bluuebunny/crossref_metadata_2025_split huggingface dataset:
Medicare 2005 demonstration project: Patient reporting of nausea symptoms and its impact on improving quality of patient care
Authors: Mueller B. , Page R. D. 
Published: March 2020

6615 Background: In 2005, the Centers of Medicare and Medicaid (CMS) conducted a one-year Oncology Demonstration Project (ODP) establishing 12 G-codes for participants to provide and document specific services related to (1) pain control, (2) fatigue reduction, (3) and minimization of nausea and vomiting. Methods: This is a retrospective study involving a chart review and G-code reporting to determine the effectiveness of the 2005 ODP to improve the quality of patient care. There were 133 patients that reported level 3 or 4 nausea and vomiting symptoms (per G-codes) during the administration of the 2005 ODP. Analysis of the 133 patient charts attempted to identify if the 2005 ODP helped to improve three areas of antiemetic care: (1) increase awareness of patients suffering from severe nausea and vomiting, (2) improve antiemetic interventions once the nausea and vomiting symptoms of the patient had been assessed, (3) and improve the ability for subsequent antiemetic changes once a previous antiemetic intervention was unsuccessful. Data were analyzed comparing Medicare ODP vs. a non-medicare reporting group using Chi-square analysis. Results: The 292 cases of reported level 3 or 4 nausea and vomiting symptoms received a proper antiemetic assessment 57% of the time. Also, when a patient received an assessment for a reported level 3 or 4 nausea and vomiting symptom, an intervention occurred 74.5% of the time. This 74.5% was statistically insignificant (P=0.3283) when compared to the 70% of antiemetic interventions that occurred when a nausea and vomiting assessment was made without the reporting mechanism of the 2005 ODP. And finally, there was statistical insignificance (P=0.2389) when comparing the change of antiemetic care, with and without the administration of the 2005 ODP (89% vs. 85%, respectively), once a previous antiemetic intervention was unsuccessful. Conclusions: Based upon the three criteria of improving patient outcomes of nausea and vomiting, the 2005 ODP and the reporting of G-codes did not aid the ability of oncologists to administer better quality of patient care in the area of antiemetic management. No significant financial relationships to disclose.
Relationship between compliance with imatinib mesylate and medical costs for patients with CML and GIST
Authors: Halpern R. , Barghout V. , Williams D. 
Published: March 2020

6618 Background: Imatinib mesylate, an oral tyrosine kinase inhibitor for treatment of chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST), has been found both effective and cost-effective. This study examines the relationship between imatinib compliance and health care costs for patients (pts) with CML and GIST. Methods: This retrospective study used claims data from a large national US health plan. Pts had =2 imatinib claims from 6/1/01–3/31/05; =1-year follow-up after the 1st imatinib claim; and diagnosis of CML (ICD9 205.1x) or GIST (ICD9 159.0, 159.8, 159.9 or evaluation of claims and attribution of GIST by independent hematologist/oncologist). Compliance was measured with a medication possession ratio ((days of imatinib during follow-up / days of follow- up)*100). Compliance categories were good, =90%; medium, 70–89.9%; poor, <70%. Total follow-up medical and health care (medical + pharmacy) costs were measured and compared across compliance categories; t-tests compared mean costs. Results: 374 CML and 91 GIST pts had mean age of 52.1 ± 14.0 years. 274 (59%) pts were male. 234 (50%) of pts had 12–24 months follow-up; 231 (50%) had 25–57 months. Mean and median compliance across all pts were 69.4% and 79.7%, respectively. 122 (33%) CML and 32 (35%) GIST pts had good compliance; 149 (40%) CML and 42 (46%) GIST pts had poor compliance. Mean medical costs across all pts were lower and less variable with good compliance ($22,882 ± 22,791) than with medium ($40,366 ± 68,186), p=0.007) and poor ($104,961 ± 190,559), p<0.001). Similarly, mean medical costs for CML pts with good, medium, and poor compliance were $21,456 (±22,127), $41,537 (±72,238, p=0.008), and $117,004 (±211,292, p<0.001), respectively. Mean medical costs for GIST pts were: good=$28,318 (±24,781); medium=$33,270 (±35,356, p=0.584); and poor=$62,235 (±68,751, p<0.001). Mean total health care costs were 21.7% lower for pts with good compliance relative to those with poor. Conclusions: Good imatinib compliance was associated with significantly lower medical costs. Mean total medical costs were 78% lower with good compliance relative to poor. Compliance is an important treatment issue for both clinical and medical cost outcomes. No significant financial relationships to disclose.
Patterns of care regarding adjuvant hormonal agents and treatment of bone health in postmenopausal women with breast cancer in community and academic centers before and after the availability of ATAC (Adjuvant Tamoxifen, Armidex or Combination) study
Authors: Tummala M. K. , Wajahath M. , Kotlarewsky M. , Aggarwal A. , Muller D. , Liu M. C. , McGuire W. P. , Ottaviano Y. 
Published: March 2020

