Effect of amifostine in head and neck cancer patients treated with radiotherapy: a systematic review and meta-analysis based on randomized controlled trials

Amifostine is the most clinical used chemical radioprotector, but its effect in patients treated with radiation is not consistent. By searching Medline, CENTRAL, EMBASE, ASCO, ESMO, and CNKI databases, the published randomized controlled trials (RCTs) about the efficacy of amifostine in HNSCC patien...

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Veröffentlicht in:PloS one 2014-05, Vol.9 (5), p.e95968
Hauptverfasser: Gu, Jundong, Zhu, Siwei, Li, Xuebing, Wu, Hua, Li, Yang, Hua, Feng
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Wu, Hua
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description Amifostine is the most clinical used chemical radioprotector, but its effect in patients treated with radiation is not consistent. By searching Medline, CENTRAL, EMBASE, ASCO, ESMO, and CNKI databases, the published randomized controlled trials (RCTs) about the efficacy of amifostine in HNSCC patients treated with radiotherapy were collected. The pooled efficacy and side effects of this drug were calculated by RevMan software. Seventeen trials including a total of 1167 patients (604 and 563 each arm) were analyzed in the meta-analysis. The pooled data showed that the use of amifostine significantly reduce the risk of developing Grade 3-4 mucositis (relative risk [RR],0.72; 95% confidence interval [CI],0.54-0.95; p
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By searching Medline, CENTRAL, EMBASE, ASCO, ESMO, and CNKI databases, the published randomized controlled trials (RCTs) about the efficacy of amifostine in HNSCC patients treated with radiotherapy were collected. The pooled efficacy and side effects of this drug were calculated by RevMan software. Seventeen trials including a total of 1167 patients (604 and 563 each arm) were analyzed in the meta-analysis. The pooled data showed that the use of amifostine significantly reduce the risk of developing Grade 3-4 mucositis (relative risk [RR],0.72; 95% confidence interval [CI],0.54-0.95; p&lt;0.00001), Grade 2-4 acute xerostomia (RR,0.70; 95%CI,0.52-0.96; p = 0.02), or late xerostomia (RR,0.60; 95%CI,0.49-0.74; p&lt;0.00001) and Grade 3-4 dysphagia (RR,0.39; 95%CI,0.17-0.92; p = 0.03). However, subgroup analysis demonstrated that no statistically significant reduction of Grade 3-4 mucositis (RR,0.97; 95% CI,0.74-1.26; p = 0.80), Grade 2-4 acute xerostomia (RR,0.35; 95%CI,0.02-5.44; p = 0.45), or late xerostomia (RR,0.40; 95%CI,0.13-1.24; p = 0.11) and Grade 3-4 dysphagia (RR,0.23; 95%CI,0.01-4.78; p = 0.35) was observed in patients treated with concomitant chemoradiotherapy. Compared with placebo or observation, amifostine does not show tumor protective effect in complete response (RR,1.02; 95%CI,0.89-1.17; p = 0.76) and partial response (RR,0.90; 95%CI, 0.56-1.44; p = 0.66). For the hematologic side effect, no statistical difference of Grade 3-4 leucopenia (RR,0.60; 95%CI,0.35-1.05; p = 0.07), anemia (RR,0.80; 95%CI, 0.42-1.53; p = 0.50) and thrombocytopenia (RR,0.43; 95%CI,0.16-1.15; p = 0.09) were found between amifostine and control groups. The most common amifostine related side effects were nausea, emesis, hypotension and allergic with an average incidence rate (Grade 3-4) of 5%, 6%, 4% and 4% respectively. This systematic review showed that amifostine significantly reduce the serious mucositis, acute/late xerastomia and dysphagia without protection of the tumor in HNSCC patients treated with radiotherapy. And the toxicities of amifostine were generally acceptable.