bluuebunny/crossref_metadata_2025_split huggingface dataset:
Outcomes in patients with p0 versus PCIS on final cystectomy pathology.
Authors: Golla Vishnukamal , Kamat Ashish M. , Dinney Colin P. N. , Grossman H. Barton , Shah Jay Bakul 
Published: February 2017

312 Background: For patients with superficial bladder cancer, the presence of Carcinoma in situ (CIS) is known to increase the risk of subsequent upper tract recurrence. In this study, we focused on patients with no residual invasive carcinoma at cystectomy to determine if those patients with pCIS only on final pathology have worse outcomes than patients with p0 bladders. Methods: We performed a retrospective review of our institutional cystectomy database to identify patients with no residual invasive carcinoma on final pathology (p0 or pCIS only). Chi squared test was used to analyze categorical variables and recurrence rates and the Kaplan-Maier method was used to assess the impact of surgical pathology on recurrence-free survival and overall survival over time. Results: Of the 1,897 cystectomy patients in our institutional database, 630 had no residual invasive carcinoma and had complete follow up data. Of these, 285 had stage p0 and 345 had stage pCIS. Local recurrence, upper tract recurrence, and distant recurrence rates were similar between the two groups (p> 0.05 for all). Disease-specific and overall survival rates were also similar for the two groups. In the subset of patients that had received neoadjuvant chemotherapy, there were also no differences in recurrence and survival rates between the p0 and the pCIS groups. Conclusions: The presence of CIS alone in the cystectomy specimen does not increase risk of upper tract recurrence, distant recurrence, or worsened survival compared to patients with p0 bladder pathology. To note there was no financial funding for this study.
Quantification and molecular profiling of circulating tumor cells (CTCs) in urothelial cancer (UC) before and during systemic treatment: Implications across the clinical stages.
Authors: Necchi Andrea , Fina Emanuela , Giannatempo Patrizia , Colecchia Maurizio , Iacona Chiara , Farè Elena , Raggi Daniele , Nicolai Nicola , Salvioni Roberto , Gianni Alessandro M. , Mariani Luigi , Daidone Maria Grazia , Cappelletti Vera 
Published: February 2017

319 Background: CTCs from patients (pts) at different clinical stages were analyzed by a never explored experimental approach based on a combination of two techniques. Provision of this information may contribute to optimize tailored therapies. Methods: 3 cohorts were analyzed: pts with muscle-invasive bladder cancer receiving neoadjuvant (NA) sorafenib + chemotherapy (CT) (NCT01222676), and metastatic (M1) pts receiving 1st-line MVAC, and 2nd-line (M2) anti-TGFβ receptor ALK1 PF-03446962 (NCT01620970). 5 ml of whole blood were filtered by ScreenCell Cyto devices and CTC status was assessed with centralized scoring by referral pathologists. Additional 5 ml of whole blood were processed by immunomagnetic beads (AdnaTestSelect kit) and the expression level of a panel of markers (including EPCAM and MUC1) was studied using RT-multiplex PCR. The objective was the association with clinical response/relapse. Results: From 07/2012 to 08/2013, 48 pts (17 NA, 17 M1, and 14 M2) were enrolled. Rates of baseline CTC+ were: 91, 77, 75% (ScreenCell), and 36, 41, 69% with AdnaTest, respectively. NA setting: from baseline to post-CT, all pts had a stepwise reduction of CTC count/5 ml blood by ScreenCell (median baseline of 15 [0-40] to 0 [0-3]). Increase in circulating EPCAM±MUC1 levels by CTC was seen in accordance with the 3 disease progressions (PD). M1 setting: Pts who relapsed had a median of 25 CTC/5 ml (IQR: 12-47) at the end of CT, while all the others had levels <10. EPCAM profile was concordant in all cases (median 1.10 vs 0.42 ng/µl). Despite classified as partial/complete responders by RECIST criteria, 5/7 cases with >6 month follow-up displayed an increase in EPCAM levels and CTC number which anticipated a relapse. M2 setting: increase in CTC signals from baseline to +2 months was observed in 8/9 evaluable cases by AdnaTest and 4/5 evaluable cases by ScreenCell, in accordance with PD. Conclusions: This combined technique showed a promising ability to anticipate the detection of clinical relapse, although it still needs a larger sample size. Refining molecular characterization will help designing informed clinical trials.
