Evaluation of an Every-Other-Day Palonosetron Schedule to Control Emesis in Multiple-Day High-Dose Chemotherapy

Mirabile, Aurora; Celio, Luigi; Magni, Michele; Bonizzoni, Erminio; Gianni, Alessandro M.; Nicola, Massimo Di

doi:10.2217/fon.14.132

Cited by 8 publications

(7 citation statements)

References 25 publications

(32 reference statements)

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“…Despite clinical findings in CINV prophylaxis, control of nausea and vomiting continues to be a significant problem particularly in the days after the start of CT since MD-HD regimens trigger a prolonged, enhanced, and diverse emetogenic stimulus during each day of the treatment [25,26]. Indeed, studies have evaluated that CINV prophylaxis based on palonosetron and dexamethasone, either in single or multiple dose, do not provide an extensive control of nausea and vomiting in patients undergoing MD-CT and MD-HD-CT [27,28]. Similar rates were found in trials that evaluated the efficacy of the triple combination 5HT 3 -RA/NK 1 -RA/ dexamethasone using ondansetron or tropisetron and aprepitant in patients treated for several days with ablative preparative regimens [18,20,21].…”

Section: Discussionmentioning

confidence: 99%

“…However, this is the first study that evaluates the efficacy of an antiemetic prophylaxis in the transplantation setting without the use of dexamethasone as antiemetic or as part of the CT regimen. The use of palonosetron with an every-other-day schedule has already been investigated and established [28] and this study aimed also to confirm the safety profile of netupitant administered on multiple days. Moreover, netupitant is a moderate inhibitor of cytochrome P450 3A4 (CYP3A4) and it may interfere with the pharmacokinetics of other drugs that interact with the same enzyme.…”

Section: Discussionmentioning

confidence: 99%

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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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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

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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“…In the HDM setting, palonosetron [ 9 , 11 , 17 , 20 , 25 , 26 ], granisetron [ 21 , 32 , 37 ], and ondansetron [ 5 , 7 , 36 ] have been investigated. None of the aforementioned studies was randomized and the three drugs can be considered equivalent in terms of efficacy for CINV prevention.…”

Section: Discussionmentioning

confidence: 99%

“…Guidelines for CINV prophylaxis recommend the use of olanzapine in high emetic risk chemotherapy, but the advantage of its use in high-dose chemotherapy with ASCT is not clear [ 13 , 16 , 25 ].…”

Section: Discussionmentioning

confidence: 99%

Netupitant/palonosetron without dexamethasone for preventing nausea and vomiting in patients with multiple myeloma receiving high-dose melphalan for autologous stem cell transplantation: a single-center experience

Loteta

Paviglianiti

Naso

et al. 2021

Support Care Cancer

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Chemotherapy-induced nausea and vomiting (CINV) is one of the most frequent adverse events compromising quality of life (QoL) in patients undergoing autologous stem cell transplantation (ASCT). However, CINV prophylaxis is still lacking uniformity for high-dose melphalan (HDM), which is used to condition patients with multiple myeloma (MM). Netupitant/palonosetron (NEPA) is administered with dexamethasone (DEXA) for CINV prevention in several chemotherapy regimens. Our study aims to assess the efficacy of NEPA, without DEXA, in preventing CINV in 106 adult patients with MM receiving HDM and ASCT. All patients had antiemetic prophylaxis with multiple doses of NEPA 1 h before the start of conditioning and after 72 h and 120 h. A complete response (CR) was observed in 99 (93%) patients at 120 h (overall phase). The percentage of patients with complete control was 93%. The CR rate during the acute phase was 94% ( n = 100). During the delayed phase, the CR rate was 95% ( n = 101). Grade 1 nausea and vomiting were experienced by 82% and 12% of the patients, respectively. Grade 2 nausea was reported in 18% and vomiting in 10% of patients. Our results showed, for the first time, that NEPA, without DEXA, was a well-tolerated and effective antiemetic option for MM patients receiving HDM followed by ASCT. Supplementary Information The online version contains supplementary material available at 10.1007/s00520-021-06472-7.

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“…A regimen of palonosetron, aprepitant, and dexamethasone was also reported to control nausea and emesis in testicular germ cell tumor patients receiving a 5-day cisplatin-based combination chemotherapy [59]. Complete control in the acute period (24 h post chemotherapy) was improved compared to historical controls receiving ondansetron in 58 patients undergoing multiple-day high-dose chemotherapy who received palonosetron every other day plus daily dexamethasone [60].…”

Section: Prevention and Treatment Of Nausea With Palonosetronmentioning

confidence: 97%

Palonosetron for the treatment of chemotherapy-induced nausea and vomiting

Navari

2014

Expert Opinion on Pharmacotherapy

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The clinical data in the literature have established palonosetron as the 5-HT3 receptor antagonist of choice in terms of efficacy and safety for the prevention of CINV for patients receiving moderately or highly emetogenic chemotherapy. Three international guidelines have listed palonosetron as the preferred 5-HT3 receptor antagonist. Due to its higher efficacy, the use of palonosetron may be more cost effective compared to the generic first-generation 5-HT3 receptor antagonists. Clinical organizations' pharmacy and formulary committees should consider efficacy when making recommendations for agents for the prevention of CINV.

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Evaluation of an Every-Other-Day Palonosetron Schedule to Control Emesis in Multiple-Day High-Dose Chemotherapy

Abstract: Palonosetron every other day plus daily dexamethasone is an effective anti-emetic coverage in patients undergoing HDC.

Cited by 8 publications

References 25 publications

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

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

Netupitant/palonosetron without dexamethasone for preventing nausea and vomiting in patients with multiple myeloma receiving high-dose melphalan for autologous stem cell transplantation: a single-center experience

Palonosetron for the treatment of chemotherapy-induced nausea and vomiting

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