bluuebunny/crossref_metadata_2025_split huggingface dataset:
Assessment of the variability of and effect of hormone therapy on circulating tumor cell numbers and androgen receptor expression in patients with prostate cancer.
Authors: Clarke Noel W , Marley Sarah E , Hughes Andrew M. , Nash Anthony F , Malone Michael D , Growcott Jim W , Hodgson Darren R , Sloane Robert , Moore David J , Ward Tim H , Elliott P. Anthony , Dive Caroline 
Published: March 2020

e15141 Background: In prostate cancer (PC) CTC number and character may offer a means of assessing disease load and target engagement. However, capture platforms differ, presenting challenges to enumeration and molecular characterisation. We report the findings of a pilot study assessing the intra- and inter-patient variability of 2 different platforms, and the feasibility of measuring CTC-androgen receptor (AR) expression by immunohistochemistry (IHC) in a single platform. Methods: Following ethical approval, 4 PC cohorts (n = 12, 12, 10, and 6 respectively) were recruited; #1 localised, no hormonal therapy; #2 and #3: castrate-resistant, receiving LHRHa or LHRHa and bicalutamide, respectively; #4: newly diagnosed locally advanced, no hormonal therapy. Blood (2 x 10 mL, 2 visits #1-3; 2 x 10 mL,1 visit #4) was taken and CTCs isolated using either the Cell Search CTC Test (Veridex) or Isolation by Size of Epithelial Cells Technique (ISET) for enumeration, and ISET for AR expression (H-score [(% 1*1+) + (% 2*2+) + (% 3*3+)]). Results: There was no correlation between Veridex and ISET for detection of CTCs (Veridex enumeration:14%, 63%, 53% and 0% of samples in #1 - 4, respectively, vs ISET enumeration: 100% of samples across all cohorts) with the latter platform detecting a significantly higher number of CTCs/4mls from patients in cohort #4 vs #1 (GLS Means 119 vs 46, p=0.0135). For both platforms there was no evidence of a systematic change in the counts at two separate visits 2 weeks apart. AR was detectable in approximately 25-35% CTCs from all cohorts and there were no significant differences in the H-score between the cohorts, although the number of AR-positive cells/4mls was significantly higher in #4 vs #1, and #2 (GLS Means 25 vs 14, 15, p= 0.0197, 0.0398, respectively). Conclusions: Populations of CTCs detected by Veridex and ISET appear stable over short durations (2 weeks) and AR was detected in a proportion of CTCs by ISET using IHC. Further work is required to find alternative methodologies with greater specificity.
Characteristics of stage III and IV M0 prostate cancer (PCa) patients in SEER-Medicare who develop bone metastasis (BM) following diagnosis.
Authors: Hussain Arif , Onukwugha Ebere , Jayasekera Jinani , McNally Diane L. , Seal Brian S. , Mullins C. Daniel 
Published: March 2020

e15146 Background: BM is diagnosed in 70-80% of men with metastatic PCa. Less is known about the timing of BM diagnosis following incident non-metastatic PCa and associated patient characteristics. In this study, we determined the incidence and timing of post-diagnosis BM (BMpd) among PCa patients (pts) by incident stage, age, race and year of diagnosis using a large observational dataset. Methods: We analyzed pts aged 66 or older from the linked Surveillance, Epidemiology, and End Results and Medicare (SEER-Medicare) database. Pts with PCa were identified between 2000 and 2007 and were followed until death, Medicare disenrollment, HMO enrollment, or end of the study (December 31, 2009). The cohort included incident stage III and IV(M0) PCa in SEER, and identified BM occurring either within (i.e., +/-) 1 month of the SEER diagnosis month (BM90) or beyond the initial 90-day window (BMgt90) based on the presence of at least one inpatient or one