tbuckley/cabot-search huggingface dataset:
Utility of multiparametric MRI at 3 tesla and MRI/ultrasound fusion-guided biopsy in detecting seminal vesicle invasion by prostate cancer.
Authors: Dima Raskolnikov, Soroush Rais-Bahrami, Arvin George, Baris Turkbey, Chinonyerem Okoro, Jason Rothwax, Nabeel Shakir, Annerleim Walton-Diaz, Minhaj Siddiqui, Daniel Su, Lambros Stamatakis, Bradford J. Wood, Peter L. Choyke, Peter A. Pinto
Journal: Journal of Clinical Oncology (2014)

128 Background: We aim to evaluate the correlation between multiparametric prostate MRI (MP-MRI) suspicion for seminal vesicle invasion (SVI) and pathology on MRI/US fusion-guided biopsy, as well as radical prostatectomy (RP). Methods: 822 patients underwent MP-MRI and MRI/US fusion-guided biopsy. 24 patients underwent targeted seminal vesicle biopsies. 5 patients had MRI findings suspicious for bilateral SVI, for a total of 29 lesions. MP-MRI targets were scored as low, moderate, or high suspicion for PCa involvement according to the validated NIH scoring system. Patient demographics were reviewed and positive predictive values (PPVs) of pre-biopsy suspicion levels were calculated with respect to correlative biopsy pathology and final RP pathology. Results: At the time of MP-MRI, the median age was 64 years with a median PSA of 10.74 ng/ml (Table). Thirteen (54.2%) had not been previously diagnosed with PCa. Of the 29 SV lesions on imaging, MP-MRI suspicions of low, moderate, and high were assigned to 3, 18, and 8 lesions, respectively. The PPVs of these MRI suspicion levels, confirmed by MRI/US fusion biopsy, were 0%, 77.7%, and 62.5%, respectively. The 3 patients in the low suspicion cohort all underwent RP, confirming targeted biopsy findings. Of those with moderate or high suspicion of SVI on MP-MRI, only 5 underwent RP, with a targeted biopsy accuracy of 80%. The overall accuracy of targeted SV biopsy was 87.5% (7/8) on final RP pathology. Conclusions: MP-MRI suspicion of SVI correlates highly with findings on targeted SV biopsy and final RP pathology, thus potentially playing a vital role in future preoperative staging for PCa. [Table: see text]
A phase I/II study of capecitabine combined with peginterferon alfa-2a in sorafenib-refractory advanced hepatocellular carcinoma patients.
Authors: Sadahisa Ogasawara, Tetsuhiro Chiba, Yoshihiko Ooka, Naoya Kanogawa, Tenyu Motoyama, Eiichiro Suzuki, Akinobu Tawada, Fumihiko Kanai, Osamu Yokosuka
Journal: Journal of Clinical Oncology (2014)

346 Background: Several studies have demonstrated the effectiveness of combining a pyrimidine fluoride drug with interferon. Therefore, this study examined the dose of capecitabine in combination with peginterferon alfa-2a (PEG-IFN α-2a) (Phase I part) and evaluated its safety and efficacy in sorafenib-refractory advanced hepatocellular carcinoma patients (Phase II part). Methods: Capecitabine was administrated daily on days 1–14 and PEG-IFN α-2a was given on days 1, 8, and 15. The cycles were repeated every 21 days. Patients were scheduled to received capecitabine (mg/m 2 /day) and PEG-IFN α-2a (μg/week) at one of three dose levels in phase I: 1200/90, 1600/90, and 2000/90 (levels 1–3, respectively). Results: Thirty patients were enrolled. The recommended dose was level 3. Of the 24 patients given the drug at the recommended dosage, two (8%) showed partial responses, nine (38%) had stable disease, ten (42%) had progressive disease, and three (13%) were not evaluated. The median time to progression was 3.0 months. The most common toxicities were decreased white blood cell, neutrophil, and platelet counts, palmar-plantar erythrodysesthesia syndrome, and fatigue. Dose modification was required in ten (42%) patients. Four (17%) patients discontinued treatment because of severe adverse events. Conclusions: Capecitabine at 2000 mg/m 2 /day combined with PEG-IFN α-2a 90 μg/week had moderate, but manageable toxicity. Further investigation is needed to refine the efficacy. Clinical trial information: UMIN000005697.
Prostate specific antigen nadir: A prognostic marker of disease-free survival?
Authors: M. V. Mishra, R. Shirazi, K. Hertzfeld, W. Barrett
Journal: Journal of Clinical Oncology (2005)

