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Re: Live Robotic Surgery: Are Outcomes Compromised?
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LAPAROSCOPY/NEW TECHNOLOGY
Laparoscopy/New Technology Re: Population-Based Comparative Effectiveness of Nephron-Sparing Surgery vs Ablation for Small Renal Masses J. M. Whitson, C. R. Harris and M. V. Meng Department of Urology, Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, California BJU Int 2012; 110: 1438 –1443.
Objective: To determine, in a population-based cohort, if disease-specific survival (DSS) was equivalent in patients undergoing ablation vs nephron-sparing surgery (NSS) for clinical stage T1a renal cell carcinoma (RCC). Patients and Methods: A retrospective cohort study was performed using patients from the Surveillance, Epidemiology and End Results cancer registry with RCC ⬍ 4 cm and no evidence of distant metastases, who underwent ablation or NSS. Kaplan-Meier and Cox regression analyses were performed to determine if treatment type was independently associated with DSS. Results: Between 1998 and 2007, a total of 8818 incident cases of RCC were treated with either NSS (7704) or ablation (1114). The median (interquartile range) follow-up was 2.8 (1.2– 4.7) years in the NSS group and 1.6 (0.7–2.9) years in the ablation group, although 10% of each cohort were followed up beyond 5 years. After multivariable adjustment, ablation was associated with a twofold greater risk of kidney cancer death than NSS (hazard ratio 1.9, 95% confidence interval 1.1–3.3, P⫽ 0.02). Age, gender, marital status and tumour size were also significantly associated with outcome. The predicted probability of DSS at 5 years was 98.3% with NSS and 96.6% with ablation. Conclusion: After controlling for age, gender, marital status and tumour size, the typical patient presenting with clinical stage T1a RCC, who undergoes ablation rather than NSS, has a twofold increase in the risk of kidney cancer death; however, at 5 years the absolute difference is small, and may only be realized by patients with long life expectancies. Editorial Comment: This study encompassing SEER (Surveillance, Epidemiology and End Results) cases from 1998 to 2007 confirms the findings of the American Urological Association guidelines for managing small renal masses, in that nephron sparing surgery provides superior oncologic control compared to tumor ablation. However, the difference in 5-year disease specific survival was only 1.7% (98.3% vs 96.6%). We must consider that for most patients this difference may be clinically irrelevant. In addition, the authors appropriately acknowledge that tumor selection for ablation has likely improved during the last decade, as reflected by the finding that there was no survival difference in the most recently treated patients. Jeffrey A. Cadeddu, M.D.
Re: Live Robotic Surgery: Are Outcomes Compromised? J. K. Mullins, M. S. Borofsky, M. E. Allaf, S. Bhayani, J. H. Kaouk, C. G. Rogers, S. P. Hillyer, B. F. Kaczmarek, Y. S. Tanagho and M. D. Stifelman Department of Urology, New York University, Langone Medical Center, New York, New York Urology 2012; 80: 602– 607.
Objective: To determine the outcomes of patients undergoing robotic partial nephrectomy as a live broadcast surgery compared to a cohort treated without observers. Methods: From 2007 to 2011, 39 robotic partial nephrectomies were performed as live broadcast surgery by 1 of 5 high volume surgeons. Live broadcast cases were defined as surgeries viewed by multiple visiting physicians via live teleconference in which the visitors were able to interact with the operating surgeon. Live cases were compared with 847 cases performed under standard operating procedure during the same period. Cases performed under standard operating procedure were not broadcasted. Demographic, clinicopathologic, and perioperative outcomes were compared between groups. Logistic regression analysis was performed to the test the association between live broadcast surgery and
BLADDER, PENIS AND URETHRA CANCER, AND BASIC PRINCIPLES OF ONCOLOGY
adverse perioperative outcomes. Results: Demographic and clinicopathologic data were similar between both groups. The live broadcast surgery group experienced equivalent operative times (196.3 vs 183.8 minutes; P ⫽ .22), estimated blood loss (EBL; 187.8 vs 190.7; P ⫽ .93), warm ischemia time (WIT; 20.8 vs 18.8; P ⫽ .17), hospital length of stay (LOS; 2.8 vs 2.8 days; P ⫽ .99), positive surgical margin rate (2.6% vs 2.3%; P ⫽ .83), and rates of postoperative complications (5.1% vs 12.8%; P ⫽ .16). There were no Clavien III to V complications in the live broadcast group. Logistic regression analyses demonstrated that live broadcast surgery was not associated with any unfavorable perioperative parameter. Conclusion: Live robotic surgery is associated with excellent patient outcomes which compare favorably to cases done under normal operating procedures. Live robotic surgery represents a powerful educational tool which may be used without increasing patient morbidity. Editorial Comment: These authors studied robotic partial nephrectomy as the model procedure to assess the safety of live surgical demonstration as a teaching modality. This is a timely study, as several societies have banned live surgical cases from national meetings. Importantly, in the 39 live demonstration cases there were no adverse changes in any measurable perioperative parameter. This finding is reassuring, and the authors make an eloquent case for the value of live robotic demonstration as an educational tool. However, I am not convinced that viewing an unedited recorded case narrated by the surgeon cannot offer the same educational value. In addition, the possibility to rewind, slow down and fast forward as the educational environment requires (including management or avoidance of complications) may be even more valuable. In many educational courses 2 or more cases are running simultaneously, with limited possibility for the surgeon to slow down and certainly no ability to rewind or fast forward through a case. In this age of digital video recording and Internet video on demand for home entertainment and sports events showing the safety of live surgery is important, although the educational superiority to these technologies remains to be determined. Jeffrey A. Cadeddu, M.D.
