bluuebunny/crossref_metadata_2025_split huggingface dataset:
Treatment facility volume and survival in patients with metastatic renal cell carcinoma.
Authors: Geynisman Daniel M. , Handorf Elizabeth , Zibelman Matthew R. , Plimack Elizabeth R. , Uzzo Robert , Kutikov Alexander , Smaldone Marc C. 
Published: February 2018

594 Background: Higher treatment facility (TF) volume has been linked with improved surgical and hematologic malignancy outcomes. We evaluated the association between TF volume and overall survival (OS) in pts with metastatic renal cell carcinoma (mRCC). Methods: The National Cancer Data Base was queried for all pts with mRCC and survival data available (2004 to 2013, cohort A). We defined high volume TFs as those in the top 20th percentile of mean number of mRCC pts treated per year ( > 5 pts). The effect of volume on OS was determined using unadjusted Kaplan-Meier curves and Cox regression models (MVA) adjusting for pt (age, sex, race, ethnicity, insurance type, income, Charlson-Deyo Score), facility (location, practice setting) and clinical characteristics (histology, presence or absence of liver and lung metastasis). Increasingly more stringent inclusion criteria were used to confirm the overall cohort association (cohort B = mRCC pts with active treatment; cohort C = mRCC pts with systemic therapy; cohort D = mRCC pts with systemic therapy at the reporting institution; cohort E = mRCC pts with systemic therapy at the reporting institution with liver and lung metastatic status known). Results: There were 44,109 mRCC pts treated at 1,224 TFs. The median age was 65, 66% were men and 75% had clear cell mRCC. Median TF volume was 2.4 pts/year (range 0.1-46.8). High volume TFs treated 54% of all mRCC pts. The unadjusted median overall survival of mRCC patients (cohort A) treated at high vs low volume TFs was 9.2 vs 6.4 months (P < 0.0001). This difference was maintained in all cohorts: cohort B = 13.7 vs 10.9, cohort C = 12.4 vs 10.0, cohort D = 12.5 vs 9.3, and cohort E = 13.4 vs 10.6 months (P < 0.0001 for all cohorts). MVA confirmed that facility volume was associated with all-cause mortality after adjustment: HR = 0.85, [95% CI 0.82-0.88], P < 0.001. These results were consistent regardless of inclusion criteria, e.g. for cohort E: HR = 0.839, [95% CI 0.785-0.897], P < 0.0001. Considering the definition of high volume, all thresholds > 5 pts/year showed a survival benefit, with the largest effects at ≥10 pts/year. Conclusions: Patients with mRCC treated at higher volume facilities had a longer survival compared with those treated at lower volume facilities.
Prospective evaluation of geriatric assessments as predictors of complications and functional outcome after major urologic tumor surgery in the older population.
Authors: Kahlmeyer Andreas , Losensky Wencke , Sikic Danijel , Keck Bastian , Goebell Peter J. , Wullich Bernd 
Published: February 2018

597 Background: Old patients undergoing major urologic tumor surgery are at severe risk of functional deterioration. In this study we prospectively performed a comprehensive geriatric assessment to identify potential risk predictors for early functional outcome. Methods: Since January 2016, 75 patients undergoing elective cystectomy, prostatectomy or nephrectomy at the age of 70 or older have been enrolled prospectively. A selection of geriatric assessment tools was applied before surgery. Follow up data including standardized peri- and postoperative parameters were obtained at discharge and at day 30 and 180 after surgery (DRKS-ID: DRKS00009825). Results: 14.7% had radical cystectomy, 33.3% had radical prostatectomy and 52.0% had kidney surgery due to malignant tumor. The average age was 75.7 (70-88) years. Within hospital stay, 20.3% had major complications (Clavien-Dindo > = 3) and 25% showed incomplete functional recovery at day 30 after surgery. The average reduction in activities of daily living (ADL) was -34.71. Major complications were significantly associated with impaired mobility (TUG, OR 7.350, p = 0.002), frailty (FrailScale, OR 5.007, p = 0.019) and ASA-Score (ASA, OR 4.400, p = 0.015). Incomplete functional recovery was strongly associated with preoperative impaired mobility (TUG, OR 11.524, p < 0.001) but correlation with ASA-Score (ASA, OR 3.288, p = 0.070) and comorbidities (CCI, OR 3.833, p = 0.106) missed statistical significance. No correlation of functional deterioration was found with age and functional status at admission. The combination of selected assessment tools showed good prediction of early functional recovery (ErlangerIndex, OR 4.400, p = 0.019). Conclusions: Major urologic tumor surgery has a high risk of severe complications and incomplete recovery in old patients. Fast and easy-to-do preoperative assessment tools may predict functional outcome more precisely than age or preoperative functional status alone. Clinical trial information: DRKS00009825.
The combination of platelet count and neutrophil to lymphocyte ratio (COP-NLR) for prediction of treatment outcome for patients with localized renal cell carcinoma.
Authors: Komura Kazumasa , Tsujino Takuya , Ibuki Naokazu , Inamoto Teruo , Azuma Haruhito 
Published: February 2018

