tbuckley/cabot-search huggingface dataset:
Using tablet computers to collect clinical and research data: Ease-of-use analysis
Authors: E. Fromme, L. Nail, S. Tolle, N. Perrin, T. Kenworthy-Heinige, T. M. Beer
Journal: Journal of Clinical Oncology (2008)

20593 Background: Physicians struggle to accurately assess subjective data like quality-of-life (QOL). Validated paper instruments exist but must be completed by the patient and then manually scored. Touch screen computers could accomplish both tasks, making it possible for QOL measurement to support clinical care in real time. To be practical, computer applications must be easily usable by patients with little education, little computer familiarity, or disabilities. We designed such a system and here describe its patient-reported ease-of-use. Methods: A series of web pages are presented using a 9x12” tablet computer. Users answer questions from the EORTC QLQ-C30 (QLQ) using a pen to click on response buttons. Buttons and question text were rendered as large as possible (font sizes 24 to 48) to aid subjects with low vision or poor hand-eye coordination. Ease-of-use testing included 2 phases: 1) observing and interviewing 7 elderly cancer patients while they used the tablet computer application, and 2) surveying 60 subjects with solid tumors from medical oncology clinic who completed demographic information, the tablet computerized QLQ, and Davis’ validated 8 item ease of use questionnaire. Results: Observational testing yielded 3 methods to make tablet computers easier for novice users: 1) Provide a tilting lap table so the screen can be viewed at the most visible angle 2) Lock the display to prevent flipping between portrait and landscape modes 3) Disable the right- click function of the pen. 58 of 60 subjects participated in the survey. The mean age was 67 (SD = 10) and 43% were 65+. 22% did not have or use a computer at home, 22% had high school education or less and 47% had graduated from college. All 58 (100%) were able to complete the computerized questionnaire with no assistance. Most preferred the computer - only 10% preferred paper questionnaires. The QLQ-C30 data were 100% complete. Greater age and less education were associated with lower ease of use scores, although using a computer at home was not. Conclusions: By paying close attention to ease-of-use considerations, tablet computer applications can be made accessible to a general cancer population for research and clinical purposes. The ability of real time QLQ assessment in clinical practice to improve patient outcomes is under investigation. No significant financial relationships to disclose.
Pharmacokinetics (PK) and immunologic responses in a phase I/II study of a sustained release formulation of IL-2 in renal cell carcinoma (RCC) patients
Authors: S. Oudard, N. Thiounn, H. Fridman, D. Amsellem-Ouazana, M. Colombel, D. Jacqmin, B. Malavaud, R. Kravtzoff
Journal: Journal of Clinical Oncology (2006)

2558 Background: The utility of interleukin-2 (IL-2) in treating RCC is limited by its significant toxicity, expense, and limited efficacy. Formulations that reduce post-injection peak concentration (C max ) and support sustained therapeutic levels may improve efficacy and tolerability of IL-2 therapy. In preclinical studies, IL-2 formulated with Medusa (IL-2XL), a novel sustained drug delivery system, reduces C max and supports controlled release of IL-2 for up to 6 days. Methods: The open-label Phase I/II study was designed to accrue 12 patients (pts), with a goal of 10 evaluable pts. Pts aged 18–85 at high risk of recurrence after surgical resection of histologically confirmed RCC, and without CNS metastases, other malignancy, autoimmune disorders were eligible. Pts received one single subcutaneous (SC) injection of 10.6 MIU naked IL-2 (IL-2N) or IL-2XL. At least two weeks later, patients were crossed over to receive a single SC administration of 10.6 MIU of the other agent. Safety, PK, biological activity and immunological responses were assessed. Results: 8 patients have accrued and results from 6 pts evaluable to date show a 4-fold reduction in Cmax following IL-2XL injection compared with IL-2N. IL-2 was detectable in serum 7 days after IL-2XL treatment, compared with 2 days for IL-2N. Relative bioavailability of IL-2XL was approximately 150% of IL-2N, and T max was appoximately 48 hrs compared with 2–4 hrs. T50 also was higher following IL-2XL administration compared with IL-2N (48 vs. 8 hrs). Soluble CD25 and neopterine, markers of IL-2 activity, had much higher C max (159 vs. 63 pg/ml and 14 vs. 6 pM for sCD25 and neopterin) and AUC (14,749 vs. 7,701 pg/ml/hrs and 1,569 vs. 665 pM/hrs for sCD25 and neopterin) following IL-2XL treatment compared with IL-2N. Compared to IL-2N immunoflowcytometry showed an increase in percentage and activation of lymphocytes (CD3+/CD45+; CD8+/CD25+ and CD4+/CD25+). Conclusions: Weekly dosing of IL-2XL reduces Cmax, increases induction of IL-2 biomarkers and improves immunologic responses compared with IL-2N. Data support the development of IL-2-XL used on a weekly schedule for treating cancer and viral disease such as HIV. No significant financial relationships to disclose.
Side effects, toxicity, fertility, and quality of life in 115 seminoma patients stage I during and after radiotherapy.
Authors: M. Gamulin, Z. Kastelan, M. Grgic
Journal: Journal of Clinical Oncology (2011)

