bluuebunny/crossref_metadata_2025_split huggingface dataset:
What care is appropriate and necessary for metastatic gastric cancer patients? Results of a RAND/UCLA expert panel.
Authors: Mahar Alyson L. , Helyer Lucy K. , Swallow Carol Jane , Law Calvin , Paszat Lawrence Frank , Seevaratnam Rajini , Cardoso Roberta , McLeod Robin S. , Bocicariu Alina , Coburn Natalie G. ,   The Gastric Cancer Processes of Care Expert Panel
Published: February 2017

70 Background: Most gastric cancer patients present with advanced stage disease precluding curative surgical treatment. The utility of surgical and non-surgical options for non-curative, advanced disease is debated and the appropriate treatment strategy unclear. Methods: A multi-disciplinary expert panel of 16 physicians from 6 countries, scored 47 scenarios using the RAND/UCLA Appropriateness Methodology. Appropriateness was scored from 1 (highly inappropriate) to 9 (highly appropriate). Median appropriateness scores (AS) from 1-3 were considered inappropriate, 4-6 uncertain, and 7-9, appropriate. Agreement was reached when 11 of 16 panelists scored the statement similarly. If a statement was agreed to be appropriate, it was then given a necessity score (NS) in the same manner. Results: Surgical resection and bypass were agreed to be inappropriate in patients with minor symptoms and visible carcinomatosis, liver metastases or more than one site of metastatic disease for cardia and distal lesions (AS 1.0-3.5). The expert panel disagreed on the role for surgical resection in patients who were cytology positive only (AS 4-6). The role of resection for patients with major symptoms if they had visible carcinomatosis, liver metastases or more than one site of metastatic disease (AS 2-5) was indeterminate. Patients with distal tumours and major symptoms and multiple liver metastases or more than one site of metastatic disease were considered indeterminate for surgical resection (AS 2). Best supportive care was agreed to be appropriate for patients with minor symptoms and multiple liver metastases or more than one site of metastatic disease (AS 8, NS 5-6). Conclusions: The role of surgery in metastatic gastric cancer treatment decision-making is not supported by experts for the majority of scenarios. Continued uncertainty in appropriate and necessary treatment decision-making for advanced patients with a minimal burden metastatic disease exists and underscores the need for randomized controlled trials.
Population-based outcome of stages IA-IIA resected gastric adenocarcinoma: Who should get adjuvant treatment?
Authors: Gold Jason S. , Al Natour Riad H. , Saund Mandeep S. , Yoon Charles H. , Sharma Ashish M. , Huang Qin , Boosalis Valia A. , Whang Edward E. 
Published: February 2017

75 Background: The benefit of adjuvant treatment in gastric adenocarcinoma was demonstrated by randomized controlled studies that predominantly enrolled patients with locally advanced tumors. Thus its role for stage IIB – IIIC disease is widely accepted. Our aim was to identify patients with stage IA – IIA gastric adenocarcinoma who have a poor prognosis and therefore may benefit from adjuvant treatment. Methods: Patients with local or local-regional gastric adenocarcinoma who underwent surgical resection with pathological evaluation of ≥15 lymph nodes and had available disease-specific survival (DSS) data were identified from the Surveillance Epidemiology and End Results Registry. AJCC 7th edition gastric cancer staging was used. Kaplan-Meier survival was estimated. Survival differences were evaluated with the logrank test and Cox multivariate analysis. Results: TN grouping strongly predicted DSS (p<0.001, n=8515 patients). Stage IA (T1N0) (n=887) tumors had a distinctly excellent outcome, 91±1.2% DSS at 5 years, and thus were excluded from further analysis. The 5 TN groups of stages IB and IIA (n=1544) had the next best outcomes with DSS ranging from 66±4.6% to 81±2.3% at 5 years. Older age (p<0.001), higher grade (p=0.004), larger size (p<0.001), and proximal tumor location (p<0.001) were independent predictors of worse DSS in stage IB and IIA tumors. Interestingly, T and N stages did not independently predict outcome (p=0.07, p=0.41 respectively). We devised a risk stratification scheme for stage IB and IIA tumors where 1 point was assigned for each of the following variables: age >60 years, tumor size >5 cm, proximal tumor location, and grade other than well differentiated. DSS was 100% at 5 years for patients with no points (n=2); 86±4.3% for those with 1 point (n=92); 76±3.0%, 2 points (n=325); 72±2.8%, 3 points (n=372); and 48±4.9%, 4 points (n=136) (p<0.001). Conclusions: Patients with stage IB and IIA gastric adenocarcinomas with at least 2 adverse features (age >60 years, tumor size >5 cm, proximal tumor location, and grade other than well differentiated) have 5 year DSS ≤76%. Adjuvant therapy may be warranted for these patients.
Prevalence and characteristics of patients with metastatic prostate cancer who receive no anticancer therapy.
Authors: Small Alexander C. , Tsao Che-Kai , Moshier Erin , Godbold James , Sonpavde Guru , Oh William K. , Galsky Matt D. 
Published: February 2017

