tbuckley/cabot-search huggingface dataset:
Predictors of pathological upgrading and upstaging in patients eligible for active surveillance submitted to radical prostatectomy (RARP).
Authors: Ana Maria Autran-Gomez, Fernando P. Secin, Arjun Sivaraman, Rafael Sanchez-Salas, Juan I Monzo, Dominic Prapotnich, Eric Barret, Francois Rozet, Marc Galiano, Annick Mombet, Nathalia Cathala, Xavier Cathelineau
Journal: Journal of Clinical Oncology (2015)

59 Background: To evaluate the pathological outcomes in patients who were suitable for Active Surveilance (AS) and underwent Radical Prostatectomy (RP) and to explore the potential predictive factors to identify Gleason upgrading and upstaging. Methods: A prospectively maintained database was used to evaluate 1,552 consecutive patients who underwent RP [Laparoscopic / Robotic] at our institution between 1998 and 2012. We identified 405 RP patients fulfilling the Memorial Sloan-Kettering Cancer Center criteria for AS (PSA ≤10 ng/ml, clinical stage ≤2a, Gleason≤6, ≤2 + cores and less 50% cancer in any one core). In the final RP specimen, upgrading was defined as identification of Gleason &gt;6 and upstaging as presence of ≥ pT3. The clinical and the pathological features of upstaged/upgraded patients were compared with the remaining patients and the cox’s regression model was applied to identify potential predictors. Kaplan Meir curve was used to identify Biochemical Recurrence Free Survival (BCR-FS) at 5 years. Results: We noticed upstaging in 195 (48%) patients and Gleason upgrading in 55 (13%) at RP specimen. Multivariate analysis showed percent of positive core had significant association with upstaging/upgrading. Positive Surgical Margin (PSM) was noted in 66(16%) patients, and the PSM rate was significantly higher in upstaged patients. The mean follow-up of the study population was 28 months and the predicted BCR-FS at 5 years was 92% and 88% in the patients who were not and were upstaged/upgraded. Conclusions: Percentage of positive cores in patients subjected to Active Surveillance appears to predict pathological upstaging/upgrading at radical prostatectomy. [Table: see text]
Primary dose reduction (PDR) of chemotherapy (chemo) in patients (Pts) older than age 65 with advanced cancer (Ca) and toxicity outcomes.
Authors: A. Gajra, M. Hardt, W. P. Tew, S. G. Mohile, C. Owusu, H. D. Klepin, C. P. Gross, S. M. Lichtman, R. Ramani, J. Brown, V. Katheria, R. Jayani, K. Hansen, K. Togawa, S. Klapper, A. Hurria
Journal: Journal of Clinical Oncology (2011)

9037 Background: Oncologists may empirically reduce chemo doses with the 1st cycle (PDR) presumably to minimize tox. We studied the factors associated with PDR in pts > age 65 with advanced CA receiving chemo with palliative intent and evaluated the association of PDR with tox outcomes. Methods: This is a secondary data analysis of a multi-site prospective study which identified risk factors for chemo tox in pts > age 65 (Hurria, ASCO 2010). Chemo dosing was per MD discretion and categorized as standard (SD) or PDR per NCCN guidelines. We studied clinical (sociodemographic, CA type), treatment (line of chemo, multi vs single agent) and geriatric assessment factors (functional status, comorbidity, social support, psychological, cognitive, and nutritional status) associated with PDR using bivariate and multivariate logistic regression. The association of PDR and tox was evaluated. Results: 319 pts (mean age 73; range 65-91) with advanced lung (35%) GI (25%), GYN (15%) and GU (12%) CA were included in this analysis. Of these, 92 pts (29%) received PDR. Factors associated with PDR are listed in the Table. In multivariate analysis, factors independently associated (p<0.05) with PDR include: older age (OR 1.09 CI 1.04-1.14), depression (OR 2.29 CI 1.08-4.86), liver/kidney disorders (OR 6.7 CI 2.1-21), prior CA (OR 2.41 CI 1.23- 4.75) and lung CA (OR 0.41 CI 0.19-0.89). Grade 3-5 tox occurred in 51% of PDR and 53% of SD pts. There was no significant difference between PDR and SD groups in grade 3-5 tox (overall, heme, non-heme), dose delays, or early chemo discontinuation. Despite PDR, pts had a higher incidence of hospitalization (30% PDR vs. 19% SD, p .03). Conclusions: PDR is common in pts > age 65. Predictors of PDR include age and comorbid conditions. Chemo tox is high despite PDR. Studies are needed to assess the implications of PDR on treatment efficacy vs toxicity and to develop evidence based guidelines for optimal patient selection. Variable PDR SD P value Age (mean) 76 72 <.0001 Widowed (%) 29 19 .041 GI/ GU cancer (%) 47 34 .032 Lung cancer (%) 23 40 .003 Comorbidity Depression (%) 25 10 .0006 Heart disease (%) 32 18 .008 Liver/kidney disease (%) 14 3 <.0001 Prior cancers (%) 30 15 .002 Stomach disorder (%) 30 16 .004
Burden in caregivers of patients with cancer.
Authors: R. R. L. Fumis, M. C. Miranda, A. T. Lera, H. L. Schaffnausser, M. C. Vieira, A. Del Giglio
Journal: Journal of Clinical Oncology (2011)

