tbuckley/cabot-search huggingface dataset:
Phase II study of low dose (weekly) docetaxel and estramustine in elderly males (age ≥75 years) with hormone-refractory prostate cancer <u>or</u> patients age 18 to 74 years with an ECOG performance status of 2 or 3
Authors: S. R. Chittoor, W. R. Berry, D. M. Loesch, K. W. Logie, J. Fleagle, S. Mull, K. A. Boehm, F. Zhan, L. Asmar
Journal: Journal of Clinical Oncology (2005)

4646 Background: Chemotherapy is often poorly tolerated in the elderly or subjects with poor PS. This trial was designed to determine if docetaxel and estramustine, delivered weekly in less than standard doses, could produce good responses in HRPC, with acceptable toxicity. Methods: Dexamethasone was administered to minimize the duration/severity of docetaxel- associated reactions. Subjects received 25 mg/m2 IV docetaxel over 30 minutes on Days 2, 9, and 16 and 140 mg estramustine orally BID on Days 1–3, 8–10, and 15–17 (estramustine was to be taken at least 1 hour before or 2 hours after meals). Cycles were defined as 28 days. Subsequent cycles were initiated for a maximum of 6 cycles unless a subject developed disease progression or intolerable toxicity. Results: 56 eligible study subjects were enrolled at 31 sites in the US Oncology network. The median age was 78 years (range, 64–92), 91% were white, and the PS scores (0/1/2/3) were 38%, 39%, 21% and 2%, respectively; 55 subjects received at least 1 cycle of treatment, and 4 participants were nonevaluable for response as they completed <2 cycles. Among the 51 evaluable subjects, 32 (63%) had a decreased PSA (≥50% compared with baseline level and maintained for ≥4 weeks). Responses, assessed using either RECIST and/or PSA, were 3 CR (6%, with normalization of PSA), 30 PR (59%), 15 SD (29%) and 3 PD (6%). At 1-year, 17% of participants were estimated as progression-free; the median progression-free survival was 7.5 months (range 1.0–18.2). The estimated 1-year survival was 64%. There were no Grade 4 treatment-related adverse events. Grade 3 treatment-related events included fatigue/asthenia (13%) and arrhythmia, thrombocytopenia, and dyspnea (4%, each). There was 1 treatment-related death (adult respiratory distress syndrome). Conclusions: These data suggest that elderly males with advanced prostate cancer tolerate this chemotherapy regimen well, with significant responses and prolonged progression-free survival. These patients should not be excluded from chemotherapeutic interventions, based on age alone. Supported by Aventis Pharmaceuticals, Inc., Bridgewater, NJ Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Aventis Aventis Aventis
A phase I-II trial of gefitinib in combination with vinorelbine and oxaliplatin as salvage therapy in women with advanced ovarian cancer (AOC)
Authors: D. Mavroudis, E. Efstathiou, A. Polyzos, A. Athanasiadis, G. Milaki, E. Kastritis, A. Kalykaki, Z. Saridaki, A. Dimopoulos, V. Georgoulias
Journal: Journal of Clinical Oncology (2004)

