Addition of docetaxel, zoledronic acid, or both to first-line long-term hormone therapy in prostate cancer (STAMPEDE): survival results from an adaptive, multiarm, multistage, platform randomised controlled trial

James, Nicholas D; Sydes, Matthew R; Clarke, Noel W; Mason, Malcolm D; Dearnaley, David P; Spears, Melissa R; S, Alastair W; Parker, Christopher C; Russell, J Martin; Attard, Gerhardt; Bono, Johann de; Cross, William; Jones, Rob J; Thalmann, George; Amos, Claire; Matheson, David; Millman, Robin; Alzouebi, Mymoona; Beesley, Sharon; Birtle, Alison J; Brock, Susannah; Cathomas, Richard; Chakraborti, Prabir; Chowdhury, Simon; Cook, Audrey; Elliott, Tony; Gale, Joanna; Gibbs, Stephanie; Graham, John D; Hetherington, John; Hughes, Robert; Laing, Robert; McKinna, Fiona; McLaren, Duncan B; O'Sullivan, Joe M; Parikh, Omi; Peedell, Clive; Protheroe, Andrew; Robinson, Angus J; Srihari, Narayanan; Srinivasan, Rajaguru; Staffurth, John; Sundar, Santhanam; Tolan, Shaun; Tsang, David; Wagstaff, John; B, Mahesh K

doi:10.1016/S0140-6736(15)01037-5

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Addition of docetaxel, zoledronic acid, or both to first-line long-term hormone therapy in prostate cancer (STAMPEDE): survival results from an adaptive, multiarm, multistage, platform randomised controlled trial

Nicholas D James, Matthew R Sydes, Noel W Clarke, Malcolm D Mason, David P Dearnaley, Melissa R Spears, Alastair W S Ritchie, Christopher C Parker, J Martin Russell, Gerhardt Attard, Johann de Bono, William Cross, Rob J Jones, George Thalmann, Claire Amos, David Matheson, Robin Millman, Mymoona Alzouebi, Sharon Beesley, Alison J Birtle, Susannah Brock, Richard Cathomas, Prabir Chakraborti, Simon Chowdhury, Audrey Cook, Tony Elliott, Joanna Gale, Stephanie Gibbs, John D Graham, John Hetherington, Robert Hughes, Robert Laing, Fiona McKinna, Duncan B McLaren, Joe M O'Sullivan, Omi Parikh, Clive Peedell, Andrew Protheroe, Angus J Robinson, Narayanan Srihari, Rajaguru Srinivasan, John Staffurth, Santhanam Sundar, Shaun Tolan, David Tsang, John Wagstaff, Mahesh K B Parmar

The Lancet

Swansea University Author: John Wagstaff

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DOI (Published version): 10.1016/S0140-6736(15)01037-5

Abstract

In this multi arm multi stage designed trial 2962 men with hormone sensitive prostate cancer were randomised to one of four arms. The control arm consisted of either surgical or chemical castration alone (standard of care (SOC)). In all other arms patients received either surgical or chemical castra...

