Palonosetron plus dexamethasone versus granisetron plus dexamethasone for prevention of nausea and vomiting during chemotherapy: a double-blind, double-dummy, randomised, comparative phase III trial

Saito, Mitsue; Aogi, Kenjiro; Sekine, Ikuo; Yoshizawa, Hirohisa; Yanagita, Yasuhiro; Sakai, Hiroshi; Inoue, Kentaro; Kitagawa, Chiyoe; Ogura, Takashi; Mitsuhashi, Shoichi

doi:10.1016/s1470-2045(08)70313-9

Cited by 388 publications

(319 citation statements)

References 33 publications

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“…In certain cases in the present study, granisetron was replaced by palonosetron in an attempt to achieve higher efficacy of the newly developed antiemetics to determine the effects of chemotherapy on food intake. Improvements in appetite were previously reported (11), particularly in the delayed phase, in one-quarter of the patients in whom the antiemetic agent was switched to palonosetron. There were no serious side effects and, although there has not yet been a listing of palonosteron in the Japanese guidelines (5), it was suggested that the use of palonosetron as a 5-HT 3 RA be prioritised over that of other available 5-HT 3 RAs.…”

Section: -Htmentioning

confidence: 68%

“…The development of granisetron, a first-generation 5-HT 3 RA, was shown to mitigate acute nausea and vomiting (8), although its efficacy for delayed nausea and vomiting is limited (9). However, the more recently developed aprepitant (10) and palonosetron (11) have demonstrated promising outcomes in the control of acute-and delayed-phase nausea and vomiting.…”

Section: Introductionmentioning

confidence: 99%

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Palonosetron exhibits higher total control rate compared to first-generation serotonin antagonists and improves appetite in delayed-phase chemotherapy-induced nausea and vomiting

Ueda

Shimono

Nishimura

et al. 2014

Molecular and Clinical Oncology

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Abstract. In order to ensure the continuity of chemotherapy, it is crucial to provide appropriate supportive care to prevent chemotherapy-induced nausea and vomiting (CINV). The frequency of CINV is greatly affected by the type and combination of chemotherapy employed, which requires further investigation. With the use of patient diaries, a prospective study on the efficacy of antiemetic regimens for nausea and vomiting was conducted in 103 patients receiving highly or moderately emetogenic chemotherapy in the Ambulatory Therapy Center of our institution between August, 2010 and March, 2011. In this study, the efficacy of palonosetron in the delayed phase was affirmed. On days 4 and 5, in particular, palonosetron exhibited a significantly higher efficacy compared to that of other conventional serotonin (5-HT 3 ) receptor antagonists (5-HT 3 RAs). When the effects of chemotherapy on food intake were assessed by switching granisetron to palonosetron, an improvement in appetite was observed in one-quarter of the cases in the delayed phase. In addition, palonosetron has not been associated with any severe adverse drug reactions. It was therefore suggested that the use of palonosetron be recommended as a 5-HT 3 RA. In conclusion, our data suggested that palonosetron is effective and may be used as a 5-HT 3 RA, since it is crucial that we take adequate measures against CINV in order to maintain the patients' quality of life and to develop antiemetic regimens that ensure the continuity of chemotherapy without dose reduction.

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Section: -Htmentioning

confidence: 68%

Section: Introductionmentioning

confidence: 99%

Palonosetron exhibits higher total control rate compared to first-generation serotonin antagonists and improves appetite in delayed-phase chemotherapy-induced nausea and vomiting

Ueda

Shimono

Nishimura

et al. 2014

Molecular and Clinical Oncology

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“…The superior anti-emetic efficacy of palonosetron compared with other 5-HT3 receptor antagonists may also be attributed to allosteric interactions and a positive cooperative effect of palonosetron, prolonged structural changes of the receptor and internalization (13)(14)(15), in addition to other factors.…”

Section: Discussionmentioning

confidence: 99%

Comparative investigation of the anti-emetic effects of granisetron and palonosetron during the treatment of acute myeloid leukemia

