4 research outputs found
Conceptual models in health economic evaluation: a new role
- Publication venue
- Publication date
- 01/01/2021
- Field of study
Healthcare budgets are limited, and decisions must be made about which healthcare technologies should be funded from these limited budgets. Decision makers rely on clinical and cost-effectiveness evidence on which to base their decisions, the gold standard vehicle for this evidence is a clinical trial. Guidance exists for conducting economic evaluations alongside clinical trials using standard treatment arm-based comparisons to assess cost-effectiveness, however because of differences in the purposes of the clinical effectiveness and cost-effectiveness analyses this conventional treatment arm-based economic evaluation is often uncertain. Furthermore, economic evaluations focus on the final cost-effectiveness summary measure without consideration of what is driving this measure. There is scope for providing a more detailed understanding of the conventional cost-effectiveness results. Conceptual models are simplified versions of real-life systems in a visual format, illustrating how key components of the system are linked and interact within it. In the field of economic evaluation conceptual models are recommended for and used as a guide to establish the structure of decision analytic models, in other fields they are also used as a communication tool, to aid understanding of the system and to give direction to research. The aim of this thesis was to expand the role of conceptual models in economic evaluation. This thesis proposed a new role for conceptual models to provide additional understanding to decision makers, extending the conventional economic evaluation analysis beyond a treatment arm-based analysis. This role was demonstrated using two case studies as illustrative examples, aiming to show how the role could be applied. This thesis demonstrates the value of an additional conceptual model driven analysis to supplement the conventional treatment arm-based analysis, adding further insight into the trial mechanism and what is driving the economic evaluation results. The contribution of this thesis to the field of economic evaluation is twofold; a new role for conceptual models in economic evaluation and a methodological framework for developing conceptual models in this new role
Adding 6 months of androgen deprivation therapy to postoperative radiotherapy for prostate cancer: a comparison of short-course versus no androgen deprivation therapy in the RADICALS-HD randomised controlled trial
- Author
- Abab Julie
- Abbas Ali
- Abbassi Sara
- Abd Alazeez Mohamed
- Abdulwahid Danya
- Abdulwahid Danya
- Abed Jessy
- Adab Fawzi
- Adams Marion
- Adamson Vanessa
- Addison Anglise
- Adeyoju Adebanji
- Adinkra Victoria
- Adnaan Jamila
- Afzal Naveed
- Agdiran Didem
- Aggarwal Ajay
- Ahamadali Sheefa
- Ahmad Belal
- Ahmed Ilyas
- Ahmed Imtiaz
- Ahmed Shahida
- Aiku Abimbola
- Ainsworth Sarah
- Ainsworth Sarah
- Aitken Katherine
- Ajzensztejn Daniel
- Akhtar Naeem
- Al-Chamali Hiba
- Al-hasso Abdulla
- Al-hasso Abdulla
- Al-Samarraie Amir
- Albrecht Virginia
- Alcock Christopher
- Alder Leanne
- Alderton Kate
- Aldous Mary
- Ali Jennyfa
- Ali Maryam
- Ali Zulfiqer
- Ali Zulfiqer
- Allan Elaine
- Allan Elaine
- Allen Julie
- Allen Kirsten
- Allen Rachael
- Allen Susan
- Allison Joanna
- Allison Michele
- Alonzi Roberto
- AlRashdan Abdulla
- Alzouebi Mymoona
- Amanie John Oliver
- Ammeter Barb
- Amoaten Thomas
- Amos Claire
- Anderson Beverley
- Anderson Chris
- Anderson Jim
- Anderson John
- Anderson John
- Anderson Juliette
- Anderson Juliette
- Anderson Leanne
- Anderson Naomi
- Anderson Susan
- Anderson Susan
- Andrade Gerard
- Andrews (nee Moore) Eleanor
- Andrews Kelly
- Andrews Stephen
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- Rodda Sree
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- Tapping Sister Hayley
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- Tickle Vivienne
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- Tiessen Kyoko
- Tighe (nee Bussey) Rachel
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- Zafar Waheed
- Zaidi Sadaf
- Zarkar Anjali
- Zarkar Anjali
- Zarkar Anjali M.
