Aug 26, 2014
By L. Michael Glodé, MD, FACP, FASCO
University of Colorado Cancer Center
The following articles by Dr. Quoc-Dien Trinh and Dr. Joel Nelson nicelyreview the current status of prostatecancer surgery and provide a frameworkwithin which one can discussthe approaches to definitive surgicalablation of the prostate. Although costconsiderations should have been a partof the equation before disseminationof the robotic technology, they seldomplay a role in current patient decisions.In many cases, the more difficult decisionfor those patients with low-volumeGleason 6 tumors is whether to betreated at all, and in the case of moreadvanced/higher-grade tumors, whetherto choose radiation or surgery.
Active surveillance for low-gradetumors remains an important optionand is widely advocated as “theanswer” to the screening and overtreatmentconundrum, although it isboth costly and carries a considerablepsychological burden that is underrecognized.As stated in these articles,a large prospective trial comparingrobot-assisted radical prostatectomy(RARP) to open retropubic prostatectomy(ORP) is unlikely to be performed,because it would be difficult to controlfor the intangibles such as patientselection, institutional bias, and skill/experience of the surgeons involved.
As there are a vanishing number ofurologic surgeons who perform bothprocedures with equal frequency,patients should be advised to be surethat their surgeon of choice has previousand ongoing experience with alarge number of patients using eithertechnique and not to expect that theiroutcomes will differ significantly basedon the technology employed. Their ownanatomy and the surgeon’s skill willplay an important role, but they willusually have some loss of normal function,even if it is minor. Unfortunately,as demonstrated in the PIVOT trial,1there are few “free rides” in treatinglocalized prostate cancer with anymodality. The good news is that mostpatients treated in high-volume centersdo well and are generally happy withtheir treatment choice.2
Dr. Glodé is a Professor in the Division ofMedical Oncology at the School of Medicineat the University of Colorado Denver. AnASCO member since 1980, he previouslyserved as Chair of the Integrated Media& Technology and Cancer EducationCommittees.
- Wilt TJ, Brawer MK, Jones KM, et al. N EnglJ Med. 2012;367:203-213.
- Sanda MG, Dunn RL, Michalski J, et al. NEngl J Med. 2008;358:1250-1261.
The Lack of Value for Robot-Assisted Radical Prostatectomy
By Joel B. Nelson, MD
University of Pittsburgh School ofMedicine
Radical prostatectomy by anyapproach has the same goals. First,cure the prostate cancers that can becured. Second, minimize postoperativeurinary incontinence. Third, minimizepostoperative erectile dysfunction.Fourth, minimize perioperative complicationsand suffering. Finally, maximizevalue by providing clear benefits at thelowest cost. In terms of these goals,robot-assisted radical prostatectomy(RARP) has not shown superiority toopen radical prostatectomy (ORP) and,in fact, has often shown inferiority.
There are three reasons radical prostatectomyfails to cure prostate cancer:tumor biology, surgical technique, orboth. The best measure of surgicaltechnique is the rate of recurrenceafter radical prostatectomy for tumorswith no biologic potential for failure. Forexample, there is growing evidence thatGleason 3+3 prostate cancer has nometastatic potential and is rarely locallyinvasive; in over 14,000 fully embeddedGleason 3+3 radical prostatectomyspecimens, not one had an associatedpelvic lymph node metastasis.1 In thehands of an experienced ORP surgeon,the five-year biochemical recurrencerate is 1.6% for Gleason 3+3 cancers2;in my ORP experience, that rate is 1.3%.For experienced RARP surgeons, bycontrast, the rates range from 6% to12.5%.3-5 It is reasonable to assume thatfailure due to surgical technique wouldbe the same or worse for more biologicallyaggressive prostate cancers.
Why such a large difference? In myopinion, ORP provides a degree ofintraoperative flexibility and nuancethat simply does not exist with RARP.With ORP, planes of dissection aredetermined by the combination ofbinocular vision and tactile cues transmittedthrough the instruments. RARPsurgeons claim they can compensatefor the lack of haptic feedback, butnone would reject a device providingthe sense of touch. Furthermore, theuse of continuous suction during surgeryallows ORP to proceed in a largelybloodless field; the RARP requirementfor pneumoperitoneum makes continuoussuction technically impossible.Although RARP is associated with lessoverall blood loss and 10-fold magnification,its other technical handicapsmay explain the lack of improved oncologicoutcomes.