outpatient claim with a diagnosis code of 198.5. We calculated summary and chi-square statistics to examine BMpd, BM90, and BMgt90 by incident stage, age, race and year of PCa diagnosis. Results: Among 9,188 Stage III (72%) and IV(M0) (28%) PCa pts who met inclusion/exclusion criteria, 14.6% (n=1,345) had BMpd: 2.3% (n= 217) had BM90 and 12.3% (n=1,128) had BMgt90. Average age was 72 years and 9% were African American (AA). Incidence of BMpd varied by stage (stage III: 11%; stage IV/M0: 25%; p<0.001) and by age group (66-74 years: 13%; 75-84 years: 19%; >85 years: 22%; p<0.001) but not by race (White: 15%; AA: 16%; Other: 13%; p=0.49). The diagnosis BM90 and BMgt90 varied with stage (stage III: 2% and 9%; stage IV(M0): 4% and 21%; p<0.0001) and age (66-74 years: 2% and 11%; 75-84 years: 3% and 16%; >85 years: 5% and 17%; p<0.001). The incidence of BM decreased over time whether considering BMpd (19% in 2000 to 9% in 2007; p<0.001), BM90 (4% in 2000 to 2% in 2007; p=0.03) or BMgt90 (16% in 2000 to 6% in 2007; p<0.001). Conclusions: BM occurred in only 2% of incident stage III/IV(M0) PCa pts within 1 month of diagnosis, but nearly 15% were diagnosed with BM during a median follow-up of 57 months. Prevalence of BM was highest in stage IV(M0) and older pts.
Cabazitaxel in patients with advanced CRPC after docetaxel failure: Results of expanded program access (EAP) in Spain: Safety and efficacy.
Authors: De Velasco Guillermo , Aparicio Luis Anton , Esteban Emilio , Perez Quionia , Sanchez-Hernandez Alfredo , Pérez-Valderrama Begoña , Batista Norberto , Sepulveda Juan , Castellano Daniel E. 
Published: March 2020

e15149 Background: Cabazitaxel is the new chemotherapy standard as second line in castrate resistant prostate cancer (CPRC) [Tropic Trial, Lancet 2010]. The aim of this study was to analyze the baseline characteristics and outcomes in a different cohort of patients (pts) from six hospitals in Spain within to EAP. Methods: We report a cohort of 65 pts including in EAP trial, who have progressed on or after docetaxel-based chemotherapy. Cabazitaxel was administered a standard dose of 25 mg/m2 IV q3wks. All pts had proven histology confirmation of prostate adenocarcinoma and progressive disease (radiologic and/or rising PSA) at the beginning of the treatment. Results: We collected data of 65 pts between 3-2011 to 12-2012. Median age was 63 years (range 45-83) and ECOG 0-1-2 in 26%-58%-16% respectively. Median basal PSA was 864 and Gleason grade was 7. Seventy-eight percent had bone metastases, 33% ganglionar metastases and 14% visceral metastases. Previous therapy was: hormonal, median 2 lines and chemotherapy was median of 1.6 lines. Thirty percent (20 pts) had received ketoconazole. Median of previous docetaxel dose was 1029 mg/m2(50-3750). Seventy percent of pts received G-CSF as primary prophylaxis in any cycle, 24% (16pts) had grade >3 neutropenia and 6 pts (9%) had febrile neutropenia. Other toxicities were: g3 anemia 3pts (4,6%), g3 asthenia 5pts (7,7%), g3 diarrhea 1 pt (1,5%). No toxic death was reported. The PSA response rate to cabazitaxel was 64% (31pts) and the median of cabazitaxel cycles administered was 6 at last follow-up. Median progression free survival was 4.4 months (2.7-6.1). Conclusions: These results confirm the efficacy and safety of cabazitaxel in this setting. Similar baselines parameters to Tropic trial were observed. This data reflex that Cabazitaxel in CRPC pts after docetaxel failure require the use of G-CSF in daily clinical practice.
Factorial phase II randomized trial of continuous (C) or intermittent (I) docetaxel (D) with or without estramustine (E) as first-line treatment for castration-resistant prostate cancer (CRPC): Preliminary results of HOPLITE trial.
