tbuckley/cabot-search huggingface dataset:
Dynamic correlation of serum C-reactive protein (CRP) levels with serum prostate-specific antigen (PSA) levels in patients with prostate cancer (PCa) on androgen deprivation therapy (ADT).
Authors: Omer Kucuk, Bengi Balci, Yuan Liu, Chao Zhang, Bahiddin Yilmaz, Elif Atag, Aziz Karaoglu, Ashesh B. Jani, Wayne Harris, Bradley Curtis Carthon, Peter John Rossi, Viraj A. Master, Mehrdad Alemozaffar, Christopher Paul Filson, Martin George Sanda
Journal: Journal of Clinical Oncology (2016)

181 Background: CRP, a marker of inflammation, has been associated with disease extent and prognosis in urologic cancers (Huang J, et al. Mol Aspects Med, 2015). In this study we wanted to see whether CRP is dynamically correlated with PSA in patients with PCa when they were on ADT. Methods: 83 patients on ADT were included in this analysis. Their CRP and PSA were recorded longitudinally and the range of length of follow up time is from 3 to 47 (median 16) months. All patients had at least 3 pairs of CRP and PSA measurements available. Statistical analysis was conducted using Dynamic Correlation (Dubin JA, Muller H-G. J Am Stat Assoc, 2005) package ‘dynCorr’ in R 3.1.2, and SAS Version 9.4. Significance levels were set at 0.05. We calculated dynamical correlation as function of time lag between CRP and PSA measurements along with 95% bootstrap confidence intervals and p value. Results: See below table. Conclusions: We found that at lag = 30 days (CRP leads PSA by 30 days), the correlation is significant at level of &lt; 0.05, which means any increase or decrease of CRP at a given time point will lead to about same change in PSA 30 days later. Though these findings must be verified in a larger setting, our results support, in the setting of ADT use, the role of CRP as an early marker of PCa progression and treatment response. [Table: see text]
Caution in Generalizing the Use of Adjunctive Primary Corticosteroids in Kawasaki Disease to Unselected Non-Japanese Populations—Reply
Authors: Ying Dong, Shaojie Chen
Journal: JAMA Pediatrics (2017)

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Long-term comparative toxicity of LDR versus HDR prostate brachytherapy ± EBRT and evaluation of risk hazard over time: A SEER-Medicare analysis.
Authors: Jonathan D. Tward, Stephanie Jarosek, Haitao Chu, Dennis C. Shrieve, Sean Elliott
Journal: Journal of Clinical Oncology (2016)

108 Background: Severe urinary adverse events (UAEs) include surgical treatment of urethral stricture, urinary incontinence and radiation cystitis. Our objective is to compare the incidence of late UAEs after low dose rate BT (LDR) and high dose rate BT (HDR) as well as LDR+EBRT and HDR+EBRT. Methods: We identified men treated with LDR (n=12,801), HDR (n=685), LDR+EBRT (8,518) and HDR+EBRT (n=2,392) from the SEER-Medicare Database. The populations were balanced by propensity weighting and the Kaplan-Meier incidence of severe UAEs was compared. Propensity-weighted Cox proportional hazards models were used to compare the adjusted hazard of UAEs. These UAEs were compared to a cohort of men not treated for prostate cancer. Results: Median follow-up was 4.3 years. At 8 years, the propensity weighted cumulative UAE incidence was highest after HDR+EBRT (28%) and lowest after LDR (17%; see Figure). The absolute excess risk over non-treated controls of a UAE at 8 years was 1.9%, 3.8%, 8.4% and 12.9% for the LDR, HDR, LDR + EBRT, and HDR + EBRT respectively. This translates into a number needed to harm of 53, 26, 12, and 8 persons. There is no statistical difference in severe UAE risk between HDR vs. LDR or between HDR+EBRT vs. LDR+EBRT. The additional risk for developing a UAE related to treatment for LDR, LDR+EBRT, and HDR+EBRT, was greatest within the 2 years following treatment, and continued to decline over time. For HDR monotherapy, the risk was greatest within the first 4 years, and then declined. The risk of developing a severe UAE matched the baseline risk of the control population for all treatments at 4 years following therapy. Conclusions: LDR and HDR brachytherapy are statistically indistinguishable for late severe urinary adverse events. However, combination radiotherapy (either HDR+EBRT or LDR+EBRT) increases the risk of severe UAEs compared to HDR alone or LDR alone. In the 8 years following brachytherapy treatment, the increased risk of urinary toxicity occurs almost exclusively within the 2 years following therapy, and then declines to a baseline hazard. The hypothesis that late urinary radiation toxicity accelerates over time is not supported by this study.
Intra- and post-operative catumaxomab in patients with epithelial ovarian cancer: Two-year efficacy results from a multicenter, single-arm, phase II study.
Authors: J. Sehouli, A. Reinthaller, C. Marth, D. Reimer, T. Reimer, W. Stummvoll, L. Angleitner-Boubenizek, B. Lehnert, M. Marquardt, M. M. Essing, R. Chekerov
Journal: Journal of Clinical Oncology (2011)

