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Re: Reproducibility of Lymphoscintigraphy for Lymphatic Mapping in Patients With Penile Carcinoma
Letters to the Editor/Errata Re: Treatment Delay and Prognosis in Invasive Bladder Cancer
3.
F. Liedberg, H. Anderson and W. Månsson J Urol, 174: 1777–1781, 2005 To the Editor. We read with interest the article by Liedberg et al describing the effect of treatment delay on the prognosis of patients diagnosed with invasive bladder cancer. In their series of 141 cystectomies the authors concluded that delay in instituting curative treatment did not have a negative impact on cancer specific survival rates, contradicting widely cited previous reports.1,2 Our own data support the conclusions of Liedberg et al. In our prospective study of 112 consecutive patients 60 underwent radical cystectomy within 6 weeks of the decision to operate, whereas 52 waited for more than 6 weeks.3 The stage and grade distribution were similar in the 2 groups. There was no statistically significant difference in 5-year cancer specific outcomes between the 2 groups. How long can treatment be delayed without compromising the chance for cure? Wallace and Harris contend that the metastatic potential of these tumors is at least as important in determining survival as any delay in treatment.4 Wallace et al suggest that by the time the detrusor muscle is invaded tumor biology rather than treatment delay may have a greater effect on survival.5 Despite these results, one cannot advocate delay in treating invasive bladder cancer, and we concur with the editorial comment that even if there is no survival disadvantage in delaying treatment, appropriate treatment should be instituted as soon as possible, not in the least on the grounds of limiting patient anxiety. However, in practice treatment delays occur for a variety of reasons, clinical as well as nonclinical. In such instances it is important to reassure patients that such a delay will not have an adverse effect on their chance of cure. Respectfully, Shikohe Masood, Peter Pietrzak, Chryssanthos Kourief, Irina Vieira and G. R. Mufti Department of Urology Medway Maritime Hospital Gillingham, Kent United Kingdom 1.
2.
Sanchez-Ortiz, R. F., Huang, W. C., Mick, R., Van Arsdalen, K. N., Wein, A. J. and Malkowicz, S. B.: An interval longer than 12 weeks between the diagnosis of muscle invasion and cystectomy is associated with worse outcome in bladder carcinoma. J Urol, 169: 110, 2003 Chang, S. S., Hassan, J. M., Cookson, M. S., Wells, N. and Smith, J. A., Jr.: Delaying radical cystectomy for muscle invasive bladder cancer results in worse pathological stage. J Urol, 170: 1085, 2003
0022-5347/06/1756-2364/0 THE JOURNAL OF UROLOGY® Copyright © 2006 by AMERICAN UROLOGICAL ASSOCIATION
Masood, S., Naseem, M. S., Patel, H. R. H. and Mufti, G. R.: Does delay in radical cystectomy affect pathological stage and survival? BJU Int, suppl., 90: 198, abstract P-5.3.20, 2002 4. Wallace, D. M. and Harris, D. L.: Delay in treating bladder tumours. Lancet, 19: 332, 1965 5. Wallace, D. M., Bryan, R. T., Dunn, J. A., Begum, G. and Bathers, S. for the West Midlands Urological Research Group: Delay and survival in bladder cancer. BJU Int, 89: 868, 2002
Re: Reproducibility of Lymphoscintigraphy for Lymphatic Mapping in Patients With Penile Carcinoma B. K. Kroon, R. A. Valdés Olmos, H. van Tinteren, O. E. Nieweg and S. Horenblas J Urol, 174: 2214 –2217, 2005 To the Editor. We congratulate Kroon et al for this well performed and well documented study. However, a couple of points need to be addressed. The promising and highly convincing results in this and previous reports of the authors are the result of 10 years of routine clinical practice and frequent detailed self-analysis within this leading institution.1,2 The authors observed 100% reproducibility in this series of 20 patients but they also reported a false-negative rate of 16% in 140 patients who underwent sentinel lymph node biopsy (SLNB), which mainly occurred at the beginning of their clinical practice.1 We should learn the lesson that quality control is essential for SLNB in penile cancer. For breast cancer specific recommendations are defined for the implementation of SLNB at a qualified institution. The surgeons should be substantially experienced in conventional lymphadenectomy and should perform at least 50 breast surgeries with potential for 20 SLNBs annually. It is recommended that to learn the procedure, 20 SLNBs be performed with the assistance of an experienced surgeon at a breast center where the procedure is already clinically routine. Before routinely adopting the procedure in the clinic surgeons should complete 20 procedures followed by full lymphatic clearance with a false-negative rate of less than 5%.3 Transferring these recommendations to penile carcinoma, there are few institutions that fulfill these requirements. Moreover, success rates are not related exclusively to the surgical procedure itself. Sentinel lymph node biopsy in penile cancer entails an interdisciplinary team approach involving urologists, pathologists and nuclear medicine physicians. The availability of adequate nuclear medicine facilities and technical equipment, a histopathological evaluation protocol, and standardized documentation and evaluation are mandatory for quality control in SLNB.
