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1998 EARLY PRIMARY TUMOR RESPONSE IS AN INDEPENDENT PREDICTOR OF OVERALL SURVIVAL IN PATIENTS WITH METASTATIC RCC UNDERGOING TREATMENT WITH SUNITINIB
Vol. 185, No. 4S, Supplement, Tuesday, May 17, 2011
THE JOURNAL OF UROLOGY姞
e799
becoming more commonplace, clinician’s should be aware of characteristics associated with advanced disease. Source of Funding: The Doris Duke Charitable Foundation
1997 NATURAL HISTORY OF PATIENTS WITH DISEASE RECURRENCE AFTER NEPHRECTOMY FOR LOCALIZED RENAL CELL CARCINOMA Ari Adamy*, Shahrokh F. Shariat, Kian Tai Chong, Grace Russo, James Costaras, Melanie Bernstein, Paul Russo, New York, NY
Source of Funding: None
1996 AGE AND GENDER PREDICTS RISK OF NON-LOCALIZED DISEASE IN SMALL RENAL TUMORS <3CM IN SIZE IN THE UNITED STATES FROM 1988 –2007 Max Kates*, Ruslan Korets, Neda Sadeghi, New York, NY; Phillip Pierorazio, Baltimore, MD; James McKiernan, New York, NY INTRODUCTION AND OBJECTIVES: It is thought that patients with small renal masses (SRMs) have a negligible risk of metastases. However, recent publications have shown there to be a significant burden of metastatic RCC (mRCC) even in masses ⱕ3cm. The aim of this study was to assess the prevalence and characteristics of mRCC in the US population with SRMs to help identify patients at risk for non-localized disease. METHODS: Using the Surveillance, Epidemiology, and End Results (SEER) registry we identified 14,962 patients diagnosed between 1988-2007 with renal cell carcinoma (RCC) ⱕ3cm in size. Patients were separated by stage into metastatic, locally advanced, and localized disease. Differences in baseline characteristics amongst patients in these 3 groups were assessed. After controlling for age, sex, grade, tumor size, and year of surgery, a logistic regression analysis was performed to determine likelihood of having non-localized disease. RESULTS: In the SEER cohort, 13,574 (90.7%) patients with RCC ⱕ3cm were diagnosed with localized disease, 938 (6.3%) patients had invasion beyond the kidney into regional lymph nodes or nearby organs, and 450 (3.0%) patients had distant metastasis. Patients with metastasis were older (65.9 years) compared to those with localized disease (59.5 years) (p⬍.001). The rate of metastatic disease was higher in patients with tumors 2.5–3.0cm (4.3%) compared with tumors ⬍2.5cm (2.4%). Independent preoperative predictors of having more aggressive disease at diagnosis (locally advanced/metastatic) included older age, particularly age ⬎70 (OR: 2.46; 95% CI: 2.06 –2.92), male sex(OR: 1.50; 95% CI: 1.33–1.70), and tumor size ⬎2.5 (OR: 1.41; 95% CI: 1.25–1.58). CONCLUSIONS: A small subset (3%) of patients in the US with RCC ⱕ3cm have distant metastasis. Older patients, men, and those with tumors 2.5-3cm are more likely to present with regionally advanced and metastatic disease despite having a mass ⬍3cm. As the incidence of SRMs is increasing and active surveillance protocols are
INTRODUCTION AND OBJECTIVES: We investigated the natural history of patients who experienced disease recurrence in a large single center series of patients treated with nephrectomy for a clinically localized RCC. METHODS: We identified 2,368 patients with unilateral, clinically localized RCC treated with either partial or radical nephrectomy between January 1989 and October 2008. Overall, 256 patients who experienced disease recurrence were included in the analysis. The previously published MSKCC prognostic scoring system was used to categorize patients at the time of recurrence. Univariate and multivariable Cox regression models were used to evaluate predictors of cancer-specific survival. The predictors included in the model were those present at the time of nephrectomy and those at the time of disease recurrence. RESULTS: The median time from nephrectomy to disease recurrence was 19.5 months. Overall, 146 patients died from RCC and 6 patients died from other causes. The median follow-up from time of disease recurrence for those patients alive at the last