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      Palonosetron in combination with 1-day versus 3-day dexamethasone for prevention of nausea and vomiting following moderately emetogenic chemotherapy: a randomized, multicenter, phase III trial

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          Abstract

          Purpose

          A phase III trial assessed the efficacy of palonosetron plus dexamethasone given once in preventing acute and delayed chemotherapy-induced nausea and vomiting (CINV) following a broad range of moderately emetogenic chemotherapy (MEC) regimens.

          Methods

          This multicentre, randomized, open-label, non-inferiority trial evaluated two different treatment groups. One group received palonosetron (0.25 mg intravenously) and dexamethasone (8 mg intravenously) before chemotherapy, while the other was administered the same regimen on day 1 followed by dexamethasone 8 mg orally on days 2 and 3. The primary endpoint was complete response (CR; defined as no emetic episodes and no rescue medication) during the overall phase (days 1–5 after chemotherapy initiation). The non-inferiority margin was predefined as a 15% difference between groups in the primary endpoint.

          Results

          Of 332 chemotherapy-naïve patients included in the intention-to-treat analysis, 65.1% were female, and 35.2% received anthracycline plus cyclophosphamide (AC)-based regimens. Overall CR rates were 67.5% for those administered dexamethasone only on day 1 ( n = 166), and 71.1% for those also administered dexamethasone on days 2 and 3 ( n = 166; difference −3.6% (95% confidence interval, −13.5 to 6.3)). CR rates were not significantly different between groups during the acute (0–24 h post-chemotherapy; 88.6% versus 84.3%; P = 0.262) and delayed phases (days 2–5; 68.7% versus 77.7%; P = 0.116).

          Conclusions

          Palonosetron plus single-dose dexamethasone administered before common MEC regimens provide protection against acute and delayed CINV which is non-inferior to that of palonosetron plus dexamethasone for 3 days. However, the major benefit of the single-day regimen occurs in patients receiving non-AC MEC regimens.

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          Most cited references 19

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          Chemotherapy-induced nausea and vomiting.

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            Efficacy and tolerability of aprepitant for the prevention of chemotherapy-induced nausea and vomiting in patients with breast cancer after moderately emetogenic chemotherapy.

            This is the first study in which the NK(1)-receptor antagonist, aprepitant (APR), was evaluated for the prevention of chemotherapy-induced nausea and vomiting (CINV) with moderately emetogenic chemotherapy. Eligible breast cancer patients were naive to emetogenic chemotherapy and treated with cyclophosphamide +/- doxorubicin or epirubicin. Patients were randomly assigned to either an aprepitant regimen (day 1, APR 125 mg, ondansetron (OND) 8 mg, and dexamethasone 12 mg before chemotherapy and OND 8 mg 8 hours later; days 2 through 3, APR 80 qd) [DOSAGE ERROR CORRECTED] or a control regimen (day 1, OND 8 mg and dexamethasone 20 mg before chemotherapy and OND 8 mg 8 hours later; days 2 through 3, OND 8 mg bid). Data on nausea, vomiting, and use of rescue medication were collected with a self-report diary. The primary efficacy end point was the proportion of patients with complete response, defined as no vomiting and no use of rescue therapy, during 120 hours after initiation of chemotherapy in cycle 1. The secondary end point was the proportion of patients with an average item score higher than 6 of 7 on the Functional Living Index-Emesis questionnaire. Of 866 patients randomized, 857 patients (99%) were assessable. Overall complete response was greater with the aprepitant regimen than with the control regimen (50.8% v 42.5%; P = .015). More patients in the aprepitant group reported minimal or no impact of CINV on daily life (63.5% v 55.6%; P = .019). Both treatments were generally well tolerated. The aprepitant regimen was more effective than the control regimen for prevention of CINV in patients receiving both an anthracycline and cyclophosphamide.
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              Palonosetron improves prevention of chemotherapy-induced nausea and vomiting following moderately emetogenic chemotherapy: results of a double-blind randomized phase III trial comparing single doses of palonosetron with ondansetron.

              Although all first-generation 5-HT(3) receptor antagonists demonstrate efficacy in preventing acute chemotherapy-induced nausea and vomiting (CINV), effective prevention of delayed CINV has not yet been achieved. This study compared the efficacy and tolerability of palonosetron, a novel, second-generation 5-HT(3) receptor antagonist, with ondansetron. In this multicenter, randomized, double-blind, stratified, phase III study, 570 adult cancer patients were randomized to receive a single i.v. dose of palonosetron 0.25 mg, palonosetron 0.75 mg or ondansetron 32 mg, each administered 30 min before initiation of moderately emetogenic chemotherapy. The primary end point was the proportion of patients with no emetic episodes and no rescue medication [complete response (CR)] during the 24 h after chemotherapy administration (acute period). Secondary end points included efficacy in treatment of delayed CINV (
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                Author and article information

                Contributors
                +39-22-3902597 , +39-22-3902149 , luigi.celio@istitutotumori.mi.it
                Journal
                Support Care Cancer
                Supportive Care in Cancer
                Springer-Verlag (Berlin/Heidelberg )
                0941-4355
                1433-7339
                25 June 2010
                25 June 2010
                August 2011
                : 19
                : 8
                : 1217-1225
                Affiliations
                [1 ]Medical Oncology Unit 2, Fondazione IRCCS “Istituto Nazionale dei Tumori”, Via Venezian 1, 20133 Milan, Italy
                [2 ]Centro di Riferimento Oncologico, Via Gallini 2, 33081 Aviano, Italy
                [3 ]Ospedale San Gerardo, Via Pergolesi 33, 20052 Monza, Italy
                [4 ]Ospedale L. Sacco, Via Grassi 74, 20157 Milan, Italy
                [5 ]Istituto Regina Elena, Via Chianesi 53, 00144 Rome, Italy
                [6 ]Centro Riferimento Oncologico della Basilicata, Strada Provinciale n. 8 del Vulture, 85028 Rionero in Vulture, Italy
                [7 ]Ospedale Serbelloni, Via Bellini 5, 20064 Gorgonzola, Italy
                [8 ]Ospedale Guglielmo da Saliceto, Via Taverna 49, 29100 Piacenza, Italy
                [9 ]Ospedale di Sondrio, Via Stelvio 25, 23100 Sondrio, Italy
                [10 ]ITMO operative office, Via Ponzio 44, 20133 Milan, Italy
                Article
                941
                10.1007/s00520-010-0941-7
                3128271
                20574663
                © The Author(s) 2010
                Categories
                Original Article
                Custom metadata
                © Springer-Verlag 2011

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