tbuckley/cabot-search huggingface dataset:
Prevention of Venous Thromboembolism after Total Hip Replacement with Once-Daily BAY 59-7939 - An Oral, Direct Factor Xa Inhibitor.
Authors: Bengt I. Eriksson, Lars Borris, Ola E. Dahl, Sylvia Haas, Menno V. Huisman, Ajay K. Kakkar, Frank Misselwitz, Eva Muehlhofer, Peter Kälebo
Journal: Blood (2005)
Pharmacogenomic analysis from a phase III study of pemetrexed plus carboplatin (PC) versus etoposide plus carboplatin (EC) in chemonaive patients (pts) with extensive-stage disease small cell lung cancer (ED-SCLC)
Authors: E. F. Smit, M. A. Socinski, B. P. Mullaney, S. P. Myrand, E. Powell, P. Lorigan, C. Kaiser, S. C. Guba, N. Thatcher
Journal: Journal of Clinical Oncology (2009)

8030 Background: We have reported results of a randomized phase III trial in chemonaive patients with ED-SCLC comparing PC to EC. Study enrollment was closed for futility but pharmacogenomic endpoints were not reported. Here we report the results of immunohistochemistry (IHC) analysis from tumor tissues and single nucleotide polymorphism (SNP) analysis of selected genes implicated in pemetrexed, carboplatin, or etoposide activity. Methods: Proteins studied by validated IHC on Benchmark XT were thymidylate synthase (TS), excision repair cross complementing-1 (ERCC1), glycinamide ribonucleotide formyl transferase (GARFT), and folylpolyglutamate synthetase (FPGS). SNP data from whole blood were genotyped by massArray mass spectrometry from 611 samples. One hundred fifty-eight SNPs were genotyped for TS, FPGS, γ-glutamyl hydrolase (GGH), methylene tetrahydrofolate reductase (MTHFR), folate receptor- α (FR-α), solute carrier 19A1 (SLC19A1) and adjacent regions. Allele frequency and Hardy-Weinberg equilibrium were calculated for each SNP. Results: Of 408 tissue samples (from 908 enrolled pts) available for IHC, 336 samples were assayed for &gt; 1 assay target. The IHC analyses showed improved OS in the EC arm relative to the PC arm for patients with low TS nuclear (12.9 vs 7.5 month, p &lt; 0.001, interaction p value = 0.017). There was no differential treatment effect within the PC arm for low vs. high TS. High vs low ERCC1 levels did not predict outcome following C exposure. GARFT was not associated with outcome by treatment. SNP rs2838952 (adjacent to SLC19A1) was significant for improved OS (HR = 0.590, p = 0.01) in both study arms. SNP rs12379987 (FPGS) was significantly associated with treatment for OS (interaction p value = 0.036). Exploratory analyses found associations between additional SNPs and PFS within and across treatments. Conclusions: Pharmacogenomic analyses of tumor samples show that low TS nuclear expression correlates with OS in the EC arm. Two germline SNPs in regions including FPGS and SLC19A1 were associated with better OS. Further analysis of these pharmacogenomic results is ongoing. [Table: see text]
Abstract 14553: Greater Than 3g of a Dietary Sodium Intake Independently Predicts Worsening Health-Related Quality of Life in Heart Failure Patients With No Cardiac Events Over 1-Year Follow-Up
Authors: Eun Kyeung Song, Debra K Moser, Sandra B Dunbar, Susan J Pressler, Seongkum Heo, Terry A Lennie
Journal: Circulation (2011)

Background. A major desirable outcome in heart failure (HF) management is to improve health-related quality of life (HRQoL). The recommendation for dietary sodium restriction is a standard componen...
A brief measure of patients self-reported chemotherapy-related memory problem: Psychometric studies
Authors: P. Jean-Pierre, G. R. Morrow, K. Fiscella, M. Parrella, S. Kohli, R. Khanna, A. D. Jacobs, B. Issell
Journal: Journal of Clinical Oncology (2007)

