bluuebunny/crossref_metadata_2025_split huggingface dataset:
Cardiovascular events and clinical responses in prostate cancer patients treated with transcutaneous estrogen patches compared with LHRH analogues: Results from a randomized phase II trial (MRC PR09 PATCH).
Authors: Abel P. D. , Sundaram S. K. , Kynaston H. G. , Clarke N. , Alhasso A. A. , Rosen S. D. , Jinks R. C. , Pollock P. , Cafferty F. , Langley R. E. ,   PATCH Trial Management Group
Published: February 2017

201 Background: Androgen-deprivation therapy (ADT) with a luteinising hormone-releasing hormone analogue (LHRHa) is widely used in the management of prostate cancer. LHRHa suppresses testosterone to castrate levels but can lead to long term toxicities including osteoporosis, adverse metabolic effects and cardiovascular (CV) complications. Transcutaneous oestrogen is an attractive potential alternative to ADT. This approach circumvents first-pass hepatic metabolism and so should avoid the CV effects previously reported with oral oestrogen in men with prostate cancer. Castrate levels of testosterone, and hence prostate cancer outcomes, are expected to be equivalent but the side-effects associated with ADT will potentially be avoided. Methods: PATCH is a multi-centre phase II randomized study of 254 men with locally advanced or metastatic prostate cancer assigned (2:1) to either oestrogen patches (Merck FemSeven 100mcg/24hr; 4 patches changed twice-weekly, reducing to 3 after 4 weeks) or LHRHa. The primary outcome is CV morbidity and mortality, including arterial and venous thromboembolic events, acute coronary syndrome and heart failure. These have been assessed by an independent committee, blind to the treatment arm. Secondary outcome measures include PSA response, serum testosterone and also toxicities. Results: Baseline data on the 254 men will be presented including age, cardiovascular risk factors (smoking history, lipid levels and family history), and stage/grade of tumour at presentation and randomisation. CV events will be presented by randomisation arm and by treatment at the time of the event. Data relating to rates of castrate levels of hormones, PSA responses, sexual dysfunction, other toxicities (including gynaecomastia, hot flushes, anaemia and bone fractures) and compliance will also be available. Conclusions: Providing the data demonstrate that the patches are a safe and potentially efficacious therapy we propose to recruit a further 410 patients with progression-free survival as the primary outcome. CV events will continue to be closely monitored, alongside other outcomes. [Table: see text]
Factors associated with a delay in diagnosis of recurrent prostate cancer after radical prostatectomy.
Authors: Hoffman K. E. , Chen M. , Nguyen P. L. , Bennett C. L. , Sartor A. O. , Stein K. , Kuban D. A. , D'Amico A. V. 
Published: February 2017

208 Background: Salvage radiation therapy has an improved chance of increasing prostate cancer survival if it is administered at the earliest sign of recurrence, when prostate-specific antigen (PSA) is low. We identified factors associated with delay in diagnosis of recurrent prostate cancer after prostatectomy. Methods: We analyzed 375 men with PSA recurrence after prostatectomy enrolled in the Comprehensive, Observational, Multicenter, Prostate Adenocarcinoma Registry. Delay in diagnosis was defined as the time, in months, between recorded PSA greater than or equal to 0.2 ng/ml and enrollment in the registry. Multivariable regression analysis was used to identify sociodemographic and clinical factors associated with diagnosis delay. Diagnosis delay was dichotomized at the median (10 months) for the analysis. Results: At enrollment the median age was 70 years, median time since prostatectomy was 71 months, and median PSA was 0.7 ng/ml. On multivariable analysis, older men (p=0.043), men with greater length of time since surgery (p<0.001), and men who contemplated delaying their PSA test (p=0.004) were more likely to have a delay in diagnosis of PSA recurrence. Men with Gleason 8 or higher disease at initial cancer diagnosis were less likely to have a delay (p=0.028). Conclusions: Older men, men with greater time interval since prostatectomy, and men who contemplate delaying their PSA test are more likely to have a delay in diagnosis of recurrent prostate cancer. Since early salvage radiation therapy may be curative, physicians should encourage PSA vigilance and early referral if a rising PSA is noted among men with these characteristics. [Table: see text]
Educating African American men on prostate health and informed decision making: Initial report from a peer-education program in Louisiana.
Authors: Robinson M. M. , Sartor A. O. , Jack L. 
Published: February 2017

