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01.12.2012 | Research article | Ausgabe 1/2012 Open Access

BMC Health Services Research 1/2012

Impact of 5-HT3 receptor antagonists on chemotherapy-induced nausea and vomiting: a retrospective cohort study

Zeitschrift:
BMC Health Services Research > Ausgabe 1/2012
Autoren:
Swu-Jane Lin, Hind T Hatoum, Deborah Buchner, David Cox, Sanjeev Balu
Wichtige Hinweise

Competing interest

S. Lin is a consultant to Hind T. Hatoum & Company. H. T. Hatoum is a paid consultant to Eisai, Inc., the marketer of palonosetron in the United States and the sponsor of the study. Deborah Buchner. David Cox, and Sanjeev Balu are, or were employees of Eisai, Inc. The authors had full control of the all primary data and findings. All authors agree to allow the Journal to review the data if requested. Results are presented without any oversight or interference from the sponsor of the work.

Authors' contributions

SJL performed the statistical analysis of data, and participated in the writing of the manuscript. HTH contributed to the study design, the interpretation of data and the writing of the manuscript. DB was involved in the conception of the study and its design, and in the writing of the manuscript, DC contributed to the interpretation of results, and to providing input into the important intellectual clinical content and to manuscript development, SB contributed to the design of the study, the interpretation of results, and in the writing of the manuscript . All authors gave final approval of the version submitted.

Abstract

Background

1st generation 5-hydroxytryptamine receptor antagonists (5-HT3 RAs), and palonosetron, a 2nd generation 5-HT3 RA, are indicated for the prevention of chemotherapy (CT)-induced nausea and vomiting (CINV) associated with moderately (MEC) and highly emetogenic CT agents (HEC). This study explores the impact of step therapy policies requiring use of an older 5-HT3 RA before palonosetron on risk of CINV associated with hospital or emergency department (ED) admissions.

Methods

Patients who received cyclophosphamide post breast cancer (BC) surgery or who were diagnosed with lung cancer on carboplatin (LC-carboplatin) or cisplatin (LC-cisplatin) were selected from PharMetrics’ (IMS LifeLink) claims dataset (2005-2008). Patients were followed for 6 months from initial CT administration for CINV events identified through ICD-9-CM codes. Patients were grouped into those initiated with older, generic 5-HT3 RAs (ondansetron, granisetron, and dolasetron) and those initiated and maintained on palonosetron throughout study follow-up. CINV events and CINV days were analyzed using multivariate regressions controlling for demographic and clinical variables.

Results

Eligible patients numbered 3,606 in BC, 4,497 in LC-carboplatin and 1,154 in LC-cisplatin cohorts, with 52%, 40%, and 34% in the palonosetron group, respectively. There was no significant difference between the two 5-HT3 RA groups in age or Charlson Comorbidity Index among the two MEC cohorts (BC and LC-carboplatin). Among the LC-cisplatin cohort, palonosetron users were older with more males than the older 5-HT3 RA group (age: 60.1 vs. 61.3; males, 66.9% vs. 56.9%). Compared to the older 5-HT3 RAs, the palonosetron groups incurred 22%-51% fewer 5-HT3 RA pharmacy claims, had fewer patients with CINV events (3.5% vs. 5.5% in BC, 9.5% vs. 12.8% in LC-carboplatin, 16.4% vs. 21.7% in LC-cisplatin), and had lower risk for CINV events (odds ratios 0.62, 0.71, or 0.71, respectively; p < 0.05). The BC and LC-carboplatin palonosetron groups experienced 50% and 30% fewer CINV days than the generic 5-HT3 RA group (p < 0.05).

Conclusions

Patients with breast or lung cancer initiated and maintained on palonosetron were at significantly lower risk for potentially costly CINV versus those on older 5-HT3 RAs. Further studies on impact of step therapy policy are warranted in order to minimize the clinical and economic burden of CINV.
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