19655 Background: Memory is a central component of individuals’ functional systems of behavior, (i.e., cognition, emotionality, and executive functioning) that can be deleteriously affected by cancer treatment. It is important to identify and understand the effects of cancer treatment on memory in order to develop effective interventions to ameliorate these problems. This study involves structural and reliability analyses of a brief measure of chemotherapy-related memory problem to facilitate prompt and reliable preliminary assessments in oncology research and practice. Methods: Patients (N = 821) included in this analysis were part of a larger randomized clinical trial on cancer-related fatigue. These patients completed the Fatigue Symptom Checklist (FSCL) at four time points. Five items from the FSCL that assess memory problems were aggregated into a brief self-report memory problem measure (SRMP). Results: Reliability assessment of the SRMP revealed a Cronbach coefficient alpha of 0.90. The data was found suitable for latent structure analysis using various criteria: Kaiser-Myer-Olkin, Bartlett’s Test of sphericity, Kaiser’s (1959) simplest criterion test of γ &gt;1, and the presence of item-correlation coefficients of r = .30. Principal components analysis showed one component with eigenvalue (γ) exceeding 1, that explained 72% of the variance. Subsequent reliability assessments of the SRMP revealed Cronbach coefficients alpha of 0.90 and above, all with a single component explaining 71.36% to 73.36% of the variances. Conclusions: The results supported the use of the SRMP as a reliable one- dimensional measure of cancer treatment-related memory problem. The SMRP could be used for preliminary assessment of possible underlying memory problems that might need further examinations. Studies to establish the construct validity of the SRMP are under way. Supported by NCI grant R25CA102618. No significant financial relationships to disclose.
Factors influencing 3D-MRI diagnosis in preoperative breast cancer patients
Authors: K. Hisamatsu, W. Takiyama, R. Sakabe, Y. Satou, S. Saeki, H. Mukaida, Y. Yamashita, N. Hirabayashi, M. Kaneko, T. Ono
Journal: Journal of Clinical Oncology (2009)

620 Background: We presented 3D-MRI will be the useful breast imaging tool in diagnosing intraductal spread and tumor size in breast cancer patients. (ASCO 2008).To do breast conserving surgery, careful management was needed in cases with widely ductal spreading and multifocal lesion. This study was to evaluate factors influencing false negative diagnosis and multifocal types of 3D-MRI, retrospectively. Methods: From July 2000, pre-operative 3D-MRI was underwent 488 cases and images were obtained 479 cases (98%). These patients could be divided into three groups according to 3D-MRI images: pattern 1) localized type (273 cases), 2) widely enhanced type (106 cases) and 3) multi-focal type (100 cases). From April 2005, resected specimen was serially step cut and total specimens were microscopically evaluated. Tumor size in 3D-MRI was 1cm over smaller than resected specimens were defined false negative cases. Investigated factors influencing 3D-MRI were age, patterns of 3D-MRI images, presence of pre-operative chemotherapy, histological type, histological grade, microscopical invasive tumor size (mm) and presence of ductal spreading. Results: The rate of histological confirmed intraductal spread were seen in 58% (158/273cases), 89% (94/106 cases) of patients with 3D-MRI pattern 1) and 2), respectively. Tumor size was correlated between MRI and specimens, significantly (n = 162, r = 06706, p &lt; 0.001). Factors influencing false negative diagnosis of 3D-MRI were presence of pre-operative chemotherapy (p &lt; 0.05), presence of ductal spreading (p &lt; 0.001) and patterns of 3D-MRI images (p &lt; 0.05). In the cases with multi-focal 3D- images, there were only 11(11/41, 26%) cases with true multifocal lesions by total specimens examination. Selection for breast conserving surgery and margin width were based by 3D-MRI images. The proportion of breast-conserved surgery were obtained 90% (437/488 cases) and local failure seen only 6 cases (local failure rate 1.4%) in 3D-MRI guided surgery. (median follow up 52 months). Conclusions: These results suggest that MRI will be the useful breast imaging tool, but caution will be needed in cases with pre-operative systemic therapy, cases expected intraductal spread by imaging tools and cases with multi-focal 3D- images. No significant financial relationships to disclose.
Biweekly intensified ambulatory chronomodulated chemotherapy with oxaliplatin, fluorouracil, and leucovorin in patients with metastatic colorectal cancer.
Authors: F Bertheault-Cvitkovic, A Jami, M Ithzaki, P D Brummer, S Brienza, R Adam, F Kunstlinger, H Bismuth, J L Misset, F Lévi
Journal: Journal of Clinical Oncology (1996)