598 Background: The combination of platelet count and neutrophil to lymphocyte ratio (COP-NLR) has been shown to provide prognostic information in several cancers. The object of the present study was to examine the preoperative prognostic value of the COP-NLR in localized RCC. Methods: The records of 268 patients were analyzed in the study. The cut-off value of platelet count and NLR were defined by receive operating characteristic (ROC) analysis and the areas under the curve (AUC). Patients with both an increased platelet count ( > 31.0×104 mm-3) and an elevated NLR ( > 3.85) were assigned a score of 2, and patients with one or neither were assigned as a score of 1 or 0, respectively. Results: There were 198, 63, and 7 patients assigned to the COP-NLR of 0, 1, and 2, respectively. Five year OS rates were 93.8% in COP-NLR0, 72.2% in COP-NLR1 and 0% in COP-NLR 2, demonstrating a significant difference in their prognosis among the COP-NLR in localized RCC patients. Multivariate analysis using the 10 clinicopathological findings selected by univariate analyses demonstrated that the preoperative COP-NLR was an independent prognostic factor for OS (HR: 2.32, 95%CI: 1.22 to 4.26, p = 0.011) and RFS (HR: 1.91, 95%CI: 1.02 to 3.53, p = 0.044). Conclusions: The preoperative COP-NLR is an independent prognostic indicator of OS and RFS for patients with localized RCC. [Table: see text]
CASPIR trial: Using prostatic calculi as an alternative to fiducial markers for IGRT in for localized prostate cancer.
Authors: O'Neill Angela G.M , King Raymond , Osman Sarah , Jain Suneil , Hounsell Alan R , O'Sullivan Joe M. 
Published: February 2018

60 Background: Image guided Radiotherapy (IGRT) for prostate cancer (PCA) frequently employs surgically implanted fiducial markers (FMs). However, it is estimated that up to 35% of prostate radiotherapy patients have prostatic calculi (PC) visible on treatment cone beam CTs (CBCT). The purpose of this clinical trial is to directly compare FMs with PCs as an aid to prostate IGRT. Methods: We report data from a single institution prospective clinical trial investigating the feasibility of using prostate calcifications as natural FMs for IGRT. Patients planned for standard prostate radical EBRT +/- brachytherapy were eligible. Prior to CT planning, 3 gold fiducial markers are inserted into the prostate by the trans-perineal route under TRUS guidance. PCs visible within the PTV were contoured. Participants were aligned to FMs for EBRT using daily CBCT image guidance on a Varian TrueBeam linac. Off-line, a single experienced user analyses CBCTs using Image Registration in Eclipse (version 13.6). Random and systematic set-up errors are determined based on FMs, PCs (where present), prostate gland (PG) and bony landmarks (BL) and CTV-PTV margins derived for each data set. Results: 30 participants with PC have been recruited. Data from the first 19 patients (365 fractions), resulted in 2555 individual image registrations (7665 individual data points). The PTV margins required based on each reference structure are summarised in Table 1. The maximum difference between the CTV-PTV(PC) margin and CTV-PTV(FM) margin is 2.2mm in the X or L/R dimension. Margins required for FM, PG and PC in the Y and Z dimensions are comparable, with a maximum difference of 0.5mm between CTV-PTV(PC) and CTV-PTV(PG). Conclusions: Preliminary results from this study demonstrate some evidence to support the use of PCs as an alternative to FMs for prostate IGRT. Future analysis will include location of PC according to the PIRADs schema and patient feedback in relation to FM implantation. Clinical trial information: NA. [Table: see text]
Treatment modification with sunitinib in first-line (1L) metastatic renal cell carcinoma (mRCC): An analysis of the STAR-TOR registry.
Authors: Boegemann Martin , Hubbe Marcus , Thomaidou Despina , Blackburn Stuart , Bent-Ennakhil Nawal , Wood Robert , Bargo Danielle 
Published: February 2018