e15074 Background: Therapy options for patients (pts) with testicular seminoma stage I include radiotherapy (RT), chemotherapy or surveillance. Beside the therapy, acceptable side effects and life quality represent significant factors in choosing the therapy option. Methods: In this study, data on symptoms, body image and sexual functioning were reported for 115 testicular seminoma patients (pts) using a questionnaire (EORTC QLQ-C30, sexual and sociodemografic) after RT. The paraaortic lymph nodes (LNs) were irradiated with a total dose of 24 Gy/16 fractions. The mean age of patients was 34 years (19-72 y), 71% of the middle and 29% high social class; 36% were smokers and 64% non-smokers. The median follow-up was 28 months (13-84 m). Results: Side effects: no symptoms 7%; nausea 25%; diarrhea 7%; constipation 8%; fatigue 11%; nausea/vomiting 15%; nausea/fatigue 27%. Weight loss: none in 50% pts; ≤ 10% in 49% pts; >10% in 1% pts. Sleep disturbance 12% pts; worry 35%; difficulty remembering 8%; depressed 32%, none cognitive/physical problems 13% pts; social activities problems 23% pts. Sexual functioning: normal in 43% pts, no sex during RT 11%, sexual problems during RT in 43%, after RT worse sex 3% pts. During RT 3.4% pts required therapy for nausea/sleeping. The overall quality of life in the last week of RT: poor 34% pts and good 66% pts. After RT 5% pts had late side effects. 12-72 months after the RT, 76% of pts (18-39y) had children. The statistical analysis by Mann-Whitney nonparametric test showed that symptoms of nausea were not related to smoking, age or education. Two patients relapsed at 12 months after RT in ipsilateral pelvic LNs. Conclusions: RT caused side effects which required therapy in a small number of patients. Weight loss and weakness caused an additional need for psychological assistance which confirms the significant impact of the oncologist who has to recognize the patient's needs on individual basis. Sexual activity and fertility were retained as before radiotherapy in majority of patients. Adjuvant RT is an acceptable treatment concerning side effects and life quality.
British Society for Dermatopathology
Journal: British Journal of Dermatology (2012)

Journal Article British Society for Dermatopathology Get access British Journal of Dermatology, Volume 167, Issue s1, 1 July 2012, Pages 100–113, https://doi.org/10.1111/j.1365-2133.2012.10985.x Published: 01 July 2012
Evaluating the effects of zoledronic acid (ZOL) on overall survival (OS) in patients (Pts) with multiple myeloma (MM): Results of the Medical Research Council (MRC) Myeloma IX study.
Authors: G. Morgan, F. Davies, W. Gregory, S. E. Bell, A. Szubert, N. Navarro Coy, M. Drayson, R. G. Owen, G. H. Jackson, J. A. Child
Journal: Journal of Clinical Oncology (2010)

