bluuebunny/crossref_metadata_2025_split huggingface dataset:
Cancer clinical trial accrual patterns among community cancer centers in the United States
Authors: Lee J. A. , Mathiason M. A. , Czeczok C. A. , Keller J. K. , Go R. S. 
Published: March 2020

6041 Background: Most cancer patients are diagnosed and treated in the community but clinical trial accrual rate is low. Published data on trial accrual from community-based cancer centers throughout the U.S. are limited. The Association of Community Cancer Centers (ACCC) is a national multidisciplinary education and advocacy organization that maintains a membership caring for over 60% of all patients with cancer in the U.S. In order to determine the clinical trial accrual patterns in the community across various geographic regions in the U.S., we performed a retrospective study utilizing the data from ACCC membership maintained at their web site. Methods: Data available from the most recent year (2003–2005) were obtained from 621 centers throughout the U.S., representing 49 states (no data for WY) and the DC. We investigated the number of patients (new and old) accrued into trials per year relative to the number of new analytical patients seen in the same year, a value we termed accrual ratio (AR). In addition, we studied the effects of geographic location, size of the cancer program, number of affiliations with National Cancer Institute sponsored cancer cooperative groups, and the number of medical/support/data management staffs on trial accrual. Results: A total of 670,215 new patients were seen across the ACCC membership with 43,743 patients accrued into trials for a median AR of 6.5% (range, 0.3–16.9). The top and bottom 5 accruing states were VT, MD, SD, LA, ID and KS, ND, VA, NH, AR, respectively. Regionally, the AR for Midwest, Middle Atlantic, West, South, Southwest, and New England were as follows: 7.4%, 7.0%, 6.2%, 6.0%, 5.7%, and 5.4% (p < 0.001). One hundred (16.1%) centers representing 11.8% of all new patients were not affiliated with any of the cooperative groups. This group had the lowest AR (3.1%). AR increased when centers were affiliated with more cooperative groups (p < 0.001) or cared for more new patients (p < 0.001). The number of medical, support, and data management staffs did not influence accrual. Conclusions: Overall, clinical trial accrual in the U.S. community cancer centers is low. Accrual patterns differed significantly among various geographic locations. Better access to trials is needed in order to improve participation of cancer patients. No significant financial relationships to disclose.
Early closure of clinical trials: The experience of the National Cancer Institute of Canada Clinical Trials Group
Authors: Parulekar W. , Pater J. L. 
Published: March 2020

6053 Background: Phase III studies require a significant commitment on behalf of researchers and patients. Closure of a study before the originally planned number of patients have been enrolled may be due to a number of reasons such as poor accrual, information within the study that precludes continuation such as excess toxicity, an interim futility or extreme efficacy analysis or data from outside sources that render the study question obsolete. Methods: We reviewed the phase III activity of our group since inception. Reasons for early closure were classified in the following manner: accrual failure (AF), external information (EI), internal information (II). Studies were grouped by site and time period of study activation to demonstrate any trends over time. Results: 94 phase III studies led by our group were identified from our roster. Reasons for early closure are presented below. Other sites include brain with an early closure due to AF, head/neck where 1 of 3 studies closed due to AF, melanoma where 1 of 3 studies closed due to EI and sarcoma where 2 studies were successfully completed. Several of the studies that closed for accrual failure were nevertheless published either singly or as part of a meta-analysis. Conclusions: Slightly over one third of studies closed prior to achievement of the targeted sample size. Accrual failure continues to be the main cause of early study closure (27/34 or 80%) with a trend towards decreasing frequency of occurrence over time. Emerging data within or external to a study leading to study closure are important but relatively rare reasons for early closure. [Table: see text] No significant financial relationships to disclose.
What can we glean from linking registry and Medicaid claims data?
Authors: Schrag D. , Virnig B. , Xu F. , Allen M. , Warren J. L. 
Published: March 2020