The efficacy of EORTC risk tables in Japanese patients with non-muscle invasive bladder cancer.
Authors: Muto Satoru , Ieda Takeshi , Sugiura Syou-ichiro , Nakajima Akiko , Horiuchi Akira , Shimizu Fumitaka , Inoue Masahiro , Noma Yasuo , Kitamura Kousuke , Saito Keisuke , Isotani Shuji , Ide Hisamitsu , Yamaguchi Raizo , Horie Shigeo 
Published: February 2017

331 Background: To predict recurrence and progression of non-muscle invasive bladder cancer (NMIBC), EORTC risk tables are widely used worldwide. EORTC risk tables were, however, developed on the basis of individual data from 2,596 NMIBC patients included in seven special European Organization for Research and Treatment of Cancer trials. Therefore, it is not clear the efficacy of these risk tables in clinical practice, especially in Japan. I will report the recurrence and progression rate on the basis of EORTC risk tables in Japanese NMIBC patients. Methods: A retrospective analysis of 619 patients with NMIBC treated between January 1998 and 2012 was performed. Patients were divided into three groups on the basis of EORTC risk tables. We compared recurrence- and progression-free survival rates between groups. Recurrence- and progression-free survival was estimated using the Kaplan-Meier method. Results: We evaluated the clinical outcome of 1,032 TUR-Bt. The recurrence rate is 32.3% in low risk group (n=31), 44.5% in intermediate risk group (n=757), and 49.4% in high risk group (n=85). The median recurrence free survival time is 87 months in low risk group, 35 months in intermediate risk group, and 25 months in high risk group. Although there are significant differences in recurrence free survival time between low risk group and intermediate risk group (p=0.0351), there are no significant differences between intermediate risk group and high risk group (p=0.1871). On the other hand, the progression rate is 1.6% in low risk group (n=128), 5.8% in intermediate risk group (n=451), and 18.0% in high risk group (n=294). The median progression free survival time is 176 months in low risk group, 131 months in intermediate risk group, and 109 months in high risk group. There are significant differences in progression free survival time between low risk group and intermediate risk group (p=0.0138), and between intermediate risk group and high risk group (p=<0.0001). Conclusions: There is an urgent need to establish the standard of recurrence risk classification in Japan.
Intravesical ethiodized oil injection technique for image-guided radiation therapy for bladder cancer.
Authors: Baumgarten Adam S. , Emtage Justin B. , Wilder Richard , Biagioli Matthew C. , Gupta Shilpa , Spiess Philippe E. 
Published: February 2017

337 Background: Bladder sparing trimodality therapy consisting of maximal TURBT, radiation, and chemotherapy offers a feasible and effective option to patients with muscle invasive bladder cancer that are unwilling to undergo cystectomy. The shape and position of the bladder change significantly during radiation therapy, and it is possible to miss the tumor bed when a radiation boost is delivered to only part of the bladder. This study describes the technique of injecting ethiodized oil in the submucosa of the urinary bladder wall as a novel modality to improve localization of muscle invasive bladder tumors prior to image-guided radiation therapy (IGRT). Methods: Eight patients underwent submucosal ethiodized oil injections at the time of transurethral bladder tumor re-resection. A rigid cystoscope with a working port was used to inject ethiodized oil into bladder submucosa circumferentially around the tumor bed (2-3 mm from margin of resection). Roughly 20-30 injections were used to demarcate the tumor bed for external beam radiation therapy, which was used as part of a bladder sparing approach. All patients were diagnosed with clinically localized, high-grade, muscle invasive carcinoma and were deemed nonsurgical candidates or were unwilling to undergo radical cystectomy. Results: 5 of the 8 patients underwent IGRT at our institution. 95% of ethiodized oil injections were visible on treatment planning CT scans and kV portal images throughout the 7-week course of IGRT. In 2 of 5 patients, the tumor bed based upon ethiodized oil extended outside a planning target volume that would have been treated with radiation therapy based upon cystoscopy reports and computed tomography scans without ethiodized oil. There were no adverse events or treatment-related toxicities secondary to ethiodized oil injection. Conclusions: Intravesical ethiodized oil injection is an easy-to-perform technique that is safe and effective. Ethiodized oil serves as a fiducial marker that improves tumor bed localization for radiation therapy, thereby reducing the likelihood of missing the tumor.
