0022-534 7/92/14 73-0916$03.00/0 THE JOURNAL OF UROLOGY Copyright© 1992 by AMERICAN UROLOGICAL ASSOCIATION, INC.
Vol. 147,916, March 1992 Printed in U.S.A.
Editorial RADICAL SURGERY FOR ADVANCED PROSTATE CANCER AND FOR RADIATION FAILURES During the last decade improvements in surgical techniques have resulted in a dramatic reduction in blood loss and in the incidence of urinary incontinence, impotence and rectal injury associated with radical prostatectomy. These advances, along with the development of improved metnods of detecting radiation failures, including measurement of serum prostate specific antigen (PSA) levels, prostatic ultrasonography and automatic biopsy guns, have led to a substantial shift towards surgical treatment of nearly all stages of prostate cancer. It was not so long ago that the accepted dogma was that only patients with small clinical stage B tumors were legitimate candidates for radical prostatectomy. Now, urologists at some of our most prestigious institutions recommend radical prostatectomy for patients with stages A, B, C and Dl disease, as well as for those who have failed radiation therapy. "Neoadjuvant hormonal therapy" or "endocrine downstaging" is also commonly used for patients with bulky, clinically localized tumors and for those with extracapsular disease in hopes of enhancing the chances for subsequent complete tumor resection. Cystoprostatectomy or total pelvic exenteration is being performed more frequently for advanced disease and in radiation failures. This aggressive surgical approach is becoming so commonplace that soon it may be accepted as a "community standard" option that must be offered to all patients. There is no convincing evidence that these expanded indications for radical surgery for prostate cancer are justified. Why have they been so readily embraced by our profession? One reason is that there are no other potentially curative treatment options for these unfortunate patients. Another is that we have become proficient at performing these operations. Moreover, as surgeons, we want to make every reasonable effort to remove all of the cancer. However, are these efforts "reasonable," and do we accomplish anything other than providing an element of false hope and postponing the inevitable acceptance of the reality of the situation? It is my opinion (some may disagree) that we should not recommend radical cancer operations for most patients with stage C or Dl disease or for those who have failed radiation therapy. The case against radical surgery for stage C disease is that complete tumor excision is almost never achieved and there is no evidence that adjuvant hormonal or radiation therapy prolongs survival. Most evidence suggests that adequate local tumor control can be achieved in the vast majority of cases with the judicious use of radiation therapy, hormonal therapy and transurethral resection. It is questionable whether it is justified to perform a radical cancer operation on all patients to spare the small proportion who will have local problems not controlled by conservative means. Most of the reports, such as that by Kennedy et al (page 891), do not support the efficacy of endocrine downstaging. The case against radical prostatectomy in patients with lymph node metastasis is based on the preponderance of published data showing that adjuvant radiation therapy adds little, if anything, to survival in patients with lymph node metastases, and that while adjuvant hormonal therapy may delay cancer progression, it does not prolong survival. The latest update of the Mayo Clinic experience by Myers et al (page 910) provides no convincing evidence for any greater benefit. Their claim that patients with diploid cancers treated with radical surgery and early endocrine therapy did better than similar patients
treated without early endocrine therapy may be viewed skeptically by some biostatisticians as a possible example of "post hoc subset analysis" (dividing the data set into subsets increases the possibility that a "significant" difference will be found between sunsets by chance alone): Moreover~ their data still donot answer the question about how the patients would have done with early endocrine therapy without the radical surgery. Most published evidence suggests that about 30% of the patients with nodal metastases treated conservatively with hormonal therapy will require transurethral resection for local disease. Thus, the routine performance of radical prostatectomy in all patients with nodal metastases to prevent later local problems trades the morbidity of transurethral resection in 30% of the patients for that of radical prostatectomy in 100%. Although we have become more proficient at this operation, there is a finite incidence of postoperative complications even in the best of hands (Frazier et al, page 888; Borland and Walsh, page 905; Zincke, page 894; Leandri et al, page 883, and Ahlering et al, page 900), 1 and this does not appear to be a reasonable trade-off unless the surgeon has extraordinary expertise with the operation and demonstrated low operative morbidity and mortality rates. The case against salvage radical prostatectomy in radiation failures is as follows. The morbidity of salvage radical prostatectomy is high. Approximately 10% of the patients will have rectal injuries that will require colostomy for repair, as suggested by Borland and Walsh. Between 10 and 64 % of the patients will have postoperative urinary incontinence. Only about 30% of the patients will have pathologically specimen confined cancer with undetectable postoperative PSA levels. These complications and results are documented in the studies by Ahlering et al and by Zincke. Furthermore, node dissections are difficult or impossible to perform following radiation therapy. Taken together, the proportion of patients who have no rectal injury, normal postoperative continence and complete tumor resection with undetectable postoperative PSA levels (without adjuvant hormonal therapy) is only about 15 to 20% as reported by Ahlering et al. These poor prospects for an overall favorable result mitigate against recommending salvage radical prostatectomy in most patients. The performance of cystoprostatectomy or pelvic exenteration eliminates the risk of urinary incontinence but, as suggested by Zincke, it does not usually allow for complete tumor excision. These extensive operations also carry a substantial risk for postoperative morbidity and impose functional sacrifices in terms of the ilea! conduit or continent urinary diversion. There is no convincing evidence that the benefits of radical surgery offset the associated risks in patients with advanced prostate cancer or in those who have failed radiation therapy. The available evidence suggests that hormonal therapy alone provides equivalent therapeutic benefits with less potential for morbidity. William J. Catalana Division of Urologic Surgery Washington University Medical Center St. Louis, Missouri
916
REFERENCE 1. Fisher, R. E. and Koch, M. 0.: Recognition and management of
delayed disruption vesicourethral anastomosis in radical prostatectomy. J. Urol., in press.