6621 Background: Results from the ATAC trial comparing Tamoxifen to the Aromatase inhibitors (AIs) anastrozole in PM women with early stage breast cancer were initially presented in San Antonio, Texas, in December 2001. ASCO issued guidelines for the adjuvant use of AIs in 2002, updated in 2003. We compared patterns of usage of adjuvant hormonal agents and bone health management before and after availability of the ATAC data in community versus academic centers. Methods: We conducted a retrospective analysis of 432 patients between 1999–2005 from group practices affiliated with two large community hospitals and one academic center. Data were collected from tumor registries regarding demographics, first-line hormonal agent choice, and use of bone density studies, vitamin D/calcium supplements and bisphosphonates. Results: Demographics were identical in both groups before and after January 2002. Before 2002, 96% of the patients were prescribed Tamoxifen in both community and academic centers. After the initial presentation of the ATAC data, 55.08% (65/118) of patients from the community centers versus only 17.11% (19/111) from the academic center were prescribed AIs (p=0.0001). Of the 84 patients who received an AI after January 2002, similar proportions of patients had baseline bone density scans (38.5% community vs. 36.8% academic; p=0.89) and follow up annual/biannual scans (33 % vs. 32%; p=0.85). In addition, similar proportions of patients on AIs were prescribed calcium/vitamin D supplements (47.4% vs. 52.6%; p=0.69) and bisphosphonates (36.8% vs. 21.05%; p=0.20) in community and academic centers, respectively. Conclusions: Community oncologists adopted AIs into clinical practice sooner than academic physicians on the basis of unpublished clinical trial results, even before ASCO published guidelines. Although patients on AIs are deemed to be at higher risk for bone fractures, fewer than 40% were evaluated with baseline or surveillance bone density scans in both community and academic practices. Similar proportions of patients received calcium/vitamin D supplements or bisphosphonates among centers. No significant financial relationships to disclose.
The implementation of a rapid response team at Memorial Sloan-Kettering Cancer Center: A preliminary report
Authors: Klotz A. D. , Thattassery E. , Graham D. 
Published: March 2020

6627 Background: The implementation of a rapid response team (RRT) has become a popular patient safety initiative at many health care institutions during the past decade. To date, there are no studies evaluating the utilization or impact of a rapid response team in a population of cancer patients. We report on our experience implementing such a team at Memorial Sloan-Kettering Cancer Center. Methods: A consecutive cohort of all consults performed by the RRT between July 1st and December 31th, 2006 had the following variables recorded: primary cancer diagnosis, reason for consult, RRT intervention. Outcomes measured were survival to discharge and 30 day survival. Hospital mortality and hospital codes were compared to historical data from 2005 and were adjusted for hospital census. Results: There were 195 consults requested between July 1st and December 31st, 2006. The majority of these patients were on the medical service (124 vs 66 on surgical service). The most common primary malignancies for which the RRT was called arose from the gastrointestinal tract (30.2%), thoracic cavity (12.8%), urologic tract (9.3%), and breast (7.6%). Most consults were requested for compromised respiratory function (n=76), cardiovascular (n=72, 34 hypotension, 23 tachycardia), and neurologic derangements (n=13). 33 patients (16.9%) required transfer to an alternate level of care such as telemetry or the intensive care unit. 121 patients (65%) seen by the RRT survived to discharge however 92 (47%) died within 30 days of an RRT consult. Hospital codes decreased 21% (55 vs 70, p<0.10) and hospital mortality decreased 22% (3.43 deaths per 1,000 discharges vs 4.43 deaths per 1,000 discharges) following implementation of the RRT although these results did not achieve statistical significance. Conclusions: The Rapid Response Team at MSKCC assists in the acute management of hospitalized cancer patients. Many of these patients are critically-ill and are near the end of their oncologic course. Further studies are necessary to better characterize the impact of this resource and determine how it can be utilized most effectively. No significant financial relationships to disclose.
Assessment of the total cost of FNAC as a diagnostic tool in patients with thyroid nodules
Authors: Borget I. , Vielh P. , Allyn M. , Schlumberger M. , De Pouvourville G. 
Published: March 2020