5082 Background: In previous studies of patients (pts) with malignant ascites due to epithelial cancers, the trifunctional antibody catumaxomab (anti-EpCAM x anti-CD3) demonstrated destruction of EpCAM+ tumor cells in the peritoneal cavity. This is the first study investigating the safety and efficacy of catumaxomab administered directly into the peritoneal cavity of patients with epithelial ovarian cancer (FIGO stages IA–IV) during radical cytoreductive surgery and postoperatively prior to standard chemotherapy. Methods: Pts with ovarian cancer undergoing surgery received catumaxomab 10 µg intraoperatively followed by four intraperitoneal doses of 10, 20, 50, and 150 µg on days 7, 10, 13, and 16, respectively. During the post-study observation period, patients received standard anticancer therapy and were followed every 3 months for 24 months. Efficacy endpoints were disease-free survival (DFS) rate and overall survival (OS) rate. Results: Of 58 screened pts, 41 (all Caucasian, median age 58 years [range, 33–75]) were evaluable for the primary safety analysis and 35 patients were alive at 24 months. Forty (98%) patients received chemotherapy in the post-study period. Kaplan-Meier survival estimates of DFS, OS and time to progression (TTP) for all patients were 56%, 85%, and 60%. Conclusions: Intra- and post-operative application of catumaxomab is a feasible and promising new therapeutic strategy. The clinical outcome in this patient population is very promising, but long-term survival data must be awaited. Further development in this indication is clearly warranted.
Incidence and risk factors of thromboembolism (TE) in advanced gastric cancer (AGC) receiving chemotherapy: A prospective observational study (NCT01047618).
Authors: Baek-Yeol Ryoo, Min-Hee Ryu, Sook Ryun Park, Myoung Joo Kang, Kwon-Oh Park, Jeong Hye Kim, Yoon-Koo Kang
Journal: Journal of Clinical Oncology (2014)

