tbuckley/cabot-search huggingface dataset:
CA 19-9 and ALP as potential biomarkers for pancreatic cancer risk: Analysis from a large lab test database.
Authors: Carol Smyth, Jason M. Bhan, Ajitpal Singh Dhaliwal, Tatiana Sorokina, Mauricio Alarcon, Jason S. Levitz
Journal: Journal of Clinical Oncology (2015)

e15211 Background: The search for effective biomarkers to screen for pancreatic cancer continues. We used results from a large lab test database (Medivo Lab Value Exchange Database, LVX) to study possible serum biomarkers. Methods: We studied all patients tested for CA 19-9 in the LVX between Jan 2010 and Oct 2014, N = 9,335, of whom 1,674 had an ICD-9 code for pancreatic cancer. In all patients, we found a total of 20,458 CA 19-9 tests. Based on # of CA 19-9 tests, timing of CA 19-9 tests, and ICD-9 code, we divided patients into groups - those with no further CA 19-9 testing after: 1 test/no code (NODx); multiple tests/no code (B_NODX); 1 test/code (B_Dx); multiple tests/code (Dx); and additional testing after diagnosis in patients who had 1 test/code (Dx_A) or multiple tests/code (B_Dx_A). We also looked at alkaline phosphatase (ALP) and bilirubin results. Logistic regression was used to model the probability of a pancreatic cancer diagnosis based on abnormally high test results defined as CA 19-9 >100 U/ml and ALP > 100 U/L. Results: See table for group comparisons. We found that patients with high levels of both CA 19-9 and ALP had a 46% risk of being diagnosed with pancreatic cancer. The risk of being diagnosed with pancreatic cancer was 30% in those with only high CA 19-9, 13% in those with only high ALP and 7% in those with neither abnormal result. Bilirubin results were not found to be associated with risk for pancreatic cancer. Conclusions: In the absence of a specific serum biomarker to screen for pancreatic cancer, high levels of both CA 19-9 and ALP may indicate a need for follow-up radiological screening for a pancreatic tumor. More study is needed to confirm this finding, and to further study the demographics and outcomes of the patient population being tested for CA 19-9. NODx B_NODX B_DX DX DX_A B_DX_A Total # of patients 6,366 1,295 55 607 851 161 # of patients with other cancer ICD-9 code 862 275 8 - - 48 Avg CA 19-9 test result 1,399 1,787 8,831 17,986 851 5,706 Avg # of CA 19-9 Tests 1.0 4.0 1.0 2.5 7.1 9.1 Pts w/CA19-9 and ALP test result 3,012 684 25 258 308 54 Avg ALP test result 126.33 153.41 225.72 230.40 166.47 187.52 Avg bilirubin test result (mg/dL) 0.85 0.98 0.98 1.40 0.79 1.97 Avg Age (yrs) 63 65 67 69 67 65
Time to follow-up and treatment in patients with newly diagnosed prostate cancer (PC) across clinical stages in an equal access health system.
Authors: Anitha Nallu, Nirupama Devi Mitikiri, Ebere Onukwugha, C. Daniel Mullins, Arif Hussain
Journal: Journal of Clinical Oncology (2013)