602 Background: The standard dosing schedule for administration of Sunitinib is 50mg once daily for a 4-week period followed by 2 weeks off. However, in clinical practice, many patients require schedule or dose reductions to mitigate toxicity. We aimed to assess if these treatment modifications result in improved outcomes in mRCC patients. Methods: Data were drawn from STAR-TOR, a German, multi-centre, real-world, prospective registry to report outcomes of mRCC patients who received Sunitinib in 1L. Patients were categorised into 2 treatment groups: 1) Sunitinib initiated at standard schedule/dose with subsequent schedule/dose modification (SM), 2) Sunitinib as per standard schedule/dosage (SS). Kaplan-Meier survival analysis was used to determine time on treatment (TT) of Sunitinib and progression-free survival (PFS). Differences between groups were assessed using log-rank tests. Results: In total 297 patients were identified initiating 1L Sunitinib. Schedule or dose reductions occurred in 33% of patients. Significant differences between groups at baseline are noted in Table 1. Median TT was greater in SM vs. SS (15.1 vs. 3.9 months (m), p < 0.0001). Median PFS was improved in SM vs. SS (15.1 vs. 6.0 m, p < 0.0001). Fatigue (31/14%), hand-foot syndrome (HFS) (28/10%), diarrhea (35/19%) and stomatitis (20/6%) were more frequently reported in SM vs. SS since initiation of Sunitinib. Incidence of adverse events, (excluding diarrhea) was reduced following schedule/ dose modification of sunitinib; fatigue (before SM/ after SM) (18/7%), HFS (21/8%) and stomatitis (8/4%). Conclusions: Modifying Sunitinib schedule or individualizing the dose represent therapy management strategies that are associated with improved tolerability, prolonged treatment duration and significant improvement in PFS in a real life setting. These data suggest that effective management of toxicity of Sunitinib can optimize patient outcomes. [Table: see text]
Incidence and mortality of renal cell carcinoma in the U.S.: A SEER-based study investigating trends over the last four decades.
Authors: Gad Mohamed M , Saad Anas M , Al-Huseini Muneer J , Ruhban Inas A. , Sonbol Mohamad B. 
Published: February 2018

604 Background: Renal cell carcinoma (RCC) is the third most common urologic malignancy worldwide, with clear cell subtype being the most common. In this study, we sought to investigate RCC incidence and mortality trends by demographic and tumor characteristics using data from the surveillance, epidemiology and end results (SEER) database. Methods: We used SEER database to study RCC cases between 1973 and 2014. Incidence and mortality rates were calculated by sex, age, race, state, stage, size, and histological subtype of RCC. Annual percent change (APC) was calculated using joinpoint regression software. Results: A total of 96,058 RCC cases were identified, with 54,000 RCC deaths between 1973 and 2014. Overall incidence was 9.712 per 100,000 persons-years, being highest among males (13.698), blacks (11.886), and people older than 65 years (38.693). Incidence rates of localized cases (5.845) and tumors smaller than 7 cm (6.550) were higher than other tumor subgroups with distant disease incidence of 1.773 per 100,000 persons-years. Overall incidence rates increased by 2.709% (95% CI, 2.544-2.875, p < .001) per year over the study period, but rates became stable since 2007 with only an increase in the incidence of clear-cell subtype (2.538%; 95% CI, 1.300-3.791, p < .001). Overall RCC mortality rates have been declining since 2000, and distant disease mortality have been decreasing since 2008 with most profound decline in the period between 2012 and 2014 with APC of -22.635% (-37.419- -4.359, P = .019) Conclusions: Despite overall increase in rates over the last 40 years, recent years have shown stable incidence and decrease in mortality rates of RCC. The significant decline in mortality over the last 10 years since the approval of the first Vascular Endothelial Growth Factor ‘VEGF’ inhibitor highlights the impact of this class of medications along with other subsequent agents such as mTOR inhibitors and checkpoint inhibitors on the prognosis of renal cell carcinoma.
Conditional survival and landmark analysis for patients with small renal masses undergoing active surveillance at a tertiary care center.
Authors: Petros Firas G. , Venkatesan Aradhana M. , Kaya Diana , Ng Chaan S. , Fellman Bryan M. , Karam Jose A. , Wood Christopher G. , Matin Surena F. 
Published: February 2018

