bluuebunny/crossref_metadata_2025_split huggingface dataset:
Phase II trial of 177Lutetium radiolabeled anti-prostate-specific membrane antigen (PSMA) monoclonal antibody J591 (177Lu- J591) in patients (pts) with metastatic androgen-independent prostate cancer (AIPC)
Authors: Bander N. H. , Nanus D. M. , Milowsky M. I. , Morris M. J. , Jeske S. , Vallabhajosula S. , Goldsmith S. J. 
Published: March 2020

15523 Background: A phase 1 trial of 177Lu-J591 in pts with metastatic AIPC demonstrated acceptable toxicity, excellent targeting of metastatic sites and biologic activity. Methods: Pts with progressive, metastatic AIPC receive one dose of 177Lu-J591 in two- cohorts: cohort 1 (65 mCi/m2), 15 pts; cohort 2: (70 mCi/m2), 17 pts. The primary endpoint is PSA and/or measurable disease response; secondary endpoint is toxicity. A 177Lu-J591 imaging study is done to confirm tumor targeting. Results: 21 pts (8 chemo-naive), median age 73, have been treated to date, 15 in cohort 1, 6 in cohort 2. Two pts with bone-only metastases achieved PSA declines of >50%. One had an 87% PSA decline lasting 126 days with resolution of bone pain. A 2nd pt has a PSA decline of 58% that continues without progression at 6 mo post-rx. PSA stabilization (<25% PSA rise above baseline) occurred in an additional 9 pts (43%), 7 through wk 8 (1 of whom is still under follow-up) and 2 pts through wk 12. Of 7 pts with measurable disease, 6 have had post-rx CT scans completed, 3 were stable, 3 progressed. In these pts with measurable disease, PSA was more likely to diagnose progression, with only 1 stable and 5 progressed by PSA criteria. Platelet nadir <20 x 10e9/L occurred in 6 pts, 3 of whom required platelet transfusions (mean = 2). 17/19 evaluable pts recovered normal platelet counts; the remaining 2 pts had rapidly progressive disease, 1 of whom had biopsy confirmed marrow replacement by tumor. Neutropenia </= 0.5 x 10e9/L occurred in 4 pts, 2 of whom received brief rx with growth factors. All 19 evaluable pts had normal neutrophil recovery. No significant drug-related non-hematologic toxicity has occurred. Targeting of known sites of PC metastases has been observed in all pts. Conclusions: Single dose 177Lu-J591 demonstrates anti-tumor activity in pts with progressive, metastatic AIPC with reversible myelosuppression. Accrual is continuing. [Table: see text]
Audit of excisional breast biopsies in a Nigeria teaching hospital
Authors: Adisa C. A. 
Published: March 2020

1553 Background: Excision biopsy is an accurate method for diagnosis of breast tumors especially where facilities for needle biopsies like tru cut needle biopsy or aspiration cytology method are not readily available. We report a 10-year prospective study of the clinical and pathological characteristics of excised breast masses in our centre. Methods: Clinical records and pathological results of all excised breast masses of consecutive patients referred to the Breast Clinic of the Abia State University Teaching Hospital, Aba, Nigeria were studied from January 1994 to December 2003. We present the outcome of the histology reports from breast biopsy for a period of 10 years (1994–2003) in Abia State University Teaching Hospital. Results: A total of 421 patients had breast masses excised. The age ranged from 12 years to 80 years. 79% of the patients with cancer of the breast were 50 years old or younger and the youngest patient was 14 years. Malignancies were discovered in 24% of the cases and the predominant histological type was infiltrating ductal carcinoma (NOS). 79% of the breast cancers occur in pre menopausal women and the majorities (85%) were late stages. Conclusions: Majority of breast masses in Nigerian women are benign. The preponderance of late staged tumors and pre menopausal patients call for early detection, public awareness and improved screening methods. No significant financial relationships to disclose.
Factors predicting the development of and survival from brain metastasis in transitional cell carcinoma of the bladder
Authors: Tran C. T. , George J. , Miranda G. , Hamid O. , Stein J. P. , Quinn D. I. 
Published: March 2020

