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Randomized Trial Comparing Open Radical Cystectomy and Robot-assisted Laparoscopic Radical Cystectomy: Oncologic Outcomes.
Eur Urol 2018; 74(4):465-471EU

Abstract

BACKGROUND

Open radical cystectomy (ORC) has proven to be an important component in the treatment of high-risk bladder cancer (BCa). ORC surgical morbidity remains high; therefore, minimally invasive surgical techniques have been introduced in an attempt to improve patient outcomes.

OBJECTIVE

To compare cancer outcomes in BCa patients managed with ORC or robotic-assisted radical cystectomy (RARC).

DESIGN, SETTING, AND PARTICIPANTS

A prospective, randomized trial was completed between 2010 and 2013. Patients were randomized to ORC/pelvic lymphadenectomy (PLND) or RARC/PLND, with all undergoing open/extracorporeal urinary diversion. Median follow-up was 4.9 (IQR: 3.9-5.9) yr after surgery among surviving patients.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS

Secondary outcomes to the trial included recurrence-free, cancer-specific, and overall survival.

RESULTS AND LIMITATIONS

The trial randomized 118 patients who underwent RC/PLND and urinary diversion. Sixty were randomized to RARC and 58 to ORC. Four RARC-assigned patients refused randomization and received ORC; however, an intention to treat analysis was performed. No differences were observed in recurrence (hazard ratio [HR]: 1.27; 95% confidence interval [CI]: 0.69-2.36; p=0.4) or cancer-specific survival (p=0.4). No difference in overall survival was observed (p=0.8). However, the pattern of first recurrence demonstrated a nonstatistically significant increase in metastatic sites for those undergoing ORC (sub-HR [sHR]: 2.21; 95% CI: 0.96-5.12; p=0.064) and a greater number of local/abdominal sites in the RARC-treated patients (sHR: 0.34; 95% CI: 0.12-0.93; p=0.035). The major limitation to this study is that the trial was not powered to determine differences in cancer recurrences, survival outcomes, or patterns of recurrence.

CONCLUSIONS

The secondary outcomes from our randomized trial did not definitively demonstrate differences in cancer outcomes in patients treated with ORC or RARC. However, differences in observed patterns of first recurrence highlight the need for future studies.

PATIENT SUMMARY

Of 118 patients randomly assigned to undergo radical cystectomy/pelvic lymphadenectomy and urinary diversion, half were assigned to open surgery and half to robot-assisted techniques. We found no difference in risk of recurring or dying of bladder cancer between the two groups.

Authors+Show Affiliations

Urology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Urology, Weill Cornell Medical College, New York, NY, USA. Electronic address: bochnerb@mskcc.org.Urology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Urology, Weill Cornell Medical College, New York, NY, USA.Urology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.Urology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.Urology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Urology, Weill Cornell Medical College, New York, NY, USA.Urology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Urology, Weill Cornell Medical College, New York, NY, USA.Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.Urology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Urology, Weill Cornell Medical College, New York, NY, USA.Urology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Urology, Weill Cornell Medical College, New York, NY, USA.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

29784190

Citation

Bochner, Bernard H., et al. "Randomized Trial Comparing Open Radical Cystectomy and Robot-assisted Laparoscopic Radical Cystectomy: Oncologic Outcomes." European Urology, vol. 74, no. 4, 2018, pp. 465-471.
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(4):465-471.
Bochner, B. H., Dalbagni, G., Marzouk, K. H., Sjoberg, D. D., Lee, J., Donat, S. M., ... Laudone, V. P. (2018). Randomized Trial Comparing Open Radical Cystectomy and Robot-assisted Laparoscopic Radical Cystectomy: Oncologic Outcomes. European Urology, 74(4), pp. 465-471. doi:10.1016/j.eururo.2018.04.030.
Bochner BH, et al. Randomized Trial Comparing Open Radical Cystectomy and Robot-assisted Laparoscopic Radical Cystectomy: Oncologic Outcomes. Eur Urol. 2018;74(4):465-471. PubMed PMID: 29784190.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Randomized Trial Comparing Open Radical Cystectomy and Robot-assisted Laparoscopic Radical Cystectomy: Oncologic Outcomes. AU - Bochner,Bernard H, AU - Dalbagni,Guido, AU - Marzouk,Karim H, AU - Sjoberg,Daniel D, AU - Lee,Justin, AU - Donat,Sheri M, AU - Coleman,Jonathan A, AU - Vickers,Andrew, AU - Herr,Harry W, AU - Laudone,Vincent P, Y1 - 2018/05/18/ PY - 2018/01/22/received PY - 2018/04/30/accepted PY - 2018/5/23/pubmed PY - 2019/4/26/medline PY - 2018/5/23/entrez KW - Bladder cancer KW - Radical cystectomy KW - Robotics SP - 465 EP - 471 JF - European urology JO - Eur. Urol. VL - 74 IS - 4 N2 - BACKGROUND: Open radical cystectomy (ORC) has proven to be an important component in the treatment of high-risk bladder cancer (BCa). ORC surgical morbidity remains high; therefore, minimally invasive surgical techniques have been introduced in an attempt to improve patient outcomes. OBJECTIVE: To compare cancer outcomes in BCa patients managed with ORC or robotic-assisted radical cystectomy (RARC). DESIGN, SETTING, AND PARTICIPANTS: A prospective, randomized trial was completed between 2010 and 2013. Patients were randomized to ORC/pelvic lymphadenectomy (PLND) or RARC/PLND, with all undergoing open/extracorporeal urinary diversion. Median follow-up was 4.9 (IQR: 3.9-5.9) yr after surgery among surviving patients. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Secondary outcomes to the trial included recurrence-free, cancer-specific, and overall survival. RESULTS AND LIMITATIONS: The trial randomized 118 patients who underwent RC/PLND and urinary diversion. Sixty were randomized to RARC and 58 to ORC. Four RARC-assigned patients refused randomization and received ORC; however, an intention to treat analysis was performed. No differences were observed in recurrence (hazard ratio [HR]: 1.27; 95% confidence interval [CI]: 0.69-2.36; p=0.4) or cancer-specific survival (p=0.4). No difference in overall survival was observed (p=0.8). However, the pattern of first recurrence demonstrated a nonstatistically significant increase in metastatic sites for those undergoing ORC (sub-HR [sHR]: 2.21; 95% CI: 0.96-5.12; p=0.064) and a greater number of local/abdominal sites in the RARC-treated patients (sHR: 0.34; 95% CI: 0.12-0.93; p=0.035). The major limitation to this study is that the trial was not powered to determine differences in cancer recurrences, survival outcomes, or patterns of recurrence. CONCLUSIONS: The secondary outcomes from our randomized trial did not definitively demonstrate differences in cancer outcomes in patients treated with ORC or RARC. However, differences in observed patterns of first recurrence highlight the need for future studies. PATIENT SUMMARY: Of 118 patients randomly assigned to undergo radical cystectomy/pelvic lymphadenectomy and urinary diversion, half were assigned to open surgery and half to robot-assisted techniques. We found no difference in risk of recurring or dying of bladder cancer between the two groups. SN - 1873-7560 UR - https://www.unboundmedicine.com/medline/citation/29784190/Randomized_Trial_Comparing_Open_Radical_Cystectomy_and_Robot_assisted_Laparoscopic_Radical_Cystectomy:_Oncologic_Outcomes_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0302-2838(18)30336-1 DB - PRIME DP - Unbound Medicine ER -