- Zaza Khaled O
- Zelley Sarah
- Zeltser Fred
- Zhang Hanbo
- Zhang Tina Wanting
- Zietz Maria
- Zilkha Helene
- Zinck Connie
- Zinyemba Vivian
- Zurakovsky Hilary
- Zwarych Darlene
- Publication venue
- 'Elsevier BV'
- Publication date
- 01/06/2024
- Field of study
Background
Previous evidence indicates that adjuvant, short-course androgen deprivation therapy (ADT) improves metastasis-free survival when given with primary radiotherapy for intermediate-risk and high-risk localised prostate cancer. However, the value of ADT with postoperative radiotherapy after radical prostatectomy is unclear.
Methods
RADICALS-HD was an international randomised controlled trial to test the efficacy of ADT used in combination with postoperative radiotherapy for prostate cancer. Key eligibility criteria were indication for radiotherapy after radical prostatectomy for prostate cancer, prostate-specific antigen less than 5 ng/mL, absence of metastatic disease, and written consent. Participants were randomly assigned (1:1) to radiotherapy alone (no ADT) or radiotherapy with 6 months of ADT (short-course ADT), using monthly subcutaneous gonadotropin-releasing hormone analogue injections, daily oral bicalutamide monotherapy 150 mg, or monthly subcutaneous degarelix. Randomisation was done centrally through minimisation with a random element, stratified by Gleason score, positive margins, radiotherapy timing, planned radiotherapy schedule, and planned type of ADT, in a computerised system. The allocated treatment was not masked. The primary outcome measure was metastasis-free survival, defined as distant metastasis arising from prostate cancer or death from any cause. Standard survival analysis methods were used, accounting for randomisation stratification factors. The trial had 80% power with two-sided α of 5% to detect an absolute increase in 10-year metastasis-free survival from 80% to 86% (hazard ratio [HR] 0·67). Analyses followed the intention-to-treat principle. The trial is registered with the ISRCTN registry, ISRCTN40814031, and ClinicalTrials.gov, NCT00541047.
Findings
Between Nov 22, 2007, and June 29, 2015, 1480 patients (median age 66 years [IQR 61–69]) were randomly assigned to receive no ADT (n=737) or short-course ADT (n=743) in addition to postoperative radiotherapy at 121 centres in Canada, Denmark, Ireland, and the UK. With a median follow-up of 9·0 years (IQR 7·1–10·1), metastasis-free survival events were reported for 268 participants (142 in the no ADT group and 126 in the short-course ADT group; HR 0·886 [95% CI 0·688–1·140], p=0·35). 10-year metastasis-free survival was 79·2% (95% CI 75·4–82·5) in the no ADT group and 80·4% (76·6–83·6) in the short-course ADT group. Toxicity of grade 3 or higher was reported for 121 (17%) of 737 participants in the no ADT group and 100 (14%) of 743 in the short-course ADT group (p=0·15), with no treatment-related deaths.
Interpretation
Metastatic disease is uncommon following postoperative bed radiotherapy after radical prostatectomy. Adding 6 months of ADT to this radiotherapy did not improve metastasis-free survival compared with no ADT. These findings do not support the use of short-course ADT with postoperative radiotherapy in this patient population
Duration of androgen deprivation therapy with postoperative radiotherapy for prostate cancer: a comparison of long-course versus short-course androgen deprivation therapy in the RADICALS-HD randomised trial
