tbuckley/cabot-search huggingface dataset:
Obesity and mortality in patients with esophageal cancer: A systematic review and meta-analysis.
Authors: Arjun Gupta, Kaustav Majumder, Nivedita Arora, Preet Paul Singh, Siddharth Singh
Journal: Journal of Clinical Oncology (2016)

20 Background: Obesity influences incidence of esophageal cancer (EC) with contrasting impact on esophageal adenocarcinoma (EAC) and esophageal squamous cell carcinoma (ESC). However, it is unclear whether it influences mortality in patients with EC. We performed a systematic review and meta-analysis to assess the association between obesity and EC mortality. Methods: Through a systematic search of major databases and conference proceedings, up to June 2015, we identified observational studies reporting the association between obesity (premorbid body mass index [BMI] ≥ 30 kg/m 2 ) and all-cause mortality in patients with EC. We estimated summary adjusted hazard ratio (aHR) with 95% confidence intervals (CI), comparing highest BMI category with reference category in each study using random effects model; heterogeneity was measured using the inconsistency index (I 2 ). Results: We identified 8 studies (including 1 pooled cohort study) with 2,784,027 people, of whom 18% were obese. On meta-analysis, compared with EC patients with reference BMI, obese EC patients had aHR for mortality of 0.97 (95% CI, 0.66-1.43), with high heterogeneity (I2 = 88%) after pooling maximally adjusted HRs. On analyzing patients with EAC alone (3 studies), mortality aHR was 1.10 (95% CI, 0.43-2.82), with high heterogeneity (I2 = 95%). Data to separately analyze ESC or to perform subgroup analysis in males vs females, smokers vs never smokers and Asia Pacific vs Western populations was limited. Conclusions: Based on meta-analysis, obesity does not appear to be associated with mortality in patients with EC. However, high heterogeneity and limited data for subgroup analysis limits the interpretation of this analysis. Further prospective studies evaluating mortality in patients with established EC are needed to answer this question. [Table: see text]
The predicting value of FETNIM PET/CT during radiotherapy for local control in patients with esophageal cancer: Initial observation.
Authors: S. Yuan, G. Yang, L. Ma, S. Zhao, W. Yang, W. Zhang, D. Han, X. Liu, T. Liu, J. Yu
Journal: Journal of Clinical Oncology (2011)

e14535 Background: PET with fluorine-18 fluoroerythronitroimidazole (FETNIM -PET) is a non-invasive method for measuring tumor hypoxia. We analysed changes of FETNIM uptake during radiotherapy (RT) and their impact on local control in patient with esophageal cancer (EC). Methods: Patients with stage I-III EC undergoing radiation based treatment were enrolled in a prospective study (NSFC30700196). FETNIM-PET/CT scans were acquired prior to RT in all patients and rescans were acquired at 40 Gy in patients with hypoxia tumor (FETNIM activity>2.5). All patients were treated with conformal radiation therapy up to 70Gy, with or without chemotherapy per standard of care based on their stage of disease. FETNIM-activity was quantified by calculating tumor-muscle-ratios (TMR). Results: Total 27 enrolled patients underwent 64-70Gy radiotherapy and 4-6 cycles concurrent cemotherapy (fluorouracil and cisplatin). The tumor FETNIM activity of all patients prior to RT were 2.6±0.3. 14 patients with hypoxia tumor (FETNIM activity 3.2±0.4 prior to RT) acquired rescans after 40 Gy delivered. FETNIM activity decrased to a level lower than 2.5 in 8 patients and remained higher than 2.5 in 6 patients. According to FETNIM activity prior to and during RT, the patients were categrized into 3 sub-groups, non-hypoxia, tempory hypoxia and static hypoxia and had degressive 1 year local control (69.2%, vs. 37.5% vs. 16.7%). Conclusions: Tumor FETNIM activity and its change during-RT maybe associated with local control in patients with EC and deserve further study.
