Addition of docetaxel to hormonal therapy in low- and high-burden metastatic hormone sensitive prostate cancer: long-term survival results from the STAMPEDE trial
STAMPEDE has previously reported that the use of upfront docetaxel improved overall survival (OS) for metastatic hormone naïve prostate cancer patients starting long-term androgen deprivation therapy. We report on long-term outcomes stratified by metastatic burden for M1 patients. We randomly alloca...
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| Veröffentlicht in: | Annals of oncology 2019-12, Vol.30 (12), p.1992 |
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| creator | Clarke, N W Ali, A Ingleby, F C Hoyle, A Amos, C L Attard, G Brawley, C D Calvert, J Chowdhury, S Cook, A Cross, W Dearnaley, D P Douis, H Gilbert, D Gillessen, S Jones, R J Langley, R E MacNair, A Malik, Z Mason, M D Matheson, D Millman, R Parker, C C Ritchie, A W S Rush, H Russell, J M Brown, J Beesley, S Birtle, A Capaldi, L Gale, J Gibbs, S Lydon, A Nikapota, A Omlin, A O'Sullivan, J M Parikh, O Protheroe, A Rudman, S Srihari, N N Simms, M Tanguay, J S Tolan, S Wagstaff, J Wallace, J Wylie, J Zarkar, A Sydes, M R Parmar, M K B James, N D |
| description | STAMPEDE has previously reported that the use of upfront docetaxel improved overall survival (OS) for metastatic hormone naïve prostate cancer patients starting long-term androgen deprivation therapy. We report on long-term outcomes stratified by metastatic burden for M1 patients.
We randomly allocated patients in 2 : 1 ratio to standard-of-care (SOC; control group) or SOC + docetaxel. Metastatic disease burden was categorised using retrospectively-collected baseline staging scans where available. Analysis used Cox regression models, adjusted for stratification factors, with emphasis on restricted mean survival time where hazards were non-proportional.
Between 05 October 2005 and 31 March 2013, 1086 M1 patients were randomised to receive SOC (n = 724) or SOC + docetaxel (n = 362). Metastatic burden was assessable for 830/1086 (76%) patients; 362 (44%) had low and 468 (56%) high metastatic burden. Median follow-up was 78.2 months. There were 494 deaths on SOC (41% more than the previous report). There was good evidence of benefit of docetaxel over SOC on OS (HR = 0.81, 95% CI 0.69-0.95, P = 0.009) with no evidence of heterogeneity of docetaxel effect between metastatic burden sub-groups (interaction P = 0.827). Analysis of other outcomes found evidence of benefit for docetaxel over SOC in failure-free survival (HR = 0.66, 95% CI 0.57-0.76, P |
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We randomly allocated patients in 2 : 1 ratio to standard-of-care (SOC; control group) or SOC + docetaxel. Metastatic disease burden was categorised using retrospectively-collected baseline staging scans where available. Analysis used Cox regression models, adjusted for stratification factors, with emphasis on restricted mean survival time where hazards were non-proportional.
Between 05 October 2005 and 31 March 2013, 1086 M1 patients were randomised to receive SOC (n = 724) or SOC + docetaxel (n = 362). Metastatic burden was assessable for 830/1086 (76%) patients; 362 (44%) had low and 468 (56%) high metastatic burden. Median follow-up was 78.2 months. There were 494 deaths on SOC (41% more than the previous report). There was good evidence of benefit of docetaxel over SOC on OS (HR = 0.81, 95% CI 0.69-0.95, P = 0.009) with no evidence of heterogeneity of docetaxel effect between metastatic burden sub-groups (interaction P = 0.827). Analysis of other outcomes found evidence of benefit for docetaxel over SOC in failure-free survival (HR = 0.66, 95% CI 0.57-0.76, P < 0.001) and progression-free survival (HR = 0.69, 95% CI 0.59-0.81, P < 0.001) with no evidence of heterogeneity of docetaxel effect between metastatic burden sub-groups (interaction P > 0.5 in each case). There was no evidence that docetaxel resulted in late toxicity compared with SOC: after 1 year, G3-5 toxicity was reported for 28% SOC and 27% docetaxel (in patients still on follow-up at 1 year without prior progression).
