bluuebunny/crossref_metadata_2025_split huggingface dataset:
G-CSF utilization during abiraterone acetate (AA) and cabazitaxel (C) therapy: A retrospective U.S. claims analysis.
Authors: Mehra Maneesha , Stellhorn Robert , Ng Yvette , Todd Mary Beth 
Published: February 2017

205 Background: AA and C are two recently approved therapies shown to extend survival in men with metastatic castrate-resistant prostate cancer (mCRPC) progressing after docetaxel treatment. The toxicity profiles of AA and C differ, and therefore it was hypothesized that the utilization of concomitant medications and supportive care measures, in particular G-CSF for the treatment of neutropenia, would differ as well. Methods: The Pharmetrics database (2008 to Jan 2012), a nationally representative, nonpayer-owned, integrated, commercial U.S. claims database, was used for this analysis. Eligible patients included those identified with a diagnosis of prostate cancer (ICD 9 code 185.X or 233.4) and a claim for either AA or C (identified by the appropriate NDC or J codes). Use of G-CSF was analyzed during treatment (defined as the period between the first claim to the last claim, full months inclusive) and also analyzed for the year prior to the first claim of either AA or C (index date). Results: 278 patients were identified with a claim for both cohorts. Median ages of patients in the two cohorts were similar (69 years in the AA cohort, 67.5 years in the C cohort). Docetaxel use in the year prior to the index date was 57% and 64% in the AA and C cohorts, respectively. The median duration of follow-up post-index date was 2.6 months in the AA cohort and 6.0 months in the C cohort. While the median number of prescriptions (3) was the same for the AA and C cohorts, the mean was slightly higher for C (4.4 vs 3.3). In the AA cohort, the use of G-CSF was as follows: 35% in the year before the index date and 3% during treatment. In the C cohort, the use of G-CSF was as follows: 42% in the year before the index date, and 67% during treatment. Conclusions: Based on this claims analysis, patients who received C were more likely to receive concomitant G-CSF vs patients who were receiving AA. This finding is consistent with the known risks/precautions relating to neutropenia as described in the TROPIC study for C. Prior to treatment, both cohorts had G-CSF use, which may be attributed to neutropenia during or following docetaxel therapy.
Efficacy and toxicity of q 2 weeks versus weekly versus q 3 weeks docetaxel in metastatic castration-resistant prostate cancer (CRPC).
Authors: Malhotra Akshiv , Poiesz Bernard J. 
Published: February 2017

206 Background: Standard treatment for metastatic CRPC is docetaxel 75 mg/m2q3weeks. Methods: We retrospectively studied patients treated with q 1, 2, or 3 weeks docetaxel regimens at 30, 60 and 75 mg/m2, respectively. The choice of regimen and duration of treatment was decided by their oncologist. Patients who had been in a clinical trial previously, or treated with any other chemotherapy before docetaxel were excluded. On this basis 41 patients were studied. Prostate specific antigen (PSA) was used as the primary method to assess response and progression. Response was a decline of >/=50% from baseline value with no clinical or radiographic evidence of disease progression. For patients whose PSA did not decrease, progression was a >/= 25% increase from baseline. If the PSA decreased without reaching response criteria, progression was a >/= 25% increase from nadir. In those who responded, progression was a >/= 50% increase from nadir. The increase had to be at least 5ng/ml. Toxicity was graded on the basis of CTCAE version 4.0. Response rate and toxicity in the 3 arms was compared using a two by two square t-test. Results: There were 12, 14, and 15 patients in the q1w, q2w and q3w arms, respectively. Response rates, mean progression free survival (PFS), median PFS, mean overall survival (OS), median OS, mean cumulative dose (MCD) and toxicity are shown in the Table. Three-year OS was 0%, 20%, and 0% in the q1w, q2w, and q3w arms, respectively. Toxicity was similar in the q1w, q2w, and q3w arms, except grade 1/2 neuropathy was higher in the q2w arm vs. the q1w arm (p=0.005). Conclusions: The MCD, response rates, PFS and OS in the q1w and q3w arms were similar to previously published reports. Patients in the q2w arm received a statistically significant higher MCD. Our data suggest a better outcome in the q2w arm as compared to the q1w and q3w arms. However, given the small number of patients studied, the results are not statistically significant. Toxicity was similar save for grade 1/2 neuropathy. [Table: see text]
Clinical outcomes and toxicity of estramustine phosphate (EP) addition to docetaxel (D) as first-line therapy for castration-resistant prostate cancer (CRPC): A cumulative analysis on 243 patients (pts) from two randomized phase II trials.
Authors: Caffo Orazio , Sava Teodoro , Zustovich Fable , Lodde Michele , Sacco Cosimo , Lo Re Giovanni , Buti Sebastiano , Basso Umberto , Gamucci Teresa , Facchini Gaetano , Perin Alessandra , Segati Romana , Russo Lucianna , Veccia Antonello , Galligioni Enzo 
Published: February 2017