101 Background: Clinical experience reveals that a subset of patients presenting with advanced solid tumors, including prostate cancer, never receive anticancer therapy due to a variety of factors including poor functional status, comorbidities, and patient preference. We sought to determine the prevalence, and characteristics, of this patient population. Methods: The National Cancer Database (NCDB) was queried to identify patients diagnosed with stage IV prostate cancer between 2000 and 2008. Patients who received no anticancer therapy (including chemotherapy, hormonal therapy, radiation, and surgery) were identified and were further categorized by age, race, insurance status, and income. For these subcategories, prevalence ratios were generated using the proportion of untreated metastatic prostate cancer (uMPC) to metastatic prostate cancer (MPC). Results: Of the 1,201,732 patients with prostate cancer diagnosed between 2000-2008, 59,074 (4.9%) had MPC. Of those patients presenting with MPC, 6582 (11.1%) received no anticancer therapy. With every 10-year increase in age, the prevalence of uMPC increased 43% (PR=1.43; p<0.0001). Blacks (PR=1.32, p<0.0001) and Hispanics (PR=1.41, p<0.0001) were more likely than Caucasians to have uMPC. With every $10,000 increase in income the prevalence of uMPC decreased by 7% (PR=0.93; p<0.0001). Patients with Medicaid were 57% more likely to be untreated, patients with Medicare were 82% more likely to be untreated, and uninsured patients were 96% more likely to be untreated than those patients with private insurance (p<0.0001). Conclusions: A large subset of patients presenting with MPC never receive anticancer therapy. While tumor biology likely plays a role with regard to rapid disease onset and progression, these data suggest that age, racial and socioeconomic disparities exist in the treatment of MPC.
The influence of regional radiation oncologist and urologist capacities on treatment choice for prostate cancer management.
Authors: Yu James B. , Aneja Sanjay , Makarov Danil V. , Roberts Kenneth B , Gross Cary P. 
Published: February 2017

108 Background: Our study investigates the influence of regional variations of radiation oncology and urology services on the treatment modality chosen for prostate cancer (PCa) management. Methods: PCa treatment choice and patient data from 2004-2007 were obtained from the NCI Surveillance, Epidemiology, and End Results (SEER) database and combined with the health system data from the Area Resource File. The health system characteristics analyzed were radiation oncologist (RO) density, urologist (U) density, primary care provider (PCP) density, IMRT equipped hospital density, general radiation therapy (RT) equipped hospital density, and median household income. Patient factors analyzed included race, marital status, and age. Separate logistic regression models were built to test the association between health system characteristics and whether patients received any form of RT (EBRT, brachytherapy, or a combination) or just surgical treatment. Results: Overall of the 108,612 patients in our sample, 43.7% received some form of RT. Patients residing in Health Service Areas (HSAs) with increased RO densities were more likely to receive some form of radiation to treat PCa (OR 1.07 [SE 0.02, p<.001]). Conversely increased U density was associated decreased use of RT (OR .95 [SE .01, p<.001]). Presence of IMRT equipped and general RT equipped hospitals were both associated with increased use of radiation therapy (OR 1.53 [SE .05, p<.001] and OR 1.13 [SE .03, p<.001] respectively). Alternatively, 39.3% of patients in our sample received just surgical interventions. Patients residing in HSAs with increased RO densities were less likely to receive only surgical treatment for PCa (OR .91 [SE .01, p<.001]). Increased U density was associated with increased likelihood of only surgical treatment for PCa (OR 1.09 [SE 0.01, p<.001]). Presence of IMRT equipped and general RT hospitals were both associated with decreased use of only surgical treatment for PCa (OR .82 [SE .03, p<.001] and OR .82 [SE .02, p<.001] respectively). Conclusions: Radiation oncologist and urologist capacities influence the regional variations in the treatment choice for prostate cancer.
Impact of different definitions of high-risk prostate cancer on survival after radical prostatectomy.
Authors: Nepple Kenneth Gerard , Sandhu Gurdarshan S , Kallogjeri Dorina , Strope Seth A. , Grubb Robert L. , Klein Eric A. , Stephenson Andrew J. , Kibel Adam Stuart 
Published: February 2017

