Robot-assisted radical cystectomy versus open radical cystectomy in patients with bladder cancer(RAZOR):an open-label,randomised,phase 3,non-inferiority trial.
49712431
Robot assisted radical cystectomy versus open radical cystectomy in patients with bladder cancer (RAZOR) an open label, randomised, phase 3, non inferiority trial
BACKGROUND Radical cystectomy is the surgical standard for invasive bladder cancer. Robot assisted cystectomy has been proposed to provide similar oncological outcomes with lower morbidity. We aimed to compare progression free survival in patients with bladder cancer treated with open cystectomy and robot assisted cystectomy. METHODS The RAZOR study is a randomised, open label, non inferiority, phase 3 trial done in 15 medical centres in the USA. Eligible participants (aged =18 years) had biopsy proven clinical stage T1 T4, N0 N1, M0 bladder cancer or refractory carcinoma in situ. Individuals who had previously had open abdominal or pelvic surgery, or who had any pre existing health conditions that would preclude safe initiation or maintenance of pneumoperitoneum were excluded. Patients were centrally assigned (1:1) via a web based system, with block randomisation by institution, stratified by type of urinary diversion, clinical T stage, and Eastern Cooperative Oncology Group performance status, to receive robot assisted radical cystectomy or open radical cystectomy with extracorporeal urinary diversion. Treatment allocation was only masked from pathologists. The primary endpoint was 2 year progression free survival, with non inferiority established if the lower bound of the one sided 97*5% CI for the treatment difference (robotic cystectomy minus open cystectomy) was greater than 15 percentage points. The primary analysis was done in the per protocol population. Safety was assessed in the same population. This trial is registered with ClinicalTrials.gov, number NCT01157676. FINDINGS Between July 1, 2011, and Nov 18, 2014, 350 participants were randomly assigned to treatment. The intended treatment was robotic cystectomy in 176 patients and open cystectomy in 174 patients. 17 (10% of 176 patients in the robotic cystectomy group did not have surgery and nine (5% patients had a different surgery to that they were assigned. 21 (12% of 174 patients in the open cystectomy group did not have surgery and one (1% patient had robotic cystectomy instead of open cystectomy. Thus, 302 patients (150 in the robotic cystectomy group and 152 in the open cystectomy group) were included in the per protocol analysis set. 2 year progression free survival was 72*3% (95% CI 64*3 to 78*8) in the robotic cystectomy group and 71*6% (95% CI 63*6 to 78*2) in the open cystectomy group (difference 0*7% 95% CI 9*6% to 10*9% pnon inferiority=0*001) indicating non inferiority of robotic cystectomy. Adverse events occurred in 101 (67% of 150 patients in the robotic cystectomy group and 105 (69% of 152 patients in the open cystectomy group. The most common adverse events were urinary tract infection (53 [35% in the robotic cystectomy group vs 39 [26% in the open cystectomy group) and postoperative ileus (33 [22% in the robotic cystectomy group vs 31 [20% in the open cystectomy group) INTERPRETATION In patients with bladder cancer, robotic cystectomy was non inferior to open cystectomy for 2 year progression free survival. Increased adoption of robotic surgery in clinical practice should lead to future randomised trials to assess the true value of this surgical approach in patients with other cancer types. FUNDING National Institutes of Health National Cancer Institute.
The Lancet
Dipen J Parekh Isildinha Marques dos Reis Erik P Castle Mark L Gonzalgo Michael E Woods Robert S Svatek Alon Z Weizer Badrinath Konety Mathew Tollefson Tracey L Krupski Norm D Smith Ahmad Shabsigh Daniel A Barocas Marcus L Quek Atreya Dash Adam S Kibel Lynn R Shemanski Raj S Pruthi Jeffrey Scott Montgomery Christopher J Weight David S Sharp Sam S Chang Michael Cookson Gopal N Gupta Alex Gorbonos Edward Uchio Eila Curlee Skinner Vivek Venkatramani Nachiketh Soodana-Prakash Kerri Kendrick Joseph A Smith Ian M Thompson
52074995
Re: Robot assisted Radical Cystectomy Versus Open Radical Cystectomy in Patients with Bladder Cancer (RAZOR) An Open label, Randomised, Phase 3, Non inferiority Trial.
