the effect and adverse events.
Identifiants
pubmed: 33742244
doi: 10.1007/s00520-021-06067-2
pii: 10.1007/s00520-021-06067-2
doi:
Substances chimiques
Antiemetics
0
Olanzapine
N7U69T4SZR
Types de publication
Journal Article
Multicenter Study
Observational Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
5831-5838Informations de copyright
© 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH, DE part of Springer Nature.
Références
Cherny NI, Fallon M, Kaasa S, Portenoy RK, Currow D (2015) Oxford textbook of palliative medicine, Fifth edn. Oxford University Press, Oxford
Walsh D, Davis M, Ripamonti C, Bruera E, Davies A, Molassiotis A (2017) 2016 Updated MASCC/ESMO consensus recommendations: management of nausea and vomiting in advanced cancer. Support Care Cancer 25(1):333–340. https://doi.org/10.1007/s00520-016-3371-3
doi: 10.1007/s00520-016-3371-3
pubmed: 27534961
Stephenson J, Davies A (2006) An assessment of aetiology-based guidelines for the management of nausea and vomiting in patients with advanced cancer. Support Care Cancer 14(4):348–353. https://doi.org/10.1007/s00520-005-0897-1
doi: 10.1007/s00520-005-0897-1
pubmed: 16228185
Harder S, Herrstedt J, Isaksen J, Neergaard MA, Frandsen K, Sigaard J, Mondrup L, Jespersen BA, Groenvold M (2019) The nature of nausea: prevalence, etiology, and treatment in patients with advanced cancer not receiving antineoplastic treatment. Support Care Cancer 27(8):3071–3080. https://doi.org/10.1007/s00520-018-4623-1
doi: 10.1007/s00520-018-4623-1
pubmed: 30610434
Prommer E (2013) Olanzapine: palliative medicine update. Am J Hosp Palliat Care 30(1):75–82. https://doi.org/10.1177/1049909112441241
doi: 10.1177/1049909112441241
pubmed: 22495793
Bymaster FP, Calligaro DO, Falcone JF, Marsh RD, Moore NA, Tye NC, Seeman P, Wong DT (1996) Radioreceptor binding profile of the atypical antipsychotic olanzapine. Neuropsychopharmacology 14(2):87–96. https://doi.org/10.1016/0893-133x(94)00129-n
doi: 10.1016/0893-133x(94)00129-n
pubmed: 8822531
Hesketh PJ, Kris MG, Basch E, Bohlke K, Barbour SY, Clark-Snow RA, Danso MA, Dennis K, Dupuis LL, Dusetzina SB, Eng C, Feyer PC, Jordan K, Noonan K, Sparacio D, Lyman GH (2020) Antiemetics: ASCO Guideline Update. J Clin Oncol 38(24):2782–2797. https://doi.org/10.1200/jco.20.01296
doi: 10.1200/jco.20.01296
pubmed: 32658626
National Comprehensive Cancer Network. Antiemesis (Version 2.2020). https://www.nccn.org/professionals/physician_gls/pdf/antiemesis.pdf . Accessed 10th October, 2020
Fonte C, Fatigoni S, Roila F (2015) A review of olanzapine as an antiemetic in chemotherapy-induced nausea and vomiting and in palliative care patients. Crit Rev Oncol Hematol 95(2):214–221. https://doi.org/10.1016/j.critrevonc.2015.02.010
doi: 10.1016/j.critrevonc.2015.02.010
pubmed: 25779971
Saudemont G, Prod'Homme C, Da Silva A, Villet S, Reich M, Penel N, Gamblin V (2020) The use of olanzapine as an antiemetic in palliative medicine: a systematic review of the literature. BMC Palliat Care 19(1):56. https://doi.org/10.1186/s12904-020-00559-4
doi: 10.1186/s12904-020-00559-4
pubmed: 32321488
pmcid: 7178955