113 Background: Multiple definitions of high risk prostate cancer exist. Studies have primarily correlated these definitions with biochemical recurrence and not with survival. We applied six previously described high risk definitions to men treated with radical prostatectomy and evaluated their ability to predict survival outcomes in a multi-institutional cohort. Methods: The study population included 6477 men treated with radical prostatectomy between 1995 and 2005 and followed for a median of 67 months. The six high risk definitions were 1) preoperative PSA≥20ng/ml, 2) biopsy Gleason score 8-10, 3) clinical stage≥T2c, 4) clinical stage T3, 5) D’Amico definition, or 6) National Comprehensive Cancer Network definition. Survival was evaluated with the Kaplan-Meier method to generate unadjusted prostate cancer survival estimates. To control for the competing risks of age and comorbidity, multivariable Cox proportional hazard regression models were used to estimate the hazard ratio for prostate cancer specific mortality (PCSM) and overall mortality (OM) in high risk patients compared to low/intermediate risk. Results: High risk patients comprised between 0.7% (cT3) and 8.2% (D’Amico) of the study population. The 10-year Kaplan Meier prostate cancer survival estimates varied from 89.7% for PSA≥20 to 69.7% for cT3. On multivariable analysis controlling for age and comorbidity, high risk prostate cancer (of all definitions) had an increased risk of PCSM compared to low/intermediate risk with a hazard ratio (HR) ranging from 4.38 for PSA≥20 to 19.97 for cT3 (all p<0.0001). For OM, again controlling for age and comorbidity, high risk patients of all definitions except preoperative PSA≥20 (HR=0.98, p=0.99) were associated with increased risk of OM (HR range: 1.72 for D’Amico, 1.73 for stage≥T2c, 1.88 for NCCN, 2.63 for Gleason 8-10, 3.31 for cT3; all p<0.01). Conclusions: In a contemporary cohort of men with high risk prostate cancer treated with radical prostatectomy, the majority of men experienced long term prostate cancer survival. However, heterogeneity in survival outcomes existed based on the definition of high risk used. Clinical stage T3 and high Gleason score were most strongly associated with PCSM and OM.
Centralized revision of diagnostic pathologic slides for prostate cancer patients on active surveillance: Is it just time- and resource-consuming?
Authors: Colecchia Maurizio , Alvisi MariaFrancesca , Paolini Biagio , Nicolai Nicola , Villa Sergio , Salvioni Roberto , Marenghi Cristina , Rancati Tiziana , Valdagni Riccardo 
Published: February 2017

132 Background: Active Surveillance (AS) is offered to prostate cancer (PCa) patients (pts) with very low risk disease, with well defined diagnostic biopsy details. For this reason, in order to standardize diagnostic inclusion criteria, we requested pathologic review before AS enrollment. We here report on second opinion of PCa needle biopsies to determine how often the expert opinion of a uro-pathologist resulted in a different diagnosis, in the group of pts who were proposed for AS. Methods: AS institutional protocol (SAINT) started in Mar 05. Entry criteria: initial PSA≤10ng/ml, Tstage≤T2a, GPS≤3+3, positive biopsy cores≤20%, max core length containing cancer≤50%. In Nov 07 PRIAS started. PRIAS vs SAINT differs on: max 2 positive cores and PSA density<0.2ng/ml/cc. A second opinion on biopsy was requested in 248 cases (Oct 05 - Jul 10), due to outside diagnosis. We analyzed differences between outside diagnosis and institutional expert opinion. We considered two classes of differences: minor differences (which did not prevent AS enrollment) and significant changes (which resulted in a change in prognosis and closed the possibility of AS enrollment). Results: 40/248 (16.1%) cases had minor differences (18 SAINT and 22 PRIAS). In SAINT pts, 12/18 (66.7%) biopsies were increased in the max core length containing cancer (but still≤50%) and 6/18 (33.3%) had a change in the number of positive cores (but still≤20% of total cores). In PRIAS pts 10/22 (45.5%) changes were related to upsizing (from 1 to 2 positive cores) and 5/12 to downsizing (from 2 to 1 positive core). 7/22 changes were related to differences in core length containing cancer (from below to above 50%). Significant differences were observed in 30/248 (12.1%). 20/30 were related to upgrading, 10/30 pts had an upsizing: 1 SAINT pt exceeded 20% of positive cores, 5 SAINT pts exceeded 50% of max tumor length of positive cores, while 4 PRIAS pts increased from 2 to 3 or 4 positive cores. Conclusions: Central pathology review reduces population heterogeneity in the specific setting of AS programs, significant reclassification of risk category involved 12% of pts. Current clinical consequences of central review cannot be determined.
The effect of the diagnosis and treatment of lower urinary tract symptoms (LUTS) on the diagnosis of prostate cancer in a population cohort with 20-year follow-up.
Authors: Weight Christopher J. , Kim Simon P. , Boorjian Stephen A. , Karnes R. Jeffrey , Jacobson Debra , McGree Michaela , St. Sauver Jennifer 
Published: February 2017

