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      A Comprehensive Prognostic Stratification for Patients with Metastatic Renal Clear Cell Carcinoma

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          Abstract

          Purpose

          To develop a reliable prognostic model for patients with metastatic renal cell carcinoma (RCC) based on features readily available in common clinical settings.

          Patients and Methods

          A total of 197 patients with RCC who underwent nephrectomy and immunotherapy from 1995 to 2004 were retrospectively reviewed. Their mean age was 55.1 ± 11.8 yrs (24 - 83 yrs) and mean survival time from metastasis was 22.6 ± 20.2 mos (3 - 120 mos). The impact of 24 clinicopathological features on disease specific survival was investigated.

          Results

          On univariate analysis, constitutional symptoms, sarcomatoid differentiation, tumor necrosis, multiple primary lesions, liver metastasis, Eastern Cooperative Oncology Group Performance Status (ECOG-PS), thrombocytosis, alkaline phosphatase, hematocrit, T stage, N stage, and nuclear grade had significant influence on survival ( p < 0.05). Multivariate analysis revealed the following features associated with survival: sarcomatoid differentiation [hazard ratio (HR) = 2.99, p < 0.001], liver metastasis (HR = 2.09, p = 0.002), ECOG-PS (HR = 1.95, p = 0.005), N stage (HR = 1.94, p = 0.002), and number of metastatic sites (HR = 1.76, p = 0.003). An individual prognostic score was defined as the sum of the weight of these features. According to prognostic scores, patients could be subdivided into 3 groups: low risk (score 0), intermediate risk (score 1 or 2), and high risk (score ≥ 3).

          Conclusion

          A comprehensive prognostic stratification model was developed to predict survival and stratify patients for prospective clinical trials.

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          Most cited references17

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          Interferon-alfa as a comparative treatment for clinical trials of new therapies against advanced renal cell carcinoma.

          To define outcome data and prognostic criteria for patients with metastatic renal cell carcinoma (RCC) treated with interferon-alfa as initial systemic therapy. The data can be applied to design and interpretation of clinical trials of new agents and treatment programs against this refractory malignancy. Four hundred sixty-three patients with advanced RCC administered interferon-alpha as first-line systemic therapy on six prospective clinical trials were the subjects of this retrospective analysis. Three risk categories for predicting survival were identified on the basis of five pretreatment clinical features by a stratified Cox proportional hazards model. The median overall survival time was 13 months. The median time to progression was 4.7 months. Five variables were used as risk factors for short survival: low Karnofsky performance status, high lactate dehydrogenase, low serum hemoglobin, high corrected serum calcium, and time from initial RCC diagnosis to start of interferon-alpha therapy of less than one year. Each patient was assigned to one of three risk groups: those with zero risk factors (favorable risk), those with one or two (intermediate risk), and those with three or more (poor risk). The median time to death of patients deemed favorable risk was 30 months. Median survival time in the intermediate-risk group was 14 months. In contrast, the poor-risk group had a median survival time of 5 months. Progression-free and overall survival with interferon-alpha treatment can be compared with new therapies in phase II and III clinical investigations. The prognostic model is suitable for risk stratification of phase III trials using interferon-alpha as the comparative treatment arm.
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            The changing natural history of renal cell carcinoma.

            Our understanding of the natural history of renal cell carcinoma, the role of nephrectomy, the benefits of immunotherapy and the possibilities of new technologies are evolving and being integrated with advances in classification and staging. We reviewed the relevant literature to clarify these pertinent questions and provide a current review of the changes in the epidemiology, treatment and prognosis of patients with renal cell carcinoma. We comprehensively reviewed the peer reviewed literature on the current management of and results of treatment for renal cell carcinoma. The incidence of and mortality from renal cell carcinoma have continuously increased during the last 50 years. Despite this increase in the number of new patients and consequently the number of deaths yearly the percent of those surviving for 5 years has notably improved. Factors related to improved survival include advances in renal imaging, earlier diagnosis, improved staging, better understanding of prognostic indicators, refinement in surgical technique and the introduction of immunotherapy approaches for advanced disease. Currently patients with localized and metastatic renal cell carcinoma have had improvements in outlook and the therapeutic options available have expanded.
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              An outcome prediction model for patients with clear cell renal cell carcinoma treated with radical nephrectomy based on tumor stage, size, grade and necrosis: the SSIGN score.

