Comparative clinical effectiveness of various 5-HT3 RA antiemetic regimens on chemotherapy-induced nausea and vomiting associated with hospital and emergency department visits in real world practice

Hind T Hatoum, Swu-Jane Lin, Deborah Buchner, David Cox, Hind T Hatoum, Swu-Jane Lin, Deborah Buchner, David Cox

Abstract

Purpose: The aim of this study was to compare the risk of chemotherapy-induced nausea and vomiting (CINV) events for various 5-HT(3) RAs in patients who received moderately (MEC) or highly emetogenic chemotherapy (HEC) by evaluating hospital or emergency department (ED) admissions.

Methods: PharMetrics claims database was used to identify patients diagnosed with breast cancer (BC) who were initiated on cyclophosphamide-based adjuvant chemotherapy or with lung cancer (LC) initiated on carboplatin-based or cisplatin-based chemotherapy between 2005 and 2008. Patients were stratified in two groups: those initiated and maintained on palonosetron versus those treated with any other 5-HT(3) RA regimens in the 6-month post first chemotherapy. Risk for CINV events, identified by ICD-9-CM for nausea, vomiting, and/or dehydration, were estimated using logistic regressions, controlling for age, gender, comorbidity, and total chemotherapy doses or days.

Results: Of the 4,868 cyclophosphamide-treated BC, 5,414 carboplatin-treated LC, and 1,692 cisplatin-treated LC identified, there were 1,864 BC (38.5%), 1,806 carboplatin-treated LC (33.4%), and 390 cisplatin-treated LC (23.0%) in the palonosetron-only group. Palonosetron-only group had significantly lower probability of CINV events associated with ED/hospital admissions in all three cohorts (3.5% vs. 6.3% in BC, 9.5% vs. 13.8% in carboplatin-treated LC, and 16.4% vs. 22.6% in cisplatin-treated LC, all at p < 0.05). Logistic regressions found palonosetron-only group had significantly lower risk of CINV events (odds ratios = 0.550, 0.653, and 0.689 in BC, carboplatin-treated LC and cisplatin-treated LC, respectively, p < 0.05).

Conclusion: Patients with lung or breast cancer receiving MEC or HEC had significantly lower risk of CINV events associated with hospital/ED admissions if initiated and maintained on palonosetron relative to patients receiving 5-HT(3) RA regimens.

Figures

Fig. 1
Fig. 1
Selection of patients in the breast cancer cohort
Fig. 2
Fig. 2
Selection of patients in the two lung cancer cohorts

