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01.08.2011 | Original Article

Palonosetron plus 3-day aprepitant and dexamethasone to prevent nausea and vomiting in patients receiving highly emetogenic chemotherapy

verfasst von: Flavia Longo, Giovanni Mansueto, Vittoria Lapadula, Rita De Sanctis, Silvia Quadrini, Roberta Grande, Bruno Gori, Amelia Altavilla, I. D’Antoni, Ester Del Signore, Luciano Stumbo, Cristina De Luca, Barbara Cimadon, Enrico Cortesi, Teresa Gamucci, Marisa Di Seri

Erschienen in: Supportive Care in Cancer | Ausgabe 8/2011

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Abstract

Background

The combination of a neurokinin-1 receptor antagonist, dexamethasone, and a 5-HT₃ receptor antagonist is currently the standard antiemetic treatment in patients receiving cisplatin-based high emetogenic chemotherapy (HEC). The aim of this study was to evaluate the efficacy of a combination of palonosetron, a unique second-generation 5-HT₃ receptor antagonist, aprepitant, the only approved neurokinin-1 receptor antagonist, and dexamethasone as antiemetic prophylaxis in patients receiving HEC (cisplatin ≥50 mg/mq).

Methods

Chemotherapy-naïve adult patients, receiving cisplatin-based HEC, were treated with palonosetron 0.25 mg/i.v., dexamethasone 20 mg/i.v., and aprepitant 125 mg/p.o., 1-h before chemotherapy. Aprepitant 80 mg/p.o. and dexamethasone 4 mg p.o. were administered on days 2–3. Primary end point was complete response (CR; no vomiting and no use of rescue medication), during the overall study period (0–120 h). Secondary end points were complete control (CR and no more than mild nausea), emesis-free rate, and nausea-free rate during the acute (0–24 h), delayed (24–120 h), and overall (0-120 h) periods. Safety was also evaluated.

Results

A total of 222 patients were included in the study. Median age was 62 years, 76.6% were male and 23.4% female, and most common tumors were lung (66.7%) and head and neck (15.8%); 70.3% of patients achieved CR during the overall study period. Complete control, emesis-free rate, and nausea-free rate were 70.3%, 92.8%, and 59.9%, respectively, during the overall phase. The most commonly reported side effects were constipation (39% of patients) and headache (5%).

Conclusions

This study shows that palonosetron in combination with aprepitant and dexamethasone is effective to prevent chemotherapy-induced nausea and vomiting in patients treated with cisplatin-based HEC.

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Titel: Palonosetron plus 3-day aprepitant and dexamethasone to prevent nausea and vomiting in patients receiving highly emetogenic chemotherapy
verfasst von: Flavia Longo
Giovanni Mansueto
Vittoria Lapadula
Rita De Sanctis
Silvia Quadrini
Roberta Grande
Bruno Gori
Amelia Altavilla
I. D’Antoni
Ester Del Signore
Luciano Stumbo
Cristina De Luca
Barbara Cimadon
Enrico Cortesi
Teresa Gamucci
Marisa Di Seri
Publikationsdatum: 01.08.2011
Verlag: Springer-Verlag
Erschienen in: Supportive Care in Cancer / Ausgabe 8/2011
Print ISSN: 0941-4355
Elektronische ISSN: 1433-7339
DOI: https://doi.org/10.1007/s00520-010-0930-x

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Palonosetron plus 3-day aprepitant and dexamethasone to prevent nausea and vomiting in patients receiving highly emetogenic chemotherapy