210 Background: The purpose of this pilot study is to describe the time interval from diagnosis to initial specialist visit and treatment initiation in pts with newly diagnosed PC across different clinical stages (S1- 4) in an equal access system such as a Veterans Affairs Medical Center (VAMC). Methods: Data from the Baltimore VAMC database were used to examine pts diagnosed with PC in 2010 to assess variation across different clinical stages with respect to follow up with specialists, diagnostic tests and treatment initiation during the year following diagnosis. Specialists include urologists, medical oncologists and radiation oncologists. Diagnostic tests included CT and/or bone scans. Treatments based on clinical staging included active surveillance, radical prostatectomy, external beam radiation therapy, brachytherapy, androgen deprivation therapy, chemotherapy or enrollment into clinical trials. Results: One hundred and nine pts were diagnosed with PC at the BVAMC in 2010. All but one patient had follow-up with a specialist after positive prostate biopsy. Majority of pts in each stage saw more than one specialist (S1-50%, S2-74%, S3-60%, S4-82%). The median number of days to first follow up visit with a specialist was similar across all stages (S1-16 d, S2-15 d, S3-17 d, S4-14 d). Four out of the 109 pts were lost to follow up. S4 pts were initiated on treatment at a median of 26 days after diagnosis, whereas S1, S2 and S3 pts were initiated on treatment at a median of 151,100 and135 days respectively, after diagnosis. Pretreatment CT scan and/or bone scans were done in S1-38%, S2 -70%, S3-80% and S4-100% pts. Conclusions: The results of this pilot study showed that while time to initial follow up visit after diagnosis of PC does not differ across the clinical stages, treatment for S4 pts is initiated much earlier than for the other stages. It will be of interest to determine whether these patterns hold for other years and in other VA Medical Centers.
Expanding Nilotinib Access in Clinical Trials (ENACT) study in adult patients with imatinib-resistant or -intolerant Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) in chronic phase (CP), accelerated phase (AP), or blast crisis (BC): Updated safety analysis
Authors: F. E. Nicolini, G. Alimena, H. Al-Ali, A. Y. Zaritskey, Z. Shen, S. Jootar, G. Smith, Y. Hsu, M. L. Veronese, D. A. Rizzieri
Journal: Journal of Clinical Oncology (2008)

7059 Background: Nilotinib, is a potent and highly selective oral inhibitor of BCR-ABL, approved in both the US and Europe for the treatment of patients (pts) with Ph+ CML-CP and -AP who are resistant or intolerant to prior therapy including imatinib. Methods: The ENACT study, which is ongoing, was initiated to provide expanded access to nilotinib and to obtain additional safety information in pts with imatinib-resistant or -intolerant CML-CP, -AP, or -BC. Pts received 400 mg nilotinib twice daily (BID). Dose escalation was not permitted. Pts who required dose reduction to 400 mg once daily due to toxicity were allowed to have a dose re-escalation to 400 mg BID after resolution of the adverse events (AEs) to grade 1, lack of response, or persistent disease at the investigator's discretion. Results: Results are available for the first 1056 of the more than 1400 currently enrolled pts (CP, n = 818; AP, n = 120; BC, n = 118). Median age of pts was 53 years, and 69% were imatinib-resistant. AE data are available for 974 pts. At data cutoff (June 30, 2007), 710 pts (67%) were continuing on nilotinib. Median duration of nilotinib exposure was 124 days for CP, 90 days for AP, and 54 days for BC. The main reasons for discontinuation were inadequate responses (13%) and AEs (11%). The majority of AEs were hematologic, with the most common grade 3/4 hematologic lab abnormalities being thrombocytopenia (22%) and neutropenia (13%). Non-hematologic AEs were mostly mild to moderate and included headache, rash, and nausea. Deaths were reported for 28 (3%) pts, and occurred more frequently among those with BC (n = 15). A low incidence of QT prolongation (QTcF > 500 msec, n = 2, 0.2%) was observed overall. Conclusions: This updated analysis of a large expanded access study further demonstrates that nilotinib is generally well tolerated in heavily pretreated pts in all phases of CML and shows no change in the safety profile of nilotinib in Ph+ CML. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Novartis Novartis Novartis Novartis
Feasibility and savings of a suspicion of cancer clinic at a large county hospital.
Authors: Sarah Schellhorn Mougalian, Jennifer Wang, Maria Alejandra Zarzour, Doris Quinn, Alyssa G. Rieber
Journal: Journal of Clinical Oncology (2012)