15541 Background: To date there are no substantial series reported evaluating brain mets in TCC of the bladder. This makes therapeutic evidence-based decision making in this setting extremely difficult. Methods: We followed 1898 pts with TCC of the bladder treated with cystectomy from 1972–2004. Cohort analysis was undertaken for factors predisposing to and of factors that predict survival after brain mets. Results: With median follow-up of 3.6 yrs for this cohort, 545/1898 (28.7%) recurred, 30 (1.6%) with brain mets. Median time to brain mets development was 1.14 yrs, range 0.0710.92 yrs. Median time to first TCC recurrence in brain met pts was 0.86 yrs vs. 1.03 yrs for whole cohort (p=0.25). Median OS from cystectomy 1.36 yrs vs. 3.49 yrs for whole cohort (p<0.0001). Median time from brain mets to death, 3.3 mths range 0–143 mths, skewed by 2 outliers surviving 18 and 143 mths. The following factors were associated with risk of brain mets: younger age (60.2 vs. 66.3 yrs, p=0.01) and LN status at cystectomy (p=0.02) while gender, smoking status, T stage, margin status were not; tumor grade showed a nonsignificant trend to association with brain mets (p=0.14). Pathological parameters did not correlate with duration to development of brain mets. In predicting OS after brain mets, diagnosis age, duration to first recurrence, duration to brain met, original T and N stage and development of multiple vs. brain alone recurrence did not impact overall survival. Patients having any therapy (19/30): surgery (6), radiation (11) or chemotherapy (10) or combination had a better survival that those not treated (p=0.0002). Each modality was associated with at least a trend to better OS: surgery (p=0.03), RT (p=0.09), CT (p=0.08). Conclusions: These results need to be interpreted in the context of selection bias for active treatment, however, selected patients with brain mets from TCC bladder do appear to benefit from active therapy. More work in this area will hopefully lead to more rational therapy and better outcomes. No significant financial relationships to disclose.
Radical retropubic prostatectomy in patients with high risk prostate cancer
Authors: Özgür E. , Ohlmann C. , Pfister D. , Engelmann U. , Heidenreich A. 
Published: March 2020

15549 Background: Patients with high risk prostate cancer (Gleason score 8 to 10, cT3 disease or PSA > 20 ng/ml) are at high for cancer recurrence after local therapy such as radical retropubic prostatectomy (RPE) or radiation therapy. We examined the long-term oncological and functional outcome of patients with high risk prostate cancer (PCA) on biopsy. We further investigated prognostic risk factors associated with good prognosis. Methods: We retrospectively analysed the outcome of 304 patients with high risk PCA. All patients received a questionnaire to obtain information with regard to continence, potency, PSA recurrence, PSA mortality and quality of life (EORTC QLQ-30). 237 (78%) patients returned the questionnaires. Results: The mean follow-up is 94 (15–146) months, mean age of all patients is 62.6 (32–78) years. 231 (76%) patients had PSA serum levels of 20–50ng/ml, 62 (23.4%) and 39 (12.8%) had PSA serum levels of 50–100 ng/ml and > 100 ng/ml, resp., a pT3 PCA was identified in 192 (63.1%) patients, pTxpN1 disease was found in 84 (27.6%) patients. Overall survival rate is 81.9%, 86.2% and 85.3% in patients with PSA > 20ng/ml, pT3 or pTxpN1 PCA, resp.; cancer specific survival was 85%, 89.5% and 88.7% in PSA > 20ng/ml, pT3 and pTxpN1 PCA, resp. PSA recurrence rate is 28%; the most significant parameters associated with survival are biopsy Gleason score (p = 0.02), pN1 status (p = 0.001), perineural invasion (p = 0.001), seminal vesicle invasion (p < 0.0005). There was no significant difference with regard to pre- and postoperative quality of life. Continence was good with no pads in 85%, 1- 2 pads/day and = 3 pads/day in 10.6% and 4.4%, resp. Conclusions: RPE can be safely performed in patients with high risk PCA resulting in a high cancer specific survival rate. Most suitable candidates are patients with biopsy Gleason score < 8, pN0 and = pT3a; even in cT3 PCA RPE is a valuable therapeutic option with long-term PCA-free survival and might be considered in men with a long life expectancy. No significant financial relationships to disclose.
Prostate specific antigen doubling time (PSADT) in patients with hormone refractory prostate cancer (HRPC) undergoing docetaxel chemotherapy as a predictor of overall survival
Authors: Pachynski R. K. , King C. , Srinivas S. 
Published: March 2020