5020 Background: To evaluate activity and tolerability of gefitinib (Iressa) in combination with vinorelbine and oxaliplatin as salvage therapy in women with AOC. Methods: Women with AOC recurrent or refractory after ≥ 1 previous line of platinum-containing chemotherapy who had measurable disease by RECIST criteria or assessable by Ca-125 received oral gefitinib 250 mg/day with vinorelbine 25 mg/m2 and oxaliplatin 50 mg/m2 on days 1 and 8 every 3 weeks without prophylactic growth factor support. Gefitinib was continued until disease progression. Results: So far 33 patients (pts) have been entered, (10 CDDP-sensitive; 23 CDDP-refractory disease). Among the first 10 pts, 4 DLTs were observed in the first cycle (2 febrile neutropenias, 1 grade 4 neutropenia lasting >5 days, 1 grade 3 diarrhea) resulting in dose reduction for vinorelbine (20 mg/m2) and oxaliplatin (40 mg/m2). In the next 10 pts only 2 DLTs (febrile neutropenia and grade 4 neutropenia lasting >5 days) were observed and the study is ongoing as phase II. All pts were evaluable for toxicity and 29 (19 CDDP-refractory; 10 CDDP-sensitive) for response (2 too early, 1 protocol violation, 1 lost to follow up). Three complete (CR) and 2 partial responses (PR) were seen in the CDDP-refractory group (ORR 23.8%; 95%CI: 5.6–42.0%) and 4 CR with 5 PR in the CDDP-sensitive group (ORR 90%; 95%CI: 71.4–100%). Median duration of response was 5.2 months (range 1–6) for CDDP-refractory and 6.6 (range 1–10) for CDDP-sensitive; median time to progression was 4.1 months (range 1–14) and 8.6 (range 1–12), respectively. So far 8 pts have died (7 disease progression; 1 pulmonary embolism), 14 had disease progression, and 11 continue treatment. 134 cycles have been administered: median 3 (range 1–9) cycles per pt. Τoxicity included grade 3/4 neutropenia each in 8 (24%) pts, febrile neutropenia 4 (12%), grade 3 anemia 1 (3%), grade 3 diarrhea 3 (9%), neurotoxicity 1 (3%), rash 1 (3%) and transaminase elevation 1 (3%). Conclusions: The concurrent administration of gefitinib with vinorelbine and oxaliplatin is feasible and shows promising activity in pretreated pts with AOC. No significant financial relationships to disclose.
Effect of dasatinib on the activity of trastuzumab in HER2-overexpressing breast cancer cells
Authors: S. Seoane, J. C. Montero, A. Pandiella, A. Ocana
Journal: Journal of Clinical Oncology (2009)

1084 Background: Breast cancer is the most common neoplasia in women. Although important advances in its treatment have been made along the last years, in the metastatic setting this disease remains incurable. One group of molecules involved in breast cancer genesis/progression are tyrosine kinases. HER-2 is a receptor tyrosine kinase that is overexpressed in a subset of patients with breast cancer. Targeting of HER-2 with trastuzumab a monoclonal antibody that acts on HER-2 has demonstrated clinical benefit. However, as a single agent its antitumoral activity is limited. Methods: Here we have investigated whether the action of trastuzumab, can be potentiated by dasatinib, a small molecule inhibitor that acts on several receptor and non-receptor tyrosine kinases. To this end, we have used cancer cell lines and in vivo xenografted mouse models. MTT proliferation and other apoptosis assays, biochemical and microarray experiments were performed to investigate the molecular bases of the action of the combined trastuzumab plus dasatinib treatment. Results: Combination of trastuzumab and dasatinib was synergic on breast cancer cells overexpressing HER-2, but not on cells with a normal complement of its receptor. In vivo xenograft studies confirmed the antitumoral action of this drug combination. Studies on the mechanism of action showed that this drug combination triggered apoptosis in HER-2 overexpressing cells. Apoptosis was evidenced by increased Annexin V staining, and was found to occur in a caspase-independent manner. In addition, an action of the drug combination on cell cycle could be identified, and the drugs decreased cyclins E1/2, B, and Cdk2, in addition to increasing p27. Microarray as well as biochemical analyses showed that the drug combination provoked a decrease in HER receptor phosphorylation, followed by interruption of downstream signalling. These changes resulted in alterations in the levels of proteins involved in DNA repair. Moreover, treatment with the drug combination caused a DNA damage response as evidenced by increased γH2AX. Conclusions: The effective antitumoral action of the drug combination opens new avenues for the clinical exploration of this drug combination in breast cancer patients overexpressing HER-2. No significant financial relationships to disclose.
The quantification of DNA in the serum is a useful prognostic factor in advanced non-small cell lung cancer (NSCLC) patients
Authors: A. Berrocal, R. Sirera, C. Camps, R. M. Bremnes, V. Alberola, P. Bayo, M. J. Safont, A. Blasco, M. Taron, J. J. Sanchez, R. Rosell
Journal: Journal of Clinical Oncology (2005)

