bluuebunny/crossref_metadata_2025_split huggingface dataset:
Do CT perfusion measures predict early clinical response in patients with advanced renal cell carcinoma?
Authors: Fan Alice C. , Kino Aya , Schmiedeskamp Heiko , Sundaram Vandana , Srinivas Sandy , Chen Viola , Imae Yori , Desai Manisha , Kamaya Aya 
Published: March 2017

496 Background: We need biomarkers of response to guide treatment decisions in RCC. Our pilot study uses perfusion CT to assess early changes in tumor vascularity in response to targeted therapies. We will determine if perfusion CT measurements can help predict response to therapy after 1 week of treatment in patients with metastatic RCC. Methods: Nine patients with metastatic renal cell carcinoma treated with targeted therapy have been enrolled to date. CT perfusion measures were collected: (1) prior to treatment, (2) 7-10 days after start of treatment, and (3) 12 weeks after start of treatment. At each time point, 5 measures were analyzed: (1) blood volume (BV), (2) blood flow (BF), (3) mean transit time (MTT), (4) flow extraction product (FEP), and (5) tumor size. Clinical response was determined based on RECIST criteria. Univariate and multivariate logistic regression analyses were conducted to determine the association of the CT perfusion measures and clinical response. The relationship between clinical response and individual measure at each time point, change in each measure at each time point, and the rate of change over the measure across all time points (slope) were evaluated in each patient. Results: We found that two blood volume measurements are associated with outcome. 5/9 (56%) patients had stable disease and 4/9 (44%) had progressive disease. Decrease in blood volume from time prior to treatment to 7-10 days after start of treatment was significantly associated with decreased odds of having stable disease (OR 0.63 (0.4-0.99), p=0.04). When examining the rate of change, the slope of blood volume was significantly associated with decreased odds of having stable disease (OR 0.52 (0.27-1.01), p=0.05). Univariable logistic regression for each individual CT measure, FEP prior to treatment (OR 1.07 (0.99-1.15), p=0.08) and 12 weeks after treatment (OR 1.13 (0.99-1.29), p=0.06) were not significantly associated with stable disease. Conclusions: Changes in blood volume including absolute difference as well as rate of change of blood volume were statistically significantly different between patients with stable disease versus progressive disease. Clinical trial information: NCT01926990.
The role of cytoreductive nephrectomy in elderly patients with metastatic renal cell carcinoma in an era of targeted therapy.
Authors: Uprety Dipesh , Bista Amir , Vallatharasu Yazhini , Marinier David E. 
Published: March 2017

499 Background: The role of cytoreductive nephrectomy (CN) for metastatic renal cell carcinoma (mRCC) has not been clearly understood after the approval of new targeted therapies, particularly in an elderly population. We therefore conducted this study to evaluate survival difference (CN vs. no CN) among elderly patients with mRCC in targeted era. To limit the heterogeneity in use of targeted agents we define targeted era as February 2006 to December 2011, as sunitinib got FDA approval for use in RCC in January 2006. Methods: We utilized Surveillance, Epidemiology, and End Results (SEER-18) database to identify elderly (≥ 65 years) patients with mRCC, as first primary malignancy, who were diagnosed between February 2006 and 2011. Kaplan-Meier curve and log rank test were used to compare overall survival (OS) and cancer-specific survival (CSS) between patients receiving CN and not receiving CN. Cox proportional hazard model was used for multivariate analysis. Results: Out of 3,365 patients, 1088 (32.3%) received CN. There was a significant survival benefit for those who received CN vs. those who did not (Median OS: 22 months vs. 5 months, p< 0.001; Median CSS: 25 months vs. 6 months, p<0.001). After adjusting for age, sex, race, T-stage, N-stage, histology types, and year of diagnosis, patient receiving CN had significantly better 3-year OS and 3-year CSS compared to patients not receiving CN with HR of 0.37, 95% CI of 0.34 to 0.41; p<0.001 and HR of 0.37, 95% CI of 0.34 to 0.42, p <0.001 respectively. Among patients who received CN, younger age at diagnosis, other races (other than Caucasian and African American), and N0 stage were found to be independent factors predicting better survival. Conclusions: SEER database lacks individual patient’s information. One may argue that the non-surgical group may have larger proportion of patients with poor performance status. Despite this limitation, our study showed that CN has significant survival benefit and should be a serious consideration in elderly patients if they have good performance status.