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Published in:	The Lancet
Published:	London The Lancet 2015
URI:	https://cronfa.swan.ac.uk/Record/cronfa25288
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first_indexed	2015-12-29T01:52:58Z
last_indexed	2019-07-16T20:28:51Z
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In all other arms patients received either surgical or chemical castration plus docetaxel (Doc) alone, zoledronic acid (ZA) alone or Doc plus ZA. 1817 (61%) men had metastatic (M)+ disease, 448 (15%) had nodal (N)+/X M0, and 697 (24%) had N0M0. Median overall survival was 71 months for SOC alone, not reached for SOC+ZA (p=0.45), 81 months for SOC+Doc (p=0.006) & 76 months for SOC+Doc+ZA (0.022). Grade 3–5 adverse events were reported for 399 (32%) patients receiving SOC, 197 (32%) receiving SOC+ZA, 288 (52%) receiving SOC+Doc, and 269 (52%) receiving SOC + ZA + Doc. ZA showed no evidence of survival benefit and should not be part of SOC. Doc showed a significant improvement in overall survival and should become SOC for suitably fit men with prostate cancer starting long term hormone therapy.</abstract><type>Journal Article</type><journal>The Lancet</journal><publisher>The Lancet</publisher><placeOfPublication>London</placeOfPublication><keywords>prostate cancer, docetaxel, zoledronic acid, hormone therapy</keywords><publishedDay>21</publishedDay><publishedMonth>12</publishedMonth><publishedYear>2015</publishedYear><publishedDate>2015-12-21</publishedDate><doi>10.1016/S0140-6736(15)01037-5</doi><url/><notes/><college>COLLEGE NANME</college><department>Medical School - School</department><CollegeCode>COLLEGE CODE</CollegeCode><DepartmentCode>SGMED</DepartmentCode><institution>Swansea University</institution><apcterm/><lastEdited>2019-07-16T10:43:53.4670467</lastEdited><Created>2015-12-28T12:05:23.2050366</Created><path><level id="1">Faculty of Medicine, Health and Life Sciences</level><level id="2">Swansea University Medical School - Medicine</level></path><authors><author><firstname>Nicholas D</firstname><surname>James</surname><order>1</order></author><author><firstname>Matthew R</firstname><surname>Sydes</surname><order>2</order></author><author><firstname>Noel W</firstname><surname>Clarke</surname><order>3</order></author><author><firstname>Malcolm D</firstname><surname>Mason</surname><order>4</order></author><author><firstname>David P</firstname><surname>Dearnaley</surname><order>5</order></author><author><firstname>Melissa R</firstname><surname>Spears</surname><order>6</order></author><author><firstname>Alastair W S</firstname><surname>Ritchie</surname><order>7</order></author><author><firstname>Christopher C</firstname><surname>Parker</surname><order>8</order></author><author><firstname>J Martin</firstname><surname>Russell</surname><order>9</order></author><author><firstname>Gerhardt</firstname><surname>Attard</surname><order>10</order></author><author><firstname>Johann</firstname><surname>de Bono</surname><order>11</order></author><author><firstname>William</firstname><surname>Cross</surname><order>12</order></author><author><firstname>Rob J</firstname><surname>Jones</surname><order>13</order></author><author><firstname>George</firstname><surname>Thalmann</surname><order>14</order></author><author><firstname>Claire</firstname><surname>Amos</surname><order>15</order></author><author><firstname>David</firstname><surname>Matheson</surname><order>16</order></author><author><firstname>Robin</firstname><surname>Millman</surname><order>17</order></author><author><firstname>Mymoona</firstname><surname>Alzouebi</surname><order>18</order></author><author><firstname>Sharon</firstname><surname>Beesley</surname><order>19</order></author><author><firstname>Alison J</firstname><surname>Birtle</surname><order>20</order></author><author><firstname>Susannah</firstname><surname>Brock</surname><order>21</order></author><author><firstname>Richard</firstname><surname>Cathomas</surname><order>22</order></author><author><firstname>Prabir</firstname><surname>Chakraborti</surname><order>23</order></author><author><firstname>Simon</firstname><surname>Chowdhury</surname><order>24</order></author><author><firstname>Audrey</firstname><surname>Cook</surname><order>25</order></author><author><firstname>Tony</firstname><surname>Elliott</surname><order>26</order></author><author><firstname>Joanna</firstname><surname>Gale</surname><order>27</order></author><author><firstname>Stephanie</firstname><surname>Gibbs</surname><order>28</order></author><author><firstname>John