- Author
- Abab Julie
- Abbas Ali
- Abbassi Sara
- Abd Alazeez Mohamed
- Abdulwahid Danya
- Abdulwahid Danya
- Abed Jessy
- Adab Fawzi
- Adams Marion
- Adamson Vanessa
- Addison Anglise
- Adeyoju Adebanji
- Adinkra Victoria
- Adnaan Jamila
- Afzal Naveed
- Agdiran Didem
- Aggarwal Ajay
- Ahamadali Sheefa
- Ahmad Belal
- Ahmed Ilyas
- Ahmed Imtiaz
- Ahmed Shahida
- Aiku Abimbola
- Ainsworth Sarah
- Ainsworth Sarah
- Aitken Katherine
- Ajzensztejn Daniel
- Akhtar Naeem
- Al-Chamali Hiba
- Al-hasso Abdulla
- Al-hasso Abdulla
- Al-Samarraie Amir
- Albrecht Virginia
- Alcock Christopher
- Alder Leanne
- Alderton Kate
- Aldous Mary
- Ali Jennyfa
- Ali Maryam
- Ali Zulfiqer
- Ali Zulfiqer
- Allan Elaine
- Allan Elaine
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- Allen Kirsten
- Allen Rachael
- Allen Susan
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- Allison Michele
- Alonzi Roberto
- AlRashdan Abdulla
- Alzouebi Mymoona
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- Amoaten Thomas
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- Harding Joshua
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- Harinarayanan Sathish
- Harinarayanan Sathish
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- Haydock Helen
- Haydock Helen
- Hayes Jill A
- Hayward Lesley
- Healey Gail
- Healey-Mariano Jennifer
- Healey-Mariano Jennifer
- Heasley Karen
- Heath Catherine
- Heath Catherine M
- Heckford Louise
- Hedges Andy
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- Hefferon Billy
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- Keng-Koh Pek
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- Ong Aldrich D
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- Rodda Sree
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- Singson Angelina
- Siu Bernard
- Sivananthan Gokulan
- Sivananthan Gokulan
- Sivoglo Virgil
- Sizer Bruce
- Skelton Amy
- Skene Anna
- Skewes Johanna
- Skwarski Michael
- Slack Jonathan
- Slessor Janet
- Slevin Kathryn
- Sloan Andrew
- Smale Daisy May
- Smallwood Sarah
- Smedley (nee McCabe) Janine
- Smedley (nee McCabe) Janine
- Smedley (nee McCabe) Janine
- Smith Beccy
- Smith Carlie
- Smith Carolyn
- Smith Dan
- Smith Gill
- Smith Jackie
- Smith Lucy
- Smith Lucy
- Smith Lucy
- Smith Margaret
- Smith Matthew
- Smith Nick
- Smith Rachel
- Smith Rowena
- Smith Sandra
- Smith Sarah-Ellen
- Smith Sister Catherine
- Smith Susan
- Smith Suzanne
- So Alan I
- Sohanpal Sundip
- Sohanpal Sundip
- Somasiri Ashane
- Sorice Vittoria
- Souhami Luis
- Southgate Elizabeth
- Spalton Catherine
- Sparrow Geoffrey
- Spearman Mary
- Speed Lesley
- Spence Rachael
- Spencer Craig
- Spencer Hazel
- Spencer Patti
- Spencer Sue
- Spickett Helen
- Spillane Maria
- Spittle Ben
- Spoor Willemijn
- Springall Christine
- Spruce Debbie
- Squires Mandy
- Sreenivasan Thiagarajan
- Sreenivasan Thiagarajan
- Srihari Narayanan
- Srinivasan Rajaguru
- Srinivasan Rajaguru
- Srinivasan Vaiku
- Stacey Wendy
- Stafferton Ruth
- Staffurth John
- Staines Nikki
- Stammers Tracey
- Stancliffe May
- Stanley Laura
- Stapleton Stephanie
- Starling Ellen
- Steele Anita
- Steffensen Kirsten
- Stephens Rebekah
- Stephenson Anna
- Stephenson Anna
- Stevens Christiaan
- Stevens Nicole
- Stevenson Garry
- Stevenson Lesley
- Stevenson Robert
- Steventon Emily
- Stewart David
- Stewart Simon
- Stewart Simon
- Stewart Simon