211 Background: Informed decision making for prostate cancer health is widely endorsed but systematic programs to address this need are sparse. Herein we report initial progress in a statewide effort targeting African American men. Methods: The Louisiana Cancer and Lung Trust Fund Board (LCLTFB) Prostate Cancer Program is funded via a “check box” on the state income tax form, in which a portion of refunds could be allocated for prostate cancer efforts. The LCLTFB partnered with the statewide comprehensive cancer control program to develop a pilot lay program to educate men on prostate informed decision. The program was developed and modeled after “My Brother's Keeper,” a CDC funded program and implemented in five regions of the state. African American men active in the cancer community and regional cancer coalitions were identified as possible trainers for the program. Staff members from “My Brother's Keeper” trained the Cancer Control regional staff, as well as the community trainers in a two day session. Upon completion, the community trainers were charged to go into their community and convene three education sessions. Educational sessions were conducted in local churches, head start centers, men social club meeting, Greek organizational meetings, and labor union meetings. Men attending the session received a short pre- and post-test assessing whether or not they had discussed prostate informed decision making with a health care provider, if they had made an appointment with a health care provider, or was any follow up from the educational session initiated. Results: A total of 250 African American men in Louisiana were educated by the program. Upon followup phone calls, 172 men self-reported that they had initiated some form of follow up as a consequence of the participation. 35 men were unable to be contacted for follow up (number no longer in service or no phone number listed) 43 men (messages left but no returned call). Conclusions: Peer education can engage African American men regarding informed decision making on prostate cancer health issues. More data are needed to verify and determine the type of followup that was initiated after the educational sessions. [Table: see text]
The impact of pathologic review by central pathologist on selection for treatment modality of localized prostate cancer in candidate for brachytherapy.
Authors: Kishimoto R. , Saika T. , Bekku K. , Nose H. , Abarzua F. , Kobayashi Y. , Yanai H. , Nasu Y. , Kumon H. 
Published: February 2017

213 Background: To evaluate the impact of pathological review by pathologist with genitourinary expertise (PGU) on treatment modality of localized prostate cancer, we analyzed migration of Gleason grade (GG), and final treatment decision in a cohort of patients who were candidate of permanent prostate brachytherapy (PPB). Methods: From February 2005 to July 2010, a total of 247 patients with localized prostate cancer diagnosed by local community hospital were referred to our hospital for PPB, and all pathological slides of the prostate biopsy were reviewed by single PGU. The patient finally selected their treatment modality based on our recommendation made by reference to the pathological review. Our indication of PPB, basically, is a patient classified good or intermediate risk by NCCN classification. In addition, a patient with primary GS 4 was regarded as unadapted case. Results: Six cases were reinterpreted as no cancer (2.4%), and GG change occurred in 95 cases (38.4%). GG was upgraded in 77 cases (31.2%), and downgraded in 18 cases (7.3%). As a result, a total of 86 patients changed their therapies, and 25 of 86 patients (29%) were changed their therapy based on the pathological review. Conclusions: Approximately 10% of patients were changed to proper therapies by PPB's pathological review. This study shows pathological review for biopsy specimen is mandatory for determination of treatment modality, especially in candidate for PPB. No significant financial relationships to disclose.
Clinical management of small cell carcinoma of the urinary tract (SCCUT): A single-center experience.
Authors: Abella L. E. , Zudaire M. , Castillo A. , Del Barrio A. , Carranza O. E. , Arevalo E. , Perez-Gracia J. L. , Zudaire J. J. , Cambeiro M. , Gil- Bazo I. 
Published: February 2017

