bluuebunny/crossref_metadata_2025_split huggingface dataset:
Prediction of reclassification at repeat biopsy with [-2]proPSA during active surveillance for low-risk prostate cancer: Prospective longitudinal analysis of a Japanese multicenter study cohort.
Authors: Sugimoto Mikio , Hirama Hiromi , Ito Kazuto , Shiraishi Taizo , Kakehi Yoshiyuki 
Published: March 2020

e16054 Background: Biomarkers that predict aggressiveness and tumor burden of prostate cancer are needed for patients who undergo AS. One of such candidates is [-2]proPSA. It has been reported that expression of [-2]proPSA is specific to prostate cancer and associated with grade and stage. The aim of this research is to evaluate the predictive ability of [-2]proPSA and its related parameters for the biopsy reclassification during AS. Methods: 13 institutions participated in the multi-center Japanese AS study (a prospective one-arm cohort study). 134 patients were enrolled in this study between January 2002 and December 2003. Inclusion criteria are as follows; (1) stage T1cN0M0, (2) age from 50 to 80, (3) serum PSA = 20 ng/ ml or less, (4) one or two positive cores per 6 to 12 systematic biopsy cores, (5) Gleason score = 6 or less and (6) maximum cancer involvement in positive core = 50% or less. We prospectively collected blood samples from patients who opted AS as an initial treatment. The serum samples were stocked frozen until testing. The patients who remained on AS for 1-year were recommended to undergo repeat biopsy. Reclassification was judged by a central pathologist who was also involved in the initial diagnosis at inclusion. Results: 67 patients underwent repeat biopsy at 1-year after AS. Biopsy reclassification was histopathologically found in 25 of 67 patients (37.3%). Table shows the patients’ backgrounds and the cutoff values of predictive variables at 90% and 80% sensitivity and specificity. p2PSA, %p2PSA and phi; (p2PSA/fPSA) × √(tPSA) levels at baseline and p2PSA and phi at 1-year after AS were significantly higher in the reclassification group than those in the non-reclassification group. At 90% sensitivity, the cutoff values of p2PSA, %p2PSA and phi at baseline were 12.52, 1.51 and 37.91 with a specificity of 23.81%, 26.19% and 26.19%, respectively. In both 90% and 80% sensitivity, p2PSA and its related parameters have higher specificity than PSA and its related parameters. Conclusions: [-2]proPSA and its related parameters could predict pathological reclassification in repeat biopsy during AS.
Apoptotic activity in patient serum while on an acai juice product in the setting of a slowly rising PSA.
Authors: Kessler Elizabeth , Su Lih-Jen , Lu Xian , Morales Diana , Chronister Nicole , Anduha Mary , Wacker Michael , Yang Xiaoping , Flaig Thomas W. , Glode L. Michael , Lam Elaine Tat 
Published: March 2020

e16055 Background: For patients with a slowly rising PSA, the timing of androgen deprivation therapy (ADT) initiation is highly debated given the long term side effects. In this setting, numerous nutraceuticals, or plant derivatives, such as grape seed, milk thistle, or pomegranate have been shown to slow the growth of prostate cancer (PCa). The acai berry has been shown to be rich in flavinoids with high antioxidant properties and was evaluated in this phase II single-institution study in asymptomatic PCa patients with a rising PSA. The primary endpoint was decline in PSA of 50% from baseline. While flavinoids have been shown to induce cell cycle arrest, understanding the actions of the mix of phytochemicals has not been rigorously undertaken for the acai berry. It has shown proapoptotic effects in vitro on leukemic cell lines, and decreased cytokine production correlated with subsequent anti-esophageal tumorogenesis effects in vivo. In order to better understand the mechanism of action of acai, patient serum samples were analyzed in vitro. Methods: While on trial, patients consumed 2oz of acai juice product daily for 30 weeks. Two serum samples were drawn at weeks 0, 2, 6, and 18 for correlative analysis with the M30 Apoptosense ELISA. This measures caspase cleaved Keratin18 (ccK18) as a marker of early apoptotic activity. Results: An increase from baseline in ccK18 was seen at 2 weeks in a majority of patients (13/19; p= 0.12). Additionally, the one clinical responder on trial had a significantly higher level of ccK18 throughout the trial with a peak at week 6. Baseline ccK18 values did not correlate with clinical outcome (Spearman coefficient r=-0.13, p=0.6). Conclusions: Nutraceuticals may offer a well-tolerated treatment option for slowing the growth of prostate cancer as evidenced by the prolongation in doubling time in 86% of patients in this trial. The rise of ccK18 at week 2 and elevated levels in the responder’s serum suggest there is a pro-apoptotic treatment effect with acai. Additional cytokine analysis, and ratio of necrotic death to apoptotic death is underway in order to compare additional mechanisms. This initial evaluation offers early insight of the mechanism of action of acai in PCa.
Timing of PSA response to guide cessation of docetaxel in prostate cancer.
Authors: Dickinson Peter D. , Malik Jahangeer , Slevin Finbar , Sivanandan Ananth , Clarke Noel W. , Choudhury Ananya , Elliott Tony 
Published: March 2020