The clinically significant benefit in survival for upfront docetaxel persists at longer follow-up, with no evidence that benefit differed by metastatic burden. We advocate that upfront docetaxel is considered for metastatic hormone naïve prostate cancer patients regardless of metastatic burden.</description><identifier>EISSN: 1569-8041</identifier><identifier>PMID: 31987303</identifier><language>eng</language><publisher>England</publisher><ispartof>Annals of oncology, 2019-12, Vol.30 (12), p.1992</ispartof><rights>2019 THE AUTHORS. Published by Elsevier Ltd on behalf of the European Society for Medical Oncology. This is an open access article under the CC-BY license (http://creativecommons.org/licenses/by/4.0/).</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31987303$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Clarke, N W</creatorcontrib><creatorcontrib>Ali, A</creatorcontrib><creatorcontrib>Ingleby, F C</creatorcontrib><creatorcontrib>Hoyle, A</creatorcontrib><creatorcontrib>Amos, C L</creatorcontrib><creatorcontrib>Attard, G</creatorcontrib><creatorcontrib>Brawley, C D</creatorcontrib><creatorcontrib>Calvert, J</creatorcontrib><creatorcontrib>Chowdhury, S</creatorcontrib><creatorcontrib>Cook, A</creatorcontrib><creatorcontrib>Cross, W</creatorcontrib><creatorcontrib>Dearnaley, D P</creatorcontrib><creatorcontrib>Douis, H</creatorcontrib><creatorcontrib>Gilbert, D</creatorcontrib><creatorcontrib>Gillessen, S</creatorcontrib><creatorcontrib>Jones, R J</creatorcontrib><creatorcontrib>Langley, R E</creatorcontrib><creatorcontrib>MacNair, A</creatorcontrib><creatorcontrib>Malik, Z</creatorcontrib><creatorcontrib>Mason, M D</creatorcontrib><creatorcontrib>Matheson, D</creatorcontrib><creatorcontrib>Millman, R</creatorcontrib><creatorcontrib>Parker, C C</creatorcontrib><creatorcontrib>Ritchie, A W S</creatorcontrib><creatorcontrib>Rush, H</creatorcontrib><creatorcontrib>Russell, J M</creatorcontrib><creatorcontrib>Brown, J</creatorcontrib><creatorcontrib>Beesley, S</creatorcontrib><creatorcontrib>Birtle, A</creatorcontrib><creatorcontrib>Capaldi, L</creatorcontrib><creatorcontrib>Gale, J</creatorcontrib><creatorcontrib>Gibbs, S</creatorcontrib><creatorcontrib>Lydon, A</creatorcontrib><creatorcontrib>Nikapota, A</creatorcontrib><creatorcontrib>Omlin, A</creatorcontrib><creatorcontrib>O'Sullivan, J M</creatorcontrib><creatorcontrib>Parikh, O</creatorcontrib><creatorcontrib>Protheroe, A</creatorcontrib><creatorcontrib>Rudman, S</creatorcontrib><creatorcontrib>Srihari, N N</creatorcontrib><creatorcontrib>Simms, M</creatorcontrib><creatorcontrib>Tanguay, J S</creatorcontrib><creatorcontrib>Tolan, S</creatorcontrib><creatorcontrib>Wagstaff, J</creatorcontrib><creatorcontrib>Wallace, J</creatorcontrib><creatorcontrib>Wylie, J</creatorcontrib><creatorcontrib>Zarkar, A</creatorcontrib><creatorcontrib>Sydes, M R</creatorcontrib><creatorcontrib>Parmar, M K B</creatorcontrib><creatorcontrib>James, N D</creatorcontrib><title>Addition of docetaxel to hormonal therapy in low- and high-burden metastatic hormone sensitive prostate cancer: long-term survival results from the STAMPEDE trial</title><title>Annals of oncology</title><addtitle>Ann Oncol</addtitle><description>STAMPEDE has previously reported that the use of upfront docetaxel improved overall survival (OS) for metastatic hormone naïve prostate cancer patients starting long-term androgen deprivation therapy. We report on long-term outcomes stratified by metastatic burden for M1 patients.
We randomly allocated patients in 2 : 1 ratio to standard-of-care (SOC; control group) or SOC + docetaxel. Metastatic disease burden was categorised using retrospectively-collected baseline staging scans where available. Analysis used Cox regression models, adjusted for stratification factors, with emphasis on restricted mean survival time where hazards were non-proportional.