2364
Vol. 175, 2364-2369, June 2006 Printed in U.S.A. DOI:10.1016/S0022-5347(06)00332-6
LETTERS TO THE EDITOR To offer equivalent staging accuracy but decreased morbidity by SLNB in penile cancer compared to inguinal lymphadenectomy, consideration of quality control appears indispensable for the implementation of SLNB in routine clinical practice. Due to the relative rareness of this disease, one must acknowledge that management of penile cancer belongs at specialized centers providing sufficient experience and quality assurance concerning SLNB. Unless great care is taken to achieve high levels of accuracy in SLNB, this procedure may lead to incorrect staging, which results in inappropriate management and decreased survival. The approach of “see one, do one, teach one” with respect to SLNB in penile cancer cannot be advised. Consensus recommendations of a dedicated committee comparable to those for breast cancer need to be established. Respectfully, Carsten Maik Naumann Christof van der Horst Christoph Seif Moritz Hamann Peter M. Braun and Klaus P. Juenemann Department of Urology and Pediatric Urology University Hospital Schleswig-Holstein Kiel, Germany 1.
Kroon, B. K., Horenblas, S., Meinhardt, W., van der Poel, H. G., Bex, A., van Tinteren, H. et al: Dynamic sentinel node biopsy in penile carcinoma: evaluation of 10 years experience. Eur Urol, 47: 601, 2005 2. Kroon, B. K., Horenblas, S., Estourgie, S. H., Lont, A. P., Valdes Olmos, R. A. and Nieweg, O. E.: How to avoid false-negative dynamic sentinel node procedures in penile carcinoma. J Urol, 171: 2191, 2004 3. Kuehn, T., Bembenek, A., Decker, T., Munz, D. L., Sautter-Bihl, M. L., Untch, M. et al: A concept for the clinical implementation of sentinel lymph node biopsy in patients with breast carcinoma with special regard to quality assurance. Cancer, 103: 451, 2005
Reply by Authors. We would like to thank Naumann et al for their valuable comments. We agree that dynamic sentinel node biopsy in penile carcinoma should be restricted to specialized centers because of the rarity of the disease. However, the number of procedures that should be performed in the learning phase is difficult to estimate. Data from our institute for breast cancer revealed that a learning phase of at least 150 procedures with 60 tumor positive cases is recommended to draw any reliable conclusion about the quality of sentinel node biopsy.1 But even in a common tumor type such as breast cancer these numbers are not realistic in daily practice, resulting in a workable compromise between the reliability of the results and the practically achievable number of procedures. Nevertheless, it is obvious that specialized centers are a must in the treatment of penile carcinoma. To facilitate centralization, patients could have the primary tumor treated at a general hospital, and be referred afterward for lymphatic mapping and sentinel node biopsy. It is our belief that results of paired lymphoscintigraphic examinations performed before and after excision of a penile carcinoma are reproducible because of the relatively simple lymphatic
2365
drainage pattern of the penis. Most lymphatics tend to drain to a few collecting lymphatic vessels that are located on the dorsal side of the penis. It may be anticipated that patients who already have had the primary tumor treated can also be safely offered a dynamic sentinel node biopsy. We are planning such a study soon. 1.
