bluuebunny/crossref_metadata_2025_split huggingface dataset:
Oncologic outcomes of radical prostatectomy with neoadjuvant LHRH agonist/estramustine and radiotherapy with neoadjuvant hormonal therapy for high-risk prostate cancer.
Authors: Koie Takuya , Yamamoto Hayato , Imai Atsushi , Hatakeyama Shingo , Yoneyama Takahiro , Hashimoto Yasuhiro , Ohyama Chikara 
Published: February 2017

259 Background: To date, the different treatment modalities for high-risk prostate cancer (Pca) have not been compared in any sufficiently large-scale, prospective, randomized clinical trial. We used propensity-score matching analysis to compare the oncological outcomes of high-risk prostate cancer between patients treated with radical prostatectomy (RP) and those treated with radiation therapy (RT). Methods: We studied 216 patients who received neoadjuvant therapy followed by RP (RP cohort) and 81 patients who received neoadjuvant androgen-deprivation therapy (ADT) followed by RT (RT cohort). The RP cohort received a luteinizing hormone-releasing hormone agonist and estramustine phosphate (280 mg/day) for 6 months prior to RP. The RT cohort received ADT for at least 6 months prior to RT using a 3-dimensional conformal radiotherapy technique. The total radiation dose was 70–76 Gy administered at 2 Gy/fraction. Results: Propensity-score matching identified 78 matched pairs of patients. The 3-year overall survival (OS) rates were 98.3% and 92.1% in the RP and RT groups, respectively (P = 0.156). The 3-year biochemical recurrence-free survival rates were 86.4% and 89.4% in the RP and RT groups, respectively (P = 0.878). Conclusions: Our study findings may suggest almost identical cancer control of RP and RT with appropriate neoadjuvant therapy in high-risk Pca. Therefore, issues of health-related quality of life may have important impact on decision making of treatment in high-risk Pca.
Pilot study of focal salvage high-dose rate (HDR) prostate brachytherapy in patients with local recurrence after definitive external-beam radiotherapy (XRT).
Authors: Chung Hans T. , Loblaw D. Andrew , D'Alimonte Laura , Ravi Ananth , Haider Masoom A. , Morton Gerard 
Published: February 2017

264 Background: Studies of post-treatment biopsies of the prostate after definitive dose-escalated XRT for intermediate-risk prostate cancer suggest that approximately 20% will be positive. Salvage options include surgery, brachytherapy, cryotherapy or high-frequency ultrasound. However, the complication risk, such as fistula, incontinence or bladder neck contracture, is not insignificant. The objective of this pilot study is to explore the toxicities and efficacy of focal salvage HDR prostate brachytherapy. Methods: This study was approved by the institution’s research ethics board. Eligible patients included those with biopsy-confirmed local recurrence >30 months after completing XRT, MRI of the prostate demonstrating solitary recurrence confined to the prostate, negative metastatic workup, IPSS <15, post-XRT PSA <10ng/mL, prostate volume ≤50cc. Salvage HDR brachytherapy was performed under transrectal ultrasound guidance with a prescription dose of 27Gy divided over two implants separated by 1 week to the target volume (TV) as seen on MRI with dose constraints to the urethra and rectum. Results: Six patients were enrolled in the study. The mean age was 73 years, all had either low- or intermediate-risk disease at presentation, and initial XRT received was 70-78Gy at least 5 years ago. The Gleason score of the local recurrence was 7 and 8-10 in 4 and 2 patients, respectively. The pre-HDR mean PSA was 5.5. The median size of the recurrence on MRI was 9mm and median size of the TV was 5.0cc (2.2-10.2), TV V100% 95.1%, urethral D10% 51.8% and rectal D1cc 39.2%. Four patients have at least 3 months of follow-up, and no acute GU/GI grade 3-5 toxicities were observed, including urinary retention. The most common acute toxicity was frequency and nocturia. Mean IPSS at baseline, 4-weeks, 3-months was 7, 9 and 7. Conclusions: Preliminary data suggests that focal salvage HDR brachytherapy was technically feasible with mild acute toxicities. Clinical trial information: NCT01583920.
Prostate cancer patients' adherence to medication while on abiraterone acetate (AA) therapy.
Authors: Kozma Chris M. , Slaton Terra L , Ellis Lorie , McKenzie R. Scott , Lafeuille Marie-Helene , Grittner Amanda M. , Lefebvre Patrick 
Published: February 2017

