Retrospective analysis of serum testosterone levels by LC-MS/MS in chemically castrated prostate cancer patients: Biological variation and analytical performance specifications
•An LC-MS/MS assay for the quantitation of castration levels of testosterone was validated.•Within- and between patient variation was estimated using 474 samples from 72 patients.•Biological variation was estimated at 6.1%, 24.6% and 60.3% for CVA, CVI and CVG, respectively.•Desirable APS were 12.3%...
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| Veröffentlicht in: | Clinica chimica acta 2021-10, Vol.521, p.70-75 |
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| creator | van Winden, Lennart J. Lanfermeijer, Mirthe Heijboer, Annemieke C. van Tellingen, Olaf Bergman, Andries M. van der Poel, Henk G. Jonker, Niels van Rossum, Huub H. |
| description | •An LC-MS/MS assay for the quantitation of castration levels of testosterone was validated.•Within- and between patient variation was estimated using 474 samples from 72 patients.•Biological variation was estimated at 6.1%, 24.6% and 60.3% for CVA, CVI and CVG, respectively.•Desirable APS were 12.3% for imprecision, 16.3% for bias and 26.4% for total error.
A sensitive liquid chromatography tandem-mass spectrometry (LC-MS/MS) method was used to monitor serum testosterone levels in castrated prostate cancer patients. We subsequently performed an observational and retrospective study to estimate the within- and between-subject biological variation of these patients.
In total, 474 samples from 72 prostate cancer patients in the Netherlands receiving either chemical castration (CAS) or castration plus enzalutamide (ENZA) treatment were selected for data analysis. ANOVA was performed to estimate analytical variation (CVA) and within-patient variation (CVI). A nested ANOVA was applied to estimate between-patient variation (CVG). From these data, the reference change value (RCV) and analytical performance specifications (APS) were calculated.
Testosterone levels were significantly higher in the ENZA group (0.318 vs. 0.191 nmol/L, p |
| doi_str_mv | 10.1016/j.cca.2021.06.030 |
| format | Article |
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A sensitive liquid chromatography tandem-mass spectrometry (LC-MS/MS) method was used to monitor serum testosterone levels in castrated prostate cancer patients. We subsequently performed an observational and retrospective study to estimate the within- and between-subject biological variation of these patients.
In total, 474 samples from 72 prostate cancer patients in the Netherlands receiving either chemical castration (CAS) or castration plus enzalutamide (ENZA) treatment were selected for data analysis. ANOVA was performed to estimate analytical variation (CVA) and within-patient variation (CVI). A nested ANOVA was applied to estimate between-patient variation (CVG). From these data, the reference change value (RCV) and analytical performance specifications (APS) were calculated.
Testosterone levels were significantly higher in the ENZA group (0.318 vs. 0.191 nmol/L, p < 0.005) than the CAS group. Overall, variation components were estimated at 6.1%, 24.6% and 60.3% for CVA, CVI and CVG, respectively. Both groups showed high individuality (<0.6). The RCV was 70.3% for all patients. Desirable APS were 12.3% for imprecision, 16.3% for bias and 26.4% for total error.
The generated APS are valuable for sensitive testosterone assays and the high individuality indicates that castrated testosterone levels can be studied as a predictive or prognostic biomarker in prostate cancer patients.</description><identifier>ISSN: 0009-8981</identifier><identifier>EISSN: 1873-3492</identifier><identifier>DOI: 10.1016/j.cca.2021.06.030</identifier><identifier>PMID: 34217697</identifier><language>eng</language><publisher>Netherlands: Elsevier B.V</publisher><subject>Androgen deprivation therapy ; Biological variation ; Chromatography, Liquid ; Humans ; LC-MS/MS ; Male ; Prostate cancer ; Prostatic Neoplasms ; Retrospective Studies ; Steroids ; Tandem Mass Spectrometry ; Testosterone</subject><ispartof>Clinica chimica acta, 2021-10, Vol.521, p.70-75</ispartof><rights>2021 Elsevier B.V.</rights><rights>Copyright © 2021 Elsevier B.V. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c353t-e18cc03802926023bd1ac64133daca741cf500b57e9c820a0d2146bd5eb76f903</citedby><cites>FETCH-LOGICAL-c353t-e18cc03802926023bd1ac64133daca741cf500b57e9c820a0d2146bd5eb76f903</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S000989812100231X$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3536,27903,27904,65309</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/34217697$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>van Winden, Lennart J.</creatorcontrib><creatorcontrib>Lanfermeijer, Mirthe</creatorcontrib><creatorcontrib>Heijboer, Annemieke C.</creatorcontrib><creatorcontrib>van Tellingen, Olaf</creatorcontrib><creatorcontrib>Bergman, Andries M.</creatorcontrib><creatorcontrib>van der Poel, Henk G.</creatorcontrib><creatorcontrib>Jonker, Niels</creatorcontrib><creatorcontrib>van Rossum, Huub H.</creatorcontrib><title>Retrospective analysis of serum testosterone levels by LC-MS/MS in chemically castrated prostate cancer patients: Biological variation and analytical performance specifications</title><title>Clinica chimica acta</title><addtitle>Clin Chim Acta</addtitle><description>•An LC-MS/MS assay for the quantitation of castration levels of testosterone was validated.•Within- and between patient variation was estimated using 474 samples from 72 patients.•Biological variation was estimated at 6.1%, 24.6% and 60.3% for CVA, CVI and CVG, respectively.•Desirable APS were 12.3% for imprecision, 16.3% for bias and 26.4% for total error.