              Currently outcome prediction in renal cell carcinoma is largely based on pathological stage and tumor grade. We developed an outcome prediction model for patients treated with radical nephrectomy for clear cell renal cell carcinoma, which was based on all available clinical and pathological features significantly associated with death from renal cell carcinoma. We identified 1,801 adult patients with unilateral clear cell renal cell carcinoma treated with radical nephrectomy between 1970 and 1998. Clinical features examined included age, sex, smoking history, and signs and symptoms at presentation. Pathological features examined included 1997 TNM stage, tumor size, nuclear grade, histological tumor necrosis, sarcomatoid component, cystic architecture, multifocality and surgical margin status. Cancer specific survival was estimated using the Kaplan-Meier method. Cox proportional hazards regression models were used to test associations between features studied and outcome. The selection of features included in the multivariate model was validated using bootstrap methodology. Mean followup was 9.7 years (range 0.1 to 31). Estimated cancer specific survival rates at 1, 3, 5, 7 and 10 years were 86.6%, 74.0%, 68.7%, 63.8% and 60.0%, respectively. Several features were multivariately associated with death from clear cell renal cell carcinoma, including 1997 TNM stage (p <0.001), tumor size 5 cm. or greater (p <0.001), nuclear grade (p <0.001) and histological tumor necrosis (p <0.001). In patients with clear cell renal cell carcinoma 1997 TNM stage, tumor size, nuclear grade and histological tumor necrosis were significantly associated with cancer specific survival. We present a scoring system based on these features that can be used to predict outcome.
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                Author and article information

                Journal
                Yonsei Med J
                YMJ
                Yonsei Medical Journal
                Yonsei University College of Medicine
                0513-5796
                1976-2437
                30 June 2008
                20 June 2008
                : 49
                : 3
                : 451-458
                Affiliations
                [1 ]Department of Urology, Urological Science Institute, Yonsei University, Seoul, Korea.
                [2 ]Department of Urology, Ajou University, Suwon, Korea.
                [3 ]Department of Urology, Keimyung University, Daegu, Korea.
                [4 ]Department of Urology, Inha University, Incheon, Korea.
                [5 ]Department of Urology, Ewha Womans University, Seoul, Korea.
                [6 ]Department of Urology, Hallym University, Chuncheon, Korea.
                [7 ]Department of Urology, Inje University, Busan, Korea.
                European Organisation for Research and Treatment of Cancer (EORTC) Genitourinary Group
                DGCIN-German Cooperative Renal Carcinoma Chemo-Immunotherap Trial Group
                Author notes
                Reprint address: requests to Dr. Sung Joon Hong, Department of Urology, Urological Science Institute, Yonsei University College of Medicine, 250 Seongsanno, Seodaemun-gu, Seoul 120-752, Korea. Tel: 82-2-2228-2315, Fax: 82-2-312-2538, sjhong346@ 123456yuhs.ac
                Article
                10.3349/ymj.2008.49.3.451
                2615339
                18581596
                424d9810-5fc8-47f8-8924-e49eaa9717d9
                Copyright © 2008 The Yonsei University College of Medicine

                This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted noncommercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 28 September 2007
                : 27 November 2007
                Categories
                Original Article

                Medicine
                renal cell,prognosis,neoplasm metastasis,immunotherapy,nephrectomy,carcinoma
                Medicine
                renal cell, prognosis, neoplasm metastasis, immunotherapy, nephrectomy, carcinoma

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