Urological Oncology: Bladder, Penis and Urethra Cancer, and Basic Principles of Oncology Re: A Phase 2 Cancer Chemoprevention Biomarker Trial of Isoflavone G-2535 (Genistein) in Presurgical Bladder Cancer Patients E. Messing, J. R. Gee, D. R. Saltzstein, K. Kim, A. diSant’Agnese, J. Kolesar, L. Harris, A. Faerber, T. Havighurst, J. M. Young, M. Efros, R. H. Getzenberg, M. A. Wheeler, J. Tangrea, H. Parnes, M. House, J. E. Busby, R. Hohl and H. Bailey University of Rochester Medical Center, Rochester, New York Cancer Prev Res (Phila) 2012; 5: 621– 630.
The soy compound genistein has been observed preclinically to inhibit bladder cancer growth with one potential mechanism being the inhibition of epidermal growth factor receptor phosphorylation (p-EGFR). A phase 2 randomized, placebo-controlled trial investigated whether daily, oral genistein (300 or 600 mg/d as the purified soy extract G-2535) for 14 to 21 days before surgery alters molecular pathways in bladder epithelial tissue in 59 subjects diagnosed with urothelial bladder cancer (median age, 71 years). G-2535 treatment was well tolerated; observed toxicities were primarily mild to moderate gastrointestinal or metabolic and usually not attributed to study drug. Genistein was detected in plasma and urine of subjects receiving G-2535 at concentrations greater than placebo subjects’ but were not dose-dependent. Reduction in bladder cancer tissue p-EGFR staining between
1287
LAPAROSCOPY/NEW TECHNOLOGY
Laparoscopy/New Technology Re: Population-Based Comparative Effectiveness of Nephron-Sparing Surgery vs Ablation for Small Renal Masses J. M. Whitson, C. R. Harris and M. V. Meng Department of Urology, Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, California BJU Int 2012; 110: 1438 –1443.
Objective: To determine, in a population-based cohort, if disease-specific survival (DSS) was equivalent in patients undergoing ablation vs nephron-sparing surgery (NSS) for clinical stage T1a renal cell carcinoma (RCC). Patients and Methods: A retrospective cohort study was performed using patients from the Surveillance, Epidemiology and End Results cancer registry with RCC ⬍ 4 cm and no evidence of distant metastases, who underwent ablation or NSS. Kaplan-Meier and Cox regression analyses were performed to determine if treatment type was independently associated with DSS. Results: Between 1998 and 2007, a total of 8818 incident cases of RCC were treated with either NSS (7704) or ablation (1114). The median (interquartile range) follow-up was 2.8 (1.2– 4.7) years in the NSS group and 1.6 (0.7–2.9) years in the ablation group, although 10% of each cohort were followed up beyond 5 years. After multivariable adjustment, ablation was associated with a twofold greater risk of kidney cancer death than NSS (hazard ratio 1.9, 95% confidence interval 1.1–3.3, P⫽ 0.02). Age, gender, marital status and tumour size were also significantly associated with outcome. The predicted probability of DSS at 5 years was 98.3% with NSS and 96.6% with ablation. Conclusion: After controlling for age, gender, marital status and tumour size, the typical patient presenting with clinical stage T1a RCC, who undergoes ablation rather than NSS, has a twofold increase in the risk of kidney cancer death; however, at 5 years the absolute difference is small, and may only be realized by patients with long life expectancies. Editorial Comment: This study encompassing SEER (Surveillance, Epidemiology and End Results) cases from 1998 to 2007 confirms the findings of the American Urological Association guidelines for managing small renal masses, in that nephron sparing surgery provides superior oncologic control compared to tumor ablation. However, the difference in 5-year disease specific survival was only 1.7% (98.3% vs 96.6%). We must consider that for most patients this difference may be clinically irrelevant. In addition, the authors appropriately acknowledge that tumor selection for ablation has likely improved during the last decade, as reflected by the finding that there was no survival difference in the most recently treated patients. Jeffrey A. Cadeddu, M.D.