Authors: Caffo Orazio , Lo Re Giovanni , Sava Teodoro , Buti Sebastiano , Sacco Cosimo , Basso Umberto , Zustovich Fable , Martini Thomas , Perin Alessandra , Veccia Antonello , Russo Lucianna , Facchini Gaetano , Barile Carmen , Gernone Angela , Pappagallo Giovanni L. , Galligioni Enzo 
Published: March 2020

e15160 Background: Pts who receive first line for CRPC are usually treated with 8-10 consecutive courses of D. The pts quality of life (QL) may be worsened and an I administration could limit this effect. E is an old drug showing a synergistic action with D. This study is aimed to compare QL of C and I D and whether E added to D improved its activity, in a 2 × 2 factorial design. Methods: CRPC pts were randomized to: C D 70 mg/m2 IV q 3 wks for 8 courses alone (arm A) or with E 280 mg/TID PO for 5 days starting 1 day prior to D (arm B), or the same treatments given with a 3-month rest period after the first 4 courses (arm C and D, respectively). The primary end points were QL (EORTC QLQ C30 and BPI) of A+B vs C+D and 1-y PFS (according to PCWG2) of A+C vs B+D. Results: 148 CRPC pts were enrolled from 11/06 to 10/10 with 128 pts evaluable at this time. The median age was 69 (range 42-81) and the median baseline PSA was 55.6 (range 0.33-4212). The major hematological toxicities were: anemia G3 (3 pts), neutropenia G3 (4 pts) – G4 (5 pts), febrile neutropenia (5 pts). Comparing C and I, QL outcomes were not statistically different in terms of general QL items. Comparing D and DE, 1-y PFS was superimposable (10% and 13.5%, respectively). The 2-y overall survival was not different between I and C arms 42.5% and 53.7% respectively) and between D and DE arms (42.8% and 53.5% respectively). Conclusions: These preliminary results suggest that I treatment did not produce a QL advantage compared to C treatment, while the addition of E to D did not improve 1-y PFS of CRPC pts.
Outcome research: Ambulatory intraperitoneal chemotherapy in stage IIIC ovarian cancer.
Authors: Garcia Gerardi Carlos , Vidaurreta Javier , Gil Deza Ernesto , Kohen Nelson , Levit Claudio , Morgenfeld Eduardo L. , Alessandria Sebastian , Rivarola Edgardo G. J. , Gercovich Felipe G. 
Published: March 2020

e15507 Background: Intraperitoneal chemotherapy in stage III ovarian cancer is indicated following the results of the GOG 172 study but the ambulatory application of the scheme in 24 hours continuous infusion is not feasible. Following expert recommendations (Walker, ASCO 2009 Educational Book), we evaluated the feasibility of administrating a modified GOG 172 regime in an ambulatory form. Methods: Between September 2009 and October 2010, ten patients diagnosed with stage IIIC ovarian cancer and optimal cytoreduction received the following treatment in ambulatory form: IV paclitaxel (135mg/m2/3hrs Day 1), followed by IP cisplatin (60-75mg/m2 Day 2), plus IP paclitaxel (60mg/m2 Day 8). Cycles were administered every 21 days, up to a maximum of six cycles. The tolerance for this treatment was evaluated according to the CTC for Adverse Event 3.0. Results: Population Characteristics: Mean age (47 years; range 26-64). PS (0: 4 pt; 1: 6 pt). Pathology (Papillary: 7 Pts; Mucinous, Endometroid and Poorly Differentiated: 1 pt each). N-positives: 4 pt; N-negatives: 6 pt. Intestinal resection: 1pt. In all cases, treatment was applied according to the specified parameters. Total number of cycles administered: 37 (mean cycles per pt 3 range 2-6). The average time of treatment application was 3 hours per day (9 hours total). Toxicity (G3-4): Leukopenia (2 pts). Toxicity (G1-2): Alopecia (10 pts), Anemia (9 pts), Myalgia (8 pts), Neurologic (7 pts), Fatigue (6 pts), Nausea and vomiting (6pt), Renal (2 pts), Allergy (1 pt), Pain at Catheter site (1 pt). With an average follow up time of 16 months (Range: 9-26), none of the patients have died. Three patients have progressed after the Intraperitoneal chemotherapy, while seven are alive without evidence of disease after the treatment. Conclusions: 1) The modified GOG 172 scheme can be safely applied in an ambulatory form. 2) The time required for applying the treatment is similar to that of other frequently used treatments (BEP, paclitaxel – trastuzumab, R-CHOP, b-FOL). 3) Patient tolerance was very good. 4) With an average follow-up of 16 months, all 10 patients are alive and 7 of them remain free of disease.