7195 Background: Analysis of circulating DNA in blood is a promising non-invasive diagnostic tool. The purpose was to study the association between the quantity of free circulating DNA and clinical variables in advanced NSCLC patients. Methods: 100 stage IIIB and stage IV patients, homogeneously treated with gemcitabine/cisplatin, were examined. Blood samples were collected before chemotherapy, and circulating DNA was extracted from the serum using commercial adsorption columns. The amount of free circulating DNA in the serum was assayed by means of the titration of the catalytic subunit of telomerase (hTERT), quantified using RT-PCR. Results: Median age was 61 years (35–82) and 91% were males. 86% had performance status 0–1. 71% were in stage IV and 29% in stage IIIB. The histological subtypes were: 38% squamous cell carcinoma, 37% adenocarcinoma, 5% anaplastic large cell, and 20% undifferentiated. Patients received a median of 6 cycles of chemotherapy (1–7). 4% achieved complete response (CR), 38% partial response (PR), 25% had stable disease (SD) and 30% progressive disease (PD). hTERT levels for patients in stage IIIB were 21.1 [4.9–152.02] versus 18.03 [2.9–848.8] in patients in stage IV (p=0.53). There was not association between hTERT values and therapy response, 17.8 (2.9–845.8) in the CR+PR group vs. 22.1 (5.2–534.7) in the SD+PD group (p=0.23). hTERT values were not related with the localization of the metastasis. In the multivariate analysis, hTERT was an independent predictive variable for time to progression (TTP) (HR 1.1, CI 95% 1.1–1.2, p=0.02) and overall survival (HR 1.1, CI 95% 1.1–1.2, p=0.004). Conclusions: The quantification of free circulating DNA in serum, by means of hTERT, is an affordable and accurate method due to the low intra-assay variability and its high specificity. In advanced NSCLC, high serum hTERT levels may be a poor prognostic indicator for TTP and survival. No significant financial relationships to disclose.
Abstract 12382: Short And Long-term Outcome And Benefit Of Surgery In Patients With Low Flow, Low Gradient Severe Aortic Stenosis With Preserved Left Ventricular Ejection Fraction: Results From A Cardiac Catheterization-based Study
Authors: Dania Mohty, Philippe Pibarot, Julien Magne, Mathieu Deltreuil, Najmeddine Echahidi, Jean G Dumesnil, Victor Aboyans, Claude Cassat, Marc Laskar, Patrice Virot
Journal: Circulation (2012)

Background: The exact prevalence, characteristics and impact on short and long-term outcome of low flow, low gradient severe aortic stenosis (LFLG) despite preserved left ventricular ejection fract...
Measuring the Quality of Care for Patients With Traumatic Brain Injury
Authors: Yaseen Arabi, Sami Alsolamy, Saad Al-Qahtani
Journal: JAMA Surgery (2015)

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NK-Cell Lymphoma Shares Strikingly Similar Molecular Features with a Distinct Set of γδ T-Cell Lymphoma and Identification of Aurora Kinase A Inhibitor as a Novel Therapeutic Agent.
Authors: Javeed Iqbal, Dennis D. Weisenburger, Aparajita Chowdhury, Gopesh Srivastava, Timothy C. Greiner, Karen E Deffenbacher, Can Kucuk, Julie M. Vose, Wing Au, Shigeo Nakamura, Masao Seto, Jan Delabie, Francoise Berger, Florence Loong, Young-Hyeh Ko, Ivy Sng, Xin Liu, Thomas P. Loughran, Ming Tsai, James O. Armitage, Wing C. Chan
Journal: Blood (2009)
Abstract 17838: High-Pitch Spiral Coronary Angiography by 128-Slice Dual-Source Computed Tomography (CT) Realizes a Sensational Low Radiation Exposure Without Reduced Image Quality
Authors: Yuko Utanohara, Nobuo Iguchi, Mitsumi Yamashita, Jun Umemura, Tetsuya Sumiyoshi
Journal: Circulation (2010)

Background: Coronary CT angiography (CTA) is well-accepted for the noninvasive evaluation of the patients with known or suspected coronary artery disease. However, the problem of the radioactive exposure is remaining. Purpose: The aim of this study was to evaluate image quality and radiation dose of coronary CTA using a 128-slice dual source CT in prospectively ECG triggered and high-pitch spiral (high-pitch DSCT). Methods: A total of 2023 consecutive patients underwent coronary CTA. We used Siemens' Definition flash which is latest high-end scanner in all patients.Coronary CTA with high-pitch DSCT were performed in the patients with stable heart rate (lower than 65 bpm). The patients with tachycardia, severe calcification and received coronary revasculization were excluded. Data acquisition was prospectively ECG-triggered using a pitch of 3.2. Images were reconstructed with 75ms temporal resolution, 0.6mm slice thickness and 0.3mm increment. Tube voltage (100kV or 120kV) was selected according to body su...
Phase II study of bevacizumab in combination with capecitabine as first line treatment in elderly patients with metastatic colorectal cancer (MCC)
Authors: E. Vrdoljak, T. Omrcen, A. Hrabar
Journal: Journal of Clinical Oncology (2009)