The performance of targeted magnetic resonance imaging/ultrasound fusion biopsy versus random 12-core biopsy for prediction of total prostate cancer tumor volume.
Authors: Okoro Chinonyerem , Rais-Bahrami Soroush , George Arvin , Walton-Diaz Annerleim , Siddiqui Minhaj , Shakir Nabeel , Rothwax Jason , Raskolnikov Dima , Stamatakis Lambros , Su Daniel , Turkbey Baris , Choyke Peter L. , Wood Bradford J. , Merino Maria , Pinto Peter A. 
Published: February 2017

34 Background: Tumor quantification with percent core and/or core length involvement is a parameter used to determine burden of disease for patients with prostate cancer (PCa). However, controversy exists regarding tumor quantification in random 12-core biopsies due to discrepancies in lesion targeting and overall needle core lengths obtained. Targeted MRI/US fusion biopsy allows for more optimal lesion targeting and interpretation of this parameter. We aim to correlate highest percentage core involvement and corresponding tumor length for both targeted fusion and random 12-core biopsies with total tumor volume. Methods: Patients who underwent multiparametric MRI (MP-MRI) with targeted MRI/US fusion biopsy at our institution between 2007 and 2012 were reviewed. Those that met Johns Hopkins criteria for active surveillance (AS) based on outside 12−core biopsy were then identified. MRI tumor volumes were calculated in fusion biopsy positive lesions and correlated with the highest percentage core involvement and corresponding tumor length for both targeted fusion biopsy and 12-core biopsy. Bivariate analysis was used to determine the empirical relationship between these variables. Results: Six hundred ninety six patients had MP-MRI with MRI/US fusion biopsy, 109 of which met Johns Hopkins criteria for AS upon entry and 47 of these patients had fusion biopsy confirmed PCa. Mean age was 61 and mean PSA was 5.6ng/ml. For highest percentage core involvement, targeted biopsy showed a positive correlation (r=0.57) whereas 12-core biopsy showed a poor correlation (r=0.016) with the total tumor volume (p<0.0001 and p=0.91 respectively). Similarly, for tumor length of the highest percentage core, targeted biopsy showed a positive correlation (r=0.6) whereas 12-core biopsy showed a poor correlation (r=0.01) with the total tumor volume (p<0.0001 and p=0.94 respectively). Conclusions: Highest percentage core involvement and corresponding tumor length on targeted MRI/US fusion biopsy positively correlate with total tumor volume. Targeted biopsy better predicts overall burden of disease and can aid in risk stratification of patients seeking AS.
Impact of number of lines of prior chemotherapy in patients (pts) with advanced urothelial carcinoma (UC) receiving salvage therapy.