216 Background: SCCUT is a rare but aggressive condition. No standard treatment has been established. The management of small cell lung cancer has been adopted by analogy. We aim to review the clinical features, therapy and natural course of patients with SCCUT. Methods: From 2002 to 2010 12 patients (pts) were diagnosed with SCCUT and treated at the Clínica Universidad de Navarra, Pamplona (Spain). Results: The median age was 62 (50-78). Male to female ratio was 11:1. The primary disease was prostate in 6/12 (50%) of cases, urinary bladder in 5/12 (41.7%) and kidney in 1/12 (8.3%). Overall, 5 pts (41.7%) had limited disease (LD) and 7 (58.3%) had extensive disease (ED) at onset. Basal serum levels of Neuronal Specific Enolase (NSE) were determined in 6 pts. In all of them levels over the upper-limit were observed. Treatment information was available for 10 pts, 5 with LD and 5 with ED. LD pts received multimodal therapy. Surgery (S) was the initial treatment in 4 pts (80%), 3 of them additionally received adjuvant treatment either with platinum-based chemotherapy (C) (2 pts) or chemoradiation (1 pt). The remainder received neoadjuvant C followed by radical S. Prophylactic whole brain radiation (WBR) was administered in 1 pt. Median progression-free-survival (PFS) for pts with LD was 9.3 months (m) (2-22 months). Median overall survival (OS) was 26 m. Pts with ED mostly received palliative chemotherapy with platinum-etoposide (80%) while 1 pt underwent palliative radiotherapy as exclusive therapy. Response rate for C was 75%: 2/4 complete response, 1/4 partial response and 1/4 disease stabilization. Median PFS was 3.3 m. WBR was administered in 2 pts with ED, 1 of them with prophylactic intent. Median OS was 14 m for ED pts. Conclusions: In our experience, SCCUT was more common among male pts and the prostate the most frequent primary site. Despite its chemosensitivity SCCUT showed an aggressive clinical course and poor prognosis in our series. SCCUT must be suspected in any genitourinary neoplasm of atypical or aggressive behavior. NSE serum levels may help to achieve an early diagnosis and to provide a proper systemic treatment up-front. [Table: see text] No significant financial relationships to disclose.
Brain and meningeal metastases (BMm) from castration-resistant prostate cancer (CRPC) in the era of docetaxel (DOC).
Authors: Caffo O. , Gernone A. , Ortega C. , Sava T. , Carteni G. , Facchini G. , Amadio P. , Veccia A. , Pagliarulo A. , Galligioni E. 
Published: February 2017

217 Background: The occurrence of BMm is usually viewed as an exceptional event in the history of prostate cancer (PC) patients (pts). In two large retrospective series the incidence of BMm in PC pts was about 0.5%. Since the introduction of DOC as first line treatment has improved survival of CRPC pts, we have retrospectively evaluated the occurrence of BMm in such setting of pts, to explore whether the incidence of BMm has changed. Methods: The clinical records of a series of 801 pts with CRPC treated from 2002 to 2010 were reviewed. All pts met the definition of CRPC according to international guidelines: all pts received or were eligible for DOC-based treatment. Results: We collected a series of 28 pts with BMm (incidence 2.9%). Sixteen pts had a median number of 1 brain metastases (range 1-8) and neurological symptoms were present in 11 cases. Teen cases presented meningeal metastases: in this case all but one pt were symptomatic. To date, no detailed information are available for the 2 remaining cases. After BMm diagnosis, local treatments were proposed in 16 pts: 5 pts underwent metastasectomy (M) + external brain irradiation (BI), 1 M alone, 9 BI alone, 1 gamma-knife. Eleven pts received chemotherapy after BMm, while the remaining received only best supportive care. The median interval from the PC diagnosis and the achievement of CRPC was 23 mos (range 7-141) while the appearance of BMm was documented after 6-173 mos (median 42) The median survival after BMm was 3 mos (range 1-29) with 6 pts surviving more than 1 year. These long-term survivors had brain metastases in 5 cases and meningeal metastases in 1 case and were managed with surgery in 3 cases, radiotherapy in 2 cases and DOC in 1 case. Conclusions: It appears from our data that in the DOC era 1) the incidence of BMm in CRPC pts is higher than in the historical reports; 2) the interval from PC diagnosis and the appearance of BMm is clearly longer (42 mos) compared to that reported in historical series (28 mos). These findings could be related to the changes in survival of CRPC, produced by DOC introduction in the clinical practice. A special attention should be reserved to the appearance of neurological symptoms in a long-term CRPC survivor due to a possible relation with BMm. No significant financial relationships to disclose.
Extramammary Paget's disease of the penis and anogenital area: SEER analysis.
Authors: Master V. A. , Herrel L. , Johnson T. V. , Delman K. A. 
Published: February 2017