follow-up was 28 months. The 2- and 5-year survival probabilities from time of disease recurrence for the entire cohort were 64% (95% CI 58% – 70%) and 36% (29% – 43%). On univariate analyses, T4 stage at nephrectomy (HR 3.63; 95%CI 1.78 –7.40; p⬍0.001), presence of symptoms at recurrence (HR 2.23; 95% CI 1.56 –3.17; p⬍0.001), lack of metastasectomy (HR 2.02; 95%CI 1.39 –2.94; p⬍0.001), intermediate (HR 2.98; 95%CI 1.86 – 4.78; p⬍0.001) and poor risk score (HR 18.1; 95%CI 9.25 – 35.3; p⬍0.001), and shorter time from nephrectomy to recurrence (HR 0.99; 95%CI 0.98 – 0.99; p⫽0.001) were significantly associated with worse cancer-specific survival. Age, gender, tumor size, T2 and T3 stage, N stage, and tumor histology were not associated with cancer-specific survival. On multivariable analysis, T4 stage (HR 4.03; 95%CI 1.49 – 10.8; p⫽0.006), presence of symptoms at recurrence (HR 2.55; 95%CI 1.66 – 3.91; p⬍0.001), lack of metastasectomy (HR 1.77; 95%CI 1.14 – 2.77; p⫽0.011) and intermediate (HR 2.52; 95%CI 1.50 – 4.24; p⬍0.001) and poor risk (HR 13.4; 95%CI 6.25 – 28.8; p⬍0.001) remained independent predictors of cancerspecific survival. CONCLUSIONS: We confirmed that intermediate and poor MSKCC risk score and the absence of metastasectomy are independently associated with a higher risk of cancer-specific death. In addition, patients diagnosed with recurrence due to symptoms related to metastatic disease have also worst outcomes. Factors related to the primary tumor were not associated with survival after the development of metastatic disease. Source of Funding: None
1998 EARLY PRIMARY TUMOR RESPONSE IS AN INDEPENDENT PREDICTOR OF OVERALL SURVIVAL IN PATIENTS WITH METASTATIC RCC UNDERGOING TREATMENT WITH SUNITINIB E Jason Abel*, Madison, WI; Stephen H Culp, Nizar M. Tannir, Surena F. Matin, Pheroze Tamboli, Christopher G. Wood, Houston, TX INTRODUCTION AND OBJECTIVES: In metastatic renal cell carcinoma (mRCC) patients treated with sunitinib and the primary tumor in situ, there is minimal predictive data available to help guide clinicians during treatment with targeted therapy. In prior studies, early primary tumor response (PTR) was associated with improved overall PTR, but the effect on overall survival (OS) is unknown. The purpose of our study was to evaluate whether early PTR was associated with improved OS in mRCC patients undergoing treatment with sunitinib.
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THE JOURNAL OF UROLOGY姞
METHODS: We reviewed our institutional database to identify patients with mRCC treated with sunitinib with primary tumor in situ. Clinical and pathological data were collected for each patient. Sequential abdominal CT or MRI scans were reviewed to evaluate PTR. Early PTR was defined as ⱖ10% decrease in tumor diameter within the first 90 days of treatment. Univariable and multivariable stepwise Cox proportional hazards regression analysis were performed to identify predictors of OS in these patients. RESULTS: 75 consecutive patients were identified between 2005 and 2009 with a median follow-up of 15 months. 24 patients exhibited an early PTR; median maximum response 23.1% (range: -53.4, -10.2) and decrease in primary tumor diameter at a median of 90.5 days. Early PTR was associated with a decreased risk of death on multivariate analysis (HR: 0.18; 95% CI 0.05, 0.62, p⬍0.01). In addition, median OS was improved in patients with an early PTR (30.2 vs. 12.7 months). Independent predictors of decreased survival on multivariate analysis included local symptoms, multiple bone metastases, clinical evidence of venous thrombus, LDH ⬎ upper limit of normal, and ⬎2 visceral metastatic sites. CONCLUSIONS: Early PTR ⱖ10% is associated with improved survival, better response in metastatic sites, and better overall PTR in patients with mRCC. Future studies should consider this variable when evaluating sunitinib in mRCC treatment. Source of Funding: None