- Stilling Sine
- Stockdale Andrew
- Stockdale Andrew
- Stockley Emma
- Stockport Jane
- Stoddart Jonathan
- Stone Helena
- Stone Matthew
- Stone Sarah
- Storer Julie
- Storrs Sarah
- Stott Mark
- Stott Matthew
- Stower Michael
- Stranex Stephen
- Stretch Alison
- Strider Paula
- Stringer (pr. Davis) Sally
- Strong-Sheldrake Sophia
- Stuart Robert
- Subramaniam Ramachandran
- Sullivan Frank
- Sumner Lesley
- Sundar Santhanam
- Sundar Santhanam
- Sundaram Subramanian Kanaga
- Sunny Manju
- Sutherland Donna
- Swann Michelle
- Sydes Matthew
- Sydes Matthew R
- Sylvestre Alma
- Symon Lesley
- Syndikus Isabel
- Szolin-Jones Jacob
- Szumacher Ewa
- Szymiczek Kinga
- Tahir Saad
- Tait Ellen
- Tan Matthew
- Tappenden Nancy
- Tapping Sister Hayley
- Tapping Sister Hayley
- Tasker Lorraine
- Tate Janine
- Taussky Daniel
- Tay Jessica
- Taylor Becky
- Taylor Beverley
- Taylor Carol
- Taylor Helen
- Taylor Henry
- Taylor Jacob
- Taylor Jacob
- Taylor Jennifer
- Taylor Jill
- Taylor Jo-Anne
- Taylor Kate
- Taylor Katy
- Taylor Katy
- Taylor Lisa
- Taylor Sister Melanie
- Teahan Seamus
- Teasdale Breanne
- Tedd Gemma
- Tee Elizabeth
- Teh Chiaw Woon
- Teh Jonathan
- Telfer Sheena
- Templeton Maureen
- tenHaaf Darlene
- Tennant Virginia
- Teo Mark
- TetreaultLaflamme Audrey
- Thackray Louis
- Thallury Sheeba
- Tharahan Nanthini
- Thevarajah Vaishaali
- Thibeault Andreanne
- Thim Stine
- Thind Manreet
- Thoi Anne-Maree
- Thoi Anne-Maree
- Thoi Anne-Maree
- Thomas Carys
- Thomas Carys
- Thomas Dianne
- Thomas Heather
- Thomas Helen
- Thomas Isobel
- Thomas Jacqueline
- Thomas Rachel
- Thomas Robert
- Thomas Sister Viv
- Thomasson Georgia
- Thominson Bronwen
- Thompson Catherine
- Thompson Catherine
- Thompson Chloe-Anne
- Thompson Emma
- Thompson Jane
- Thoms John
- Thomson Alastair H
- Thomson Sister Jane
- Thornton Lorraine
- Thorogood Lucy
- Tickle Vivienne
- Tickle Vivienne
- Tiessen Kyoko
- Tighe (nee Bussey) Rachel
- Tighe Helen
- Tighe Mary
- Tikoo Archana
- Timmings Katie
- Tindall Annie
- Tippins Anna
- Tipples Karen
- Todd Anne
- Todd Joanna
- Tolan Shaun
- Toledo Jesusa
- Tomlinson Annabel
- Tomlinson Eve
- Toms Julie
- Topalovich Aleksandra
- Topps Alice
- Torin Lehmann Anna
- Torres Cynthia
- Totten Grace
- Toussi H
- Townley Barbara
- Townley Luke
- Townsend-Thorn Debra
- Towse Jo
- Toy Elizabeth
- Trakalo Kathy
- Tran Anna
- Tran Anna
- Tranter Fiona
- Tranter Helen
- Tranter Helen
- Treasure Ann
- Tree Alison
- Tree Alison
- Treeby Jo
- Treherne Katy
- Tremlett Jean
- Trewsmith Neil
- Tribe Lisa
- Trigg-Hogarth Kate
- Trigonis Ioannis
- Trudel Diane
- Tsakirdis Thedoros
- Tsalic Medy
- Tsang David
- Tsang Lilian
- Tsawayo Tan
- Tse Karen
- Tseng Eric Chia Lin
- Tsuji Debbie
- Tuazon Juel
- Tuck Jonathan
- Tufail Aisha
- Turley Claudia
- Turley Claudia
- Turner Christy
- Turner Nikki
- Turner Sarah
- Turriff Lisa
- Tweedle James
- Tyldesley Scott
- Tyler Jayne
- Tyner Sharah
- Uherek Maja
- Upson Susan
- Urquhart Zoe
- Uscinska Barbara
- Usmani Nawaid
- Vallieres Isabelle
- Vamplew Luke
- Van As Nicholas
- Van der Voet Hans
- Van Someren Chloe
- Van-Koutrik Lynne
- Vandal Mohammad Tanvir
- Vandborg Maria
- Vandecandalaere Elaine
- Varley Gail
- Varro Robert
- Varughese Mohini
- Varughese Mohini
- Vasanthan Subramanian
- Vaughn Jamie
- Vavassis Peter
- Velec Erin
- Vengalil Salil
- Venkatesan Varagur M
- Venkitaraman Ramachandran
- Venkitaraman Ramachandran