Unbiased population-based studiesdo not support the widespread claimsof improved continence and potencyassociated with RARP. For example,in a 2012 study, 20% of Medicarerecipients who had undergone ORPor RARP were queried about theirfunctional outcomes after surgery.6With a remarkable 86% response rate,one-third reported a moderate to “big”problem with continence and nearly90% reported the same degree of difficultywith sexual function after bothORP and RARP. Sexual function wasequivalently poor for both approaches,but there was a nonsignificant trendfor more incontinence after RARP(odds ratio 1.41; 95% CI 0.97-2.05).Another study, which used a Surveillance,Epidemiology, and End Results–Medicare linked database to examine3,467 men undergoing RARP and3,467 men undergoing ORP, found thatthe former had a higher probability ofexperiencing 30- and 90-day genitourinarycomplications.7 The inability ofRARP to leverage its alleged technicaladvances into improved functionaloutcomes in a community setting is agreat disappointment.
Claims of reduced perioperative painand quicker return to full activities with RARP are not supported by careful, prospectivenonrandomized observationalstudies.8,9 Likewise, RARP has beenassociated with increased miscellaneousmedical complications7 and diminishedperioperative patient safety.10 Thistechnology is not kinder or gentlercompared to an open surgery and mayexplain why regret is reported moreoften by men who underwent RARP.11
Value in health care has been definedas the ratio of benefit to cost.12 Anylevel of benefit of RARP over ORP mustaccount for the uniformly higher costsassociated with the robot. At the Universityof Pittsburgh Medical Center,RARP is performed at a $4,300 lossper case when considering both directand indirect costs.13 Median chargesassociated with RARP in the first postoperativeyear were $1,400 higher perpatient in a Medicare population whencompared to ORP.7 At a time whenhealth care expenditures are beingappropriately scrutinized, the value ofRARP to society—and not just to therobot’s sole manufacturer or thoseperforming the procedure—is dubious.
Dr. Nelson is the Frederic N. SchwentkerProfessor and Chair of the Department ofUrology at University of Pittsburgh Schoolof Medicine. He has been an ASCO membersince 1998 and has previously served on theScientific Program Committee.
- Ross HM, Kryvenko ON, Cowan JE, et al.Am J Surg Pathol. 2012;36:1346-52.
- Donin NM, Laze J, Zhou M, et al. Urology.2013;82:148-52.
- Sooriakumaran P, Haendler L, Nyberg, T,et al. Eur Urol. 2012;62:768-74.
- Suardi N, Ficarra V, Willemsen P, et al.Urology. 2012;79:133-8.
- Badani KK, Kaul S, Menon M. Cancer.2007;110:1951-8.
- Barry MJ, Gallagher PM, Skinner JS, et al.J Clin Oncol. 2012;30:513-8.
- Gandaglia G, Sammon JD, Chang SL, et al.J Clin Oncol. 2014;32:1419-26.
- Wood DP, Schulte R, Dunn RL, et al. Urology.2007;70:945-9.
- Webster TM, Herrell SD, Chang SS, et al.J Urol. 2005;174:912-4.
- Parsons JK, Messer K, Palazzi K, et al.JAMA Surg. doi:10.1001/jamasurg.2014.31.
- Schroeck FR, Krupski TL, Sun L, et al.Eur Urol. 2008;54:785-93.
- Porter ME. N Engl J Med. 2010;363:2477-81.
- Tomaszewski JJ, Matchett JC, Davies BJ,et al. Urology. 2012;80:126-9.
Robot-AssistedRadicalProstatectomyIs Superior toOpen RetropubicProstatectomy
By Quoc-Dien Trinh, MD, FRCSC
Brigham and Women’s Hospital, Dana-Farber Cancer Institute, and HarvardMedical School
Over the past decade, robot-assistedradical prostatectomy (RARP) hasreplaced open retropubic prostatectomy(ORP) as the most commonapproach for prostate cancer surgery.1Although there is much controversysurrounding the rapid adoption ofRARP—for example, the concern thatit is largely driven by market forcesrather than pure medical evidence—there are notable benefits to bederived from this technique.
