Landmark studies: Difference between revisions

From UrologySchool.com
Jump to navigation Jump to search
← Older editNewer edit →
VisualWikitext
(12 intermediate revisions by 2 users not shown)
Line 16: Line 16:
* CAP 2018
* CAP 2018


==== Diagnosis and Evalutation ====
==== Diagnosis and Evaluation ====


* MRI PROMIS 2017
* MRI PROMIS 2017
Line 24: Line 24:
* STHLM3 NEJM 2021 (MRI-targetted vs. standard biopsy in prostate cancer screening)  
* STHLM3 NEJM 2021 (MRI-targetted vs. standard biopsy in prostate cancer screening)  
* PET proPSMA 2020  
* PET proPSMA 2020  
* [[Prostate Cancer: Diagnosis and evaluation#Targeted biopsy only vs. targeted and systematic|Goteborg-2 NEJM 2022 & 2024]] (Systematic +/- targeted vs. targeted only prostate biopsy diagnosis and screening)


==== PSA and Other Markers ====
==== PSA and Other Markers ====
Line 49: Line 50:
* REDEEM Lancet 2012 (dutasteride in AS progression)
* REDEEM Lancet 2012 (dutasteride in AS progression)


===== Radical prostatectomy =====
==== Radical prostatectomy ====


* Antibiotic prophylaxis at the time of catheter removal after radical prostatectomy
* Antibiotic prophylaxis at the time of catheter removal after radical prostatectomy


===== Radiation and ADT =====
==== Radiation and ADT ====


* EORTC 22863 NEJM 1997 (EBRT +/- 3 years ADT)
* EORTC 22863 NEJM 1997 (EBRT +/- 3 years ADT)
Line 62: Line 63:
* SPCG-7/SFUO-3  
* SPCG-7/SFUO-3  


===== Management of Locally Advanced Disease =====
==== Post-prostatectomy radiation ====


====== Post-prostatectomy radiation ======
* Adjuvant vs. Observation
**[https://test.urologyschool.com/index.php/Prostate_Cancer:_Management_of_Locally_Advanced_Prostate_Cancer#Southwest_Oncology_Group_(SWOG)_8794 SWOG 8794]
**[https://test.urologyschool.com/index.php/Prostate_Cancer:_Management_of_Locally_Advanced_Prostate_Cancer#European_Organization_for_Research_and_Treatment_of_Cancer_(EORTC)_22911 EORTC 22911]
**[https://test.urologyschool.com/index.php/Prostate_Cancer:_Management_of_Locally_Advanced_Prostate_Cancer#ARO_96-02 ARO 96-02]
*ARTISTIC Lancet 2020 (meta-analysis of adjuvant vs. salvage)
*RADICALS Lancet 2020 (adjuvant vs. salvage)


* ARTISTIC Lancet 2020 (meta-analysis of adjuvant vs. salvage) RADICALS Lancet 2020 (adjuvant vs. salvage)
==== Metastatic Hormone-Sensitive Prostate Cancer ====
 
===== Metastatic Hormone-Sensitive Prostate Cancer =====


* CHAARTED NEJM 2015 (docetaxel)
* CHAARTED NEJM 2015 (docetaxel)
Line 78: Line 82:
* ARCHES JCO 2019 (enzalutamide)
* ARCHES JCO 2019 (enzalutamide)
* TITAN NEJM 2019 (enzalutamide)
* TITAN NEJM 2019 (enzalutamide)
*[https://test.urologyschool.com/index.php/Hormonal_Therapy#LHRH_antagonists HERO NEJM 2020 (LHRH antagonist)]


===== Castrate-Resistant Prostate Cancer =====
==== Castrate-Resistant Prostate Cancer ====


====== Non-metastatic ======
===== Non-metastatic =====


* ARAMIS NEJM 2018 (darolutamide)
* ARAMIS NEJM 2018 (darolutamide)
Line 87: Line 92:
* PROSPER NEJM 2018 (enzalutamide)
* PROSPER NEJM 2018 (enzalutamide)


====== Metastatic ======
===== Metastatic =====
Pre-docetaxel  
Pre-docetaxel  


Line 134: Line 139:


==== NMIBC ====
==== NMIBC ====
Blue-light vs. white-light flexible cystoscopy in NMIBC surveillance 2018
 