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0095968</identifier><identifier>PMID: 24788761</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Amifostine ; Amifostine - pharmacology ; Amifostine - therapeutic use ; Analysis ; Anemia ; Cancer ; Cancer patients ; Cancer therapies ; Carcinoma, Squamous Cell - drug therapy ; Carcinoma, Squamous Cell - radiotherapy ; Care and treatment ; Chemoradiotherapy ; Clinical trials ; Combined Modality Therapy ; Confidence intervals ; Data processing ; Dysphagia ; Handbooks ; Head &amp; neck cancer ; Head and neck cancer ; Head and Neck Neoplasms - drug therapy ; Head and Neck Neoplasms - radiotherapy ; Hematology ; Humans ; Hypotension ; Laboratories ; Leukopenia ; Lung cancer ; Medicine and Health Sciences ; Meta-analysis ; Metastasis ; Mucositis ; Nausea ; Oncology ; Patients ; Radiation ; Radiation Injuries - prevention &amp; control ; Radiation therapy ; Radiotherapy ; Randomization ; Randomized Controlled Trials as Topic - methods ; Researchers ; Side effects ; Squamous cell carcinoma ; Squamous Cell Carcinoma of Head and Neck ; Statistical analysis ; Studies ; Systematic review ; Thrombocytopenia ; Toxicity ; Vomiting ; Xerostomia</subject><ispartof>PloS one, 2014-05, Vol.9 (5), p.e95968</ispartof><rights>COPYRIGHT 2014 Public Library of Science</rights><rights>2014 Gu et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2014 Gu et al 2014 Gu et al</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c692t-b2db61043764cdbd50d3b0f9b0e75255557087e61322ac0836a8019724e045273</citedby><cites>FETCH-LOGICAL-c692t-b2db61043764cdbd50d3b0f9b0e75255557087e61322ac0836a8019724e045273</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4008569/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4008569/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,864,885,2102,2928,23866,27924,27925,53791,53793</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24788761$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><contributor>Gires, Olivier</contributor><creatorcontrib>Gu, Jundong</creatorcontrib><creatorcontrib>Zhu, Siwei</creatorcontrib><creatorcontrib>Li, Xuebing</creatorcontrib><creatorcontrib>Wu, Hua</creatorcontrib><creatorcontrib>Li, Yang</creatorcontrib><creatorcontrib>Hua, Feng</creatorcontrib><title>Effect of amifostine in head and neck cancer patients treated with radiotherapy: a systematic review and meta-analysis based on randomized controlled trials</title><title>PloS one</title><addtitle>PLoS One</addtitle><description>Amifostine is the most clinical used chemical radioprotector, but its effect in patients treated with radiation is not consistent. By searching Medline, CENTRAL, EMBASE, ASCO, ESMO, and CNKI databases, the published randomized controlled trials (RCTs) about the efficacy of amifostine in HNSCC patients treated with radiotherapy were collected. The pooled efficacy and side effects of this drug were calculated by RevMan software. Seventeen trials including a total of 1167 patients (604 and 563 each arm) were analyzed in the meta-analysis. The pooled data showed that the use of amifostine significantly reduce the risk of developing Grade 3-4 mucositis (relative risk [RR],0.72; 95% confidence interval [CI],0.54-0.95; p&lt;0.00001), Grade 2-4 acute xerostomia (RR,0.70; 95%CI,0.52-0.96; p = 0.02), or late xerostomia (RR,0.60; 95%CI,0.49-0.74; p&lt;0.00001) and Grade 3-4 dysphagia (RR,0.39; 95%CI,0.17-0.92; p = 0.03). However, subgroup analysis demonstrated that no statistically significant reduction of Grade 3-4 mucositis (RR,0.97; 95% CI,0.74-1.26; p = 0.80), Grade 2-4 acute xerostomia (RR,0.35; 95%CI,0.02-5.44; p = 0.45), or late xerostomia (RR,0.40; 95%CI,0.13-1.24; p = 0.11) and Grade 3-4 dysphagia (RR,0.23; 95%CI,0.01-4.78; p = 0.35) was observed in patients treated with concomitant chemoradiotherapy. Compared with placebo or observation, amifostine does not show tumor protective effect in complete response (RR,1.02; 95%CI,0.89-1.17; p = 0.76) and partial response (RR,0.90; 95%CI, 0.56-1.44; p = 0.66). For the hematologic side effect, no statistical difference of Grade 3-4 leucopenia (RR,0.60; 95%CI,0.35-1.05; p = 0.07), anemia (RR,0.80; 95%CI, 0.42-1.53; p = 0.50) and thrombocytopenia (RR,0.43; 95%CI,0.16-1.15; p = 0.09) were found between amifostine and control groups. The most common amifostine related side effects were nausea, emesis, hypotension and allergic with an average incidence rate (Grade 3-4) of 5%, 6%, 4% and 4% respectively. This systematic review showed that amifostine significantly reduce the serious mucositis, acute/late xerastomia and dysphagia without protection of the tumor in HNSCC patients treated with radiotherapy. And the toxicities of amifostine were generally acceptable.</description><subject>Amifostine</subject><subject>Amifostine - pharmacology</subject><subject>Amifostine - therapeutic use</subject><subject>Analysis</subject><subject>Anemia</subject><subject>Cancer</subject><subject>Cancer patients</subject><subject>Cancer therapies</subject><subject>Carcinoma, Squamous Cell - drug therapy</subject><subject>Carcinoma, Squamous Cell - radiotherapy</subject><subject>Care and treatment</subject><subject>Chemoradiotherapy</subject><subject>Clinical trials</subject><subject>Combined Modality Therapy</subject><subject>Confidence intervals</subject><subject>Data processing</subject><subject>Dysphagia</subject><subject>Handbooks</subject><subject>Head &amp; neck cancer</subject><subject>Head and neck cancer</subject><subject>Head and Neck Neoplasms - drug therapy</subject><subject>Head and Neck Neoplasms - radiotherapy</subject><subject>Hematology</subject><subject>Humans</subject><subject>Hypotension</subject><subject>Laboratories</subject><subject>Leukopenia</subject><subject>Lung cancer</subject><subject>Medicine and Health Sciences</subject><subject>Meta-analysis</subject><subject>Metastasis</subject><subject>Mucositis</subject><subject>Nausea</subject><subject>Oncology</subject><subject>Patients</subject><subject>Radiation</subject><subject>Radiation Injuries - prevention &amp; control</subject><subject>Radiation therapy</subject><subject>Radiotherapy</subject><subject>Randomization</subject><subject>Randomized Controlled Trials as Topic - methods</subject><subject>Researchers</subject><subject>Side effects</subject><subject>Squamous cell carcinoma</subject><subject>Squamous Cell Carcinoma of Head and Neck</subject><subject>Statistical analysis</subject><subject>Studies</subject><subject>Systematic review</subject><subject>Thrombocytopenia</subject><subject>Toxicity</subject><subject>Vomiting</subject><subject>Xerostomia</subject><issn>1932-6203</issn><issn>1932-6203</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>DOA</sourceid><recordid>eNqNk11rFDEUhgdRrFb_gWhAELzYNR8zyYwXQilVC4WCX7fhTHJmN3UmWZNs6_pb_LGm7bZ0QcGZi2Qyz_vOOyc5VfWM0TkTir05C-voYZyvgsc5pV3TyfZe9Yh1gs8kp-L-nfle9TilM0ob0Ur5sNrjtWpbJdmj6vfRMKDJJAwEJjeElJ1H4jxZIlgC3hKP5jsx4A1GsoLs0OdEckTIaMmFy0sSwbqQlxhhtXlLgKRNyjgV1JCI5w4vrnwmzDCDkniTXCI9pCIPvoi9DZP7VZ5M8DmGcSzTHB2M6Un1YCgDPt2O-9XX90dfDj_OTk4_HB8enMyM7Hie9dz2ktFaKFkb29uGWtHToespqoY35VK0VSiZ4BwMbYWElrJO8Rpp3XAl9qsX176rMSS9LWzSrOG0UZwLUYjja8IGONOr6CaIGx3A6auFEBcaYvnhEXUPkvWmV00NpqZt2zHOBG27kouVFLZ4vdt-bd1PaE0paIRxx3T3jXdLvQjnuqa0bWRXDF5uDWL4scaU_xF5Sy2gpHJ-CMXMTC4ZfVAzqZSSrSzU_C9UuS1OrmwIDq6s7whe7wguNw1_5gWsU9LHnz_9P3v6bZd9dYctp2_MyxTGdXbBp12wvgZNDClFHG4rx6i-7IybaujLztDbziiy53erfiu6aQXxB1K2Cqs</recordid><startdate>20140502</startdate><enddate>20140502</enddate><creator>Gu, Jundong</creator><creator>Zhu, Siwei</creator><creator>Li, Xuebing</creator><creator>Wu, Hua</creator><creator>Li, Yang</creator><creator>Hua, Feng</creator><general>Public Library of Science</general><general>Public Library of Science (PLoS)</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>IOV</scope><scope>ISR</scope><scope>3V.