e16069 Background: Docetaxel plus prednisolone is an established treatment for men with advanced prostate cancer. Clinicians need to be able to identify men who are not benefiting from chemotherapy, and a key unanswered question is how many cycles of docetaxel should men receive before this assessment is made. We investigated the prognostic significance of a PSA response to docetaxel chemotherapy and the number of cycles after which an absence of PSA response could reliably predict future non-response. Methods: Data was collected for men who received one to ten cycles of docetaxel for castrate refractory prostate cancer between 2005 and 2011. PSA was monitored during treatment. All men were treated at a single centre, The Christie NHS Foundation Trust, UK. Survival is defined as the interval between the first dose of docetaxel and the date of death. Results: Data was available for 320 patients. At the commencement of chemotherapy, median age was 67 years (range 49-81yrs) and median PSA was 207ng/ml. All patients had a Karnofsky Performance Status ≥ 70%. There were 239 deaths and the median survival of the whole group was 403 days. 140 (44%) patients received 6 cycles of docetaxel and 23 patients (7%) received 10 cycles. Median survival was significantly longer in men who had any fall in PSA during chemotherapy compared to those whose PSA did not fall (462 days vs 268 days, p<0.001). Any PSA fall occurred during the first 4 cycles of docetaxel for 95.1% of men. Median survival was significantly longer in men who had a 50% fall in PSA during chemotherapy compared to those who did not (491 vs 357 days, p<0.001). The 50% fall in PSA occurred during the first 5/6 cycles of chemotherapy in 91.5% and 97.7% of men respectively. Conclusions: A patient’s clinical condition is of paramount importance when assessing them during docetaxel chemotherapy. Our data suggest that a fall in PSA following docetaxel is an indicator of improved overall survival. PSA response could help clinicians decide when to stop docetaxel; patients are unlikely to have a fall in PSA if it has not occurred during the first 4 cycles of chemotherapy and they fall into a poor prognostic group. These patients should be considered for alternative treatment in order to improve outcomes and spare them unnecessary toxicity.
Quality of life in patients receiving herbal therapy for biochemically recurrent prostate cancer.
Authors: Beam Eric , Yang Dongyun , Ji Linyung , Quinn David I. , Groshen Susan G. , Pinski Jacek K. , Dorff Tanya B. 
Published: March 2020

e16073 Background: Men who experience biochemical recurrence after curative therapy for prostate cancer are often treated with androgen deprivation therapy (ADT), though there is no proven survival benefit in this setting. Side effects of ADT negatively impact quality of life (QOL). There is interest in alternative therapies to control PSA without ADT side effects. In conjunction with clinical testing of prostate health cocktail (PHC), a combination herbal therapy for men with biochemically recurrent prostate cancer, we surveyed QOL in trial subjects who were still receiving PHC (n=11), or had moved on to ADT (n=12) or observation (n=16). Methods: Subjects were surveyed using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) instrument, in which respondents report their level of physical and psychological functioning during the past 7 days. The survey was completed in person, by phone, by mail or via online submission. Results: Of the 40 men (93% of total trial subjects) who responded to the survey, the median age was 66 (range 54-84) and PSA was 2.8 (range 1.1-84). 23% had received radiation as primary treatment, 25% radical prostatectomy, and 52% had received both. One patient was receiving radiation at the time of survey and was excluded. In the Physical Well-Being domain, which assesses energy, feeling ill, nausea, pain and trouble meeting needs, there was a significantly lower score among men receiving ADT (median 25; 95% CI 23.5-26.2) compared to those taking PHC (26.5; CI 24.2-27.8) or being observed (28; 26.4-28) (p =0.006). There was no significant difference among the groups in the other domains, though within the Prostate Cancer-Specific Concerns domain significantly more men indicated they were "not at all" able to have/maintain erections in the ADT group (11/12) compared to PHC (6/11) and observation (5/15) (p=0.009). Conclusions: Decisions about treatment for rising PSA levels after curative-intent therapy must be informed by therapeutic value as well as consideration for QOL. We found that men being treated with ADT have a significantly lower physical function score, and the relatively high QOL for patients on a clinical trial of an herbal supplement was similar to that of patients being observed. Clinical trial information: NCT00669656.
Midterm oncologic outcomes after robotic-assisted laparoscopic radical prostatectomy.
Authors: Negron Edris J , Razmaria Aria , Ledezma Rodrigo , Richards Kyle A , Szmulewitz Russell Zelig , Zagaja Gregory 
Published: March 2020