Experts' summary: The RAZOR trial is the first randomised (1:1) phase 3 study assessing cancer control for both surgical approaches. The primary objective of this noninferiority trial was to compare 2 yr progression free survival (PFS) among patients with radical treatment for bladder cancer. Between 2011 and 2014, 159 and 153 patients were included in the intentionto treat analysis and underwent robot assisted (RARC) and open radical cystectomy (ORC) respectively. All urinary diversions were extracorporeal. Patients were randomly allocated by institutions (n 15) and stratified by urinary diversion type, cT stage and Eastern Cooperative Oncology Group performance status. Surgeons who participated in the study were required to have performed at least ten RARC or ORC procedures in the year before the study. A noninferiority margin of 15% points was considered on the basis of previous trials in colon and rectal cancers comparing open to minimally invasive surgery. Baseline characteristics were similar between the groups, and 2 yr PFS was 72.3% in the RARC versus 71.6% in the ORC arm, showing noninferiority of RARC to ORC (0.7% difference, 95% confidence interval 9.6% to 10.9% p 0.90) PFS was worse for positive surgical margins (PSMs) or higher pT stage, with no significant differences between treatment groups.
European urology
Gianluca Giannarini Alessandro Crestani Vincenzo Ficarra
52894999
Re: Dipen J. Parekh, Isidinha M. Reis, Erik P. Castle, et al. Robot assisted Radical Cystectomy Versus Open Radical Cystectomy in Patients with Bladder Cancer (RAZOR) An Open label, Randomised, Phase 3, Non inferiority Trial. Lancet 2018;391:2525 36: Blood Loss in Robot assisted Radical Cystectomy:
We read with interest the report by Parekh and colleagues [1] on an open label, randomised, noninferiority phase 3 trial comparing robot assisted radical cystectomy with open radical cystectomy in biopsy confirmed T1 4 N0 1 M0 bladder cancer and refractory carcinoma in situ. Patients were block randomised to receive either robot assisted radical cystectomy or open radical cystectomy with extracorporeal urinary diversion. The primary outcome observed was progression free survival at 2 yr after surgery. Secondary outcomes observed included blood loss, transfusion requirement, surgical margin status, lymph nodes resected, operating time, length of stay, 90 d complications, and quality of life outcomes at 3 and 6 mo postoperatively. Importantly, the authors found that estimated blood loss was significantly lower for robot assisted cystectomy (mean 300 ml) than for open surgery (mean 700 ml) In addition, the transfusion requirement was significantly lower for robot assisted surgery, with only 24% of cases requiring transfusion compared with 45% for open cystectomy. Blood transfusion is common among cystectomy patients [2] and is associated with worse surgical outcomes [3] Surgical blood loss may be associated with poor surgical skill [4] and recurrence may be directly associated with transfusion related immunosuppression [2]
European urology
Sandaruwani Abeysiri Toby Richards
52090038
Re: Robot assisted Radical Cystectomy Versus Open Radical Cystectomy in Patients with Bladder Cancer (RAZOR) An Open label, Randomised, Phase 3, Non inferiority Trial.