208 Background: Although EP exerts a synergism with D and a meta-analysis suggested a survival advantage in combining EP to chemotherapy, D+EP combination is usually discouraged due to a marginal improvement in disease control at cost of an enhanced toxicity compared to D alone. In order to assess the role of EP added to D we have analyzed data from pts enrolled in two randomized trials with D ± EP conducted by our group (BJU Int 2008 – ASCO GU 2012). Methods: All patients received D 70 mg/m2IV q 3 wks ± E 280 mg/TID PO for 5 days starting 1 day prior to D. Ninety-five pts of the first study (started in 2002) were treated until progression; 148 pts of the second study received 8 D courses in continuous or intermittent fashion. We evaluated PSA response, PFS according to PCWG2, OS and toxicity. Results: We shared the clinical data from all 243 pts (123 D, 120 D+EP): the median baseline PSA values were 53 and 60 respectively; 49.5% and 59.1% of the D and D+EP pts presented visceral metastases, respectively. Clinical outcomes and main toxicities are summarized in the Table. Conclusions: The addition of EP to D was tolerable with a mild toxicity profile; it was able to double the biochemical responses which did not translate in any PFS or OS advantage. From our data the addition of EP addition to D should not further role in first line of CRPC, while it may help to overcome D resistance in selected cases according to our previously published data (Urol Oncol 2010). However, this statement should be critically considered at the light of new drugs availabile and active after D failure. Clinical trial information: 2006-005728-17. [Table: see text]
A pilot study of high-dose exisulind in men with biochemical relapse (BCR) of prostate cancer after definitive local therapy treated with intermittent androgen deprivation (IAD).
Authors: Yu Evan Y. , Kuo Kevin F , Hunter-Merrill Rachel , Gulati Roman , Cheng Heather H. , Flamiatos Jason Frederick , Gambol Teresa E , Hall Suzanne P , Higano Celestia S. 
Published: February 2017

209 Background: Exisulind is an apoptotic drug shown in vitro to inhibit expression and function of the androgen receptor. At lower doses as a single agent and in combination with chemotherapy it has demonstrated limited efficacy. In this pilot study, the potential for high dose exisulind to prolong the duration of the off treatment interval of IAD was studied. Methods: Eligible patients (pts) underwent prior definitive local therapy, had BCR, and received at least one full prior cycle of IAD, defined as a 9-month on- and variable off-treatment period (terminated by reaching PSA threshold 1 ng/mL for radical prostatectomy and 4 ng/mL for radiation). Exisulind (250 mg po bid) was started 3 months before completing the 2nd on-treatment period and continued through the 2nd off treatment interval and other IAD cycles until castration resistance (CRPC). We used a Cox proportional hazards model to estimate the association between receiving exisulind and time to resuming AD for pts who initiated exisulind during their 2nd on-treatment period. The model controlled for 1st off-treatment duration. Results: Nineteen pts were enrolled and treated with exisulind. Median age was 62 (range 50-75) years. Median PSA at diagnosis was 11 (3.9-99) ng/mL and 5 (1-19.2) ng/mL at initiation of IAD. Median Gleason score was 8 (6-9). Median duration of exisulind treatment was 1.5 (0.5-7.7) yrs and median follow-up was 9.3 (1.1-10.1) yrs. In 9 evaluable pts, taking exisulind was associated with a non-significant prolongation of the off treatment interval (15% decreased risk of progressing to PSA threshold and the next AD cycle, HR 0.85, 95% CI 0.41, 1.75, p=0.654). Six pts (32%) required at least one dose hold, 9 (47%) underwent a dose reduction for toxicity, and 7 (37%) came off trial for drug toxicity. Most common adverse events were elevated liver function tests (53%) and fatigue (42%). Median time to CRPC was 5.5 (0.3-not reached) yrs. Conclusions: High-dose exisulind was poorly tolerated and did not clearly extend the duration of 2nd off-treatment intervals compared to the 1st. More potent contemporary agents may be more beneficial in this setting. Clinical trial information: NCT00283803.
Time to follow-up and treatment in patients with newly diagnosed prostate cancer (PC) across clinical stages in an equal access health system.
Authors: Nallu Anitha , Mitikiri Nirupama Devi , Onukwugha Ebere , Mullins C. Daniel , Hussain Arif 
Published: February 2017

