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Originally published as JCO Early Release 10.1200/JCO.2008.18.8300 on September 22 2008 © 2008 American Society of Clinical Oncology.
In Reply
Division of Urology, Brigham and Women's Hospital, Lank Center for Genitourinary Oncology, Dana Farber Cancer Institute, Harvard Medical School, Boston, MA A historical perspective of radical prostatectomy may frame the context of our findings relative to the Blute editorial1 and Tewari Correspondence. Before Walsh's description and dissemination of landmark surgical maneuvers in the late 1970s and early 1980s, virtually all men who underwent radical prostatectomy were impotent, many had significant urinary incontinence and, when performed via the retropubic approach, excessive bleeding was common.2 With the option of external beam radiotherapy, it became possible to avoid many severe adverse effects, and radical prostatectomy was rarely performed during this era. Moreover, Boxer et al3 noted in 1977 that open radical prostatectomy (ORP) complication rates were 46% for attending surgeons versus 59% for resident staff, and that few alterations in surgical approach had occurred during the past 70 years. Though this study is unlikely to be repeated in the present day, it foreshadowed subsequent studies that demonstrated an association of high-ORP–surgery volume with better outcomes.4,5 Hence, the aim of our study was not to confirm these ORP volume outcome effects, but rather to assess the potential consequences of rapid adoption of minimally invasive radical prostatectomy (MIRP). Given that more than half of prostate cancer surgeries presently performed in the United States are via robotic-assisted MIRP,6 we will focus primarily on ORP versus robotic-assisted MIRP. Blute describes the use of Medicare administrative data as a panoramic view that cannot be used reliably as a surrogate for surgical outcomes data, and Tewari seconds this opinion. Both recapitulate the limitations of our study, which were addressed in the paper, and question whether findings in Medicare beneficiaries may be generalized to the population at large. However, this shared opinion may stem from different origins. Blute, an open surgeon, concludes that the open technique is state of the art and long-term results for MIRP do not exist, whereas Tewari, a robotic surgeon, was surprised by the high MIRP salvage therapy and complication rates, and contrasts his surgical outcomes with the findings from our study. In addition, Tewari contends that CPT-4 code 55899, unlisted procedure male genital system, may be used to bill for robotic-assisted MIRP. Because code 55899 may be used for any urologic procedure that lacks a corresponding administrative code, we chose to exclude it based on poor sensitivity. However, we agree that robotic-assisted MIRP usage during the study period may be more prevalent than our estimates. In addition, several points are relevant for an informed debate about Medicare administrative data versus single-center studies and ORP versus robotic-assisted MIRP outcomes studies. Lawthers et al7 found that Medicare claims have a high degree of validity for detecting complications of surgery; 89% of Medicare complications were corroborated by medical record abstraction. Similarly, Potosky et al8 compared Medicare claims versus questionnaire responses in 1,500 men to identify the prevalence of postprostatectomy anastomotic strictures and found excellent concordance of 17% versus 15%. Conversely, challenges to accurate reporting in single-surgeon series include interviewer and recall bias and loss to follow-up, particularly for men who travel for surgery with high-volume surgeons. Furthermore, observation bias may influence analyses of data and results. For instance, reporting of urinary and sexual function is most accurate when elicited by written confidential surveys that are self-administered and submitted to third parties rather than by physician assessment.9 Moreover, variations in the definition of complications and outcomes from single-center studies obfuscate comparisons of surgical techniques and outcomes.10 Finally, outcomes from single-center studies may differ markedly from population based studies that encompass community settings, and the converse must be considered, whether single surgeon findings are generalizable to the majority of men undergoing robotic-assisted MIRP. In attempting to maintain market share, every hospital in the United States is motivated to acquire robots and market robotic-assisted MIRP as a minimally invasive procedure with no morbidity.6 Moreover, the widespread direct–to-consumer advertising and rapid adoption of robotic-assisted MIRP in the United States may result in publication bias against studies that detail challenges and suboptimal outcomes early in the learning curve. Though enthusiasm for robotic-assisted MIRP exists internationally in less free-spending health systems, its adoption has