220 Background: Extramammary Paget's disease (EMPD) is a rare cancer with poorly described outcomes comprising primarily single-institution small case series. We used the Surveillance, Epidemiology, and End Results (SEER) registries to further define survival and predictors of survival in EMPD. Methods: 17 SEER registries were queried for male patients diagnosed with EMPD from 1973 to 2007. Patients were categorized by: penis and anogenital structures (anorectum, scrotum, and skin). Descriptive analyses were conducted to characterize each group including age, year of diagnosis, race, tumor stage, and treatment. Kaplan-Meier and multivariate Cox regression analyses were performed. Results: The cohort consisted of 328 patients. Overall survival based on primary sites of EMPD were: anorectum (24.3%), scrotum (62.4%), penis (62.5%), skin (50.8%). Controlling for patient and disease characteristics, significant factors negatively impacting survival were primary site in the anorectal region compared to scrotum, penis and skin (p<0.001, p=0.008, p=0.005 respectively), presence of distant disease versus localized disease (p=0.01) and radiation only (RT) treatment versus surgery alone (p=0.016). Survival benefit was not increased in patients who underwent combined RT and surgery treatment, as compared to those who were treated with surgery alone (p=0.61). Conclusions: Predictors of lower survival in men with EMPD in this cohort include anorectal location, distant disease and RT-only treatment. RT in addition to surgery does not appear to confer increased survival. [Table: see text] No significant financial relationships to disclose.
Knowledge of testicular cancer and screening acceptance: Results from a prospective study.
Authors: Kedzeriewicz R. , Chargari C. , Le Moulec S. , Jacques Ferrandes N. , Houlgatte A. , Vedrine L. 
Published: February 2017

231 Background: A delayed diagnosis of testicular cancer is associated with both greater morbidity and poorer prognosis. We conducted a prospective study in the French Armed Forces to assess whether a short medical education could increase the degree of acceptance of the routine clinical screening for testicular cancer. Methods: We enrolled 415 consecutive military patients aged 18-45 years and consulting their army general practitioner. The degree of knowledge on the testicular cancer was assessed using a self-questionnaire, which also served as short medical education. We compared the degree of acceptance for testicular palpation before and after the education delivery. Results: Only 26.8% of patients (n = 107) assumed that they had previously received general information on testicular cancer and 31 patients (7.8%) reported that they were informed on the risk factors of testicular cancer (CI95: 5.5-10.8). In the population, 16.3% of patients (n = 65) had been informed on the usefulness of self-palpation of testes. Wilcoxon tests show significant differences between baseline acceptance level before any intervention and after information delivery (p<0.000001). In details, acceptance of testicular palpation after responding the questionnaire did not change in 82.25%, increased in 15%, and decreased in 2.75%. Conclusions: Young males in military environment are poorly aware of testicular cancer, but there is a demand on medical education regarding this disease. The time of annual medical visit for aptitude is probably the optimal time for this education. No significant financial relationships to disclose.
Accelerated MVAC as neoadjuvant chemotherapy for patients with muscle-invasive transitional cell carcinoma of the bladder.
Authors: Blick C. , Hall P. , Pwint T. , Munro N. , Crew J. , Powles T. , Macaulay V. M. , Al-Terkait F. , Protheroe A. , Chester J. D. 
Published: February 2017