137 Background: LUTS are one of the most common reasons patients visit urologists. These symptoms have not been typically associated with the development of prostate cancer (CaP). However, we hypothesized that visiting a physician for LUTS may modify the diagnostic intensity for CaP compared to population controls. Methods: We examined data from a longitudinal, population-based cohort of 2,447 men between 40 and 79 years old who were followed prospectively from 1990 to 2010. Participants completed the American Urological Association Symptom Index (AUASI) every two years. Self-reported moderate/severe LUTS were defined as an AUASI score >7 (n=1627). Data including the treatment for LUTS (n=874), prostate biopsy (PBx), family history of CaP and diagnosis of CaP were obtained through self-report and review of medical records. Associations between self-reported LUTS, treatment for LUTS, and risk of PBx or CaP were estimated using multivariate Cox proportional hazard models. Results: An interaction was noted between age and LUTS and PBx and CaP diagnosis. In younger men, the diagnosis and treatment of LUTS was associated with increased risk of PBx (HR 2.39: 95% CI 1.83, 3.13) and CaP (HR 3.47: 95% CI 2.38, 5.07). Conversely in older men, treatment for LUTS was associated with a decreased risk of PBx and CaP (Table). Self reported LUTS was not significantly associated with CaP diagnosis in younger men and was protective in older men (Table). Conclusions: There is a differential effect of LUTS on prostate cancer testing and diagnosis when stratified by age. The reason for this difference is unclear, but appears to be due largely to diagnostic intensity rather than a true biologic association between LUTS and CaP. [Table: see text]
Safety and efficacy of maintenance therapy (MT) with a nonspecific cytochrome-P 17 inhibitor (CYP17i) after response/stabilization to docetaxel in metastatic castratation-resistant prostate cancer (mCRPC) patients.
Authors: Gil-Bazo Ignacio , Castillo Ainhoa , Zudaire Maria E. , Arevalo Estefania , Carranza Omar Esteban , Fusco Juan Pablo , Castanon Eduardo , Perez-Gracia Jose Luis , López-Picazo José María , Gurpide Alfonso , Garcia-Foncillas Jesus 
Published: February 2017

145 Background: ACRPC causes >30,000 deaths/year in the USA. The front-line treatment consists of docetaxel-based chemotherapy (D). 50% of patients (pts) show at least a 50% PSA decline during D and >15% show a partial response (R) in measurable disease. However, most of these pts present progression (P) after a median of 6-8 months (m). mCRPC remains driven by ligand-dependent androgen (A) receptor signaling. Ketoconazole (K) is a nonspecific cytochrome-P 17 inhibitor (CYP17i) able to block adrenal A synthesis. Low-dose K (LDK), (200 mg, t.d.s) has shown interesting activity in mCRPC after P to androgen deprivation therapy (ADT). The FDA recently granted approval to Abiraterone acetate, a selective CYP17i showing a survival benefit after P to D. The role of a CYP17i in the maintenance setting after response/stabilization to D has never been studied. Methods: 38 mCRPC pts starting D after P to ADT maintained LHRHa and additionally received a median of 7 cycles (3-12) of front-line three-weekly D (75 mg/m2) plus daily prednisone (10 mg). 20/38 pts showing no progression to D were enrolled. One month after the last D cycle 10 pts were assigned to MT with LDK plus prednisone (10 mg daily) and continued to receive LHRHa while the 10 pts in the control arm continued on LHRHa alone. Progression-free survival (PFS) was the primary endpoint of the study. Results: After a median follow-up of 27 m, all pts in the control arm progressed after D treatment while 8/10 pts progressed to MT. PFS from D initiation was 11.4 m for MT and 8.9 m for control arm (p=0.025). Toxicity profiles showed no significant differences between both arms. No pts discontinued LDK for toxicity reasons. Conclusions: To our knowledge, this is the first study testing a CYP17i for MT after response/stabilization to D in mCRPC. Although this is a small cohort of pts and a longer follow-up is needed, these preliminary data show a significant benefit in PFS of more than 2 months with LDK MT compared to no MT after D with a favorable toxicity profile. Thus, a further analysis in a larger series and the potential impact of this PFS benefit on the overall survival is warranted.
An ambispective observational study in the safety and efficacy of abiraterone acetate in the French temporary authorizations for use (ATU): Predictive parameters of response.
Authors: Azria David , Massard Christophe , Tosi Diego , Houede Nadine , Joly Florence , Gravis Gwenaelle , Delva Remy , Le Moulec Sylvestre , Latorzeff Igor , Ferrero Jean-Marc , Culine Stephane , Ladoire Sylvain , Tartas Sophie , Oudard Stephane , Rodier Jean-Michel Pierre , Laguerre Brigitte , Alexandre Jerome , Topart Delphine , Beuzeboc Philippe 
Published: February 2017