e16084 Background: The robotic surgery has been extensively adopted in many surgical areas, especially in Urology. It's proven benefits (less blood loss, shorter recovery and reduced complication rates) has made it the most popular method to perform a radical prostatectomy nowadays. However, scarce data exists on the long-term oncologic outcome of robotic assisted laparoscopic prostatectomy (RALP). Since 2003, over 3,000 RALPs have been performed at our institution. We report the midterm oncologic outcome data of 1,054 patients with a median follow up of 60 months after RALP. Methods: From March 2003 to August 2008, 1,054 patients underwent RALP. Prospectively attained clinical data has been stored in an IRB approved database. Follow up has been maintained every 6 months for 2 years, and yearly thereafter. Salvage RALPs were excluded. Biochemical recurrence (BCR) defined as PSA > 0.2ng/ml, disease free survival, cancer specific and overall survival were assessed. Results: Of the 1,054 patients within the database, 1,019 met the criteria for evaluation. Mean age was 60 years (IQR 55-65), and mean BMI 27 kg/m2 (IQR 25-30). 181 patiemts (17.3%) were African Americans. Pre-operative mean PSA was 5.3 ng/ml (IQR 4.2-7.4). The majority of patient's clinical stage was T1c [ 776 (73.6%)] while 278 were T2. Biopsy Gleason score (GS) was 6, 7, and ≥8, in 666 (63.2%), 324 (30.7%), and 64 patients (6.1%), respectively. 298 patients underwent a bilateral pelvic lymph node dissection (28.3%). Pathologic GS was 6, 7 and ≥8, in 563 (53.5%), 431 (41%), and 58 patients (5.5%), respectively. The pathological tumor stage was T2 in 834 (79.3%), T3a in 164 (15.6%) and T3b in 54 (5.1%). 14 patients (1.3%) had nodal involvement. Positive surgical margins occurred in 205 cases (20%). BCR occurred in 123 patients (12%). 2 deaths due to prostate cancer (0.2%) and 7 due to other causes (0.7%). Cancer specific survival is thus 99.1% at the mean follow up (60months) by Kaplan Meier analysis. Conclusions: Our midterm oncologic outcomes are consistent with those previously reported in open radical prostatectomy series. Ongoing, long term follow up is necessary in order to solidify it's role in prostate cancer managment.
Impact of news drugs in the median overall survival of patients with metastatic castration resistant prostate cancer (mCRPC).
Authors: Chaumard-Billotey Natacha , Chabaud Sylvie , Boyle Helen Jane , Favier Bertrand , Devaux Yves , Droz Jean-Pierre , Flechon Aude 
Published: March 2020

e16096 Background: In the past 3 years new therapies, such as cabazitaxel (C): a novel taxane, enzulatamide (E): a new androgen receptor signaling inhibitor and abiraterone acetate (A): an inhibitor of androgen synthesis, have been developed in the treatment of post-docetaxel metastatic CRPC patients. This study assessed the clinical impact of these new drugs, comparing the outcomes of two historical cohorts of patients with mCRPC. Methods: We retrospectively reviewed the data of all patients with mCRPC treated by first line chemotherapy with docetaxel (D) at the Centre Léon Bérard. Based on the timing of the development of new drugs, we defined two cohorts based on two time periods depending on drugs available on the market: group 1: 2006-2009 corresponding to the period when only conventional drugs (D, mitoxantrone) were available; group 2: 2009-2012 corresponding to the period when new drugs like C, E, A could be used post docetaxel. Outcome evaluated was overall survival (OS). OS was defined as the time from date of D introduction to date of death or date of last follow-up for patients alive at last contact. Survival distributions were estimated by the Kaplan-Meier method and compared between groups using Log-Rank test. Results: One-hundred and thirty five patients were included: 66 patients in group 1 and 69 patients in group 2. Median age was 64 years in both groups. Karnofsky score was ≥ 80% for 67.7% of patients in group 1 and 81.8% in group 2. Gleason score was ≥ 9 for 38.7% and 31.4% of patients, respectively. In group 1, 47% of patients had visceral metastases when started on chemotherapy vs 40.6% in group 2. The weekly schedule of D (25mg/m2) was significantly more frequently used in group 1 than in group 2 (53% vs 15%, p<0.001). Median cumulative doses of D at first line treatment were significantly higher in group 2: 643 mg/m2 vs 454 mg/m2 (p<0.001). Median overall survival was 10.6 months (95% CI 7.8–15.7) in group 1 vs 32.5 months (95% CI 25–42.4) in group 2 (p<0·0001). Conclusions: This study reflects how the management of mCRPC patients has evolved over the last 7 years. Survival has improved especially through an earlier management, a more intensive schedule of D and the impact of these new drugs.
Low doses of ketoconazole and prednisone in patients with castration resistant prostate cancer (CRPC): A retrospective study on 73 patients.
Authors: Amaniera Gloria , Ballatore Valentina , Ruatta Fiorella , Prati Veronica , D'Urso Leonardo , Muto Giovanni , Aglietta Massimo , Ortega Cinzia 
Published: March 2020

