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      Hyponatremia as a prognostic and predictive factor in metastatic renal cell carcinoma

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          Abstract

          Background:

          Low serum sodium has recently been associated with poor survival in localised renal cell carcinoma (RCC). We now show the prognostic effect of serum sodium in patients with metastatic RCC (mRCC).

          Methods:

          Cohort A comprised 120 consecutive patients with mRCC receiving subcutaneous, low-dose interleukin-2 and interferon- α. Hyponatremia was assessed in univariate and multivariate analyses. An independent cohort of another 120 patients with mRCC was used for validation (cohort B).

          Results:

          In cohort A, estimated 5-year survival was 15% and median survival was 15.1 months. Serum sodium ranged between 126 and 144 m M. Twenty-four patients (20%) had serum sodium levels below normal range (<136 m M). In multivariate analysis, significant independent risk factors for short survival were low serum sodium ( P=0.014), high neutrophils ( P=0.018), lactate dehydrogenase >1.5 upper normal level ( P=0.002), and number of metastatic sites (+3) ( P=0.003). In cohort B, serum sodium ranged between 128 and 146 m M. Seventeen patients (14%) had sodium levels below normal range. In multivariate analysis, serum sodium was validated as an independent prognostic factor ( P=0.001). A significant association between lack of response and hyponatremia was observed in both cohorts ( P=0.003 and P=0.02, respectively).

          Conclusion:

          Low serum sodium is a new, validated, independent prognostic, and predictive factor in patients with mRCC.

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          Most cited references23

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          Reporting results of cancer treatment.

          On the initiative of the World Health Organization, two meetings on the Standardization of Reporting Results of Cancer Treatment have been held with representatives and members of several organizations. Recommendations have been developed for standardized approaches to the recording of baseline data relating to the patient, the tumor, laboratory and radiologic data, the reporting of treatment, grading of acute and subacute toxicity, reporting of response, recurrence and disease-free interval, and reporting results of therapy. These recommendations, already endorsed by a number of organizations, are proposed for international acceptance and use to make it possible for investigators to compare validly their results with those of others.
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            Hyponatremia and mortality among patients on the liver-transplant waiting list.

            Under the current liver-transplantation policy, donor organs are offered to patients with the highest risk of death. Using data derived from all adult candidates for primary liver transplantation who were registered with the Organ Procurement and Transplantation Network in 2005 and 2006, we developed and validated a multivariable survival model to predict mortality at 90 days after registration. The predictor variable was the Model for End-Stage Liver Disease (MELD) score with and without the addition of the serum sodium concentration. The MELD score (on a scale of 6 to 40, with higher values indicating more severe disease) is calculated on the basis of the serum bilirubin and creatinine concentrations and the international normalized ratio for the prothrombin time. In 2005, there were 6769 registrants, including 1781 who underwent liver transplantation and 422 who died within 90 days after registration on the waiting list. Both the MELD score and the serum sodium concentration were significantly associated with mortality (hazard ratio for death, 1.21 per MELD point and 1.05 per 1-unit decrease in the serum sodium concentration for values between 125 and 140 mmol per liter; P<0.001 for both variables). Furthermore, a significant interaction was found between the MELD score and the serum sodium concentration, indicating that the effect of the serum sodium concentration was greater in patients with a low MELD score. When applied to the data from 2006, when 477 patients died within 3 months after registration on the waiting list, the combination of the MELD score and the serum sodium concentration was considerably higher than the MELD score alone in 32 patients who died (7%). Thus, assignment of priority according to the MELD score combined with the serum sodium concentration might have resulted in transplantation and prevented death. This population-wide study shows that the MELD score and the serum sodium concentration are important predictors of survival among candidates for liver transplantation. 2008 Massachusetts Medical Society
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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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                Author and article information

                Journal
                Br J Cancer
                British Journal of Cancer
                Nature Publishing Group
                0007-0920
                1532-1827
                09 February 2010
                02 March 2010
                02 March 2010
                : 102
                : 5
                : 867-872
                Affiliations
                [1 ]Department of Oncology, Aarhus University Hospital Nørrebrogade 44, 8000 Aarhus C, Denmark
                [2 ]Department of Experimental Clinical Oncology, Aarhus University Hospital Nørrebrogade 44, 8000 Aarhus C, Denmark
                [3 ]Department of Clinical Pathology, Odense University Hospital Winsløewparken 15, 5000 Odense C, Denmark
                [4 ]Department of Oncology, Rigshospitalet, Copenhagen University Hospital Blegdamsvej 9, 2100 København Ø, Denmark
                Author notes
                [* ]Author for correspondence: anni.jeppesen@ 123456gmail.com
                Article
                6605563
                10.1038/sj.bjc.6605563
                2833254
                20145619
                3aff546a-c5f1-4bc6-a235-6b523a09ddf3
                Copyright 2010, Cancer Research UK
                History
                : 04 November 2009
                : 07 January 2010
                : 12 January 2010
                Categories
                Molecular Diagnostics

                Oncology & Radiotherapy
                mortality,metastatic,predictive,sodium,renal cell carcinoma
                Oncology & Radiotherapy
                mortality, metastatic, predictive, sodium, renal cell carcinoma

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