tbuckley/cabot-search huggingface dataset:
An electronic intervention to improve structured cancer stage data capture.
Authors: Kerin B. Adelson, Kim Framski, Patricia Lazette, Teresita Vega, Rogerio Lilenbaum
Journal: Journal of Clinical Oncology (2016)

151 Background: Cancer Staging is critical for prognosticating, treatment planning, outcomes analysis, registry reporting and clinical trial eligibility determination. Oncology EHRs have structured staging modules but use by physicians is inconsistent. Typically, stage is entered as unstructured free text in clinical notes and cannot be used for reporting. Instead, institutions depend the tumor registry (TR) which typically lag 6 months behind. Our Cancer Committee determined that real-time capture of structured cancer staging was an imperative. Methods: We created an EPIC best practice advisory (BPA) decision support tool that requires physicians to enter cancer stage if the following criteria are met: 1)unstaged cancer on the problem list 2)EPIC staging module exists for that cancer 3)physician is from a specialty with staging expertise. This BPA was implemented 12/18/14. If physicians chose not to stage they had to enter a reason why. Choices were: 1) cancer diagnosed before 2014, at which the BPA was permanently removed 2) staging studies not yet completed, at which the BPA fired at a future encounter 3) Not a staging provider, at which the BPA no longer fires for that individual provider 4) Cannot stage: document reason, at which the BPA was permanently removed. Results: We used TR data to determine the number of patients who were eligible for staging. In 12 months prior to the intervention, 1480/5222, or 28% of patients who were eligible for staging were staged in the structured staging module. After we launched the intervention, between 12/18/14 and 4/30/15, 1654/1831 or 90% of eligible patients were staged electronically. This is an absolute improvement of &gt; 200% Conclusions: Electronic decision support can dramatically improve rates of structured staging. Such data allows automated reports for clinical trial screening, outcomes analysis, quality comparisons, and reporting. We are now building automated reports for: clinical trial eligibility, Commission on Cancer/ QOPI breast, colon and lung measures, rates of palliative care consultation for advanced disease and outcome measures like disease free interval by stage and overall survival.
History of smoking and future of lung cancer mortality: A cross-national comparison.
Authors: S. S. Soneji, A. Syse
Journal: Journal of Clinical Oncology (2011)

e16503 Background: The association of smoking and lung cancer mortality has been well established for over 50 years. Smoking patterns differ by age, sex, year, and country reflected in public health campaigns, taxation, and social stigma. Historically, smoking has been more prevalent among men than women, but lately it has declined more rapidly among men. We forecast lung cancer mortality over the next decades in two countries with different smoking patterns: In Norway, smoking rates declined slowly for men and remained stagnant for women, whereas in the US, smoking has declined more consistently, especially for men, but lately also among women. Methods: US and Norwegian death certificates and population counts (1969-2007) and historical smoking prevalence by age, sex, and year (1961-2007) were used. Bayesian hierarchical forecasting modeling was employed to forecast lung cancer mortality by age, sex, and year, taking into account known demographic patterns and smoking prevalence 25-years earlier in age and year. Results: Smoking levels were historically higher for men in both countries. The pace of decline was fastest for US men, next US women and Norwegian males, and finally relatively stagnant for Norwegian females. Strong time-lagged correlation of age-specific lung cancer mortality and smoking prevalence 25-years earlier in age and year. Between 2007 and 2032, we forecast the age-standardized crude death rate change from 80 to 53 for US males, 52 to 34 for US females, 58 to 74 for Norwegian males, and 34 to 91 for Norwegian females (lung cancer deaths per 100,000 person-years). Conclusions: The burden of lung cancer mortality is shifting to females, and there is thus a greater need for anti-smoking and lung cancer screening initiatives directed towards women in both the US and Norway. Whereas the total lung cancer burden will decline in the US in the near future, our forecast predicts that this burden will increase in Norway. This population-level mortality forecast may be useful for setting research priorities and allocating public health expenditures.
Making the (business) case for outpatient and home-based palliative care for cancer patients.
Authors: Brian Cassel, Kathleen Kerr, Egidio Del Fabbro
Journal: Journal of Clinical Oncology (2013)