* [https://test.urologyschool.com/index.php/Bladder_Cancer:_Diagnosis_and_Evaluation#Enhanced_cystoscopy Blue-light vs. white-light flexible cystoscopy in NMIBC surveillance 2018]


===== Intravesical Therapy =====
===== Intravesical Therapy =====
Line 158: Line 164:
===== Neoadjuvant Chemotherapy =====
===== Neoadjuvant Chemotherapy =====


* SWOG 8710 NEJM 2003 (neoadjuvant MVAC)
* [https://test.urologyschool.com/index.php/Muscle-Invasive_Bladder_Cancer#Evidence SWOG 8710 NEJM 2003 (neoadjuvant MVAC)]
* BA06 30894 JCO 2011 (neoadjuvant CMV)
* [https://test.urologyschool.com/index.php/Muscle-Invasive_Bladder_Cancer#Evidence BA06 30894 JCO 2011 (neoadjuvant CMV)]


===== Immunotherapy =====
===== Immunotherapy =====


* CheckMate 274 NEJM 2021 (adjuvant nivolumab)  
* [https://test.urologyschool.com/index.php/Muscle-Invasive_Bladder_Cancer#CheckMate_274_(adjuvant_nivolumab) CheckMate 274 NEJM 2021 (adjuvant nivolumab)]


===== Cystectomy =====
===== Cystectomy =====


* RAZOR Lancet 2018 (robotic vs. open radical cystectomy)
* [https://test.urologyschool.com/index.php/Cystectomy#RAZOR_(Lancet_2018) RAZOR Lancet 2018 (robotic vs. open radical cystectomy)]
* LEA AUO AB 25/02 (limited vs. extended LND)  
* [https://test.urologyschool.com/index.php/Cystectomy#Extended_lymph_node_dissection LEA AUO AB 25/02 (limited vs. extended LND)]


==== Systemic treatment for locally advanced, unresectable, or metastatic disease ====
==== Systemic treatment for locally advanced, unresectable, or metastatic disease ====
Line 182: Line 188:
=== Andrology ===
=== Andrology ===


* TEAAM (Testosterone's Effects on Atherosclerosis Progression in Aging Men) JAMA 2015
* Testosterone Deficiency
**[https://test.urologyschool.com/index.php/Male_Reproductive_Physiology#TEAAM_(Testosterone's_Effects_on_Atherosclerosis_Progression_in_Aging_Men)_(JAMA_2015) TEAAM (Testosterone's Effects on Atherosclerosis Progression in Aging Men) JAMA 2015]
*Peyronie's Disease
**[https://test.urologyschool.com/index.php/Peyronie%27s_Disease#Intralesional_injection IMPRESS I & 2 (Clostridial collagenase (Xiaflex) trials)]


=== Functional ===
=== Functional ===


* TOMUS (retropubic vs. transobturator MUS)
* MTOPS (combination alpha-blocker + 5ARI)
* MTOPS (combination alpha-blocker + 5ARI)
* CombAT (combination alpha-blocker + 5ARI)
* CombAT (combination alpha-blocker + 5ARI)
Line 197: Line 205:


* Mechanical Bowel Preparation for Elective Colorectal Surgery Cochrane Review 2011
* Mechanical Bowel Preparation for Elective Colorectal Surgery Cochrane Review 2011
=== Urogynecology and Reconstructive Pelvic Surgery ===
* Fecal Incontinence
**CAPABLE (biofeedback vs loperamide for FI)
*Mixed Urinary Incontinence
**ESTEEM (PT + Sling vs Sling alone)
*Pelvic Organ Prolapse
**OPTIMAL/eOPTIMAL (SSLF vs USLS for apical prolapse; PMFT vs no intervention for associated urinary symptoms)
**PESSRI (ring vs gelhorn pessary)
**SUPeR/eSUPeR (vaginal mesh hysteropexy vs TVH/USLS for POP)
*Prolapse Associated Incontinence
**CARE/eCARE (Burch + colpopexy vs colpopexy alone in women with preop SUI)
**OPUS (Vaginal POP surgery + TVT vs vaginal POP surgery alone)
*Non-neurogenic Overactive Bladder
**ABC (Anticholinergics vs Onabotulinum toxin A)
**ORBIT (PTNS vs Tolterodine ER)
**ROSETTA (Onabotulinum Toxin A 200u vs Interstim)
**SUMiT/STEP (PTNS vs Sham; PTNS longitudinal single arm)
*Stress Urinary Incontinence
**ATLAS (Continence pessary vs behavioral therapy vs Combined therapy)
**SISTeR (Burch vs fascial sling)
**TOMUS (retropubic vs. transobturator MUS)
**VALUE (office eval vs preop UDS for preop eval of uncomplicated SUI and MUS outcomes)
*Other
**Surgical Outcomes in Urogynecology-Assessment of Perioperative and Postoperative Complications Relative to Preoperative Hemoglobin A1c

