32 research outputs found
Palonosetron for the prevention of chemotherapy-induced nausea and vomiting: approval and efficacy
Chemotherapy-induced nausea and vomiting (CINV) is associated with a significant deterioration in quality of life. The emetogenicity of the chemotherapeutic agents, repeated chemotherapy cycles, and patient characteristics (female gender, younger age, low alcohol consumption, history of motion sickness) are the major risk factors for CINV. This review provides a detailed description of palonosetron, a second-generation 5-hydroxytryptamine 3 (5-HT3) receptor antagonist. The chemistry and pharmacology of palonosetron are described, as well as the initial and recent clinical trials. Palonosetron has a longer half-life and a higher binding affinity than the first-generation 5-HT3 receptor antagonists. Palonosetron has been approved for the prevention of acute CINV in patients receiving either moderately or highly emetogenic chemotherapy and for the prevention of delayed CINV in patients receiving moderately emetogenic chemotherapy. In recent studies, compared to the first-generation 5-HT3 receptor antagonists, palonosetron in combination with dexamethasone demonstrated better control of delayed CINV in patients receiving highly emetogenic chemotherapy. There were no clinically relevant adverse reactions reported in the palonosetron clinical trials which were different from the common reactions reported for the 5-HT3 receptor antagonist class. Due to its efficacy in controlling both acute and delayed CINV, palonosetron may be very effective in the clinical setting of multiple-day chemotherapy and bone marrow transplantation
Olanzapine for the Prevention of Chemotherapy-Induced Nausea and Vomiting
BACKGROUND
We examined the efficacy of olanzapine for the prevention of nausea and vomiting in patients receiving highly emetogenic chemotherapy.
METHODS
In a randomized, double-blind, phase 3 trial, we compared olanzapine with placebo, in combination with dexamethasone, aprepitant or fosaprepitant, and a 5-hydroxytryptamine type 3–receptor antagonist, in patients with no previous chemotherapy who were receiving cisplatin (≥70 mg per square meter of body-surface area) or cyclophosphamide–doxorubicin. The doses of the three concomitant drugs administered before and after chemotherapy were similar in the two groups. The two groups received either 10 mg of olanzapine orally or matching placebo daily on days 1 through 4. Nausea prevention was the primary end point; a complete response (no emesis and no use of rescue medication) was a secondary end point.
RESULTS
In the analysis, we included 380 patients who could be evaluated (192 assigned to olanzapine, and 188 to placebo). The proportion of patients with no chemotherapy-induced nausea was significantly greater with olanzapine than with placebo in the first 24 hours after chemotherapy (74% vs. 45%, P = 0.002), the period from 25 to 120 hours after chemotherapy (42% vs. 25%, P = 0.002), and the overall 120-hour period (37% vs. 22%, P = 0.002). The complete-response rate was also significantly increased with olanzapine during the three periods: 86% versus 65% (P<0.001), 67% versus 52% (P = 0.007), and 64% versus 41% (P<0.001), respectively. Although there were no grade 5 toxic effects, some patients receiving olanzapine had increased sedation (severe in 5%) on day 2.
CONCLUSIONS
Olanzapine, as compared with placebo, significantly improved nausea prevention, as well as the complete-response rate, among previously untreated patients who were receiving highly emetogenic chemotherapy. (Funded by the National Cancer Institute; ClinicalTrials.gov number, NCT02116530.
2023 updated MASCC/ESMO consensus recommendations : prevention of nausea and vomiting following multiple-day chemotherapy, high-dose chemotherapy, and breakthrough nausea and vomiting
PURPOSE : This review is an update of the MASCC/ESMO 2015 recommendations for the prophylaxis of acute and delayed nausea and vomiting induced by multiple-day chemotherapy, high-dose chemotherapy, and breakthrough nausea and vomiting.
METHODS :
A systematic literature search was conducted using PubMed from June 1, 2015, through February 1, 2023.
RESULTS : We identified 56 references (16 were duplications or invalid), leaving 40 manuscripts for this search. The panel classified level I evidence (three manuscripts) and level II evidence (14 manuscripts). High-dose chemotherapy and stem cell transplant were discussed in four of these manuscripts, and multiple-day chemotherapy treatment in 15. Some manuscripts covered both topics. Additionally, a search for breakthrough nausea and vomiting resulted in 12 “hits.” No new relevant studies were identified.