National predictors and trends for androgen deprivation therapy use in low-risk prostate cancer.
Authors: Yang David , Muralidhar Vinayak , Mahal Brandon Arvin Virgil , Nezolosky Michelle Daniel , Vastola Marie , Labe Shelby , Orio Peter F. , Martin Neil E. , King Martin T. , Trinh Quoc-Dien , Sweeney Christopher , Choueiri Toni K. , Nguyen Paul L. 
Published: March 2017

50 Background: Androgen deprivation therapy (ADT) is not recommended for low-risk prostate cancer due to its known harms and lack of benefits. We evaluated the incidence and predictors of ADT use in men with low-risk prostate cancer. Methods: We identified 197,980 patients in the National Cancer Database (NCDB) with low-risk prostate cancer (Gleason 3+3 = 6, PSA < 10ng/mL, and cT1-T2a) diagnosed from 2004 to 2012 with complete demographic and treatment information. We determined the incidence of ADT use and utilized multiple logistic regression to evaluate predictors of ADT use. Results: ADT use in low-risk prostate cancer patients declined steadily from 2004 to 2012 (17.6% vs. 3.5%). 80.6% of these patients underwent radiation, and 10.0% received ADT as primary therapy. Among 82,354 low-risk disease patients treated with radiation, demographic and treatment factors associated with increased likelihood of ADT use include older age (adjusted odds ratio [AOR] 1.04 per year, p < 0.001); Hispanic vs. non-Hispanic white ethnicity (18.9% vs. 17.8%, AOR 1.26, p < 0.001); having Medicare at age < 65 (15.3%, AOR 1.14, p = 0.008) or Medicare at age ≥ 65 (21.5%, AOR 1.11, p < 0.001) vs. private insurance (13.9%); having bottom quartile vs. top quartile income (19.4% vs. 16.3%, AOR 1.26, p < 0.001); being treated in a community cancer program (22.0%, AOR 1.60, p < 0.001) or a comprehensive community cancer program (18.7%, AOR 1.38, p < 0.001) vs. an academic/research cancer program (13.9%); and receiving brachytherapy vs. external beam radiation therapy (19.3% vs. 15.5%, AOR 1.32, p < 0.001). Increasing distance from the treatment facility was associated with decreased likelihood of receiving ADT (AOR 0.97 for every 100 miles, p = 0.001). Conclusions: Among men with low-risk prostate cancer, increasing age, Hispanic ethnicity, Medicare insurance, lower income level, treatment in a non-academic/research cancer program, and brachytherapy use were all associated with increased odds of receiving ADT. Given the lack of evidence supporting ADT use in low-risk disease and increasing evidence of its many side-effects, it is critical to understand why low-risk prostate cancer patients are still receiving ADT so that this practice may be reduced.
Meta-analysis of upfront VEGF targeted therapy prior to nephrectomy in metastatic clear cell renal cancer.