267 Background: Oral medications have become more widely available for treatment of various cancers, and adherence to dosing/ refill patterns, or medication possession, are important considerations for treatment. Abiraterone acetate (AA), prodrug of aberaterone, is a novel oral androgen biosynthesis inhibitor approved for metastatic castration resistant prostate cancer. This study reports adherence to AA dosing and administration recommendations by prostate cancer (PC) patients as observed in two separate data sources. Methods: PC patients with ≥1 AA prescription fill were identified in two retrospective pharmacy claim data sources: (1) Truven Commercial Claims and Encounters; and (2) Symphony ProMetis. Patients with no evidence of recent chemotherapy (NRC) or with evidence of recent chemotherapy (RC) were identified in the 6 months prior to AA initiation. The average AA daily dose per prescription per patient was reported. To evaluate adherence, the Medication Possession Ratio (MPR), a measure of consistency calculated as the sum of the AA days of supply divided by the total number of days between first and end of last AA fill, was assessed for patients with ≥2 AA fills. Data were summarized by descriptive statistics. Results: In both datasets the mean medication consistency/MPR was greater than 90% and the mean daily dose was within 1% of the recommended daily dose (1,000 mg). Medication consistency and AA daily dose per patient appeared similar between patients with recent chemotherapy and patients without recent chemotherapy (Table). Conclusions: Results from two observational studies representing > 3,700 PC patients reported high levels of AA adherence to AA dosing and administration consistent with prescribing information. Such data support providers’ understanding of the consistency to which AA treated PC patients adhere to AA medication use. [Table: see text]
Novel dosimetric criteria for salvage permanent brachytherapy based on 3D-cancer mapping.
Authors: Okihara Koji , Kobayashi Kana , Kamoi Kazumi , Iwata Tsuyoshi , Miki Tsuneharu 
Published: February 2017

269 Background: Salvage permanent brachytherapy (SPB) is one of treatment options in recurred men after external beam radiation therapy (EBRT). The accurate 3D correspondence between recurred cancer focus and location of seed implants using transrectal sonography (TRUS) is indispensable to design excellent dosimetry. The application of MRI-TRUS fusion targeted/systematic biopsy (Fusion-B) has enabled us to draw 3D recurred-cancer mapping. We have started SPB in men who recurred 3D-conformal EBRT using 3D-cancer mapping from Fusion-B. We introduce the novel dosimetric criteria for SPB-based on 3D cancer mapping. Methods: The patients with PSA failure (defined by Pheonix criteria) and without lymphnode/distant metastasis were enrolled in this study. In men who had suspicious recurrent focus/foci in MRI, we performed Fuision-B (ultrasound equipment: Image fusion: Koelis in France, and Biopsy: Medison in South Korea). We classified the three dosimetric patterns as follows: (1) Focal pattern: one core positive from target biopsy alone within hemilobe and GS less than 8. (2) Hemi-lobe pattern: positive cores within hemi-lobe from target/ systematic biopsies and GS less than 8. (3) Whole / focused gland pattern c/w hormonal therapy: Positive core(s) with GS greater than seven was identified regardless of positive biopsies location, or positive cores with GS less than eight from bilateral lobes. Prescribed dose to the target lesion, rV100 and uD90 were planned greater than 160Gy, 0% and less than 165Gy respectively. Results: Since August 2012, SPB has underwent in nine cases (PSA range prior to SPB: 2.22- 4.97ng/ml, age 61 to 77). In those cases, prescription dose at the 3D-conformal EBRT was 72 Gy and the duration between the 3D-conformal EBRT and SPB ranged from 41 to 107 months. The biopsy GS (-7/8-) obtained from Fuison-B distributed in 6/3 cases. Biopsy revealed single focus obtained from target biopsy in two cases. Focal and hemi-lobe pattern were chosen in two and one case, respectively. For the present, there is no re-PSA failure and G3-4 GI and GU comorbidities. Conclusions: To reduce the incidence of co-morbidity and maintain reasonable oncological outcome, it is informative to apply the 3D Cancer mapping for the SPB candidates. It is necessary to assess this criteria with the further follow-up.
An indirect treatment comparison (ITC) and cost-effectiveness analysis of abiraterone acetate and enzalutamide for the treatment of metastatic castration-resistant prostate cancer (mCRPC) post-chemotherapy.
Authors: Li Tracy , Thompson Melissa , Todd Mary Beth , Yu Margaret K. , Kheoh Thian San , He Jianming , Saadi Ryan 
Published: February 2017

