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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Chemoradiation for advanced primary vulval cancer</title><author><name sortKey="Shylasree, T S" sort="Shylasree, T S" uniqKey="Shylasree T" first="T S" last="Shylasree">T S Shylasree</name><affiliation><nlm:aff id="A1">Gynaecological Oncology Division, Department of Surgical Oncology, Tata Memorial Centre, Mumbai, India</nlm:aff></affiliation></author><author><name sortKey="Bryant, Andrew" sort="Bryant, Andrew" uniqKey="Bryant A" first="Andrew" last="Bryant">Andrew Bryant</name><affiliation><nlm:aff id="A2">Institute of Health & Society, Newcastle University, Newcastle upon Tyne, UK</nlm:aff></affiliation></author><author><name sortKey="Howells, Robert Ej" sort="Howells, Robert Ej" uniqKey="Howells R" first="Robert Ej" last="Howells">Robert Ej Howells</name><affiliation><nlm:aff id="A3">South East Wales Gynaecological Oncology Centre (SEWGOC), Cardiff and Vale University Health Board, Cardiff, UK</nlm:aff></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">21491387</idno><idno type="pmc">4164938</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4164938</idno><idno type="RBID">PMC:4164938</idno><idno type="doi">10.1002/14651858.CD003752.pub3</idno><date when="2011">2011</date><idno type="wicri:Area/Pmc/Corpus">003435</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">003435</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Chemoradiation for advanced primary vulval cancer</title><author><name sortKey="Shylasree, T S" sort="Shylasree, T S" uniqKey="Shylasree T" first="T S" last="Shylasree">T S Shylasree</name><affiliation><nlm:aff id="A1">Gynaecological Oncology Division, Department of Surgical Oncology, Tata Memorial Centre, Mumbai, India</nlm:aff></affiliation></author><author><name sortKey="Bryant, Andrew" sort="Bryant, Andrew" uniqKey="Bryant A" first="Andrew" last="Bryant">Andrew Bryant</name><affiliation><nlm:aff id="A2">Institute of Health & Society, Newcastle University, Newcastle upon Tyne, UK</nlm:aff></affiliation></author><author><name sortKey="Howells, Robert Ej" sort="Howells, Robert Ej" uniqKey="Howells R" first="Robert Ej" last="Howells">Robert Ej Howells</name><affiliation><nlm:aff id="A3">South East Wales Gynaecological Oncology Centre (SEWGOC), Cardiff and Vale University Health Board, Cardiff, UK</nlm:aff></affiliation></author></analytic><series><title level="j">The Cochrane database of systematic reviews</title><idno type="eISSN">1469-493X</idno><imprint><date when="2011">2011</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec id="S1"><title>Background</title><p id="P6">Vulval cancer is a rare gynaecological cancer. There is no standard approach for treating locally advanced primary vulval cancer (FIGO stage III and IV). Combined treatment modalities have been developed using radiotherapy, chemotherapy and surgery. The advantages and disadvantages of such treatment is not well evaluated.</p></sec><sec id="S2"><title>Objectives</title><p id="P7">To evaluate the effectiveness and safety of neoadjuvant and primary chemoradiation for women with locally advanced primary vulval cancer compared to other primary modalities of treatment such as primary surgery or primary radiation.</p></sec><sec id="S3"><title>Search methods</title><p id="P8">We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (<italic>The Cochrane Library</italic> 2009, Issue 3), Cochrane Gynaecological Cancer Group Trials Register, MEDLINE and EMBASE (to July 2009). We also searched registers of clinical trials, abstracts of scientific meetings, reference lists of included studies and contacted experts in the field.</p></sec><sec id="S4"><title>Selection criteria</title><p id="P9">Randomised controlled trials (RCTs) or non-randomised studies that included multivariate analyses of chemoradiation in women with locally advanced, primary squamous cell carcinoma of the vulva.</p></sec><sec id="S5"><title>Data collection and analysis</title><p id="P10">Two review authors independently abstracted data and assessed risk of bias. An adjusted hazard ratio (HR) for overall survival was calculated for one non-randomised study and risk ratios (RRs) were used in an RCT to compare five-year death rates and adverse events in women who received neoadjuvant, primary chemoradiation or primary surgery. Adverse events were also reported more extensively in a further non-randomised study. All results were displayed in single study analyses.</p></sec><sec id="S6"><title>Main results</title><p id="P11">One RCT and two non-randomised studies that allowed for multivariate analyses met the inclusion criteria and included a total of 141 women.</p><p id="P12">One RCT found that neoadjuvant chemoradiation did not appear to offer longer survival compared to primary surgery in advanced vulval tumours (RR = 1.29, 95% confidence interval (CI) 0.87 to 1.91). There was also no statistically significant difference in survival between primary chemoradiation and primary surgery in a study that included 63 women (pooled adjusted HR= 1.09, 95% CI 0.37 to 3.17) and in another study that only included 12 eligible women and compared the same interventions (HR was non-informative when statistical adjustment was made).