Hospital readmission after surgical cytoreduction for epithelial ovarian carcinoma: An assessment of risk.
Authors: Clark Rachel Marie , Growdon Whitfield Board , Wiechert Andrew , del Carmen Marcela G , Goodman Annekathryn , Boruta David M. , Bradford Leslie , Garrett Leslie A. , Schorge John O. 
Published: March 2020

e15545 Background: Hospital readmissions are common, possibly avoidable, and may be used as a metric for assessing an institution’s quality of care. We performed a retrospective analysis to determine risk factors associated with readmission after ovarian cancer cytoreduction surgery. Methods: We identified all patients with stage II-IV ovarian cancer who underwent cytoreduction at our institution between 2003-2011. A retrospective chart review was performed and clinical variables extracted. Utilizing linear and logistic regression these variables were correlated with risk of readmission. Results: A total of 463 patients were included in the analysis. Average age was 62 years. Median length of stay was 8.6 days (range 2-55). Optimal cytoreduction (<1.0cm residual disease) was obtained in 368 patients (81%) and 233 patients (50%) underwent bowel resection or radical upper abdominal procedure (splenectomy, liver resection, diaphragmatic surgery). Perioperative complications were observed in 148 patients (32%). A large proportion of our cohort was discharged to rehabilitation facilities (12%) or with a visiting nurse (38%). Of the entire cohort, 55 (12%) were readmitted within 30 days. Readmission was significantly associated with increased length of stay (OR 1.05, 95% 1.01 – 1.1) and perioperative complications (OR 3.5, 95% 2.0 – 6.3). Radical surgery was associated with an increased length of stay (p <0.001) but not with readmission (p = 0.8). Multivariate logistic regression revealed that complications were the only independent factor associated with readmission (OR 3.2, 95% 1.7- 6.0). Further multivariate analysis revealed that reoperation was associated with the greatest risk (OR 8.4, 95% 3.3 -21.1) of readmission. Conclusions: Readmission after ovarian cancer cytoreduction affected 12% of our population. While perioperative complications and increased length of stay were associated with an increased risk of readmission, multivariate analyses suggested that perioperative complications, specifically reoperation, placed the patient at the greatest risk. Comorbidities, radical surgery and the use of ancillary/rehabilitation services had no significant effects on the risk of readmission.
Growth in head and neck cancer clinical research in the NCRN and NCRI: Expanding opportunities for patients across the United Kingdom.