1999 PROGNOSTIC ROLE OF TUMOR NECROSIS IN CLEAR CELL RENAL CELL CARCINOMA: RESULTS OF THE SATURN PROJECT C. Valotto*, G. Novara, Padua, Italy; A. Antonelli, Brescia, Italy; G. Carmignani, Genova, Italy; S. Cosciani Cunico, Brescia, Italy; N. Longo, Naples, Italy; G. Martignoni, Verona, Italy; G. Martorana, Bologna, Italy; A. Minervini, Florence, Italy; V. Mirone, Naples, Italy; F. Montorsi, Milan, Italy; S. Serni, Florence, Italy; A. Simonato, Genova, Italy; S. Siracusano, Trieste, Italy; V. Ficarra, Padua, Italy INTRODUCTION AND OBJECTIVES: To evaluate the prognostic role of tumor necrosis in a large multi-institutional series of patients undergoing radical or partial nephrectomy for clear cell renal cell carcinoma (RCC). METHODS: We collected retrospectively the data of 2719 patients who were surgically treated for clear cell RCC in 16 academic centers involved in the Surveillance And Treatment Update Renal Neoplasms (SATURN) project. Pathological slide review was not performed in these cases. Coagulative tumor necrosis was defined by the presence of homogenous clusters and sheets of degenerating and dead cells. RESULTS: Tumor necrosis was present in 578 (21%) patients. At a median follow-up of 40 months (IQR 24 –75), 506 patients (19%) had developed disease recurrence and 400 (15%) were dead of RCC. The median follow-up for 2015 (74%) patients who were alive and disease-free at last follow-up was 47 months (IQR 24-83). Five and 10-year cancer-specific survival (CSS) estimates were 89.4% (standard error [SE] 0.8%) and 84% (SE1.4%) in those patients without tumor necrosis, respectively, compared with 58.9% (SE 2.5%) and 45.3% (SE3.4%), respectively, in patients harboring tumor necrosis (log rank p value ⬍0.0001). In univariable analysis, presence of tumor necrosis was significantly associated with CSS (H.R: 4.9; p ⬍0.001). On multivariable Cox regression analyses that adjusted for the effect of for age, gender, symptoms, pT, pN, M stages, and Fuhrman grade, microscopic tumor necrosis was an independent predictor of CSS (H.R. 1.7; p⬍0.0001). CONCLUSIONS: Microscopic tumor necrosis was a strong predictor of CSS in patients with clear cell RCC. Source of Funding: None
Vol. 185, No. 4S, Supplement, Tuesday, May 17, 2011
2000 PROGNOSTIC FACTOR OF PAPILLARY RENAL CELL CARCINOMA: RESULTS OF THE SATURN PROJECT A. Zucchi*, E. Costantini, Perugia, Italy; G. Martorana, R. Schiavina, Bologna, Italy; A. Antonelli, C. Simeone, Brescia, Italy; A. Minervini, M. Carini, Florence, Italy; A. Simonato, G. Carmignani, Genova, Italy; G. Novara, Padua, Italy; S. Siracusano, Trieste, Italy; M. Brunelli, Verona, Italy; R. Bertini, Milan, Italy; F. Zattoni, Padua, Italy; N. Longo, V. Mirone, Naples, Italy; V. Ficarra, Padua, Italy INTRODUCTION AND OBJECTIVES: To investigate the prognostic factors of papillary renal cell carcinoma (pRCC) in a large series of patients who underwent radical or partial nephrectomy for renal neoplasm. METHODS: We collected retrospectively the data of 579 patients with pRCC surgically treated for RCC in 16 academic centers involved in the Surveillance And Treatment Update Renal Neoplasms (SATURN) project. Univariable and multivariable Cox regression models addressed time to cancer-specific survival (CSS) after surgery. RESULTS: Median patients age was 64 years (IQR 55-71). 361 pazienti underwent radical nephrectomy (62.3%), whereas nephornsparing surgery (NSS) was adepte in 218 cases (184 elective and 34 imperative NSS). The median follow up of the entire cohort was 39 months (IQR 22-72). At follow-up, 63 patients (11%) died of disease. The overall 5 and 10-year CSS were 87.4% and 83.3%, respectively. In Cox univariable analyses, mode of presentation, pathological T stage, pathological N stage, M stage, and Fuhrman nuclear grade were significantly associated with CSS (all p values ⬍0.001). In Cox multivariable analysis, only mode of presentation (p for trend ⫽ 0.04), pathological T stage (p for trend ⫽ 0.012), pathologic N stage (p for trend ⬍0.0001), M stage (H.R.: 2.6; p ⫽ 0.03), and Fuhrman nuclear grade (H.R.: 2.3; p ⫽ 0.07) were independent predictors of CSS. CONCLUSIONS: Our patients with pRCC showed low tendency to progress and metastasize, with only 11% of those patients dying of the disease. Only mode of presentation, T, N, and M stage, and, notably, Funrman nuclear grade were independent predictors of CSS. Source of Funding: None