8021 Background: Bisphosphonates (BPs) are standard of care for reducing the risk of skeletal-related events (SREs) in pts with bone metastases from solid tumours or bone lesions from MM. Several BPs have also demonstrated anticancer activity in preclinical models. With the highest level of activity among approved BPs, ZOL has shown anticancer activity in preclinical and clinical studies in various cancer types, including MM. Of note, in pts with early breast cancer, ZOL improved disease-free survival by 36% (P = 0.01) vs endocrine therapy alone (Gnant, et al. NEJM. 2009). Among other endpoints, the MRC Myeloma IX Study investigated effects of ZOL vs clodronate (CLO) on SREs, progression-free survival (PFS), and OS in MM pts. Methods: Newly diagnosed MM pts were randomised to ZOL (4 mg q 21-28 days) or CLO (1,600 mg q day) plus antimyeloma therapy. Treatment continued at least until disease progression. Results: Of 1,970 pts randomised,1,960 were evaluable, with a median follow-up of 3.7 yrs. To date, approximately 75% of pts have stayed on treatment until disease progression. The median time on treatment for the 25% of discontinued pts was 156 days (CLO) and 270 days (ZOL). ZOL reduced the proportion of pts with an SRE vs CLO (27.0% vs 35.3%, respectively; P = 0.0004). ZOL-treated pts showed 5.5 months' prolonged OS (50 vs 44.5 months, respectively; P = 0.0118) and 2 months greater PFS (19.5 vs 17.5 months, respectively; P = 0.0179) versus CLO. Of note, the OS benefit with ZOL was maintained after adjustment for potential effects of SREs on survival. After time to first SRE was included as a time-dependent covariate in a Cox model, ZOL maintained OS benefits (P = 0.0178). Both BPs were generally well-tolerated, and deterioration in renal function was similar between treatment groups. The incidence of confirmed osteonecrosis of the jaw was also low (ZOL, 3.5%; CLO, 0.3%). Conclusions: The results demonstrate a beneficial effect of ZOL on survival, in addition to superior SRE prevention versus CLO, in pts with MM. Moreover, survival benefits associated with ZOL seem to be independent of SRE prevention, suggesting that ZOL may improve survival through anticancer activity. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Bayer-Schering, Novartis
Effect of neoadjuvant therapy on the risk for atrial fibrillation in patients undergoing esophagectomy.
Authors: Matthew Doepker, Andrea M. Abbott, Ravi Shridhar, Sarah E. Hoffe, Khaldoun Almhanna, Kenneth L. Meredith
Journal: Journal of Clinical Oncology (2015)

210 Background: Neoadjuvant chemoradiation (NT) has become the standard for patients with locally advanced esophageal cancer. Thirty percent of patients who undergo esophagectomy will develop atrial fibrillation (AF). NT may contribute to patients developing AF and this may be a surrogate for anastomotic dehiscence (AD). Methods: We queried a prospective esophageal database to identify patients who underwent esophagectomy with or without NT. Demographics and post-operative complications were all compared with fisher exact test and considered significant at p&lt;0.05. Results: We identified 811 patients who underwent esophagectomy with a mean age of 68 +/- 12 years. Five-hundred and fifteen (63.5%) were treated with NT and 296 (36.5%) were not. Eighty-nine (11%) of patients developed AF, 59 (11.5%) in the NT group, and 30 (10.1%) in the non NT group. There was no significant differences noted in the incidence of AF in those that were treated with NT and those that were not (p=0.64). A total of 54 (6.7%) patients were identified as having AD, 27 (5.2%) in the NT cohort and 27 (9.1%) in the non NT cohort. The NT group had lower incidence of AD compared to their non NT counterparts (p=0.04). Of the 54 patients who experienced AD, 6 (11%) had concomitant AF, and 48 (89%) did not and the remaining 83 patients who developed AF did not develop AD (p=1). Conclusions: NT prior to esophagectomy does not increase patient’s risk for developing postoperative AF. Moreover, the presence of AF in the post esophagectomy patient, did not serve as a surrogate for identifying AD.
Gemcitabine and radiotherapy: Analysis of safe use
Authors: A. Czarnecki
Journal: Journal of Clinical Oncology (2007)

18146 Background: Radiation in combination with chemotherapy offers a significant survival advantage. Preclinical and clinical data indicate that gemcitabine (GEM) is a potent radiosensitizing agent in numerous cancer types used subsequently with radiation given in different doses and techniques. We compared safety/toxic effects of GEM with GEM plus radiation. Methods: Lilly Safety Database was searched for all reports where patients received radiation before, during and after GEM therapy. The string search for ‘radio’, ‘radia’ and a search for MedDRA terms covering possible radiation recall and typical recall phenomena were conducted. Cases were reviewed by a physician and allocated to one of the categories: ‘concurrent’ (radiation and GEM was given at the same time or 7 days apart), and ‘non-concurrent’ (treatment was given more than 7 days apart). Results: In one third of cases who received concurrent treatment the toxicity reported was higher in 3 System Organ Classes (SOC): ‘Injury’, ‘Gastrointestinal disorders’ (GI), and ‘Respiratory’ in comparison to non radiation treated patients: 4.1%, 16%, 14.8% versus 1.4%, 11.2% and 10.5% respectively but toxicity was lower for ‘Blood and lymphatic disorders’ and ‘General disorders’. In cases with ‘non-concurrent’ treatment the results were similar to ‘concurrent’ treatment for the Injury, Respiratory and Blood SOCs but GI toxicity was only 60% of the one seen in non radiation treated patients. In patients with reported radiation recall the most frequent were skin reactions, pneumonitis and myositis. Radiation injury mainly affected targeted tissue organs exposed to direct radiation e.g eosophagitis and pneumonitis for chest irradiation, GI effects for abdominal irradiation. In Non-concurrent administration no correlation between GEM dose and toxicity could be established. In Concurrent cases, treatment dose and technique of radiation, target tissue and volume were factors together with dose and frequency of GEM administration. Conclusions: Review of adverse drug reactions for GEM and radiation treatment reported from estimated GEM exposure of nearly 1.1 million patients suggests that any increase in GEM toxicity in non- concurrent combination regimen other than radiation recall is due to typical radiation toxicity and mainly affects directly irradiated tissues. No significant financial relationships to disclose.
Malignant Lymphoma Leukemia Induced in &lt;italic&gt;Herpesvirus saimiri&lt;/italic&gt;&lt;xref ref-type="fn" rid="FN1"&gt;2&lt;/xref&gt;&lt;xref ref-type="fn" rid="FN2"&gt;3&lt;/xref&gt;
Authors: D. V. Ablashi, W. F. Loeb, Marion G. Valerio, R. H. Adamson, G. R. Armstrong, D. G. Bennett, Ursula Heine
Journal: JNCI Journal of the National Cancer Institute (1971)