104 Background: The Lyndon B. Johnson General Hospital (LBJGH) is part of the Harris County Hospital District (HCHD), serving the third largest county in the United States. Many patients are admitted to the hospital for expedited workup when cancer is suspected to avoid outpatient delays. We sought to establish the main contributors to delays in cancer diagnosis and to calculate the potential savings, both in terms of time and expense, of an ambulatory Suspicion of Cancer Clinic. Methods: The charts of 327 consecutive new patients to the LBJGH medical oncology clinic between June 2011 and November 2011 were reviewed. Only patients whose cancer was diagnosed within HCHD (n=165) were included in the analysis. Dates of initial presentation, emergency department (ED) visits, abnormal imaging, admissions, diagnosis, and initial oncology visit were collected, along with the method of diagnosis. Additional chart review was performed to determine which admissions were solely for expedited work up based on the documentation provided. The project was approved by the MD Anderson Quality Improvement Assessment Board. Results: 60% of cancer diagnoses were made in the ambulatory setting, whereas 40% of patients were diagnosed inpatient. Breast cancer was the most frequent cancer diagnosis. The mean time from presentation to diagnosis in the inpatient setting was 3.9 days for breast cancer, 12.9 days for colon cancer, and 5.5 days for lung cancer. For patients diagnosed in the ambulatory setting, the times were 77.1 days, 65.4 days, and 70.8 days respectively. 15.6% of patients were admitted to the hospital for expedited work up, accounting for 130 hospital days. Based on the average costs in HCHD, elimination of hospitalizations and multiple ED visits using an ambulatory suspicion of cancer clinic could save more than $300,000 annually. Conclusions: We propose a Suspicion of Cancer Clinic to expedite outpatient diagnostic workup, in collaboration with diagnostic imaging, surgical specialties, and pathology. The establishment of a Suspicion of Cancer Clinic could reduce ambulatory diagnostic times, decrease the frequency of admissions, and potentially improve patient outcomes. Piloting of this clinic is underway.
Initiative to streamline clinical trials (ISCT): Guidance for academic investigators/sponsors.
Authors: Jasmine Grant, Katherine Brodeur-Robb, Alison May Urton, Jacqueline Bosch, Lesley Seymour, Karen E. Arts
Journal: Journal of Clinical Oncology (2016)

219 Background: The 2011 Canadian Cancer Research Alliance (CCRA) report on the State of Cancer Clinical Trials in Canada outlined in detail the threats to the conduct of academic oncology clinical trials caused by increasing complexity and workload resulting from a perceived onerous regulatory environment. The report recommended engaging Health Canada and key stakeholders to foster agreement in appropriate interpretations of the Canadian Food and Drug Regulations Part C Division 5 and ICH Good Clinical Practice (GCP) guidelines. Methods: The ISCT Working Group (ISCT WG) was formed in 2012 to address the CCRA recommendations for academic clinical trials and include experts from multiple therapeutic areas. The primary objective of the ISCT is to develop specific, practical interpretations of current regulations, laws and guidelines to facilitate Canadian clinical trials. Feedback was obtained from interested parties and ISCT members by means of surveys, face-to-face meetings and conference calls. Results: The major areas of concern identified include Health Canada Clinical Trial Applications, Investigational Product supply, monitoring, oversight of equipment and facilities, delegation of duties, validation of electronic systems, source documents and records retention, trial costs, the consistency of interpretation by different divisions of Health Canada, and access to related resources. A subcommittee was established for each area identified above and a series of recommendations to streamline processes with a focus to reduce regulatory burden for academic clinical trials. The ISCT WG used other relevant documents including the OECD framework and FDA Guidance on Risk Based Monitoring to inform its work. Conclusions: The final recommendations of the ISCT have been provided to all stakeholders, presented at international conferences and published on the N2 website. Canadian academic sites have used guidelines during Health Canada inspections with success. Future goals include an ISCT Workshop for academic site leaders to facilitate implementation of the ISCT guidelines, continue to address areas of concern, and track the success of the recommendations in ameliorating the conduct of academic trials.
Primary care physician (PCP) referral patterns for prostate cancer (PC) patients: Web-based survey.
Authors: Rajitha Sunkara, Uday Lele, Aixa Soyano, Olga Kozyreva
Journal: Journal of Clinical Oncology (2014)