For one, recent population-based datasuggest that RARP is associated withlower perioperative complication rates,at least in the general U.S. populationundergoing extirpative surgery forprostate cancer.1,2 A meta-analysisof 400 original research articlesalso showed that intraoperative andpostoperative complication rateswere lower with RARP relative to ORP.3 Conversely, a recent studyby Gandaglia et al. showed similarcomplication rates between RARP andORP,4 but these results were derivedfrom the Medicare population, whoare age 65 and older, and thus notapplicable to the general population,where the majority of patientsundergoing RARP are younger thanage 65 and have private insurance.
There is overwhelming evidence thatRARP is associated with decreasedblood loss, lower transfusion rates, andshorter length of hospital stay. Thesefindings have been substantiated andreproducible across multiple datasets,age categories,4 and countries,and have been further confirmed by arecent meta-analysis.3 Taken together,these observations confirm that theminimally invasive aspect of this surgicalapproach leads to better perioperativeoutcomes, and in consequence,better short- and mid-term recovery.5
Finally, a series of recently publishedmeta-analyses demonstrated superiorityof the robotic approach withregard to functional endpoints such aserectile/sexual function recovery6 andurinary continence recovery,7 whiledemonstrating equivalence8 or possiblysuperiority3 for oncologic endpoints.Although randomized studies addressingthis topic are scarce, two randomizedcontrolled trials examining erectileand/or urinary function recovery didshow some benefits for RARP relativeto pure laparoscopic radical prostatectomy.9,10 These functional findings areof utmost relevance, given that mostpatients with prostate cancer will notdie from prostate cancer, and long-termadverse outcomes are likely to affect apatient’s long-term quality of life.
It is important to highlight how difficultit is to perform comparative effectiveness studies using observationalsurgical data. These studies sufferfrom heterogeneity and publicationbias, an inherent challenge of benchmarkingthe performance of surgicaltechniques. The lack of standardizedendpoints evaluating functional outcomesfurther undermines the validityof studies comparing RARP with ORP.Regardless of such considerations,data are data: while there may beseries suggesting better results withORP for selected endpoints in a specificsetting, the systematic summationof published studies suggest superiorityof RARP for the aforementionedoutcomes. One cannot overstate thefact that choosing the surgeon ismore important than choosing thetechnique—famously summarized byone of my peers as, “Is it the Singer,the Song, or Both?”11 However, if oneassumes that adjustment for case mixis appropriately performed, the bestinterpretation of these data is that theoutcomes of the best RARP series (orsurgeons) are better than those of thebest ORP series (or surgeons); giventhe choice of RARP or ORP performedby an experienced surgeon, the vastmajority of informed patients wouldchoose the robotic approach.
From a broader public health perspective,the data need to be furtherpolished to better define the value ofrobot-assisted surgery, in the interestof limiting out-of-control health carecosts to society. However, if money isof no concern, the robotic approach issuperior in many tangible ways.
Dr. Trinh is an Assistant Professor of Surgeryand a Urologic Oncologist at Brighamand Women’s Hospital, Dana-Farber Cancer Institute, and Harvard Medical School. He isa Core Faculty at the Brigham and Women’sHospital Center for Surgery and PublicHealth. He currently serves as the AssociateEditor for Health Services at the BritishJournal of Urology (BJU) International.
- Trinh QD, Sammon J, Sun M, et al. EurUrol. 2012;61:679-85.
- Kowalczyk KJ, Levy JM, Caplan CF, et al.Eur Urol. 2012;61:803-9.
- Tewari A, Sooriakumaran P, Bloch DA, etal. Eur Urol. 2012;62:1-15.
- Gandaglia G, Sammon JD, Chang SL, et al.J Clin Oncol. 2014;32:1419-26.
- Hohwu L, Akre O, Pedersen KV, et al.Scand J Urol Nephrol. 2009;43:259-64.
- Ficarra V, Novara G, Ahlering TE, et al. EurUrol. 2012;62:418-30.
- Ficarra V, Novara G, Rosen RC, et al. EurUrol. 2012;62:405-17.
- Novara G, Ficarra V, Mocellin S, et al. EurUrol. 2012;62:382-404.
- Porpiglia F, Morra I, Lucci Chiarissi M, et al.Eur Urol. 2013;63:606-14.
- Asimakopoulos AD, Pereira Fraga CT,Annino F, et al. J Sex Med. 2011;8:1503-12.
- Cooperberg MR, Odisho AY, Carroll PR. JClin Oncol. 2012;30:476-8.