Protocol for the Examination of Specimens From Patients With Invasive Carcinoma of Renal Tubular Origin

The College of American Pathologists offers these protocols to assist pathologists in providing clinically useful and relevant information when reporting results of surgical specimen examinations. The College regards the reporting elements in the “Surgical Pathology Cancer Case Summary (Checklist)” portion of the protocols as essential elements of the pathology report. However, the manner in which these elements are reported is at the discretion of each specific pathologist, taking into account clinician preferences, institutional policies, and individual practice.The College developed these protocols as an educational tool to assist pathologists in the useful reporting of relevant information. It did not issue the protocols for use in litigation, reimbursement, or other contexts. Nevertheless, the College recognizes that the protocols might be used by hospitals, attorneys, payers, and others. Indeed, effective January 1, 2004, the Commission on Cancer of the American College of Surgeons mandated the use of the checklist elements of the protocols as part of its Cancer Program Standards for Approved Cancer Programs. Therefore, it becomes even more important for pathologists to familiarize themselves with these documents. At the same time, the College cautions that use of the protocols other than for their intended educational purpose may involve additional considerations that are beyond the scope of these documents.This protocol applies to invasive carcinoma of renal tubular origin only. Wilms tumors and tumors of urothelial origin are not included. The 7th edition TNM staging system for carcinoma of the kidney of the American Joint Committee on Cancer (AJCC) and the International Union Against Cancer (UICC) is recommended.Note: Checklist Is Optional for Biopsy SpecimensSelect a Single Response Unless Otherwise Indicated*Data elements with asterisks are not required. However, these elements may be clinically important but are not yet validated or regularly used in patient management.*Procedure*Specimen Laterality*Histologic Type (note A)*Sarcomatoid Features (note B)*Histologic Grade (Fuhrman Nuclear Grade) (note C)*Additional Pathologic Findings*Comment(s): ____________________________________Select a Single Response Unless Otherwise Indicated*Data elements with asterisks are not required. However, these elements may be clinically important but are not yet validated or regularly used in patient management.Procedure (note D)Specimen Laterality*Tumor Site (select all that apply)Tumor Size (largest tumor if multiple)Greatest dimension: ___ cm*Additional dimensions: ___ × ___ cm___ Cannot be determined (see “Comment”)Tumor FocalityMacroscopic Extent of Tumor (select all that apply) (note E)Histologic Type (note A)Sarcomatoid Features (note B)*Tumor Necrosis (any amount)Histologic Grade (Fuhrman Nuclear Grade) (note C)Microscopic Tumor Extension (select all that apply)Margins (select all that apply) (note F)*Lymph-Vascular Invasion (excluding renal vein and its muscle containing segmental branches and inferior vena cava)Pathologic Staging (pTNM) (note G)TNM Descriptors (required only if applicable) (select all that apply)Primary Tumor (pT)Regional Lymph Nodes (pN)Distant Metastasis (pM)Pathologic Findings in Nonneoplastic Kidney (select all that apply) (note H)*Other Tumors and/or Tumorlike Lesions (select all that apply)*Comment(s): ____________________________________The histopathologic classification published by the World Health Organization (WHO)1 and the Armed Forces Institute of Pathology2 is recommended for usage.Clear cell renal cell carcinomaMultilocular clear cell renal cell carcinomaPapillary renal cell carcinoma*Chromophobe renal cell carcinomaCarcinoma of the collecting ducts of BelliniRenal medullary carcinomaXp11 translocation carcinomasCarcinoma associated with neuroblastomaMucinous tubular and spindle cell carcinomaTubulocystic renal cell carcinoma†Renal cell carcinoma, unclassifiedOccasionally more than one histologic type of carcinoma occurs within the same kidney specimen. Each tumor type should be separately recorded along with its associated prognostic factors.Sarcomatoid carcinoma is not a specific morphogenetic subtype of renal cell carcinoma but is considered a pattern of dedifferentiation.1,2 Sarcomatoid change in a renal cell carcinoma is associated with an adverse outcome.8 Sarcomatoid morphology may be found in renal cell carcinomas of clear cell, papillary, chromophobe, collecting duct, and unclassified subtypes.9–14 When the background carcinoma subtype is recognized, it should be specified under histologic type (see note A). Pure sarcomatoid carcinoma or sarcomatoid carcinoma associated with epithelial elements that do not conform to usual renal carcinoma cell types should be considered unclassified renal cell carcinoma.There is some indication that the percentage of sarcomatoid components in a renal cell carcinoma has prognostic importance.13,14The following grading scheme for renal cell carcinoma, developed by Fuhrman et al,15 is recommended and shown below. Beyond clear cell renal cell carcinoma, Fuhrman grading has not been fully established for each histologic subtype of renal parenchymal neoplasia.16 The protocol does not preclude the use of other grading schemes.16,17 The system of grading should be specified in the pathologist's report. Scoring is based on the worst (highest) grade present in the tumor, even if it constitutes only a minor component.A standard radical nephrectomy specimen consists of the entire kidney, including the calyces, pelvis, and a variable length of ureter. The adrenal gland is usually removed en bloc with the kidney. The entire perirenal fatty tissue is removed to the level of Gerota fascia, a membranous structure that is similar to the consistency of the renal capsule that encases the kidney in perirenal fat. Variable lengths of the major renal vessels at the hilus are submitted.Regional lymphadenectomy is not generally performed even with a radial nephrectomy. A few lymph nodes may occasionally be seen in the renal hilus around major vessels. Other regional lymph nodes (eg, paracaval, para-aortic, and