228 Background: Prostate cancer (PC) is the most common cancer and second most common cause of cancer related death in men. The therapeutic options for PC patients are rapidly expanding making treatment decisions more complex. For patients with high-risk PC, significant body of evidence demonstrates that multidisciplinary approach improves outcome. PCP has a major role in early detection, provision of counseling, appropriate referral and management of metabolic side effects (SE) of androgen deprivation therapy (ADT). We conducted a survey among PCP’s to understand their referral patterns. Methods: We emailed a 10 question web based survey to around 300 practicing PCP’s in the Boston area. Of them, 56 responded. We analyzed the responses using independent t test for demographics and ANOVA for years of experience of the individual physician. Additional multivariate analysis was done using all independent variables together. Results: 30.3% of the physicians never feel the need to refer a newly diagnosed prostate cancer patient to a medical oncologist (MO). 60.8% of the PCP’s anticipate that urologist should refer the patients to a MO. Only 9% of PCP’s feel responsible for managing the SE of ADT. 46.4% anticipate urologist and 44.6 % anticipate oncologist to manage the SE of ADT. Female physicians appear to be more comfortable in providing counseling to the newly diagnosed PC patients than the male physicians (P=0.001). Male physicians and US medical graduates tend to refer to the MO most often than the female physicians and foreign medical graduates (P=0.013 and p=0.015 respectively). On multivariate analysis US medical graduates with higher years of experience are more comfortable providing the counseling and discussion of newer treatment options for a newly diagnosed PC (p=0.011 and 0.016 respectively). Overall 44.6% are not aware of newer treatment options for castration resistant PC. Conclusions: In the era of expanding armamentarium of treatments for PC, our results indicate the need to increase the awareness of PCP’s regarding the available treatments and emphasize the importance of multidisciplinary approach to better serve the PC patients with appropriate and timely referrals.
Unnecessary axillary lymph node dissection in the era of sentinel lymph node biopsy.
Authors: Tina W.F. Yen, Purushottam W. Laud, Liliana E Pezzin, Emily McGinley, Erica Wozniak, Rodney A. Sparapani, Ann B Nattinger
Journal: Journal of Clinical Oncology (2015)

71 Background: No population-based effectiveness studies have been performed to determine to what extent breast cancer patients are benefiting from sentinel lymph node biopsy (SLNB). This study investigates the extent of unnecessary axillary lymph node dissection (ALND) by surgeon volume and specialty, and estimates the resultant rates of excess lymphedema (LE). Methods: Women with Stage I-III pathologically node-negative (pN0) breast cancer diagnosed in 2008-2009 were identified from the SEER-Medicare linked database. Patients who received neoadjuvant chemotherapy were excluded. Type of axillary surgery was defined by claims. Unnecessary ALND was defined as a patient who underwent either an initial ALND or SLNB followed by ALND. Surgeon volume tertiles were created with roughly a third of cases in each volume group (low, medium, high). Surgical specialty (surgical oncologist, general, other) was determined by the specialty code listed on the claim. A logistic regression model, adjusting for patient and tumor characteristics, was performed to predict the likelihood of receiving an unnecessary ALND. Estimates of LE rates were determined based on the number of nodes removed. Results: 7,946 pN0 patients underwent surgery by 2,101 surgeons. Half underwent SLNB only; 50% had unnecessary ALND (39% converted from SLNB to ALND, 11% ALND only). There was an interaction between surgeon volume and specialty (p &lt; 0.01); surgical oncologists, compared to non-surgical oncologists, were less likely to perform unnecessary ALND in all three volume groups. This effect was largest in the medium volume group (OR 0.37; 95% CI: 0.26-0.51). The LE probability was 14% with an excess LE rate of 4.5%. Unnecessary ALNDs accounted for 84% of the estimated excess LE patients and represented 27% of all potentially avoidable LE cases. Conclusions: Half of pN0 patients underwent unnecessary ALNDs, which accounts for 27% of all potentially avoidable LE cases. The likelihood of undergoing an unnecessary ALND was lower in all three surgeon volume groups if patients were operated on by surgical oncologists. Policies to assess surgeon proficiency in SLNB and/or regionalization of care should be considered to decrease rates of unnecessary ALND and ultimately LE.
Preventive skin care among cancer survivors.
Authors: S. C. Lau, W. Y. Cheung
Journal: Journal of Clinical Oncology (2011)