Biomarkers of Hemostatic Activation in a Randomized, Double-Blind, Phase 2 Study of Prasugrel Compared to Placebo in Adults with Sickle Cell Disease
Authors: Ted Wun, Charles L. Knupp, Lillian E. McMahon, John J. Strouse, Chunmei Zhou, Lori E. Heath, Chuke E. Nwachuku, Joseph A. Jakubowski, Kenneth J. Winters, Jeffrey S. Riesmeyer
Journal: Blood (2011)
Pharmacist-led monitoring program for patients on sunitinib for metastatic renal-cell carcinoma: A Canadian experience.
Authors: Scott Edwards, Lori Wood, Joy S. McCarthy, Andrew Collins, Lynn Hartery, Rick Abbott, Maria Whelan
Journal: Journal of Clinical Oncology (2014)

479 Background: Sunitinib is a standard of care for first-line treatment of metastatic clear cell renal-cell carcinoma (mRCC). Despite having a relatively good safety profile, Sunitinib does have several clinically important toxicities. With the rapid rise in the use of Sunitinib and other oral cancer agents, we instituted a pharmacist-led monitoring program in the ambulatory care setting to prospectively document, monitor, and manage toxicities in our Canadian province. Methods: The pharmacist-led monitoring program consisted of patient assessments in clinic with the oncology team combined with a call back program. The program consisted of a patient assessment in the oncology clinic on day 1 of a Sunitinib cycle followed with a call back on day 14. A chart review of consecutive patients who were prospectively monitored by this progam after receiving Sunitinib for mRCC was conducted. Treatment specific data for the first six cycles of therapy included dose reductions, therapy delays/interruptions, therapy discontinuation, and reason for each was recorded. Toxicity data including the occurrence and severity grade was collected. The time to treatment failure (TTF) defined as the time from therapy initiation to treatment discontinuation for any reason was measured. Results: Fifty six patients are included in the study cohort. Of these, 52 (92.86%) started at the standard 50 mg once daily and the remainder at a reduced dose. Additionally, 15 patients experienced hypertension requiring drug therapy adjustment or additional antihypertensive therapy. Two patients required drug therapy for hypothyroidism. There were a total of 39 dose reductions in this patient population over a six cycle period. The majority of dose reductions (46.2%) and therapy interruptions (34.5%) occurred during cycle one. The time to treatment failure for the 45 patients that discontinued therapy was 9.72 months. Conclusions: Pharmacist-Led monitoring of oral cancer therapies is a practical and feasible method of monitoring patients on Sunitinib for mRCC. The success has led to its implementation with other agents and disease sites.
Improving transitions of care through implementation of a standardized handoff at a comprehensive cancer center.
Authors: Diane C. Bodurka, Mohamed Ait Aiss, Helene P Phu, Lakeisha R Day, Varkey Abraham, Karen Chen, Mejia Rodrigo, Shehla Razvi, Carmen E. Gonzalez, Norman Brito-Dellan, Srinivas Banala, David Rubio, Nicole Vaughan-Adams, Debra S Ruiz, Tan Jens, Charles F. Levenback, Michael M. Frumovitz, Behrouz Zand, Carmelita P. Escalante
Journal: Journal of Clinical Oncology (2016)

242 Background: Communication failures cause two-thirds of sentinel events in hospitals. These adverse occurrences are often both fatal and preventable. Consequently, improving the quality of handoffs has been identified by multiple accreditation constituents as a top priority patient safety goal. This project was part of an institutional initiative to standardize handoffs among physicians, trainees, and midlevel providers. Methods: Four subgroups were identified as pilot areas: Gynecologic Oncology (Gyn Onc) fellows to nocturnalists, Surgical Oncology fellows, Pediatric Oncology residents and fellows, and Emergency Center attending staff to inpatient hospitalists. This abstract focuses on the Gyn Onc and Pediatric Oncology services. All teams used a PDSA cycle (Plan, Do, Study, Act) to conduct its pilot study. A gap analysis, root cause analysis, and process mapping were performed in each area to identify specific handoff issues. A validated standardized handoff tool, I-PASS (Illness severity, Patient summary, Action list, Situational awareness and contingency planning, and Synthesis by receiver), was selected. Of note, “Illness severity” highlights patients identified at higher risk for complications and denotes their status as “watcher” or “unstable.” Interventions included I-PASS skills training and utilization of the I-PASS mnemonic. Each service developed a standardized definition to identify patients classified as “watchers.” Medical errors, ICU transfers, and provider satisfaction were assessed pre- and post-intervention. Results: Results from 40 handoff surveys showed communication errors dropped by 10% (16.49 vs 14.93). Minor harm as result of a problematic handoff decreased by 45% (2.55 vs 1.39), with a 55% reduction in ICU transfers. There was an overall increase in handoff satisfaction using I-PASS and 100% standardization of handoffs across the Gyn Onc and Pediatric Oncology units. Conclusions: Implementation of I-PASS, a validated standardized handoff was associated with reductions in medical errors and improvement in communication. Our institution is moving toward implementing I-PASS across all units to increase the safety and quality of patient care.
