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Morbidity of Inguinal Lymphadenectomy for Invasive Penile Carcinoma
1584
BLADDER, PENIS AND URETHRAL CANCER, AND BASIC PRINCIPLES OF ONCOLOGY
Para-Aortic Irradiation for Stage I Testicular Seminoma: Results of a Prospective Study in 675 Patients. A Trial of the German Testicular Cancer Study Group (GTCSG) J. CLASSEN, H. SCHMIDBERGER, C. MEISNER, C. WINKLER, J. DUNST, R. SOUCHON, L. WEISSBACH, V. BUDACH, W. ALBERTI AND M. BAMBERG, Department of Radiation Oncology, Universita¨tsklinikum and Institute for Medical Information Processing, Tu¨bingen University, Tu¨bingen, Departments of Radiation Oncology, Universita¨tsklinikum, Go¨ttingen, Dresden, Halle/Saale and Hamburg, Department of Radiation Oncology, Allgemeines Krankenhaus, Hagen, Department of Urology, Euromed Clinic, Fu¨rth and Department of Radiation Oncology, Klinikum Charite´, Berlin, Germany Br J Cancer, 90: 2305–2311, 2004 A prospective nonrandomised trial was performed in order to evaluate tumour control and toxicity of low-dose adjuvant radiotherapy in stage I seminoma with treatment portals confined to the para-aortic lymph nodes. Between April 1991 and March 1994, 721 patients were enrolled for the trial by 48 centres in Germany. Patients with pure seminoma and no evidence of lymph node involvement or distant metastases received 26 Gy prophylactic limited para-aortic radiotherapy. Disease-free survival at 5 years was the primary end point. With a median follow-up of 61 months, 675 patients with follow-up investigations were evaluable for this analysis. Kaplan-Meier estimates of disease-free and disease-specific survival were 95.8% (95% CI: 94.2–97.4) and 99.6% (95% CI: 99.2–100%) at 5 years and 94.9% (95% CI: 92.5–97.4%) and 99.6% (95% CI: 99.2–100%) at 8 years, respectively. A total of 26 patients relapsed. All except two were salvaged from relapse. In all, 21 recurrences were located in infradiaphragmatic lymph nodes without any ‘in-field’ relapse. Nausea and diarrhoea grade 3 were observed in 4.0 and 1.0% of the patients, respectively. Grade 3 late effects have not been observed so far. The results of our trial lend further support to the concept of limited para-aortic irradiation as the recently defined new standard of radiotherapy in stage I seminoma. There is no obvious compromise in disease-specific or disease-free survival compared to more extensive hockey-stick portals, which were used as standard portals at the time this study was initiated. Editorial Comment: Patients with stage I testicular seminoma have an excellent prognosis, with cure rates after orchiectomy and adjuvant radiation therapy approaching 95%. Radiation target volumes have been minimized to the infradiaphragmatic para-aortic and ipsilateral iliac lymph nodes to minimize complications. The authors have performed a prospective multicenter trial to evaluate the potential of small volume para-aortic irradiation, eliminating the ipsilateral iliac lymph nodes (hockey stick portals). Candidates were patients with pure seminoma and no evidence of lymph node involvement, receiving 2,600 cGy prophylactic radiation limited to the para-aortic region. Acute toxicity was dominated by grade 1 nausea noted in almost half of the patients. Diarrhea was infrequent. A total of 17 patients (2.5%) had development of secondary tumors of a variety of histological subtypes. Disease-free survival was 95% at 8 years. Of the 26 recurrences 21 were located infradiaphragmatically but were not in field relapses. The authors concluded that limited portals in a large study population are safe and feasible, with excellent cure rates and low treatment related toxicity. Jerome P. Richie, M.D.