References

    1. Mertens WC, Higby DJ, Brown D, Parisi R, Fitzgerald J, Benjamin EM, Lindenauer PK. Improving the care of patients with regard to chemotherapy-induced nausea and emesis: the effect of feedback to clinicians on adherence to antiemetic prescribing guidelines. J Clin Oncol. 2003;21:1373–1378. doi: 10.1200/JCO.2003.08.118.
    1. Aapro MS, Grunberg SM, Manikhas GM, Olivares G, Suarez T, Tjulandin SA, Bertoli LF, Yunus F, Morrica B, Lordick F, Macciocchi A. 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. 2006;17:1441–1449. doi: 10.1093/annonc/mdl137.
    1. Oo TH, Hesketh PJ. Drug insight: new antiemetics in the management of chemotherapy-induced nausea and vomiting. Nat Clin Pract Oncol. 2005;2:196–201. doi: 10.1038/ncponc0132.
    1. Li Y, Wu X, Rojas C. Palonosetron uniquely inhibits substance P-mediated neuronal responses in rat nodose ganglia. New Orleans: Annual American Society of Hematology Meeting; 2009.
    1. Rojas C, Thomas AG, Alt J, Stathis M, Zhang J, Rubenstein EB, Sebastiani S, Cantoreggi S, Slusher BS. Palonosetron triggers 5-HT(3) receptor internalization and causes prolonged inhibition of receptor function. Eur J Pharmacol. 2010;626:193–199. doi: 10.1016/j.ejphar.2009.10.002.
    1. Siddiqui MA, Scott LJ. Palonosetron. Drugs. 2004;64:1125–1132. doi: 10.2165/00003495-200464100-00006.
    1. Yang LP, Scott LJ. Palonosetron: in the prevention of nausea and vomiting. Drugs. 2009;69:2257–2278. doi: 10.2165/11200980-000000000-00000.
    1. Gralla R, Lichinitser M, Van Der Vegt S, Sleeboom H, Mezger J, Peschel C, Tonini G, Labianca R, Macciocchi A, Aapro M. 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. 2003;14:1570–1577. doi: 10.1093/annonc/mdg417.
    1. Eisenberg P, Figueroa-Vadillo J, Zamora R, Charu V, Hajdenberg J, Cartmell A, Macciocchi A, Grunberg S. 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. 2003;98:2473–2482. doi: 10.1002/cncr.11817.
    1. Saito M, Aogi K, Sekine I, Yoshizawa H, Yanagita Y, Sakai H, Inoue K, Kitagawa C, Ogura T, Mitsuhashi S. 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. 2009;10:115–124. doi: 10.1016/S1470-2045(08)70313-9.
    1. Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chron Dis. 1987;40:373–383. doi: 10.1016/0021-9681(87)90171-8.
    1. Quan H, Sundararajan V, Halfon P, Fong A, Burnand B, Luthi JC, Saunders LD, Beck CA, Feasby TE, Ghali WA. Coding algorithms for defining comorbidities in ICD-9-CM and ICD-10 administrative data. Med Care. 2005;43:1130–1139. doi: 10.1097/01.mlr.0000182534.19832.83.
    1. Zhang J, Yu KF. What’s the relative risk? A method of correcting the odds ratio in cohort studies of common outcomes. JAMA. 1998;280:1690–1691. doi: 10.1001/jama.280.19.1690.
    1. Yeh YC, McDonnell A, Klinger EV, Fowler B, Matta L, Voit D, Reddy P. Comparison of healthcare resource use between patients receiving ondansetron or palonosetron as prophylaxis for chemotherapy-induced nausea and vomiting. J Oncol Pharm Pract. 2011
    1. Perez E, Muss HB. Optimizing adjuvant chemotherapy in early-stage breast cancer. Oncology. 2005;19:1759–1767.
    1. Bonadonna G, Moliterni A, Zambetti M, Daidone MG, Pilotti S, Gianni L, Valagussa P. 30 years’ follow up of randomised studies of adjuvant CMF in operable breast cancer: cohort study. BMJ. 2005;330:217. doi: 10.1136/bmj.38314.622095.8F.
    1. Grote T, Hajdenberg J, Cartmell A, Ferguson S, Ginkel A, Charu V. Combination therapy for chemotherapy-induced nausea and vomiting in patients receiving moderately emetogenic chemotherapy: palonosetron, dexamethasone, and aprepitant. J Support Oncol. 2006;4:403–408.
    1. Grunberg SM, Dugan M, Muss H, Wood M, Burdette-Radoux S, Weisberg T, Siebel M. Effectiveness of a single-day three-drug regimen of dexamethasone, palonosetron, and aprepitant for the prevention of acute and delayed nausea and vomiting caused by moderately emetogenic chemotherapy. Support Care Canc. 2009;17:589–594. doi: 10.1007/s00520-008-0535-9.
    1. Herrington JD, Jaskiewicz AD, Song J. 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. 2008;112(9):2080–2087. doi: 10.1002/cncr.23364.
    1. Schwartzberg L, Jackson J, Jain G, Balu S, Buchner D. Risk of uncontrolled chemotherapy induced nausea and vomiting (CINV) with highly emetogenic chemotherapy and a triple combination anti-emetic prophylaxis regimen. Abtract accepted at 2011 Hematology/Oncology Pharmacists Association Annual Meeting; March 23–26, Salt Lake City, Utah
    1. Hamadani M, Chaudhary L, Awan FT, Khan JK, Kojouri K, Ozer H, Tfayli A. Management of platinum-based chemotherapy-induced acute nausea and vomiting: is there a superior serotonin receptor antagonist? J Oncol Pharm Pract. 2007;13:69–75. doi: 10.1177/1078155207078137.

Source: PubMed

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