4716 Background: The purpose of this retrospective study was to determine the nadir prostate specific antigen (PSA) level associated with biochemical control by the American Society for Therapeutic Radiation and Oncology (ASTRO) consensus statement in patients undergoing transperineal radioactive seed implantation for cancer of the prostate. Methods: Between 1995 and 2002, 148 consecutive patients were treated with permanent Iodine- 125 (I-125) seed implantation alone for presumed localized adenocarcinoma of the prostate at our institution. PSA nadir achieved and maintained was determined. Patients were followed for a minimum of 2 years and no patient received hormonal therapy. The patients were evaluated for biochemical failure according to the ASTRO consensus statement. The median age of the patients was 67 years (range 45–84). The median Gleason score was 6.07 (range 2 - 8). The median pre-treatment PSA was 6.7 ng/ml (range 1.6 - 17 ng/ml). All patients were followed continuously with a median follow-up time of 55 months (range 24 mo.- 104 mo.). Results: Table 1. Indicates percentage of patients considered to be disease free by ASTRO consensus statement correlating with nadir PSA. Conclusion: A nadir PSA of 0.15 ng/ml is highly predictive, with 97% confidence, of freedom from subsequent biochemical failure based on the ASTRO consensus statement for prostate cancer patients treated with I-125 seed implants. A nadir PSA level of 0.5 ng/ml is associated with a 91% likelihood of biochemical disease control. No significant financial relationships to disclose.
Evaluation of tobacco use and HER2 expression in a racially and ethnically diverse inner-city population.
Authors: D. M. Hansra, T. Ambros, C. Hawk, C. Hansra, J. Hurley
Journal: Journal of Clinical Oncology (2011)

e11075 Background: Tobacco is the leading cause of preventable death in the United States and is linked to many cancers. Despite overwhelming biological plausibility and over four decades of epidemiological studies, no definite association has been established between tobacco and breast cancer. Ovarian, stomach, and uterine cancer are associated with tobacco consumption and these cancers express HER2. Although estrogen receptor status has been looked at as a variable there has been no evaluation of the role of her-2 and smoking in breast cancer. Methods: A retrospective review of medical records from patients treated at the University of Miami/Jackson Memorial Hospital from 1998-2009 was undertaken after IRB approval. The incidence of smoking and her-2 expression in a population of 850 women was evaluated. Data was analyzed by age, race, ethnic group, menopausal status, tumor stage and estrogen receptor. Results: 850 charts were analyzed with 720 having full information. Median age was 57(range 28 to 94). Smoking rates were significantly higher in Caucasian versus African American women (26% vs. 17%, P=0.014). There was no difference in smoking rates in Hispanic vs. non Hispanic women (24% vs. 22% p=0.5). Overall rate of her-2 expression 16.2%. The rate of her-2 expression was 26.2% in smokers and 22.7% in non smokers (p=0.40). The rate of her-2 expression was 26.9% in Caucasian smokers and 25.2% in Caucasian non smokers (p=0.74). The rate of her-2 expression was 25% in smokers of African descent and 15.5% in non smokers of African descent (p=0.19). The rate of her-2 expression was 25.3% in Latino smokers and 23.5% in Latino non smokers (p=0.72). The rate of her-2 expression was 28.2% in non Latino smokers and 21.2% in non Latino non smokers (p=0.335). Secondary analysis for ER revealed no associations (results not included). Conclusions: Although a positive trend was identified, no statistically significant association was found between her-2 expression and tobacco exposure when analyzed by race, age, ethnicity, stage and estrogen receptor. Larger number of patients needs to be investigated in order to clarify this relationship.
The relationship between the local inflammatory response and postoperative infective complications following resection for colorectal cancer.
Authors: Michelle Leana Ramanathan, Campbell S. D. Roxburgh, Paul G. Horgan, Donald C. Mcmillan
Journal: Journal of Clinical Oncology (2014)