Matsumaru

Tsutsumi

2017

Molecular and Clinical Oncology

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Abstract. Chemotherapy-induced nausea and vomiting has a considerable negative impact on the quality of life of patients with cancer. Unfortunately, there has been little progress in the development of supportive therapies for the anti-emetic treatment of patients with hematopoietic tumors. This lack of supportive treatments motivated the present retrospective comparison between two groups of anti-emetic drugs. The current study aimed to compare granisetron and palonosetron in order to determine which is more effective, based on cases of patients undergoing remission induction therapy and consolidation therapy for the treatment of acute myeloid leukemia. Granisetron or palonosetron were administered in Japanese-approved dosages (3 mg granisetron once per day for 5 or 7 days, or one administration of 0.75 mg palonosetron). Patients were randomly selected, and their clinical information was acquired from medical records. The data represent the doctors' and nurses' records. The results demonstrated that palonosetron treatment (in which the drug was administered alone or in combination with aprepitant) was more effective than granisetron treatment for the complete control of acute vomiting. Therefore, in the treatment of hematopoietic malignancies, palonosetron is an effective regimen to be administered alongside more than 5 continuous days of anticancer agents. Furthermore, the combination of palonosetron and aprepitant was found to be the optimal combination. In conclusion, palonosetron is superior to granisetron for the prevention of nausea and vomiting induced by chemotherapy for hematological cancers. In Japan, the standard dose of palonosetron is 0.75 mg; a dose of 0.25 mg of palonosetron must be compared with 0.75 mg in future studies.

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“…Although ondansetron, granisetron, tropisetron, and dolasetron differ in receptor specificity, potency, and plasma half-life [3,47], each has demonstrated equivalent efficacy and adverse effects when used to prevent emesis following chemotherapy of high emetic risk. Recently, the 5-HT 3 antagonist palonosetron has shown superior efficacy to granisetron when both were used in combination with dexamethasone in a trial designed to show equivalence [52]. This is the first conclusive demonstration of a meaningful efficacy difference when two 5-HT 3 antagonists were compared.…”

Section: Introductionmentioning

confidence: 88%

Consensus recommendations for the prevention of vomiting and nausea following high-emetic-risk chemotherapy

Kris

Tonato²,

Bria³

et al. 2010

Support Care Cancer

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In this update of our 2005 document, we used an evidence-based approach whenever possible to formulate recommendations, emphasizing the results of controlled trials concerning the best use of antiemetic agents for the prevention of emesis and nausea following anticancer chemotherapies of high emetic risk. A three-drug combination of a 5-hydroxytryptamine type 3 receptor (5-HT 3 ) receptor antagonist, dexamethasone, and aprepitant beginning before chemotherapy and continuing for up to 4 days remains the standard of care. We address issues of dose, schedule, and route of administration of five selective 5-HT 3 receptor antagonists. We conclude that, for each of these five drugs, there is a plateau in therapeutic efficacy above which further dose escalation does not improve outcome. In trials designed to prove the equivalence of palonosetron to ondansetron and granisetron, palonosetron proved superior in emesis prevention, while adverse effects were comparable. Furthermore, for all classes of antiemetic agents, a single dose is as effective as multiple doses or a continuous infusion. The oral route is as efficacious as the intravenous route of administration.

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Palonosetron plus dexamethasone versus granisetron plus dexamethasone for prevention of nausea and vomiting during chemotherapy: a double-blind, double-dummy, randomised, comparative phase III trial

Cited by 388 publications

References 33 publications

Palonosetron exhibits higher total control rate compared to first-generation serotonin antagonists and improves appetite in delayed-phase chemotherapy-induced nausea and vomiting

Palonosetron exhibits higher total control rate compared to first-generation serotonin antagonists and improves appetite in delayed-phase chemotherapy-induced nausea and vomiting

Comparative investigation of the anti-emetic effects of granisetron and palonosetron during the treatment of acute myeloid leukemia

Consensus recommendations for the prevention of vomiting and nausea following high-emetic-risk chemotherapy

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