A sensitive liquid chromatography tandem-mass spectrometry (LC-MS/MS) method was used to monitor serum testosterone levels in castrated prostate cancer patients. We subsequently performed an observational and retrospective study to estimate the within- and between-subject biological variation of these patients.
In total, 474 samples from 72 prostate cancer patients in the Netherlands receiving either chemical castration (CAS) or castration plus enzalutamide (ENZA) treatment were selected for data analysis. ANOVA was performed to estimate analytical variation (CVA) and within-patient variation (CVI). A nested ANOVA was applied to estimate between-patient variation (CVG). From these data, the reference change value (RCV) and analytical performance specifications (APS) were calculated.
Testosterone levels were significantly higher in the ENZA group (0.318 vs. 0.191 nmol/L, p < 0.005) than the CAS group. Overall, variation components were estimated at 6.1%, 24.6% and 60.3% for CVA, CVI and CVG, respectively. Both groups showed high individuality (<0.6). The RCV was 70.3% for all patients. Desirable APS were 12.3% for imprecision, 16.3% for bias and 26.4% for total error.
The generated APS are valuable for sensitive testosterone assays and the high individuality indicates that castrated testosterone levels can be studied as a predictive or prognostic biomarker in prostate cancer patients.</description><subject>Androgen deprivation therapy</subject><subject>Biological variation</subject><subject>Chromatography, Liquid</subject><subject>Humans</subject><subject>LC-MS/MS</subject><subject>Male</subject><subject>Prostate cancer</subject><subject>Prostatic Neoplasms</subject><subject>Retrospective Studies</subject><subject>Steroids</subject><subject>Tandem Mass Spectrometry</subject><subject>Testosterone</subject><issn>0009-8981</issn><issn>1873-3492</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9Uc1u1DAYtBCILoUH4IJ85JL0s504MZxgRQFpK6QWzpbjfAGvkjjY3pX2rfqIddjCkZPt8cx8P0PIawYlAyav9qW1puTAWQmyBAFPyIa1jShEpfhTsgEAVbSqZRfkRYz7_KxAsufkQlScNVI1G3J_iyn4uKBN7ojUzGY8RRepH2jEcJhowph8TBj8jHTEI46Rdie62xY3d1c3d9TN1P7CyVkzjidqTUzBJOzpkl1TvmVothjoYpLDOcV39KPzo_-5CujRBJdxP-fC_bl4-vOxYBh8mFYpXZtzQ4ZXYnxJng1mjPjq8bwkP64_fd9-KXbfPn_dftgVVtQiFchaa0G0wBWXwEXXM2NlxYTojTVNxexQA3R1g8q2HAz0nFWy62vsGjkoEJfk7dk3D_L7kJegJxctjqOZ0R-i5nXV1kq1UmQqO1NtnjkGHPQS3GTCSTPQa1B6r3NQeg1Kg9Q5qKx582h_6Cbs_yn-JpMJ78-EvHA8Ogw62rxAi70LOSzde_cf-wd2RKfa</recordid><startdate>202110</startdate><enddate>202110</enddate><creator>van Winden, Lennart J.</creator><creator>Lanfermeijer, Mirthe</creator><creator>Heijboer, Annemieke C.</creator><creator>van Tellingen, Olaf</creator><creator>Bergman, Andries M.</creator><creator>van der Poel, Henk G.</creator><creator>Jonker, Niels</creator><creator>van Rossum, Huub H.</creator><general>Elsevier B.V</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>7X8</scope></search><sort><creationdate>202110</creationdate><title>Retrospective analysis of serum testosterone levels by LC-MS/MS in chemically castrated prostate cancer patients: Biological variation and analytical performance specifications</title><author>van Winden, Lennart J. ; Lanfermeijer, Mirthe ; Heijboer, Annemieke C. ; van Tellingen, Olaf ; Bergman, Andries M. ; van der Poel, Henk G. ; Jonker, Niels ; van Rossum, Huub H.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c353t-e18cc03802926023bd1ac64133daca741cf500b57e9c820a0d2146bd5eb76f903</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Androgen deprivation therapy</topic><topic>Biological variation</topic><topic>Chromatography, Liquid</topic><topic>Humans</topic><topic>LC-MS/MS</topic><topic>Male</topic><topic>Prostate cancer</topic><topic>Prostatic Neoplasms</topic><topic>Retrospective Studies</topic><topic>Steroids</topic><topic>Tandem Mass Spectrometry</topic><topic>Testosterone</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>van Winden, Lennart J.