Five owl monkeys inoculated with Herpesvirus saimiri (HVS), propagated in owl and African green monkey kidney cell cultures, developed malignant lymphoma with lymphocytic leukemia. The virus was recovered from these monkeys and identified as HVS. The disease lasted from 57–78 days. It was characterized by generalized lymphadenopathy and lymphocytic leukemia with circulating actively motile lymphocytes. The lesions were characterized by the obliteration of normal lymphoid tissue architecture by neoplastic lymphocytes and invasion of most organs by neoplastic lymphocytes. On cultivation of tissues, HVS was recovered, however, virus particles could not be detected by electron microscopy.
Adherence to cardiovascular (CV) medications after myocardial infarction (MI) in cancer survivors (CS).
Authors: S. Setoguchi, M. L. McBride, R. Levin, W. Y. Cheung
Journal: Journal of Clinical Oncology (2010)

6095 Background: Studies of noncancer patients (NCP) indicate that medication adherence is poor. Adherence among CS has not been evaluated specifically even though this is a crucial aspect of their ongoing care. Our aims were to 1) characterize adherence to CV medications in CS vs NCP, 2) compare temporal trends in adherence in these 2 cohorts, and 3) determine predictors for adherence. Methods: Using linked data from Medicare, pharmacy assistance programs, and cancer registries, we identified patients discharged from hospital for MI between 1997 and 2004. For those prescribed a statin, β-blocker, ACE inhibitor (ACEi) or all 3, we assessed adherence between CS and propensity score (PS) matched NCP. Adherence was measured using proportion of days covered (PDC), which was the number of days (NOD) of medication supplied divided by NOD in the 1st year after initial prescription. Patient was considered adherent if PDC ≥ 80%. Modified Poisson regression was used to describe trends over time and predictors of adherence. Results: In total, 964 CS and 6,923 NCP received at least 1 CV medication. Median ages were 80.3/80.2 years, 66/68% were female, and 90/91% were white, respectively. Adherence rates were suboptimal in both cohorts (18 to 45%). Between 1997 and 2004, adherence to statins and β-blockers (p<0.01 for both), but not ACEi, increased significantly among NCP (see Table). For CS over the same period, only adherence to statins improved (p<0.01). Of those prescribed all 3 medications, there was improvement in adherence among NCP (p<0.01), but not for CS (p=0.26). Comorbidities, such as heart failure and depression, were associated with poor adherence. Conclusions: Adherence to highly efficacious therapies remains low. While adherence to β-blockers and all 3 medications improved over time for NCP, this trend was not observed among CS. Medication All years P for baseline difference Year of MI P for trend P for difference in trend 1997–1998 1999–2000 2001–2002 2003–2004 Statin CS 45% 0.92 42% 51% 49% 55% < 0.01 0.24 NCP 44% 39% 47% 49% 54% < 0.01 β-blocker CS 40% 0.54 42% 40% 42% 41% 0.78 0.04 NCP 41% 39% 43% 47% 50% < 0.01 ACEi CS 38% 0.06 45% 39% 38% 39% 0.96 0.70 NCP 43% 41% 43% 45% 43% 0.11 All 3 medications CS 18% 0.21 22% 21% 20% 21% 0.26 0.02 NCP 22% 21% 24% 26% 27% < 0.01 No significant financial relationships to disclose.
Efficacy and compliance of small-bore chest tube insertion and pleurodesis protocols for the treatment of malignant pleural effusions
Authors: R. A. Goodwin, M. Reaume, V. Gallant, G. MacArtney, D. Maziak, F. Matzinger, S. Gertler
Journal: Journal of Clinical Oncology (2007)