Between 05 October 2005 and 31 March 2013, 1086 M1 patients were randomised to receive SOC (n = 724) or SOC + docetaxel (n = 362). Metastatic burden was assessable for 830/1086 (76%) patients; 362 (44%) had low and 468 (56%) high metastatic burden. Median follow-up was 78.2 months. There were 494 deaths on SOC (41% more than the previous report). There was good evidence of benefit of docetaxel over SOC on OS (HR = 0.81, 95% CI 0.69-0.95, P = 0.009) with no evidence of heterogeneity of docetaxel effect between metastatic burden sub-groups (interaction P = 0.827). Analysis of other outcomes found evidence of benefit for docetaxel over SOC in failure-free survival (HR = 0.66, 95% CI 0.57-0.76, P < 0.001) and progression-free survival (HR = 0.69, 95% CI 0.59-0.81, P < 0.001) with no evidence of heterogeneity of docetaxel effect between metastatic burden sub-groups (interaction P > 0.5 in each case). There was no evidence that docetaxel resulted in late toxicity compared with SOC: after 1 year, G3-5 toxicity was reported for 28% SOC and 27% docetaxel (in patients still on follow-up at 1 year without prior progression).
The clinically significant benefit in survival for upfront docetaxel persists at longer follow-up, with no evidence that benefit differed by metastatic burden. We advocate that upfront docetaxel is considered for metastatic hormone naïve prostate cancer patients regardless of metastatic burden.</description><issn>1569-8041</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><recordid>eNqFT8tKw0AUHQpiq_YXyv2BgYnR2rgrGnEjFOy-TDM3zZR5hHsn0f6OX-oU6trVOXBenImYFY_LSq7UQzEVN8xHpdSyuq-uxbQsqtVTqcqZ-FkbY5ONAWILJjaY9Dc6SBG6SD4GnXmHpPsT2AAufknQwUBnD53cD2QwgM8ZTjrZ5pJBYAycW0eEnuJZQ2h0aJCec0U4yITkgQca7ZgHCHlwiaGl6M9r8Lldf2zq1xoSWe3uxFWrHeP8grdi8VZvX95lP-w9ml1P1ms67f5Olf8afgFzjVr0</recordid><startdate>201912</startdate><enddate>201912</enddate><creator>Clarke, N W</creator><creator>Ali, A</creator><creator>Ingleby, F C</creator><creator>Hoyle, A</creator><creator>Amos, C L</creator><creator>Attard, G</creator><creator>Brawley, C D</creator><creator>Calvert, J</creator><creator>Chowdhury, S</creator><creator>Cook, A</creator><creator>Cross, W</creator><creator>Dearnaley, D P</creator><creator>Douis, H</creator><creator>Gilbert, D</creator><creator>Gillessen, S</creator><creator>Jones, R J</creator><creator>Langley, R E</creator><creator>MacNair, A</creator><creator>Malik, Z</creator><creator>Mason, M D</creator><creator>Matheson, D</creator><creator>Millman, R</creator><creator>Parker, C C</creator><creator>Ritchie, A W S</creator><creator>Rush, H</creator><creator>Russell, J M</creator><creator>Brown, J</creator><creator>Beesley, S</creator><creator>Birtle, A</creator><creator>Capaldi, L</creator><creator>Gale, J</creator><creator>Gibbs, S</creator><creator>Lydon, A</creator><creator>Nikapota, A</creator><creator>Omlin, A</creator><creator>O'Sullivan, J M</creator><creator>Parikh, O</creator><creator>Protheroe, A</creator><creator>Rudman, S</creator><creator>Srihari, N N</creator><creator>Simms, M</creator><creator>Tanguay, J S</creator><creator>Tolan, S</creator><creator>Wagstaff, J</creator><creator>Wallace, J</creator><creator>Wylie, J</creator><creator>Zarkar, A</creator><creator>Sydes, M R</creator><creator>Parmar, M K B</creator><creator>James, N D</creator><scope>NPM</scope></search><sort><creationdate>201912</creationdate><title>Addition of docetaxel to hormonal therapy in low- and high-burden metastatic hormone sensitive prostate cancer: long-term survival results from the STAMPEDE