413 Background: In patients with colorectal cancer, the presence of both systemic and/ or local inflammatory responses are predictors of survival independent of tumour stage. The relationship between a raised perioperative systemic inflammatory response and the development of postoperative infective complications is also well established. The aim of the present study was to examine the relationship between the local inflammatory response and the development of postoperative infective complications, in patients undergoing resection for colorectal cancer. Methods: Patients with histologically proven colorectal cancer who, on the basis of laparotomy findings and preoperative abdominal computed tomography, were considered to have undergone potentially curative resection were included in the study (n = 310). Patient characteristics and postoperative complications within 30 days were recorded in a prospective surgical database. Local inflammation was analysed using Klintrup-Makinen criteria and Jass scoring on routine hematoxylin and eosin slides. Results: The majority of patients were 65 or older (66%), male (57%), had colonic tumours (68%) and node negative disease (60%). Most patients underwent elective resection (87%) and were from a deprived area (55%). During follow up 109 (35%) patients developed a postoperative complication; 88 (81%) of which had infective complications. There were no significant associations between local inflammation, as evidenced by Klintrup-Makinen criteria and Jass score, and all infective complications (p = 0.929, p = 0.317), surgical site infections (p = 0.956, p = 0.115), or anastomotic leak (p = 0.771, p = 0.157). Conclusions: The results of the present study show that there is no significant relationship between the degree of local inflammation, as evidenced by Klintrup-Makinen criteria and Jass score, and the development of postoperative infective complications following potentially curative resection for colorectal cancer.
Impact of radiotherapy practice structure on prostate cancer treatment and outcomes.
Authors: Karen Elizabeth Hoffman, Jinhai Huo, Sharon Hermes Giordano, Benjamin D. Smith
Journal: Journal of Clinical Oncology (2014)

47 Background: Traditionally men with prostate cancer were treated in clinics created, managed and overseen by radiation oncologists. Urology-owned “integrated” practices emerged in the 2000s. Proponents of integrated (INT) practices argue they improve quality-of-care by fostering multidisciplinary care while detractors argue they decrease quality-of care because they employ only one or two radiation oncologists which limits quality-assurance peer review. We compared radiation techniques and treatment toxicity for men who received radiation therapy (RT) in INT and non-INT practices. Methods: Men 66 years and older diagnosed with prostate cancer from 2006 to 2009 were obtained from the Texas Cancer Registry. Cancer-directed therapy, comorbid medical conditions and late treatment toxicity (diagnosis or procedure codes for toxicity 12 or more months after diagnosis) were determined from linked Medicare claims. Practice type was classified based on practice location of the treating radiation oncologist. Chi-square statistics compared categorical variables. Cox proportional hazards models evaluated predictors of toxicity. Results: External beam RT (&gt; 20 fractions) was administered to 781 men in INT and 3,257 men in non-INT practices. Median follow up was 44 months. Men treated in INT practices lived in counties with higher income (p&lt;0.001). There was no difference in patient age (p=0.55) or comorbidity (p=0.88) between practice types. Men treated in INT practices were more likely to receive intensity-modulated RT (98% vs. 82%, p&lt;0.001) and image-guided RT (73% vs. 23%, p&lt;0.001). Androgen deprivation therapy use was similar between practice types (p=0.36). Adjusting for patient and tumor characteristics, there was no difference in risk of late gastrointestinal (p=0.52), urinary (incontinence, p=0.10; other p=0.28), or erectile (p=0.28) toxicity between practice types. Conclusions: Men treated in INT practices were more likely to receive intensity-modulated RT and image-guided RT for their prostate cancer. Risk of late gastrointestinal, urinary and sexual side effects for men who received radiotherapy in INT practices was similar to risk of late side effects for men who received radiotherapy in non-INT practices.
To what degree is there interobserver variability among pathologists for T1 penile cancer?
Authors: Adam Luchey, Patrick Espiritu, Gautum Agarwal, Chris Protzel, Jasreman Dhillon, Philippe E. Spiess
Journal: Journal of Clinical Oncology (2014)