31 Background: The incidence of TE in gastric cancer patients (pts) is known to be high. But because the previous reports were retrospectively analyzed in heterogeneous population, they give us only limited information. We therefore conducted a prospective study to investigate the incidence of TE and prognostic factors related with TE in AGC pts receiving chemotherapy. Methods: We checked D-dimer and coagulation battery at the start of chemotherapy and every 3 months thereafter. If there developed symptoms or signs of TE, or if D-dimer elevated 5 μg/mL or more we checked imaging studies to detect TE. The chemotherapy regimen mainly included fluoropyrimidine plus platinum-based for 1st-line, taxane-based for 2nd-line, and irinotecan-based for 3rd-line chemotherapy. Results: Between Nov 2009 and Apr 2012, 241 pts were analyzed. They received median 9 (range 1 - 42) cycles of chemotherapy. During the median observational duration of 16.7 months, 32 events (13.3%, 95% CI; 8.9 - 17.7%) of TE were detected. The types of TE were as follows; deep vein thrombosis (DVT) only in 18 (56.3%), pulmonary embolism (PE) only in 4 (12.5%), DVT and PE in 5 (15.6%), cerebral infarction in 4 (12.5%), and intra-abdominal arterial thrombosis 1 (3.1%) pts. The 1-year and 2-year cumulative incidences of TE were 15.0% (95% CI, 9.6 - 20.0%) and 20.0% (95% CI, 12.1 - 26.9%), respectively. The incidence rate of TE was 14.1 (95% CI, 9.6 - 19.9) events/100 person-years. In univariate analysis, the previous gastrectomy history, baseline CA72-4 level and baseline D-dimer level were statistically significant risk factor related with TE development. But in multivariate analysis, baseline D-dimer level was the only independent risk factor associated with TE development (Hazard ratio 2.46 [95% CI, 1.08 - 5.63], P= 0.033). Among 32 pts with baseline D-dimer 5.0 μg/mL or higher, 8 pts (25.0%) developed TE, while for pts whose baseline D-dimer was lower than 5.0 μg/mL, 24 out of 209 pts (11.5%) developed TE. Conclusions: The incidence rate of TE in AGC pts receiving chemotherapy was 14.1 (95% CI, 9.6 - 19.9) events/100 person-years. D-dimer was an important prognostic factor related with TE development. Clinical trial information: NCT01047618.
Prospective synoptic template recording to assess for compliance of care with NCCN guidelines for breast cancer.
Authors: Titilayo Adegboyega, Jeffrey Landercasper, Jared Linebarger, Jeanne Johnson, Leah L. Dietrich, Collin Driscoll, Jeremiah Andersen, Ronald S. Go, Choua Vang, Kristen Marcou, Jane Hudak
Journal: Journal of Clinical Oncology (2012)

197 Background: There is a wide variation of compliance with National Comprehensive Cancer Network (NCCN) guidelines for diagnosis and treatment. Overutilization of preoperative testing and underutilization of adjuvant treatments have been documented. The former is associated with higher costs of care; the latter with poor patient outcomes. Prior reports of adherence to NCCN Guidelines contain methodological limitations due to lack of contemporary review and incomplete listing of reasons for non-compliance. This limits the “real time” analysis of breast cancer quality and delays action plans to address quality and cost issues of care. Methods: NCCN Guideline compliance was recorded prospectively by use of electronic synoptic templates for all newly diagnosed breast cancer patients treated at a single institution between January 2010 and December 2011. A retrospective review of the synoptic templates was then conducted. Accuracy of the synoptic auditing method was assessed as well as NCCN compliance and reasons for non-compliance. Results: A total of 312 new breast cancer patients who underwent surgery as initial treatment were identified. Compliance with NCCN Guidelines for preoperative testing, breast surgery and lymph node surgery was 98% (306/312), 99.7% (311/312) and 93% (290/312) respectively. Reasons for non-compliance include patient refusal, comorbidities, advanced age and overutilization of systemic imaging. There was 100% compliance to College of American Pathologist (CAP) molecular profile documentation for all breast cancer cases. There were two discrepancies noted between the prospective template reporting and medical record review. The average time needed to populate data into synoptic templates was less than 2 minutes per patient. Conclusions: Prospective auditing of adherence to NCCN Guidelines with electronic synoptic templates is accurate and time efficient. High compliance rates with NCCN Guidelines were demonstrated. Electronic synoptic NCCN templates potentially facilitate early recognition of quality gaps in compliance and provide a framework for peer performance comparison.
Molecular prescreening (MP) to treat patients (pts) with advanced pancreatic cancer (PC) in early clinical trials.
Authors: Tamara Sauri, Teresa Macarulla, Guadalupe Cabrera, Helena Verdaguer, Jorge Zeron-Medina, Ana Vivancos, Jaume Capdevilla, Elena Elez, Maria Alsina, Guillem Argiles, Cinta Hierro, Julieta Grasselli, Ignacio Matos, Jordi Rodon, Paolo Nuciforo, Rodrigo Dienstmann, Josep Tabernero
Journal: Journal of Clinical Oncology (2016)