Authors: Wimalasingham Akhila Ganeshi , Gomez De Liano Lista Alfonso , de Bruijn Roderick , Haanen John B. A. G. , Szabados Bernadett , Hall Peter , Blank Christian U. , Chowdhury Simon , Hopkins Thomas , Powles Thomas , Bex Axel 
Published: March 2017

514 Background: The safety and efficacy of upfront VEGF targeted, before nephrectomy in metastatic clear cell renal cancer (mCCRC) has not been robustly evaluated. Methods: In this study we performed a meta-analysis of 3 studies (NCT) with an almost identical design and included a single institution experience (which adopted this approach as a standard). Patients with newly diagnosed mCCRC had 12-18 weeks of sunitinib or pazopanib therapy prior to planned cytoreductive nephrectomy (CN). Results: 224 patients were included in this analysis (54% had sunitinib and 46% pazopanib). Overall, 73% had MSKCC intermediate risk and 23% poor risk disease. 20% of patients had an ECOG performance status of 0.84% of patients obtained stable disease or a response to therapy (by RECIST) before surgery. The median reduction of size of the primary tumour was 14%. 60% of patients had CN. The commonest reason for not performing CN was progression of disease. Progression free survival (PFS) and overall survival (OS) was 6.2 (95% CI 5.7-6.7) and 13 (95% CI: 10.2-15.7) respectively. Patients with MSKCC poor risk disease had a poor outcome irrespective of CN (OS = 7.5 months 95% CI 5.8-9.2). A comparison of sunitinib and pazopanib showed no significant difference in median PFS 7.1 (95% CI, 6.0-9.2) and 6.0 (95% CI: 5.1-6.8) or surgical complications (p<0.05). Conclusions: Outcomes with this approach are in line with expected survival for this population. Results with sunitinib and pazopanib were similar. This approach is attractive for patients with MSKCC intermediate risk disease.
Brain metastases (BM) from renal cell carcinoma treated with nivolumab: Evidence of early brain flare?
Authors: Albiges Laurence , Flippot Ronan , Arfi-Rouche Julia , Caramella Caroline , Ruatta Fiorella , Derosa Lisa , Louvel Guillaume , Maroun Pierre , Bossi Alberto , Escudier Bernard J. 
Published: March 2017

520 Background: Brain metastases (BMs) are associated with poor prognosis in metastatic renal cell carcinoma (mRCC). Patients with BM were excluded from pivotal studies of nivolumab in mRCC. Therefore, activity of nivolumab in BM is currently unknown. Methods: Data from mRCC patients with BMs, treated at Gustave Roussy with nivolumab, were collected. RECIST 1.1 assessments of both BM and metastatic sites outside the brain have been prospectively centrally reviewed. Treatment for BM: surgery, stereotactic radiation therapy (SBRT), whole brain radiotherapy (WBRT), and systemic treatment were collected. Results: Between February 2016 and September 2016, 62 consecutive patients have been treated with nivolumab in 2nd/3rdline at Gustave Roussy as part of the GETUG-AFU-26 NIVOREN trial (EudraCT 2015-004117). Among those, 8 patients (13%) had baseline non symptomatic BM, either untreated (n=6), or after SBRT (n=2). Among the 8 patients, median follow up from study enrollment is 8.1 months (range: 3.7-8.5). All 8 patients are alive at the time of analysis, only one still receiving nivolumab. 6/6 patients previously untreated required focal therapy to the brain due to early symptomatic disease progression to the brain: SBRT=5; surgery=1; WBRT=1 (one patient had SBRT +WBRT). Disease progression of BM was symptomatic in 8/8 patients and required steroid use as well as nivolumab discontinuation in 7/8 patients due to either brain and/or systemic disease progression. Conclusions: To our knowledge,this is the first experience evaluating BMs from mRCC treated with nivolumab. Our report suggests that BM from mRCC may not derive benefit from nivolumab and that prior focal therapy to the brain may be discussed in patients before nivolumab start. This finding is currently being investigated in the entire GETUG-AFU-26 NIVOREN trial population (n=499 patients, from 27 centers), which included 54 patients (11%) with BM at treatment start, to be presented at ASCO GU.[Table: see text]
Cryotherapy and thermal ablation for renal malignancy over 3cm: Comparative analysis of survival with small renal masses.