609 Background: Conditional survival can provide guidance for patients once they have survived a period of time after diagnosis of their disease. We determine conditional survival for patients with small renal masses (SRM) undergoing active surveillance (AS). Methods: Patients were enrolled in a prospective AS registry at our institution between May 2005 and January 2016. Patients with localized SRM ≤4cm were included, with serial radiologic imaging available in-house for re-review. Overall survival (OS) was estimated using the Kaplan-Meier method and modeled via Cox proportional hazards models. The primary end points analyzed were the conditional probability of survival and tumor growth over time. Landmark analysis was used to evaluate survival outcomes. Results: A total of 272 patients were included in this analysis. Mean initial tumor size was 1.74 ± 0.77 cm and mean tumor size closest to the 2-year mark was 1.97 ± 0.83 cm. The likelihood of continued survival to 5 years improved after the 2-year landmark was reached. Patients with tumors < 3cm who survived the first 2-years on AS had a 0.84-0.85 chance of surviving to 5 years, and if they survived 3 years, the probability of surviving to 5 years improved to 0.91. Multivariable Cox proportional hazards analysis of survival revealed eGFR, Charlson comorbidity index (CCI), and tumor size of 3-4cm were significantly predictive of OS both at baseline and at 2-year mark (all p < 0.05). Patients with a tumor size 3-4 cm were at a greater risk of non-RCC death (HR > 3.5; p ≤ 0.001). A linear mixed effects model revealed slow tumor growth (beta: 0.12; p < 0.001) for tumors < 3cm. Adjusted tumor size predictions disclosed parallel growth rates for SRM of < 2cm and 2-2.99cm with insignificant difference (p = 0.969). Conclusions: Our study provides insight into the survival of patients with SRM on AS who have already survived a certain period of time. The conditional survival probability of patients with SRM < 3cm on AS improved after the initial 2 years, suggesting a role for re-counseling for those who survive to the 2-year landmark. Patient factors (renal function and CCI) were significantly associated with survival at baseline and at the 2-year landmark.
Metamodeling of late rectal bleeding in patients undergoing radiotherapy for prostate cancer.
Authors: Cicchetti Alessandro , Palorini Federica , Rancati Tiziana , Fiorino Claudio , Cozzarini Cesare , Avuzzi Barbara , Vavassori Vittorio , Fellin Giovanni , Stucchi Claudio , Procopio Giuseppe , Ebert Martin , Kennedy Angel , Denham James William , Joseph David John , Gabriele Pietro , Degli Esposti Claudio , Valdagni Riccardo 
Published: February 2018

61 Background: Predictive models for late rectal bleeding (LRB) after radiotherapy (RT) for prostate cancer were established by several studies, with good performance on development population (POP). Nonetheless, they were found to be unsatisfactory in their generalization to independent validation cohorts. Aim of the study is to build a metamodel for grade 2-3 (G23) and grade 3 (G3) LRB (LENT/SOMA) starting from literature evidence and to validate it on a new POP. Methods: The metamodel was constituted by clinical/dosimetric features and by their coefficients. Available predictive models for LRB were selected by literature search. Models including rectal Equivalent Uniform Dose (EUD) with/without patient-related dose-modifying factors were retrieved. The process allowed identification of “evidence-based” clinical/dosimetric features associated to LRB. Coeff. for identified features were resolved by weighted mean of published values, using their standard deviation as weight and then inserted in a sigmoid-shaped logit-EUD model. The resulting metamodel was validated on a pooled POP of radically treated pts (3DCRT & IMRT). Performance was assessed through calibration. Results: The search identified rectal EUD, previous abdominal surgery (SURG), hormone therapy (HT) and use of cardiovascular drugs (CARDIO) as relevant features (coeff. presented in table). Validation POP included 1591 pts with 240 (15%) LRBG23 and 98 (6.2%) LRBG3 pts. Calibration was very good: LRBG23 slope = 1.4 with R2 = 0.86; LRBG3 slope = 1.1 with R2 = 0.96. Conclusions: A metamodel for prediction of LRB has been developed from literature, including all currently available information on association between LRB and clinical/dosimetric factors. The model was successfully validated on a large POP, proving to be a valuable tool for predicting LRB before RT. [Table: see text]
Efficacy of antiangiogenic renal neoplasm with bone metastasis: A mono-institutional study in France.
Authors: Sajous Christophe , Peron Julien , Boyle Helen Jane , Negrier Sylvie , Moriceau Guillaume , Blay Jean-Yves , Flechon Aude 
Published: February 2018