2001 ARTIFICIAL NEURAL NETWORKS AND LOGISTIC REGRESSION MODELS FOR OUTCOME PREDICTION IN PATIENTS WITH METASTATIC RENAL CELL CARCINOMA UNDER SYSTEMIC THERAPY Alexander Buchner*, Martin Kendlbacher, Philipp Nuhn, Cordula Tu¨llmann, Nicolas Haseke, Christian Stief, Michael Staehler, Munich, Germany INTRODUCTION AND OBJECTIVES: Precise outcome prediction in patients with advanced renal cell carcinoma (RCC) under systemic therapy is still an unresolved task. The aim of this study was the evaluation of artificial neural networks (ANN) as a novel tool to identify high-risk patients within this group, based on parameters that are available before systemic therapy. Furthermore, logistic regression (LR) models were developed for outcome assessment in advanced RCC. METHODS: Data from 175 patients with advanced RCC that started systemic therapy with cytokines (interleukin-2 and interferonalpha) or tyrosine kinase inhibitors (TKI; sorafenib or sunitinib) between January 2004 and May 2009 were collected. Median follow-up time was 36 months. A random sample of 70% of the patients was used as training data for the ANN, the remaining 30% served as independent validation group. Age, gender, body mass index, performance status, TNMG classification, histological subtype, tumor invasion in perirenal structures and vessels, time interval between primary tumor and detection of metastases, type of systemic therapy (cytokines vs. TKI), number of metastases and metastatic sites were used as input data for the ANN. Additionally, logistic regression (LR) models were developed using the same input variables. Target variable for ANN and LR analysis was tumor-specific survival after 36 months.
THE JOURNAL OF UROLOGY姞
e799
becoming more commonplace, clinician’s should be aware of characteristics associated with advanced disease. Source of Funding: The Doris Duke Charitable Foundation
1997 NATURAL HISTORY OF PATIENTS WITH DISEASE RECURRENCE AFTER NEPHRECTOMY FOR LOCALIZED RENAL CELL CARCINOMA Ari Adamy*, Shahrokh F. Shariat, Kian Tai Chong, Grace Russo, James Costaras, Melanie Bernstein, Paul Russo, New York, NY
Source of Funding: None
1996 AGE AND GENDER PREDICTS RISK OF NON-LOCALIZED DISEASE IN SMALL RENAL TUMORS <3CM IN SIZE IN THE UNITED STATES FROM 1988 –2007 Max Kates*, Ruslan Korets, Neda Sadeghi, New York, NY; Phillip Pierorazio, Baltimore, MD; James McKiernan, New York, NY INTRODUCTION AND OBJECTIVES: It is thought that patients with small renal masses (SRMs) have a negligible risk of metastases. However, recent publications have shown there to be a significant burden of metastatic RCC (mRCC) even in masses ⱕ3cm. The aim of this study was to assess the prevalence and characteristics of mRCC in the US population with SRMs to help identify patients at risk for non-localized disease. METHODS: Using the Surveillance, Epidemiology, and End Results (SEER) registry we identified 14,962 patients diagnosed between 1988-2007 with renal cell carcinoma (RCC) ⱕ3cm in size. Patients were separated by stage into metastatic, locally advanced, and localized disease. Differences in baseline characteristics amongst patients in these 3 groups were assessed. After controlling for age, sex, grade, tumor size, and year of surgery, a logistic regression analysis was performed to determine likelihood of having non-localized disease. RESULTS: In the SEER cohort, 13,574 (90.7%) patients with RCC ⱕ3cm were diagnosed with localized disease, 938 (6.3%) patients had invasion beyond the kidney into regional lymph nodes or nearby organs, and 450 (3.0%) patients had distant metastasis. Patients with metastasis were older (65.9 years) compared to those with localized disease (59.5 years) (p⬍.001). The rate of metastatic disease was higher in patients with tumors 2.5–3.0cm (4.3%) compared with tumors ⬍2.5cm (2.4%). Independent preoperative predictors of having more aggressive disease at diagnosis (locally advanced/metastatic) included older age, particularly age ⬎70 (OR: 2.46; 95% CI: 2.06 –2.92), male sex(OR: 1.50; 95% CI: 1.33–1.70), and tumor size ⬎2.5 (OR: 1.41; 95% CI: 1.25–1.58). CONCLUSIONS: A small subset (3%) of patients in the US with RCC ⱕ3cm have distant metastasis. Older patients, men, and those with tumors 2.5-3cm are more likely to present with regionally advanced and metastatic disease despite having a mass ⬍3cm. As the incidence of SRMs is increasing and active surveillance protocols are