Authors: Sonpavde Guru , Bellmunt Joaquim , Rosenberg Jonathan E. , Bajorin Dean F. , Regazzi Ashley Marie , Choueiri Toni K. , Qu Angela Q. , Niegisch Guenter , Albers Peter , Necchi Andrea , di Lorenzo Giuseppe , Fougeray Ronan , Wong Yu-Ning , Sridhar Srikala S. , Ko Yoo-Joung , Milowsky Matthew I. , Galsky Matt D. , Pond Gregory Russell 
Published: February 2017

353 Background: The prognostic impact of number of lines of prior chemotherapy and prior perioperative chemotherapy on survival results in salvage trials for advanced UC is unknown. Methods: We pooled 10 prospective phase II trials of salvage therapy for advanced UC with data on the number of prior lines of therapy in addition to known prognostic factors: TFPC (time from prior chemotherapy), Hb (hemoglobin), PS (performance status), and LM (liver metastasis) status. Cox proportional hazards regression was used to evaluate the association of number of prior lines with overall survival (OS) and progression-free survival (PFS). Trial was included as a stratification factor. Sub-analysis examined the impact of prior perioperative chemotherapy. Results: Of 731 pts, data for all factors was available for 711. The overall median PFS and OS were 2.7 and 6.8 months, respectively. Trials evaluated vinflunine (N=151), docetaxel +/- vandetanib (N=147), paclitaxel-gemcitabine (N=83), sunitinib (N=77), nab-paclitaxel (N=48), volasertib (N=46), everolimus (N=45), pazopanib (N=43), cetuximab +/-paclitaxel (N=39) and paclitaxel-cyclophosphamide (N=32). The number of prior lines of therapy were 1 in 559 (78.6%), 2 in 111 (15.6%), 3 in 29 (4.1%), 4 in 10 (1.4%) and 5 in 2 (0.3%) pts. Prior perioperative chemotherapy was given to 277 (39.1%) and chemotherapy for metastatic disease to 454 (64.1%) pts. While TFPC, Hb, PS and LM were significantly associated with OS and PFS on multivariate analyses, the number of prior lines was not associated with OS (HR 0.99 [95% CI: 0.86-1.14]) or PFS (0.92 [0.80-1.05]). Prior peri-operative chemotherapy was a favorable factor for both OS and PFS on univariable but not multivariable analysis. Conclusions: The number of prior lines of therapy and prior perioperative chemotherapy were not independently prognostic for OS or PFS in UC pts receiving salvage therapy, although the data are limited by few pts with >2 prior regimens. We infer that interpretation of OS and PFS results in salvage therapy trials will not be affected by inclusion of pts with ≥ 2 prior regimens including perioperative and/or metastatic disease treatment. These data need external validation.
Gemcitabine-cisplatin (GC) plus radical cystectomy-pelvic lymph node dissection (RC-PLND) for patients (pts) with muscle-invasive bladder cancer (MIBC): Assessing impacts of neoadjuvant chemotherapy (NAC) and the PLND.
Authors: Tully Christopher Michael , Bochner Bernard H. , Dalbagni Guido , Zabor Emily C. , Herr Harry W. , Donat S. Machele , Ostrovnaya Irina , Regazzi Ashley Marie , Kim Philip H. , Sfakianos John P. , Rosenberg Jonathan E. , Bajorin Dean F. 