272 Molecular prescreening (MP) to treat advanced pancreatic cancer (PC) patients (pts) in early clinical trials Background: Advanced PC has a dismal prognosis, with conventional therapies having poor impact on disease course. The aim of this study was to investigate the impact of a MP program to identify potentially targetable alterations (PTa) in PC pts eligible for clinical trials with matched targeted therapies. Methods: From Jan 2011 to June 2015, a total of 86 chemorefractory PC pts were referred to MP at the VHIO Phase I Unit. Archived tumor samples were analyzed for selected gene mutations (mut) in using mass spectrometry (MassARRAY, Sequenom) until June 2014 or next-generation sequencing (Amplicon, MiSeq) thereafter. PTEN and PDL1 expression levels were measured with immunohistochemistry. All demographic, treatment and survival data were extracted retrospectively from electronic medical records. Results: Median age was 61 years (range 29-78) and 64% were male. Median treatment lines before MP was 2 (range 1-5). Tissue used for MP was primary tumor in 74% and metastatic lesion in 26%. In total, 29% of the samples did not have enough material for mut analysis. The most common PTa were KRAS mut (20/35 with Sequenom, 57%; 22/26 with Amplicon, 85%; p = 0.02), PTEN low (9/22, 41%), PTEN null (4/22, 18%) and CDKN2A mut (2/26, 8%). RNF43 mut, STK11 mut, BRAF V600E and BRAF G469A were found in one sample each. A total of 30 pts were enrolled in Phase I trials following MP, 10 of them with a direct matched therapy (5 with PI3K pathway inh - PTEN low/null, 3 with PI3K + MEK inhibitor - KRAS mut, 1 anti-PDL1 therapy - PDL1 high, 1 HDM2 inh - TP53 wild-type). Partial response was observed in 1 case (PI3K inh + chemotherapy, PTEN null) and stable disease in additional 4 pts (3 with PI3K inh +/- chemotherapy, PTEN low/null; 1 PI3K + MEK inh, KRASmut). Median time on treatment with matched therapy was 2.5 months (CI95% 1.8 – not reached). Conclusions: Genomic/proteomic characterization of PC is able to identify a subpopulation eligible for matched therapy in early clinical trials, with rare cases presenting a clear treatment benefit. Low recruitment can be linked to lack of enough material for MP, low prevalence of PTa and patient characteristics
Characteristics associated with in-hospital death in commercially insured decedent.
Authors: Gabriel Brooks, Sherri Oliver Stuver, Yichen Zhang, Stephanie Gottsch, Belen Fraile, Kristen K. McNiff, Anton Dodek, Joseph O. Jacobson
Journal: Journal of Clinical Oncology (2016)

35 Background: A majority of patients with poor-prognosis cancer express a preference for in-home death, however, in-hospital deaths are common. We sought to identify characteristics associated with in-hospital death among commercially-insured decedents. Methods: Building on a data-sharing project between our institution and Blue Cross/Blue Shield of MA, we obtained health care claims records for a sample of commercially insured decedents who died between July 2010 and December 2013. All patients received cancer care at Dana-Farber. In-hospital vs. out-of-hospital death was ascertained from hospital claims. Odds ratios (OR) and 95% confidence intervals (CI) were used to evaluate the association of in-hospital death with patient characteristics and established retrospective measures of end-of-life (EOL) care quality. Results: 904 commercially insured decedents were included in our sample, and 537 decedents (59%) enrolled in hospice prior to death. There were 254 in-hospital deaths (28% of all deaths), and 79 in-hospital deaths (31%) occurred at unaffiliated hospitals. Three measures of EOL care quality were found to be associated with in-hospital death, including chemotherapy within 14 days (OR 4.0 [95% CI 2.6-6.2]) or 15-30 days (OR 2.1 [1.4-3.1]) of death, 2 or more ED visits within the last 30 days of life (OR 3.0 [2.1-4.3]), and non-enrollment in hospice (OR 28.8 [18.7-44.3]). Hematologic malignancy, but not other cancer types, was significantly associated with in-hospital death (OR 5.09 [3.1-8.5]). Age at death, sex, marital status, race/ethnicity, and distance of residence from the cancer center were not significantly associated with in-hospital death, though sample sizes for some comparison groups were small. Conclusions: In-hospital deaths are common among commercially insured cancer patients, and data sharing identified nearly 1/3 of in-hospital deaths that occurred at unaffiliated hospitals. Retrospective measures of intensive EOL care quality were significantly associated with in-hospital death, and patients enrolled in hospice were dramatically less likely to experience an in-hospital death.
Palliative care for patients with advanced lung cancer.
Authors: M. Koczywas, B. R. Ferrell, K. L. Reckamp, M. C. Cristea, B. Tiep, D. Tarcatu, J. Thomas, F. W. Grannis, G. Uman
Journal: Journal of Clinical Oncology (2011)