210 Background: The purpose of this pilot study is to describe the time interval from diagnosis to initial specialist visit and treatment initiation in pts with newly diagnosed PC across different clinical stages (S1- 4) in an equal access system such as a Veterans Affairs Medical Center (VAMC). Methods: Data from the Baltimore VAMC database were used to examine pts diagnosed with PC in 2010 to assess variation across different clinical stages with respect to follow up with specialists, diagnostic tests and treatment initiation during the year following diagnosis. Specialists include urologists, medical oncologists and radiation oncologists. Diagnostic tests included CT and/or bone scans. Treatments based on clinical staging included active surveillance, radical prostatectomy, external beam radiation therapy, brachytherapy, androgen deprivation therapy, chemotherapy or enrollment into clinical trials. Results: One hundred and nine pts were diagnosed with PC at the BVAMC in 2010. All but one patient had follow-up with a specialist after positive prostate biopsy. Majority of pts in each stage saw more than one specialist (S1-50%, S2-74%, S3-60%, S4-82%). The median number of days to first follow up visit with a specialist was similar across all stages (S1-16 d, S2-15 d, S3-17 d, S4-14 d). Four out of the 109 pts were lost to follow up. S4 pts were initiated on treatment at a median of 26 days after diagnosis, whereas S1, S2 and S3 pts were initiated on treatment at a median of 151,100 and135 days respectively, after diagnosis. Pretreatment CT scan and/or bone scans were done in S1-38%, S2 -70%, S3-80% and S4-100% pts. Conclusions: The results of this pilot study showed that while time to initial follow up visit after diagnosis of PC does not differ across the clinical stages, treatment for S4 pts is initiated much earlier than for the other stages. It will be of interest to determine whether these patterns hold for other years and in other VA Medical Centers.
Is routine prostate biopsy needed prior to radical cystectomy?
Authors: Hashimoto Yasuhiro , Suzuki Yuichiro , Imai Atsushi , Okamoto Akiko , Yamamoto Hayato , Hatakeyama Shingo , Yoneyama Takahiro , Koie Takuya , Ohyama Chikara 
Published: February 2017

223 Background: Prostate cancer (Pca) can be detected coincidentally in radical cystoprostatectomy (RCP) specimens for invasive bladder cancer. However, there is no uniformity of opinion on the need for prostate biopsy prior to RCP. We evaluated the necessity of preoperative prostate biopsy in invasive bladder cancer. Methods: From 1998 through 2009, of 300 patients undergoing radical cystectomy for muscle-invasive bladder cancer, 252 were male. Of these, we focused 212 patients, whose prostate-specific antigen (PSA) was measured preoperatively. Results: The median age was 66years and median follow-up period was 46 months. Thirty-five patients with PSA > 4.0 ng/mL or digital rectal examination (DRE) positive were all subjected to transrectal ultrasound (TRUS)-guided prostate biopsy (Pbx), and Pca was detected in 7 cases (20%) (Group I). Pca was also detected in 5 patients (17.9%) in RCP specimens of the 28 whose Pbx results were negative (Group II). Seventy-seven of the 177 patients with PSA ≤ 4.0ng/mL and DRE negative were underwent TRUS-guided Pbx, and Pca was detected in 1 case (1.3%) (Group III). Pca was detected in 10 patients (13.2%) out of the 76 whose Pbx results were negative (Group IV). Of the 177 patients, 100 underwent RCP without prostate biopsy, and Pca was detected in 16 cases (16%) (Group V). The average Gleason score of each Group, I, II, III, IV, and V were 6.6, 6.6, 7, 6.2, and 6.5, respectively. Tumor volumes of each Group, I, II, III, IV, and V were 3.12mL, 1.0mL, 0.65mL, 0.43mL, and 0.19mL, respectively. No patients experienced recurrence of PC, including biochemical recurrence. Conclusions: In cases with PSA ≤4.0 ng/mL and/or DRE negative, Pbx is not considered necessary. In cases with PSA > 4.0 ng/mL or DRE positive, Pca with an average volume of 3.12 mL were detected by Pbx in 20% of the patients. However, most are localized Pca, and postoperative recurrence of the Pca is not seen during follow-up period. The question of whether all patients in this group require Pbx needs to be examined through further stratification.
Cabazitaxel in patients with metastatic castrate-resistant prostate cancer previously treated with a docetaxel-containing regimen: A single U.K. cancer center's experience using Early Access Programme and Cancer Drugs Fund.
Authors: Kelly Claire L. S. , Hague Christina J. , Cornthwaite Stephanie A. , Birtle Alison J. 
Published: February 2017