149 Background: The Temporary Authorizations for Use (ATU) procedure is an exceptional measure making available medicinal products that have not yet been granted a Marketing Authorisation. Abiraterone acetate (AA) was available for ATU since December 2010 in France. We then decided to evaluate the tolerance and efficacy of this treatment and identify predictive factors of response. Methods: 82 centers were contacted and clinical data were reported in two months (15th July-19th September 2011). Patients were defined as non-responders in case of interruption of AA due to disease progression or death. PSA values were recorded at each medical visit. Reported toxicities were also recorded. Statistical analyses were descriptive and predictive factors were determined. Results: A total of 18 centers accepted to participate in this study including 381 patients. Median age at diagnosis was 63 years. The Gleason score (n=320) were 4-6, 7, and 8-10 in 13.4%, 36.9% and 49.7%, respectively. Before AA, the type of metastasis was bone only, organs only, and bone+organs in 45.4%, 7.9% and 46.7%, respectively. Median PSA before CT and before AA was 58.1 and 137.5 ng/ml, respectively. Median duration of hormonotherapy (HT) before any CT was 34 months. Median duration of CT before AA was 6.1 months with a median number of CT lines of one. Median duration of AA was 117 days. In the non-responders group (n=114), median duration of AA was significantly shorter than in the responders group (n=267), 87 days vs 147 days, respectively (p<0.0001). One third of the patients in the responders group presented a PSA increase over time but continued AA as they clinically improved. Only 13 patients stopped AA for grade 3-4 toxicities. GIeason 8-10 and the number of CT lines (>1) before AA were identified as independent predictive factors of non response. Conclusions: This report is the largest ambispective observational study of AA in an ATU process. PSA values during AA treatment were used as a good indicator of progression. GIeason 8-10 and the number of CT lines (>1) before AA were identified as independent predictive factors and therefore could be used for further strategies in this setting.
Exploratory analysis of survival benefit and prior docetaxel (D) treatment in COU-AA-301, a phase III study of abiraterone acetate (AA) plus prednisone (P) in metastatic castration-resistant prostate cancer (mCRPC).
Authors: Chi Kim N. , Scher Howard I. , Molina Arturo , Logothetis Christopher , Jones Robert J. , Staffurth John , North Scott A. , Vogelzang Nicholas J. , Saad Fred , Mainwaring Paul N. , Harland Stephen John , Li Jinhui , Kheoh Thian San , Haqq Christopher M. , Fizazi Karim 
Published: February 2017

15 Background: AA, a selective androgen biosynthesis inhibitor, blocks the action of CYP17, thereby inhibiting adrenal and intratumoral androgen synthesis. AA has demonstrated improved overall survival (OS) by 4.6 months (mos) vs placebo (HR=0.74) in patients (pts) previously treated with D. Methods: COU-AA-301 is a randomized double-blind study of AA (1 g) + P (5 mg po BID) vs placebo + P administered to mCRPC pts post-D with a primary endpoint of OS. To evaluate the robustness of the primary survival results, we performed post hoc exploratory analyses to assess whether the timing of first and last dose of D and reason for D discontinuation impacted OS. Results: At the time of randomization, treatment arms were balanced with respect to baseline characteristics, prior D use, and reasons for discontinuation. In both arms, almost half (45%) discontinued D due to progressive disease (PD); the remainder discontinued D as part of planned treatment (37%), toxicity (12%), or for other reasons (5%) per investigator reporting. Median OS from first and last dose of D were longer with AA vs placebo (Table). Median OS was longer with AA vs placebo in pts who discontinued D for PD or for all other reasons. Conclusions: These exploratory analyses suggest that the survival benefit of AA in mCRPC was maintained when calculated from first or last dose of prior D, and whether or not pts discontinued D for PD. Pts in the AA arm of this study had a prolonged median OS of > 32 mos from the time of initial D therapy. Congruity among these analyses demonstrates the robustness of the primary survival result. [Table: see text]