266 Background: Randomized controlled trials by Temel (2010) and Brumley (2003, 2007) have demonstrated the positive clinical, psycho-social, and utilization impact of providing early clinic or home-based palliative care (PC) concurrently with standard disease-focused treatment. Despite clear benefits, the growth of outpatient PC has been constrained by lack of clarity about the “business case” for hospitals or health systems to develop and fund PC services outside the inpatient setting. Methods: We will present findings from Virginia Commonwealth University (VCU) that provide a compelling quantification of the risks for hospitals to continue “business as usual” in this changing environment. Our approach measures quality, quantity, and costs of care for patients with cancer over a period of 6-12 months prior to death. Performance on some of these measures impact revenues in the prevailing fee-for-service reimbursement model; others are utilized in national, public ratings of quality; and still others influence organizational ability to compete in the population health management model that rewards quality and efficiency over time. Results: We used these data to highlight VCU Health System’s exposure to financial risks to create a strong business case for outpatient palliative care in which patient-centered and hospital-centered outcomes are aligned. This approach elevated our proposal to be included in a broader strategic initiative by our health system to manage complex care more efficiently, and to manage population health more proactively. Our analytic approach was then replicated by a diverse group of California provider groups who adopted or adapted the VCU model to advance their community-based palliative care programs as part of the California Health Care Foundation’s “Palliative Care Action Community” initiative. Conclusions: Our analytic model and articulation of the business case for community-based palliative care can help others to create and sustain quality-driven, patient-centered, cost-effective PC programs in their own institutions.
Changing characteristics of patients treated with sipuleucel-T (sip-T) over time: Real-world experience from the PROCEED registry.
Authors: Andrew J. Armstrong, Celestia S. Higano, A. Oliver Sartor, Nicholas J. Vogelzang, William R. Berry, David F. Penson, Vahan Kassabian, Luke T. Nordquist, Nancy N. Chang, Jennifer Susan LIll, Matthew R. Cooperberg
Journal: Journal of Clinical Oncology (2016)

320 Background: Sip-T is an autologous cellular immunotherapy approved by the FDA for the treatment of asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer. PROCEED (NCT01306890) is a phase 4 registry evaluating men receiving sip-T therapy in the US. Patient characteristics and treatment trends were assessed from 2011 to 2013, when several agents with an overall survival benefit became commercially available. Methods: For patients enrolled from 2011 to 2013, baseline patient and disease characteristics at the first sip-T infusion, trends in prior therapy, and pre–sip-T baseline prostate-specific antigen (PSA) levels were examined year over year. Results: From 2011 to 2013, 1902 patients were enrolled and received ≥ 1 sip-T infusion: 2011, n = 145; 2012, n = 967; 2013, n = 790. During this time period, enrollment of African American men nearly doubled from 6.9% to 13.4%, and central venous catheter use to facilitate sip-T infusion decreased (from 53.8% to 44.1%). Median baseline lactate dehydrogenase (LDH) levels and the number of lymph node metastases also decreased as well as median baseline PSA values (17.8 ng/mL to 11.9 ng/mL [P = 0.002]). Prior use of first-generation anti-androgens (from 73.1% to 60.5%), ketoconazole (17.2% vs. 6.3%), and estrogen (4.8% vs. 1.6%) decreased along with prior docetaxel use (19.3% vs. 7.5%). In contrast, prior investigational use of abiraterone acetate (from 3.4% to 8.9%) and enzalutamide (1.4% vs. 3.2%) increased over time. Conclusions: Over the duration of PROCEED, the decrease in baseline PSA, lower LDH, fewer nodal metastases, and decline in prior docetaxel use suggest that sip-T is being used earlier in the course of metastatic castration-resistant disease. Moreover, second-line hormonal therapy use with agents that do not improve overall survival appears to be substituted by therapies that do. This decrease in second-line hormonal therapies during PROCEED could suggest a real-world preference for earlier sip-T use. Clinical trial information: NCT01306890.
Temporal changes in the survival of metastatic renal cell cancer patients and the impact of targeted agents: Single center experience.
Authors: Mustafa Erman, Zafer Arik, Saadettin Kilickap, Cenk Yucel Bilen, Sertac Yazici, Bulent Akdogan, Haluk Ozen
Journal: Journal of Clinical Oncology (2014)