235 Background: Meta-analysis data demonstrate a 5% absolute survival benefit for the use of neoadjuvant chemotherapy (NAC) using cisplatin-based combination regimens in the radical treatment of muscle-invasive bladder cancer (MIBC). However, there is currently no randomized controlled trial data on the optimum regimen for this setting. Accelerated MVAC (AMVAC) is effective in advanced disease, and has the potential advantage over other NAC regimens of minimising delays to definitive, potentially curative therapy. We present data regarding its use as NAC in MIBC patients. Methods: Retrospective analysis was performed on all 80 consecutive patients with muscle-invasive transitional cell carcinoma of the bladder, treated during a 50-month period at 2 U.K. centers. Patients received either 3 or 4 cycles of methotrexate 30mg/m2, vinblastine 3mg/m2, doxorubicin 30mg/m2 and 4-hour infusion of cisplatin 70mg/m2 at 2-week intervals, with G-CSF support, prior to definitive therapy with either radical surgery (RS) or radical radiotherapy (RT). Results: All planned cycles of chemotherapy were completed in 84% of patients. All 80 patients received their planned definitive therapy. Pathological complete response (pCR) was seen in 43% of 60 patients treated with surgery following chemotherapy. There were no chemotherapy-related deaths and grade 3 or 4 toxicities were seen in 11% of patients. Median duration of chemotherapy was 34 days. Dose reduction or delay was required in 7% and 9% of patients, respectively. Objective radiological local response was seen in 75% of patients. At a median follow-up of 27.5 months, 25 (32%) patients have relapsed and 11 (14%) died. Two-year disease-free survival was 65% overall, and was statistically significantly superior in patients who were radiologically node-negative prior to chemotherapy. Conclusions: AMVAC is a safe, well-tolerated, and easily deliverable regimen with excellent treatment outcomes and minimizes delays to definitive treatment. It is an appropriate comparator for future randomized trials. No significant financial relationships to disclose.
A phase II trial of neoadjuvant ABI-007, carboplatin, and gemcitabine (ACG) in patients with locally advanced carcinoma of the bladder.
Authors: Smith D. C. , Grivas P. , Daignault S. , Hafez K. , Wood D. P. , Lee C. T. , Montie J. E. , Weizer A. Z. , Montgomery J. , Hussain M. 
Published: February 2017

244 Background: Neoadjuvant cisplatin-based chemotherapy benefits patients with bladder cancer, particularly in the 30% with pathologic complete response (pCR) at cystectomy. Many patients with bladder cancer are not candidates for cisplatin. Taxane-based regimens have activity in urothelial cancer. ABI-007 is an albumin-bound paclitaxel with increased activity and decreased toxicity compared to standard paclitaxel preparations. Methods: Eligible pts have T2-4,N0,M0 or Tany,N1- 3,M0 bladder cancer with ECOG PS 0-1, and adequate marrow (granulocyte count > 1,500/mm3, platelet > 100,000/mm3, and hemoglobin > 9.0 g/dl), hepatic (transaminases < 2.5 X upper limit of normal, alkaline phosphatase < 2.5 X upper limit of normal, and bilirubin < 1.5 mg/dl) and renal function (serum creatinine < 2.0 mg/dl and/or creatinine clearance > 40 ml/min). Pts are treated with intravenous ABI-007 260 mg/m2 and carboplatin (target area under the curve=5) on day 1 with gemcitabine 800 mg/m2 on days 1 and 8, followed by radical cystectomy after three cycles of therapy. The primary study endpoint is the proportion of patients with pCR at cystectomy. Results: 27 patients have been enrolled. By clinical staging, 20 had T2 disease, 5 had T3, 2 had T4, and 2 had nodal enlargement. All are evaluable for toxicity with 22 evaluable for response (exclusions-3 for change in dose schedule, 1 each for refusal of cystectomy and withdrawal from study). 25/27 patients received all three cycles (78 total cycles) with doses reduced in 26 cycles for toxicity. All patients had transient grade 3-4 neutropenia and 17 received filgrastim, but only two had febrile neutropenia. Six pts had pCR with an additional 5 having residual carcinoma in situ (CIS) and 1 with T1 disease at cystectomy. 54% of evaluable patients had no muscle invasive disease at cystectomy. Conclusions: Neoajuvant ACG is active in bladder cancer with pCR rate nearing 30% and nearly as many patients with CIS but no residual invasive disease. Marrow toxicity is significant but manageable. [Table: see text]