Authors: Jones Alex , Dinino Megan , Wakefield Mark , Murray Katie , Pokala Naveen 
Published: March 2017

531 Background: Ablative treatments achieve good oncological outcome for renal parenchymal tumors 3 cm or smaller. Larger renal malignancies are increasingly being treated with ablation. This comparative study determines the survival following ablation in these large renal masses. Methods: Patients undergoing cryotherapy or thermal ablation (Procedure codes 13, 15, or 23) for renal tumors were identified from SEER database (1998-2013). Exclusions: T stage not recorded, more than one primary, metastatic, or node positive disease. Demographics, stage, and overall (OS) and cancer specific survival (CSS) were analyzed. T1a tumors were compared to T1b or T2 tumors. Tumors 3 cm or less were compared to greater than 3 cm. Results: 4886 patients were identified, and 2340 patients met inclusion criteria. The mean age was 66.5 years, 1943 were white, 243 were black, and 1419 were male. The stage distribution included T1a (n=2159), T1b (n=172), and T2 (n=9). 1186 tumors had right sided, 1149 had left ,and the others were bilateral or not specified. 2326 patients had the size recorded and 1637 patients had 3 cm or smaller tumors and 689 tumors were larger than 3 cm. The OS in T1a tumors was 84.4% at 5 years and 69.2% at 9 years. The patients with T1b tumors had 62% at 5 years and 38% at 9 years. The T2 tumors had an OS of 64.8% at 57 months. The 5 yr CSS was 97.4% in the whole group, 97.9% in T1a, and 97.4% in the T1b group. The corresponding 9 yr CSS was 96.9, 97.5, and 96.9%. Comparative CSS in patients with T1a tumors was 98% at 5 years and 97.5% at 9 years. In T1b or greater tumors the 5 and 9 year survival was 90.2%. All patients that survived beyond 5 years were alive at 9 years of follow-up. On analysis by size, tumors 3 cm or less had a 98.4 5-yr and a 98.2 9-yr CSS and tumors that were greater than 3 cm had 95% 5-yr and a 93.9 9-yr survival. On univariate analysis both T1a tumors and tumors smaller than 3 cm had significantly better survival (p=0.001). Conclusions: Ablative therapies for small renal masses can achieve excellent CSS at 97% at 9 years. This study demonstrates that reasonable CSS can be achieved in masses larger than 3 cm and patients with T1b or larger tumors. Further studies are required to address the role of ablative therapies for larger renal masses.
Outcomes of patients (pts) with renal cell carcinoma and sarcomatoid dedifferentiation (sRCC) treated with nephrectomy (Nx) and systemic therapies (T) over three decades: The MD Anderson Cancer Center (MDACC) experience.
Authors: Keskin Sarp K. , Msaouel Pavlos , Hess Kenneth R. , Matin Surena F. , Jonasch Eric , Wood Christopher G. , Karam Jose A. , Tannir Nizar M. 
Published: March 2017

534 Background: Pts with sRCC historically have had a poor prognosis. We determined the overall survival (OS) and prognostic factors of pts treated with Nx and T in the cytokine and targeted therapy eras. Methods: This is a retrospective study of pts with sRCC who had Nx and received T at MDACC in the cytokine era (1987-2005) or the targeted therapy era (2006-2015). OS was measured from time of diagnosis until death of any cause or last follow-up. OS times were estimated by Kaplan-Meier plots and were compared using the log-rank test. Cox regression models were used to determine the association of covariables with OS. Results: Among 199 pts with sRCC (80.9% clear-cell) identified, 167 pts (83.9%) have died at a median follow-up of 8.8 years (median OS 16.5 months; 95% CI: 15.2, 20.9). The 1-year, 2-year, and 5-year OS rates were 67%, 38%, and 14%, respectively. There was no significant difference in OS between pts with clear-cell vs. those with non-clear cell histology. Pts with metastatic disease at initial diagnosis had a significantly shorter OS compared with pts with localized disease (median 12.1 months vs. 23.3 months; p=0.0064). Biopsy of the primary tumor or a metastatic site was able to detect the presence of sarcomatoid features in only 7% of cases. The % of sarcomatoid component (<10%, 10-40%, >40%) in the primary tumor did not impact OS. For first-line (1L) therapy, 77 pts (39%) received targeted agents, and 122 pts (61%) received chemotherapy or cytokines. Although a significant improvement in OS rate was observed at 1 year for pts treated in the targeted therapy era (p = 0.011), this effect was attenuated at year 2 and disappeared at years 3-5 after diagnosis. Conclusions: Pts with sRCC still have poor prognosis with no clear long-term benefit of targeted therapy, underscoring the need to develop more effective systemic therapies for these patients.
