Effectiveness of an (18)F-FDG-PET based strategy to optimize the diagnostic trajectory of suspected recurrent laryngeal carcinoma after radiotherapy: The RELAPS multicenter randomized trial
The purpose of this study is to evaluate the efficacy of (18)F-FDG-PET as first-line diagnostic investigation, prior to performing a direct laryngoscopy with biopsy under general anesthesia, in patients suspected of recurrent laryngeal carcinoma after radiotherapy. 150 patients suspected of recurren...
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| Veröffentlicht in: | Radiotherapy and oncology 2016-02, Vol.118 (2), p.251-256 |
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| creator | de Bree, Remco van der Putten, Lisa van Tinteren, Harm Wedman, Jan Oyen, Wim J G Janssen, Luuk M van den Brekel, Michiel W M Comans, Emile F I Pruim, Jan Takes, Robert P Hobbelink, Monique G G Valdés Olmos, Renato van der Laan, Bernard F A M Boers, Maarten Hoekstra, Otto S Leemans, C René |
| description | The purpose of this study is to evaluate the efficacy of (18)F-FDG-PET as first-line diagnostic investigation, prior to performing a direct laryngoscopy with biopsy under general anesthesia, in patients suspected of recurrent laryngeal carcinoma after radiotherapy.
150 patients suspected of recurrent T2-4 laryngeal carcinoma at least two months after prior (chemo)radiotherapy with curative intent for resectable disease were randomized to direct laryngoscopy (CWU: conventional workup strategy) or to (18)F-FDG-PET only followed by direct laryngoscopy if PET was assessed 'positive' or 'equivocal' (PWU: PET based workup strategy), to compare the effectiveness of these strategies. Primary endpoint was the number of indications for direct laryngoscopies classified as unnecessary based on absence of recurrence, both on direct laryngoscopy and on six month follow up. Safety endpoints comprised resectability of recurrent lesions and completeness of surgical margins following salvage laryngectomy.
Intention-to-treat analyses were performed on all randomized patients (CWU: n=74, PWU: n=76). Tumor recurrence was similar in both groups: 45 patients (30%; 21 CWU, 24 PWU) within six months. In 53 patients in the CWU arm (72%, 95% CI: 60-81) unnecessary direct laryngoscopies were performed compared to 22 in the PWU arm (29%, 95% CI: 19-40) (p |
| doi_str_mv | 10.1016/j.radonc.2015.10.010 |
| format | Article |
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150 patients suspected of recurrent T2-4 laryngeal carcinoma at least two months after prior (chemo)radiotherapy with curative intent for resectable disease were randomized to direct laryngoscopy (CWU: conventional workup strategy) or to (18)F-FDG-PET only followed by direct laryngoscopy if PET was assessed 'positive' or 'equivocal' (PWU: PET based workup strategy), to compare the effectiveness of these strategies. Primary endpoint was the number of indications for direct laryngoscopies classified as unnecessary based on absence of recurrence, both on direct laryngoscopy and on six month follow up. Safety endpoints comprised resectability of recurrent lesions and completeness of surgical margins following salvage laryngectomy.
Intention-to-treat analyses were performed on all randomized patients (CWU: n=74, PWU: n=76). Tumor recurrence was similar in both groups: 45 patients (30%; 21 CWU, 24 PWU) within six months. In 53 patients in the CWU arm (72%, 95% CI: 60-81) unnecessary direct laryngoscopies were performed compared to 22 in the PWU arm (29%, 95% CI: 19-40) (p<0·0001). The percentage of salvage laryngectomies (resectability) and positive surgical margins were similar between CWU and PWU (81%, 63% respectively, p=0·17, and 29%, 7%, respectively, p=0.20). The prevalence of the combination of local unresectability and positive margins is in the CWU group 24% and in the PWU group 8%. No difference (p=0.32) in disease specific survival between both groups was found.