INTRODUCTION AND OBJECTIVES: We investigated the natural history of patients who experienced disease recurrence in a large single center series of patients treated with nephrectomy for a clinically localized RCC. METHODS: We identified 2,368 patients with unilateral, clinically localized RCC treated with either partial or radical nephrectomy between January 1989 and October 2008. Overall, 256 patients who experienced disease recurrence were included in the analysis. The previously published MSKCC prognostic scoring system was used to categorize patients at the time of recurrence. Univariate and multivariable Cox regression models were used to evaluate predictors of cancer-specific survival. The predictors included in the model were those present at the time of nephrectomy and those at the time of disease recurrence. RESULTS: The median time from nephrectomy to disease recurrence was 19.5 months. Overall, 146 patients died from RCC and 6 patients died from other causes. The median follow-up from time of disease recurrence for those patients alive at the last follow-up was 28 months. The 2- and 5-year survival probabilities from time of disease recurrence for the entire cohort were 64% (95% CI 58% – 70%) and 36% (29% – 43%). On univariate analyses, T4 stage at nephrectomy (HR 3.63; 95%CI 1.78 –7.40; p⬍0.001), presence of symptoms at recurrence (HR 2.23; 95% CI 1.56 –3.17; p⬍0.001), lack of metastasectomy (HR 2.02; 95%CI 1.39 –2.94; p⬍0.001), intermediate (HR 2.98; 95%CI 1.86 – 4.78; p⬍0.001) and poor risk score (HR 18.1; 95%CI 9.25 – 35.3; p⬍0.001), and shorter time from nephrectomy to recurrence (HR 0.99; 95%CI 0.98 – 0.99; p⫽0.001) were significantly associated with worse cancer-specific survival. Age, gender, tumor size, T2 and T3 stage, N stage, and tumor histology were not associated with cancer-specific survival. On multivariable analysis, T4 stage (HR 4.03; 95%CI 1.49 – 10.8; p⫽0.006), presence of symptoms at recurrence (HR 2.55; 95%CI 1.66 – 3.91; p⬍0.001), lack of metastasectomy (HR 1.77; 95%CI 1.14 – 2.77; p⫽0.011) and intermediate (HR 2.52; 95%CI 1.50 – 4.24; p⬍0.001) and poor risk (HR 13.4; 95%CI 6.25 – 28.8; p⬍0.001) remained independent predictors of cancerspecific survival. CONCLUSIONS: We confirmed that intermediate and poor MSKCC risk score and the absence of metastasectomy are independently associated with a higher risk of cancer-specific death. In addition, patients diagnosed with recurrence due to symptoms related to metastatic disease have also worst outcomes. Factors related to the primary tumor were not associated with survival after the development of metastatic disease. Source of Funding: None
1998 EARLY PRIMARY TUMOR RESPONSE IS AN INDEPENDENT PREDICTOR OF OVERALL SURVIVAL IN PATIENTS WITH METASTATIC RCC UNDERGOING TREATMENT WITH SUNITINIB E Jason Abel*, Madison, WI; Stephen H Culp, Nizar M. Tannir, Surena F. Matin, Pheroze Tamboli, Christopher G. Wood, Houston, TX INTRODUCTION AND OBJECTIVES: In metastatic renal cell carcinoma (mRCC) patients treated with sunitinib and the primary tumor in situ, there is minimal predictive data available to help guide clinicians during treatment with targeted therapy. In prior studies, early primary tumor response (PTR) was associated with improved overall PTR, but the effect on overall survival (OS) is unknown. The purpose of our study was to evaluate whether early PTR was associated with improved OS in mRCC patients undergoing treatment with sunitinib.