270 Background: Abiraterone acetate (AA) and enzalutamide (ENZ) are two new agents indicated for the treatment of patients with mCRPC. Presently, there is a high level of interest in understanding the relative clinical and economic value of these therapies. The objective of this study was to determine the comparative effectiveness and cost-effectiveness of AA vs. ENZ. Methods: The PICO (population, intervention, comparison, and outcomes) construct was used to assess the comparability of Study COU-AA-301 for AA and the AFFIRM trial for ENZ, and an ITC was conducted using the Bucher method and Bayesian statistics. A survival-based Markov cohort model with three health states (progression-free, progressed, and death) was developed to project cost-effectiveness over a life time horizon. Since only the US price of ENZ was publicly available at the time of analysis, US drug acquisition costs were used. Average wholesale prices for 30-day supplies of AA and ENZ were $7,674 and $8,940, respectively. One-way sensitivity analyses were performed for all probability, utility, and cost values incorporated into the model. Results: The ITC result on overall survival (OS) was HR = 0.95 (95% CI: 0.71-1.26) for AA vs. ENZ on the risk of mortality, after accounting for important differences in comparators and background treatments. In the base case of the economic analysis, AA was found to provide a substantial cost savings of $13,322 per patient vs. ENZ, primarily due to higher acquisition costs. Quality adjusted life years gained were comparable for AA and ENZ. These results were supported by sensitivity analyses. Conclusions: While benefits are similar for OS, AA is cost-saving compared with ENZ for the treatment of patients with mCRPC following treatment with docetaxel.
Allegheny General Hospital experience with LDR prostate brachytherapy comparing Pd-103 with I-125.
Authors: Hall Michael William , Horn Jeffrey , Fuhrer Russell 
Published: February 2017

274 Background: To report a retrospective review of a single institution’s experience treating patients with localized adenocarcinoma of the prostate with low-dose rate brachytherapy (LDR-BT) comparing clinical outcomes at 5 years of patients treated with Pd-103 vs. I-125. Methods: 332 hormone-naïve patients with localized adenocarcinoma of the prostate were treated with LDR-BT without androgen deprivation therapy (ADT) between 1998-2008 at Allegheny General Hospital. 300 patients had more than 12 months of follow-up and were included in the statistical analysis. 40 patients (13%) were treated with Pd-103 and 260 (87%) were treated with I-125. The decision to treat with Pd-103 was based on physician preference and pretreatment urinary AUA score. Both treatment groups (Pd-103 vs. I-125) were otherwise stratified similarly with regards to median patient age (65 vs. 65), NCCN low-risk category (87.5% vs. 89.9%), Gleason score 6 (92.5% vs. 88.1%), Clinical T1c (85% vs. 79.9%), pretreatment median PSA (5.9 vs. 5.6), and pretreatment mean AUA score (8 vs. 6.5). All pathology was reviewed by a single genitourinary pathologist. All prostate seed implants were performed by a single radiation oncologist. Results: Median follow-up was 67 months for Pd-103 patients and 80 months for I-125 patients. Mean D90 for the Pd-103 group was 140.7 Gy versus 170.9 Gy in the I-125 group. There was one biochemical failure in the Pd-103 group and 21 biochemical failures in the I-125 group. 5-year biochemical failure free-survival rates were 95.7% for the Pd-103 group and 90.1% for the I-125 group (p=0.13). Conclusions: Prior studies have shown no difference in outcomes between patients treated with Pd-103 and I-125 for early stage prostate cancer. Therefore the choice of isotope in LDR-BT is based on urologist and/or radiation oncologist preference and patient clinical presentation (AUA score). Our institution’s experience indicates a trend towards increased rates of biochemical failure in a homogenous group of patients treated with I-125 compared to Pd-103. Due to the retrospective nature of our study as well as the limited number of patients, this requires validation in a prospective trial.
Quality of life after high-dose rate brachytherapy monotherapy for prostate cancer.
Authors: Contreras Jessika , Wilder Richard , Mellon Eric Albert , Strom Tobin Joel Crill , Fernandez Daniel Celestino , Biagioli Matthew C. 
Published: February 2017