In patients with suspected laryngeal carcinoma after radiotherapy, PET as the first diagnostic procedure can reduce the need for direct laryngoscopy by more than 50% without jeopardizing quality of treatment.</description><identifier>EISSN: 1879-0887</identifier><identifier>DOI: 10.1016/j.radonc.2015.10.010</identifier><identifier>PMID: 26477395</identifier><language>eng</language><publisher>Ireland</publisher><subject>Aged ; Female ; Fluorodeoxyglucose F18 ; Humans ; Laryngeal Neoplasms - diagnostic imaging ; Laryngeal Neoplasms - radiotherapy ; Laryngoscopy ; Larynx - diagnostic imaging ; Male ; Middle Aged ; Neoplasm Recurrence, Local - diagnostic imaging ; Neoplasm Recurrence, Local - radiotherapy ; Positron-Emission Tomography - methods ; Radiopharmaceuticals ; Reproducibility of Results ; Salvage Therapy ; Treatment Outcome</subject><ispartof>Radiotherapy and oncology, 2016-02, Vol.118 (2), p.251-256</ispartof><rights>Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27923,27924</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26477395$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>de Bree, Remco</creatorcontrib><creatorcontrib>van der Putten, Lisa</creatorcontrib><creatorcontrib>van Tinteren, Harm</creatorcontrib><creatorcontrib>Wedman, Jan</creatorcontrib><creatorcontrib>Oyen, Wim J G</creatorcontrib><creatorcontrib>Janssen, Luuk M</creatorcontrib><creatorcontrib>van den Brekel, Michiel W M</creatorcontrib><creatorcontrib>Comans, Emile F I</creatorcontrib><creatorcontrib>Pruim, Jan</creatorcontrib><creatorcontrib>Takes, Robert P</creatorcontrib><creatorcontrib>Hobbelink, Monique G G</creatorcontrib><creatorcontrib>Valdés Olmos, Renato</creatorcontrib><creatorcontrib>van der Laan, Bernard F A M</creatorcontrib><creatorcontrib>Boers, Maarten</creatorcontrib><creatorcontrib>Hoekstra, Otto S</creatorcontrib><creatorcontrib>Leemans, C René</creatorcontrib><title>Effectiveness of an (18)F-FDG-PET based strategy to optimize the diagnostic trajectory of suspected recurrent laryngeal carcinoma after radiotherapy: The RELAPS multicenter randomized trial</title><title>Radiotherapy and oncology</title><addtitle>Radiother Oncol</addtitle><description>The purpose of this study is to evaluate the efficacy of (18)F-FDG-PET as first-line diagnostic investigation, prior to performing a direct laryngoscopy with biopsy under general anesthesia, in patients suspected of recurrent laryngeal carcinoma after radiotherapy.
150 patients suspected of recurrent T2-4 laryngeal carcinoma at least two months after prior (chemo)radiotherapy with curative intent for resectable disease were randomized to direct laryngoscopy (CWU: conventional workup strategy) or to (18)F-FDG-PET only followed by direct laryngoscopy if PET was assessed 'positive' or 'equivocal' (PWU: PET based workup strategy), to compare the effectiveness of these strategies. Primary endpoint was the number of indications for direct laryngoscopies classified as unnecessary based on absence of recurrence, both on direct laryngoscopy and on six month follow up. Safety endpoints comprised resectability of recurrent lesions and completeness of surgical margins following salvage laryngectomy.
Intention-to-treat analyses were performed on all randomized patients (CWU: n=74, PWU: n=76). Tumor recurrence was similar in both groups: 45 patients (30%; 21 CWU, 24 PWU) within six months. In 53 patients in the CWU arm (72%, 95% CI: 60-81) unnecessary direct laryngoscopies were performed compared to 22 in the PWU arm (29%, 95% CI: 19-40) (p<0·0001). The percentage of salvage laryngectomies (resectability) and positive surgical margins were similar between CWU and PWU (81%, 63% respectively, p=0·17, and 29%, 7%, respectively, p=0.20). The prevalence of the combination of local unresectability and positive margins is in the CWU group 24% and in the PWU group 8%. No difference (p=0.32) in disease specific survival between both groups was found.