D</firstname><surname>Graham</surname><order>29</order></author><author><firstname>John</firstname><surname>Hetherington</surname><order>30</order></author><author><firstname>Robert</firstname><surname>Hughes</surname><order>31</order></author><author><firstname>Robert</firstname><surname>Laing</surname><order>32</order></author><author><firstname>Fiona</firstname><surname>McKinna</surname><order>33</order></author><author><firstname>Duncan B</firstname><surname>McLaren</surname><order>34</order></author><author><firstname>Joe M</firstname><surname>O'Sullivan</surname><order>35</order></author><author><firstname>Omi</firstname><surname>Parikh</surname><order>36</order></author><author><firstname>Clive</firstname><surname>Peedell</surname><order>37</order></author><author><firstname>Andrew</firstname><surname>Protheroe</surname><order>38</order></author><author><firstname>Angus J</firstname><surname>Robinson</surname><order>39</order></author><author><firstname>Narayanan</firstname><surname>Srihari</surname><order>40</order></author><author><firstname>Rajaguru</firstname><surname>Srinivasan</surname><order>41</order></author><author><firstname>John</firstname><surname>Staffurth</surname><order>42</order></author><author><firstname>Santhanam</firstname><surname>Sundar</surname><order>43</order></author><author><firstname>Shaun</firstname><surname>Tolan</surname><order>44</order></author><author><firstname>David</firstname><surname>Tsang</surname><order>45</order></author><author><firstname>John</firstname><surname>Wagstaff</surname><order>46</order></author><author><firstname>Mahesh K B</firstname><surname>Parmar</surname><order>47</order></author></authors><documents><document><filename>0025288-20072017125455.pdf</filename><originalFilename>STAMPEDELancetppr2015.pdf</originalFilename><uploaded>2017-07-20T12:54:55.8930000</uploaded><type>Output</type><contentLength>695827</contentLength><contentType>application/pdf</contentType><version>Version of Record</version><cronfaStatus>true</cronfaStatus><embargoDate>2017-07-20T00:00:00.0000000</embargoDate><documentNotes>Copyright © James et al. Open Access article distributed under the terms of CC BY</documentNotes><copyrightCorrect>true</copyrightCorrect><language>eng</language></document></documents><OutputDurs/></rfc1807>
spelling	2019-07-16T10:43:53.4670467 v2 25288 2015-12-28 Addition of docetaxel, zoledronic acid, or both to first-line long-term hormone therapy in prostate cancer (STAMPEDE): survival results from an adaptive, multiarm, multistage, platform randomised controlled trial fdab5e9e2fe06c93d3ffa19c816bdcf6 John Wagstaff John Wagstaff true false 2015-12-28 SGMED In this multi arm multi stage designed trial 2962 men with hormone sensitive prostate cancer were randomised to one of four arms. The control arm consisted of either surgical or chemical castration alone (standard of care (SOC)). In all other arms patients received either surgical or chemical castration plus docetaxel (Doc) alone, zoledronic acid (ZA) alone or Doc plus ZA. 1817 (61%) men had metastatic (M)+ disease, 448 (15%) had nodal (N)+/X M0, and 697 (24%) had N0M0. Median overall survival was 71 months for SOC alone, not reached for SOC+ZA (p=0.45), 81 months for SOC+Doc (p=0.006) & 76 months for SOC+Doc+ZA (0.022). Grade 3–5 adverse events were reported for 399 (32%) patients receiving SOC, 197 (32%) receiving SOC+ZA, 288 (52%) receiving SOC+Doc, and 269 (52%) receiving SOC + ZA + Doc. ZA showed no evidence of survival benefit and should not be part of SOC. Doc showed a significant improvement in overall survival and should become SOC for suitably fit men with prostate cancer starting long term hormone therapy. Journal Article The Lancet The Lancet London prostate cancer, docetaxel, zoledronic acid, hormone therapy 21 12 2015 2015-12-21 10.1016/S0140-6736(15)01037-5 COLLEGE NANME Medical School - School COLLEGE CODE SGMED Swansea University 2019-07-16T10:43:53.4670467 2015-12-28T12:05:23.2050366 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Medicine Nicholas D James 1 Matthew R Sydes 2 Noel W Clarke 3 Malcolm D Mason 4 David P Dearnaley 5 Melissa R Spears 6 Alastair W S Ritchie 7 Christopher C Parker 8 J Martin Russell 9 Gerhardt Attard 10 Johann de Bono 11 William Cross 12 Rob J Jones 13 George Thalmann 14 Claire Amos 15 David Matheson 16 Robin Millman 17 Mymoona Alzouebi 18 Sharon Beesley 19 Alison J Birtle 20 Susannah Brock 21 Richard Cathomas 22 Prabir Chakraborti 23 Simon Chowdhury 24 Audrey Cook 25 Tony Elliott 26 Joanna Gale 27 Stephanie Gibbs 28 John D Graham 29 John Hetherington 30 Robert Hughes 31 Robert Laing 32 Fiona McKinna 33 Duncan B McLaren 34 Joe M O'Sullivan 35 Omi Parikh 36 Clive Peedell 37 Andrew Protheroe 38 Angus J Robinson 39 Narayanan Srihari 40 Rajaguru Srinivasan 41 John Staffurth 42 Santhanam Sundar 43 Shaun Tolan 44 David Tsang 45 John Wagstaff 46 Mahesh K B Parmar 47 0025288-20072017125455.pdf STAMPEDELancetppr2015.pdf 2017-07-20T12:54:55.8930000 Output 695827 application/pdf Version of Record true 2017-07-20T00:00:00.0000000 Copyright © James et al. Open Access article distributed under the terms of CC BY true eng