6055 Background: Cancer quality of care problems are concentrated among the indigent. Although Medicare claims linked to tumor registry data have become an important source for evaluating cancer care, parallel efforts to use Medicaid claims are not well developed. Objective: To evaluate the feasibility and potential value of linking the California state cancer registry with Medicaid claims for health services research. Methods: Cases reported to the California Cancer Registry (CCR) between 1988 and 2000 were matched with California Medicaid enrollment and claims data. We assessed the number of cancer cases that appeared in the Medicaid enrollment data. We evaluated the sensitivity of Medicaid claims to capture cancer diagnoses and treatments reported in the registry data. Results: 6,800 patients ages 18–64 had records in the 1998 CCR data that were matched to the 1998 Medicaid enrollment file; Medicaid enrollees accounted for 34.4% of patients with hepatoma and 21.1% of patients with cervix cancer, but only 8.9% of breast and 8.9% of testicular cancer patients in this age bracket. Medicaid data had only modest sensitivity to capture cancer diagnoses and procedures. For 5 cancers, Medicaid claims included procedure codes for about 70% of surgeries reported in the registry data. Missing diagnoses and procedures could be attributed to discontinuous enrollment, Medicare crossover and enrollment in pre-paid health plans. Conclusion: Linkage of CCR and Medicaid enrollment data identified sizable populations of indigent patients. However, the modest sensitivity of Medicaid claims to capture cancer diagnoses and procedures currently limits the utility of Medicaid data to assess cancer treatment and outcomes. No significant financial relationships to disclose.
Cancer clinical trials available in the community setting: A 5-year analysis from 1999–2004
Authors: Keller J. K. , Bowman J. , Lee J. A. , Mathiason M. A. , Frisby K. A. , Meyer C. M. , Meyer L. A. , Wright L. J. , Go R. S. 
Published: March 2020

6056 Background: Less than 5% of newly diagnosed cancer patients are accrued into clinical trials. In the community setting, the lack of appropriate clinical trials is a major barrier. Our prospective study in 2004 determined that 58% of newly diagnosed adult cancer patients at our community-based cancer center didn’t have a clinical trial available appropriate for their disease stage. Among those with clinical trials, 23% were subsequently found to be ineligible (Go RS, et al. Cancer 2006, in press). However, the availability of clinical trials may vary from year to year. Methods: A retrospective study was conducted to determine what clinical trials were available for newly diagnosed adult cancer patients at our institution from June 1999-July 2004. The study also investigated the proportions of newly diagnosed patients who had a clinical trial available appropriate for type and stage of disease and patients accrued. Results: Over the 5-year period, 207 (82, 87, 99, 102, 117, years 1–5, respectively) trials were available. Most (50.7%) trials were for the following cancers: breast (15.5%), lung (13.5%), head and neck (7.7%), colorectal (7.2%) and lymphoma (6.8%). ECOG (53%), RTOG (26%), and CTSU (9%) provided the majority of the trials. A total of 5,776 new adult cancer patients were seen during this period. Overall, 60% of the patients had a trial available appropriate for type and stage of their cancer, but only 103 (3%) were enrolled. There was a significant upward trend in the proportions of patients with available trials over the years (60.2%, 55.9%, 59.2%, 60.7%, 63.9%, years 1–5, respectively; Mantel-Haenszel P=.008). The proportion of patients with a trial available was highest for prostate (97.3%), lung (90.9%), and breast (73.9%), and lowest for melanoma (17.1%), renal (11.6%), and bladder (7.2%). The majority of patients accrued to trials had the following cancers: breast (32%), lung (17%), lymphoma (9%), colon (7%), and prostate (5%). Conclusions: Nearly half of the newly diagnosed adult patients at our center had no trials available appropriate for type and stage of their cancers. It is likely that if strict clinical trial eligibility criteria were applied, approximately 2/3 of our patients would not be eligible for a clinical trial. No significant financial relationships to disclose.
Black box warning on lenalidomide-associated venous thromboembolism (VTE) in off-label setting: A preemptive and unusual safety initiative
Authors: Angelotta C. , Lurie A. J. , Yarnold P. R. , Singhal S. , Mehta J. , Lyons E. A. , Bennett C. L. 
Published: March 2020