In patients with suspected laryngeal carcinoma after radiotherapy, PET as the first diagnostic procedure can reduce the need for direct laryngoscopy by more than 50% without jeopardizing quality of treatment.</description><subject>Aged</subject><subject>Female</subject><subject>Fluorodeoxyglucose F18</subject><subject>Humans</subject><subject>Laryngeal Neoplasms - diagnostic imaging</subject><subject>Laryngeal Neoplasms - radiotherapy</subject><subject>Laryngoscopy</subject><subject>Larynx - diagnostic imaging</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Neoplasm Recurrence, Local - diagnostic imaging</subject><subject>Neoplasm Recurrence, Local - radiotherapy</subject><subject>Positron-Emission Tomography - methods</subject><subject>Radiopharmaceuticals</subject><subject>Reproducibility of Results</subject><subject>Salvage Therapy</subject><subject>Treatment Outcome</subject><issn>1879-0887</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNo1kM1OwzAQhC0kxP8bIOQjHFLsxIkTbgjaglQJBOVcbZxNcZXYwXaQyrvxbpi_02pXM99olpBTziac8eJyM3HQWKMmKeN5PE0YZzvkgJeySlhZyn1y6P2GMZayTO6R_bQQUmZVfkA-p22LKuh3NOg9tS0FQ895eTFLZrfz5HG6pDV4bKgPDgKutzRYaoege_2BNLwibTSsjfVBKxolmwizbvsN8qMf4ha9DtXoHJpAO3Bbs0boqAKntLE9UGgDOhoLaBt5DobtFV1G8NN0cf34TPuxi-xo_hGZxn4nNzFLQ3dMdlvoPJ78zSPyMpsub-6SxcP8_uZ6kQy8KkKSZ4XKBa9z1qZ53YimULxVSkiQqVA8K3gpQJapVBVIiWmFUoGqseJZCTmX2RE5_-UOzr6N6MOq115h14FBO_oVl1LwIhUij9KzP-lY99isBqf7WHr1__LsC6Yihpw</recordid><startdate>20160201</startdate><enddate>20160201</enddate><creator>de Bree, Remco</creator><creator>van der Putten, Lisa</creator><creator>van Tinteren, Harm</creator><creator>Wedman, Jan</creator><creator>Oyen, Wim J G</creator><creator>Janssen, Luuk M</creator><creator>van den Brekel, Michiel W M</creator><creator>Comans, Emile F I</creator><creator>Pruim, Jan</creator><creator>Takes, Robert P</creator><creator>Hobbelink, Monique G G</creator><creator>Valdés Olmos, Renato</creator><creator>van der Laan, Bernard F A M</creator><creator>Boers, Maarten</creator><creator>Hoekstra, Otto S</creator><creator>Leemans, C René</creator><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7X8</scope></search><sort><creationdate>20160201</creationdate><title>Effectiveness of an (18)F-FDG-PET based strategy to optimize the diagnostic trajectory of suspected recurrent laryngeal carcinoma after radiotherapy: The RELAPS multicenter randomized trial</title><author>de Bree, Remco ; van der Putten, Lisa ; van Tinteren, Harm ; Wedman, Jan ; Oyen, Wim J G ; Janssen, Luuk M ; van den Brekel, Michiel W M ; Comans, Emile F I ; Pruim, Jan ; Takes, Robert P ; Hobbelink, Monique G G ; Valdés Olmos, Renato ; van der Laan, Bernard F A M ; Boers, Maarten ; Hoekstra, Otto S ; Leemans, C René</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-p196t-536c541b50f25bd4d6c1fcc47a724c136184a7827c9a77e29e7cacbe9138a5173</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Aged</topic><topic>Female</topic><topic>Fluorodeoxyglucose F18</topic><topic>Humans</topic><topic>Laryngeal Neoplasms - diagnostic imaging</topic><topic>Laryngeal Neoplasms - radiotherapy</topic><topic>Laryngoscopy</topic><topic>Larynx - diagnostic imaging</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Neoplasm Recurrence, Local - diagnostic imaging</topic><topic>Neoplasm Recurrence, Local - radiotherapy</topic><topic>Positron-Emission Tomography - methods</topic><topic>Radiopharmaceuticals</topic><topic>Reproducibility of Results</topic><topic>Salvage Therapy</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>de Bree, Remco</creatorcontrib><creatorcontrib>van der Putten, Lisa</creatorcontrib><creatorcontrib>van Tinteren, Harm</creatorcontrib><creatorcontrib>Wedman, Jan</creatorcontrib><creatorcontrib>Oyen, Wim J G</creatorcontrib><creatorcontrib>Janssen, Luuk M</creatorcontrib><creatorcontrib>van den Brekel, Michiel W M</creatorcontrib><creatorcontrib>Comans, Emile F I</creatorcontrib><creatorcontrib>Pruim, Jan</creatorcontrib><creatorcontrib>Takes, Robert P</creatorcontrib><creatorcontrib>Hobbelink, Monique G G</creatorcontrib><creatorcontrib>Valdés Olmos, Renato</creatorcontrib><creatorcontrib>van der Laan, Bernard F A M</creatorcontrib><creatorcontrib>Boers, Maarten</creatorcontrib><creatorcontrib>Hoekstra, Otto