</scope><scope>7QG</scope><scope>7QL</scope><scope>7QO</scope><scope>7RV</scope><scope>7SN</scope><scope>7SS</scope><scope>7T5</scope><scope>7TG</scope><scope>7TM</scope><scope>7U9</scope><scope>7X2</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FD</scope><scope>8FE</scope><scope>8FG</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABJCF</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>ARAPS</scope><scope>ATCPS</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BGLVJ</scope><scope>BHPHI</scope><scope>C1K</scope><scope>CCPQU</scope><scope>D1I</scope><scope>DWQXO</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>H94</scope><scope>HCIFZ</scope><scope>K9.</scope><scope>KB.</scope><scope>KB0</scope><scope>KL.</scope><scope>L6V</scope><scope>LK8</scope><scope>M0K</scope><scope>M0S</scope><scope>M1P</scope><scope>M7N</scope><scope>M7P</scope><scope>M7S</scope><scope>NAPCQ</scope><scope>P5Z</scope><scope>P62</scope><scope>P64</scope><scope>PATMY</scope><scope>PDBOC</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PTHSS</scope><scope>PYCSY</scope><scope>RC3</scope><scope>5PM</scope><scope>DOA</scope></search><sort><creationdate>20140502</creationdate><title>Effect of amifostine in head and neck cancer patients treated with radiotherapy: a systematic review and meta-analysis based on randomized controlled trials</title><author>Gu, Jundong ; 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Medical Complete (Alumni)</collection><collection>Materials Science Database</collection><collection>Nursing &amp; Allied Health Database (Alumni Edition)</collection><collection>Meteorological &amp; Geoastrophysical Abstracts - Academic</collection><collection>ProQuest Engineering Collection</collection><collection>ProQuest Biological Science Collection</collection><collection>Agricultural Science Database</collection><collection>Health &amp; Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Biological Science Database</collection><collection>Engineering Database</collection><collection>Nursing &amp; Allied Health Premium</collection><collection>Advanced Technologies &amp; Aerospace Database</collection><collection>ProQuest Advanced Technologies &amp; Aerospace Collection</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Environmental Science Database</collection><collection>Materials Science Collection</collection><collection>Access via ProQuest (Open Access)</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>Engineering Collection</collection><collection>Environmental Science Collection</collection><collection>Genetics Abstracts</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>PloS one</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Gu, Jundong</au><au>Zhu, Siwei</au><au>Li, Xuebing</au><au>Wu, Hua</au><au>Li, Yang</au><au>Hua, Feng</au><au>Gires, Olivier</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effect of amifostine in head and neck cancer patients treated with radiotherapy: a systematic review and meta-analysis based on randomized controlled trials</atitle><jtitle>PloS one</jtitle><addtitle>PLoS One</addtitle><date>2014-05-02</date><risdate>2014</risdate><volume>9</volume><issue>5</issue><spage>e95968</spage><pages>e95968-</pages><issn>1932-6203</issn><eissn>1932-6203</eissn><abstract>Amifostine