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      Antiemetics: American Society of Clinical Oncology Focused Guideline Update

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          Abstract

          Purpose

          To update a key recommendation of the American Society of Clinical Oncology antiemetic guideline. This update addresses the use of the oral combination of netupitant (a neurokinin 1 [NK 1] receptor antagonist) and palonosetron (a 5-hydroxytryptamine-3 [5-HT 3] receptor antagonist) for the prevention of acute and delayed nausea and vomiting in patients receiving chemotherapy.

          Methods

          An update committee conducted a targeted systematic literature review and identified two phase III clinical trials and a randomized phase II dose-ranging study.

          Results

          In one phase III trial, the oral combination of netupitant and palonosetron was associated with higher complete response rates (no emesis and no rescue medications) compared with palonosetron alone in patients treated with anthracycline plus cyclophosphamide chemotherapy (74% v 67% overall; P = .001). In another phase III trial, the oral combination of netupitant and palonosetron was safe and effective across multiple cycles of moderately or highly emetogenic chemotherapies. In the phase II dose-ranging study, each dose of netupitant (coadministered with palonosetron 0.50 mg) produced higher complete response rates than palonosetron alone among patients receiving cisplatin-based chemotherapy. The highest dose of netupitant (ie, 300 mg) was most effective.

          Recommendations

          All patients who receive highly emetogenic chemotherapy regimens (including anthracycline plus cyclophosphamide) should be offered a three-drug combination of an NK 1 receptor antagonist, a 5-HT 3 receptor antagonist, and dexamethasone. The oral combination of netupitant and palonosetron plus dexamethasone is an additional treatment option in this setting. The remaining recommendations from the 2011 ASCO guideline are unchanged pending a full update. Additional information is available at www.asco.org/guidelines/antiemetics and www.asco.org/guidelineswiki .

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          Most cited references7

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          How quickly do systematic reviews go out of date? A survival analysis.

          Systematic reviews are often advocated as the best source of evidence to guide clinical decisions and health care policy, yet we know little about the extent to which they require updating. To estimate the average time to changes in evidence that are sufficiently important to warrant updating systematic reviews. Survival analysis of 100 quantitative systematic reviews. Systematic reviews published from 1995 to 2005 and indexed in ACP Journal Club. Eligible reviews evaluated a specific drug or class of drug, device, or procedure and included only randomized or quasi-randomized, controlled trials. Quantitative signals for updating were changes in statistical significance or relative changes in effect magnitude of at least 50% involving 1 of the primary outcomes of the original systematic review or any mortality outcome. Qualitative signals included substantial differences in characterizations of effectiveness, new information about harm, and caveats about the previously reported findings that would affect clinical decision making. The cohort of 100 systematic reviews included a median of 13 studies and 2663 participants per review. A qualitative or quantitative signal for updating occurred for 57% of reviews (95% CI, 47% to 67%). Median duration of survival free of a signal for updating was 5.5 years (CI, 4.6 to 7.6 years). However, a signal occurred within 2 years for 23% of reviews and within 1 year for 15%. In 7%, a signal had already occurred at the time of publication. Only 4% of reviews had a signal within 1 year of the end of the reported search period; 11% had a signal within 2 years of the search. Shorter survival was associated with cardiovascular topics (hazard ratio, 2.70 [CI, 1.36 to 5.34]) and heterogeneity in the original review (hazard ratio, 2.15 [CI, 1.12 to 4.11]). Judgments of the need for updating were made without involving content experts. In a cohort of high-quality systematic reviews directly relevant to clinical practice, signals for updating occurred frequently and within a relatively short time.
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            Antiemetics: American Society of Clinical Oncology clinical practice guideline update.