15556 Background: Few data correlating PSADT and overall survival(OS) in patients with HRPC undergoing chemotherapy exist. Docetaxel has recently been shown to significantly improve OS in patients with HRPC, but with significant toxicities. The decision of when to initiate chemotherapy is not well defined, but the presence of symptoms or narcotic use has widely been used to indicate this. The current retrospective study aims to identify a specific PSADT that independently correlates with OS in HRPC patients receiving docetaxel. Methods: A retrospective review of all patients with HRPC receiving docetaxel from 2001 to 2006 was performed. Androgen independent prostate cancer (AIPC) was defined as the time of a rising PSA despite castrate levels of testosterone. Variables evaluated from time of AIPC to initiation of chemotherapy included PSA, PSADT, hemoglobin, alkaline phosphatase, Gleason score. Time to AIPC was also evaluated. Patients who had pain or were on narcotics at the time of chemotherapy initiation were considered symptomatic. OS was calculated for both time from AIPC to death or last follow-up, and for time from chemotherapy to death or last follow-up. Results: 50 patients treated with docetaxel for HRPC were evaluated. Median OS was 32 months, and median survival from start of docetaxel was 14 months. There was no difference in OS between symptomatic or asymptomatic patients. A PSADT of >2 mos was significantly correlated with improved median OS (p= 0.005). Univariate analyses of all other factors were not significant. Furthermore, in patients with a favorable outcome ( >14 mos) from start of docetaxel, a PSADT of >2 mos was a significant predictor of improved survival (p=0.02). Conclusions: This is the first study to evaluate PSADT in HRPC patients receiving docetaxel exclusively. Our data shows that a shorter PSADT (<2 mos) significantly predicts shorter OS. Symptoms or narcotic use did not correlate with OS. Taken together, these data suggest that a PSADT of <2 mos may be a better predictor of when to initiate chemotherapy than symptoms or narcotic use. The lack of significant correlation between the other variables and OS may further suggest the robustness of PSADT as a predictive variable. No significant financial relationships to disclose.
Cost of illness of renal cell carcinoma in Canada
Authors: Abugaber A. , Lang K. , Danchenko N. , Thompson D. , Bhardwaj T. , Bjarnason G. , Finelli A. , Kapoor A. , Jaszewski B. 
Published: March 2020

15560 Background: Renal cell carcinoma (RCC) is the most common form of kidney cancer. RCC patients have limited treatment options and low survival rates, particularly for advanced-staged patients. Despite its importance, data on the economic burden of RCC are limited. Methods: A prevalence-based approach was used to estimate the aggregate annual societal cost burden of RCC in Canada. Key relationships represented in the model include the annual number of patients treated for RCC by age group and cancer stage; utilization of cancer treatments; unit costs; work-days missed, and wage rates. Results: The annual prevalence of RCC in Canada in 2005 was estimated to be 17,845 cases. The associated annual burden of RCC (Canadian $2005) was approximately $357 million ($19,981 per patient). Health-care costs and lost productivity accounted for 65.6% ($234 million) and 34.4% ($123 million) of the total, respectively. Reflecting its higher prevalence, the total cost associated with Stage II RCC accounted for the greatest share (67%) followed by Stage I, Stage III, and Stage IV RCC, at 19.8%, 11.6% and 1.6%, respectively. Conclusions: The economic burden of RCC in Canada is substantial at a cost of $357M which represents 2% of the total cost of illness of cancer in Canada ($16.64B, inflated to $2005). Interventions to reduce the prevalence of RCC have the potential to yield considerable economic benefits. [Table: see text]
Relapse patterns and outcomes in a population-based study of Nova Scotia patients with germ cell tumors (GCT)
Authors: Murphy E. , Douglas J. , Qi Q. , Wood L. 
Published: March 2020