Tanis, P. J., Nieweg, O. E., Hart, A. A. and Kroon, B. B.: The illusion of the learning phase for lymphatic mapping. Ann Surg Oncol, 9: 142, 2002
Re: Treatment of Chronic Bacterial Prostatitis With Levofloxacin and Ciprofloxacin Lowers Serum Prostate Specific Antigen A. J. Schaeffer, S.-C. Wu, A. M. Tennenberg and J. B. Kahn J Urol, 174: 161–164, 2005 To the Editor. We read this article with keen interest. We see about 200 men with increased prostate specific antigen (PSA) levels annually at our combined practices, and have also observed that in a significant proportion of patients (approximately 40%) with increased serum PSA and negative digital rectal findings the PSA levels return to normal after a 4-week course of quinolones. However, the majority of our patients in this category (more than 80%) have PSA levels well in excess of 4 ng/ml. Indeed, 17% of these patients have PSA greater than 100 ng/ml. Initially, all of these men were biopsied. However, we have since changed our protocol after noticing that a high proportion of the specimens were reported as benign hyperplasia with foci of chronic prostatitis. We now empirically treat all patients with increased PSA and negative rectal examination (and without signs of metastasis) with a 4-week course of a quinolone, and repeat the PSA at 4 weeks. At the second visit those with a persistent increase in PSA are biopsied. With this protocol we have increased our prostate cancer detection rate while decreasing the morbidity from transrectal prostatic biopsies. Also, similar to the present study, we have found all quinolones (ciprofloxacin, ofloxacin and levofloxacin) equally effective in this regard, except in cases where urine culture showed sensitivity to a particular antibiotic. Thus, while agreeing with the authors that it is appropriate to give antibiotics in the presence of increased PSA and negative digital rectal examination findings, we would submit that this approach should not always be limited to PSA values less than 10 ng/ml, as advocated by the authors. Furthermore, our findings suggest that the assertion by others that the change in serum PSA value after antibiotic therapy has a positive predictive value of 85% for prostate cancer and could be used to improve the use of the marker in screening for prostate cancer in men with PSA levels of 4 to 10 ng/ml and nonsuspicious digital rectal examination could also be applied to men with much higher PSAs.1 Interestingly, our observations also provide evidence in contrast to a previous study advocating the use of PSA value 60 ng/ml or greater as a surrogate marker for prostate cancer, obviating
3.
F. Liedberg, H. Anderson and W. Månsson J Urol, 174: 1777–1781, 2005 To the Editor. We read with interest the article by Liedberg et al describing the effect of treatment delay on the prognosis of patients diagnosed with invasive bladder cancer. In their series of 141 cystectomies the authors concluded that delay in instituting curative treatment did not have a negative impact on cancer specific survival rates, contradicting widely cited previous reports.1,2 Our own data support the conclusions of Liedberg et al. In our prospective study of 112 consecutive patients 60 underwent radical cystectomy within 6 weeks of the decision to operate, whereas 52 waited for more than 6 weeks.3 The stage and grade distribution were similar in the 2 groups. There was no statistically significant difference in 5-year cancer specific outcomes between the 2 groups. How long can treatment be delayed without compromising the chance for cure? Wallace and Harris contend that the metastatic potential of these tumors is at least as important in determining survival as any delay in treatment.4 Wallace et al suggest that by the time the detrusor muscle is invaded tumor biology rather than treatment delay may have a greater effect on survival.5 Despite these results, one cannot advocate delay in treating invasive bladder cancer, and we concur with the editorial comment that even if there is no survival disadvantage in delaying treatment, appropriate treatment should be instituted as soon as possible, not in the least on the grounds of limiting patient anxiety. However, in practice treatment delays occur for a variety of reasons, clinical as well as nonclinical. In such instances it is important to reassure patients that such a delay will not have an adverse effect on their chance of cure. Respectfully, Shikohe Masood, Peter Pietrzak, Chryssanthos Kourief, Irina Vieira and G. R. Mufti Department of Urology Medway Maritime Hospital Gillingham, Kent United Kingdom 1.
2.