- Vermette Tracy
- Vesprini Danny
- Vickery Kathryn
- Vigneault Eric
- Vijayakumar Vijitha
- Vilarino-Varela Maria
- Vincent Francois
- Vincent LindaSuzanne
- Vinod Cellins
- Virgo Azarel
- Vowell Emma
- Vu Thi
- Wade Lynne
- Wade Rob
- Wadsworth Oliver
- Wakefield Shauna
- Wakelen Paula
- Waldron Eleanor
- Walker Beth
- Walker Caroline
- Walker Georgina
- Walker Georgina
- Walker Heather
- Walker Jayashree
- Walker Julia
- Walker Karen
- Walker Lori
- Walker Suzanne
- Wall Elaine
- Wallace Jan
- Wallace Kris
- Wallbutton Rebecca
- Walmsley Catherine
- Walsh Donna
- Walton Jenny
- Walton Sharon
- Ward Angela
- Ward Colin
- Warde Padraig
- Waring Lynsey
- Waring Lynsey
- Wassall Rebecca
- Watkinson Catrin
- Watson Melanie R
- Watson Michaella
- Watson-Jones Phillip
- Watts Angela
- Watts Erica
- Weaver Andrew
- Weaver Emma
- Webb Andrew
- Webb Claire
- Webb Kerrie
- Webb Paula
- Websdale Cheryl
- Webster Christine
- Wei Joyce
- Weir JoAnn
- Wellman Sandie
- Wells Paula
- Wells Paula
- Wells Paula
- Wells Tom
- Welsh Liam
- Welsh Linda
- Westley Rosalyne
- Weston Alison
- Weston Philip
- Westrop Anna
- Westrop Anna
- Westrop Anna
- Wheatley Duncan
- Wheeler Lucie
- Wheelwright Roger
- Whelan Kate
- Whillis David
- Whinn Samantha
- Whitcher Alison
- White Ann
- White Holly
- White Joanna
- Whitehouse James
- Whitehouse James
- Whiteway Chrystal
- Whittle Stacy
- Whotton Nikita
- Wiggins Sarah
- Wightman John
- Wignall Suzy
- Wild Karen
- Wilke Derek
- Wilkie Karen
- Wilkins Marie
- Wilkinson Nicola
- Williams (Née Allen) Sister Tania
- Williams Amanda
- Williams Bethan
- Williams Candra
- Williams Jo
- Williams Joanne
- Williams Rachel
- Williams Rachel
- Williams-Yesson Barbara
- Williamson Elizabeth
- Williamson Nicola
- Willing Stephanie
- Wilson David
- Wilson Jim
- Wilson Jo
- Wilson Mark
- Wilson Paula
- Wilson Paula
- Wilson Russ
- Winn Carol
- Winter Sister Helen
- Wise Marcus
- Wise Marcus
- Wise Marcus
- Wiss Elliott
- Wollaston Julie
- Woloshyn Rose
- Wong Jason W T
- Wood Allison
- Wood Catherine
- Wood Cathryn
- Wood Marian
- Wood Pauline
- Wood Pauline
- Wood Sister Kim
- Wood Sister Kim
- Wood Sister Kim
- Woodhouse Iain
- Woods Catherine
- Woods Jane
- Woods Martin
- Woodward Cathryn
- Woodward Elizabeth
- Woolf David
- Woolf David
- Workman Bridget
- Worlding Jane
- Worlding Jane
- Worsley Lucy
- Worthington Hannah
- Wright Ann
- Wright Natalie
- Wright Seonaid
- Wrigley Martha
- Wronski Sue
- Wu Helen
- Wu Min
- Wyatt Clare
- Wylie James
- Wylie James
- Wylie James
- Wynn Hazel
- Wynn Hazel
- Yanchuk Janet
- Yarrow Sue
- Yassa Michael
- yates Victoria
- Yee Don
- Yeo Tanya
- Yoon Frederick
- Youd Sister Jill
- Young Anita
- Young Bobbie
- Young Douglas
- Young Sally
- Youngs Nora
- Yu Jason
- Yunace Lorrie
- Yusof Hilawati
- Zafar Waheed
- Zaidi Sadaf
- Zarkar Anjali
- Zarkar Anjali
- Zaza Khaled O
- Zelley Sarah
- Zeltser Fred
- Zhang Hanbo
- Zhang Tina Wanting
- Zietz Maria
- Zilkha Helene
- Zinck Connie
- Zinyemba Vivian
- Zurakovsky Hilary
- Zwarych Darlene
- Publication venue
- Elsevier
- Publication date
- 07/06/2024
- Field of study
Background
Previous evidence supports androgen deprivation therapy (ADT) with primary radiotherapy as initial treatment for intermediate-risk and high-risk localised prostate cancer. However, the use and optimal duration of ADT with postoperative radiotherapy after radical prostatectomy remains uncertain.