e15074 Background: The aim of this prospective study was to evaluate efficacy and safety of bevacizumab in combination with capecitabine as first line treatment in elderly patients with MCC. Methods: 40 elderly patients (median age 75 years) with MCC have been treated with bevacizumab in combination with capecitabine as their first line therapy. Regimen consisted of bevacizumab 7.5 mg mg/kg on day 1 plus capecitabine 1000 mg/m 2 on day 1–14 followed by 7 days rest. Results: The median follow up time at time of ASCO will be 12 months. Median number of 9 cycles was administrated, ranging from 1 to 23. 3 patients (7.5 %) had complete response, 19 patients (47.5 %) had partial response, 11 patients (27.5 %) had stable disease, 1 patient (2.5 %) progressed according to RECIST criteria and 6 patients (15%) were not evaluated yet. Until this report 15 of 40 patients progressed and 9 of 40 patients died. Median time to progression is 6.37 months. Median overall survival will be reported at ASCO 2009 meeting. The most common hematological adverse events were mild (grade I and II): anemia (27.5%) neutropenia (22.5%), and thrombocytopenia (20%). The most common non-hematological toxicity were mild as well (grade I and II): hand-foot syndrome (70%), arterial hypertension (52.5%), proteinuria (45%), hyperbilirubinemia (45%), diarrhea (25%), loss of appetite (23.5%), fever (22.5%), fatigue (17.5%), tearing (17.5%), and nail changes (12.5%). Grade 3 and 4 adverse events occurred rarely: hand-foot syndrome (12.5%), deep vein thrombosis (7.5%), fever (5%), and arterial hypertension (2.5%). Conclusions: This prospective phase II study has demonstrated that bevacizumab in combination with capecitabine as first line treatment in elderly patients with metastatic colorectal cancer is an effective and well-tolerated regimen. [Table: see text]
Expectations of palliative patients (pts)
Authors: F. G. Foerster, J. Szczesny, G. Brandt
Journal: Journal of Clinical Oncology (2005)

8241 Introduction: Pts with far advanced and metastazised malignant tumors represent a large group among the totality of pts in our hospital. Objective Our aim was review the expectations of the pts on the therapy and to check our communicative behaviour. Patients & Methods: The prospective study in our palliativ ward in November 2004 involved 54 pts (30 men, average age 67.2 [48 to 85] years; 24 women, average age 66.8 [39 to 82] years). 83% (n=45) suffered from a metastasized malignancy and 17% (n=9) from a far advanced metastasized malignancy. In 11% (n=6) of them a secondary malignant tumor and in 87% relevant secondary deseases were found. There was no prospect for recovering in any patient, although performance status was favourable (average 80% [70 to 100%]) and life quality only partly limited. 87% (n=47) were treated with chemotherapy. Statistical evaluation was performed using the Chi-square test. Results: 72% (n=39) of all repeatedly treated patients expected a recovery (p < .001) due to chemotherapy. 28% (n=15) hoped for prolongation of life or stablizing of illness course. The checking of our communication with the patients showed that only in 24% (p < .001) the prognosis death was mentioned. Conclusion: We suppose that the only partly limited life quality and the insuffient communication are to blame for the wrong interpretation of the prognosis by the pts. No significant financial relationships to disclose.
655. Immunostimulating Gene Therapy Using an Oncolytic Adenovirus Armed with CD40 Ligand Potently Kill Tumor Cells, Activates Dendritic Cells and Induces T Cell Responses
Journal: Molecular Therapy (2014)

Immunostimulating Gene Therapy Using an Oncolytic Adenovirus Armed with CD40 Ligand Potently Kill Tumor Cells, Activates Dendritic Cells and Induces T Cell Responses
Active Crosstalk with the Microenvironment Leading to Clonal Evolution in Chronic Lymphocytic Leukemia with Stereotyped IGHV4–34/IGKV2–30 Antigen Receptors.
Authors: Lesley-Ann Sutton, Efterpi Kostareli, Evangelia Stalika, Athanasios Tsaftaris, Achilles Anagnostopoulos, Nikos Darzentas, Richard Rosenquist, Kostas Stamatopoulos
Journal: Blood (2012)
Cancer screening practice and misplaced priorities in Greece
Authors: K. Kamposioras, A. Valachis, I. Cortinovis, V. Karampoiki, N. P. Polyzos, G. Koukourakis, D. Tzachanis, D. Pectasides, G. Casazza, D. Mauri
Journal: Journal of Clinical Oncology (2008)