Revision as of 13:00, 2 October 2024

Oncology

Prostate Cancer

Prevention

  • PCPT 2003 (Finasteride)
  • SELECT 2009 (Selenium and Vitamin E)
  • REDUCE 2010 (Dutasteride)

Screening

  • PLCO 2008
  • ERSPC 2009
  • Goteburg 2010
  • CAP 2018

Diagnosis and Evaluation

  • MRI PROMIS 2017
  • PRECISION 2018
  • MRI-FIRST 2019
  • ASIST 2019 (MRI in AS)
  • STHLM3 NEJM 2021 (MRI-targetted vs. standard biopsy in prostate cancer screening)
  • PET proPSMA 2020
  • Goteborg-2 NEJM 2022 & 2024 (Systematic +/- targeted vs. targeted only prostate biopsy diagnosis and screening)

PSA and Other Markers

  • Stamey et al. NEJM 1987
  • Catalona et al. NEJM 1991
  • Catalona et al. J Urol 1994 (PSA vs. DRE detection in screening)
  • Catalona et al. 1998 (%fPSA)

Prostate Biopsy

  • Antibiotic Prophylaxis in TRUS Biopsy of the Prostate Cochrane Review 2011
  • Rates of hospital admission and mortality after TRUS-biopsy J Urol 2013

Management of Localized Disease

Observation vs. Treatment of Prostate Cancer
  • PIVOT NEJM 2012
  • SPCG-4 NEJM 2014
  • PROTECT NEJM 2016

Active surveillance

  • REDEEM Lancet 2012 (dutasteride in AS progression)

Radical prostatectomy

  • Antibiotic prophylaxis at the time of catheter removal after radical prostatectomy

Radiation and ADT

  • EORTC 22863 NEJM 1997 (EBRT +/- 3 years ADT)
  • RTOG 86-10 (EBRT +/- 4 months ADT)
  • RTOG 92-02
  • EORTC 22961
  • PR3/PR07
  • SPCG-7/SFUO-3

Post-prostatectomy radiation

  • Adjuvant vs. Observation
  • ARTISTIC Lancet 2020 (meta-analysis of adjuvant vs. salvage)
  • RADICALS Lancet 2020 (adjuvant vs. salvage)

Metastatic Hormone-Sensitive Prostate Cancer

  • CHAARTED NEJM 2015 (docetaxel)
  • STAMPEDE Lancet 2016 (docetaxel)
  • STAMPEDE NEJM 2017 (abiraterone)
  • LATITUDE NEJM 2017 (abiraterone)
  • STAMPEDE Lancet 2018 (radiation)
  • ENZAMET NEJM 2019 (enzalutamide)
  • ARCHES JCO 2019 (enzalutamide)
  • TITAN NEJM 2019 (enzalutamide)
  • HERO NEJM 2020 (LHRH antagonist)

Castrate-Resistant Prostate Cancer

Non-metastatic
  • ARAMIS NEJM 2018 (darolutamide)
  • SPARTAN NEJM 2018 (apalutamide)
  • PROSPER NEJM 2018 (enzalutamide)
Metastatic

Pre-docetaxel

  • AFFIRM NEJM 2012 (enzalutamide)
  • PREVAIL NEJM 2014 (enzalutamide)
  • COU-AA-302
  • TAX-327
  • IMPACT

Post-docetaxel

  • COU-AA-301
  • VISION (177Lu-PSMA-617)
  • PROfound NEJM 2020 (Olaparib)
  • Denosumab vs. zoledronate
  • TheraP (177Lu-PSMA-617 vs. cabazitaxel)
  • ALSYMPCA (Radium-223)

Incidence of germline mutations in genes mediating DNA-repair processes in prostate cancer NEJM 2016

Kidney Cancer

  • EORTC 30904 Partial vs. Radical Nephrectomy
  • EORTC 30811 Eur Urol 2009 LND for cN0 suspected RCC