e16099 Background: The management of rising PSA in metastatic CRPC remains controversial. In Italy, abiraterone and enzalutamide are not at all approved in this setting of patients (pts). Ketoconazole is an inhibitor of adrenal androgen synthesis that has shown anti-tumor activity by interfering with C-17,20-lyase and could be used as secondary hormonal manipulation. In this retrospective study we report our experience with low doses of ketoconazole and prednisone in the treatment for CRPC. Methods: From March 2007 to March 2012, 73 pts with progressive CRPC who were previously treated with maximal androgen blockade received 200 mg ketoconazole orally 2 times daily, orally replacement prednisone (5 mg bid) and maintained LHRH-agonists. Overall, 40/73 (55%) pts had only bone metastases, 13/73 (18%) had nodal metastases, 20/73 (27%) both. Pts were monitored clinically and with serial PSA measurements every month. Partial biochemical response (PR) was defined as a >50% fall in PSA from baseline. Progressive disease (PD) was defined by objective disease progression or PSA increase of >50% above nadir or >25% above baseline. The endpoints of the study were biochemical response (BR), progression free survival (PFS), overall survival (OS) and adverse events assessment. Results: Median age was 74 (70-78) years; median baseline PSA was 33.09 (1.18-1348.8) ng/ml; median duration of the treatment was 5.05 (0-56.8) months. Twenty out 73 pts (27%) showed a decrease in PSA >50%, with a median duration of PSA response of 3.56 (1.17-33.58) months and 3 pts (4%) a PD. Fifty out 73 pts (68%) achieved a SD with an overall disease control (PR+SD) of 85%. PFS was 10 months for pts who achieved PR and 4 months for those with SD. Differences in PFS stratified according to site of metastases showed better prognosis in patients with only lymph nodes disease (p<0.05). Treatment with Ketoconazole was well tolerated and grades 3-4 toxicities occurred in only 3% of patients. Conclusions: Low-dose ketoconazole is an effective and well-tolerated treatment in pts with CRPC and should be considered in the subset of pts with low tumor burden and a rising PSA level despite maximal androgen blockade.
Prostate cancer survival at Oncologos del Occidente from Colombia, South America.
Authors: Salazar Piedrahita Hernan Dario , Villegas Mejia Carlos Raul , Chacon Cardona Jose Arnoby , Sanchez Villegas Tomas 
Published: March 2020

e16102 Background: Prostate cancer occupies the first place in USA and the sixth in developing countries. In our records is the seventh and the second as general attention and mortality cause on men. Methods: A descriptive analysis of patients attending and treated at Oncologos del Occidente a Private Cancer Center was developed with 404 cases from January 2007 to June 2012. Results: Age mean 69.161 (Range 49-92 SD.8.614), 54% under 70 and 36% 70-80 years old; 56% Stage II and 0.7% unknown stage, 39% with Gleasson score under 6, 35% of Gleasson 7 and 25% with 8-10; PSA mean 41.394 (Range 0.002-900, SD.81.380) with 33% with PSA 4-10 and 24% with PSA of 10-20 ng/dl and 14% over 100; 64% without previous treatment; mean Previous Symptoms in months 6.002 (Range 1-120 months SD.11.901) with 75% under 3 months of symptoms; 90% of patients with Karnofsky over 80%; 29% relapsed and 56% of them biochemical relapsed; 75% of patients without any surgery and 17% Radical prostatectomy; 60% Radical radiation only to the prostate and 15% because of metastases and 9% because of post-Surgery cause; 34% with T1c; survival to 5 and 10 years about many prognosis factors are shown in the Table. Conclusions: This is the first effort in a specific area from Colombia related to general survival to 5 and 10 years based on prognosis factor and the results are similar to others experience centers. [Table: see text]
Clinical research on radiotherapy at different time for unresectable cervical cancer.
Authors: Li Wenhui , Chang Li , Ju Yunhe , Jiang Meiping , Li Lang , Wang Li , Liu Yanyou , Wang Yuhui , Jiang Zhou , Xiao Jing , Wang Zhengrong 
Published: March 2020