trial</title><author>Clarke, N W ; Ali, A ; Ingleby, F C ; Hoyle, A ; Amos, C L ; Attard, G ; Brawley, C D ; Calvert, J ; Chowdhury, S ; Cook, A ; Cross, W ; Dearnaley, D P ; Douis, H ; Gilbert, D ; Gillessen, S ; Jones, R J ; Langley, R E ; MacNair, A ; Malik, Z ; Mason, M D ; Matheson, D ; Millman, R ; Parker, C C ; Ritchie, A W S ; Rush, H ; Russell, J M ; Brown, J ; Beesley, S ; Birtle, A ; Capaldi, L ; Gale, J ; Gibbs, S ; Lydon, A ; Nikapota, A ; Omlin, A ; O'Sullivan, J M ; Parikh, O ; Protheroe, A ; Rudman, S ; Srihari, N N ; Simms, M ; Tanguay, J S ; Tolan, S ; Wagstaff, J ; Wallace, J ; Wylie, J ; Zarkar, A ; Sydes, M R ; Parmar, M K B ; James, N D</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-pubmed_primary_319873033</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Clarke, N W</creatorcontrib><creatorcontrib>Ali, A</creatorcontrib><creatorcontrib>Ingleby, F C</creatorcontrib><creatorcontrib>Hoyle, A</creatorcontrib><creatorcontrib>Amos, C L</creatorcontrib><creatorcontrib>Attard, G</creatorcontrib><creatorcontrib>Brawley, C D</creatorcontrib><creatorcontrib>Calvert, J</creatorcontrib><creatorcontrib>Chowdhury, S</creatorcontrib><creatorcontrib>Cook, A</creatorcontrib><creatorcontrib>Cross, W</creatorcontrib><creatorcontrib>Dearnaley, D P</creatorcontrib><creatorcontrib>Douis, H</creatorcontrib><creatorcontrib>Gilbert, D</creatorcontrib><creatorcontrib>Gillessen, S</creatorcontrib><creatorcontrib>Jones, R J</creatorcontrib><creatorcontrib>Langley, R E</creatorcontrib><creatorcontrib>MacNair, A</creatorcontrib><creatorcontrib>Malik, Z</creatorcontrib><creatorcontrib>Mason, M D</creatorcontrib><creatorcontrib>Matheson, D</creatorcontrib><creatorcontrib>Millman, R</creatorcontrib><creatorcontrib>Parker, C C</creatorcontrib><creatorcontrib>Ritchie, A W S</creatorcontrib><creatorcontrib>Rush, H</creatorcontrib><creatorcontrib>Russell, J M</creatorcontrib><creatorcontrib>Brown, J</creatorcontrib><creatorcontrib>Beesley, S</creatorcontrib><creatorcontrib>Birtle, A</creatorcontrib><creatorcontrib>Capaldi, L</creatorcontrib><creatorcontrib>Gale, J</creatorcontrib><creatorcontrib>Gibbs, S</creatorcontrib><creatorcontrib>Lydon, A</creatorcontrib><creatorcontrib>Nikapota, A</creatorcontrib><creatorcontrib>Omlin, A</creatorcontrib><creatorcontrib>O'Sullivan, J M</creatorcontrib><creatorcontrib>Parikh, O</creatorcontrib><creatorcontrib>Protheroe, A</creatorcontrib><creatorcontrib>Rudman, S</creatorcontrib><creatorcontrib>Srihari, N N</creatorcontrib><creatorcontrib>Simms, M</creatorcontrib><creatorcontrib>Tanguay, J S</creatorcontrib><creatorcontrib>Tolan, S</creatorcontrib><creatorcontrib>Wagstaff, J</creatorcontrib><creatorcontrib>Wallace, J</creatorcontrib><creatorcontrib>Wylie, J</creatorcontrib><creatorcontrib>Zarkar, A</creatorcontrib><creatorcontrib>Sydes, M R</creatorcontrib><creatorcontrib>Parmar, M K B</creatorcontrib><creatorcontrib>James, N D</creatorcontrib><collection>PubMed</collection><jtitle>Annals of oncology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Clarke, N W</au><au>Ali, A</au><au>Ingleby, F C</au><au>Hoyle, A</au><au>Amos, C L</au><au>Attard, G</au><au>Brawley, C D</au><au>Calvert, J</au><au>Chowdhury, S</au><au>Cook, A</au><au>Cross, W</au><au>Dearnaley, D P</au><au>Douis, H</au><au>Gilbert, D</au><au>Gillessen, S</au><au>Jones, R J</au><au>Langley, R E</au><au>MacNair, A</au><au>Malik, Z</au><au>Mason, M D</au><au>Matheson, D</au><au>Millman, R</au><au>Parker, C C</au><au>Ritchie, A W S</au><au>Rush, H</au><au>Russell, J