e19707 Background: Families and informal caregivers experience substantial psychological distress and fatigue. Their vital role play in supporting cancer patients is well recognized, but the burden and economic impact on these caregivers is poorly understood. We aimed at evaluating the prevalence of burden on informal caregivers of cancer patients and to relate possible predictors facing patient's health and the information received concerning the disease and the proposed treatment for the patient. Methods: We examined 120 informal caregivers of patients with cancer in ABC Foundation School of Medicine affiliated service to answer to questionnaires of depression (The Hospital Anxiety and Depression Scale), fatigue (The Chalder’s Fatigue Scale) and Burden (the Zarit Burden Inventory). We also evaluated the quality of the clinical information conveyed to these families. Caregiver and patient sociodemographic data were collected. Results: Most of the caregivers were female; a half of caregivers showed from moderate to severe burden and has to diminish their job. There was a significant correlation between burden and depression (p <0.001, correlation coefficient = 0, 521) and fatigue (p <0.001, correlation coefficient = 0.520). Palliative care exclusively had significant association with both depression (p=0.002) and fatigue (p=0.022). Regression analysis showed that interference in their daily actives was a determinant of burden (OR 7.76; CI 2.79 - 21.5) as well as presence of physical fatigue (OR 2.96; CI 1.18-7.87). We also found that disagreement between caregiver and physician regarding the treatment was a determinant of dissatisfaction (OR 11.8; CI 1.48-94.6). Conclusions: The change of daily activities of informal caregivers with restriction of their previous activities and incorporation of new tasks can cause fatigue and depression. Enhancing agreement regarding the proposed treatment and clarity of the diagnostic information may improve caregiver’s satisfaction.
The impact of screening mammography in breast cancer patients age 40-49 at an urban city hospital.
Authors: C. Checka, S. Dhage, S. Adams, E. Samii, T. Shah, S. Shaylor, K. P. Joseph
Journal: Journal of Clinical Oncology (2011)

1598 Background: Recent recommendations by the U.S. Preventive Services Task Force were based on population-based studies and meta-analyses that did not specifically address minority women. A recognized disparity in health care delivery is the underutilization of screening services by minority patients. The purpose of this study was to characterize the clinico-pathologic features multi-ethnic breast cancer patients at an urban tertiary hospital who would not be screened under these new guidelines. Methods: A retrospective chart review of breast cancer cases diagnosed between 2005-09 at Bellevue Hospital was performed. Data included age, stage, presentation (palpable vs non-palpable), ethnicity, and mammographic findings. Results: Of 520 cases, 110 (21%) were 40-49 yrs old; data were available for 93. The majority were Chinese (n==36), Hispanic (n==31), or African-American (n==21). Only 5 were Caucasian. Fifty-two (56%) presented with palpable masses vs 41 (44%) with non-palpable cancers. The majority had heterogeneously dense tissue on mammography. Patients with non-palpable lesions were more likely to have been detected by screening mammography, more likely to have had a mammogram the prior year (p == <0.001), and were more likely to have had early-stage disease (p == 0.004) than those with palpable masses. Conclusions: Among minority women with breast cancer, we identified a significant percentage (21%) who would not have been screened under the new guidelines due to their age. Furthermore, most women presented with palpable masses and were not being screened regularly as recommended by current guidelines. Targeted interventions should continue to be directed at minority populations to increase participation in screening programs and narrow the disparities in mammography utilization and stage at presentation. Features of breast cancer patients age 40-49. Nonpalpable Palpable P value No. of patients 41 (44%) 52 (56%) Average mammographic density (BIRADs density categories 1-4) 2.8 2.9 AJCC stage 0 I II III IV 19 12 5 5 0 1 16 24 8 3 Early stage (0, I, II) Late stage (III, IV) 31 10 17 35 p = <0.001 Mammogram in prior year No mammogram in prior year 20 (48%) 21 13 (25%) 39 p = 0.004
Prospective validation of risk prediction models for acute and delayed chemotherapy-induced nausea and vomiting (CINV).
Authors: N. Bouganim, G. Dranitsaris, L. Vandermeer, S. Hopkins, S. Dent, P. Wheatley-Price, S. Verreault, C. Young, M. J. Clemons
Journal: Journal of Clinical Oncology (2011)