PURPOSE This study sought to determine the feasibility and antitumor efficacy of an intensified three-drug chronomodulated regimen with maximum delivery at 4:00 AM for fluorouracil (5-FU)-leucovorin (folinic acid [FA]) and at 4:00 PM for oxaliplatin (I-OHP). PATIENTS AND METHODS Fifty patients with metastatic colorectal cancer were enrolled in the trial. The first treatment course consisted of daily administration of 5-FU (700 mg/m2/d), FA (300 mg/m2/d), and L-OHP (25 mg/m2/d) for 4 days with a multichannel programmable pump. Courses were repeated every 14 days, with 5-FU escalation by 100 mg/m2/d if toxicity was less than grade 2. RESULTS World Health Organization (WHO)-modified grade 3 or 4 diarrhea (40% of patients and 7% of courses) or stomatitis (28% of patients and 4% of courses) or grade 2 cumulative peripheral sensitive neuropathy (28% of patients) were dose-limiting. Median 5-FU and L-OHP dose-intensities (DIs), were increased by 32% and 18%, respectively, as compared with our previous 5 days on-16 days off schedule. The overall objective response rate was 48% (95% confidence limits [CL], 34% to 62%), being 40% (24% to 57%) in 37 previously treated patients and 69% (48% to 90%) in 13 chemotherapy-naive patients. A 5-FU DI &gt; 1,400 mg/m2/wk over four courses was associated with a near doubling of the response rate. Residual metastases were surgically removed in 13 patients (26%). Median progression-free survival and survival durations were 9.3 months (95% CL, 6.6 to 11.2) and 17.8 months (95% CL, 14.1 to 21.4), respectively. CONCLUSION This highly effective fully ambulatory outpatient regimen deserves further testing in randomized trials both in chemotherapy-naive patients and before surgery to remove metastases.
A randomized discontinuation phase II study of sorafenib versus placebo in patients with non-small cell lung cancer who have failed at least two prior chemotherapy regimens: E2501
Authors: J. H. Schiller, J. W. Lee, N. H. Hanna, A. M. Traynor, D. P. Carbone
Journal: Journal of Clinical Oncology (2008)

8014 Background: Sorafenib (S) is a raf kinase and angiogenesis inhibitor with activity in hepatoma and renal cell carcinoma. Given the activity of other angiogenic inhibitors in non-small cell lung cancer, we conducted this randomized, double blind, placebo (P) controlled Phase II study in third line and beyond disease (dx). We utilized a unique randomized discontinuation design in order to enrich for patients (pts) with slower growing dx, who theoretically might be more likely to derive benefit. Methods: Pts were required to have PS of 0–1; at least 2 prior chemotherapy regimens; and progressing dx. All pts received 400 mg of S orally twice daily for 2 cycles (2 months) (Step 1). Responding pts on Step 1 continued on S; progressing pts went off study, and pts with stable dx were randomized to P or S (Step 2). Pts randomized to P were allowed to cross over to S on progression (PD). The primary endpoint of this study was the proportion of pts having stable or responding dx 2 months after randomization. Accrual goal was 311 pts in order to randomize 98, giving a 91% power to detect a difference in stable dx at 2 mo of 25% for P vs. 56% for S. Results: 342 pts were enrolled in step 1; 97 eligible pts were subsequently randomized to step 2 and treated; 36 of 41 pts on P on step 2 were crossed over to S. Demographics on step 2 were well balanced except for more pts on P having weight loss of 5% - 10 % (22% vs. 7% on S; p = 0.048). Major grade (Gr) 3- 4 treatment related toxicities from 320 pts on Step 1 included rash/hand-foot syndrome (15%); fatigue (11%); and INR abnormalities (3%). 2 pts on Step 1 and 1 pt on maintenance S had Gr 3, 5 and 5 hemoptysis, respectively. Conclusions: Preliminary results suggest sorafenib may prolong PFS in heavily pretreated pts with slowly growing dx. Updated results will be presented. Outcome of Eligible Pts Randomized to Step 2, from Date of Randomization N Median PFS (mo) Stable Dx PD Data pending (N=44) or pts unevaluable for response (N=6) Sorafenib 56 3.6 16 (29%) 14 (25%) 26 (46%) Placebo 41 1.9 (p=0.01) 2 (5%) (p=0.002) 15 (37%) 24 (58%) Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Bayer Bayer, Onyx
Dihydroartemisinin–piperaquine resistance in Plasmodium falciparum malaria in Cambodia: a multisite prospective cohort study
Authors: Chanaki Amaratunga, Pharath Lim, Seila Suon, Sokunthea Sreng, Sivanna Mao, Chantha Sopha, Baramey Sam, Dalin Dek, Vorleak Try, Roberto Amato, Daniel Blessborn, Lijiang Song, Gregory S Tullo, Michael P Fay, Jennifer M Anderson, Joel Tarning, Rick M Fairhurst
Journal: The Lancet Infectious Diseases (2016)
Pulmonary cavitating squamous cell carcinoma.
Authors: F P Peters, F B Thunnissen, G P ten Velde
Journal: Journal of Clinical Oncology (1998)