Re: Live Robotic Surgery: Are Outcomes Compromised? J. K. Mullins, M. S. Borofsky, M. E. Allaf, S. Bhayani, J. H. Kaouk, C. G. Rogers, S. P. Hillyer, B. F. Kaczmarek, Y. S. Tanagho and M. D. Stifelman Department of Urology, New York University, Langone Medical Center, New York, New York Urology 2012; 80: 602– 607.
Objective: To determine the outcomes of patients undergoing robotic partial nephrectomy as a live broadcast surgery compared to a cohort treated without observers. Methods: From 2007 to 2011, 39 robotic partial nephrectomies were performed as live broadcast surgery by 1 of 5 high volume surgeons. Live broadcast cases were defined as surgeries viewed by multiple visiting physicians via live teleconference in which the visitors were able to interact with the operating surgeon. Live cases were compared with 847 cases performed under standard operating procedure during the same period. Cases performed under standard operating procedure were not broadcasted. Demographic, clinicopathologic, and perioperative outcomes were compared between groups. Logistic regression analysis was performed to the test the association between live broadcast surgery and
BLADDER, PENIS AND URETHRA CANCER, AND BASIC PRINCIPLES OF ONCOLOGY
adverse perioperative outcomes. Results: Demographic and clinicopathologic data were similar between both groups. The live broadcast surgery group experienced equivalent operative times (196.3 vs 183.8 minutes; P ⫽ .22), estimated blood loss (EBL; 187.8 vs 190.7; P ⫽ .93), warm ischemia time (WIT; 20.8 vs 18.8; P ⫽ .17), hospital length of stay (LOS; 2.8 vs 2.8 days; P ⫽ .99), positive surgical margin rate (2.6% vs 2.3%; P ⫽ .83), and rates of postoperative complications (5.1% vs 12.8%; P ⫽ .16). There were no Clavien III to V complications in the live broadcast group. Logistic regression analyses demonstrated that live broadcast surgery was not associated with any unfavorable perioperative parameter. Conclusion: Live robotic surgery is associated with excellent patient outcomes which compare favorably to cases done under normal operating procedures. Live robotic surgery represents a powerful educational tool which may be used without increasing patient morbidity. Editorial Comment: These authors studied robotic partial nephrectomy as the model procedure to assess the safety of live surgical demonstration as a teaching modality. This is a timely study, as several societies have banned live surgical cases from national meetings. Importantly, in the 39 live demonstration cases there were no adverse changes in any measurable perioperative parameter. This finding is reassuring, and the authors make an eloquent case for the value of live robotic demonstration as an educational tool. However, I am not convinced that viewing an unedited recorded case narrated by the surgeon cannot offer the same educational value. In addition, the possibility to rewind, slow down and fast forward as the educational environment requires (including management or avoidance of complications) may be even more valuable. In many educational courses 2 or more cases are running simultaneously, with limited possibility for the surgeon to slow down and certainly no ability to rewind or fast forward through a case. In this age of digital video recording and Internet video on demand for home entertainment and sports events showing the safety of live surgery is important, although the educational superiority to these technologies remains to be determined. Jeffrey A. Cadeddu, M.D.
Urological Oncology: Bladder, Penis and Urethra Cancer, and Basic Principles of Oncology Re: A Phase 2 Cancer Chemoprevention Biomarker Trial of Isoflavone G-2535 (Genistein) in Presurgical Bladder Cancer Patients E. Messing, J. R. Gee, D. R. Saltzstein, K. Kim, A. diSant’Agnese, J. Kolesar, L. Harris, A. Faerber, T. Havighurst, J. M. Young, M. Efros, R. H. Getzenberg, M. A. Wheeler, J. Tangrea, H. Parnes, M. House, J. E. Busby, R. Hohl and H. Bailey University of Rochester Medical Center, Rochester, New York Cancer Prev Res (Phila) 2012; 5: 621– 630.
The soy compound genistein has been observed preclinically to inhibit bladder cancer growth with one potential mechanism being the inhibition of epidermal growth factor receptor phosphorylation (p-EGFR). A phase 2 randomized, placebo-controlled trial investigated whether daily, oral genistein (300 or 600 mg/d as the purified soy extract G-2535) for 14 to 21 days before surgery alters molecular pathways in bladder epithelial tissue in 59 subjects diagnosed with urothelial bladder cancer (median age, 71 years). G-2535 treatment was well tolerated; observed toxicities were primarily mild to moderate gastrointestinal or metabolic and usually not attributed to study drug. Genistein was detected in plasma and urine of subjects receiving G-2535 at concentrations greater than placebo subjects’ but were not dose-dependent. Reduction in bladder cancer tissue p-EGFR staining between
1287