European urology
Estefania Linares-Espinos Rafael Sanchez-Salas
211034536
Editorial Comment from Dr Abe to Oncological outcomes and recurrence patterns after laparoscopic radical cystectomy for bladder cancer: A Japanese multicenter cohort
scopic intracorporeal ileal conduit after laparoscopic radical cystectomy: a modified technique to facilitate ureteroenteric anastomosis. Int. J. Urol. 2018; 25: 976 8. 11 Stein JP, Lieskovsky G, Cote R et al. Radical cystectomy in the treatment of invasive bladder cancer: long term results in 1,054 patients. J. Clin. Oncol. 2001; 19: 666 75. 12 Raza SJ, Wilson T, Peabody JO et al. Long term oncologic outcomes following robot assisted radical cystectomy: results from the International Robotic Cystectomy Consortium. Eur. Urol. 2015; 68: 721 8. 13 Albisinni S, Rassweiler J, Abbou CC et al. Long term analysis of oncological outcomes after laparoscopic radical cystectomy in Europe: results from a multicentre study by the European Association of Urology (EAU) section of Uro technology. BJU Int. 2015; 115: 937 45. 14 Parekh DJ, Reis IM, Castle EP et al. Robot assisted radical cystectomy versus open radical cystectomy in patients with bladder cancer (RAZOR) an open label, randomised, phase 3, non inferiority trial. Lancet 2018; 391: 2525 36. 15 Sathianathen NJ, Kalapara A, Frydenberg M et al. Robotic assisted radical cystectomy vs open radical cystectomy: systematic review and meta analysis. J. Urol. 2019; 201: 715 20. 16 Fujimura T. Current status and future perspective of robot assisted radical cystectomy for invasive bladder cancer. Int. J. Urol. 2019; 26: 1033 42. 17 Audenet F, Sfakianos JP. Evidence of atypical recurrences after robot assisted radical cystectomy: a comprehensive review of the literature. Bladder Cancer 2017; 3: 231 6. 18 Collins JW, Hosseini A, Adding C et al. Early recurrence patterns following totally intracorporeal robot assisted radical cystectomy: results from the EAU Robotic Urology Section (ERUS) Scientific Working Group. Eur. Urol. 2017; 71: 723 6. 19 Khetrapal P, Shen Tan W, Lamb B et al. Port site metastases after robotic radical cystectomy: a systematic review and management options. Clin. Genitourin. Cancer 2017; 15: 440 4. 20 Nguyen DP, Al Awamlh BAH, O'Malley P et al. Factors impacting the occurrence of local, distant and atypical recurrences after robot assisted radical cystectomy: a detailed analysis of 310 patients. J. Urol. 2016; 196: 1390 6. 21 Williams SB, Kamat AM, Lamm DL. Pelvic recurrence after radical cystectomy: a call to arms. BJU Int. 2015; 116: 172 3. 22 Porpiglia F, Renard J, Billia M et al. Fast and safe closing of urethra during laparoscopic radical cystectomy. J. Endourol. 2006; 20: 651 3. 23 Kubota Y, Nakaigawa N. Essential content of evidence based clinical practice guidelines for bladder cancer: the Japanese Urological Association 2015 update. Int. J. Urol. 2016; 23: 640 5. 24 Ramirez PT, Frumovitz M, Pareja R et al. Minimally invasive versus abdominal radical hysterectomy for cervical cancer. N. Engl. J. Med. 2018; 379: 1895 904. 25 Venkatramani V, Reis IM, Castle EP et al. Predictors of recurrence, progression free and overall survival following open versus robotic radical cystectomy: analysis from the RAZOR trial with a 3 year follow up. J. Urol. 2019; 101097JU0000000000000565.
International journal of urology official journal of the Japanese Urological Association
Takashige Abe
211037652
Editorial Comment from Dr Tanaka and Dr Fujii to Oncological outcomes and recurrence patterns after laparoscopic radical cystectomy for bladder cancer: A Japanese multicenter cohort
1 Kanno T, Inoue T, Ito K et al. Oncological outcomes and recurrence patterns after laparoscopic radical cystectomy for bladder cancer: A Japanese multicenter cohort. Int. J. Urol. 2020; 27: 250 6. 2 Parekh DJ, Reis IM, Castle EP et al. Robot assisted radical cystectomy versus open radical cystectomy in patients with bladder cancer (RAZOR) an open label, randomised, phase 3, non inferiority trial. Lancet 2018; 391: 2525 36. 3 Nguyen DP, Al Hussein Al Awamlh B, Wu X et al. Recurrence patterns after open and robot assisted radical cystectomy for bladder cancer. Eur. Urol. 2015; 68: 399 405. 4 Albisinni S, Fossion L, Oderda M et al. Critical analysis of early recurrence after laparoscopic radical cystectomy in a large cohort by the ESUT. J. Urol. 2016; 195: 1710 7.
