Severity of constipation related to palonosetron during first-line chemotherapy: a retrospective observational study.


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:
Aug 2021
Historique:
received: 09 09 2020
accepted: 21 01 2021
pubmed: 31 1 2021
medline: 24 7 2021
entrez: 30 1 2021
Statut: ppublish

Résumé

Palonosetron, a long-acting 5-HT We retrospectively analyzed the incidence and severity of constipation after intravenous administration of 0.75-mg palonosetron in 150 chemotherapy-naïve patients who received first-line chemotherapy at Saga University Hospital. Constipation was classified into grades 1-5 according to the Common Terminology Criteria for Adverse Events version 5.0. Multiple logistic regression analysis was performed to identify factors associated with palonosetron-related worsening of constipation to grade 2 or higher. Palonosetron significantly increased the incidence and severity of constipation (incidence: before vs. after palonosetron, 35.4% vs. 74.0%, p < 0.0001, and severity: before vs. after palonosetron, 26.7% and 8.7% in grades 1 and 2, respectively, vs. 46.7%, 23.3%, and 4.0% in grades 1, 2, and 3, respectively, p < 0.0001). Despite the use of laxatives, 4.0% of patients had grade 3 constipation requiring manual evacuation. Combination treatment with aprepitant (odds ratio (OR), 10.9; 95% confidence interval (CI), 1.3-90.0; p = 0.026) and older age (OR, 1.25; 95% CI, 1.01-1.57; p = 0.039) were factors associated with the severity of constipation. Constipation was more severe in patients receiving combination treatment with aprepitant than in those treated with palonosetron alone. Older age was also associated with increased risk of severe palonosetron-related constipation. Identification of risk factors can help target risk-based laxative therapy.

Identifiants

pubmed: 33515108
doi: 10.1007/s00520-021-06023-0
pii: 10.1007/s00520-021-06023-0
doi:

Substances chimiques

Antiemetics 0
Palonosetron 5D06587D6R

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

4723-4732

Références

Larkin PJ, Cherny NI, Carpia DL, Guglielmo M, Ostgathe C, Scotte F, Ripamonti CI, ESMO Guidelines Committee (2018) Diagnosis, assessment and management of constipation in advanced cancer: ESMO Clinical Practice Guidelines. Ann Oncol 29:iv111–iv125
doi: 10.1093/annonc/mdy148
Davies A, Leach C, Caponero R, Dickman A, Fuchs D, Paice J, Emmanuel A (2020) MASCC recommendations on the management of constipation in patients with advanced cancer. Support Care Cancer 28:23–33
doi: 10.1007/s00520-019-05016-4
Cash BD, Chey WD (2005) Review article: the role of serotonergic agents in the treatment of patients with primary chronic constipation. Aliment Pharmacol Ther 22(11-12):1047–1060
doi: 10.1111/j.1365-2036.2005.02696.x
Constenla M (2004) 5-HT3 receptor antagonists for prevention of late acute-onset emesis. Ann Pharmacother 38:1683–1691
doi: 10.1345/aph.1D191
Wong EH, Clark R, Leung E, Loury D, Bonhaus DW, Jakeman L, Parnes H, Whiting RL, Eglen RM (1995) The interaction of RS 25259-197, a potent and selective antagonist, with 5-HT3 receptors, in vitro. Br J Pharmacol 114:851–859
doi: 10.1111/j.1476-5381.1995.tb13282.x
Berger MJ, Ettinger DS, Aston J, Barbour S, Bergsbaken J, Bierman PJ, Brandt D, Dolan DE, Ellis G, Kim EJ, Kirkegaard S, Kloth DD, Lagman R, Lim D, Loprinzi C, Ma CX, Maurer V, Michaud LB, Nabell LM, Noonan K, Roeland E, Rugo HS, Schwartzberg LS, Scullion B, Timoney J, Todaro B, Urba SG, Shead DA, Hughes M (2017) NCCN Guidelines insights: Antiemesis, Version 2.2017. J Natl Compr Cancer Netw 15:883–893
doi: 10.6004/jnccn.2017.0117
Hesketh PJ, Kris MG, Basch E, Bohlke K, Barbour SY, Clark-Snow RA et al (2017) American Society of Clinical Oncology Clinical Practice Guideline Update. J Clin Oncol 35:3240–3261
doi: 10.1200/JCO.2017.74.4789
Herrstedt J, Roila F, Warr D, Celio L, Navari RM, Hesketh PJ, Chan A, Aapro MS (2017) 2016 Updated MASCC/ESMO consensus recommendations: prevention of nausea and vomiting following high emetic risk chemotherapy. Support Care Cancer 25:277–288
doi: 10.1007/s00520-016-3313-0
Takeuchi H, Saeki T, Aiba K, Tamura K, Aogi K, Eguchi K, Okita K, Kagami Y, Tanaka R, Nakagawa K, Fujii H, Boku N, Wada M, Akechi T, Udagawa Y, Okawa Y, Onozawa Y, Sasaki H, Shima Y, Shimoyama N, Takeda M, Nishidate T, Yamamoto A, Ikeda T, Hirata K (2016) Japanese Society of Clinical Oncology clinical practice guidelines 2010 for antiemesis in oncology: executive summary. Int J Clin Oncol 21:1–12
doi: 10.1007/s10147-015-0852-1
Palonosetron hydrochloride drug package insert: https://www.info.pmda.go.jp/go/pack/2391404A1020_1_06/?view=frame&style=XML&lang=ja . Accessed 8th December 2020
Maemondo M, Masuda N, Sekine I, Kubota K, Segawa Y, Shibuya M, Imamura F, Katakami N, Hida T, Takeo S (2009) A Phase II study ofpalonosetron combined with dexamethasone to prevent nausea and vomiting induced by highly emetogenic chemotherapy. Ann Oncol 20:1860–1866
doi: 10.1093/annonc/mdp195
Segawa Y, Aogi K, Inoue K, Sano M, Sekine I, Tokuda Y, Isobe H, Ogura T, Tsuboi M, Atagi S (2009) A phase II dose-ranging study of palonosetron in Japanese patients receiving moderately emetogenic chemotherapy, including anthracycline and cyclophosphamide-based chemotherapy. Ann Oncol 20:1874–1880
doi: 10.1093/annonc/mdp243
Saito M, Aogi K, Sekine I, Yoshizawa H, Yanagita Y, Sakai H, Inoue K, Kitagawa C, Ogura T, Mitsuhashi (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 10:115–124
doi: 10.1016/S1470-2045(08)70313-9
Summary basis of palonosetron approval: https://www.pmda.go.jp/drugs/2010/P201000003/400107000_22200AMX00247_A100_1.pdf . Accessed 8
Björnsson ES, Chey WD, Ladabaum U, Woods ML, Hooper FG, Owyang C, Hasler WL (1998) Differential 5-HT3 mediation of human gastrocolonic response and colonic peristaltic reflex. Am J Phys 275:G498–G505
Björnsson ES, Chey WD, Hooper F, Woods ML, Owyang C, Hasler WL (2002) Impaired gastrocolonic response and peristaltic reflex in slow-transit constipation: role of 5-HT3 pathways. Am J Physiol Gastrointest Liver Physiol 283:G400–G407
doi: 10.1152/ajpgi.00082.2001
Delvaux M, Louvel D, Mamet JP, Campos-Oriola R, Frexinos J (1998) Effect of alosetron on responses to colonic distension in patients with irritable bowel syndrome. Aliment Pharmacol Ther 12:849–855
doi: 10.1046/j.1365-2036.1998.00375.x