CONCLUSIONS : The recommendations for patients receiving high-dose chemotherapy with stem cell transplants and patients undergoing multiple-day cisplatin were updated. For patients receiving high-dose chemotherapy for stem cell transplant, a combination of a 5-HT3 receptor antagonist with dexamethasone and aprepitant is recommended. Olanzapine could be considered part of the antiemetic regimen. Patients receiving multiple-day cisplatin should receive a 5-HT3 receptor antagonist plus dexamethasone plus aprepitant plus olanzapine. For patients experiencing breakthrough nausea and vomiting, the available evidence suggests using a single dose of olanzapine daily for 3 days.Open access funding provided by University of Pretoria.https://link.springer.com/journal/520hj2024ImmunologySDG-03:Good heatlh and well-bein
Safety of Polysorbate 80 in the Oncology Setting
<p></p><p><b>Article full text</b></p>
<p><br></p>
<p>The full text of this article can
be found here<b>. </b><a href="https://link.springer.com/article/10.1007/s12325-018-0707-z">https://link.springer.com/article/10.1007/s12325-018-0707-z</a></p><p></p><p></p><p>
</p><p><br></p>
<p><b>Provide enhanced content for this
article</b></p>
<p><br></p>
<p>If you are an author of this
publication and would like to provide additional enhanced content for your
article then please contact <a href="http://www.medengine.com/Redeem/âmailto:[email protected]â"><b>[email protected]</b></a>.</p>
<p><br></p>
<p>The journal offers a range of
additional features designed to increase visibility and readership. All
features will be thoroughly peer reviewed to ensure the content is of the
highest scientific standard and all features are marked as ‘peer reviewed’ to
ensure readers are aware that the content has been reviewed to the same level
as the articles they are being presented alongside. Moreover, all sponsorship
and disclosure information is included to provide complete transparency and
adherence to good publication practices. This ensures that however the content
is reached the reader has a full understanding of its origin. No fees are
charged for hosting additional open access content.</p>
<p><br></p>
<p>Other enhanced features include,
but are not limited to:</p>
<p><br></p>
<p>• Slide decks</p>
<p>• Videos and animations</p>
<p>• Audio abstracts</p>
<p>• Audio slides</p><br><p></p
2016 updated MASCC/ESMO consensus recommendations: prevention of nausea and vomiting following multiple-day chemotherapy, high-dose chemotherapy, and breakthrough nausea and vomiting
Purpose
This review summarizes the recommendations for the prophylaxis of acute and delayed nausea and vomiting induced by multiple-day chemotherapy, high-dose chemotherapy, and breakthrough nausea and vomiting as agreed at the MASCC/ESMO Antiemetic Guidelines update meeting in Copenhagen in June 2015.
Methods
A systematic literature search using PubMed from January 01, 2009 through January 06, 2015 with a restriction to papers in English was conducted.
Results
There were three phase III randomized trials in patients undergoing high-dose chemotherapy and stem cell transplant and eight single arm non-randomized clinical studies (single in patients undergoing transplantation and one in patients receiving multiple-day chemotherapy treatment). We used a total of two randomized clinical trials in this guideline update. For patients receiving treatment for breakthrough chemotherapy-induced nausea and vomiting, a phase III randomized trial investigating the use of olanzapine versus metoclopramide in patients receiving highly emetogenic chemotherapy and a second single arm study looking at the effectiveness of olanzapine were identified.
Conclusions
It was concluded that for patients receiving high-dose chemotherapy with stem cell transplant, a combination of a 5-HT3 receptor antagonist with dexamethasone and aprepitant (125 mg orally on day 1 and 80 mg orally on days 2 to 4) is recommended before chemotherapy.
For patients undergoing multiple-day chemotherapy-induced nausea and vomiting, a 5-HT3 receptor antagonist, dexamethasone, and aprepitant, are recommended before chemotherapy for the prophylaxis of acute emesis and delayed emesis.
For patients experiencing breakthrough nausea and vomiting, the available evidence suggests the use of 10 mg oral olanzapine, daily for 3 days. Mild to moderate sedation in this patient population (especially elderly patients) is a potential problem with this agent
Rolapitant for the prevention of nausea in patients receiving highly or moderately emetogenic chemotherapy
Most patients receiving highly or moderately emetogenic chemotherapy experience
chemotherapy-induced
nausea and vomiting without antiemetic prophylaxis. While
neurokinin-1
receptor antagonists (NK-1RAs)
effectively prevent emesis, their ability
to prevent nausea has not been established. We evaluated the efficacy of the long-acting
NK-1RA
rolapitant in preventing chemotherapy-induced
nausea using post
hoc analyses of data from 3 phase 3 trials. Patients were randomized to receive
180 mg oral rolapitant or placebo approximately 1-2
hours before chemotherapy in
combination with a 5-hydroxytryptamine
type 3 RA and dexamethasone. Nausea
was assessed by visual analog scale during the acute (≤24 hours), delayed (>24-120
hours), and overall (0-120
hours) phases. Post hoc analyses by treatment group
(rolapitant vs control) were performed on pooled data within patient subgroups receiving
cisplatin-based,
carboplatin-based,
or anthracycline/cyclophosphamide
(AC)-based
chemotherapy. In the cisplatin-based
chemotherapy group, significantly
more patients receiving rolapitant than control reported no nausea (NN) in the overall
(52.3% vs 41.7% [P < .001]; absolute benefit [AB] = 10.6%), delayed (55.7% vs
44.3% [P < .001]; AB = 11.4%), and acute (70.5% vs 64.3% [P = .030]; AB = 6.2%)
phases. Similar results were observed in the carboplatin-based
chemotherapy group,
with significantly more patients receiving rolapitant than control reporting NN in the
overall (62.5% vs 51.2% [P = .023]; AB = 11.3%) and delayed (64.1% vs 53.6%
[P = .034]; AB = 10.5%) phases. In the AC-based
chemotherapy group, patients receiving
rolapitant or control reported similar NN rates during the overall and delayed phases. Rolapitant effectively prevents nausea during the overall and delayed phases
in patients receiving cisplatin-or
carboplatin-based
chemotherapy.TESARO, Inc.https://onlinelibrary.wiley.com/journal/20457634am2019Immunolog