6074 Background: Half of cancer therapies are used off-label, but regulations prohibit package inserts from describing toxicities that occur only in these settings. In 2003, RADAR reported VTE rates of 20% to 62% when thalidomide, approved for leprosy treatment, was used off-label (with dexamethasone) for multiple myeloma. In 2005, the Connecticut attorney general requested that a black box warn of high rates of VTE when thalidomide is used off-label. Subsequently, the thalidomide analogue, lenalidomide, received FDA approval as a myelodysplasia therapy. In phase II/III trials, multiple myeloma response rates were 60% to 92% with lenalidomide/dex therapy. Methods: Published literature, abstracts, and package inserts were reviewed for VTE rates in lenalidomide-treated multiple myeloma. Results: VTE rates were 8.5% to 75% in multiple myeloma treated with lenalidomide and dex or erythropoietin; rates were <3.4% when aspirin prophylaxis was added. The FDA approved package insert for lenalidomide preemptively includes a black box warning describing high VTE rates with off-label use of lenalidomide and advises physicians that VTE prophylaxis should be considered, although the effectiveness of various prophylaxis regimens is unknown. Conclusions: Six months after the attorney general requested that a black box warning describe high VTE rates with off-label use of thalidomide, the manufacturer preemptively included an analogous black box warning in the package insert for the thalidomide analogue, lenalidomide, but did not include similar warnings for this toxicity in the package insert for thalidomide. The FDA should require that package inserts describe severe toxicities that commonly occur with off-label use of cancer therapies. This is especially important for severe class-related toxicities such as lenalidomide- and thalidomide- associated VTE. [Table: see text] No significant financial relationships to disclose.
Dose banding of chemotherapy doses at the Juravinski Cancer Centre
Authors: Hirte H. W. , Kagoma S. , Zhong L. , Collins I. , Burns D. , Rand C. , Simpson T. , Snider A. 
Published: March 2020

6099 Background: As the number and complexity of chemotherapy regimens increase, the demands on pharmacy services to reduce chemotherapy preparation and checking times continues to increase. Dose banding, a system whereby doses of intravenous cytotoxic drugs calculated on an individual basis are rounded up or down to predetermined standard doses (the maximum variation of the adjustment between standard dose and doses constituting each band is 5% or less) was identified as a strategy that could be used to address some of the issues around time pressures to help reduce patient waiting times for treatment. Methods: The project consisted of 3 phases; Phase I - literature review to identify dose banding publications; Phase II - selection of drugs to be banded for the pilot. The two drugs selected were 5FU and leukovorin, and Phase III - Time studies pre-, interim and post dose banding implementation to determine drug dispensing time and patients’ wait time for pharmacy related procedures. This occurred for a 2 week period (10 working days) either prior to implementation (pre- 819 patients studied), 4 days after implementation (interim - 854 patients studied) and 4 weeks after implementation (post - 785 patients studied). Results: Drug dispensing time did not decrease with dose banding (pre- 7.9 min, interim - 7.6 min and post - 9.4 min). However, the average patient wait time decreased after piloting the dose banding project (pre - 31.6 min, interim 23.7 min, and post - 27.8 min). The percentage of doses that were banded were 37.8% in the interim time study and 58.2% in the post time study. Conclusions: Although dose banding did not reduce dispensing time in this study, likely because the preparation for dispensing 5FU and leukovorin syringes is normally very simple and quick, patient’s wait time for pharmacy related procedures did decrease. This was probably due to contributions of other factors in the pharmacy process. A reduction in dispensing time could likely be achieved if more complex regimens were considered for dose banding. Dose banding could be used to increase capacity within the chemotherapy suite on the day of administration. It also allows for a better work schedule and increases efficiencies within the chemotherapy preparation and administration areas. (Sponsored by funds from Cancer Care Ontario) No significant financial relationships to disclose.
Misunderstanding of prostate cancer (CaP) among African American (AA) men of lower socioeconomic status (Lo-SES)
Authors: Nelson E. M. , Fraser G. , Connors A. F. , Barry M. J. , Krahn M. , Conaway M. R. , Bashore R. , Wolf A. , Kilbridge K. L. 
Published: March 2020