</creatorcontrib><creatorcontrib>Lanfermeijer, Mirthe</creatorcontrib><creatorcontrib>Heijboer, Annemieke C.</creatorcontrib><creatorcontrib>van Tellingen, Olaf</creatorcontrib><creatorcontrib>Bergman, Andries M.</creatorcontrib><creatorcontrib>van der Poel, Henk G.</creatorcontrib><creatorcontrib>Jonker, Niels</creatorcontrib><creatorcontrib>van Rossum, Huub H.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Clinica chimica acta</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>van Winden, Lennart J.</au><au>Lanfermeijer, Mirthe</au><au>Heijboer, Annemieke C.</au><au>van Tellingen, Olaf</au><au>Bergman, Andries M.</au><au>van der Poel, Henk G.</au><au>Jonker, Niels</au><au>van Rossum, Huub H.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Retrospective analysis of serum testosterone levels by LC-MS/MS in chemically castrated prostate cancer patients: Biological variation and analytical performance specifications</atitle><jtitle>Clinica chimica acta</jtitle><addtitle>Clin Chim Acta</addtitle><date>2021-10</date><risdate>2021</risdate><volume>521</volume><spage>70</spage><epage>75</epage><pages>70-75</pages><issn>0009-8981</issn><eissn>1873-3492</eissn><abstract>•An LC-MS/MS assay for the quantitation of castration levels of testosterone was validated.•Within- and between patient variation was estimated using 474 samples from 72 patients.•Biological variation was estimated at 6.1%, 24.6% and 60.3% for CVA, CVI and CVG, respectively.•Desirable APS were 12.3% for imprecision, 16.3% for bias and 26.4% for total error.
A sensitive liquid chromatography tandem-mass spectrometry (LC-MS/MS) method was used to monitor serum testosterone levels in castrated prostate cancer patients. We subsequently performed an observational and retrospective study to estimate the within- and between-subject biological variation of these patients.
In total, 474 samples from 72 prostate cancer patients in the Netherlands receiving either chemical castration (CAS) or castration plus enzalutamide (ENZA) treatment were selected for data analysis. ANOVA was performed to estimate analytical variation (CVA) and within-patient variation (CVI). A nested ANOVA was applied to estimate between-patient variation (CVG). From these data, the reference change value (RCV) and analytical performance specifications (APS) were calculated.
Testosterone levels were significantly higher in the ENZA group (0.318 vs. 0.191 nmol/L, p < 0.005) than the CAS group. Overall, variation components were estimated at 6.1%, 24.6% and 60.3% for CVA, CVI and CVG, respectively. Both groups showed high individuality (<0.6). The RCV was 70.3% for all patients. Desirable APS were 12.3% for imprecision, 16.3% for bias and 26.4% for total error.
The generated APS are valuable for sensitive testosterone assays and the high individuality indicates that castrated testosterone levels can be studied as a predictive or prognostic biomarker in prostate cancer patients.</abstract><cop>Netherlands</cop><pub>Elsevier B.V</pub><pmid>34217697</pmid><doi>10.1016/j.cca.2021.06.030</doi><tpages>6</tpages></addata></record> |
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| subjects | Androgen deprivation therapy Biological variation Chromatography, Liquid Humans LC-MS/MS Male Prostate cancer Prostatic Neoplasms Retrospective Studies Steroids Tandem Mass Spectrometry Testosterone |
| title | Retrospective analysis of serum testosterone levels by LC-MS/MS in chemically castrated prostate cancer patients: Biological variation and analytical performance specifications |
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