Methods
RADICALS-HD was a randomised controlled trial of ADT duration within the RADICALS protocol. Here, we report on the comparison of short-course versus long-course ADT. Key eligibility criteria were indication for radiotherapy after previous radical prostatectomy for prostate cancer, prostate-specific antigen less than 5 ng/mL, absence of metastatic disease, and written consent. Participants were randomly assigned (1:1) to add 6 months of ADT (short-course ADT) or 24 months of ADT (long-course ADT) to radiotherapy, using subcutaneous gonadotrophin-releasing hormone analogue (monthly in the short-course ADT group and 3-monthly in the long-course ADT group), daily oral bicalutamide monotherapy 150 mg, or monthly subcutaneous degarelix. Randomisation was done centrally through minimisation with a random element, stratified by Gleason score, positive margins, radiotherapy timing, planned radiotherapy schedule, and planned type of ADT, in a computerised system. The allocated treatment was not masked. The primary outcome measure was metastasis-free survival, defined as metastasis arising from prostate cancer or death from any cause. The comparison had more than 80% power with two-sided α of 5% to detect an absolute increase in 10-year metastasis-free survival from 75% to 81% (hazard ratio [HR] 0·72). Standard time-to-event analyses were used. Analyses followed intention-to-treat principle. The trial is registered with the ISRCTN registry, ISRCTN40814031, and
ClinicalTrials.gov
,
NCT00541047
.
Findings
Between Jan 30, 2008, and July 7, 2015, 1523 patients (median age 65 years, IQR 60–69) were randomly assigned to receive short-course ADT (n=761) or long-course ADT (n=762) in addition to postoperative radiotherapy at 138 centres in Canada, Denmark, Ireland, and the UK. With a median follow-up of 8·9 years (7·0–10·0), 313 metastasis-free survival events were reported overall (174 in the short-course ADT group and 139 in the long-course ADT group; HR 0·773 [95% CI 0·612–0·975]; p=0·029). 10-year metastasis-free survival was 71·9% (95% CI 67·6–75·7) in the short-course ADT group and 78·1% (74·2–81·5) in the long-course ADT group. Toxicity of grade 3 or higher was reported for 105 (14%) of 753 participants in the short-course ADT group and 142 (19%) of 757 participants in the long-course ADT group (p=0·025), with no treatment-related deaths.
Interpretation
Compared with adding 6 months of ADT, adding 24 months of ADT improved metastasis-free survival in people receiving postoperative radiotherapy. For individuals who can accept the additional duration of adverse effects, long-course ADT should be offered with postoperative radiotherapy.
Funding
Cancer Research UK, UK Research and Innovation (formerly Medical Research Council), and Canadian Cancer Society
How the Armenian Genocide Forced a Loyal Ottoman Officer to Espouse the Arab Revolt
- Author
- Ahmad Feroz
- Akçam Taner
- Akçam Taner
- Aldington Richard
- Altınay Ayşe Gul
- Anderson Scott
- Antonius George
- Balakian Grigoris
- Bird Kai
- Brown Malcolm
- Crawford Fred D.
- Erdem Hakan
- Erickson Edward
- Foley Robert T.
- Garo Armen
- Graves Robert
- Göçek Fatma Müge
- Hathaway Jane
- James Lawrence
- Kansu Aykut
- Kennedy Judd
- Kinross Lord
- Mack John E.
- Makdisi Ussama
- Margaryan Narine
- McMeekin Sean
- Migliorino Nicola
- Neillands Robin
- Nutting Anthony
- Pierce James Wilson
- Provence Michael
- Tamari Salim
- Thomas Lowell
- Torossian Sarkis
- Torossian Sarkis
- Çetin Fethiye
- Publication venue
- 'SAGE Publications'
- Publication date
- Field of study