Pelvic SABR with HDR boost in intermediate- and high-risk prostate cancer (SPARE): Favorable early toxicity and quality-of-life outcomes.
Authors: Musunuru Hima Bindu , Deabreu Andrea , Davidson Melanie , Ravi Ananth , Helou Joelle Antoine , Ho Ling , Cheung Patrick , Vesprini Danny , Liu Stanley K. , Chu William , Korol Renee , Chung Hans T. , Mamedov Alexandre , Zhang Liying , Loblaw Andrew 
Published: March 2017

60 Background: ASCENDE-RT has provided level 1 evidence supporting the use of androgen deprivation therapy (ADT), external beam radiotherapy and brachytherapy boost in intermediate- and high-risk prostate cancer. The objectives of this study are to report early toxicity and quality of life (QOL) outcomes in patients treated on a hybrid protocol using five-fraction pelvic stereotactic ablative radiotherapy (SABR) with a MRI dose painted HDR brachytherapy boost (HDR-BT). Methods: A phase I/II study was performed where intermediate (IR) and high-risk (HR) prostate cancer patients received HDR-BT 15Gy in single fraction to the prostate and up to 22.5Gy to the MRI nodule. Gantry-based 25Gy SABR was delivered to pelvis, seminal vesicles and prostate in 5 weekly fractions. ADT was used for 6-18 months. Common Terminology Criteria for Adverse Events version 3.0 was used to assess toxicities. QOL was captured using EPIC at every follow-up. A minimally clinically important change (MCIC) definition was triggered if the EPIC QOL score at each time point decreases > 0.5 SD, where SD is the standard deviation of baseline scores. Results: Thirty-three patients (NCCN 6.0% low IR, 45.5% high IR and 48.5% HR) completed this treatment with a median follow-up of 13.8 months (IQR 12.1, 18.8). The incidence of worst toxicities is shown in Table 1.The 3 grade 3 GU patients were due to temporary urinary catheterization in the acute period following HDR-BT. Mean (95% SD) EPIC urinary QOL scores were 82.5 (16.5), 83.2 (12.9) and 83.7 (16.3) at baseline, 3 months and 12 months and the bowel scores were 95.9 (3.8), 92.6 (8.2) and 90.5 (8.3), respectively. Proportion of patients experiencing MCIC at 3 months and 12 months were 20.8% and 14.3% for urinary domain, 47.8% and 53.9% for bowel domain; respectively (see Table). Conclusions: This novel treatment protocol incorporating MRI dose painted HDR brachytherapy boost and SABR pelvic radiation for intermediate- and high-risk prostate cancer in combination with ADT is feasible and well tolerated in the acute setting. Clinical trial information: REB 269-2014. [Table: see text]
A nomogram for testosterone recovery following combined androgen deprivation therapy and radiation therapy for prostate cancer.