S</creatorcontrib><creatorcontrib>Leemans, C René</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>MEDLINE - Academic</collection><jtitle>Radiotherapy and oncology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>de Bree, Remco</au><au>van der Putten, Lisa</au><au>van Tinteren, Harm</au><au>Wedman, Jan</au><au>Oyen, Wim J G</au><au>Janssen, Luuk M</au><au>van den Brekel, Michiel W M</au><au>Comans, Emile F I</au><au>Pruim, Jan</au><au>Takes, Robert P</au><au>Hobbelink, Monique G G</au><au>Valdés Olmos, Renato</au><au>van der Laan, Bernard F A M</au><au>Boers, Maarten</au><au>Hoekstra, Otto S</au><au>Leemans, C René</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effectiveness of an (18)F-FDG-PET based strategy to optimize the diagnostic trajectory of suspected recurrent laryngeal carcinoma after radiotherapy: The RELAPS multicenter randomized trial</atitle><jtitle>Radiotherapy and oncology</jtitle><addtitle>Radiother Oncol</addtitle><date>2016-02-01</date><risdate>2016</risdate><volume>118</volume><issue>2</issue><spage>251</spage><epage>256</epage><pages>251-256</pages><eissn>1879-0887</eissn><abstract>The purpose of this study is to evaluate the efficacy of (18)F-FDG-PET as first-line diagnostic investigation, prior to performing a direct laryngoscopy with biopsy under general anesthesia, in patients suspected of recurrent laryngeal carcinoma after radiotherapy.
150 patients suspected of recurrent T2-4 laryngeal carcinoma at least two months after prior (chemo)radiotherapy with curative intent for resectable disease were randomized to direct laryngoscopy (CWU: conventional workup strategy) or to (18)F-FDG-PET only followed by direct laryngoscopy if PET was assessed 'positive' or 'equivocal' (PWU: PET based workup strategy), to compare the effectiveness of these strategies. Primary endpoint was the number of indications for direct laryngoscopies classified as unnecessary based on absence of recurrence, both on direct laryngoscopy and on six month follow up. Safety endpoints comprised resectability of recurrent lesions and completeness of surgical margins following salvage laryngectomy.
Intention-to-treat analyses were performed on all randomized patients (CWU: n=74, PWU: n=76). Tumor recurrence was similar in both groups: 45 patients (30%; 21 CWU, 24 PWU) within six months. In 53 patients in the CWU arm (72%, 95% CI: 60-81) unnecessary direct laryngoscopies were performed compared to 22 in the PWU arm (29%, 95% CI: 19-40) (p<0·0001). The percentage of salvage laryngectomies (resectability) and positive surgical margins were similar between CWU and PWU (81%, 63% respectively, p=0·17, and 29%, 7%, respectively, p=0.20). The prevalence of the combination of local unresectability and positive margins is in the CWU group 24% and in the PWU group 8%. No difference (p=0.32) in disease specific survival between both groups was found.
In patients with suspected laryngeal carcinoma after radiotherapy, PET as the first diagnostic procedure can reduce the need for direct laryngoscopy by more than 50% without jeopardizing quality of treatment.</abstract><cop>Ireland</cop><pmid>26477395</pmid><doi>10.1016/j.radonc.2015.10.010</doi><tpages>6</tpages></addata></record> |
| fulltext | fulltext |
| identifier | EISSN: 1879-0887 |
| ispartof | Radiotherapy and oncology, 2016-02, Vol.118 (2), p.251-256 |
| issn | 1879-0887 |
| language | eng |
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| source | MEDLINE; ScienceDirect Journals (5 years ago - present) |
| subjects | Aged Female Fluorodeoxyglucose F18 Humans Laryngeal Neoplasms - diagnostic imaging Laryngeal Neoplasms - radiotherapy Laryngoscopy Larynx - diagnostic imaging Male Middle Aged Neoplasm Recurrence, Local - diagnostic imaging Neoplasm Recurrence, Local - radiotherapy Positron-Emission Tomography - methods Radiopharmaceuticals Reproducibility of Results Salvage Therapy Treatment Outcome |
| title | Effectiveness of an (18)F-FDG-PET based strategy to optimize the diagnostic trajectory of suspected recurrent laryngeal carcinoma after radiotherapy: The RELAPS multicenter randomized trial |
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