M</au><au>Brown, J</au><au>Beesley, S</au><au>Birtle, A</au><au>Capaldi, L</au><au>Gale, J</au><au>Gibbs, S</au><au>Lydon, A</au><au>Nikapota, A</au><au>Omlin, A</au><au>O'Sullivan, J M</au><au>Parikh, O</au><au>Protheroe, A</au><au>Rudman, S</au><au>Srihari, N N</au><au>Simms, M</au><au>Tanguay, J S</au><au>Tolan, S</au><au>Wagstaff, J</au><au>Wallace, J</au><au>Wylie, J</au><au>Zarkar, A</au><au>Sydes, M R</au><au>Parmar, M K B</au><au>James, N D</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Addition of docetaxel to hormonal therapy in low- and high-burden metastatic hormone sensitive prostate cancer: long-term survival results from the STAMPEDE trial</atitle><jtitle>Annals of oncology</jtitle><addtitle>Ann Oncol</addtitle><date>2019-12</date><risdate>2019</risdate><volume>30</volume><issue>12</issue><spage>1992</spage><pages>1992-</pages><eissn>1569-8041</eissn><abstract>STAMPEDE has previously reported that the use of upfront docetaxel improved overall survival (OS) for metastatic hormone naïve prostate cancer patients starting long-term androgen deprivation therapy. We report on long-term outcomes stratified by metastatic burden for M1 patients.
We randomly allocated patients in 2 : 1 ratio to standard-of-care (SOC; control group) or SOC + docetaxel. Metastatic disease burden was categorised using retrospectively-collected baseline staging scans where available. Analysis used Cox regression models, adjusted for stratification factors, with emphasis on restricted mean survival time where hazards were non-proportional.
Between 05 October 2005 and 31 March 2013, 1086 M1 patients were randomised to receive SOC (n = 724) or SOC + docetaxel (n = 362). Metastatic burden was assessable for 830/1086 (76%) patients; 362 (44%) had low and 468 (56%) high metastatic burden. Median follow-up was 78.2 months. There were 494 deaths on SOC (41% more than the previous report). There was good evidence of benefit of docetaxel over SOC on OS (HR = 0.81, 95% CI 0.69-0.95, P = 0.009) with no evidence of heterogeneity of docetaxel effect between metastatic burden sub-groups (interaction P = 0.827). Analysis of other outcomes found evidence of benefit for docetaxel over SOC in failure-free survival (HR = 0.66, 95% CI 0.57-0.76, P < 0.001) and progression-free survival (HR = 0.69, 95% CI 0.59-0.81, P < 0.001) with no evidence of heterogeneity of docetaxel effect between metastatic burden sub-groups (interaction P > 0.5 in each case). There was no evidence that docetaxel resulted in late toxicity compared with SOC: after 1 year, G3-5 toxicity was reported for 28% SOC and 27% docetaxel (in patients still on follow-up at 1 year without prior progression).
The clinically significant benefit in survival for upfront docetaxel persists at longer follow-up, with no evidence that benefit differed by metastatic burden. We advocate that upfront docetaxel is considered for metastatic hormone naïve prostate cancer patients regardless of metastatic burden.</abstract><cop>England</cop><pmid>31987303</pmid></addata></record> |
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| ispartof | Annals of oncology, 2019-12, Vol.30 (12), p.1992 |
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| recordid | cdi_pubmed_primary_31987303 |
| source | Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Alma/SFX Local Collection |
| title | Addition of docetaxel to hormonal therapy in low- and high-burden metastatic hormone sensitive prostate cancer: long-term survival results from the STAMPEDE trial |
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