The Japanese Society of Gastroenterology (2017) Evidence-based clinical practice guidelines for chronic constipation 2017, ed. Research Society for the Diagnosis and Treatment of Chronic Constipation. Affiliated to The Japanese Society of Gastroenterology in Japanese, Nankodo, Tokyo
Laugsand EA, Jakobsen G, Kaasa S, Klepstad P (2011) Inadequate symptom control in advanced cancer patients across Europe. Support Care Cancer 19:2005–2014
doi: 10.1007/s00520-010-1051-2
Likun Z, Xiang J, Yi B, Xin D, Tao ZL (2011) A systematic review and meta-analysis of intravenous palonosetron in the prevention of chemotherapy-induced nausea and vomiting in adults. Oncologist 16:207–216
doi: 10.1634/theoncologist.2010-0198
Larkin PJ, Sykes NP, Centeno C, Ellershaw JE, Elsner F, Eugene B, Gootjes JR, Nabal M, Noguera A, Ripamonti C, Zucco F, Zuurmond WW, European Consensus Group on Constipation in Palliative Care (2008) The management of constipation in palliative care: clinical practice recommendations. Palliat Med 22:796–807
doi: 10.1177/0269216308096908
Davies A, Webber K (2015) Stercoral perforation of the colon: a potentially fatal complication of opioid-induced constipation. J Pain Symptom Manag 50:260–262
doi: 10.1016/j.jpainsymman.2015.02.019
Yamada N, Nakamura M, Ishikura K, Ota M, Yazu T, Ota S, Ito M, Fujioka H, Isaka N, Nakano T (2005) Triggers of acute pulmonary thromboembolism developed in hospital, with focusing on toilet activities as triggering acts. Int J Cardiol 98:409–411
doi: 10.1016/j.ijcard.2003.12.014
Rojas C, Raje M, Tsukamoto T, Slusher BS (2014) Molecular mechanisms of 5-HT3 and NK1 receptor antagonists in prevention of emesis. Eur J Pharmacol 722:26–37
doi: 10.1016/j.ejphar.2013.08.049
Darmani NA, Dey D, Chebolu S, Amos B, Kandpal R, Alkam T (2013) Cisplatin causes over-expression of tachykinin NK(1) receptors and increases ERK1/2- and PKA- phosphorylation during peak immediate- and delayed-phase emesis in the least shrew (Cryptotis parva) brainstem. Eur J Pharmacol 698:161–169
doi: 10.1016/j.ejphar.2012.09.008
Hu WP, You XH, Guan BC, Ru LQ, Chen JG, Li ZW (2004) Substance P potentiates 5-HT3 receptor-mediated current in rat trigeminal ganglion neurons. Neurosci Lett 365:147–152
doi: 10.1016/j.neulet.2004.04.072
Minami M, Endo T, Yokota H, Ogawa T, Nemoto M, Hamaue N, Hirafuji M, Yoshioka M, Nagahisa A, Andrews PL (2001) Effects of CP-99, 994, a tachykinin NK
doi: 10.1016/S0014-2999(01)01297-3
Gralla RJ, Bosnjak SM, Hontsa A, Balser C, Rizzi G, Rossi G, Borroni ME, Jordan K (2014) A phase III study evaluating the safety and efficacy of NEPA, a fixed-dose combination of netupitant and palonosetron, for prevention of chemotherapy-induced nausea and vomiting over repeated cycles of chemotherapy. Ann Oncol 25:1333–1339
doi: 10.1093/annonc/mdu096
Suzuki K, Yamanaka T, Hashimoto H, Shimada Y, Arata K, Matsui R, Goto K, Takiguchi T, Ohyanagi F, Kogure Y, Nogami N, Nakao M, Takeda K, Azuma K, Nagase S, Hayashi T, Fujiwara K, Shimada T, Seki N, Yamamoto N (2016) Randomized, double-blind, phase III trial of palonosetron versus granisetron in the triplet regimen for preventing chemotherapy-induced nausea and vomiting after highly emetogenic chemotherapy: TRIPLE study. Ann Oncol 27:1601–1606
doi: 10.1093/annonc/mdw220
Hanani M, Fellig Y, Udassin R, Freund HR (2004) Age-related changes in the morphology of the myenteric plexus of the human colon. Auton Neurosci 113:71–78
doi: 10.1016/j.autneu.2004.05.007
Bernard CE, Gibbons SJ, Gomez-Pinilla PJ, Lurken MS, Schmalz PF, Roeder JL, Linden D, Cima RR, Dozois EJ, Larson DW, Camilleri M, Zinsmeister AR, Pozo MJ, Hicks GA, Farrugia G (2009) Effect of age on the enteric nervous system of the human colon. Neurogastroenterol Motil 21(7):e746–e746
doi: 10.1111/j.1365-2982.2008.01245.x
Lagier E, Delvaux M, Vellas B, Fioramonti J, Bueno L, Albarede JL, Frexinos J (1999) Influence of age on rectal tone and sensitivity to distension in healthy subjects. Neurogastroenterol Motil 11(2):101–107
doi: 10.1046/j.1365-2982.1999.00145.x
Kepenekci I, Keskinkilic B, Akinsu F, Cakir P, Elhan AH, Erkek AB, Kuzu MA (2011) Prevalence of pelvic floor disorders in the female population and the impact of age, mode of delivery, and parity. Dis Colon Rectum 54:85–94
doi: 10.1007/DCR.0b013e3181fd2356
Bouras EP, Tangalos EG (2009) Chronic constipation in the elderly. Gastroenterol Clin N Am 38(3):463–448
doi: 10.1016/j.gtc.2009.06.001