610 Background: Although bone metastases occur frequently in metastatic renal cell carcinoma (mRCC) and represent approximatively 20-30% of the different sites of metastases, few studies have assessed the prognostic impact of these metastatic sites. In this context, the aim of our study was to evaluate the efficiency of antiangiogenic (AA) treatments in this particular site Methods: A retrospective review of patients with mRCC and bone metastases, treated with a first line of antiangiogenic therapy at the Centre Leon Berard (CLB) was conducted between January 2010 and November 2016. In order to identify a differential treatment effect according to the metastatic site, we assessed the bone progression-free survival (bPFS) defined as the time from the first day of 1st line AA to the date of bone progression or death; and extra bone PFS (ebPFS), defined as the time from the 1st day of 1st line AA to the date of extra-bone progression or death. The association between survival and potential prognosis factor, including metastases location was assessed using log-rank test for univariate analysis Results: A total of 200 patients (146 men; mean age 57,9 years; range 21-86) were analysed and the most common first line AA used was Sunitinib (147; 73,5%). Median PFS at the first AA line was 7,4 months (95% confidence interval (CI) = 6,1-9,2months). Median bPFS was higher than the median of extra bone metastasis PFS (11 months (95% CI = 9-14 months) versus 9 months (95% CI = 8 to 12 months). Other factors have a pejorative impact on the PFS such as sarcomatoid component, non clear cell RCC, Karnofsky index, and the presence of renal thrombus Conclusions: The efficacy of AA was similar on bone and extra-bone metastases, among patients with at least one bone metastasis
Clinical outcome of patients (Pts) with metastatic renal cell carcinoma (mRCC) progressing on front-line immune-oncology based combination (IO-COMBO) regimens.
Authors: Barata Pedro C. , Gomez de Liano Alfonso , Mendiratta Prateek , Crolley Valerie , Szabados Bernadett , Wood Laura S. , Zanick Beth , Allman Kimberly D , Tyler Allison Janine , Martin Allison , Gilligan Timothy D. , Grivas Petros , Ornstein Moshe Chaim , Garcia Jorge A. , Powles Thomas , Rini Brian I. 
Published: February 2018

613 Background: Several IO-COMBO regimens are under investigation in front-line mRCC. The clinical outcome of pts who progress on an IO-COMBO regimen and receive subsequent systemic therapy is unknown. Methods: A retrospective analysis of all pts with clear-cell mRCC enrolled in one of seven clinical trials investigating an IO-COMBO at Cleveland Clinic Taussig Cancer Institute and Barts Cancer Institute was conducted. Clinical outcome of subsequent therapy including best objective response according to RECIST v1.1, progression-free survival (PFS) and adverse events (AEs) using CTCAE v4.0, were collected. Results: From a total of 89 pts enrolled on an IO-COMBO trial, final analysis included 32 pts with PD who received ≥1 line of subsequent therapy, median age 57 (41-77), 83% male, 72% ECOG 0, 78% IMDC fav-/intm- risk. Prior IO-COMBO included atezolizumab/bevacizumab (n = 20), ipilimumab/nivolumab (n = 10) and axitinib/avelumab (n = 2). All except 1 pt received IO-COMBO in the front-line setting. All pts received 1 subsequent therapy (axitinib n = 15; pazopanib n = 9; sunitinib n = 4; cabozantinib n = 3; nivolumab n = 1) after progression on IO-COMBO, 12 pts were treated with a second subsequent therapy and 5 pts were treated with ≥3 subsequent lines of treatment. For pts with available response (n = 26), the overall best response to first subsequent therapy was 27% PR, 50% SD and 15% PD. Median PFS for the first subsequent therapy was 7.9 months (95% CI, 4.5-11.3) with 8 pts remaining on treatment. The median PFS for pts previously treated with a combination of IO plus anti-VEGF was 7.9 months (95% CI, 3.1-12.7) and was 9.3 months (95% CI, 3.5-15.0) for pts treated with a prior IO plus IO combination (p = 0.732). The most frequent G3/G4 treatment-related AEs observed with first subsequent therapy were LFT elevation (9%) and diarrhea (7%); 2 pts discontinued subsequent treatment due to toxicity. Conclusions: VEGF-TKIs have clinical activity in mRCC refractory to IO-COMBO therapy, possibly impacted by the inclusion of an anti-VEGF agent in prior IO-COMBO therapy. Subsequent therapy was in general well tolerated.