519 Background: Though targeted agents have dramatically changed the outcome of metastatic renal cell cancer (mRCC) patients, it has not been possible to show any survival advantage, probably due to substantial cross-over in randomized trials. The change in survival times following the introduction of targeted agents may yield indirect evidence of an improvement in overall survival (OS). Methods: First targeted agents were available in Turkey in 2007. Data from the hospital charts of adult mRCC patients treated between January 2003 and December 2012 were included. Demographic and clinical findings along with patient, tumor, and treatment-related prognostic factors and their correlation with progression-free survival (PFS), and OS were analyzed. Results: One hundred and seventy six patients had metastatic disease. Of these, 107 patients received at least one dose of interferon-α and 74 patients received at least one targeted therapy. Median follow-up was 19.1 months (range 1-97 months) and median OS was 24.6 months (95% CI, 20.4-28.9). Median OS of patients who received any targeted therapy was significantly better than those who did not (29.1 mths [95% CI, 21.4-36.8] vs 19.4 mths [95% CI, 14.2-24.6]; p=0.036). The study period of 2003-2012 was subdivided into 4 consecutive groups. Although not statistically significant, a trend toward better survival was observed with advancing years and increasing targeted therapy use (p=0.09). For example, median OS of patients diagnosed in 2006 and 2007 was 14.1 months (95% CI, 10.4-17.8) while median OS of those diagnosed in 2010 or later was 30.8 months (95% CI, 18.3-43.3). Patients in intermediate and poor Memorial Sloan-Kettering Cancer Center risk groups benefited more from targeted therapies (p=0.001). Conclusions: Patients who received any targeted therapy lived longer than those who did not. Trend toward better survival was associated with advancing years and increasing targeted therapy use. The introduction of targeted agents appear to benefit mRCC patients in terms of OS as well.
Development of a quality assurance program at a community hospital breast center for elderly breast cancer patients who do not have axillary surgery.
Authors: Elizabeth P. Tito, Joseph Barthold, Marvin Lopez
Journal: Journal of Clinical Oncology (2013)

173 Background: Sentinel lymph node biopsy (slnb) is the standard of care for patients with invasive breast cancer. Yet, in some patients, the nodal information will not change the treatment and the risk of a clinically relevant axillary event is low. It may be reasonable to offer observation of the axilla. However, this recommendation is outside national treatment guidelines. Our breast center developed a pilot program through which we offer elderly women with co-morbidities the option of avoiding axillary surgery for their invasive breast cancer and follow their outcomes. Methods: A pilot program was implemented to provide a structured method of evaluating and following elderly women with invasive breast cancer who did not have axillary surgery. Criteria for avoidance of axillary surgery were developed, cases were reviewed prospectively at multidisciplinary tumor board, data was collected and analyzed annually from 2010 to 2012. Results: Between 2010 and 2012, 282 patients had surgery for breast cancer at our hospital; 263 patents qualified for slnb by NCCN guidelines. Nineteen women did not have a slnb (Table). All cases were discussed at multidisciplinary tumor board. All women had negative axilla by exam and imaging prior to surgery. Patients were followed by annual axillary exams and imaging. One patient had a loco-regional recurrence (LRR) which was seen on axillary ultrasound. She died with disease from metastatic lung cancer. One patient, who refused radiation, developed an in breast tumor recurrence (IBTR). Conclusions: Breast cancer treatment is evolving at a rapid pace and becoming more conservative. This trend leads to practice changes before guidelines have been adjusted. Lacking a national registry, a system should be in place at hospitals to make these transitions in a safe, educated, data-driven process. Our pilot program provides a structure in which women who did not have sentinel node biopsies are evaluated, educated and followed. [Table: see text]
Prospective assessment of symptom burden among cancer survivors with common solid tumors: Results from ECOG trial E2Z02.
Authors: L. I. Wagner, L. Zickl, M. L. Smith, D. Cella, C. Coles, L. J. Patrick-Miller, J. Manola, M. Fisch
Journal: Journal of Clinical Oncology (2011)