come under greater scrutiny and regulation. Whereas a United States study11 estimated the learning curve for robotic-assisted MIRP at 18 patients, based on attaining an operative time of 4 hours, a laparoscopic radical prostatectomy series from Germany12 reported operative times of 8 hours with a 67% complication rate and 78% positive margin rate, and a Canadian robotic-assisted MIRP series13 reported almost 6-hour operative times initially, with 3 open conversions in the first 4 patients due to failure to progress, a 30% complication rate, and a 30% positive margin rate. Similarly, a United States robotic-assisted MIRP series14 reported a 45% positive margin rate for the first 33 patients. Vickers et al15 explored the learning curve for ORP cancer control and demonstrated 5-year prostate cancer recurrence rates of 18% versus 11% for surgeons with 10 or fewer versus 250 ORP-performed after residency training. Meanwhile, according to the Accreditation Council for Graduate Medical Education,16 the median or 50th percentile experience for radical prostatectomy by either surgical approach combined among graduating urology residents from 2006 was 66 patients. In addition, a recent survey of urology residents17 revealed that 74% felt that robotic-assisted MIRP was promising and usage will increase in the future; however, only 39% had participated in robotic-assisted MIRP, whereas 64% planned on doing the procedure in the next year. Though the robot provides technical advantages in terms of manual dexterity and a magnified 3-dimensional vision, it does not provide a novice with instant laparoscopic capabilities and proficiency in terms of tissue plane recognition,13 as evidenced by the high positive margin rates and suboptimal cancer control in the early learning curve phase that may warrant salvage therapy regardless of surgical approach. AUTHOR'S DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST The author(s) indicated no potential conflicts of interest. NOTES published online ahead of print at www.jco.org on September 22, 2008 REFERENCES
1. Blute ML: Radical prostatectomy by open or laparoscopic/robotic techniques: An issue of surgical device or surgical expertise? J Clin Oncol 26:2248-2249, 2008 2. Walsh PC: Anatomic radical prostatectomy: Evolution of the surgical technique. J Urol 160:2418-2424, 1998[CrossRef][Medline] 3. Boxer RT, Kaufman JJ, Goodwin WE: Radical prostatectomy for carcinoma of the prostate: 1951-1976 A review of 329 patients. J Urol 117:208-213, 1977[Medline] 4. Hu JC, Gold KF, Pashos CL, et al: Role of surgeon volume in radical prostatectomy outcomes. J Clin Oncol 21:401-405, 2003 5. Begg CB, Riedel ER, Bach PB, et al: Variations in morbidity after radical prostatectomy. N Engl J Med 346:1138-1144, 2002 6. Klotz, L: Robotic radical prostatectomy: Fools rush in, or the early bird gets the worm? Can Urol Assoc J 1:87-87, 2007[Medline] 7. Lawthers AG, McCarthy EP, Davis RB, et al: Identification of in-hospital complications from claims data. Is it valid? Med Care 38:785-795, 2000[CrossRef][Medline] 8. Potosky AL, Legler J, Albertsen PC, et al: Health outcomes after prostatectomy or radiotherapy for prostate cancer: Results from the Prostate Cancer Outcomes Study. J Natl Cancer Inst 92:1582-1592, 2000 9. Litwin MS, McGuigan KA: Accuracy of recall in health-related quality-of-life assessment among men treated for prostate cancer. J Clin Oncol 17:2882-2888, 1999 10. Donat SM: Standards for surgical complication reporting in urologic oncology: Time for a change. Urology 69:221-225, 2007[CrossRef][Medline] 11. Menon M, Shrivastava A, Tewari A, et al: Laparoscopic and robot assisted radical prostatectomy: Establishment of a structured program and preliminary analysis of outcomes. J Urol 168:945-949, 2002[CrossRef][Medline] 12. Weber HM, Eschholz G, Gunnewig M, et al: Laparoscopic radical prostatectomy? Not for us! J Urol 165:616A, 2001 (suppl)[CrossRef] 13. Chin JL, Luke PP, Pautler SE: Initial experience with robotic-assisted laparoscopic radical prostatectomy in the Canadian health care system. Can Urol Assoc J 1:97-101, 2007[Medline] 14. Atug F, Castle EP, Srivastav SK, et al: Positive surgical margins in robotic-assisted radical prostatectomy: Impact of learning curve on oncologic outcomes. Eur Urol 49:866-871, 2006[CrossRef][Medline] 15. Vickers AJ, Bianco FJ, Serio AM, et al: The surgical learning curve for prostate cancer control after radical prostatectomy. J Natl Cancer Inst 99:1171-1177, 2007 16. Accrdidation Council for Graduate Medical Education: Case Log Statistical Reports. http://www.acgme.org/residentdatacollection/documentation/statistical_reports.asp 17. Duchene DA, Moinzadeh A, Gill IS, et al: Survey of residency training in laparoscopic and robotic surgery. J Urol 176:2158-2166, 2006[CrossRef][Medline]
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Copyright © 2008 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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