is the most clinical used chemical radioprotector, but its effect in patients treated with radiation is not consistent. By searching Medline, CENTRAL, EMBASE, ASCO, ESMO, and CNKI databases, the published randomized controlled trials (RCTs) about the efficacy of amifostine in HNSCC patients treated with radiotherapy were collected. The pooled efficacy and side effects of this drug were calculated by RevMan software. Seventeen trials including a total of 1167 patients (604 and 563 each arm) were analyzed in the meta-analysis. The pooled data showed that the use of amifostine significantly reduce the risk of developing Grade 3-4 mucositis (relative risk [RR],0.72; 95% confidence interval [CI],0.54-0.95; p&lt;0.00001), Grade 2-4 acute xerostomia (RR,0.70; 95%CI,0.52-0.96; p = 0.02), or late xerostomia (RR,0.60; 95%CI,0.49-0.74; p&lt;0.00001) and Grade 3-4 dysphagia (RR,0.39; 95%CI,0.17-0.92; p = 0.03). However, subgroup analysis demonstrated that no statistically significant reduction of Grade 3-4 mucositis (RR,0.97; 95% CI,0.74-1.26; p = 0.80), Grade 2-4 acute xerostomia (RR,0.35; 95%CI,0.02-5.44; p = 0.45), or late xerostomia (RR,0.40; 95%CI,0.13-1.24; p = 0.11) and Grade 3-4 dysphagia (RR,0.23; 95%CI,0.01-4.78; p = 0.35) was observed in patients treated with concomitant chemoradiotherapy. Compared with placebo or observation, amifostine does not show tumor protective effect in complete response (RR,1.02; 95%CI,0.89-1.17; p = 0.76) and partial response (RR,0.90; 95%CI, 0.56-1.44; p = 0.66). For the hematologic side effect, no statistical difference of Grade 3-4 leucopenia (RR,0.60; 95%CI,0.35-1.05; p = 0.07), anemia (RR,0.80; 95%CI, 0.42-1.53; p = 0.50) and thrombocytopenia (RR,0.43; 95%CI,0.16-1.15; p = 0.09) were found between amifostine and control groups. The most common amifostine related side effects were nausea, emesis, hypotension and allergic with an average incidence rate (Grade 3-4) of 5%, 6%, 4% and 4% respectively. This systematic review showed that amifostine significantly reduce the serious mucositis, acute/late xerastomia and dysphagia without protection of the tumor in HNSCC patients treated with radiotherapy. And the toxicities of amifostine were generally acceptable.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>24788761</pmid><doi>10.1371/journal.pone.0095968</doi><oa>free_for_read</oa></addata></record>
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subjects Amifostine
Amifostine - pharmacology
Amifostine - therapeutic use
Analysis
Anemia
Cancer
Cancer patients
Cancer therapies
Carcinoma, Squamous Cell - drug therapy
Carcinoma, Squamous Cell - radiotherapy
Care and treatment
Chemoradiotherapy
Clinical trials
Combined Modality Therapy
Confidence intervals
Data processing
Dysphagia
Handbooks
Head & neck cancer
Head and neck cancer
Head and Neck Neoplasms - drug therapy
Head and Neck Neoplasms - radiotherapy
Hematology
Humans
Hypotension
Laboratories
Leukopenia
Lung cancer
Medicine and Health Sciences
Meta-analysis
Metastasis
Mucositis
Nausea
Oncology
Patients
Radiation
Radiation Injuries - prevention & control
Radiation therapy
Radiotherapy
Randomization
Randomized Controlled Trials as Topic - methods
Researchers
Side effects
Squamous cell carcinoma
Squamous Cell Carcinoma of Head and Neck
Statistical analysis
Studies
Systematic review
Thrombocytopenia
Toxicity
Vomiting
Xerostomia
title Effect of amifostine in head and neck cancer patients treated with radiotherapy: a systematic review and meta-analysis based on randomized controlled trials
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