Authors: Seymour Matthew T. , Moser Rachel , Cooper Matthew , Fisher Sheila , Poole Karen , Nutting Christopher 
Published: March 2020

e16007 Background: The National Institute for Health Research Cancer Research Network (NCRN) was established in 2001 to benefit patients by improving the coordination, integration and speed of cancer research. Networks were established in England (NCRN), Scotland, Wales and Northern Ireland, supporting recruitment to a national portfolio across the NHS. In a decade recruitment to cancer studies has increased five fold in England to 20% of new incident cases. Head and Neck cancers affect basic functions including breathing and eating; particularly devastating for patients. The NCRI Head and Neck Cancer Clinical Studies Group is one of 23 Groups funded by NCRI members with a UK wide remit to develop a national portfolio of clinical studies. All CSGs include patients and carers as members resulting in active patient involvement in trial design, patient information and strategic direction of the portfolio. Methods: The last decade has seen unprecedented growth in the Head and Neck portfolio, which now includes 43 studies from only three studies in 2003/4. By 2010/11, 95% of UK Cancer Local Research Networks (37 networks) were recruiting to Head and Neck studies from only 2 networks in 2001/2, expanding trial access for patients and developing Head and Neck research expertise in new sites and with new investigators. Results: Numbers of patients participating in Head and Neck studies has grown exponentially. Since 2006/7 UK patient recruitment has risen 15-fold from 126 to 1890, representing almost 25% new incident cases of Head and Neck cancer. Conclusions: Rapid portfolio growth and associated network activity has expanded opportunities for patients with Head and Neck cancer; providing access to new therapeutic agents and treatment modalities, including NIHR CRN-adopted commercial trials and studies in a surgical setting. Participation in studies demonstrating the effectiveness of Intensity Modulated Radiotherapy in reducing xerostomia (including PARSPORT), has supported integration of this technique into cancer service.
Hürthle cell neoplasm of thyroid gland: An institutional experience.
Authors: Agrawal Ritesh , Chand Gyan , Mishra Anjali , Agarwal Gaurav , Agarwal Amit , Verma Ashok Kumar , Mishra Saroj Kanta 
Published: March 2020

e16023 Background: Hürthle cell carcinoma is a relatively rare thyroid malignancy. Aim of this study was to analyze clinical behavior and outcome of patients with Hürthle cell carcinoma managed at a tertiary care academic medical institution in northern India over last two decades. Methods: This retrospective study was conducted at the Department of Endocrine Surgery, SGPGIMS, Lucknow, India. Hospital records of 27 patients with FNAC proven Hürthle cell neoplasm operated between January 1991 and December 2011 were reviewed. Demographic data, clinical presentations, FNAC reports, surgical procedure undertaken, histology reports and follow up data were reviewed. Statistical analysis was done using SPSS software version 15.0 by Kruskal-Wallis and Mann-Whitney tests. p-value <0.05 was considered siginificant. Results: Among 2,066 thyroid surgeries (796 for differentiated thyroid carcinoma) performed during the study period, 27 patients had FNAC of Hürthle cell neoplasm. Histology revealed Hürthle cell adenoma (HCA) (n=10), Hürthle cell carcinoma (HCC) (n=09), and others (n=8). Sensitivity of FNAC to diagnose Hürthle cell lesions (HCA or HCC)) is 70.37%. Among histology proven Hürthle cell lesions, mean size of nodules was 6.10 + 3.27 cm (range 2.50- 13 cm); for HCA it was 4.84 + 3.32 cm (range 2.60- 13.00 cm) and for HCC, it was 7.50 + 2.75 cm (range 2.50- 10 cm). There was no significant difference in age, sex and size of nodules for development of malignancy (p-value 0.967, 0.105, 0.100 respectively). Cervical lymph node metastases were present in 44.45% and distant metastases in 22.22% of HCC. Three patients had local recurrence; one expired of distant metastases, two had repeated surgeries with control of disease. The overall mortality was 22.22% among Hürthle cell carcinomas. Conclusions: The diagnosis of Hürthle cell neoplasm on FNAC should be interpreted with caution by the treating surgeon who should corroborate with other features such as age, duration and progress of the goiter, lymph node status etc. so as to clinically ascertain possibility of malignancy to plan appropriate surgical procedure. Regular follow-up is essential to pick up recurrence at the earliest and to treat it surgically since these tumors don’t pick radioiodine.
Paclitaxel (P) and cisplatin (C) concurrent with radiotherapy (RT) for larynx preservation (LP) in advanced resectable laryngeal (L) and hypopharyngeal (HP) squamous cell carcinoma (SCC): Final results of a prospective phase II trial.
