Palonosetron for the treatment of chemotherapy-induced nausea and vomiting

Navari, Rudolph M.

doi:10.1517/14656566.2014.972366

Cited by 24 publications

(12 citation statements)

References 52 publications

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“…Clinical trials of more affordable, generic drugs, specifically olanzapine but also gabapentin, have shown some promising data and might offer better control of CINV without the need for more expensive, newer agents [35,36]. Drugs that were recommended in the older guidelines [15] such as metoclopramide show some benefit compared with 5-HT3 antagonists in the delayed period when given with dexamethasone but have fallen to the wayside because of a low risk of extrapyramidal side effects [37]. The current evidence does not support the use of other agents such as cannabinoids and ginger for prevention or treatment of CINV [31].…”

Section: Wwwtheoncologistcom ©Alphamed Press 2015mentioning

confidence: 99%

Chemotherapy-Induced Nausea and Vomiting: Time for More Emphasis on Nausea?

Hutton

Clemons

2015

The Oncologist

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Despite advances in antiemetic therapy, chemotherapyinduced nausea and vomiting (CINV) remains the most feared and expected side effect of chemotherapy [1]. Optimization of antiemetic therapy is important because CINV can lead to reduced quality of life, increased use of health care resources, and compromised treatment adherence. The combination of anthracycline and cyclophosphamide is used extensively in breast cancer patients and traditionally has been classified as being moderately emetogenic [2]. However, in 2011, the American Society of Clinical Oncology reclassified the combination of an anthracycline with cyclophosphamide as highly emetogenic, given its propensity to induce CINV, particularly nausea, in breast cancer patients [3]. Since then, local [4], national [3, 5], and international [6] antiemetic guidelines have emphasized the use of aprepitant in combination with 5-hydroxytryptamine-3 (5-HT3) antagonists and corticosteroids in this population. Not surprisingly, aprepitant-containing regimens have become the standard recommendation at many institutions, and aprepitant use has soared. Has this optimism from both patients and physicians significantly improved patient care?Despite the significant improvements in CINV reported in the aprepitant trials, control of CINV-and nausea in particular-remains suboptimal in patients receiving anthracycline and cyclophosphamide-based regimens [7,8]. In the nontrial setting, ∼58%-71% of patients will have nausea and/or vomiting despite "optimal" antiemetic prescribing (C. Hernandez-Torres, personal communication) [9]. What is the cause of this discrepancy? It is likely a combination of factors including health care staff underestimating the incidence of CINV [10], suboptimal adherence to antiemetic guidelines [9], lack of an optimal antiemetic regimen [11], clinical trials overestimating the benefit of antiemetics [7], and, quite simply, current trial endpoints that do not fully reflect patient experience. We feel this is an opportune moment to review the evidence to illustrate how antiemetic recommendations have evolved andtoraise ongoing issues and controversies in the management of CINV, especially in the breast cancer population.As all oncologists are aware, there has been significant progress in CINV control. Historically, antiemetic regimens were developed using cisplatin (.50 mg/m 2 ) as the benchmark because it causes CINV in almost all patients not receiving antiemetic prophylaxis. Based on the proposed pathophysiology of CINV, control of emesis has also been divided into acute (0-24 hours), delayed (.24-120 hours), and overall (0-120 hours) periods following chemotherapy [12], with antiemetic combinations being specifically chosen depending on their efficacy during these different time points. Following the results from antiemetic trials for patients receiving cisplatin-based chemotherapy (Table 1), most current antiemetic guidelines recommend a three-drug regimen consisting of aprepitant (days 1-3), 5-HT3 receptor antagonist (day 1), and dexamethasone (d...

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Section: Wwwtheoncologistcom ©Alphamed Press 2015mentioning

confidence: 99%

Chemotherapy-Induced Nausea and Vomiting: Time for More Emphasis on Nausea?

Hutton

Clemons

2015

The Oncologist

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“…A combination of these two classes of molecules, together with dexamethasone, is recommended in all international guidelines for highly emetogenic CT (HEC) regimens [5,6,8]. NEPA is a fixed dose combination antiemetic that combines palonosetron, a second-generation 5HT 3 -RA, with a prolonged half-life and a higher receptor affinity compared with other first generation 5HT 3 -RAs [9][10][11][12], with netupitant a novel, highly selective NK 1 -RA [13,14]. Both molecules have an extended half-life (palonosetron: 40 h; netupitant: 90 h) and their combination makes a single oral administration sufficient to cover the acute and the delayed phase of CINV induced by a single day CT [15][16][17].…”

Section: Introductionmentioning

confidence: 99%

Efficacy and safety of multiple doses of NEPA without dexamethasone in preventing nausea and vomiting induced by multiple-day and high-dose chemotherapy in patients with non-Hodgkin’s lymphoma undergoing autologous hematopoietic stem cell transplantation: a phase IIa, multicenter study

Renzo

Musso

Scimè

et al. 2020

Bone Marrow Transplant

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Despite the availability of several antiemetics, clinical findings show that control of chemotherapy-induced nausea and vomiting (CINV) continues to be a serious concern for hematological patients, mainly for those receiving multiple-day (MD) and high-dose (HD) chemotherapy (CT). For CINV prophylaxis, 5-hydroxytryptamine type-3 receptor antagonists (5HT 3 -RAs) and neurokinin 1 receptor antagonists (NK 1 -RAs) are usually administered together with dexamethasone, which may increase the risk of serious infections in patients undergoing myeloablative treatment. The rationale of this multicenter, openlabel and phase IIa study was to explore the efficacy of multiple doses of NEPA (netupitant/palonosetron) given as an everyother-day regimen without dexamethasone in preventing CINV in patients with relapsed-refractory aggressive non-Hodgkin's lymphoma (R/R-NHL), eligible for autologous stem cell transplantation (ASCT) and treated with MD-HD-CT. Seventy patients participated to the study. According to the adopted Fleming one-stage design, the primary endpoint of this study was achieved. The CR values were 87.1% (primary endpoint, overall phase: days 1-8), 88.6% (acute phase: days 1-6), and 98.6% (delayed phase: days 7-8), while complete control (CR with no more than mild nausea) was 85.7% (overall phase), 88.6% (acute phase), and 95.7% (delayed phase). Moderate and severe episodes of nausea were reported by less than 10% of patients in the overall phase and less than 5% in both the acute and delayed phases. Regarding safety, NEPA was well tolerated with only one adverse event (constipation) evaluated as possibly related to NEPA administration.In conclusion, our study demonstrated that multiple alternate dosing of NEPA without the addition of dexamethasone is highly effective for preventing nausea and vomiting in this difficult setting, with a good tolerability profile.

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“…[13][14][15] _ENREF_12 Palonosetron has also been shown to have greater receptor selectivity, longer duration of action, and unique structural characteristics compared with other 5-HT 3 receptor antagonists. 13,[16][17][18][19][20] Palonosetron also appears to have an advantageous safety profile compared with ondansetron, granisetron, dolasetron, and tropisetron, which have been associated with electrocardiographic changes and arrhythmias, sometimes leading to the potentially fatal heart rhythm torsades de pointes. 13,14,[21][22][23][24] Palonosetron has been shown not to cause arrhythmias or symptomatic electrocardiographic changes.…”

Section: Introductionmentioning

confidence: 99%