Authors: Spiegel Daphna , Hong Julian C. , Lee W. Robert , Salama Joseph Kamel 
Published: March 2017

67 Background: Combined androgen deprivation therapy (ADT) and radiation therapy (RT) is a frequently used localized prostate cancer (PC) treatment. Testosterone recovery (TR) after combined ADT-RT is not well-characterized. We studied TR in men who received RT and either short-term (ST) ADT or long-term (LT) ADT with LHRH agonists. Methods: We identified consecutive localized PC patients treated with ADT-RT at the Durham VA Medical Center (DVAMC) from 1/2011-10/2016. All patients had a documented baseline testosterone (T) level. Individual patient records were reviewed. TR was defined as time from last ADT injection to T normalization ( > 240 ng/dL). The Kaplan-Meier method was used to estimate time to TR. Cox proportional hazards models were generated to identify TR predictors with a nomogram built based on a parsimonious multivariate model. Results: 252 patients were identified. Median follow-up was 26.7 months. Median age was 65. Prior to treatment, 69% had a normal baseline T. 67% were treated with STADT, median duration 6 months. 33% were treated with LTADT, median duration 18 months. Median time for TR was 22.6 months for all patients (19.5 months for STADT and 25.6 months for LTADT). At 1 and 2 years post ADT, estimated TR was 13% and 53% (17% and 57% for STADT and 3% and 42% for LTADT). 2-year biochemical control was 99.2% and 97.6% for STADT and LTADT, respectively; 98.9% and 98.6% for those with and without TR, respectively. On multivariate analysis, higher pre-treatment T (HR = 1.004 95% CI 1.003-1.006, p < 0.001), use of STADT (HR = 2.48 95% CI 1.45-4.25, p = 0.001), and lower BMI (HR = 0.95 95% CI 0.91-0.98, p = 0.001) were associated with shorter time to TR. White race was a negative TR predictor (HR = 0.65 95% CI 0.43-0.9992, p = 0.049). Age, smoking, and Charlson Comorbidity Index were not significant independent TR predictors. A nomogram was generated to predict probability of TR at 1, 2, and 3 years. Conclusions: In this VA population of localized PC patients treated from 2011-2016, TR following the use of ADT-RT was variable. Using pre-treatment T levels, ADT duration, BMI, and race, a predictive nomogram can estimate the likelihood of TR.
Surgical center for ambulatory extended recovery: 30-day follow-up report of minimally invasive radical prostatectomy.
Authors: Sivaraman Arjun , Ehdaie Behfar , Eastham James Andrew , Coleman Jonathan , Touijer Karim A. , O'Shaughnessy Matthew , Stein Daniel , Durany Robert , Laudone Vincent Paul 
Published: March 2017

83 Background: In January 2016, we opened a novel, multidisciplinary ambulatory surgical center dedicated to perform complex cancer surgeries on an Ambulatory Extended Recovery (AXR) pathway specifically aimed at a 1-night or less hospital stay. This is a standalone facility separate from the inpatient hospital. The aim of this study is to evaluate the 30-day post-operative follow-up of Minimally Invasive Radical Prostatectomy (MIRP) performed in an ambulatory care setting. Methods: Between January 2016 – September 2016, we performed 424 MIRP in the AXR dedicated surgical center. The baseline demographics, cancer characteristics, surgical information and follow-up data were prospectively collected. We evaluated the 30-day complications, rate of falling-off the AXR pathway, rate of transfer to our inpatient hospital, number urgent care visits and need for re-admission. Results: MIRP was performed as robot assisted (85%) and laparoscopic (15%) procedures. The median (range) overall length of hospital stay was 27.1 (11.4 – 35.2) hours with a total operative time of 4.8 (3.1 – 9.3) hours with an estimated blood loss of 175 (20 - 800) ml. Nine patients (2.1%) fell off the AXR pathway and were transferred to the main hospital for further care. In the 30-day post-surgery period, complications were noted in 6.4% patients (Grade 1 -38%, 2 - 34% 3 – 27%), while urgent care visits and re-admission rates were 10.7% and 2.6% respectively. The median (range) time from surgery to re-admission was 16 (2 - 43) days. Conclusions: A multidisciplinary ambulatory surgical center with a dedicated AXR pathway represents a significant advancement in MIRP surgical care, providing a 1-night hospital stay in an ambulatory setting with acceptably low rates of complications, urgency care visits and re-admissions.