Triage system in a high-volume domiciliary palliative care unit in urban India.
Authors: B. Duraisamy, M. A. Muckaden, M. Dighe, S. Chandorkar, S. Dhiliwal, P. Tilve, K. Midigiri, N. Shetty, M. Cardoz, S. Dhumal, A. Kanujia
Journal: Journal of Clinical Oncology (2011)

e19663 Background: The Palliative Care Service of the Tata memorial Centre caters to a monthly average of 100 patients on home care. An average of 25 patients are cared for at home in a radius of around 30 km from the hospital, over 6 working days. From May 2010, a system was introduced to prioritize patients who were planned for home care as “low”, “Medium” and “high” with an aim to deliver home care in 3 days, 7 days and 10 days respectively in an attempt to effectively optimize the available (limited) resources for maximum benefit to the patients. Methods: With an aim to review the triage system and identify factors that could possibly influence the priority given to a patient, records of patients (n=82; median age 50 years) currently on home care and coded, were analyzed. Priorities given were recorded against symptoms, psychological, social, spiritual distress, along with demographic data and analysed using SPSS for any correlation with triage. Multiple regression analysis was done to identify factors significantly affecting the triage. Results: 55 (67.1%) were coded “low”, 19 (23.2%) were coded “medium” and 8 (9.8%) were coded high priority. Median time to home care was 3 days for high priority, 8 for “medium” priority and 11 for “low” priority patients. Correlation using chi-square test revealed 4 factors – Symptom load (p=0.001), ECOG (p=0.007), Psychological distress (p=0.000), Social distress (p=0.008) which had highly significant association with a high priority. On multiple regression analysis, the model was good to fit (R2 0.774, p=1.000) and symptom load (p=0.009), psychological (p=0.016) and social distress (p=0.000) were the only significant factors associated with a “high priority”. The calculated predicted triage priority matched well with the observed triage priority 93.9%. Conclusions: A triage system is necessary in a high volume domiciliary care unit with resource limitations. Domiciliary palliative care means additional cost to the hospital but is very helpful for the patient. The results have helped us define the triage system and attempts are on to study patient satisfaction with the current model and to develop a model for home care triage relevant to resource poor palliative care settings.
An open label, randomized phase III trial evaluating the treatment (tx) effects of panitumumab (pmab) + best supportive care (BSC) versus BSC in chemorefractory wild-type (WT) <i>KRAS</i> exon 2 metastatic colorectal cancer (mCRC) and in WT <i>RAS</i> mCRC.