224 Background: The TROPIC Trial demonstrated improved overall survival in patients with mCRPC who progressed during or after treatment with docetaxel. The trial established cabazitaxel as a tolerable and viable second line treatment option in these patients. We report our experience with cabazitaxel in patients receiving treatment within the Early Access Programme (EAP) and via the Cancer Drugs Fund (CDF). Methods: Retrospective review of patients receiving cabazitaxel chemotherapy from 1st January 2011 to 1st January 2012. Chemotherapy administration was corroborated via the electronic prescribing system. Patient records provided documentation regarding disease response and treatment toxicities. For patients within the EAP, data was confirmed and supplemented via the Trials Office. Results: 22 patients were identified, of which 20 received cabazitaxel. 12 were treated within the EAP and 8 via the CDF. Median age was 68.5 years (59-83) within the EAP group and 70 years (52-78) within the CDF group, whilst median number of cycles was 6 (1-10) and 5.5 (1-8) respectively. 83.3% of EAP patients received full dose throughout, compared with 62.5% of the CDF patients. Primary GCSF was used in 91.6% of EAP patients and 75% of CDF patients, with secondary GCSF in 8.3% and 12.5% respectively. 3/20 patients had treatment discontinued due to progressive disease (after a minimum of 3 cycles). 13/20 patients had a positive biochemical and/or clinical response. 15/20 patients (Gleason score ≥ 8, 7 of 15) remain alive with a mean survival of 12.1 months (3.4-19.4). There were no treatment related deaths. Treatment related adverse events are shown in the Table. Conclusions: Our results are comparable with the TROPIC data, suggesting cabazitaxel offers demonstrable response rates and meaningful survival with an acceptable toxicity profile. [Table: see text]
Incidental prostate cancer in patients with radical cystectomy for bladder cancer.
Authors: Djaladat Hooman , Bruins Max H. , Skinner Eila C. , Miranda Gus , Cai Jie , Ahmadi Hamed , Daneshmand Siamak 
Published: February 2017

225 Background: Radical cystectomy is the gold standard surgical treatment for invasive bladder cancer. Prostate adenocarcinoma is often found incidentally in the cystoprostatectomy specimen. The clinical significance of this type of cancer has not been well characterized. We reviewed the cohort of male patients with bladder cancer who underwent radical cystectomy and found to have incidental prostate adenocarcinoma. Methods: 1,964 patients with primary transitional cell carcinoma of bladder underwent radical cystectomy between 1971 and 2008 with a median follow-up of 12.1 yrs (0.1-36) at USC. 1553 of them were male (79%) and 559 (36%) had incidental pathologic prostate adenocarcinoma (PC-group). Prostate and bladder cancer characteristics, recurrence and overall survival (OS) in the cohort of PC-group are reviewed. Results: Median age in the PC-group was 69 yo (35-92). The incidental PC was organ confined (OC) in 527 patients (94%). 32 (6%) had non-OC prostate cancer, treated by adjuvant radiation (5), hormone ablation (3) with a median follow-up of 3.9 yrs (0.1-16). Median pre-op PSA was 1.66 (0.01-83) in PC-group and 1.31 (0.01-33.2) in non-PC group. Gleason score was ≤ 6 in 458 (82%), 7 in 78 (14%) and ≥ 8 in 12 (2%) cases. Reviewing bladder cancer in the PC vs. non-PC group, 84 and 83% had high-grade cancer, 63 and 58% had associated CIS, 41 and 36% had multifocal disease and 29 and 27% had LVI respectively (P > 0.05). Incidental PC did not have significant effect on recurrence (P=0.3) and OS (P=0.4) after cystectomy for bladder urothelial cancer. No patient died of PC. 5-year OS rate was 60 ± 2% in both PC and non-PC groups. 10-year OS rate was also comparable at 42 ± 2% in PC and 44 ± 2% in non-PC-group. Conclusions: Incidental prostate adenocarcinoma is reported in more than one third of patients who undergo radical cystectomy for bladder cancer. It is organ confined in most of the cases and has no correlation with bladder cancer stage. Outcome of patients with incidental prostate adenocarcinoma at the time of radical cystectomy relies exclusively on the bladder cancer.
Characteristics and outcomes of elderly patients with systemic prostate cancer (PCa) treated with peripheral androgen blockade (PAB).
Authors: Kilari Deepak , Pandya Chintan , Fung Chunkit , Sahasrabudhe Deepak M. , Brasacchio Ralph Anthony , Messing Edward M. , Sievert Lynn , Mohile Supriya Gupta 
Published: February 2017