278 Background: There is little information in the literature on health-related quality-of-life (HRQOL) changes due to high-dose-rate (HDR) brachytherapy monotherapy for prostate cancer. Methods: We conducted a prospective study of HRQOL changes due to HDR brachytherapy monotherapy for low risk or favorable intermediate risk prostate cancer. Forty-nine of 84 (58%) patients who were treated between February 2011 and April 2013 completed 50 questions comprising the Expanded Prostate Cancer Index Composite (EPIC) before treatment and 6 and/or 12 months after treatment. Results: Six months after treatment, there was a significant decrease (p<0.05) in EPIC urinary, bowel, and sexual scores, including urinary overall, urinary function, urinary bother, urinary irritative, bowel overall, bowel bother, sexual overall, and sexual bother scores. By one year after treatment, all EPIC scores had increased and were not significantly different from baseline values. Conclusions: HDR brachytherapy monotherapy is well-tolerated in patients with low and favorable intermediate risk prostate cancer. Urinary, bowel, and sexual domain scores returned to close to baseline 12 months after treatment.
Optimizing a risk stratification for local-regional failure after radical cystectomy using the SWOG 8710 cohort.
Authors: Baumann Brian C. , He Jiwei , Hwang Wei-Ting , Tucker Kai , Lerner Seth P. , Tangen Catherine M. , Herr Harry W. , Guzzo Thomas J. , Malkowicz S. Bruce , Christodouleas John Paul 
Published: February 2017

297 Background: Trials of adjuvant radiation (RT) after radical cystectomy + pelvic node dissection (RC) are in development, but patient selection criteria have not been clearly identified. We evaluated a published model predicting the risk of local-regional failure (LF) by applying the model to a multi-center patient cohort. We also assessed the model’s ability to stratify overall survival (OS) and isolated distant metastases (DM). Methods: The original LF risk model was derived from 442 patients who had a RC +/- chemotherapy at the University of Pennsylvania (PENN). Analysis identified 3 subgroups with significantly different LF risk based on pathologic stage (pT) and number of nodes dissected (<10 vs ≥10). This risk rubric was then applied to 264 patients in the multi-center SWOG 8710 trial randomized to RC +/- neoadjuvant chemotherapy. SWOG patients differed significantly from PENN patients in mean age, pT stage, number of nodes removed, surgical margin status, and use of neoadjuvant chemotherapy. In both cohorts, LF was any pelvic failure detected before or within 3 months of DM. Secondary endpoints were OS and DM. Competing risk analysis was used. Results: The original risk stratification was not fully validated in the SWOG cohort. Regression analysis of the SWOG data found margin status was more predictive of LF than number of nodes dissected. A revised risk stratification model combining pT stage, margin status, and number of nodes removed identified 3 subgroups in both the SWOG and PENN cohorts with significantly different LF risks: low (≤pT2), intermediate (≥pT3 with negative margins AND ≥10 nodes removed), and high (≥pT3 with positive margins OR <10 nodes removed) with 5 year LF rates of 8%, 20%, and 41% in the SWOG group and 8%, 19%, and 41% in the PENN cohort. The 3 subgroups also differed significantly in OS within both cohorts with 5 year OS of 62%, 39%, and 7% for SWOG and 60%, 31%, and 10% for PENN. The model did not stratify with respect to isolated DM. Conclusions: The revised risk model combining pT stage, margin status, and number of nodes excised provides a simple rubric to stratify LF risk in two significantly different bladder cancer populations and may inform the design of adjuvant RT trials.
Multi-institutional quality care initiative (QCI) to improve the care of patients with invasive bladder cancer (BlCa).
Authors: Bochner Bernard H. , Feifer Andrew , Sperling Dahlia , Mashni Joseph W , Bajorin Dean F. , Shah Jay Bakul , Kamat Ashish M. , Steinberg Gary D. , Stadler Walter Michael , Grubb Robert L. , Kibel Adam S. , Schoenberg Mark , Black Peter C. , Zlotta Alexandre , Kassouf Wassim , Lerner Seth P. , Lotan Yair ,   Collaborators of the BCAN Quality of Care Initiative Consortium
Published: February 2017