Auteurs

Sakiko Kimura (S)

Department of Pharmacy, Saga University Hospital, 5-1-1 Nabeshima, Saga, 849-8501, Japan. mochinag@cc.saga-u.ac.jp.

Kazuhisa Hosoya (K)

Department of Pharmacy, Saga University Hospital, 5-1-1 Nabeshima, Saga, 849-8501, Japan.

Kenji Ogata (K)

Department of Pharmacy, Saga University Hospital, 5-1-1 Nabeshima, Saga, 849-8501, Japan.

Tatsuya Furuno (T)

Department of Pharmacy, Saga University Hospital, 5-1-1 Nabeshima, Saga, 849-8501, Japan.

Rintaro Sogawa (R)

Department of Pharmacy, Saga University Hospital, 5-1-1 Nabeshima, Saga, 849-8501, Japan.

Koji Takeuchi (K)

Department of Pharmacy, Saga University Hospital, 5-1-1 Nabeshima, Saga, 849-8501, Japan.

Masanobu Tasaki (M)

Department of Pharmacy, Saga University Hospital, 5-1-1 Nabeshima, Saga, 849-8501, Japan.

Atsushi Kawaguchi (A)

Education and Research Center for Community Medicine, Faculty of Medicine, Saga University, Saga, Japan.

Atsujiro Nishioka (A)

Division of Hematology, Respiratory Medicine and Oncology, Department of Internal Medicine, Faculty of Medicine, Saga University, Saga, Japan.

Naoko Sueoka-Aragane (N)

Department of Pharmacy, Saga University Hospital, 5-1-1 Nabeshima, Saga, 849-8501, Japan.
Division of Hematology, Respiratory Medicine and Oncology, Department of Internal Medicine, Faculty of Medicine, Saga University, Saga, Japan.

Hirokazu Noshiro (H)

Department of Surgery, Faculty of Medicine, Saga University, Saga, Japan.

Yuichiro Kuratomi (Y)

Department of Otolaryngology, Head and Neck Surgery, Faculty of Medicine, Saga University, Saga, Japan.

Masatoshi Yokoyama (M)

Department of Obstetrics and Gynecology, Faculty of Medicine, Saga University, Saga, Japan.

Mitsuru Noguchi (M)

Department of Urology, Faculty of Medicine, Saga University, Saga, Japan.

Keizo Anzai (K)

Division of Hepatology, Diabetes, Metabolism and Endocrinology, Department of Internal Medicine, Faculty of Medicine, Saga University, Saga, Japan.

Yoshio Yamashita (Y)

Department of Oral and Maxillofacial Surgery, Faculty of Medicine, Saga University, Saga, Japan.

Shinya Kimura (S)

Division of Hematology, Respiratory Medicine and Oncology, Department of Internal Medicine, Faculty of Medicine, Saga University, Saga, Japan.

Hiroyuki Irie (H)

Department of Pharmacy, Saga University Hospital, 5-1-1 Nabeshima, Saga, 849-8501, Japan.
Department of Radiology, Faculty of Medicine, Saga University, Saga, Japan.

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