15564 Objectives: To examine the frequency and pattern of relapse in a population-based cohort of Nova Scotia patients with germ cell tumors (GCT). Presentation and outcome of these patients will be described with an emphasis on late relapsers. Methods: A retrospective chart review of all patients diagnosed with GCT in Nova Scotia between 1984 and 2004 was completed. Data regarding initial diagnosis and treatment as well as data at time of relapse was collected. Relapse was defined as any recurrence of tumor after initial definitive therapy. Late relapse (LR) was defined as a relapse >2 years from initial definitive therapy or previous relapse. Results: Of the 383 patients diagnosed with GCT during the 20 year period, 135 received chemotherapy. 15/135 (3.7%) patients initially treated with chemotherapy relapsed; 10 early and 5 late. 1/10 early relapsers was alive and NED at 2 years from relapse compared to 4/ 5 late relapsers at 4 years. 3 of the 245 patients whose treatment did not include chemotherapy experienced a LR for a total of 8/383 (2.1%) of all patients. Median time to all LR was 6.6 years. Pathology for 6/8 (75%) patients with LR was nonseminomatous GCT. 50% of patients with LR died. Common to all LR survivors was complete surgical resection ± chemotherapy. All patients with LR who died had either no surgical resection or incomplete surgical resection of disease. Conclusions: The incidence of all GCT patients with LR was 2.1% and the incidence of LR post chemotherapy was 3.7% in this population. The only other population based report of incidence of LR in all GCT patients was 1.3%. A mixture of stages, pathology, and sites of metastases was observed with no obvious baseline or treatment differences between early and late relapsers. Interestingly, in this population, patients with LR had better outcomes than early relapsers. The success to curing patients with LR appears to be complete surgical resection of disease. No significant financial relationships to disclose.
Trastuzumab (T) combined with standard chemotherapy in HER+ metastatic bladder cancer (BC) patients: Interim safety results of a prospective randomized phase II study
Authors: Beuzeboc P. , Banu E. , Voog E. , Bousquet G. , Priou F. , Deplanque G. , Bozec L. , Machiels J. P. , Vannetzel J. M. , Oudard S. 
Published: March 2020

15565 Background: Almost 25% of BC patients overexpressed HER2 and 50 to 60% of them are responding to the combination of T with standard chemotherapy (gemcitabine and platinum salt). A prospective, randomized, European phase II study comparing this association with conventional chemotherapy alone is ongoing. Methods: Eligible HER+ BC pts were required to have an advanced and chemonaive bladder cancer and ECOG performance status (PS) 0–2. The aim is to demonstrate a progression-free survival benefit for investigational arm. Sample size was estimated at 126 patients, with a two-sided alpha and beta levels at 5 and 80%, respectively. Treatment-related toxicities were evaluated using CTC-NCI version 2. Fisher exact test was the main statistical method testing differences in percentage of toxicities. Results: Thirty-seven patients were included in 11 centres between February 2004 and December 2006. The planned safety interim analysis was performed after inclusion of 30 patients (15 in each arm). Median age was 59 years (range 46- 80), 93% of patients are men. Seven percent have an advanced disease, 33% have more than one single metastatic site and 83% were PS ECOG 0–1. There were no significant differences between arms concerning hematological and non-hematological all grade toxicities. Severe (grade III-IV) leucopenia, granulocytopenia, anemia and thrombocytopenia were registered in 53, 53, 33 and 60% for combined arm. Grade I-II of diarrhea was slightly more frequent for T arm. There were no differences for alopecia, constipation, nausea and edema. An asymptomatic reduction of the left ventricular ejection fraction was found in one patient in each arm. Conclusions: Combination of T with standard chemotherapy for BC patients was safe. No serious adverse events significant differences were registered, especially concerning T-related cardiac toxicities. The planned interim efficacy analysis is expected after inclusion of 60 patients. No significant financial relationships to disclose.
Upper genitourinary tract transitional cell carcinoma (TCC): Long-term outcome data from a large single institutional series
Authors: Roy R. , Radhakrishnan N. , Kaufman M. , Thomas A. , Weiss G. , Iqbal U. , Mehrotra B. 
Published: March 2020