International journal of urology official journal of the Japanese Urological Association
Hajime Tanaka Yasuhisa Fujii
205563851
Author Reply.
radiation anterior prostato symphyseal fistulas with interposition rectus abdominis muscle flap. Urology. 2016;92:122 126. 5. Ross JJ, Hu LT. Septic arthritis of the pubic symphysis: review of 100 cases.Medicine. 2003;82:340 345. 6. Parekh DJ, Reis IM, Castle EP, et al. Robot assisted radical cystectomy versus open radical cystectomy in patients with bladder cancer (RAZOR) an open label, randomised, phase 3, non inferiority trial. Lancet. 2018;391:2525 2536. 7. Lubbers C, Siebert WE. Arthroscopic holmium YAG laser compared to conventional procedures on the knee joint. 2 year results of a randomized prospective study. Orthopade. 1996;25:64 72. 8. Thiel D.D. YPR. Robot Assisted Radical Cystectomy: Room Setup, Patient Positioning, Instrumentation, and Anesthetic Considerations. In: Castle E, Pruthi R, eds. Robotic Surgery of the Bladder. New York, NY: Springer; 2014. 9. Dillingham MF, Fanton GS, Thabit III G. Laser assisted arthroscopic meniscal surgery of the knee. Oper Tech Orthop. 1995;5:39 45. 10. Blackwell RE, Jemison DM, Foy BD. The holmium:yttrium aluminum garnet laser in wrist arthroscopy: a five year experience in the treatment of central triangular fibrocartilage complex tears by partial excision. J Hand Surg Am. 2001;26:77 84. 11. Shaffer B. The Holmium:YAG laser in knee arthoscopy. Oper Tech Sports Med. 1998;6:147 153. 12. Collier MA, Haugland M, Bellamy J, et al. Effects of holmium: YAG laser on equine articular. Arthroscopy. 1993;9:536 545. 13. Lavien G, Chery G, Zaid UB, Peterson AC. Pubic bone resection provides objective pain control in the prostate cancer survivor with pubic bone osteomyelitis with an associated urinary tract to pubic symphysis fistula. Urology. 2017;100:234 239. 14. Nunez R, Gross K, Rebecca A, Wolter C. V10 02 robot assisted vesicovaginal fistula repair with rectuas abdominals flap: description of the Technique. J Urol. 2018;199:e1072 e1073. 15. Ibrahim AE, Sarhane KA, Pederson JC, Selber JC. Robotic harvest of the rectus abdominis muscle: principles and clinical applications. Semin Plast Surg. 2014;28:26 31. 16. Sanchez A, Rodriguez D, Cheng JS, McGovern FJ, Tabatabaei S. Prostato symphyseal fistula after photoselective vaporization of the prostate: case series and literature review of a rare complication. Urology. 2015;85:172 177. 17. Bruyere F, Bodin T, Bleuzen A, Patat F, Brunereau L. Penetration depth with the XPS GreenLight laser assessed by contrast enhanced ultrasonography. J Endourol. 2013;27:1282 1286. 18. Schwartz AJ, Kiatisevi P, Eilber FC, Eilber FR, Eckardt JJ. The Friedman Eilber resection arthroplasty of the pelvis. Clin Orthop Relat Res. 2009;467:2825 2830.
Urology
Min Chul Cho Jae-Seung Paick
220395159
Editorial Comment
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Alison M Konrad
198999279
Editorial Comment to Current status and future perspective of robot assisted radical cystectomy for invasive bladder cancer
of robot assisted vs. open radical cystectomy in bladder cancer patients: a comparison of two high volume referral centers. Eur. J. Surg. Oncol. 2016; 42: 1736 43. 55 Bochner BH, Dalbagni G, Marzouk KH et al. Randomized trial comparing open radical cystectomy and robot assisted laparoscopic radical cystectomy: oncologic outcomes. Eur. Urol. 2018; 74: 465 71. 56 Simone G, Tuderti G, Misuraca L et al. Perioperative and mid term oncologic outcomes of robotic assisted radical cystectomy with totally intracorporeal neobladder: results of a propensity score matched comparison with open cohort from a single centre series. Eur. J. Surg. Oncol. 2018; 44: 1432 8. 57 Matsumoto A, Nakagawa T, Kanatani A et al. Preoperative chronic kidney disease is predictive of oncological outcome of radical cystectomy for bladder cancer. World J. Urol. 2018; 36: 249 56. 58 Challacombe BJ, Bochner BH, Dasgupta P et al. 