UROLOGICAL ONCOLOGY: BLADDER, PENIS AND URETHRAL CANCER, AND BASIC PRINCIPLES OF ONCOLOGY Morbidity of Inguinal Lymphadenectomy for Invasive Penile Carcinoma O. BOUCHOT, J. RIGAUD, F. MAILLET, J. F. HETET AND G. KARAM, Clinique Urologique, CHU Hoˆtel Dieu, Nantes Cedex, France Eur Urol, 45: 761–766, 2004 Objective: To determine the incidence and the consequences of complications related to modified and radical inguinal lymphadenectomy in patients with invasive penile carcinoma, defined by invasion of the corpus spongiosum or cavernosum (ⱖT2). Materials and Methods: A total of 118 modified (67.0%), and 58 radical (33.0%) inguinal lymphadenectomy were performed in 88 patients between 1989 and 2000. To decrease the morbidity, radical inguinal lymphadenectomy was proposed only in patients with palpable inguinal lymph nodes, uni- or bilaterally (N1 or N2). Modified inguinal lymphadenectomy was performed bilaterally in patients with invasive penile carcinoma and non-palpable inguinal lymph nodes (N0), and unilaterally in the side without inguinal
BLADDER, PENIS AND URETHRAL CANCER, AND BASIC PRINCIPLES OF ONCOLOGY
metastases in N1 patients. Complications were assessed retrospectively with a median follow-up of 46 months and classified as early (event observed during the 30 days after the procedure) or late (event present after hospitalisation or after the first months). Results: A total of 74 complications after 176 procedures were recorded. After modified inguinal lymphadenectomy, 8 early (6.8%) and 4 late (3.4%) complications were observed. There were a total of 110 dissections with no complications and 8 dissections with 1 or 2 complications. After radical inguinal lymphadenectomy, the morbidity increased with 24 early (41.4%) and 25 late (43.1%) complications, observed in only 18 of 58 radical procedures. Leg oedema was the most common late complication, interfering with ambulation in 13 cases (22.4%). Conclusion: Modified inguinal lymphadenectomy, with saphenous vein sparing and limited dissection offers excellent functional outcome in patients with invasive penile carcinoma and nonpalpable inguinal lymph nodes. The morbidity after radical lymphadenectomy still significant, especially in patients with multiple or bilateral superficial inguinal lymph nodes treated by pelvic and bilateral inguinal lymphadenectomy. Editorial Comment: The early complication rate of 6.8% in modified inguinal lymphadenectomy for clinically negative inguinal lymph nodes in invasive carcinoma of the penis was remarkably low in this study. Could the low incidence of lymphocele formation or lymph drainage be related to the use of a tissue adhesive to afford better approximation of the tissues? Management of clinically negative lymph nodes in penile cancer is always a source of consternation. Currently, modified inguinal lymphadenectomy seems to be the safest route, with a low, but not trivial, complication rate. Nevertheless, the concept of dynamic sentinel lymph node biopsy is becoming well established in other diseases, particularly melanoma, a similar cutaneous disease. I hope the lessons learned from melanoma and breast cancer dynamic lymph node staging can be translated to penile cancer. James E. Montie, M.D.
1585
BLADDER, PENIS AND URETHRAL CANCER, AND BASIC PRINCIPLES OF ONCOLOGY
Para-Aortic Irradiation for Stage I Testicular Seminoma: Results of a Prospective Study in 675 Patients. A Trial of the German Testicular Cancer Study Group (GTCSG) J. CLASSEN, H. SCHMIDBERGER, C. MEISNER, C. WINKLER, J. DUNST, R. SOUCHON, L. WEISSBACH, V. BUDACH, W. ALBERTI AND M. BAMBERG, Department of Radiation Oncology, Universita¨tsklinikum and Institute for Medical Information Processing, Tu¨bingen University, Tu¨bingen, Departments of Radiation Oncology, Universita¨tsklinikum, Go¨ttingen, Dresden, Halle/Saale and Hamburg, Department of Radiation Oncology, Allgemeines Krankenhaus, Hagen, Department of Urology, Euromed Clinic, Fu¨rth and Department of Radiation Oncology, Klinikum Charite´, Berlin, Germany Br J Cancer, 90: 2305–2311, 2004 A prospective nonrandomised trial was performed in order to evaluate tumour control and toxicity of low-dose adjuvant radiotherapy in stage I seminoma with treatment portals confined to the para-aortic lymph nodes. Between April 1991 and March 1994, 721 patients were enrolled for the trial by 48 centres in Germany. Patients with pure seminoma and no evidence of lymph node involvement or distant metastases received 26 Gy prophylactic limited para-aortic radiotherapy. Disease-free survival at 5 years was the primary end point. With a median follow-up of 61 months, 675 patients with follow-up investigations were evaluable for this analysis. Kaplan-Meier estimates of disease-free and disease-specific survival were 95.8% (95% CI: 94.2–97.4) and 99.6% (95% CI: 99.2–100%) at 5 years and 94.9% (95% CI: 92.5–97.4%) and 99.6% (95% CI: 99.2–100%) at 8 years, respectively. A total of 26 patients relapsed. All except two were salvaged from relapse. In all, 21 recurrences