Authors: Nicolau Ulisses Ribaldo , Oliveira Thiago Bueno , Carvalho Andre Lopes , Santana Rosane O , Valadares Adriana D , Salvajoli Joao Victor , Chinen Ludmilla T.D. , Araujo Bertha Catherine B. , Martins Sandro José , Castro Junior Dalvaro Oliveira , Kowalski Luiz Paulo , Feher Olavo 
Published: March 2020

e16046 Background: Since the results of the RTOG 9111 trial, cisplatin based chemoradiation (CRT) has been the standard of care for LP in advanced laryngeal SCC. Recently, the role of taxanes in managing head and neck SCC has been studied. In 2002 we reported the interim results of a phase II clinical study designed to test the efficacy of P and C concurrent with RT for organ preservation in advanced L and HP SCC. Here we report the long term survival and LP rates. Methods: Eligible patients had untreated advanced L and HP SCC, stage T3N0 or higher and suitable for radical total laryngectomy. Treatment consisted of weekly P (30 mg/m2) and C (20 mg/m2) concurrent to RT up to 7040 cGy in 180 cGy/day fractions. Response evaluation was performed at 5040 cGy and at 4 weeks after completing RT. Salvage surgery was planned for patients not responding at 5040 cGy, residual tumor at the end of RT or at the time of local recurrence. Neck dissection was planned for clinically positive neck (cN1-3). Results: Between 06/1999 and 10/2001, 48 patients were enrolled in a single institution (35 L; 13 HP), 40 male and 8 female with a 58-year median age (39-74). The majority had T3 (64%) N1-3 (52%) disease and 38% needed tracheostomy prior to treatment. Grade (G) 3 and 4 mucositis was noted in 27% of patients, G 3-4 odynophagia in 50%, G 3-4 radiodermatitis in 35% and G 3-4 leucopenia in 13%, with no treatment related death. Two patients needed salvage surgery, one after 5040 cGy and one after 7040 cGy. The complete response rate to treatment was 95%. At a median follow up of 66 months the LP rate at 2 and 5 years were 88% and 54%, respectively. Recurrence free survival (RFS) was 51% at 2 and 47% at 5 years and overall survival (OS) was 81% and 52% at 2 and 5 years, respectively. Conclusions: The finding of similar LP rate and survival compared to the recent reports of high dose cisplatin CRT and neoadjuvant 3 drug CT followed by CRT in an advanced disease population suggests a role for platinum plus taxane as a radiosensitizer regimen in this scenario with acceptable toxicity, but further evaluation in a direct comparative trial with the standard regimen is needed.
Stereotactic radiosurgery for patients with recurrent head and neck carcinoma: Five years’ observation report.
Authors: Kawaguchi Koji 
Published: March 2020

e16049 Background: The aim of this study is to examine the effect of stereotactic radiosurgery (SRS) in the treatment of advanced, recurrent lesions for head and neck carcinoma both with and without lymph node involvement. Methods: Between April 2006 and July 2007, 22 patients (mean age 67 years) with advanced, recurrent head and neck carcinoma were treated with SRS by CyberKnife-II. All of the patients excepted one had biopsy confirmed disease prior to SRS. Patients included 3 rT2, 8 rT3, and 9 rT4; 8 of the patients had lymph node metastases. Marginal SRS doses were 20-42 Gy delivered in two to five fractions. Starting one month after SRS, all patients received S-1 oral chemotherapy for one year. Results: At an overall median follow-up of 64 months (range, 4-69 months), for the 14 locally recurrent patients without lymph node metastases, 9 patients (64.3%) had a complete response (CR), 1 patient (7.1%) had a partial response (PR), 1 patient (7.1%) had stable disease (SD), and 3 patients (21.4%) had progressive disease (PD). For the 8 patients with lymph node metastases, 1 patient with a single retropharyngeal (12.5%) had CR; the remaining 7 patients (87.5%) all progressed. Nine patients have died from their cancer. The overall 5-year survival for the patients with and without lymph node metastases was 12.5% and 78.6%, respectively. Conclusions: These results show the benefit of stereotactic radiosurgery salvage treatment for advanced, recurrent lesions, without lymph node metastases in previously irradiated head and neck cancer.