6103 Background: Despite the use of standardized anti-emetic guidelines, up to 20% of cancer patients (pts) suffer moderate to severe CINV (≥ grade 2). Prediction of pts at high risk for CINV, through the use of validated mathematical models, is important in developing management strategies. We previously developed cycle-based prediction models for acute & delayed CINV. As part of the validation process, we prospectively evaluated the ability of the scoring systems to accurately identify pts deemed to be high risk for ≥ grade 2 CINV. Methods: Pts receiving chemotherapy were provided with symptom diaries. Compliance to these was enhanced via patient phone calls 24 hours and 5 days post-chemotherapy (CT) after every cycle. All pts received standard anti-emetic prophylaxis. Prior to each cycle of CT, acute and delayed CINV scoring systems were applied to stratify pts into low and high risk groups. The external validity of each system was assessed via a receiver operating characteristic curve (AUROC) analysis. Logistic regression modeling was applied to compare the risk of ≥ grade 2 CINV between pts considered to be high vs. low risk. Results: CINV outcomes data were collected from 95 pts following 181 cycles of CT. Incidence of ≥ grade 2 acute & delayed CINV was 17.7% and 18.2% respectively. Major predictors for ≥ grade 2 CINV included; younger patient age, platinum or anthracyline-based chemotherapy, low alcohol consumption, earlier cycles of CT, previous history of morning sickness and prior emetic episodes with CT. Both the acute & delayed scoring systems had good predictive accuracy when applied to the external validation sample (AUROC = 0.69, 95%CI: 0.59-0.79 and AUROC = 0.70, 95%CI: 0.60-0.80). Pts identified to be at high risk by the scoring systems were 2.8 (p = 0.025) and 3.1 (p = 0.001) times more likely to developed ≥ grade 2 CINV. Conclusions: This study demonstrates that our scoring systems are able to accurately identify pts at high risk for acute and delayed CINV. Their application and planned continued refinement will be an important source of patient-specific risk information that will allow the optimization of anti-emetic therapy.
A multicenter, randomized, controlled study of CO-1.01 versus gemcitabine in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) and low tumor expression of human equilibrative nucleoside transporter-1 (hENT1) determined by metastasis biopsy.
Authors: T. Ikdahl, I. Davidenko, C. Bassi, E. Tomasetto, L. Smith, S. McLachlan, S. Jones, M. Raponi, J. Isaacson, C. Voong, L. Rolfe, A. R. Allen, E. Poplin
Journal: Journal of Clinical Oncology (2011)