381 Background: Molecular and genetic markers have yet to be developed to predict those patients that are at risk for lymph node metastasis. Currently, the grading of penile cancer plays a critical role in the determination of which patients receive an inguinal lymph node dissection (ILND) along with other treatment modalities. We sought out to determine the variance among genitourinary (GU) pathologists at a tertiary cancer center for penile cancer based on a European model. Methods: Nine patients that were diagnosed with stage pT1 primary penile squamous cell carcinoma were selected who underwent either a partial (8) or radical penectomy (1) from 10/2000 to 09/2009. All slides from each case were reviewed by each of the 3 reviewing pathologists, independently, who diagnosed the subtype of squamous cell carcinoma according to WHO criteria, assigned a grade, noted whether lymphovascular invasion was present or not and finally staged the tumor according to the AJCC Cancer Staging Manual, 7th edition. No access to the original, final pathological diagnosis was allowed. Interobserver variance between the 3 GU pathologists and each variable was calculated using Cohen’s kappa coefficient. Results: Complete agreement was reached in 3 cases for tumor grade and 4 cases for tumor stage out of 9. Overall, the 3 GU pathologists only displayed fair agreement at 30% for tumor grade (ê = 0.30, p = 0.018) and trended towards fair agreement at 24% (ê = 0.24, p = 0.077) and 25% (ê = 0.250, p = 0.097) for tumor stage and LVI respectively. Conclusions: The variance displayed herein demonstrates the difficulty in identifying individuals that would benefit from a diagnostic/therapeutic lymph node dissection based on pathological staging. This corroborates that of the European model and calls for novel methods to determine reproducible prognostic markers.
A multicenter, open-label phase Ib/II study to assess the safety and clinical activity of intravenous combretastatin A1 diphosphate (OXi4503) as monotherapy in subjects with primary or secondary hepatic tumor burden.
Authors: P. N. Mainwaring, J. Lickliter, M. P. Brown, M. Millward, D. J. Chaplin, Z. Goldberg
Journal: Journal of Clinical Oncology (2010)

TPS164 Background: Combretastatin A1 diphosphate (CA1P, OXi4503) is a novel vascular disrupting agent (VDA) that is a reversible tubulin-binding agent with direct cytotoxic activity when bioactivated to its reactive orthoquinone metabolite. Several oxidative enzymes have been shown to catalyze this reaction including myeloperoxidase (MPO), tyrosinase, and hepatic peroxidases. Based on these findings it is expected that OXi4503 should be more active in tissues and tumors containing high levels of these and other oxidative enzymes. Nonclinical blood flow studies in tumor-bearing SCID mice showed that OXi4503 treatment (1 to 50 mg/kg) produced a decrease in tumor-associated blood volume. A dose of 50 mg/kg resulted in approximately 100% reduction in tumor vascular volume, compared with control mice. Tumor growth inhibition has been observed in single- and repeat-dose xenograft studies in multiple tumor models including breast cancer (MDA-MB-231), colorectal, renal (Caki-1), hepatocellular (HEP-G2), melanoma (LOX-IMVI) and AML (HL60). The extent of tumor volume reduction depended on the dose of OXi4503 and the dosing schedule. Repeat-dose studies over an extended period resulted in significant reductions in tumor volumes relative to control animals. Tumor volume reductions were maintained for up to 120 days after completion of treatment. Methods: This is a phase Ib dose escalation study to determine the safety and tolerability of OXi4503 in subjects with relapsed or refractory carcinomas with hepatic tumor burden. MTD will be the recommended phase II dose. The PK profile of OXi4503 and its major metabolites in subjects with hepatic tumor burden will also be determined. An exploratory analysis of the relative response rate of hepatic vs. non-hepatic tumor deposits will also be undertaken. OXi4503 is administered IV on Days 1, 8, and 15 of a 28-day cycle. Subjects can receive up to 6 cycles if they have stable disease or better, and no intolerable AEs. Tumor assessments are performed after every even-numbered cycle. No intra-subject dose escalation is allowed. Current enrollment is in cohort 2 (11 mg/m2). Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration OXiGENE OXiGENE
Comparison of two indwelling pleural catheter types for malignant pleural effusions.
Authors: Charalampos S. Floudas, Sushilkumar Satish Gupta, Abhinav Binod Chandra
Journal: Journal of Clinical Oncology (2016)