Published: February 2017

355 Background: NAC and RC-PLND improves survival in MIBC and GC is a standard NAC option. However, little is known about GC efficacy endpoints and the individual contribution of NAC and surgery. Methods: Pts with clinical T2-T4aN0M0 MIBC treated from 1/2000 to 10/2012 with a planned 4 cycles of GC plus RC-PLND within 90 days (D) of NAC were evaluated retrospectively for the number (#) of cycles, dose delivered, D from end of NAC to RC-PLND, margin status, LN status and # of LN identified. Post-NAC pathologic endpoints included complete response (pT0), residual Non-MIBC disease (pTa/Tis/T1;N0) and ≥MIBC disease (≥pT2N0). Associations with overall survival (OS) and disease-free survival were analyzed using Cox regression; non-linear associations with # of resected LN used linear and quadratic terms. Results: 154 pts met inclusion criteria. 5-year (yr) OS was 61% (95% CI 53-71%). Post-NAC pT0 was achieved in 21% (32/154) and Non-MIBC in 25% (39/154 - pTa (2), pTis (25), pT1 (12)). Post-NAC pT0 and Non-MIBC had similar 5-yr OS (85% and 89%, respectively) and combined (<pT2) pts differed significantly from pts with ≥pT2, (87% (95% CI 78, 98%) and 38% (95% CI 27, 53%), respectively; p<0.001). Median D from NAC to RC-PLND was 34 and median # of resected LN was 19. On univariate analysis, # of cycles (4 vs <4), GC dose intensity and total dose, clinical stage (cT2 vs cT3/cT4), # of resected LN, positive (+) LN and + margins were significant for OS. In multivariate analysis, post-NAC pathology ≥pT2 (HR 6.7; 95% CI 2.6-17.4; p<0.001), + LN (HR 3.21; 95% CI 1.6-6.4; p=0.001) and + margins (HR 3.2; 95% CI 1.4-7.5; p=0.007) were significant for increased risk of death. Using a model with these 3 predictors to estimate the benefit of PLND, the hazard ratio decreased with each LN resected until 25 and then plateaued beyond 25 (p=0.016). Conclusions: NAC with GC has excellent drug delivery, permits rapid RC-PLND and achieves meaningful pathologic responses. Survival is similar with <pT2N0 and pT0N0 post NAC pathology. Pts with post NAC ≥pT2, + margins, and + LN do poorly. Increasing LN yield on PLND contributes to OS.
Development of a new outcome-prediction model for patients with urothelial carcinoma of the bladder prior to cystectomy.
Authors: Kramer Mario W. , von Klot Christoph A. J. , Heinisch Annika , Wegener Gerd , Abbas Mahmoud , Peters Inga , Tezval Hossein , Herrmann Thomas R. W. , Kuczyk Markus A. , Merseburger Axel S. 
Published: February 2017

360 Background: Prognostic models for patients undergoing cystectomy are spares and mostly rely on histopathological parameters. The present study investigated clinical prognostic indicators that are available prior to cystectomy for developing a risk stratification model. Methods: Charts were reviewed from 279 bladder cancer patients that were treated with radical cystectomy and bilateral lymphadenectomy. Of those 194 were eligible for study entry due to availability of necessary data. None of the patients had neoadjuvant therapy. Various preoperative parameters were analyzed and optimum cut-off points were identified using ROC curves. A risk stratification model was developed based on multivariate analysis. Analyzed factors included serum-creatinine, hemoglobin, white blood cells, C - reactive protein (CRP), age, gender, and body mass index. Results: In multivariate analysis, preoperative serum-creatinine (>93 umol/l), white blood cells (>10.2 tsd/ul), CRP (>3 mg/l) and BMI (<18,5 kg/m2 or ≥30 kg/m2) were independent predictor of poor cancer-specific survival (CSS). A new scoring model was developed, consisting of those four parameters. The stratification model showed significant differences based on Kaplan-Meier analysis for the whole cohort as well as for subgroup analysis (pT2-4, Nx, M0) (p<0.001). CSS after 36 (60) months for low, intermediate and high risk group was 82.6% (76.2%), 37.7% (30.9%) and 22.2% (16.7%), respectively (p<0.0001). Conclusions: Our scoring model based on preoperative clinical parameters can discriminate bladder cancer patients prior to cystectomy in respect of CSS. This might help physicians to recommend treatment options such as neoadjuvant therapy. The scoring model needs external validation considering prospective study design and discriminating patients who received neoadjuvant chemotherapy.
Palonostron with aprepitant plus dexamethasone to prevent chemotherapy-induced nausea and vomiting (CINV) during gemcitabine/cisplatin (GC) in urothelial cancer (UC) patients: A multi-institutional retrospective study in Japan.