Sanchez-Ortiz, R. F., Huang, W. C., Mick, R., Van Arsdalen, K. N., Wein, A. J. and Malkowicz, S. B.: An interval longer than 12 weeks between the diagnosis of muscle invasion and cystectomy is associated with worse outcome in bladder carcinoma. J Urol, 169: 110, 2003 Chang, S. S., Hassan, J. M., Cookson, M. S., Wells, N. and Smith, J. A., Jr.: Delaying radical cystectomy for muscle invasive bladder cancer results in worse pathological stage. J Urol, 170: 1085, 2003
0022-5347/06/1756-2364/0 THE JOURNAL OF UROLOGY® Copyright © 2006 by AMERICAN UROLOGICAL ASSOCIATION
Masood, S., Naseem, M. S., Patel, H. R. H. and Mufti, G. R.: Does delay in radical cystectomy affect pathological stage and survival? BJU Int, suppl., 90: 198, abstract P-5.3.20, 2002 4. Wallace, D. M. and Harris, D. L.: Delay in treating bladder tumours. Lancet, 19: 332, 1965 5. Wallace, D. M., Bryan, R. T., Dunn, J. A., Begum, G. and Bathers, S. for the West Midlands Urological Research Group: Delay and survival in bladder cancer. BJU Int, 89: 868, 2002
Re: Reproducibility of Lymphoscintigraphy for Lymphatic Mapping in Patients With Penile Carcinoma B. K. Kroon, R. A. Valdés Olmos, H. van Tinteren, O. E. Nieweg and S. Horenblas J Urol, 174: 2214 –2217, 2005 To the Editor. We congratulate Kroon et al for this well performed and well documented study. However, a couple of points need to be addressed. The promising and highly convincing results in this and previous reports of the authors are the result of 10 years of routine clinical practice and frequent detailed self-analysis within this leading institution.1,2 The authors observed 100% reproducibility in this series of 20 patients but they also reported a false-negative rate of 16% in 140 patients who underwent sentinel lymph node biopsy (SLNB), which mainly occurred at the beginning of their clinical practice.1 We should learn the lesson that quality control is essential for SLNB in penile cancer. For breast cancer specific recommendations are defined for the implementation of SLNB at a qualified institution. The surgeons should be substantially experienced in conventional lymphadenectomy and should perform at least 50 breast surgeries with potential for 20 SLNBs annually. It is recommended that to learn the procedure, 20 SLNBs be performed with the assistance of an experienced surgeon at a breast center where the procedure is already clinically routine. Before routinely adopting the procedure in the clinic surgeons should complete 20 procedures followed by full lymphatic clearance with a false-negative rate of less than 5%.3 Transferring these recommendations to penile carcinoma, there are few institutions that fulfill these requirements. Moreover, success rates are not related exclusively to the surgical procedure itself. Sentinel lymph node biopsy in penile cancer entails an interdisciplinary team approach involving urologists, pathologists and nuclear medicine physicians. The availability of adequate nuclear medicine facilities and technical equipment, a histopathological evaluation protocol, and standardized documentation and evaluation are mandatory for quality control in SLNB.
2364
Vol. 175, 2364-2369, June 2006 Printed in U.S.A. DOI:10.1016/S0022-5347(06)00332-6
LETTERS TO THE EDITOR To offer equivalent staging accuracy but decreased morbidity by SLNB in penile cancer compared to inguinal lymphadenectomy, consideration of quality control appears indispensable for the implementation of SLNB in routine clinical practice. Due to the relative rareness of this disease, one must acknowledge that management of penile cancer belongs at specialized centers providing sufficient experience and quality assurance concerning SLNB. Unless great care is taken to achieve high levels of accuracy in SLNB, this procedure may lead to incorrect staging, which results in inappropriate management and decreased survival. The approach of “see one, do one, teach one” with respect to SLNB in penile cancer cannot be advised. Consensus recommendations of a dedicated committee comparable to those for breast cancer need to be established. Respectfully, Carsten Maik Naumann Christof van der Horst Christoph Seif Moritz Hamann Peter M. Braun and Klaus P. Juenemann Department of Urology and Pediatric Urology University Hospital Schleswig-Holstein Kiel, Germany 1.