Passik SD, Lundberg J, Kirsh KL, Theobald D, Donaghy K, Holtsclaw E, Cooper M, Dugan W (2002) A pilot exploration of the antiemetic activity of olanzapine for the relief of nausea in patients with advanced cancer and pain. J Pain Symptom Manag 23(6):526–532
doi: 10.1016/S0885-3924(02)00391-3
Jackson WC, Tavernier L (2003) Olanzapine for intractable nausea in palliative care patients. J Palliat Med 6(2):251–255. https://doi.org/10.1089/109662103764978506
doi: 10.1089/109662103764978506
pubmed: 12854942
Srivastava M, Brito-Dellan N, Davis MP, Leach M, Lagman R (2003) Olanzapine as an antiemetic in refractory nausea and vomiting in advanced cancer. J Pain Symptom Manag 25(6):578–582. https://doi.org/10.1016/s0885-3924(03)00143-x
doi: 10.1016/s0885-3924(03)00143-x
Kaneishi K, Kawabata M, Morita T (2012) Olanzapine for the relief of nausea in patients with advanced cancer and incomplete bowel obstruction. J Pain Symptom Manag 44(4):604–607. https://doi.org/10.1016/j.jpainsymman.2011.10.023
doi: 10.1016/j.jpainsymman.2011.10.023
MacKintosh D (2016) Olanzapine in the management of difficult to control nausea and vomiting in a palliative care population: a case series. J Palliat Med 19(1):87–90. https://doi.org/10.1089/jpm.2015.0224
doi: 10.1089/jpm.2015.0224
pubmed: 26398872
Kaneishi K, Imai K, Nishimura K, Sakurai N, Kohara H, Ishiki H, Kanai Y, Oyamada S, Yamaguchi T, Morita T, Iwase S (2020) Olanzapine versus metoclopramide for treatment of nausea and vomiting in advanced cancer patients with incomplete malignant bowel obstruction. J Palliat Med 23(7):880–881. https://doi.org/10.1089/jpm.2020.0101
doi: 10.1089/jpm.2020.0101
pubmed: 32609610
Harder S, Groenvold M, Isaksen J, Sigaard J, Frandsen KB, Neergaard MA, Mondrup L, Herrstedt J (2019) Antiemetic use of olanzapine in patients with advanced cancer: results from an open-label multicenter study. Support Care Cancer 27(8):2849–2856. https://doi.org/10.1007/s00520-018-4593-3
doi: 10.1007/s00520-018-4593-3
pubmed: 30552594
Navari RM, Pywell CM, Le-Rademacher JG, White P, Dodge AB, Albany C, Loprinzi CL (2020) Olanzapine for the treatment of advanced cancer-related chronic nausea and/or vomiting: a randomized pilot trial. JAMA Oncol 6:895–899. https://doi.org/10.1001/jamaoncol.2020.1052
doi: 10.1001/jamaoncol.2020.1052
pubmed: 32379269
US Food and Drug Administration (2009) Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims. Fed Regist 74(235):65132–65133
LeBlanc TW, Abernethy AP (2017) Patient-reported outcomes in cancer care - hearing the patient voice at greater volume. Nat Rev Clin Oncol 14(12):763–772. https://doi.org/10.1038/nrclinonc.2017.153
doi: 10.1038/nrclinonc.2017.153
pubmed: 28975931
Copay AG, Subach BR, Glassman SD, Polly DW Jr, Schuler TC (2007) Understanding the minimum clinically important difference: a review of concepts and methods. Spine J 7(5):541–546. https://doi.org/10.1016/j.spinee.2007.01.008
doi: 10.1016/j.spinee.2007.01.008
pubmed: 17448732
Maeda I, Ogawa A, Yoshiuchi K, Akechi T, Morita T, Oyamada S, Yamaguchi T, Imai K, Sakashita A, Matsumoto Y, Uemura K, Nakahara R, Iwase S, Phase RDSG (2020) Safety and effectiveness of antipsychotic medication for delirium in patients with advanced cancer: a large-scale multicenter prospective observational study in real-world palliative care settings. Gen Hosp Psychiatry 67:35–41. https://doi.org/10.1016/j.genhosppsych.2020.09.001