6114 Background: CaP disproportionately affects AA men. The objective of this investigation was to assess understanding of the prostate and CaP among Lo-SES, predominantly AA men. Methods: We performed cross sectional, semistructured interviews of 105 men, age 40 and older, in two low-income medical clinics. CaP knowledge was assessed using a subset of questions by Mercer et al. Can J of Public Health 88(5):327, 1997. Patients were shown two male anatomic figures and asked to identify the prostate, bladder, bowels, and penis: 1) Please point to the _____ on the picture of the man. 2) What does the ____ do? Patients’ understanding of sexual, urinary, and bowel function was evaluated using semi-qualitative methods coded by two independent investigators. Demographic data were collected and literacy measured using REALM. Results: Patients’ median age was 58 and 87% self-identified their race as AA. Median annual household income was $16,000. Median reading level was 4th-6th grade. Although 87% of patients had heard of the prostate, only 24% could locate the prostate, and 3% could explain prostate function. Because many men learn about the prostate in the context of CaP screening during physical exam, 23% of patients thought the prostate was synonymous with prostate cancer, 15% of patients believed the prostate is located in the rectum and 4% confused prostate cancer with colorectal cancer. Prostate cancer knowledge was poor and the concept of a risk factor was not understood well. Only 7% could name a single risk factor for CaP including 3% who named race. Just 22% of men cited surgery or radiation therapy as treatments for CaP and 11% could name a side effect of early CaP treatment. Domain confusion was common: 43% of patients confused bowel function with urinary function, 21% confused urinary with sexual function, and 20% confused bowel with sexual function. Conclusions: Baseline understanding of CaP, anatomy, bowel, urinary, and sexual function is poor among older, lo-SES AA men. Substantial patient education is required for CaP screening and treatment efforts in this population with consideration for low literacy. [Table: see text]
Cost-effectiveness of lenalidomide in treating patients with transfusion-dependent myelodysplastic syndromes (MDS) in the United States
Authors: Goss T. F. , Szende A. , Schaefer C. P. , Totten P. J. , Wang M. Y. , List A. F. 
Published: March 2020

6128 Background: Lenalidomide is approved for treatment of patients with transfusion-dependent Low- or Intermediate-1-risk MDS associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. We evaluated the cost-effectiveness (CE) of lenalidomide versus best supportive care (BSC) in these MDS patients. Methods: We used a decision analytic model to compare costs and outcomes of lenalidomide [with BSC, but no erythropoietin (EPO)] vs BSC (with EPO) over 1 year. Data were obtained from a phase II trial for lenalidomide (MDS-003). Data for BSC were based on a study that included TD MDS patients (efficacy and transfusion requirements) and the placebo arm of a randomized MDS trial (safety). The model compared results of MDS-003 and a theoretical cohort with similar characteristics (TD, EPO response and IPSS low or int-1 score). Outcome measures were rate and duration of response (TI time gained). The model incorporated costs (from Medicare schedules; 2005 US$) of meds, transfusions, lab tests, office visits and other resources. Results: Response rate (TI) was 67.0% in the lenalidomide group vs 32.8% for responders with no prior EPO experience in the BSC group. Lenalidomide therapy led to an estimated 0.53 transfusion-free and 0.23 quality-adjusted life year (QALY) gain compared to BSC at 1 year. The costs of lenalidomide therapy were largely offset by reduced blood transfusion and EPO costs with 1-year total treatment costs estimated at $62,138 vs $53,965 for BSC. We estimated incremental CE of lenalidomide vs BSC per TI year and QALY gained using one-way sensitivity analyses reflecting uncertainty in parameter estimates. The incremental CE ratio for lenalidomide vs BSC varied between $5,742 - $20,940 per TI year gained and $13,216 - $47,758 per QALY gained, suggesting acceptable ranges of CE for a new therapy. Conclusions: Results suggest that treating Low- or Int-1-risk MDS associated with a deletion 5q cytogenetic abnormality with or w/o additional cytogenetic abnormalities with oral lenalidomide results in reduced transfusion requirements vs BSC. Research to confirm these results with data from ongoing randomized trials is warranted. [Table: see text]
A cost analysis of practicing oncology via telemedicine
Authors: Doolittle G. C. , Spaulding A. O. , Williams A. R. 
Published: March 2020