e19610 Background: This National Cancer Institute funded Program Project (P01) is an interdisciplinary research project focused on palliative care, quality of life (QOL), and symptom control in lung cancer which is diagnosed in 213,000 Americans each year. The purpose of this study is to test usual care versus integration of palliative care encompassing four dimensions of QOL. Methods: Our two previous pilot projects in a NCI Comprehensive Cancer Center demonstrated the unmet needs in lung cancer across QOL domains and the limited use of supportive care services by those with lung cancer. Project 2 of this Program focuses on late stage lung cancer, and uses a two group, prospective, tandem enrollment comparing usual care to a structured palliative care intervention. Patients are followed for 6 months and measures include the FACT-L, FACIT- Spiritual, MSAS, Social Support tool and a Chart Audit capturing medical care and health system resources used. A Geriatric Oncology Core also supports this project addressing concerns in elderly patients with lung cancer, including function, social support and comorbidities. Results: This usual care phase sample of Stage IV lung cancer (N=80) included 70% female, 43% minority patients. Seventy one percent had at least 1 other chronic illness and 20% had a prior cancer diagnosis. MSAS scores revealed key symptoms to include lack of energy, difficulty sleeping, worrying, dyspnea and pain and MSAS distress of x=3.3 on scale of 0-4. FACT-L data indicated key QOL concerns related to sexuality (x=2.83), fear of worsening disease (x=3.18), sleep disruption (x=3.2), overall poor QOL (x=3.24) and lack of energy (x=3.3). Greatest spiritual concerns from the FACIT-Spiritual tool included lack of meaning, lack of purpose and trouble feeling at peace. Chart audit data documented limited use of advanced directives or palliative care consultation. Conclusions: Findings identify significant gaps in supportive care in lung cancer and provide direction for the intervention phase of a comprehensive educational intervention and enhanced resources for lung cancer patients. These findings lead to creation of a four part, QOL education program specific to lung cancer and a interdisciplinary care planning process involving multiple disciplines.
Effects of simvastatin and docetaxel on different pathways in the regulation of prostate and breast cancer cell survival.
Authors: S. T. Kochuparambil, B. Al-Husein, A. Goc, S. Mohammad, M. K. Terris, T. A. Samuel, T. A. Coleman, S. P. R. Shenoy
Journal: Journal of Clinical Oncology (2011)

e13545 Background: A recent study from our lab demonstrated that simvastatin induces apoptosis in prostate cancer cells and inhibit proliferation, invasion, and tumor formation in vivo via inhibition of Akt pathway (Kochuparambil et al, J Pharm Exp Ther, 2011). Methods: In the current study we investigated the molecular mechanisms by which simvastatin (SN) and docetaxel (DL) induces apoptosis in prostate and breast cancer cells. We hypothesized that SN and DL modulates cell survival and apoptosis in cancer cells and a combination of these drugs would be an effective strategy for prostate and breast cancer therapy. Results: Our data indicated that both SN (25 µM) and DL (25 nM) induced apoptosis in prostate and breast cancer cells with an additive effect when used in combination. Gene array results showed >3 fold reduction in the mRNA levels of pro survival molecule Bcl-2 with SN treatment. A reduction in mRNA for mdm2, Nol3, Card10 and Bcl2l2, all pro-survival molecules were also observed. At the protein level, there was significant decrease in expression of pro survival molecules Bcl-2, Bcl-XL and increased expression of pro-apoptotic cleaved caspase-9, associated with a significant reduction in the phosphorylation of Akt and an anti-survival molecule BAD by SN. However, treatment with DL did not have an effect on the phosphorylation of Akt and BAD or in the expression levels of any proteins in the above mentioned survival pathway. Conclusions: Our study suggests that SN and DL follow different pathways in the regulation of cell survival and apoptosis and a combination of these drugs would be an effective strategy for prostate and breast cancer therapy. Further studies on animal models and human patient samples are currently underway in our laboratory.