title	Addition of docetaxel, zoledronic acid, or both to first-line long-term hormone therapy in prostate cancer (STAMPEDE): survival results from an adaptive, multiarm, multistage, platform randomised controlled trial
spellingShingle	Addition of docetaxel, zoledronic acid, or both to first-line long-term hormone therapy in prostate cancer (STAMPEDE): survival results from an adaptive, multiarm, multistage, platform randomised controlled trial John Wagstaff
title_short	Addition of docetaxel, zoledronic acid, or both to first-line long-term hormone therapy in prostate cancer (STAMPEDE): survival results from an adaptive, multiarm, multistage, platform randomised controlled trial
title_full	Addition of docetaxel, zoledronic acid, or both to first-line long-term hormone therapy in prostate cancer (STAMPEDE): survival results from an adaptive, multiarm, multistage, platform randomised controlled trial
title_fullStr	Addition of docetaxel, zoledronic acid, or both to first-line long-term hormone therapy in prostate cancer (STAMPEDE): survival results from an adaptive, multiarm, multistage, platform randomised controlled trial
title_full_unstemmed	Addition of docetaxel, zoledronic acid, or both to first-line long-term hormone therapy in prostate cancer (STAMPEDE): survival results from an adaptive, multiarm, multistage, platform randomised controlled trial
title_sort	Addition of docetaxel, zoledronic acid, or both to first-line long-term hormone therapy in prostate cancer (STAMPEDE): survival results from an adaptive, multiarm, multistage, platform randomised controlled trial
author_id_str_mv	fdab5e9e2fe06c93d3ffa19c816bdcf6
author_id_fullname_str_mv	fdab5e9e2fe06c93d3ffa19c816bdcf6_***_John Wagstaff
author	John Wagstaff
author2	Nicholas D James Matthew R Sydes Noel W Clarke Malcolm D Mason David P Dearnaley Melissa R Spears Alastair W S Ritchie Christopher C Parker J Martin Russell Gerhardt Attard Johann de Bono William Cross Rob J Jones George Thalmann Claire Amos David Matheson Robin Millman Mymoona Alzouebi Sharon Beesley Alison J Birtle Susannah Brock Richard Cathomas Prabir Chakraborti Simon Chowdhury Audrey Cook Tony Elliott Joanna Gale Stephanie Gibbs John D Graham John Hetherington Robert Hughes Robert Laing Fiona McKinna Duncan B McLaren Joe M O'Sullivan Omi Parikh Clive Peedell Andrew Protheroe Angus J Robinson Narayanan Srihari Rajaguru Srinivasan John Staffurth Santhanam Sundar Shaun Tolan David Tsang John Wagstaff Mahesh K B Parmar
format	Journal article
container_title	The Lancet
publishDate	2015
institution	Swansea University
doi_str_mv	10.1016/S0140-6736(15)01037-5
publisher	The Lancet
college_str	Faculty of Medicine, Health and Life Sciences
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hierarchy_top_id	facultyofmedicinehealthandlifesciences
hierarchy_top_title	Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id	facultyofmedicinehealthandlifesciences
hierarchy_parent_title	Faculty of Medicine, Health and Life Sciences
department_str	Swansea University Medical School - Medicine{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}Swansea University Medical School - Medicine
document_store_str	1
active_str	0
description	In this multi arm multi stage designed trial 2962 men with hormone sensitive prostate cancer were randomised to one of four arms. The control arm consisted of either surgical or chemical castration alone (standard of care (SOC)). In all other arms patients received either surgical or chemical castration plus docetaxel (Doc) alone, zoledronic acid (ZA) alone or Doc plus ZA. 1817 (61%) men had metastatic (M)+ disease, 448 (15%) had nodal (N)+/X M0, and 697 (24%) had N0M0. Median overall survival was 71 months for SOC alone, not reached for SOC+ZA (p=0.45), 81 months for SOC+Doc (p=0.006) & 76 months for SOC+Doc+ZA (0.022). Grade 3–5 adverse events were reported for 399 (32%) patients receiving SOC, 197 (32%) receiving SOC+ZA, 288 (52%) receiving SOC+Doc, and 269 (52%) receiving SOC + ZA + Doc. ZA showed no evidence of survival benefit and should not be part of SOC. Doc showed a significant improvement in overall survival and should become SOC for suitably fit men with prostate cancer starting long term hormone therapy.
published_date	2015-12-21T03:30:09Z
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Addition of docetaxel, zoledronic acid, or both to first-line long-term hormone therapy in prostate cancer (STAMPEDE): survival results from an adaptive, multiarm, multistage, platform randomised controlled trial

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