            To update the American Society of Clinical Oncology (ASCO) guideline for antiemetics in oncology. A systematic review of the medical literature was completed to inform this update. MEDLINE, the Cochrane Collaboration Library, and meeting materials from ASCO and the Multinational Association for Supportive Care in Cancer were all searched. Primary outcomes of interest were complete response and rates of any vomiting or nausea. Thirty-seven trials met prespecified inclusion and exclusion criteria for this systematic review. Two systematic reviews from the Cochrane Collaboration were identified; one surveyed the pediatric literature. The other compared the relative efficacy of the 5-hydroxytryptamine-3 (5-HT(3)) receptor antagonists. Combined anthracycline and cyclophosphamide regimens were reclassified as highly emetic. Patients who receive this combination or any highly emetic agents should receive a 5-HT(3) receptor antagonist, dexamethasone, and a neurokinin 1 (NK(1)) receptor antagonist. A large trial validated the equivalency of fosaprepitant, a single-day intravenous formulation, with aprepitant; either therapy is appropriate. Preferential use of palonosetron is recommended for moderate emetic risk regimens, combined with dexamethasone. For low-risk agents, patients can be offered dexamethasone before the first dose of chemotherapy. Patients undergoing high emetic risk radiation therapy should receive a 5-HT(3) receptor antagonist before each fraction and for 24 hours after treatment and may receive a 5-day course of dexamethasone during fractions 1 to 5. The Update Committee noted the importance of continued symptom monitoring throughout therapy. Clinicians underestimate the incidence of nausea, which is not as well controlled as emesis.
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              American Society of Clinical Oncology guideline for antiemetics in oncology: update 2006.

              To update the 1999 American Society of Clinical Oncology guideline for antiemetics in oncology. The Update Committee completed a review and analysis of data published from 1998 thru February 2006. The literature review focused on published randomized controlled trials, and systematic reviews and meta-analyses of published phase II and phase III randomized controlled trials. The three-drug combination of a 5-hydroxytryptamine-3 (5-HT(3)) serotonin receptor antagonist, dexamethasone, and aprepitant is recommended before chemotherapy of high emetic risk. For persons receiving chemotherapy of high emetic risk, there is no group of patients for whom agents of lower therapeutic index are appropriate first-choice antiemetics. These agents should be reserved for patients intolerant of or refractory to 5-HT3 serotonin receptor antagonists, neurokinin-1 receptor antagonists, and dexamethasone. The three-drug combination of a 5-HT3 receptor serotonin antagonist, dexamethasone, and aprepitant is recommended for patients receiving an anthracycline and cyclophosphamide. For patients receiving other chemotherapy of moderate emetic risk, the Update Committee continues to recommend the two-drug combination of a 5-HT3 receptor serotonin antagonist and dexamethasone. In all patients receiving cisplatin and all other agents of high emetic risk, the two-drug combination of dexamethasone and aprepitant is recommended for the prevention of delayed emesis. The Update Committee no longer recommends the combination of a 5-HT3 serotonin receptor antagonist and dexamethasone for the prevention of delayed emesis after chemotherapeutic agents of high emetic risk. CONCLUSION The Update Committee recommends that clinicians administer antiemetics while considering patients' emetic risk categories and other characteristics.
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                Author and article information

                Journal
                Journal of Clinical Oncology
                JCO
                American Society of Clinical Oncology (ASCO)
                0732-183X
                1527-7755
                February 01 2016
                February 01 2016
                : 34
                : 4
                : 381-386
                Affiliations
                [1 ]Paul J. Hesketh, Lahey Hospital and Medical Center, Burlington, MA; Kari Bohlke and Mark R. Somerfield, American Society of Clinical Oncology, Alexandria; Michael A. Danso, Virginia Oncology Associates, Norfolk and Virginia Beach, VA; Gary H. Lyman, Fred Hutchinson Cancer Research Center and University of Washington, Seattle, WA; Ethan Basch, University of North Carolina at Chapel Hill, Chapel Hill, NC; Maurice Chesney, patient representative, Saunderstown, RI; Rebecca Anne Clark-Snow, University of...
                Article
                10.1200/JCO.2015.64.3635
                26527784
                f936dfe9-d830-407b-b190-1da4c5026bc1
                © 2016
                History

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