Thorough evaluation of known prognostic factors is an essential part of the assessment of patients with primary renal carcinoma. This is not only critical to the planning of therapy, but also important in predicting disease outcome. Although clinical, radiographic, and pathologic assessment are important components of this process, newer studies are focusing on other laboratory parameters, particularly in the area of biomolecular markers, in an attempt to find factors that will enhance the prognostic evaluation. The rigorous assessment of the prognostic value of clinical, anatomic, histologic, and biomolecular parameters requires large prospective studies focusing on those factors that are likely to have some promise. Such studies have not been completed for many of the newer markers. The value of prognostic markers must be approached using an evidenced-based technique. Elaborate systems for assessing evidence presented in studies can be found, but for the purpose of this evaluation, the group has decided to employ a working categorization of prognostic factors as proposed by the College of American Pathologists. Prognostic factors should be clinically relevant, have significant correlation with other known factors and outcome, and have an independent prognostic significance. This classification is presented in Table 1. A. Tested in clinical trials B. Biologic and correlative studies performed; few clinical outcome studies Category I factors are well supported in the literature and used regularly to manage patients. Many of the traditional clinical, anatomic, and histologic parameters (including grade and histologic typing) fit into this category. Category II factors have been extensively studied in either clinical trials or in biologic and correlative studies. These particular factors show promise but have not been conclusively proven to be of value in multivariate analyses. Category III, the final category applies to those factors that show some promise but do not meet the above criteria. Prognostic factors in renal cell carcinoma can be categorized into patient-related, tumor-related (including macroscopic, microscopic, and biomolecular) and therapy-related factors. The only therapy-related factor of definite prognostic importance identified by the group is the presence of gross residual disease at the time of surgery. Patient- and tumor-related factors are presented in Tables 2 and 3 respectively. I IIB Cytogenetic abnormalities/ loss of heterozygosity In Category I, the major patient-related prognostic factors include symptomatic presentation, poor performance status (Eastern Cooperative Oncology Group performance status of 2-3), elevated erthyrocyte sedimentation rate, and elevated C-reactive protein. Weight loss, hypercalcemia, and an elevated alkaline phosphatase level are of importance in patients presenting with metastatic disease. Category I tumor-related factors include TNM classification, gross margin involvement, tumor grade, histologic type, and sarcomatoid architecture. In metastatic tumors, the number of metastases, resectability, and location are of importance. A wide variety of other factors, including tumor-related anatomic and microscopic factors in addition to biomolecular factors are promising in terms of their prognostic potential but have not yet been fully proven in terms of well supported clinicopathologic studies and/or meta-analyses. Furthermore, a wide variety of additional factors, especially those in the biomolecular categories, have been examined in early studies and in some situations show limited promise. Nevertheless, more work is necessary in these areas to prove their value in a prognostic model. * Workgroup participant.
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Srigley et al. (1997) studied this question.
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