Vol. 147,916, March 1992 Printed in U.S.A.
Editorial RADICAL SURGERY FOR ADVANCED PROSTATE CANCER AND FOR RADIATION FAILURES During the last decade improvements in surgical techniques have resulted in a dramatic reduction in blood loss and in the incidence of urinary incontinence, impotence and rectal injury associated with radical prostatectomy. These advances, along with the development of improved metnods of detecting radiation failures, including measurement of serum prostate specific antigen (PSA) levels, prostatic ultrasonography and automatic biopsy guns, have led to a substantial shift towards surgical treatment of nearly all stages of prostate cancer. It was not so long ago that the accepted dogma was that only patients with small clinical stage B tumors were legitimate candidates for radical prostatectomy. Now, urologists at some of our most prestigious institutions recommend radical prostatectomy for patients with stages A, B, C and Dl disease, as well as for those who have failed radiation therapy. "Neoadjuvant hormonal therapy" or "endocrine downstaging" is also commonly used for patients with bulky, clinically localized tumors and for those with extracapsular disease in hopes of enhancing the chances for subsequent complete tumor resection. Cystoprostatectomy or total pelvic exenteration is being performed more frequently for advanced disease and in radiation failures. This aggressive surgical approach is becoming so commonplace that soon it may be accepted as a "community standard" option that must be offered to all patients. There is no convincing evidence that these expanded indications for radical surgery for prostate cancer are justified. Why have they been so readily embraced by our profession? One reason is that there are no other potentially curative treatment options for these unfortunate patients. Another is that we have become proficient at performing these operations. Moreover, as surgeons, we want to make every reasonable effort to remove all of the cancer. However, are these efforts "reasonable," and do we accomplish anything other than providing an element of false hope and postponing the inevitable acceptance of the reality of the situation? It is my opinion (some may disagree) that we should not recommend radical cancer operations for most patients with stage C or Dl disease or for those who have failed radiation therapy. The case against radical surgery for stage C disease is that complete tumor excision is almost never achieved and there is no evidence that adjuvant hormonal or radiation therapy prolongs survival. Most evidence suggests that adequate local tumor control can be achieved in the vast majority of cases with the judicious use of radiation therapy, hormonal therapy and transurethral resection. It is questionable whether it is justified to perform a radical cancer operation on all patients to spare the small proportion who will have local problems not controlled by conservative means. Most of the reports, such as that by Kennedy et al (page 891), do not support the efficacy of endocrine downstaging. The case against radical prostatectomy in patients with lymph node metastasis is based on the preponderance of published data showing that adjuvant radiation therapy adds little, if anything, to survival in patients with lymph node metastases, and that while adjuvant hormonal therapy may delay cancer progression, it does not prolong survival. The latest update of the Mayo Clinic experience by Myers et al (page 910) provides no convincing evidence for any greater benefit. Their claim that patients with diploid cancers treated with radical surgery and early endocrine therapy did better than similar patients
treated without early endocrine therapy may be viewed skeptically by some biostatisticians as a possible example of "post hoc subset analysis" (dividing the data set into subsets increases the possibility that a "significant" difference will be found between sunsets by chance alone): Moreover~ their data still donot answer the question about how the patients would have done with early endocrine therapy without the radical surgery. Most published evidence suggests that about 30% of the patients with nodal metastases treated conservatively with hormonal therapy will require transurethral resection for local disease. Thus, the routine performance of radical prostatectomy in all patients with nodal metastases to prevent later local problems trades the morbidity of transurethral resection in 30% of the patients for that of radical prostatectomy in 100%. Although we have become more proficient at this operation, there is a finite incidence of postoperative complications even in the best of hands (Frazier et al, page 888; Borland and Walsh, page 905; Zincke, page 894; Leandri et al, page 883, and Ahlering et al, page 900), 1 and this does not appear to be a reasonable trade-off unless the surgeon has extraordinary expertise with the operation and demonstrated low operative morbidity and mortality rates. The case against salvage radical prostatectomy in radiation failures is as follows. The morbidity of salvage radical prostatectomy is high. Approximately 10% of the patients will have rectal injuries that will require colostomy for repair, as suggested by Borland and Walsh. Between 10 and 64 % of the patients will have postoperative urinary incontinence. Only about 30% of the patients will have pathologically specimen confined cancer with undetectable postoperative PSA levels. These complications and results are documented in the studies by Ahlering et al and by Zincke. Furthermore, node dissections are difficult or impossible to perform following radiation therapy. Taken together, the proportion of patients who have no rectal injury, normal postoperative continence and complete tumor resection with undetectable postoperative PSA levels (without adjuvant hormonal therapy) is only about 15 to 20% as reported by Ahlering et al. These poor prospects for an overall favorable result mitigate against recommending salvage radical prostatectomy in most patients. The performance of cystoprostatectomy or pelvic exenteration eliminates the risk of urinary incontinence but, as suggested by Zincke, it does not usually allow for complete tumor excision. These extensive operations also carry a substantial risk for postoperative morbidity and impose functional sacrifices in terms of the ilea! conduit or continent urinary diversion. There is no convincing evidence that the benefits of radical surgery offset the associated risks in patients with advanced prostate cancer or in those who have failed radiation therapy. The available evidence suggests that hormonal therapy alone provides equivalent therapeutic benefits with less potential for morbidity. William J. Catalana Division of Urologic Surgery Washington University Medical Center St. Louis, Missouri
916
REFERENCE 1. Fisher, R. E. and Koch, M. 0.: Recognition and management of
delayed disruption vesicourethral anastomosis in radical prostatectomy. J. Urol., in press.