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Factors impacting the occurrence of local, distant and atypical recurrences after robot assisted radical cystectomy: a detailed analysis of 310 patients. J. Urol. 2016; 196: 1390 6. 70 Linder BJ, Frank I, Cheville JC et al. The impact of perioperative blood transfusion on cancer recurrence and survival following radical cystectomy. Eur. Urol. 2013; 63: 839 45. 71 Wei L, Hussein AA, Ma Y et al. Accurate quantification of residual cancer cells in pelvic washing reveals association with cancer recurrence following robot assisted radical cystectomy. J. Urol. 2019; 201: 1105 14. 72 Lee R, Chughtai B, Herman M, Shariat SF, Scherr DS. Cost analysis comparison of robot assisted laparoscopic radical cystectomy (RC) vs open RC. BJU Int. 2011; 108(6 Pt 2) 976 83. 73 Smith A, Kurpad R, Lal A, Nielsen M, Wallen EM, Pruthi RS. Cost analysis of robotic versus open radical cystectomy for bladder cancer. J. Urol. 2010; 183: 505 9. 74 Martin AD, Nunez RN, Castle EP. Robot assisted radical cystectomy versus open radical cystectomy: a complete cost analysis. Urology 2011; 77: 621 5. 75 Bansal SS, Dogra T, Smith PW et al. Cost analysis of open radical cystectomy versus robot assisted radical cystectomy. BJU Int. 2018; 121: 437 44. 76 Leow JJ, Reese SW, Jiang W et al. Propensity matched comparison of morbidity and costs of open and robot assisted radical cystectomies: a contemporary population based analysis in the United States. Eur. Urol. 2014; 66: 569 76. 77 Yu HY, Hevelone ND, Lipsitz SR et al. Comparative analysis of outcomes and costs following open radical cystectomy versus robot assisted laparoscopic radical cystectomy: results from the US Nationwide Inpatient Sample. Eur. Urol. 2012; 61: 1239 44. 78 Ahmed K, Ibrahim A, Wang TT et al. Assessing the cost effectiveness of robotics in urological surgery a systematic review. BJU Int. 2012; 110: 1544 56. 79 Abboudi H, Khan MS, Guru KA et al. Learning curves for urological procedures: a systematic review. BJU Int. 2014; 114: 617 29. 80 Hayn MH, Hellenthal NJ, Seixas Mikelus SA et al. Is patient outcome compromised during the initial experience with robot assisted radical cystectomy? Results of 164 consecutive cases. BJU Int. 2011; 108: 882 7. 81 Hayn MH, Hussain A, Mansour AM et al. The learning curve of robot assisted radical cystectomy: results from the International Robotic Cystectomy Consortium. Eur. Urol. 2010; 58: 197 202. 82 Hayn MH, Hellenthal NJ, Hussain A, Andrews PE, Carpentier P, Castle E, et al. Does previous robot assisted radical prostatectomy experience affect outcomes at robot assisted radical cystectomy? Results from the International Robotic Cystectomy Consortium. Urology. 2010; 76: 1111 6. 83 Guru KA, Perlmutter AE, Butt ZM et al. The learning curve for robot assisted radical cystectomy. JSLS 2009; 13: 509 14. 84 Fujimura T, Menon M, Fukuhara H et al. 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International journal of urology official journal of the Japanese Urological Association
Jun Teishima Akio Matsubara
73508215
Editorial Comment to Complications and reoperations after laparoscopic radical cystectomy in a Japanese multicenter cohort
tomy and robot assisted laparoscopic radical cystectomy: a randomized clinical trial. Eur. Urol. 2015; 67: 1042 50. 11 Parekh DJ, Reis IM, Castle EP et al. Robot assisted radical cystectomy versus open radical cystectomy in patients with bladder cancer (RAZOR) an openlabel, randomised, phase 3, non inferiority trial. Lancet 2018; 391: 2525 36. 12 Chhabra S, Hegde P. Spontaneous transvaginal bowel evisceration. Indian J. Urol. 2013; 29: 139 41. 13 Chopra S, Dharmaraja A, Djaladat H, Aron M. Transvaginal bowel evisceration following robot assisted radical cystectomy. Indian J. Urol. 2016; 32: 320 2. 14 Cronin B, Sung VW, Matteson KA. Vaginal cuff dehiscence: risk factors and management. Am. J. Obstet. Gynecol. 2012; 206: 284 8. Supporting information
International journal of urology official journal of the Japanese Urological Association
Fuminori Sato