15582 Background: TCC of the upper urinary tract (renal pelvis and ureters) is a relatively rare entity and carries a poor prognosis. Literature regarding long term outcomes are lacking. We embarked on a review of pt records to evaluate patterns of practice: ie adjuvant therapies and survival outcomes of pts treated at our tertiary care institution. Methods: IRB approval was obtained for this retrospective analysis. Tumor registry data were analysed for all adult pts with TCC of the renal pelvis and ureter diagnosed from 1995 to 2005. Only patients with locoregionally confined disease were included in this study. Pt characteristics recorded: age, sex, site of disease, stage, grade, treatment modalities and survival outcome. Results: 175 patients were identified. Med. age: 75 yrs (range 40–90). Gender: M:F:107:68; Sites: Renal Pelvis: n=128; Ureters: n=47; Stages: Stg 0: n=46 (26.28%), Stg I: n=68 (38.85%), Stg II: n=19 (10.85%), Stg III: n=29 (16.57%), Stg IV (excl. M1):n=13 (7.4%). Gr 1: n=13 (7%), Gr 2: n=49 (28%), Gr 3: n=78 (45%), Gr 4: n=20 (11%); Unknown n=14 (8%). Gr 3/4 distribution for Stages 0, I, II, III, and IV were 17 (37%), 32 (47%), 15 (72%), 23 (79%) and 11 (84%) respectively. Treatment Modalities: All pts were treated with surgical resection; adjuvant chemotherapy was utilized in Stg I: 5/68; Stg II: 3/19; Stg III: 5/29; Stg IV: 1/13 pts. Adjuvant RT was administered in Stg III: 1/29; Stg IV: 3/13 pts. Med. survival and OS at 1, 2, 5 and 10 yrs are shown in Table 1 for all pts treated with surgical resection alone as standard therapy. Med. Survival of all patients who received any adjuvant therapy was 24 mos. Conclusions: Increasing frequency of higher grade disease was present in higher stage patients. Long term survival of early stage disease despite surgical resection is poor with 5 year OS of 45–62% in Stages 0-II and worse with higher stages III and IV with 5 yr OS of 17- 21%. Clearly, better adjuvant or neo-adjuvant strategies are needed to improve this dismal prognosis. [Table: see text] No significant financial relationships to disclose.
Coagulation markers D-dimer and prothrombin fragment 1.2 compared to disease and treatment status in prostate cancer patients
Authors: Wong B. Y. , Fink L. , Symanowski J. , Dincer A. , Adcock D. , Vogelzang N. 
Published: March 2020

15587 Background: Activation of the coagulation cascade is a hallmark of advanced prostate cancer (PC). In patients (pts) with advanced PC, the D-dimer and prostate specific antigen (PSA) are frequently elevated; neither is an established predictive marker for response to treatment. We hypothesized that chemotherapy refractory (CRefrac) PC is associated with active thrombin generation, and that D- dimer and prothrombin fragment 1.2 (PF1.2) as activation markers of coagulation could be markers of CRefrac PC. Methods: We analyzed PSA, D-dimer and PF1.2 from a cross section of 29 PC pts. PSA values were measured by the Bayer/Centaur method (Bayer Healthcare, Tarrytown, NY). D-dimer assay was performed using quantitative latex-agglutination (Diagnostica Stago, Asnieres, France), and PF 1.2 levels were determined by enzyme-immunoassay (Dade Behring, Marburg, Germany). Values were analyzed with respect to disease and treatment status. Results: The median age was 66. Twenty pts had metastatic PC, while 9 pts had stable or rising PSA but no evidence of metastatic disease. Among the 20 metastatic pts, 10 were CRefrac, 3 were hormone refractory and 7 were responding to or stable on hormone therapy. Median PSA was 36 ng/ml (range 0.1–1170). Median D-dimer was 372 ng/ml [range 110–13,300; normal (<256 ng/ml)]. Median PF 1.2 was 402 ng/ml (range 100–853; normal 87–325 ng/ml). Only 19 pts had sufficient sample for PF1.2 values. Stratification by disease and treatment status showed significantly higher D-dimer values in CRefrac pts compared to all other pts (median 1144 vs 317, p=0.014, rank-transformed analysis). Eight of 11 CRefrac specimens had elevated D-dimer values; 2 of the 3 exceptions were pts receiving warfarin therapy. Only 3 of 20 non-CRefrac specimens had elevated D-dimer values. Five of 8 CRefrac pts and 8 of 12 non-CRefrac pts had elevated PF1.2 values. Conclusions: D-dimer values are substantially elevated in CRefrac PC. However, the clinical significance of these findings and of the apparent suppression of D-dimer by warfarin therapy is unknown. Longitudinal studies of D-dimer and PF1.2 in PC pts undergoing chemotherapy are needed. No significant financial relationships to disclose.