Article Tools Article Tools OPTIONS & TOOLS Export Citation Track Citation Add To Favorites Rights & Permissions COMPANION ARTICLES No companion articles ARTICLE CITATION DOI: 10.1200/JCO.1998.16.1.363 Journal of Clinical Oncology - published online before print September 21, 2016 PMID: 9440765 Pulmonary cavitating squamous cell carcinoma. F P PetersxF P PetersSearch for articles by this author , F B ThunnissenxF B ThunnissenSearch for articles by this author , G P ten VeldexG P ten VeldeSearch for articles by this author Show More University Hospital Maastricht, The Netherlands. https://doi.org/10.1200/JCO.1998.16.1.363 PDF "Pulmonary cavitating squamous cell carcinoma.." Journal of Clinical Oncology, 16(1), pp. 363–364© 1998 by American Society of Clinical Oncology
Circulating endothelial cells and endothelial progenitors as predictive markers of clinical response to bevacizumab-based treatment in advanced colorectal cancer
Authors: M. Manzoni, K. Bencardino, M. Ronzoni, B. Rovati, F. Loupakis, S. Mariucci, S. Brugnatelli, E. Villa, A. Falcone, M. Danova
Journal: Journal of Clinical Oncology (2008)

14527 Background: Bevacizumab (BEV)-based therapy has improved the outcome of pts with metastatic colorectal cancer (mCRC). As for other antiangiogenetic agents, the efficacy of this drug is difficult to monitor in the clinical setting, using traditional endpoints. Flow cytometric (FCM) evaluation of circulating endothelial cells (CECs) and their progenitors (CEPs) has been proposed as a surrogate biological marker of antiangiogenetic activity of different drugs. We have recently shown that in mCRC pts, CECs and CEPs are increased by the addition of BEV (Bencardino K, ECCO 2007). We now focused on the prospective modification of CECs and CEPs during a firs-line, multicyclic therapeutic program, to verify their possible predictive value. Methods: From January to November 2007, we have evaluated CEC (resting, rCECs: CD45-, CD106-, CD34+, CD146+ and activated, aCECs: CD45-, CD34+, CD146+,CD 106+) and CEP (CD133+) number by multiparameter FCM in 10 pts with mCRC (M/F: 5/5, median age: 64 yrs; range: 33 –75), before and every 3 courses of 5FU ± CPT11 + BEV. Data from a group of 50 healthy subjects (M/F: 25/25, median age: 43; range 21–65) were utilized as control. Results: At baseline pts showed a decrease of CECs and both their subpopulations, particularly with regard to the activated subset. During BEV-based therapy, aCEC subset had a progressive, significant increase while rCECs and total CECs showing a trend to decrease. At each time point, the median number of aCECs was significantly higher in pts who showed progressive disease shortly after the end of the treatment with respect to pts that obtained an objective clinical response, while the median number of rCECs was significantly higher in responding pts. No significant changes in CEP levels were found and this could be related both to the extremely rarity of these events and/or to the lacking of their mobilization from bone marrow related the antiangiogenetic therapy. Conclusions: These data suggest significant correlations among both aCEC and rCEC levels and the antitumor efficacy of a BEV-based combination therapy in mCRC pts, confirming that these biomarkers could be used in the clinical setting, as an early predictor of tumor response. No significant financial relationships to disclose.
Patient Preference for Cancer Therapy: An Overview of Measurement Approaches
Authors: A. M. Stiggelbout, J. C.J.M. de Haes
Journal: Journal of Clinical Oncology (2001)

PURPOSE: In the era of evidence-based medicine and shared decision making, the formal assessment of patient preference for treatments or treatment outcomes has attracted much attention. In this article, the two most common approaches to the evaluation of preference, ie, utility assessment and probability trade-off assessment, are described. The purpose is to provide clinicians with the background knowledge needed to interpret preference studies published in the literature and to judge whether the reported findings are relevant to their own patients. METHODS: An overview is given of the methods used to assess utilities and probability trade-off scores. Evidence on determinants of such scores is presented. Examples from oncology are provided. Because experience with the treatment plays an important role as a determinant of preferences for both treatments and treatment outcomes, special attention is paid to the interpretation of studies in the light of subject selection. Directions for future research are suggested. CONCLUSION: The choice of approach and the measuring instrument depend on the goal of the preference assessment. Normal psychologic processes, such as coping, adaptation, and cognitive dissonance reduction, cause patients who are about to undergo a therapy or have experienced a therapy to rate it more favorably than other patients do. This should be remembered when using evidence from the literature to inform patients or for patient decision making.
Four-year follow-up of outcomes following risk-reducing salpingo-oophorectomy in <i>BRCA</i> mutation carriers
Authors: Y. Kemel, N. D. Kauff, M. E. Robson, D. J. Goldfrank, E. Wadsworth, T. Diiorio, J. Boyd, C. A. Hudis, R. R. Barakat, K. Offit
Journal: Journal of Clinical Oncology (2005)