e800
THE JOURNAL OF UROLOGY姞
METHODS: We reviewed our institutional database to identify patients with mRCC treated with sunitinib with primary tumor in situ. Clinical and pathological data were collected for each patient. Sequential abdominal CT or MRI scans were reviewed to evaluate PTR. Early PTR was defined as ⱖ10% decrease in tumor diameter within the first 90 days of treatment. Univariable and multivariable stepwise Cox proportional hazards regression analysis were performed to identify predictors of OS in these patients. RESULTS: 75 consecutive patients were identified between 2005 and 2009 with a median follow-up of 15 months. 24 patients exhibited an early PTR; median maximum response 23.1% (range: -53.4, -10.2) and decrease in primary tumor diameter at a median of 90.5 days. Early PTR was associated with a decreased risk of death on multivariate analysis (HR: 0.18; 95% CI 0.05, 0.62, p⬍0.01). In addition, median OS was improved in patients with an early PTR (30.2 vs. 12.7 months). Independent predictors of decreased survival on multivariate analysis included local symptoms, multiple bone metastases, clinical evidence of venous thrombus, LDH ⬎ upper limit of normal, and ⬎2 visceral metastatic sites. CONCLUSIONS: Early PTR ⱖ10% is associated with improved survival, better response in metastatic sites, and better overall PTR in patients with mRCC. Future studies should consider this variable when evaluating sunitinib in mRCC treatment. Source of Funding: None
1999 PROGNOSTIC ROLE OF TUMOR NECROSIS IN CLEAR CELL RENAL CELL CARCINOMA: RESULTS OF THE SATURN PROJECT C. Valotto*, G. Novara, Padua, Italy; A. Antonelli, Brescia, Italy; G. Carmignani, Genova, Italy; S. Cosciani Cunico, Brescia, Italy; N. Longo, Naples, Italy; G. Martignoni, Verona, Italy; G. Martorana, Bologna, Italy; A. Minervini, Florence, Italy; V. Mirone, Naples, Italy; F. Montorsi, Milan, Italy; S. Serni, Florence, Italy; A. Simonato, Genova, Italy; S. Siracusano, Trieste, Italy; V. Ficarra, Padua, Italy INTRODUCTION AND OBJECTIVES: To evaluate the prognostic role of tumor necrosis in a large multi-institutional series of patients undergoing radical or partial nephrectomy for clear cell renal cell carcinoma (RCC). METHODS: We collected retrospectively the data of 2719 patients who were surgically treated for clear cell RCC in 16 academic centers involved in the Surveillance And Treatment Update Renal Neoplasms (SATURN) project. Pathological slide review was not performed in these cases. Coagulative tumor necrosis was defined by the presence of homogenous clusters and sheets of degenerating and dead cells. RESULTS: Tumor necrosis was present in 578 (21%) patients. At a median follow-up of 40 months (IQR 24 –75), 506 patients (19%) had developed disease recurrence and 400 (15%) were dead of RCC. The median follow-up for 2015 (74%) patients who were alive and disease-free at last follow-up was 47 months (IQR 24-83). Five and 10-year cancer-specific survival (CSS) estimates were 89.4% (standard error [SE] 0.8%) and 84% (SE1.4%) in those patients without tumor necrosis, respectively, compared with 58.9% (SE 2.5%) and 45.3% (SE3.4%), respectively, in patients harboring tumor necrosis (log rank p value ⬍0.0001). In univariable analysis, presence of tumor necrosis was significantly associated with CSS (H.R: 4.9; p ⬍0.001). On multivariable Cox regression analyses that adjusted for the effect of for age, gender, symptoms, pT, pN, M stages, and Fuhrman grade, microscopic tumor necrosis was an independent predictor of CSS (H.R. 1.7; p⬍0.0001). CONCLUSIONS: Microscopic tumor necrosis was a strong predictor of CSS in patients with clear cell RCC. Source of Funding: None
Vol. 185, No. 4S, Supplement, Tuesday, May 17, 2011