Cytoreductive nephrectomy

  • SWOG 8949 IFN-α vs. CN + IFN-α vs.
  • EORTC 30947 IFN-α vs. CN + IFN-α
  • SURTIME JAMA Onc 2019 CN + sunitnib vs. sunitnib + CN
  • CARMENA NEJM 2018 sunitnib vs. CN + sunitnib

Systemic treatment for metastatic disease

  • CheckMate 214 NEJM 2018 (nivolumab + ipilimumab vs. sunitnib for untreated, advanced clear-cell RCC)
  • CheckMate 9ER NEJM 2020 (nivolumab + cabozantinib vs. sunitnib for untreated, advanced clear-cell RCC)
  • CLEAR NEJM 2021 (lenvatinib + pembrolizumab vs. lenvatinib + everolimus vs. sunitinib)
Adjuvant therapy after nephrectomy
  • ASSURE Lancet 2016 (sunitnib vs. sorafenib)
  • S-TRAC (sunitnib)
  • KEYNOTE-564 (pembrolizumab)

Bladder Cancer

NMIBC

Intravesical Therapy
Chemotherapy
  • Meta-analysis of trials evaluating chemotherapy on risk of NMIBC recurrence 2013
BCG
  • SWOG 8216/38 NEJM 1991 (BCG vs. doxorubicin BCG maintenance)
  • SWOG 8507 J Urol 2000 (induction vs. induction + maintenance BCG)
  • BCG and NMIBC Recurrence Cochrane Review 2000
  • BCG and NMIBC Progression Meta-analaysis 2002
  • BCG vs. MMC in NMIBC Cochrane Review 2003
BCG unresponsive NMIBC
  • KEYNOTE-057 (pembrolizumab for BCG-unresponsive CIS)

MIBC

Neoadjuvant Chemotherapy
Immunotherapy
Cystectomy

Systemic treatment for locally advanced, unresectable, or metastatic disease

  • KEYNOTE-361 Lancet Onc 2021 (pembrolizumab + chemotherapy vs. chemotherapy alone vs. pembrolizumab alone)

Upper tract urothelial carcinoma

  • Olympus Lancet Onc 2020 (UGN-101 for papillary UTUC)

Non-Oncology

Andrology

Functional

  • MTOPS (combination alpha-blocker + 5ARI)
  • CombAT (combination alpha-blocker + 5ARI)

Pediatrics

  • RIVUR NEJM 2014 (antibiotic prophylaxis in VUR)

Other

  • Mechanical Bowel Preparation for Elective Colorectal Surgery Cochrane Review 2011

Urogynecology and Reconstructive Pelvic Surgery

  • Fecal Incontinence
    • CAPABLE (biofeedback vs loperamide for FI)
  • Mixed Urinary Incontinence
    • ESTEEM (PT + Sling vs Sling alone)
  • Pelvic Organ Prolapse
    • OPTIMAL/eOPTIMAL (SSLF vs USLS for apical prolapse; PMFT vs no intervention for associated urinary symptoms)
    • PESSRI (ring vs gelhorn pessary)
    • SUPeR/eSUPeR (vaginal mesh hysteropexy vs TVH/USLS for POP)
  • Prolapse Associated Incontinence
    • CARE/eCARE (Burch + colpopexy vs colpopexy alone in women with preop SUI)
    • OPUS (Vaginal POP surgery + TVT vs vaginal POP surgery alone)
  • Non-neurogenic Overactive Bladder
    • ABC (Anticholinergics vs Onabotulinum toxin A)
    • ORBIT (PTNS vs Tolterodine ER)
    • ROSETTA (Onabotulinum Toxin A 200u vs Interstim)
    • SUMiT/STEP (PTNS vs Sham; PTNS longitudinal single arm)
  • Stress Urinary Incontinence
    • ATLAS (Continence pessary vs behavioral therapy vs Combined therapy)
    • SISTeR (Burch vs fascial sling)
    • TOMUS (retropubic vs. transobturator MUS)
    • VALUE (office eval vs preop UDS for preop eval of uncomplicated SUI and MUS outcomes)
  • Other
    • Surgical Outcomes in Urogynecology-Assessment of Perioperative and Postoperative Complications Relative to Preoperative Hemoglobin A1c
Retrieved from "https://urologyschool.com/wikiuro/index.php?title=Landmark_studies&oldid=6959"