Kroon, B. K., Horenblas, S., Meinhardt, W., van der Poel, H. G., Bex, A., van Tinteren, H. et al: Dynamic sentinel node biopsy in penile carcinoma: evaluation of 10 years experience. Eur Urol, 47: 601, 2005 2. Kroon, B. K., Horenblas, S., Estourgie, S. H., Lont, A. P., Valdes Olmos, R. A. and Nieweg, O. E.: How to avoid false-negative dynamic sentinel node procedures in penile carcinoma. J Urol, 171: 2191, 2004 3. Kuehn, T., Bembenek, A., Decker, T., Munz, D. L., Sautter-Bihl, M. L., Untch, M. et al: A concept for the clinical implementation of sentinel lymph node biopsy in patients with breast carcinoma with special regard to quality assurance. Cancer, 103: 451, 2005
Reply by Authors. We would like to thank Naumann et al for their valuable comments. We agree that dynamic sentinel node biopsy in penile carcinoma should be restricted to specialized centers because of the rarity of the disease. However, the number of procedures that should be performed in the learning phase is difficult to estimate. Data from our institute for breast cancer revealed that a learning phase of at least 150 procedures with 60 tumor positive cases is recommended to draw any reliable conclusion about the quality of sentinel node biopsy.1 But even in a common tumor type such as breast cancer these numbers are not realistic in daily practice, resulting in a workable compromise between the reliability of the results and the practically achievable number of procedures. Nevertheless, it is obvious that specialized centers are a must in the treatment of penile carcinoma. To facilitate centralization, patients could have the primary tumor treated at a general hospital, and be referred afterward for lymphatic mapping and sentinel node biopsy. It is our belief that results of paired lymphoscintigraphic examinations performed before and after excision of a penile carcinoma are reproducible because of the relatively simple lymphatic
2365
drainage pattern of the penis. Most lymphatics tend to drain to a few collecting lymphatic vessels that are located on the dorsal side of the penis. It may be anticipated that patients who already have had the primary tumor treated can also be safely offered a dynamic sentinel node biopsy. We are planning such a study soon. 1.
Tanis, P. J., Nieweg, O. E., Hart, A. A. and Kroon, B. B.: The illusion of the learning phase for lymphatic mapping. Ann Surg Oncol, 9: 142, 2002
Re: Treatment of Chronic Bacterial Prostatitis With Levofloxacin and Ciprofloxacin Lowers Serum Prostate Specific Antigen A. J. Schaeffer, S.-C. Wu, A. M. Tennenberg and J. B. Kahn J Urol, 174: 161–164, 2005 To the Editor. We read this article with keen interest. We see about 200 men with increased prostate specific antigen (PSA) levels annually at our combined practices, and have also observed that in a significant proportion of patients (approximately 40%) with increased serum PSA and negative digital rectal findings the PSA levels return to normal after a 4-week course of quinolones. However, the majority of our patients in this category (more than 80%) have PSA levels well in excess of 4 ng/ml. Indeed, 17% of these patients have PSA greater than 100 ng/ml. Initially, all of these men were biopsied. However, we have since changed our protocol after noticing that a high proportion of the specimens were reported as benign hyperplasia with foci of chronic prostatitis. We now empirically treat all patients with increased PSA and negative rectal examination (and without signs of metastasis) with a 4-week course of a quinolone, and repeat the PSA at 4 weeks. At the second visit those with a persistent increase in PSA are biopsied. With this protocol we have increased our prostate cancer detection rate while decreasing the morbidity from transrectal prostatic biopsies. Also, similar to the present study, we have found all quinolones (ciprofloxacin, ofloxacin and levofloxacin) equally effective in this regard, except in cases where urine culture showed sensitivity to a particular antibiotic. Thus, while agreeing with the authors that it is appropriate to give antibiotics in the presence of increased PSA and negative digital rectal examination findings, we would submit that this approach should not always be limited to PSA values less than 10 ng/ml, as advocated by the authors. Furthermore, our findings suggest that the assertion by others that the change in serum PSA value after antibiotic therapy has a positive predictive value of 85% for prostate cancer and could be used to improve the use of the marker in screening for prostate cancer in men with PSA levels of 4 to 10 ng/ml and nonsuspicious digital rectal examination could also be applied to men with much higher PSAs.1 Interestingly, our observations also provide evidence in contrast to a previous study advocating the use of PSA value 60 ng/ml or greater as a surrogate marker for prostate cancer, obviating