</p><p id="P13">Adverse events were extensively reported in only one study, which found no statistically significant difference in risk of adverse events between primary chemoradiation and primary surgery due to the very small numbers in each group. In the RCT there was no observed statistically significant difference between neoadjuvant chemoradiation and primary surgery. Adverse events were not reported in the largest study of 63 women. Quality of life (QoL) was not reported in any of the included studies. All studies were at high risk of bias.</p></sec><sec id="S7"><title>Authors’ conclusions</title><p id="P14">Women with advanced vulval tumours showed no significant difference in overall survival or treatment-related adverse events when chemoradiation (primary or neoadjuvant) was compared with primary surgery.</p><p id="P15">The retrospective studies had a high risk of bias as the entry criteria for primary chemoradiation was based on inoperability or tumour requiring exenteration.The radiochemotherapy regimens varied widely. There was no data on QoL.</p><p id="P16">There is no standard terminology for ‘operable and inoperable vulval cancer’, and for ‘primary and neoadjuvant chemoradiation’. Stratification according to unresectability of the primary tumour and/or lymph nodes is needed, for good quality comparison.</p></sec></div></front></TEI><pmc article-type="research-article"><pmc-comment>The publisher of this article does not allow downloading of the full text in XML form.</pmc-comment>
<pmc-dir>properties manuscript</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-journal-id">100909747</journal-id><journal-id journal-id-type="pubmed-jr-id">21711</journal-id><journal-id journal-id-type="nlm-ta">Cochrane Database Syst Rev</journal-id><journal-id journal-id-type="iso-abbrev">Cochrane Database Syst Rev</journal-id><journal-title-group><journal-title>The Cochrane database of systematic reviews</journal-title></journal-title-group><issn pub-type="epub">1469-493X</issn></journal-meta><article-meta><article-id pub-id-type="pmid">21491387</article-id><article-id pub-id-type="pmc">4164938</article-id><article-id pub-id-type="doi">10.1002/14651858.CD003752.pub3</article-id><article-id pub-id-type="manuscript">EMS57259</article-id><article-categories><subj-group subj-group-type="heading"><subject>Article</subject></subj-group></article-categories><title-group><article-title>Chemoradiation for advanced primary vulval cancer</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Shylasree</surname><given-names>T S</given-names></name><xref ref-type="aff" rid="A1">1</xref></contrib><contrib contrib-type="author"><name><surname>Bryant</surname><given-names>Andrew</given-names></name><xref ref-type="aff" rid="A2">2</xref></contrib><contrib contrib-type="author"><name><surname>Howells</surname><given-names>Robert EJ</given-names></name><xref ref-type="aff" rid="A3">3</xref></contrib></contrib-group><aff id="A1"><label>1</label>Gynaecological Oncology Division, Department of Surgical Oncology, Tata Memorial Centre, Mumbai, India</aff><aff id="A2"><label>2</label>Institute of Health & Society, Newcastle University, Newcastle upon Tyne, UK</aff><aff id="A3"><label>3</label>South East Wales Gynaecological Oncology Centre (SEWGOC), Cardiff and Vale University Health Board, Cardiff, UK</aff><author-notes><corresp id="CR1">Contact address: T S Shylasree, Gynaecological Oncology Division, Department of Surgical Oncology, Tata Memorial Centre, Dr Ernest Borges Marg, Parel, Mumbai, 400012, India. <email>shyla_sree@hotmail.com</email>. <email>shylasree@doctors.org.uk</email></corresp><fn id="FN1"><p id="P1"><bold>Editorial group:</bold> Cochrane Gynaecological Cancer Group.</p><p id="P2"><bold>Publication status and date:</bold> Edited (no change to conclusions), published in Issue 3, 2014.</p><p id="P3"><bold>Review content assessed as up-to-date:</bold> 1 March 2011.</p></fn><fn id="FN2"><p id="P4"><bold>CONTRIBUTIONS OF AUTHORS</bold> In the original review HCvD formulated the question, prepared the initial text. AA advised on methodological content and edited text. LS searched for background material with special emphasis on the radiotherapeutic area. MV-L searched for background material with special emphasis on chemotherapy, and edited text.</p><p id="P5">In the updated version of the review, TS drafted the clinical sections of the review; AB drafted the methodological sections of the review. AB and TS sifted the studies and abstracted data, assessed risk of bias and wrote up the review. All authors agreed on the final version.</p></fn></author-notes><pub-date pub-type="nihms-submitted"><day>1</day><month>8</month><year>2014</year></pub-date><pub-date pub-type="epub"><day>13</day><month>4</month><year>2011</year></pub-date><pub-date pub-type="collection"><year>2011</year></pub-date><pub-date pub-type="pmc-release"><day>16</day><month>9</month><year>2014</year></pub-date><issue>4</issue><fpage>CD003752</fpage><lpage>CD003752</lpage><pmc-comment>elocation-id from pubmed: 10.1002/14651858.CD003752.pub3</pmc-comment>