Authors: Tae Won Kim, Anneli Elme, Zvonko Kusic, Joon Oh Park, Anghel Adrian Udrea, Sun Young Kim, Joong Bae Ahn, Ricardo Villalobos Valencia, Krishnan Srinivasan, Ante Bilic, Nebojsa Manojlovic, Jun Dong, Xuesong Guan, Catherine Lofton-Day, A. Scott Jung, Eduard Vrdoljak
Journal: Journal of Clinical Oncology (2016)

642 Background: An overall survival (OS) benefit in WT KRAS exon 2 mCRC was not seen with pmab monotherapy in study 20020408 possibly due to crossover of patients (pts) in the BSC arm. Retrospective analyses have indicated that other KRAS and NRAS mutations beyond KRAS exon 2 are predictive of anti-EGFR tx effects. Study 20100007 assesses the OS benefit of pmab in chemorefractory WT KRAS exon 2 mCRC and is the first phase 3 trial to prospectively evaluate pmab tx effects in WT RAS (exons 2, 3, and 4 of KRAS and NRAS) mCRC. Methods: Anti-EGFR naive pts were randomized 1:1 to receive pmab (6 mg/kg Q2W) + BSC or BSC. KRAS exon 2 and RAS mutation status of tumors were determined centrally. The primary endpoint was OS in WT KRAS exon 2 mCRC. Secondary endpoints were OS in WT RAS mCRC and progression-free survival (PFS), objective response rate (ORR), and safety in both WT KRAS exon 2 and WT RAS groups. Crossover was not permitted. Results: 377 pts with WT KRAS exon 2 mCRC were enrolled. RAS ascertainment rate was 86%. OS was significantly improved with pmab + BSC vs BSC in both WT KRAS exon 2 (HR=0.73, 95% CI=0.57-0.93, P=0.0096) and WT RAS (HR=0.70, 95% CI=0.53-0.93, P=0.0135) mCRC (results in table). Pts with mutant RAS mCRC did not benefit from pmab tx (OS HR=0.99, 95% CI=0.49-2.00). No new safety signals were seen. Conclusions: Pmabsignificantly improved OS in chemorefractory WT KRAS exon 2 mCRC. The tx effects in OS and PFS were more pronounced in those with WT RAS mCRC, further substantiating the importance of RAS testing at diagnosis to best inform the use of pmab to treat mCRC. Clinical trial information: NCT01412957. [Table: see text]
ALK chromosomal alterations in neuroendocrine tumors.
Authors: C. Montagut, E. Arriola, A. B. Galvan, F. G. Rojo, M. Salido, M. Gallen, M. Garcia, A. Martinez, F. Pons, S. Servitja, M. Iglesias, S. Menendez, S. Serrano, F. Sole, A. Rovira, J. Albanell, J. Bellmunt
Journal: Journal of Clinical Oncology (2011)

10585 Background: Neuroendocrine tumors (NETs) comprise a heterogeneous group of neoplasms containing biologically active peptides and amines in their cytoplasm. Anaplastic lymphoma kinase (ALK) translocation has recently emerged as a potent predictor of benefit for treatment with ALK inhibitors. The endpoint of this study was to analyze ALK translocations and gene copy number status in a series of neuroendocrine tumors and correlate these findings with clinico-pathological features. Methods: Paraffin-embedded specimens from gastroenteropancreatic (GEP) and lung neuroendocrine tumors from patients diagnosed between years 2004-2010 were retrospectively retrieved from the tumor bank at our Institution. ALK gene status was characterized by fluorescence in situ hybridization (FISH) with a break-apart ALK probe (Abbot Molecular Inc). Translocation and gene copy gain were defined as previously reported (Salido et al). FISH ALK-positive and a set of negative cases were evaluated by immunohistochemistry (ALK-1, Dako). Statistical analysis was carried to evaluate the association between ALK gene alterations and clinico-pathological features. This study was approved by the review board at our Institution. Results: One hundred and eleven neuroendocrine tumors were included in the study. In 42 cases the sample was insufficient/inconclusive FISH results, leaving a final number of 69 evaluable cases (43 GEP, 20 lung, 6 other). There was one GEP neuroendocrine tumor (appendix) with an EML4-ALK translocation in 15% of tumoral cells and one lung neuroendocrine tumor with an atypical ALK translocation in 60% of tumoral cells (unknown partner). Ten cases (7 GEP; 3 lung) showed an increase in ALK gene copy number (mean 5 copies; range: 3-10 copies) with the percentage of cells with ALK copy gain ranging between 18-65% (mean 36%). Immunohistochemistry revealed <10% of tumor cells with mild ALK staining in the specimen with EML4-ALK translocation. The low number of positive cases precluded the finding of statistical associations. Conclusions: Although rare, ALK translocations are present in neuroendocrine tumors. This reveals a potential new indication for ALK inhibitors that merits further investigation.