TPS144 Background: Gemcitabine (Gem) is standard of care therapy for mPDAC, however many patients do not benefit. Gem requires a transporter protein, hENT1, to enter cells. Reduced tumor hENT1 expression predicts poor outcome after Gem therapy (Farrell). CO-1.01 is a Gem-elaidic acid conjugate which is able to enter cells independently of transporters. This clinical study tests the hypothesis that CO-1.01 is more effective than Gem at prolonging survival in patients with mPDAC and low tumor expression of hENT1 (NCT01124786). Methods: Patients with mPDAC, with no prior palliative chemotherapy are eligible. A screening biopsy of metastatic tumor tissue from every patient, assessed by a central pathology laboratory as adequate for future immunohistochemical measurement of hENT1, is required before randomization and then banked. 54/250 patients have been randomized 1:1 to Gem or CO-1.01. The primary endpoint is overall survival in the prospectively defined hENT1 low subgroup (see below). A fully validated hENT1 IHC assay (class I device) has been developed and a scoring system (modified H score) is being developed in parallel to the randomized study. The H-score cut-off that predicts poor clinical outcome with Gem is being derived from independent, large randomized controlled studies of Gem vs comparator for adjuvant treatment of PDAC. This cut-off will be applied, blinded and prospectively, to the screening metastasis biopsies to identify the patients in the primary endpoint population (hENT1 low subgroup). Additional exploratory analyses include pharmacogenetic analysis of Gem metabolizing enzymes, and pharmacogenomic analyses of tumor tissues. To our knowledge, this is the first randomized study in mPDAC that mandates metastatic tumor tissue collection to allow prospective testing of an efficacy hypothesis in a molecularly-defined subset of patients. The design of the study will enable robust investigation of the relationship between hENT1 tumor expression and clinical outcomes. Farrell J. Gastroenterology 2009:136;187
Increased frequency of multiple sclerosis among patients with bullous pemphigoid: a population-based cohort study on comorbidities anchored around the diagnosis of bullous pemphigoid
Authors: L. Kibsgaard, M. Rasmussen, A. Lamberg, M. Deleuran, A.B. Olesen, C. Vestergaard
Journal: British Journal of Dermatology (2017)

Bullous pemphigoid (BP) is a disease of the elderly and may be associated with neurological and cardiovascular diseases and diabetes. Mortality rates strongly exceed those of the background population.To investigate the frequency of comorbidities and their temporal relation to BP.A register-based matched-cohort study on all Danish patients with a hospital-based diagnosis of BP (n = 3281). The main outcomes were multiple sclerosis (MS), Parkinson disease (PD), Alzheimer disease (AD), stroke, diabetes types 1 and 2, malignancies, ischaemic heart disease (IHD), hypertension and eventually death.At baseline, patients with BP had increased prevalences of MS [odds ratio (OR) 9·7, 95% confidence interval (CI) 6·0-15·6], PD (OR 4·2, 95% CI 3·1-5·8), AD (OR 2·6, 95% CI 1·8-3·5) and stroke (OR 2·7, 95% CI 2·4-2·9). Furthermore, malignancies, cardiovascular disease and diabetes were over-represented among patients with BP: type 1 diabetes (OR 3·1, 95% CI 2·5-3·8), type 2 diabetes (OR 2·3, 95% CI 2·0-2·6), malignancies (OR 1·3, 95% CI 1·1-1·4), IHD (OR 1·7, 95% CI 1·5-1·9) and hypertension (OR 2·0, 95% CI 1·8-2·2). During follow-up, the risk of MS was significantly higher among patients with BP [hazard ratio (HR) 9·4, 95% CI 4·9-18·0], even if events during the first year after diagnosis of BP were excluded (HR 5·1, 95% CI 2·3-11·3). Patients with BP had an average increased mortality rate of 2·04 (95% CI 1·96-2·13).We discovered a significantly increased frequency of MS among patients with BP. At the time of diagnosis, patients with BP had an excessive number of comorbidities and an increased mortality rate over the following years.
Incidence rates for anal cancer in the United States: 1980-2009.
Authors: Lauren A. Eberly, Charles Wiggins, Itzhak Nir, Katherine T. Morris, John C. Russell, Ashwani Rajput
Journal: Journal of Clinical Oncology (2013)