298 Background: Level 1 evidence supports a survival benefit for BlCa pts that receive periop cisplatin chemotherapy in addition to radical cystectomy (RC). Underutilization of multimodal therapy has been reported nationally. We instituted a multicenter QCI to improve the use of periop chemotherapy. Methods: A two phase effort was initiated at 16 academic institutions. Phase 1 was initiated in 2010 and designed to evaluate baseline patterns of periop chemotherapy use for T2-4N0M0 BlCa pts that underwent RC between 2003-2008. Phase 2 was a prospective QCI. The quality indicators included (1) referral to medical oncology for consideration of multimodality therapy, (2) neoadjuvant, if recommended, be cisplatin based and at least 3 cycles, (3) adjuvant, if recommended, be cisplatin based and at least 3 cycles, (4) all treatment be completed within 6 months. Data on all eligible pts were collected prospectively for 12 months on a web-based survey system. Results: All 16 centers participated in phase 1. Of 4,344 pts on whom data was available, 34% received periop chemotherapy. Neoadjuvant and adjuvant therapy use was 14% and 20%, respectively. 65% of pts receiving periop chemotherapy were treated with a cisplatin-based regimen. Of those treated neoadjuvantly, cisplatin was received in 70% of cases. Nine of the 16 institutions completed phase 2 data collection. Over 700 pts that underwent RC were evaluated. 395 pts with T2-4N0M0 disease were deemed eligible for data entry. Fifty-six percent of eligible pts received periop systemic chemotherapy. Of this 56%, 47% received neoadjuvant cisplatin chemotherapy and 9% received adjuvant cisplatin chemotherapy. This represented a 64.7% increase in the use of any periop chemotherapy and a 3.4 fold increase in neoadjuvant chemotherapy compared to baseline data. Conclusions: We have successfully completed a multi-institutional QCI to improve the use of periop chemotherapy in pts undergoing RC for resectable, non-metastatic bladder cancer. Our data demonstrates that significant improvements can be achieved in not only overall use of periop chemotherapy but most notably in the use of neoadjuvant chemotherapy.
Peptide vaccines with low-dose dexamethasone versus dexamethasone alone for chemotherapy-naive castration resistant prostate cancer: A randomized phase II study.
Authors: Uemura Hirotsugu , Kimura Takahiro , Minami Takafumi , Yoshimura Kazuhiro , Nozawa Masahiro , Egawa Shin , Fujimoto Hiroyuki , Yamada Akira , Itoh Kyogo 
Published: February 2017

3 Background: We previously developed MHC class I restricted peptide vaccines for prostate cancer and carried out a phase 1 trial for castration resistant prostate cancer (CRPC) patients to assess safety and immunological evaluation. In the present study, we conducted a randomized phase 2 trial to evaluate the efficacy of peptide vaccination therapy for chemotherapy-naive CRPC patients. Methods: Early-stage CRPC (PSA<10ng/ml) patients positive for HLA-A02 or A24 or A3 super family were randomized into two treatment groups; peptide vaccine with low dose (1mg/day) dexamethasone (Dx) versus low dose Dx alone. Patients were vaccinated subcutaneously with 3 mg of selected peptides (max. 4 kinds) 6 times at two weeks interval. Dx 1mg/day p.o. was started on the first day of peptide vaccination. Toxicity was assessed monthly, and immunological responses such as cytotoxic T lymphocyte activity and clinical responses were evaluated every 3 months. The primary endpoint of this study is progression-free survival including serum PSA. Secondary endpoints are overall survival and safety. Results: A total of 83 chemotherapy-naive CRPC patients were selected for this trial. Of these 10 patients were excluded due to HLA type mismatch and exclusion criteria. 73 patients were enrolled and randomized; 37 in the vaccine treatment group and 36 in the Dx group. One patient in the Dx group self-withdrew from the study immediate after the randomization. Median time to PSA failure in the vaccine group was significant longer than the Dx group; 602 days vs 210 days, p<0.001 (Table). Conclusions: These findings suggest that combination therapy of peptide vaccines and low dose dexamethasone may be a promising tool for chemotherapy-naive CRPC patients. Clinical trial information: UMIN000000959.[Table: see text]