<permissions><copyright-statement>Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd</copyright-statement><copyright-year>2014</copyright-year></permissions><abstract><sec id="S1"><title>Background</title><p id="P6">Vulval cancer is a rare gynaecological cancer. There is no standard approach for treating locally advanced primary vulval cancer (FIGO stage III and IV). Combined treatment modalities have been developed using radiotherapy, chemotherapy and surgery. The advantages and disadvantages of such treatment is not well evaluated.</p></sec><sec id="S2"><title>Objectives</title><p id="P7">To evaluate the effectiveness and safety of neoadjuvant and primary chemoradiation for women with locally advanced primary vulval cancer compared to other primary modalities of treatment such as primary surgery or primary radiation.</p></sec><sec id="S3"><title>Search methods</title><p id="P8">We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (<italic>The Cochrane Library</italic> 2009, Issue 3), Cochrane Gynaecological Cancer Group Trials Register, MEDLINE and EMBASE (to July 2009). We also searched registers of clinical trials, abstracts of scientific meetings, reference lists of included studies and contacted experts in the field.</p></sec><sec id="S4"><title>Selection criteria</title><p id="P9">Randomised controlled trials (RCTs) or non-randomised studies that included multivariate analyses of chemoradiation in women with locally advanced, primary squamous cell carcinoma of the vulva.</p></sec><sec id="S5"><title>Data collection and analysis</title><p id="P10">Two review authors independently abstracted data and assessed risk of bias. An adjusted hazard ratio (HR) for overall survival was calculated for one non-randomised study and risk ratios (RRs) were used in an RCT to compare five-year death rates and adverse events in women who received neoadjuvant, primary chemoradiation or primary surgery. Adverse events were also reported more extensively in a further non-randomised study. All results were displayed in single study analyses.</p></sec><sec id="S6"><title>Main results</title><p id="P11">One RCT and two non-randomised studies that allowed for multivariate analyses met the inclusion criteria and included a total of 141 women.</p><p id="P12">One RCT found that neoadjuvant chemoradiation did not appear to offer longer survival compared to primary surgery in advanced vulval tumours (RR = 1.29, 95% confidence interval (CI) 0.87 to 1.91). There was also no statistically significant difference in survival between primary chemoradiation and primary surgery in a study that included 63 women (pooled adjusted HR= 1.09, 95% CI 0.37 to 3.17) and in another study that only included 12 eligible women and compared the same interventions (HR was non-informative when statistical adjustment was made).</p><p id="P13">Adverse events were extensively reported in only one study, which found no statistically significant difference in risk of adverse events between primary chemoradiation and primary surgery due to the very small numbers in each group. In the RCT there was no observed statistically significant difference between neoadjuvant chemoradiation and primary surgery. Adverse events were not reported in the largest study of 63 women. Quality of life (QoL) was not reported in any of the included studies. All studies were at high risk of bias.</p></sec><sec id="S7"><title>Authors’ conclusions</title><p id="P14">Women with advanced vulval tumours showed no significant difference in overall survival or treatment-related adverse events when chemoradiation (primary or neoadjuvant) was compared with primary surgery.</p><p id="P15">The retrospective studies had a high risk of bias as the entry criteria for primary chemoradiation was based on inoperability or tumour requiring exenteration.The radiochemotherapy regimens varied widely. There was no data on QoL.</p><p id="P16">There is no standard terminology for ‘operable and inoperable vulval cancer’, and for ‘primary and neoadjuvant chemoradiation’. Stratification according to unresectability of the primary tumour and/or lymph nodes is needed, for good quality comparison.</p></sec></abstract><kwd-group kwd-group-type="Medical Subject Headings"><title>Medical Subject Headings (MeSH)</title><kwd>Carcinoma, Squamous Cell [*drug therapy; mortality; *radiotherapy; surgery]</kwd><kwd>Neoadjuvant Therapy [mortality]</kwd><kwd>Vulvar Neoplasms [*drug therapy; mortality; *radiotherapy; surgery]</kwd></kwd-group><kwd-group kwd-group-type="MeSH check words"><title>MeSH check words</title><kwd>Female</kwd><kwd>Humans</kwd></kwd-group></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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