1013 Background: Our group previously reported on the efficacy of risk-reducing salpingo-oophorectomy (RRSO) for the prevention of breast and BRCA-related gynecologic cancer in a prospective cohort of women with documented mutations in BRCA1 or BRCA2. (Kauff ND, et al. NEJM 2002) Limitations of that report included a relatively short mean follow-up of 24.2 months, and inadequate power to analyze the protection afforded by RRSO against breast or BRCA-related gynecologic cancer alone. We present updated analysis of the efficacy of RRSO in a larger cohort of BRCA mutation carriers with intermediate term follow-up. Methods: All women ≥30 years of age with a deleterious mutation in BRCA1 or BRCA2 identified from 6/1/1995 - 1/1/2002 were offered enrollment in a prospective follow-up study. Women with ovarian tissue at risk were recommended to participate in intensive ovarian surveillance or undergo RRSO. Women self-selected interventions. Follow-up was by annual questionnaire, telephone contact or record review. The effect of RRSO on time to diagnosis of breast or BRCA-associated gynecologic cancer was analyzed using Kaplan-Meier analysis and a Cox proportional-hazards model. Results: 145 (67%) of 218 participants underwent RRSO a median of 5.2 months after receiving genetic test Results: Three occult ovarian or fallopian tube cancers were diagnosed at time of RRSO. During a mean 47.8 months of follow-up, 8 BRCA-associated gynecologic cancers were diagnosed in women electing observation, 2 peritoneal cancers were diagnosed in the RRSO group (p=0.010). Of 184 women with breast tissue at risk, 14 breast cancers were diagnosed in 87 women electing surveillance; 5 breast cancers were diagnosed in 97 women electing RRSO (p=0.015). Hazard Ratio (HR) for developing breast cancer following RRSO was 0.30 (95% CI: 0.11 to 0.84, p=0.022). HR for developing ovarian cancer following RRSO was 0.17 (95% CI: 0.04 to 0.78, p=0.023). Conclusions: With twice our previously reported follow-up, RRSO remains highly protective against subsequent breast and BRCA-associated gynecologic cancer. Patients considering these procedures need, however, to be aware that both breast and peritoneal cancers may still occur after these surgeries. No significant financial relationships to disclose.
High dose chemotherapy with autologous stem cell rescue as a part of combined modality therapy in stage IIIB inflammatory breast cancer
Authors: S. Farjami, F. Waheed, D. Liu, K. Seiter, T. Ahmed
Journal: Journal of Clinical Oncology (2006)

10694 Background: Despite the improvements related to introduction of neoadjuvant chemotherapy, the prognosis of patients with inflammatory breast cancer remains poor. The purpose of this study was to evaluate the efficacy, feasibility and outcomes of high dose chemotherapy in this group of patients. Methods: Between June 1991 and January 1999, twenty eight patients with pathologically confirmed inflammatory breast cancer were consecutively enrolled in this study. All patients were rendered free of clinically evident disease by using chemotherapy (adjuvant, neoadjuvant or both) either alone or in combination with surgery. Following stem cell collection patients received HD-CT with thiotepa 250mg/m 2 days 1, 2 &amp; 3(total dose of 750mg/m 2 ), mitoxantrone 40mg/m 2 on day 1 and carboplatin 333mg/m 2 on days 1, 2 &amp; 3 ( total dose of 1gm/m 2 ). Previously stored stem cells were infused on the seventh day of HD-CT chemotherapy. Eligible patients received radiation to the chest wall and tamoxifen for 5 years. Results: With median duration of follow-up of 46.9 months( range 15.1–177.2), the median overall survival (OS) and progression free survival (PFS) were 42.5 months (range 9.7–135.7) and 34.8 months (range 3.3–135.7), respectively. The multivariate analysis showed a significantly better EFS and OS in patients with estrogen receptor (ER) positive tumors ( P value ≥ 0.003). Mucositis and Infection were the most severe non-hematological toxicities. Grade four cardiac and pulmonary toxicities developed in one patient. There was no transplant related mortality. One patient developed myelodysplastic syndrome. Conclusions: The results of our study suggest that high dose chemotherapy with thiotepa, mitoxantrone and carboplatin is a safe and efficacious regimen in patients with stage IIIB inflammatory breast cancer. No significant financial relationships to disclose.