were located in infradiaphragmatic lymph nodes without any ‘in-field’ relapse. Nausea and diarrhoea grade 3 were observed in 4.0 and 1.0% of the patients, respectively. Grade 3 late effects have not been observed so far. The results of our trial lend further support to the concept of limited para-aortic irradiation as the recently defined new standard of radiotherapy in stage I seminoma. There is no obvious compromise in disease-specific or disease-free survival compared to more extensive hockey-stick portals, which were used as standard portals at the time this study was initiated. Editorial Comment: Patients with stage I testicular seminoma have an excellent prognosis, with cure rates after orchiectomy and adjuvant radiation therapy approaching 95%. Radiation target volumes have been minimized to the infradiaphragmatic para-aortic and ipsilateral iliac lymph nodes to minimize complications. The authors have performed a prospective multicenter trial to evaluate the potential of small volume para-aortic irradiation, eliminating the ipsilateral iliac lymph nodes (hockey stick portals). Candidates were patients with pure seminoma and no evidence of lymph node involvement, receiving 2,600 cGy prophylactic radiation limited to the para-aortic region. Acute toxicity was dominated by grade 1 nausea noted in almost half of the patients. Diarrhea was infrequent. A total of 17 patients (2.5%) had development of secondary tumors of a variety of histological subtypes. Disease-free survival was 95% at 8 years. Of the 26 recurrences 21 were located infradiaphragmatically but were not in field relapses. The authors concluded that limited portals in a large study population are safe and feasible, with excellent cure rates and low treatment related toxicity. Jerome P. Richie, M.D.
UROLOGICAL ONCOLOGY: BLADDER, PENIS AND URETHRAL CANCER, AND BASIC PRINCIPLES OF ONCOLOGY Morbidity of Inguinal Lymphadenectomy for Invasive Penile Carcinoma O. BOUCHOT, J. RIGAUD, F. MAILLET, J. F. HETET AND G. KARAM, Clinique Urologique, CHU Hoˆtel Dieu, Nantes Cedex, France Eur Urol, 45: 761–766, 2004 Objective: To determine the incidence and the consequences of complications related to modified and radical inguinal lymphadenectomy in patients with invasive penile carcinoma, defined by invasion of the corpus spongiosum or cavernosum (ⱖT2). Materials and Methods: A total of 118 modified (67.0%), and 58 radical (33.0%) inguinal lymphadenectomy were performed in 88 patients between 1989 and 2000. To decrease the morbidity, radical inguinal lymphadenectomy was proposed only in patients with palpable inguinal lymph nodes, uni- or bilaterally (N1 or N2). Modified inguinal lymphadenectomy was performed bilaterally in patients with invasive penile carcinoma and non-palpable inguinal lymph nodes (N0), and unilaterally in the side without inguinal
BLADDER, PENIS AND URETHRAL CANCER, AND BASIC PRINCIPLES OF ONCOLOGY
metastases in N1 patients. Complications were assessed retrospectively with a median follow-up of 46 months and classified as early (event observed during the 30 days after the procedure) or late (event present after hospitalisation or after the first months). Results: A total of 74 complications after 176 procedures were recorded. After modified inguinal lymphadenectomy, 8 early (6.8%) and 4 late (3.4%) complications were observed. There were a total of 110 dissections with no complications and 8 dissections with 1 or 2 complications. After radical inguinal lymphadenectomy, the morbidity increased with 24 early (41.4%) and 25 late (43.1%) complications, observed in only 18 of 58 radical procedures. Leg oedema was the most common late complication, interfering with ambulation in 13 cases (22.4%). Conclusion: Modified inguinal lymphadenectomy, with saphenous vein sparing and limited dissection offers excellent functional outcome in patients with invasive penile carcinoma and nonpalpable inguinal lymph nodes. The morbidity after radical lymphadenectomy still significant, especially in patients with multiple or bilateral superficial inguinal lymph nodes treated by pelvic and bilateral inguinal lymphadenectomy. Editorial Comment: The early complication rate of 6.8% in modified inguinal lymphadenectomy for clinically negative inguinal lymph nodes in invasive carcinoma of the penis was remarkably low in this study. Could the low incidence of lymphocele formation or lymph drainage be related to the use of a tissue adhesive to afford better approximation of the tissues? Management of clinically negative lymph nodes in penile cancer is always a source of consternation. Currently, modified inguinal lymphadenectomy seems to be the safest route, with a low, but not trivial, complication rate. Nevertheless, the concept of dynamic sentinel lymph node biopsy is becoming well established in other diseases, particularly melanoma, a similar cutaneous disease. I hope the lessons learned from melanoma and breast cancer dynamic lymph node staging can be translated to penile cancer. James E. Montie, M.D.
1585