Treatment for RAS wild-type (wt) metastatic colorectal cancer (mCRC): Continuation of anti-EGFR therapy while switching chemotherapy regimen.
Authors: Liubov Yu Vladimirova, Natalya A Abramova, Oleg Ivanovich Kit
Journal: Journal of Clinical Oncology (2016)

744 Background: The purpose of the study was to assess the effeciency and safety of continuing of EGFR-inhibition while switching the chemotherapy (CT) from FOLFOX+Cetuximab (C) as the 1 st -line to FOLFIRI+С as the 2 nd -line treatment for pts with RAS wt mCRC. Methods: Pts with RAS wt mCRC were enrolled to the pilot study according to inclusion criteria: ECOG≤2, normal bone marrow, liver and kidney functions, no brain metastases, measurable metastatic lesions. The therapy included: the 1 st -line with FOLFOX-6+C until progression, then FOLFIRI+C as the 2 nd -line therapy. The treatment continued until progression or unacceptable toxicity. Response rate (RR), PFS after the 1 st and the 2 nd lines of treatment as well as toxicity were evaluated. Results: 20 pts (11 men, 9 women), 38-58 years old, mean age 48.3±1.3 years, were recruited. All pts had multiple visceral metastases: to the liver –30.0%(6), lungs and pleura – 20.0%(4), liver and lungs – 50.0%(10), including the bone metastases – 15.0%(3). The RR was 85.0 %(17), including PR - 4(20.0%) and SD - 13(65.5%). Median PFS after the 1 st -line therapy was 12.3±2.6 months, median PFS after the 2 nd -line therapy - 6.5±2.8 months. Median OS was not reached yet. Adverse events included: neutropenia Gd2 – 30.0%(6), Gd3 – 20.0%(4), anemia Gd2 – 10.0%(2), stomatitis Gd2-3 – 20.0%(4), diarrhea Gd2 - 55.0%(11), thrombophlebitis – 10.0%(2). C-associated dermatologic toxicity: acneiform rash Gd2-3 – 85.0%(17), skin itching Gd2 - 30.0%(6), panaritium Gd1-2 -30.0%(6), blepharitis Gd1-2 – 10.0%(2), hypertrichosis – 20.0%(4). Conclusions: Continuing EGFR-inhibition with C while switching CT regimens beyond progression provided significant tumor control and was not accompanied by unacceptable toxicity. This strategy deserves futher evaluation in randomized studies in EGFR-dependent mCRC pts.
Newly onset hyperlipidemia in metastatic renal cell carcinoma patients treated with sunitinib.