9103 Background: Research indicates that physicians may neglect preventive care among CS because of continued focus on the primary cancer. The degree to which self-motivation of CS affects their own preventive care is unknown. Using preventive skin care as a proxy for personal willingness to engage in preventive behavior, our aims were to 1) characterize preventive skin care practices in CS and noncancer patients (NCP) and 2) identify clinical factors associated with preventive care. Methods: Using data from the U.S. Health Information National Trends Survey, we compared preventive skin care between CS and NCP. Self-reported use of 1) sunscreens, 2) long sleeved shirts, 3) hats, 4) shades and 5) tanning beds were the primary endpoints. Logistic regression models were developed to evaluate for differences in preventive skin care patterns between CS and NCP. Results: In total, 179 early CS of <5 years, 242 intermediate CS of 5 to 10 years, 412 long-term CS of >10 years and 5,951 NCP were identified: mean ages were 61 / 63 / 69 / 53 years, 47 / 52 / 68 / 60% were female, and 64 / 71 / 73 / 75% were White, respectively. In the entire cohort, the use of sunscreens (60%), long-sleeved shirts (88%), hats (58%), shades (68%) and tanning beds (6%) were suboptimal. When compared to NCP, CS were not any more likely to adhere to preventive skin care (Table). There were no significant differences among early, intermediate and long-term CS. In multivariate analyses, those who were young or female were more likely to use sunscreens while those who were elderly or male tended to use hats and shades for prevention. Conclusions: A prior diagnosis of cancer does not appear to increase self-awareness or personal compliance towards cancer prevention. In addition to physician-directed interventions, targeted strategies that increase patient motivation may be needed to improve preventive practices among CS. Preventive skin care in cancer survivors. Sunscreen P value Long shirts P value Hats P value Shades P value Tanning beds P value NCP 1.00 0.64 1.00 0.70 1.00 0.59 1.00 0.51 1.00 0.50 CS<5y 1.29 1.27 1.27 0.67 0.20 CS5-10y 1.11 0.81 0.81 0.91 0.62 CS>10y 1.18 1.24 1.24 0.79 0.84 Abbreviations: NCP, non-cancer patients; CS<5y, survivors of less than 5 years; CS5-10y, survivors of 5 to 10 years; CS>10y, survivors of more than 10 years.
Mobile solution for clinical research documentation.
Authors: Lindsay Philip, Jasmine Grant, Calven Eggert, Aaron Di Nardo, Susanna Sellmann, Heather Cole, Marcia Flynn-Post, Leslie Williams-Brennan, Pamela Degendorfer
Journal: Journal of Clinical Oncology (2014)

153 Background: As trial complexity increases, there is a growing need to facilitate rapid communication of trial data among members of the research and clinical care teams. Timeliness of investigator review and high quality data are critical to clinical trial documentation. Princess Margaret developed an electronic application that meets these needs, is integrated into a patient’s medical chart, and is accessible at the point of care on a mobile device. Methods: Focus groups were held with research staff to evaluate application and device needs. Device needs were usability, compatibility with the electronic patient record (EPR), and encryption ability, which were considered and a device was selected. Standard templates were developed for the informed consent process, clinical notes, vital signs, baseline symptoms, adverse events, and concomitant medications. Electronic source (eSource) was linked to an existing CTMS, the Clinical Research Record. eSource is accessible via the EPR, allows for electronic review and sign off by investigators, and allows data capture directly into the EPR from a mobile device. Results: A 4 month pilot was completed in December 2013 with 10 clinical research nurse coordinators (CRNCs) from 3 different treatment areas, enrolling 40 patients. The project continues to roll out and will be completely integrated by July 2014. CRNCs enter information at the point of care that is easily shared amongst research and clinical care teams; important safety information is available to all staff; investigators can sign off electronically; and data has an audit trail. Metrics collected over a two-month span demonstrate average investigator sign off is completed within 7 days, well under our established timelines of within a cycle of treatment. Conclusions: Enhancements were made within the system during the pilot to facilitate workflow as issues were identified. The system provides solutions for delayed documentation, the transfer of paper charts between team members, and investigator sign-off. This has allowed for tracking of metrics including the timeliness of documentation, review, and sign off; and quality improvements to documentation will be measured through internal quality assurance reviews.