9137 Background: The expansion of the cancer survivor population in the U.S. mandates better understanding of survivors’ symptoms. Methods: A sample of 3106 ambulatory patients diagnosed with invasive cancer of the breast, prostate, colon/rectum or lung were recruited from six academic medical centers and 32 community sites at any point in their disease trajectory. A subgroup of cancer survivors (n = 248, 8%) defined as having non-advanced cancer, not currently receiving treatment, and diagnosed at least 3 years prior to study registration were identified. Participants rated symptom severity on a 0-10 scale for 25 common cancer-related symptoms at study enrollment and 4-5 weeks later. Symptom burden was compared to remaining patients in the sample (n = 2,858). Results: Survivors (n=248) had a median age of 64 years and were predominantly White (76%) and female (75%). Primary cancer site included breast (63%), colorectal (19%), prostate (9%) and lung (8%). Most of the sample had a performance status of 0 (76%). Most survivors were greater than 5 years from diagnosis (63%) and 38% were 3-5 years from diagnosis. Survivors reported a mean of 1.5 moderate to severe symptoms at enrollment and follow-up and the most common moderate to severe symptoms were fatigue (16%, 19%), disturbed sleep (15%, 20%), cognitive difficulties (13%, 14%), pain (13%, 13%), and drowsiness (9%, 15%). There were no significant predictors for fatigue or cognitive difficulties. Performance status predicted sleep disturbance (OR 0.28, p=0.0047). The odds that a patient 64 or younger reported moderate to severe drowsiness was 9.9 times that of an older patient (p=0.002). Conclusions: Prospective assessment of a national cohort of cancer survivors predominantly treated in community settings indicate that many survivors experience ongoing symptom burden despite significant time (> 3 years) since diagnosis and absence of ongoing need for cancer treatment. The most common moderate to severe symptoms included fatigue, disturbed sleep, cognitive difficulties, pain and drowsiness. These findings, particularly predictors of long-term symptom burden, can inform ongoing efforts to improve survivorship care and research.
Correlation of tumoricidal activity of lenalidomide against hematologic tumor cells with cyclin D1/D2 expression and effect on tumor-suppressor gene upregulation.
Authors: L. Zhang, J. Kosek, P. Schafer, J. B. Bartlett
Journal: Journal of Clinical Oncology (2010)

8090 Background: Lenalidomide (len) treatment leads to cell cycle arrest and apoptosis in some but not all multiple myeloma (MM) and non-Hodgkin's lymphoma (NHL) cell lines. Len treatment of sensitive cells appears to up-regulate tumor suppressor gene expression. We sought to define the role of baseline and len-induced expression of cyclin D family members and tumor suppressor genes in mantle cell lymphoma (MCL) and MM cell lines with the aim of identifying correlates to len-induced anti-proliferative activity. Methods: Anti-proliferative activity was assessed in a panel of 10 MM and 14 NHL cell lines as well primary cells derived from 3 MM and 2 MCL patients. Anti-proliferative activity (at 72 hrs) was correlated with baseline and len-induced expression of cyclins D1-3 and multiple tumor suppressor genes measured by RT-PCR. The effect of len on the nuclear localization of p27 protein was also assessed. Results: In MM and MCL cells sensitivity to len-mediated anti-proliferative activity appeared to correlate with baseline expression of cyclin D1 (p<.01, MM; p<.05, MCL) and p16INK4A (MCL p<.05), and inversely correlate with cyclin D2 expression (p<.05, MM, MCL); no relationship with cyclin D3 expression was seen. Cyclin D1/D2 results were similar in primary MM and MCL cells. Anti-proliferative activity also correlated with len-mediated upregulation of tumor suppressor genes, p15INK4B (<.005), p16INK4A(<.01), p18INK4C(<.01), p19INK4D(<.01) and p27kip 1(<.05) and secreted protein acidic and rich in cysteine (SPARC; <.01) in MM cells, and p27kip1(<.05) and SPARC (<.01) in MCL cells. Len-treated H929 cells had a ∼2-fold increase in nuclear versus cytosolic localization of p27. Conclusions: In MM and MCL cells, len-mediated anti-proliferative activity correlates with constitutively over-expressed cyclin D1, but appears inactive in cells over-expressing cyclin D2. Len-mediated anti-proliferative activity also appears to associate with upregulation of distinct tumor suppressor genes. Identifying potential markers of len-mediated activity provides further insight into mechanisms likely to be involved in its clinical activity in B cell malignancies. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Celgene
An open-label randomized phase II trial of oral vitamin D3 supplementation in combination with standard chemotherapy or best supportive care compared with standard chemotherapy and best supportive care in patients with advanced solid tumors.
Authors: D. Trivanovic, S. Plestina, L. Jerin, L. Honovic
Journal: Journal of Clinical Oncology (2011)