1536 Background: Data comparison between EUROCARE and SEER database provided evidence that cancer survival in USA is higher than in Europe. Differences in survival rates were particularly higher for prostate cancer, skin melanoma, colon/rectum, breast and cervical cancer. A cancer screening bias was therefore hypothesized. Since up to date there are no data about overall cancer screening coverage in Greece, our aim was to estimate cancer screening coverage among a large sample of Greek individuals. Methods: 7,012 adults coming from 30 Hellenic areas were surveyed. Screening tests included fecal occult blood test (FOBT), sigmoidoscopy, chest x-ray, urine examination, trans-rectal ultrasound, full blood count (FBC), skin examination, digital rectal examination, PSA, Pap test, mammography, clinical breast examination (CBE), self breast examination (SBE), breast ultrasound. Results: Despite 88% of males and 93% of females declared to be interested in cancer screening practices, only 37.8% of men and 37.9% of women referred that that they had a medical consultation for screening purpose within the last 2 years, and these patients who underwent check-up visit still not received recommended tests. Less than 2% received screening for colorectal cancer (FOBT, sigmoidoscopy) or dermatological examination for skin malignancies. Only 39.6% of women were screened for cervical cancer; 22.8% and 27.9% underwent mammography and CBE respectively. Prostate cancer screening among males did not overcome 20%. In straight contrast we found a high proportion of individuals who were screened with tests which benefit should still be estimated or were of no evidence, both among males (chest x-ray 17.8%, urine examination 48.6 %, FBC 47.1) and females (chest x-ray 15%, urine examination 52.3%, FBC 46.7, SBE 38.1%). Conclusions: We evidenced inquiring lacks in the actual opportunistic screening approach, characterized by high costs and displaced priorities in test performance. No significant financial relationships to disclose.
Abstract 5025: Diagnostic Value of Serial Changes in Low-Positive Extra-Sensitive Troponin I Levels for Acute Myocardial Infarction
Authors: Atul R Chugh, Julius B Elmore, Sofya Kuznetsov, John H Loughran, Michael P Flaherty, Melissa A Platt, Royce D Coleman, James J Miller, Buddhadeb Dawn
Journal: Circulation (2009)

Background: The use of high sensitivity troponin I (TnI-ES) assays results in higher rates of low-positive (LP-TnI-ES) results. Diagnostic value of serial changes in LP-TnI-ES levels remains unclear. Methods: Results of serial TnI-ES tests (VITROS ECi, Ortho-Clinical Diagnostics) were obtained from July 2008 to March 2009. Demographic and clinical data were recorded. Positive (&gt;0.034 ng/ml [the 99 th percentile]) results were divided into low (0.035– 0.100 ng/ml), intermediate (0.101– 0.300 ng/ml), and high (&gt;0.300 ng/ml) categories. Serial LP-TnI-ES results were tracked in hospitalized patients for progression to a higher category, regression to normal, or no significant change. Time interval for such changes was calculated. ANOVA and Pearson’s chi-Square tests were used to analyze association with outcome variables. Results: TnI-ES was performed in a total of 4090 unique patients, of whom 1134 (27.7%) had at least one positive TnI-ES value. At least one LP-TnI-ES value was noted in 818 (73.5%; 59% male, 37% African American; age 68±11 years) of these 1134 pts. Patients diagnosed with myocardial infarction (MI) comprised 7.3% of the LP-TnI-ES group. Predictors of MI by univariate analysis included higher initial LP-TnI-ES level ( P =0.002), progression from lower or regression from higher values ( P &lt;0.001), higher GFR ( P =0.05), lower creatinine ( P =0.05), and prior history of MI ( P &lt;0.001); while age, gender, diabetes, and race were not significant. Results from a multivariate regression model are shown in Table 1 . Progression of LP-TnI-ES to high in less than 12 hours was most predictive of MI (mean LP-TnI-ES change: 10.646±27.054; mean time to change: 6:24±3:01; P &lt;0.001). Conclusions: In patients with a low-positive TnI-ES result, serial changes and higher initial LP-TnI-ES levels, prior history of MI, and higher GFR were predictive of MI. These variables may be utilized to construct a clinical algorithm to aid decision-making in patients with LP-TnI-ES in the ER. Table 1- Results of Multivariate Logistic Regression Model