6143 Background: The University of Kansas Medical Center (KUMC) has offered oncology services via interactive tele-video (ITV) to patients in rural Kansas for over a decade. A KUMC oncologist utilizes ITV technology to connect with patients at Hays Medical Center (HMC), which is approximately 265 west of KUMC. The technology enables the oncologist to conduct a complete patient visit without being in physical proximity to the patient. To date, two cost-tracking studies have been conducted to determine expenses associated with the tele-oncology practice. A third study recently analyzed costs incurred during fiscal year 2005 (FY05). Methods: In order to determine the costs of the practice during FY05, HMC and KUMC expenses were monitored for oncology services rendered via telemedicine. An analysis revealed expenses common to a traditional oncology practice and additional expenses unique to a telemedicine practice. Administrative support staff salaries, the oncologist’s contract fees, and nursing staff salaries made up the majority of the traditional practice-related expenses. Costs unique to a tele-oncology practice were those associated with technology including expenses for telemedicine equipment, telecommunication charges, and technician time. Results: Expenses for the tele-oncology practice on the KUMC side totaled $22,848, with $7,331 attributed to technology-related costs and $15,517 attributed to practice-related costs. For HMC, $5,803 in technology-related costs and $30,430 in practice-related costs totaled $36,233. At 235 tele-oncology consults and a combined total expense of $59,081 between KUMC and HMC, the FY05 analysis resulted in an average cost of $251 per consult. When compared to prior studies, this shows a substantial reduction in costs related to the practice of telemedicine. Conclusions: The average cost of a tele-oncology visit in Kansas has consistently decreased significantly since the practice’s 1995 inception. Analyses have revealed that the costs of providing oncology services via telemedicine are closely tied to utilization, as the majority of the expenses are related to personnel rather than technology. Telemedicine has proven itself to be a cost-efficient alternative to offering regular outreach clinics. No significant financial relationships to disclose.
Updated results of a phase I study of low dose decitabine and valproic acid (VA) in patients with acute myeloid leukemia (AML): Gene reexpression, demethylation, and clinical response
Authors: Klisovic R. B. , Blum W. , Hackanson B. , Kefauver C. , Liu S. , Liu Z. , Chan K. K. , Plass C. , Grever M. R. , Byrd J. C. , Marcucci G. 
Published: March 2020

6515 Background: Decitabine, an inhibitor of DNA methyltransferase (DNMT) enzymes, has activity in myeloid malignancies at doses >1 log below the MTD of 2250mg/m2/course which may be optimal for DNA demethylation and minimize cytotoxicity. Methods: We designed a two step trial for AML patients (pts) to determine: Step 1, the lowest dose of decitabine to induce 100% increase in or re-expression of epigenetically silenced genes in 5/6 pts treated at a dose level; and Step 2, the MTD of the histone deacetylase (HDAC) inhibitor VA given with this dose of decitabine, and whether this MTD or a lower dose leads to 90% decrease in HDAC activity. Results: Decitabine was administered to 17 pts at two dose levels. Pts had relapsed/refractory AML (N=10) or age>60 and ineligible/refused standard therapy (N=7) and ranged in age from 36–83 years. Pts received decitabine at 15–20mg/m2/IV over 1 hr daily for 10 days (d) (3 pts also had VA 15mg/kg on days 5–21), every 28 d. Mean plasma decitabine Cmax (by a validated LC-MS/MS method) was 93 ng/ml (N=7). 10/13 pts had at least 100% increase in expression of p15 or estrogen receptor (ER, including 5/6 given 20mg/m2/d decitabine alone), and all 10 had clinical response. Of the 3 pts who did not have increased gene expression none responded. Western blotting showed depletion of DNMT protein in 4/6 pts. Bisulfite sequencing of the promoter region of ER confirmed that decitabine induced >50% decrease in methylation in the only pt yet examined (p<0.001). 9/14 pts had decrease in global DNA methylation as measured by LC-MS/MS. 10/15 pts had clinical benefit: 6 pts had clinical response, 2 with CR (1 with t-AML) and 4 with CRi (1 with a 20yr history of P. vera); 4 pts had clinical improvement-1 met all CR criteria except for BM disease by flow, 1 had platelet >100K, 2 had stabilization of disease for 4–6 months. Conclusions: We demonstrated clinical activity of low dose decitabine associated with decreased levels of the DNMT1 target and increased or re-expression of epigenetically silenced genes. Combination of decitabine at 20mg/m2/d with VA (Step 2) has begun; complete clinical results, gene re-expression/ demethylation, and histone deacetylation data will be presented. (NCI U01 CA 76576–05) [Table: see text]