Authors: Valentina Baldazzi, Renato Tassi, Alberto Lapini, Marco Carini, Roberto Mazzanti
Journal: Journal of Clinical Oncology (2012)

459 Background: To our knowledge effects of sunitinib on serum lipids metabolism are not described. Here we report about the occurrence of hypercholesterolemia and hypertriglyceridemia in patients receiving sunitinib for metastatic renal cell carcinoma (mRCC). Methods: Between July 2008 and September 2011, we prospectively evaluated serum triglycerides and cholesterol in 37 patients receiving sunitinib for mRCC according to classic 6-week schedule. On average they received sunitinib for 10.3 cycles. Serum lipids were measured before the beginning of treatment and at the end of each sunitinib ON period as routine laboratory evaluations. Results: At baseline median triglycerides was 163,83 mg/dl (± 76,6 mg/dl 95% CI) and median cholesterol was 201.6 mg/dl (± 35.5 mg/dl 95% CI). During sunitinib administration 25 patients (67.5 %) presented an elevation of serum lipids as compared to baseline. These abnormalities usually developed within 1.8 cycles (range 1-5 cycles). While on sunitinb median triglycerides was 333,6 mg/dl and median cholesterol was 243.5 mg/dl (+ 103% and + 21% respectively, compared to baseline). Patients who developed hypercholesterolemia presented an increase of both HDL and LDL cholesterol. Conclusions: Hyperlipidemia develops in an elevate percentage of patients on sunitinib. The mechanism of this event remains unclear. Recently, an interaction between platelet derived growth factor receptor (PDGFR) and lipoprotein receptor (LR) family was described and this is supposed to be an important step towards the internalization of LR itself. Because sunitinib inhibits PDGFR, a lower plasma lipoproteins clearance could be expected, resulting in an increase of serum lipids. It is noteworthy that PDGFR inhibition was associated with delayed atherosclerotic plaque formation, having an anti-atherogenetic effect. Therefore treatment with sunitinib, even if associated to hypertension and hyperlipidemia, may not result in an increase of cardiovascular events.
Barriers to recruitment of rural patients in cancer clinical trials
Authors: S. Virani, J. Abraham, L. Burke
Journal: Journal of Clinical Oncology (2008)

17502 Background: With advancement in research, it is imperative for clinical trials to be accurate and generalizable. This is best achieved through improving patient participation in clinical trials. However, according to the National Cancer Institute, only 3% of adult cancer patients participate in clinical trials. Although, several studies have looked into the barriers to accrual in clinical trials amongst various patient subgroups, there is lack of data regarding factors that influence enrollment of rural patient population. Our study aims to identify these barriers in an attempt to improve future participation. Methods: Amongst patients with a known cancer diagnosis who followed with the Mary Babb Randolph Cancer Center at West Virginia University, we randomly selected 1000 patients. Questionnaires were mailed to the patients. Data obtained in the questionnaire consisted of demographics, clinical information, awareness about clinical trials, willingness to participate in and factors influencing participation in clinical trials. Patients had six weeks to respond. The data was tabulated and analyzed using SPSS. Results: 241 patients responded to the survey. Most respondents (68.4%) had heard about clinical trials prior to the survey. 20.3% reported of their healthcare team discussing about clinical trials. 9.2% reported having participated in clinical trials. Most respondents reported that they (87.3%) and their families (70.9%) participated in healthcare decisions. Respondents were more likely to be at least somewhat willing to participate in a cancer screening trial compared to a new cancer drug trial. With regards to their decision to participate in cancer clinical trials, patients cited discouragement from oncologist (62.5%), monetary burden (53.4%), discouragement from family physician (49.5%) and lack of information (35%) as strongly/extremely influential factors. Conclusions: Our findings specify the need for patient education through community outreach programs and through educating physicians about cancer clinical trials. Physicians should be trained to discuss clinical trial protocols and to address patient concerns regarding availability, utility and accessibility of clinical trials. Financial counseling can play an important role in improving accrual rates. No significant financial relationships to disclose.
Allogeneic Stem Cell Transplantation (allo-SCT) for Chronic Myelomonocytic Leukemia – a Multicentre Australian Experience: Prognostic Factors for Survival and Relapse
Authors: Ashish R. Bajel, Cameron Curley, Andrew Boon Ming Lim, Sasanka Handunnetti, Bartlomiej Getta, Philip A Thompson, Matthew P.F. Wright, Matthew Greenwood, Mark S Hertzberg, David J. Curtis, Jeffrey Szer, Glen A Kennedy, David Ritchie
Journal: Blood (2014)