doi: 10.1016/j.genhosppsych.2020.09.001
pubmed: 32950826
Shimizu M, Kessoku T, Ishiki H, Matsuura T, Hiratsuka Y, Matsuda Y, Hasegawa T, Imai K, Maeda I, Oyamada S (2019) Naldemedine for opioid-induced constipation in patients receiving palliative care: a real-world registry study (Phase-R OIC Study). J Clin Oncol 37(15):11582–11582. https://doi.org/10.1200/JCO.2019.37.15_suppl.11582
Farrar JT, Polomano RC, Berlin JA, Strom BL (2010) A comparison of change in the 0-10 numeric rating scale to a pain relief scale and global medication performance scale in a short-term clinical trial of breakthrough pain intensity. Anesthesiology 112(6):1464–1472. https://doi.org/10.1097/ALN.0b013e3181de0e6d
doi: 10.1097/ALN.0b013e3181de0e6d
pubmed: 20463579
Farrar JT, Portenoy RK, Berlin JA, Kinman JL, Strom BL (2000) Defining the clinically important difference in pain outcome measures. Pain 88(3):287–294
doi: 10.1016/S0304-3959(00)00339-0
Institute NC (2009) Common Terminology Criteria for Adverse Events v4.0 (CTCAE) https://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03/Archive/CTCAE_4.0_2009-05-29_QuickReference_8.5x11.pdf . Accessed 10th, October 2020
Institute NC (2013) NCI Guidelines for investigators: adverse event reporting requirements for DCTD (CTEP AND CIP) AND DCP INDs AND IDEs. https://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/aeguidelines.pdf . Accessed 10th, October 2020
Cohen J (1992) A power primer. Psychol Bull 112(1):155–159. https://doi.org/10.1037//0033-2909.112.1.155
doi: 10.1037//0033-2909.112.1.155
pubmed: 19565683
Kaneishi K, Nishimura K, Sakurai N, Imai K, Matsuo N, Takahashi N, Okamoto K, Suga A, Sano H, Maeda I, Nishina H, Yamaguchi T, Morita T, Iwase S (2016) Use of olanzapine for the relief of nausea and vomiting in patients with advanced cancer: a multicenter survey in Japan. Support Care Cancer 24(6):2393–2395. https://doi.org/10.1007/s00520-016-3101-x
doi: 10.1007/s00520-016-3101-x
pubmed: 26838020
Bedard G, Zeng L, Zhang L, Lauzon N, Holden L, Tsao M, Danjoux C, Barnes E, Sahgal A, Poon M, Chow E (2013) Minimal clinically important differences in the edmonton symptom assessment system in patients with advanced cancer. J Pain Symptom Manag 46(2):192–200. https://doi.org/10.1016/j.jpainsymman.2012.07.022
doi: 10.1016/j.jpainsymman.2012.07.022
Raman S, Ding K, Chow E, Meyer RM, Nabid A, Chabot P, Coulombe G, Ahmed S, Kuk J, Dar AR, Mahmud A, Fairchild A, Wilson CF, Wu JSY, Dennis K, DeAngelis C, Wong RKS, Zhu L, Brundage M (2016) Minimal clinically important differences in the EORTC QLQ-BM22 and EORTC QLQ-C15-PAL modules in patients with bone metastases undergoing palliative radiotherapy. Qual Life Res 25(10):2535–2541. https://doi.org/10.1007/s11136-016-1308-4
doi: 10.1007/s11136-016-1308-4
pubmed: 27138964
Shao J, Jordan DC, Pritchett YL (2009) Baseline observation carry forward: reasoning, properties, and practical issues. J Biopharm Stat 19(4):672–684
doi: 10.1080/10543400902964118