e16516 Background: Radiotherapy is one of the mainstay treatments for cervical cancer. Circadian rhythm can be associated with cancers. In this study, we focused on the therapeutic effects, acute radiation damages and expressions of circadian genes in unresectable cervical cancer irradiated at different time. Methods: A total of 67 patients of unresectable cervical cancer (stage IIB-IIIB) were randomized to morning (9:00-11:00am) and evening (9:00-11:00pm) irradiation groups. Patients were treated with external beam radiotherapy to the whole pelvis (50 Gy in 25 fractions) and brachytherapy (36-42 Gy in 6-7 fractions). Therapeutic effects and acute radiation toxicities were evaluated after radiotherapy. Samples analyzed by flow cytometry were obtained from cervix at 9:00-11:00am and 9:00-11:00pm before and after radiotherapy. Results: Of 65 patients, the overall and higher grade of diarrhea (III-IV) induced by radiation in patients after morning vs evening radiotherapy were 75.0% vs 57.6% (p = 0.138), 12.5% vs 6.1% (P=0.427). Higher grade of hematologica toxicity in evening group was significantly increased as compared with morning group (54.5% vs 21.9%. p = 0.007). But patients’ response to radiation in two groups was similar (p = 0.708). Increased cell apoptosis and decreased G2/M phase fraction were observed significantly both in two groups after radiotherapy, but the increased/decreased values between two groups were found not to differ significantly. Expressions of circadian genes Per1, Per2 and Clock also increased after radiotherapy, and the increased levels between two groups were similar. Moreover, there were significant negative correlations between expressions of circadian genes Per1, Per2, Clock and G2/M phase fraction. But their expressions were positively correlated with cell apoptosis. Conclusions: Circadian genes may be associated with the similar radiation response and different toxicity in cervical cancer irradiated at different time by influencing cell cycle and apoptosis. The knowledge may provide a possibility of treating the patients with increased effect and decreased toxicity. Clinical trial information: ChiCTR-TRC-10001228.
Surgical management and perioperative morbidity of patients with primary borderline ovarian tumor (BOT).
Authors: Trillsch Fabian , Ruetzel Jan David , Herwig Uwe , Doerste Ulrike , Woelber Linn Lena , Grimm Donata , Choschzick Matthias , Jaenicke Fritz , Mahner Sven 
Published: March 2020

e16535 Background: Surgery is the central aspect of clinical management in patients with borderline ovarian tumors (BOT). As patients have excellent overall prognosis after successful surgery, perioperative morbidity is a critical point for decision regarding the primary surgical approach. Methods: Clinical and surgical parameters of patients undergoing surgery for primary BOT at two gynecologic cancer centers between 1993 and 2008 were analyzed with regard to perioperative morbidity depending on the surgical approach (laparoscopy vs. laparotomy). Results: A total of 105 patients were analyzed (44 with primary laparoscopy [42%], 61 with primary laparotomy [58%]). Primary laparoscopy was often performed with diagnostic intention and resulted in complete surgical staging in only 9.1% with subsequent formal indication for re-staging procedures. In contrast, complete surgical staging was achieved in 47.5% at primary laparotomy (p < 0.001). Tumor rupture was significantly more frequent during laparoscopy compared to laparotomy (29.5% vs. 13.1%, p = 0.038) but no other intraoperative complications were seen in laparoscopic surgery in contrast to 7 of 61 laparotomies (0% vs. 11.5%, p = 0.020). Postoperative complication rates were similar in both groups (19.7% vs. 18.2%, p = 0.848). Conclusions: Irrespective of the surgical approach, surgical management of BOT has acceptable rates of perioperative complications and morbidity. Choice of initial surgical approach can therefore be made independent of complication-concerns. As the recently published large retrospective AGO ROBOT study observed similar oncologic outcome for both approaches, laparoscopy should be considered as the preferred surgical approach for staging of patients with BOT if this appears feasible in preoperative evaluation.