357 Background: Anal squamous cell carcinoma (SCC) is rare, but results in significant morbidity and mortality. The aim of this study was to characterize the trends of anal SCC in the U.S. between 1980-2009. Methods: Subjects were identified from records in the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) Program. The study included incident malignant squamous cell cancer of the anus, anal canal, and anorectum diagnosed among nine core areas of the SEER program from 1980-2009. Average annual age-adjusted incidence rates were calculated by the direct method with the U.S. 2000 standard population. 95% confidence intervals were calculated using the Tiwari adjustment. Temporal trends were assessed by joinpoint regression. Results: Incidence rates of anal cancer in the U.S. more than doubled during this period. A linear increase in anal cancer incidence rates was observed with an Annual Percent Change (APC) of 4.6 (p&lt;0.01) for all races and both sexes-combined. Incidence rates were consistently greater for women than men, however, the increase in incidence rates was greater for men (APC=5.4, p&lt;0.01) than for women (APC=4.3, p&lt;0.01). Similar trends were seen for whites and blacks. Conclusions: Anal cancer is a relatively rare disease, yet incidence rates increased dramatically in the U.S. over the last three decades. Correlation of this increased incidence with HPV infection remains to be determined. [Table: see text]
The first results of targeted screening with a distress thermometer and initiation of psycho-oncological care of cancer patients.
Authors: Maria Angerer-Shpilenya, Axel Heidenreich
Journal: Journal of Clinical Oncology (2015)

113 Background: Tumor disease has not only somatic but also psychological impact on patients with complete change of life dimension. This resonates not only to the patients, their relatives and friends, but also to the therapy. A precise screening helps to determine the stress factor, to capture the psychological comorbidity and to initiate an early psycho-social care. Methods: 420 patients with various tumors got since October 2011 in the Urological Clinic of Aachen University Hospital screening using a Distress Thermometer. 410 patients were stationary and 10 patients came to the outpatient (ambulant) chemotherapy. 23 of the 40 questions of the Distress Thermometer depend on somatic complaints of patients. The other 17 questions cover the psycho-social problems. Results: 141 of the 420 patients reported to have a low stress level by the tumor. 139 patients showed, according to the Distress Thermometer, an average and 140 patients significantly higher stress level. This means that 279 of the 420 patients need a psycho-oncological counseling and possibly even further care and treatment. The most common entered symptoms were fears, nervousness, sleep disturbances, fatigue, sadness and worry. Depending on the wishes of the patient the psycho-oncological consultation was initiated. Only completing the Distress Thermometer helps the patient to face their problems and worries and makes perhaps the first great step in the perception of the disease. Since January 2012 a new component was inserted into the discharge reports of the tumor patients. This component contains the recommendation, depending on the result of the Distress Thermometer, to start if necessary the professional psycho-oncological support. That gives the patients a sense of security and a feeling not to fight alone against the disease. Conclusions: A targeted screening and an interdisciplinary, together with psycho-oncologists, care to cancer patients support them and their families at all stages of the disease, helps to deal with the new life situation and can possibly also increase the patient's compliance and the therapeutic response.
Is there a therapeutic benefit for patients participating in modern phase I trials?
Authors: M. N. Stein, A. R. Tan, J. M. Mehnert, D. Gibbon, R. S. DiPaola, R. A. Moss, E. Poplin, E. H. Rubin, B. Saraiya, M. P. Kane, P. Scott, M. LaRosiliere, H. Camisa, P. Kirin, C. M. Thomas, J. Aisner
Journal: Journal of Clinical Oncology (2011)

2523 Background: Phase I studies are often criticized for lacking therapeutic intent. We therefore reviewed clinical outcome results from our phase I program, which includes institutional, NCI, and industry sponsored phase I and I/II from 2005 to 2010, and wherein response assessment was included Methods: Study results were reviewed by protocol type for complete (CR), or partial (PR) response, and stable (SD) or progressive (PD) disease. All phase I patient enrollments entered onto 1 or more phase I or I/II trials were assessed. For eligibility all patients needed to be PS = 0-2 (majority were 0-1) and ineligible for higher priority (phase II or III) or standard treatments. Other eligibilities were protocol specific. All patients gave IRB approved informed consent Results: We included 334 patient enrollments onto 40 trials; 268 were enrolled on phase I, and 66 on phase I/II trials; 32 had non-assessable disease by RECIST criteria or incomplete data (25 on phase I & 7 on phase I/II respectively). Overall, there were 14 CR (14 [5.8%] & 0 respectively); 39 PR (20 [8.2%] & 19 [32.2%] respectively); 114 SD (94 [38.7%] & 20 [33.9%] respectively); and 135 PD (115 & 20 respectively) according to RECIST. Response outcomes were well distributed among the studies, and within the 95% confidence interval of the overall data. Conclusions: Among patients with no higher priority treatment opportunities, phase I trials offer potential therapeutic benefit exhibited by response rates that are comparable to those of most second- or third-line standard treatment options.