Chemotherapy-induced nausea and vomiting and antiemetic prophylaxis with palonosetron versus other 5-HT3 receptor antagonists in patients with cancer treated with low emetogenic chemotherapy in a hospital outpatient setting in the United States

2011 ◽  
Vol 27 (8) ◽  
pp. 1613-1622 ◽  
Author(s):  
Lee Schwartzberg ◽  
Gary Morrow ◽  
Sanjeev Balu ◽  
Chris Craver ◽  
Julie Gayle ◽  
...  
Keyword(s):  
United States ◽  
The United States ◽  
Outpatient Setting ◽  
Emetogenic Chemotherapy ◽  
Nausea And Vomiting ◽  
Receptor Antagonists ◽  
Hospital Outpatient ◽  
Patients With Cancer ◽  
Antiemetic Prophylaxis ◽  
Low Emetogenic Chemotherapy

Palonosetron Versus Other 5-HT3-Receptor Antagonists for the Prevention of Chemotherapy Induced Nausea and Vomiting In Patients with Hematologic Malignancies Treated In A Hospital Outpatient Setting

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 2567-2567
Author(s):  
Chris Craver ◽  
Julie Gayle ◽  
Sanjeev Balu ◽  
Deborah Buchner
Keyword(s):  
Index Date ◽  
Hematologic Malignancies ◽  
Outpatient Setting ◽  
Emetogenic Chemotherapy ◽  
Nausea And Vomiting ◽  
Highly Emetogenic Chemotherapy ◽  
Hospital Outpatient ◽  
Group 2 ◽  
Group 1

Abstract Abstract 2567 Objective: This analysis explored the risk of uncontrolled chemotherapy induced nausea and vomiting (CINV) associated with initiation of palonosetron versus other 5-hydroxy tryptamine3-receptor antagonists (5-HT3-RAs) among patients with leukemia and/or lymphoma receiving chemotherapy (CT) [highly emetogenic chemotherapy, moderately emetogenic chemotherapy, low emetogenic chemotherapy, or minimal emetogenic chemotherapy] treatment in a hospital outpatient setting. Methods: Patients diagnosed with any leukemia and/or lymphoma [identified through appropriate International Classification of Diseases, Clinical Modification, 9th Revision codes (ICD-9-CM)] initiating any CT and anti-emetic prophylaxis with palonosetron (Group 1) or other 5-HT3-RAs (Group 2) for the first time (index date) between April 1, 2007 and March 31, 2009 were identified from the Premier Perspective comparative research database. Other inclusion criteria were patients aged ≥ 18 years, no prior evidence of nausea and vomiting or a hospital charge for a CT or anti-emetic medication in the 6-month pre-index date period, and at least one CINV event in the post-index date follow-up study period. Patients also needed to have at least 36 consecutive months of hospital data submissions. Patients were followed through eight CT cycles or six months post index date, whichever occurred first. The unit of analysis was a CT cycle. Group 1 and Group 2 patients were matched on type of CT, specific CT cycle, and leukemia/lymphoma diagnosis using propensity scoring. A negative binomial distribution generalized linear multivariate regression model estimating the number of CINV events (identified through either ICD-9-CM codes for nausea and/or vomiting and volume depletion or CINV-related rescue medications one day after CT administration) in the follow-up period between the matched groups was developed after adjusting for other significant differences in demographic and clinical variables at index date (baseline) including age, gender, patient weight, payor type, patient race, CT cycle duration, and CT duration in days. Results: Of 1,256 identified patients, 234 initiated with palonosetron (Group 1; 18.6%). Group 1 patients were significantly younger [60.8 (SD: 17.9) vs. 64.4 (14.8) years; p=0.0045], comprised more females [49.6% vs. 43.2%; p<0.0001], received more emetogenic CT (high and moderate) [88.5% vs. 77.1%; p<0.0001], and less African Americans [9.4% vs. 12.7%]. Group 1 also had a lower percentage of patients with leukemia [9.0% vs. 17.6%; p<0.0001], and more patients with lymphoma [82.5% vs. 63.1%; p<0.0001]. In the follow-up period, the unadjusted number of CINV events per patient per CT cycle for Group1 patients was significantly lower versus Group 2 patients (3.4 vs. 4.3 CINV events per patient per CT cycle; p<0.0001). The regression model predicted a 32% reduction in the total CINV events per patient per CT cycle for Group 1 patients versus Group 2 patients; p=0.0003. Other significant variable results from the model included patients aged < 65 years had a 39.9% lower risk of total CINV events per patient per CT cycle versus patients aged ≥ 65 years; p=0.0009 and commercially insured patients had a 44.2% lower risk of total CINV events per patient per CT cycle versus traditional Medicare patients; p=0.0003. Conclusion: In this hospital outpatient retrospective database analysis, patients with hematologic malignancies initiated and maintained on palonosetron were more likely to experience a significantly lower rate of CINV events per patient per CT cycle versus those initiated on other 5-HT3-RAs. Disclosures: Craver: Eisai, Inc.: Research Funding. Gayle:Eisai, Inc.: Research Funding. Balu:Eisai, Inc.: Employment. Buchner:Eisai, Inc.: Employment. Off Label Use: The study was on hematology patients on all chemotherapy types (high, moderate, low, and minimal) even though the drug (palonosetron) is approved for highly emetogenic chemotherapy and moderately emetogenic chemotherapy in the United States.

scholarly journals Are All 5-HT3 Receptor Antagonists the Same?

2007 ◽  
Vol 5 (1) ◽  
pp. 35-43 ◽  
Author(s):  
Robert McNulty
Keyword(s):  
Best Practice ◽  
The United States ◽  
Emetogenic Chemotherapy ◽  
Nausea And Vomiting ◽  
Efficacy Rate ◽  
Receptor Antagonists ◽  
Open Label ◽  
Routes Of Administration ◽  
Equivalent Efficacy ◽  
Double Blinded

The 5-hydroxytryptamine type 3 (5-HT3) receptor antagonists have become the cornerstone for preventing and treating chemotherapy-induced nausea and vomiting. Four 5-HT3 antagonists are commercially available in the United States, and numerous reports have been published comparing 2 or more agents. The studies ranged from randomized, double-blinded to open-label or retrospective trials; included chemotherapy-naïve and –non-naïve patients; and covered a range of doses and routes of administration with and without concomitant steroids, for preventing and treating nausea and vomiting after highly and moderately high emetogenic chemotherapy. With few exceptions, the studies uniformly show an equivalent efficacy rate and side effect profile among the various agents at equivalent doses. This article reviews the pharmacology of the class for insight into minor differences among the agents that could possibly influence drug selection for certain patients, and considers data on the absorption, half-life, metabolism, and receptor activity. Clinical trials support the claim of various guidelines that the 5-HT3 receptor antagonists are therapeutically similar in safety and efficacy, particularly because the current best practice for preventing nausea and vomiting after highly and moderately high emetogenic chemotherapy is a combination of a 5-HT3 antagonist, steroids, and aprepitant.

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