6628 Background: The prevalence of thyroid nodules in the general population ranges from 4 to 7% and fine-needle aspiration cytology (FNAC) is a widely used diagnostic procedure. As the final diagnosis is based on post-surgical pathology of the lesion, a number of patients with nodules classified as benign or indeterminate by cytology may have a postponed final diagnosis, impacting the procedure cost. This study aims to determine the total cost of FNAC, by taking into account of diagnostic mistakes (false-positive and false-negative), failures of FNAC (indeterminate results) and the follow-up of non operated patients. Methods: A Markov model was built to describe the management of patients through time, from the first FNA-t. We derived estimates for diagnostic accuracy values and follow-up from a retrospective study, including all patients who had their first FNAC from 2003 to 2005 at Institut Gustave Roussy. Costs were computed from the viewpoint of the hospital. A microcosting study was performed to determine the unit cost of FNAC. Sensitivity analyses were performed. Results: Out of the 624 patients who had FNAC, 15 were cytologically classified as malignant, 57 as suspicious and 171 as indeterminate. Surgical excision was carried on in 155 cases. The unit cost of FNAC was 121 €. Markov modelling showed that the mean total cost of a true diagnosis including unnecessary surgeries, repeat FNAC and follow-up was 1,145 Euros. The number of false negative and false positive cases had little impact on total cost, whereas it was significantly affected by the percentage (27%) of unsatisfactory specimens. The absence of such specimens would reduce the total cost to 738 Euros (35%). Conclusions: The cost of FNAC exceeds its unit production cost. It depends on the performance of the cytologist and on the rate of indeterminate results that might be reduced by routine ultrasound-guidance. No significant financial relationships to disclose.
Establishing a research network in Scotland more than doubles trial recruitment
Authors: Cassidy J. , Bonner-Shand S. , Nicoloson M. , Cameron D. , McLaren R. , Gordon A. 
Published: March 2020

6630 Background: Scotland has a population of 5.4 million people with 26, 000 new cases of cancer per annum. In 2002 the Scottish Executive established a research network covering all of the country with the objective of doubling recruitment to cancer trials within 3 years. Methods: A grant of £1million (circa $2 million) was provided to establish a network covering all of Scotland. The network was centred on 3 of the main cancer centres. Support staff consisting mainly of data managers and research nurses were employed in each region. Clinical trials were selected by interested clinicians from the existing NCRI portfolio in the UK. These trials were then opened in centres and regional units with the intention of recruiting patients locally. Each trial was approved by appropriate local university and NHS ethics, research and development boards. Recruitment numbers were collated by trials co-ordinators and compared with baseline figures derived from 2001–2 Results: 31 members of staff were recruited and trained. These were a mix of data managers and research nurses. In 2001, 927 patients were entered in trials which is 3.5% of all cases. In 2005 this had risen to 3557 (13.7% of all cases). These ranged across all the major common solid and haematological malignancies. In portfolio includes therapy studies in phase 1–3 including large scale RCTs, screening and prevention studies. The breakdown of patients treated within the cancer centres versus those in regional units indicated that the biggest impact on recruitment was in the latter. The network has introduced streamlined procedures for multiple ethics and R+D submissions which has facilitated recruitment in cancer units. Web based tools have been piloted to allow patient screening to be performed remote from the cancer centres. A breakdown of recruitment by trial and tumour type will be presented. Conclusions: Investment in infrastructure support in a targeted manner can very significantly improve trial recruitment. No significant financial relationships to disclose.
The NCI pediatric central institutional review board (PedCIRB) initiative: Progress and impact
Authors: Anderson B. D. , Goldberg J. , Adler J. , Covington L. , Olson D. , Gordon B. , Reaman G. , Everett J. , Smith M. , Christian M. 
Published: March 2020