226 Background: The side effect profile of androgen deprivation (ADT) warrants exploration of alternative options for elderly patients with systemic PCa. In phase 2 trials, the combination of anti-androgen and 5 alpha reductase inhibitor (PAB) demonstrated efficacy with low morbidity in the fit population. The objective of this retrospective study was to evaluate the characteristics and outcomes of elderly patients treated with PAB in lieu of ADT. Methods: We reviewed records of patients ≥65 yrs who received PAB in the geriatric oncology program from 2007-2012. Patients were evaluated with a validated comprehensive geriatric assessment (CGA) prior to PAB. Descriptive statistics were used to evaluate PAB type, characteristics of patients and their cancers, as well as PCa –specific and overall outcomes Results: Twenty-one asymptomatic PCa patients received PAB (bicalutamide alone-57%, or bicalutamide and finasteride-43%) in lieu of ADT. Indications for treatment were metastatic disease (53%) or biochemical relapse with PSA doubling time≤ 6 months (47%). Median age at the initiation of PAB was 86 years (range 65-94) and 76 % had ECOG PS≥ 2. By CGA, 57 % were vulnerable, 33% frail and 10% fit. 76% had contraindications for standard ADT (e.g., dementia, falls, etc.); the rest declined ADT due to concern about adverse effects (AE). The median PSA at PAB initiation was 14.78 (range 0.9-165.8). PSA nadir (i.e. 1st of 3 consecutive PSA levels where values were within 90%) was reached in 57% of patients at the time of analysis with the remainder demonstrating a continuing decline. Median PSA at nadir was 0.86(range 0.02-11.24). The median follow up time was 11 months (range 1-30). The median time to PSA nadir was 5 months; (range 1-19). PSA nadir was maintained for median of 10.5 months (range 3-24).The median % decline in PSA was 92 % (range 13-99%).No patients reported AE or required treatment interruption. Two fit patients of the 4 who progressed on PAB responded to subsequent ADT. Conclusions: These results provide evidence that PAB is feasible, active and well tolerated in patients for whom ADT may be contraindicated. A prospective phase II study for an older vulnerable patient population is planned.
Postdocetaxel treatment for castrate-resistant prostate cancer: The sequential use of abiraterone and cabazitaxe.
Authors: Fackrell David Gareth , James Nicholas David , Ford Daniel 
Published: February 2017

234 Background: Large phase III trials have shown both abiraterone (Abi) and cabazitaxel (Cbz) to have a survival benefit in patients with metastatic castrate resistant prostate cancer (mCRPC). They are now used routinely throughout the UK in this setting. The mechanisms of resistance of these drugs remain unclear and therefore, their sequential use is less recognised. We present data from patients who have been exposed to both therapies. Methods: In this retrospective study, we searched our own pharmacy databases to identify all patients that had been exposed to both Abi and Cbz. All patients were treated between April 2009 and October 2012. A total of 21 patients were reviewed and clinical data was collected. SPSS software was used to create Kaplan Meier curves. Results: 17 of the 21 patients received Abi before Caz. Median progression free survival for patients on the sequential regimes was 16.9 months (95% Confidence interval: 10.5-23.3). Reviewing the drugs individually found progression free survival was 5.1 months (4.4-6.0 months) with Abi and 7.1 months (5.1-9.1) with Cbz. Conclusions: In a select group of patients who are fit enough to receive both drugs, superior progression free survival is seen than can be expected on one drug alone. The data compares favourably to that seen in the TROPIC study where time to progression on Cbz was 2.8 months. Furthermore, lack of response to one drug did not preclude worthwhile response to the other agent. These findings are consistent with the drugs having separate mechanisms. At this stage the series is not mature enough to draw conclusions on survival benefit. An updated series, involving larger patient numbers, will be presented at the meeting.