Noninvasive Staging Techniques 9511 Close Surveillance

The basis of close surveillance involves a regular clinical examination of the patient proceeding to lymphadenectomy when lymph node metastases become clinically evident. This avoids the morbidity associated with lymphadenectomy and therefore patients with cN0 disease who subsequently are unlikely to develop inguinal lymph node metastases are not overtreated. While this has been advocated in the past, with seemingly good results, recent non-randomized retrospective studies indicate that this approach is associated with a negative effect on survival rates.24,26 McDougal argued a shift in philosophy toward prophylactic lymphadenectomy.24 In his report which included 27 cN0 patients, a survival advantage was described in patients undergoing prophylactic inguinal lymphadenectomy (11/12 survivors) versus therapeutic inguinal lymphadenectomy (1/3 survivors). Furthermore, 10/12 patients who had no regional treatment at diagnosis presented with metastatic inoperable disease during follow-up.24 Lont et al. have shown that the 3-years disease-specific survival of 68 patients treated with surgical staging (by dynamic sentinel node biopsy) and completion ipsilateral inguinal lymphadenectomy (only if the sentinel node was tumor-positive) was 91% compared with 79% of a historical cohort of 85 patients managed with active surveillance whereby lymphadenectomy was performed when the inguinal nodes became clinically evident.25 Thus, immediate resection of clinically occult metastases in comparison with lymphadenectomy only when metastases are clinically apparent has shown to substantially improve survival rates.24-26 Another disadvantage of close surveillance is that, despite a rigid follow-up, patients may still develop inoperable inguinal nodal disease. As there are currently no curative chemotherapeutic regimens available for the treatment of disseminated disease, early surgical staging and/or lymphadenectomy is the preferred option. Therefore, surveillance has gradually lost its role in managing all cN0-patients. Such management remains an option only in those patients at low risk for occult metastases, e.g. patients with pTis, pTa, and pT1G1 tumors. Patients with pTis and pTa tumors have a very low risk of metastatic disease, while the chance of occult metastases in pT1G1 tumors is estimated to be 0-5%.43

A recently published series by Hughes et al. has shown that the chance of regional nodal involvement of 105 cN0 patients with T1G2 tumors is 9%. This figure is probably more reliable than previously published risk estimates of 0-50%,10,44 given the large cohort in Hughes' study. The incidences of regional nodal involvement of patients with T1G3 or T2-4 tumors are reported to range between 68% and 73%.9,43,45 However, two recent studies have shown that the risk of regional involvement are considerably lower ranging from 18% to 23%.10 Given the aforementioned risk estimates of the different tumors, the 2009 EAU guidelines advise minimally invasive staging in cN0 patients with at least a T1G2 tumor and surveillance in Tis, Ta, and T1G1 tumors.30 Predictive Nomogram for Occult Metastasis

Another non-invasive approach is the use of a preoperative nomogram predictive of inguinal metastases.46 In one nomogram the following parameters were used for risk assessment: tumor thickness (<5 mm vs. >5 mm), growth pattern (vertical vs. horizontal), grade (well vs. intermediate vs. poor), lymphovascular invasion (absent vs. present), corpora cavernosa infiltration (absent vs. present), corpora spongiosum infiltration (absent vs. present), urethral infiltration (absent vs. present), cN-status (cN0 vs. cN+). In clinical practice this particular nomogram may be a useful tool but still requires validation. It remains to the discretion of the doctor in collaboration with the patient to determine at which cut-off point to embark on a lymphadenectomy. Risk-Adapted Lymphadenectomy

The basis of risk-adapted approaches is risk assessment for harboring lymph node metastases based on histopathological features in the primary tumor, such as tumor stage (T-stage),43,47 tumor grade (i.e. grade (G) 1, 2, or 3),47-49 presence of lymphovascular invasion (LVI),50,51 perineural invasion (PNI)48,49 and depth of infiltration.48 The EAU guidelines have included tumor stage, grade, and absence or presence of LVI into a risk-adapted approach for the management of the inguinal regions. Three risk-groups have been identified: low-risk tumors (pTis, pTa, pT1G1), intermediate-risk tumors (pT1G2, no LVI), and high-risk tumors (pT1G3, pT2-3 G1-3, or presence of

LVI).943 if patients are considered suitable for surveillance, the 2009 EAU guidelines advise follow-up in patients with low-risk tumors only, and surgical staging in intermediate and high-risk cN0-patients. In a prospective study of 100 patients managed according to these EAU guidelines, none of the patients considered "low-risk" developed lymph node metastases during a mean follow-up of 29 months. On the other hand, elective lymphadenectomy was unnecessary in 82% of the patients with high-risk features, because no evidence of metastatic spread was found with histo-pathology.10 In another series of 118 patients it was estimated that 63% of high-risk patients will be subjected to unnecessary lymphadenectomy.52 Both studies indicate that the current EAU high-risk stratification is not accurate enough in order to stratify these patients. It appears that the risk of occult nodal involvement in cN0 patients with low-risk (T1G1) is low and these patients can still be subjected to close surveillance with subsequent inguinal lymphadenectomy when metastases become clinically evident.

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