2000 PROGNOSTIC FACTOR OF PAPILLARY RENAL CELL CARCINOMA: RESULTS OF THE SATURN PROJECT A. Zucchi*, E. Costantini, Perugia, Italy; G. Martorana, R. Schiavina, Bologna, Italy; A. Antonelli, C. Simeone, Brescia, Italy; A. Minervini, M. Carini, Florence, Italy; A. Simonato, G. Carmignani, Genova, Italy; G. Novara, Padua, Italy; S. Siracusano, Trieste, Italy; M. Brunelli, Verona, Italy; R. Bertini, Milan, Italy; F. Zattoni, Padua, Italy; N. Longo, V. Mirone, Naples, Italy; V. Ficarra, Padua, Italy INTRODUCTION AND OBJECTIVES: To investigate the prognostic factors of papillary renal cell carcinoma (pRCC) in a large series of patients who underwent radical or partial nephrectomy for renal neoplasm. METHODS: We collected retrospectively the data of 579 patients with pRCC surgically treated for RCC in 16 academic centers involved in the Surveillance And Treatment Update Renal Neoplasms (SATURN) project. Univariable and multivariable Cox regression models addressed time to cancer-specific survival (CSS) after surgery. RESULTS: Median patients age was 64 years (IQR 55-71). 361 pazienti underwent radical nephrectomy (62.3%), whereas nephornsparing surgery (NSS) was adepte in 218 cases (184 elective and 34 imperative NSS). The median follow up of the entire cohort was 39 months (IQR 22-72). At follow-up, 63 patients (11%) died of disease. The overall 5 and 10-year CSS were 87.4% and 83.3%, respectively. In Cox univariable analyses, mode of presentation, pathological T stage, pathological N stage, M stage, and Fuhrman nuclear grade were significantly associated with CSS (all p values ⬍0.001). In Cox multivariable analysis, only mode of presentation (p for trend ⫽ 0.04), pathological T stage (p for trend ⫽ 0.012), pathologic N stage (p for trend ⬍0.0001), M stage (H.R.: 2.6; p ⫽ 0.03), and Fuhrman nuclear grade (H.R.: 2.3; p ⫽ 0.07) were independent predictors of CSS. CONCLUSIONS: Our patients with pRCC showed low tendency to progress and metastasize, with only 11% of those patients dying of the disease. Only mode of presentation, T, N, and M stage, and, notably, Funrman nuclear grade were independent predictors of CSS. Source of Funding: None
2001 ARTIFICIAL NEURAL NETWORKS AND LOGISTIC REGRESSION MODELS FOR OUTCOME PREDICTION IN PATIENTS WITH METASTATIC RENAL CELL CARCINOMA UNDER SYSTEMIC THERAPY Alexander Buchner*, Martin Kendlbacher, Philipp Nuhn, Cordula Tu¨llmann, Nicolas Haseke, Christian Stief, Michael Staehler, Munich, Germany INTRODUCTION AND OBJECTIVES: Precise outcome prediction in patients with advanced renal cell carcinoma (RCC) under systemic therapy is still an unresolved task. The aim of this study was the evaluation of artificial neural networks (ANN) as a novel tool to identify high-risk patients within this group, based on parameters that are available before systemic therapy. Furthermore, logistic regression (LR) models were developed for outcome assessment in advanced RCC. METHODS: Data from 175 patients with advanced RCC that started systemic therapy with cytokines (interleukin-2 and interferonalpha) or tyrosine kinase inhibitors (TKI; sorafenib or sunitinib) between January 2004 and May 2009 were collected. Median follow-up time was 36 months. A random sample of 70% of the patients was used as training data for the ANN, the remaining 30% served as independent validation group. Age, gender, body mass index, performance status, TNMG classification, histological subtype, tumor invasion in perirenal structures and vessels, time interval between primary tumor and detection of metastases, type of systemic therapy (cytokines vs. TKI), number of metastases and metastatic sites were used as input data for the ANN. Additionally, logistic regression (LR) models were developed using the same input variables. Target variable for ANN and LR analysis was tumor-specific survival after 36 months.