retroperitoneal) may be submitted separately.A partial nephrectomy specimen may vary from a simple enucleation of the tumor to part of a kidney containing variable portions of calyceal or renal pelvic collecting system. The perirenal fat immediately overlying the resected portion of the kidney, but not to a level of Gerota fascia, is usually included.A careful gross analysis and description of the tumor extension in a nephrectomy specimen is important and should guide the blocking of tissue samples for histologic assessment. Careful documentation of the tumor extension beyond kidney into perinephric fat and Gerota fascia provides important staging information. Renal sinus fat involvement in renal cell carcinoma is an underrecognized phenomenon.18 The renal sinus is an important pathway of spread for renal cell carcinoma (Figure 1, A and B). The renal sinus fat should be carefully assessed and generously sampled to detect renal sinus fat involvement. There is evolving literature suggesting that renal sinus fat involvement predicts a more aggressive outcome than peripheral perinephric fat invasion.19,20 When renal carcinoma involves the adrenal gland, it is important to document whether the involvement is a contiguous spread of the tumor or a separate (noncontiguous) nodule of carcinoma, the latter representing metastatic disease (pM1) (Figure 2).In a partial nephrectomy specimen, the renal parenchymal margin should be inked and histologically assessed. Most partial nephrectomy specimens also contain a portion of perinephric fat overlying the tumor site. The perirenal fat margin should also be assessed. In situations where no perirenal fat is present, the renal capsular margin should be inked and examined histologically.In radical nephrectomy specimens, the ureteric, major vascular (renal vein, renal artery), and soft tissue (Gerota fascia, renal sinus) margins should be examined and documented in the report.The TNM staging system of the AJCC and the UICC for renal cell carcinoma is recommended.21,22By AJCC/UICC convention, the designation “T” refers to a primary tumor that has not been previously treated. The symbol “p” refers to the pathologic classification of the TNM, as opposed to the clinical classification, and is based on gross and microscopic examination. pT entails a resection of the primary tumor or biopsy adequate to evaluate the highest pT category, pN entails removal of nodes adequate to validate lymph node metastasis, and pM implies microscopic examination of distant lesions. Clinical classification (cTNM) is usually carried out by the referring physician before treatment during initial evaluation of the patient or when pathologic classification is not possible.Pathologic staging is usually performed after surgical resection of the primary tumor. Pathologic staging depends on pathologic documentation of the anatomic extent of disease, whether or not the primary tumor has been completely removed. If a biopsied tumor is not resected for any reason (eg, when technically unfeasible) and if the highest T and N categories or the M1 category of the tumor can be confirmed microscopically, the criteria for pathologic classification and staging have been satisfied without total removal of the primary cancer.For identification of special cases of TNM or pTNM classifications, the “m” suffix and “y,” “r,” and “a” prefixes are used. Although they do not affect the stage grouping, they indicate cases needing separate analysis.The “m” suffix indicates the presence of multiple primary tumors in a single site and is recorded in parentheses: pT(m)NM.The “y” prefix indicates those cases in which classification is performed during or following initial multimodality therapy (ie, neoadjuvant chemotherapy, radiation therapy, or both chemotherapy and radiation therapy). The cTNM or pTNM category is identified by a “y” prefix. The ycTNM or ypTNM categorizes the extent of tumor actually present at the time of that examination. The “y” categorization is not an estimate of the tumor before multimodality therapy (ie, before initiation of neoadjuvant therapy).The “r” prefix indicates a recurrent tumor when staged after a documented disease-free interval: rTNM.The “a” prefix designates the stage determined at autopsy: aTNM.Tumor remaining in a patient after therapy with curative intent (eg, surgical resection for cure) is categorized by a system known as the R classification, shown below.For the surgeon, the R classification may be useful to indicate the known or assumed status of the completeness of a surgical excision. For the pathologist, the R classification is relevant to the status of the margins of a surgical resection specimen. That is, tumor involving the resection margin on pathologic examination may be assumed to correspond to residual tumor in the patient and may be classified as macroscopic or microscopic according to the findings at the specimen margin(s).By AJCC/UICC convention, vessel invasion (lymphatic or venous) does not affect the T category, indicating the local extent of tumor, unless specifically included in the definition of a T category. In all other cases, lymphatic and venous invasion by tumor are coded separately.It is important to recognize that medical kidney diseases may be present in nonneoplastic renal tissue in nephrectomy and nephroureterectomy specimens.23,24 Arterionephrosclerosis (or hypertensive nephropathy) and diabetic nephropathy are seen in approximately 30% and 20% of cases, respectively. Other medical renal diseases that have been identified include thrombotic microangiopathy, focal segmental glomerulosclerosis, and immunoglobulin A nephropathy. The findings of greater than 20% global glomerulosclerosis or advanced diffuse diabetic glomerulosclerosis are predictive of significant decline in renal function 6 months after radical nephrectomy.24 Evaluation for medical renal disease should be performed in each case; periodic acid–Schiff and/or Jones methenamine silver stains should applied if necessary. Consultation with a nephropathologist should be pursued as needed.The authors have no relevant financial interest in the products or companies described in this article.

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