19575 Background: Small-bore chest tubes are now recognized as a safe and effective alternative to large-bore catheter chest tubes for the treatment of malignant pleural effusions (MPEs). The Ottawa Hospital (TOH) developed protocols for insertion and pleurodesis to maximize efficiency and minimize complications. Objective: To evaluate the efficacy and compliance of small-bore chest tube insertion and pleurodesis protocols for the treatment of MPEs. Methods: Retrospective chart review of TOH medical oncology inpatients treated for a MPE using our small-bore chest tube insertion and pleurodesis protocols from February 2003 to May 2004. Outcomes reviewed included deviations from protocol (major and minor), proportion of patients proceeding to pleurodesis and efficacy at six weeks, complications, as well as length of hospital stay. Results: One-hundred and fourteen potential cases were identified, of those 78 small-bore chest tubes were inserted into 72 patients. Major deviations from the chest tube protocol occurred in 21 patients (27%) who lacked microbiological analysis of their pleural fluid. Major complications of tube insertion occurred in ten patients (13%) who developed pulmonary infections and two patients (2.5%) who developed a significant pneumothorax. Of the 78 tube insertions, 24 cases went on to pleurodesis. Major deviations from our pleurodesis protocol occurred in five patients (2.1%) who failed to have a chest xray twenty-four hours prior to pleurodesis. The most common complication post pleurodesis was pain with seven of 24 patients (29%) rating their pain as severe. Fifteen of the 24 patients (63%) had fluid reaccumulation within six-weeks post pleurodesis. Median length of stay for patients without pleurodesis versus those with pleurodesis was 14.5 and 16.0 days, respectively. Conclusions: Our preliminary data suggests that chest tube insertion and pleurodesis protocols have good compliance rates with low rates of complications. Only a minority of patients were able to proceed to pleurodesis and long term control of effusion occurs in less than half of patients in this subgroup. As well, pain control at the time of pleurodesis was not adequate in one third of patients with the current protocol. No significant financial relationships to disclose.
A prospective one year randomized comparative clinical and MRI study of the effects of methotrexate (MTX) alone or in combination with infliximab (IFX) or intravenous (IV) pulse methylprednisolone (MP) in early rheumatoid arthritis (RA)
Authors: Patrick Durez, Jacques Malghem, Bernard Lauwerys, Frédéric Houssiau, A. Nzeusseu Toukap, Geneviève Depresseux, Rene Westhovens, F. P. Luyten, P. Verschueren
Journal: Annals of the Rheumatic Diseases (2006)
The use of gene array analysis to determine down-stream molecular expression patterns of trastuzumab (T) treatment
Authors: S. Welle, S. Welt, T. Shay, C. Lanning, K. Horton, D. Kostyal
Journal: Journal of Clinical Oncology (2007)

14135 Background: Breast cancers expressing the HER/2 amplicon are more aggressive and are associated with a poorer prognosis. HER/2 over-expression has been correlated with expression of proteins responsible for invasion, metastases, rapid growth, angiogenesis and apoptosis. However, it is unknown if T treatment of HER/2 over-expressing tumors reverses these phenotypes. Methods: BT 474 and SK-BR3 breast cancer cell lines contain the HER/2 amplicon. Under growth conditions demonstrating inhibitory effects of T by MTT and 3 H-Thymidine incorporation, (0.25–50 micrograms/ml for up to 9 days), RNA extracts from treated and un- treated cells were analyzed and compared by whole human genome, gene array analysis. Results: Specific gene products reported to be up-regulated in HER/2 over-expressed breast cancer lines or responsible for aggressive behavior were assessed for down regulation by T treatment including: topoisomerase II, heregulin, egfr-1,2,3 and 4, p27, ki67, mapKinase, akt, caspase-3, caspase-7, caspase-9, bcl-2, veg-f, veg-f receptor, p38, sapk/jnk, erk1/2, LGALS1 galectin-1, LGALS3 galectin-3, proline-4-hydrolase P4HA2, FN1 fibronectin -1, CDH3 p-cadherin, laminin receptor protein -1, pro2605 and insulin like growth factor binding protein-3. No significant change in these mRNA levels were observed due to T treatment. In contrast, over 1000 other gene were found to be specifically and significantly up or down regulated including the down regulation of S100 Calcium binding protein associated with increase metastatic potential. Conclusions T treatment does not reverse the expression of a large array of proteins conferring poor prognostic features on HER/2+ tumor. The use of gene array analysis to study T induced gene expression is a robust method to assess downstream protein expression patterns mediated by antibody binding to receptor. No significant financial relationships to disclose.