e19566 Background: The majority of patients with newly diagnosed stage IV cancer are vitamin D deficient at the time of diagnosis. We conducted a phase II trial to evaluate the efficacy and safety of oral supplementation with 25-hydroxyvitamin D3 [25(OH)D] in chemotherapy-naive patients. Methods: Eligibility critera included ECOG PS 0-3, low serum 25-hydroxyvitamin D3 [25(OH)D] at the time of diagnosis (using cutoff value of 32 nmol/L) and normal serum calcium level. Patients were randomized to receive oral supplementation with 2,000 IU of Vitamin D3 daily for 6 months with standard therapy or to continue standard treatment without vit D supplementation. Results: Sixty-seven patients were accrued, 42 were males and 25 females. The most common primary cancer sites were lung (36, 54%), colorectum (14, 21%), pancreas (7, 10%), breast (7, 10%) and kidney (3, 5%). The median 25 (OH) D level for all patients was 20,69 nmol/L. Response is evaluated by RECIST criteria at 8 weeks and toxicity was graded by the NCI CTCAE. No patient had a complete response, but ORR were significantly better in experimental arm (18% versus 6%, p=0.036). Vit D was well tolerated; the most common toxicities were neutropenia, diarrhoea, fatigue, nausea and constipation. Four patients had grade 1-2 of hypercalcemia (Table). Conclusions: The safety profile of vitamin D in combination with chemotherapy or BSC was acceptable and ORR was significantly greater for patients receiving oral vit D supplementation. However, there was no significant difference between the two arms in terms of 6 months survival rates. These data suggest that adding vit D to an already-effective treatment may result in clinical benefit beyond that associated with combination chemotherapy or BSC alone. Experimental arm (n=33) Control arm (n=34) P Vitamin D median nmol/L 19.64 21.72 0.40 Age median years 66 65 0.62 Male gender 22 20 0.15 Date of diagnosis 0.49 Winter-Spring 15 16 Summer-Autumn 17 17 Treatment 0.86 Chemotherapy 22 22 BSC 11 12 ORR 6 (18%) 2 (6%) 0.036 AE gr 3 or 4 8 8 0.95 Hypercalcemia 1 3 0.32
Moving prevention of central line associated bloodstream infection efforts beyond the hospital walls: A multicenter pediatric hematology/oncology collaborative.
Authors: Amy Billett, Aditya H. Gaur, Eric J. Werner, Cindi Winkle, Jeffery D. Hord, Richard Brown, David Bundy, Marlene R. Miller
Journal: Journal of Clinical Oncology (2012)

86 Background: Elimination of central-line (CL) associated blood stream infections (BSI) (CLABSI) in the inpatient setting has been a focus for many healthcare organizations. Little is known about the rate of CLABSI in the ambulatory setting or the optimal improvement strategies. We systematically expanded CLABSI prevention efforts for children with underlying pediatric hematology/oncology (PHO) disease from inpatient to ambulatory settings and describe the related process (definitions, improvement change packages, compliance assessment) and outcome measures (CLABSI and other BSI rates). Methods: The evidence-based CL care and maintenance bundles developed for the Children’s Hospital Association Quality Transformation Network PHO inpatient multisite collaborative were adapted for the ambulatory setting. Teams self-reported compliance with bundle elements (daily goals, line entry/dressing/ port needle/ tubing change processes) and submitted total CL days for the PHO cohort in their care. National Healthcare Safety Network (NHSN) defined CLABSI, secondary BSI (as per NHSN definitions), and single positive blood cultures (SPBC) (currently not captured by NHSN) were tracked. All process and outcome measures were collected using an online data entry system. Results: Prospective data collection and ambulatory bundle implementation began in Nov. 2011; to date 24 of 36 hospitals participating in the inpatient PHO CLABSI prevention collaborative have successfully implemented the ambulatory component to their program. As of May 2012, accrued data from the ambulatory setting exists for 214 ambulatory CLABSI, 30 secondary BSI, and 72 SPBC in patients with 719,637 CL in situ (not CL accessed) line days. To date self-reported compliance with bundle elements is &gt; 80%. Conclusions: We demonstrate a successful multisite expansion of CLABSI prevention efforts to the ambulatory setting in PHO patients. Given the limitations of the current NHSN CLABSI definitions in the PHO population and the goal to reduce all BSI, not just CLABSI, we also propose tracking of secondary BSI and SPBC and discuss how this contextual information can be helpful.