205 Background: Indwelling pleural catheter (IPC) placement is an alternative to chemical pleurodesis for malignant pleural effusion (MPE), a complication of advanced cancer. In 1997 an IPC was approved which uses vacuum bottles (VB) for drainage (PleurX, Becton, Dickinson and Company, Franklin Lakes, NJ), and later another IPC system, which employs a manually operated vacuum pump (VP) for drainage (Aspira, Bard Access Systems, Salt Lake City, UT). Most studies comparing IPC versus chemical pleurodesis used the VB IPC. In clinical practice VB and VP are used interchangeably. We conducted a single-center retrospective study to compare the efficacy and safety of these two IPC systems. Methods: With Institutional Review Board approval, we recorded baseline characteristics and outcomes in patients with MPE who received an IPC in our hospital from January 2013 to March 2015. Results: 27 patients were found (median age 59 years, range 30-92). ECOG performance status was 3-4 in 24 (89%); mean ±SD albumin, 2.49 ± 0.48g/dL; median respiratory rate 24 breaths / minute (range 18-40); median heart rate 106 beats / minute (range 59 – 138). A palliative care consultation was requested in 14 (52%) patients. Cancer was of lung (9 patients, 33%), breast (8, 30%), gastrointestinal (4, 15%), hematological (2, 7%), gynecological (2, 7%), prostate (1, 4%) and melanoma (1, 4%). Pleural fluid was exudate in 24 (89%); cytology malignant in 8 (31%). Six patients (22%) received chemotherapy with IPC in situ. VP group (VPG) consisted of 18 (67%) patients and the VB group (VBG) of 9 (33%), with similar characteristics. Spontaneous pleurodesis and IPC removal were achieved in 4 patients (22%) in VPG, 3 (33%) in VBG. Additional pleural procedures were required in 6 (33%) of VPG and 2 (22%) of VBG. Median length of stay was 9 days (range 2 – 38) in VPG, 13 days (range 4-32) in VBG. Catheter-related complications (pain, obstruction, infection, hemorrhage) rate was 39% (7 patients) in VPG and 33% (3 patients) in VBG; no death was caused. Intergroup differences were not statistically significant. Conclusions: In our sample, symptom palliation was achieved in all patients; efficacy and safety were similar for either type of IPC. More studies are needed for further comparisons.
Ultra-staging of node negative (pN0i-) colon cancer: Preliminary results of an international prospective clinical trial.
Authors: Anton J. Bilchik, Aviram Nissan, Mladjan Protic, Zev A. Wainberg, Nir Wasserberg, Itzhak Avital, Alexander Stojadinovic
Journal: Journal of Clinical Oncology (2013)

484 Background: We recently reported in a prospective randomized trial that ultra-staging of patients with colon cancer is associated with significantly improved disease-free survival (DFS) compared with conventional staging (Ann Surg, Sept 2012). This trial was not controlled for lymph node (LN) number, nor use of adjuvant chemotherapy. Methods: The purpose of the present trial, “Ultra-staging in Early Colon Cancer” (UECC) NCI Clinical Trial #00949312 is to evaluate prospectively whether the 12-LN quality measure with ultra-staging impacts DFS without adjuvant chemotherapy. Eligibility criteria included: a) biopsy-proven colon adenocarcinoma; b) no evidence of metastatic disease; c) ≥ 12 LNs staged pathologically; d) pan-cytokeratin immunohistochemistry(IHC) of H&amp;E-negative LNs; d) no adjuvant chemotherapy. The accrual goal is 300 patients with minimum three-year follow-up. Results: To date 126 patients have been accrued with mean and median follow-up of 40 months; 30 didn’t meet the ≥12-LN threshold. Of 52 males and 74 females, 23, 24, and 66 had T1, T2, T3 tumors, respectively. Ninety-six patients had ≥12 H&amp;E and IHC negative LNs (pN0i-). Thirty patients were &lt;12 LNs/pN0i-. Three-year DFS for all patients was 95%. Three-year DFS for patients with ≥12 LNs and pN0i- was 98% compared with 84% for &lt;12 LNs / pN0i- (p=0.002). Three-year DFS differed significantly according to nodal yield in pN0i- patients: 96% vs. 80%, ≥12 vs. &lt;12 LNs, respectively, p=0.03. Conclusions: This is the first prospective trial to demonstrate that adjuvant chemotherapy does not offer any disease-free survival benefit if patients have ≥12LNs ultra-staged by both H&amp;E and IHC (pN0i-). Both surgical and pathological quality measures are essential in the planning of adjuvant chemotherapy trials in node-negative colon cancer. Clinical trial information: NCT00949312.