Authors: Kitamura Hiroshi , Takahashi Atsushi , Hotta Hiroshi , Kato Ryuichi , Kunishima Yasuharu , Takei Fumiyasu , Horita Hiroki , Masumori Naoya ,   Sapporo Medical University Urologic Oncology Consortium
Published: February 2017

362 Background: GC combination chemotherapy of is a standard regimen for advanced UC. Although this is a highly emetogenic chemotherapy, there has been no study concerning antiemetic prophylaxis for CINV during GC. The aims of this study were to evaluate CINV during GC and to compare the antiemetic efficacy of the triple combination of palonosetron, aprepitant and dexamethasone with that of our old regimen using first-generation 5-HT3 receptor antagonists and dexamethasone. Methods: We conducted a retrospective multi-institutional review of the medical records of 122 patients who received GC for advanced urothelial cancer between February 2005 and January 2012. Uncontrolled CINV events were identified through records of nausea and vomiting, additional infusion, rescue medications, and/or records of food intake. Nausea, vomiting, and anorexia were classified using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Results: A total of 75 and 47 patients were treated with first-generation 5-HT3 receptor antagonists (ondansetron or granisetron) plus dexamethasone (group 1) and palonosetron with dexamethasone plus aprepitant (group 2), respectively. There was no significant difference in age, sex, or the dose of cisplatin between the 2 groups. Patients in group 2 had significantly higher CR (defined as no emetic episodes and no rescue medication use) rates than those in group 1 during the overall phase in the first cycle (85.7% versus 65.3%, p=0.012) and all cycles (78.7% versus 50.7%, p=0.0019) of GC. Patients in group 2 were more likely to achieve more favorable CINV control, e.g., a lower grade of nausea, vomiting, or anorexia, lower incidence of rescue therapy required, and shorter time to become CINV-free, than patients in group 1. Conclusions: This study shows that palonosetron in combination with aprepitant and dexamethasone is more effective to prevent chemotherapy-induced nausea and vomiting in UC patients treated with GC than first-generation 5-HT3 receptor antagonists plus dexamethasone.
Patterns of relapse in poor-prognosis germ cell tumors in the GETUG 13 trial: Implications for assessment of brain progression.
Authors: Loriot Yohann , Pagliaro Lance C. , Flechon Aude , Mardiak Jozef , Geoffrois Lionnel , Kerbrat Pierre , Chevreau Christine , Delva Remy , Rolland Frederic , Theodore Christine , Bui Binh , Gravis Gwenaelle , Eymard Jean-Christophe , Malhaire Jean-pierre , Linassier Claude , Habibian Muriel , Logothetis Christopher , Culine Stephane , Laplanche Agnes , Fizazi Karim 
Published: February 2017

365 Background: GETUG 13 investigated personalized chemotherapy based on tumor marker decline in patients with poor-prognosis GCT and demonstrated that a dose-dense regimen improves progression-free survival in patients with an unfavorable decline (Fizazi K, ASCO 2013). We investigated the pattern of relapse for patients included in GETUG 13. Methods: We conducted an analysis of relapse events in patients from GETUG 13 and an unfavorable decline of tumor markers (n=203). Baseline procedures before inclusion in the trial comprised a thoraco-abdomino-pelvic CT scan and an MRI of the brain: 22 patients (10%) had evidence of brain metastases at presentation. Results: With a median follow-up of 4.1 years (0.3 ; 8.8 years) when the analysis was performed, a progression event was observed in 94/203 patients (46%). First event consisted in a marker progression only in 41 patients (43%), a radiographic progression only in 29 patients (31%), a mix progression on both markers and imaging in 11 patients (12%), and death in 13 patients (14%). In patients with radiographic progression only, brain was the predominant site (n=16/29, 55%). Among all patients who experienced a radiographic progression (as first and subsequent progression event, n=58), brain only was the site of progression in 26 patients (45%): 12/30 (40%) in patients treated with BEP and 14/28 (50%) in those treated with dose-dense chemotherapy. Conclusions: Brain metastases develop often, early, and frequently as the only site of relapse in the course of poor-prognosis GCT. This raises the question of early detection and treatment of brain metastases in these patients, for example by integrating a systematic brain MRI after 2-3 months of chemotherapy.