6632 NCI has developed a central IRB (PedCIRB) to review NCI-sponsored pediatric clinical trials conducted by the Children's Oncology Group (COG). COG comprises ∼200 U.S. medical institutions and protocol activation traditionally requires separate protocol review by each local IRB (LIRB) and, subsequently, a review of each protocol amendment and significant adverse event. The PedCIRB model seeks to increase patient protection by improving the expertise of protocol reviewers and making their review available to all PedCIRB participating institutions. The PedCIRB consists of experts in pediatric oncology, pediatric medicine, nursing, pharmacy, bioethics, biostatistics, as well as patient advocates and childhood cancer survivors. The PedCIRB model also eliminates redundant reviews, reduces administrative burdens on local COG investigators and LIRBs, and can accelerate the pace of local protocol activation, thus increasing the availability of clinical trials to children with cancer. The PedCIRB conducts a full board protocol review that is available via a confidential website to participating LIRBs. LIRBs can choose to perform a facilitated review, using PedCIRB materials, that focuses on local concerns, rather than a full LIRB protocol review. If the LIRB accepts the PedCIRB review, the PedCIRB becomes the IRB of record for that protocol and takes responsibility for the review of subsequent protocol amendments, adverse events and continuing reviews. Since starting in November 2004, the PedCIRB has reviewed 59 protocols. Initial reviews resulted in 44 approvals pending modification and 15 protocols being tabled for further information. The time from protocol submission to final approval by the PedCIRB has ranged from 3 to 28 weeks with an average time of 16.9 weeks during year one and 12.7 weeks during year two of the project. As of November 2006, 117 of a possible 197 U.S. COG institutions (59%) have signed on to the PedCIRB initiative and 70% of the participating institutions have conducted facilitated reviews (total 750) for the 30 protocols available on the PedCIRB website. The PedCIRB's influence on protocol development and patient accrual timelines will be discussed. No significant financial relationships to disclose.
The European Medicines Agency (EMEA) guideline on oncology drug development
Authors: Palmeri S. , Bergh J. , Bergmann L. , Hansen S. W. , Moraleda J. M. , Marty M. , Schellens J. H. , Smyth J. , Therasse P. , van Oosterom A. , Jonsson B. 
Published: March 2020

6636 Background: The scientific assessment and positive opinion of the EMEA is mandatory for the approval of new oncology drugs in the European Union. One of the tasks of the EMEA is to provide guidance on the conduct of the various tests and trials necessary for approval. The EMEA has recently revised its guideline on the clinical development of new anticancer drugs. The revised version includes specific guidance on the development of non-cytotoxic (i.e., cytostatic) agents ( http://www.emea.europa.eu/pdfs/human/ewp/020595en.pdf ). Specific guidance is given about methodological issues using progression-free survival (PFS) as primary endpoint in confirmatory trials for registration ( http://www.emea.europa.eu/pdfs/human/ewp/26757506en.pdf ). Methods: The key elements of the revised guideline are described with particular reference to requirements for approval. Results: The early stages of clinical drug development have to be tailored according to the assumed pharmacology of the individual compound as defined in non-clinical studies. The integration of information from exploratory (phase I-II) and confirmatory (phase III) studies is of primary importance. In general, phase III trials should be designed with the aim of establishing the benefit risk balance of the drug, in a well-characterized target population. These studies should be randomized controlled and, where possible, blinded or include blinded evaluation. Acceptable primary endpoints include overall survival (OS) and PFS or disease-free survival (DFS). It is acknowledged that there are situations where PFS can be considered as a primary endpoint that measures clinical benefit. Adherence to protocol-defined schedules for tumor assessments, typically by imaging techniques, is important and deviations should be reported. Independent, blinded review and confirmation of best tumor response and progression should be undertaken if PFS is the primary endpoint. Conclusions: The current revision of the EMEA guideline provides useful clinical regulatory guidance for the development of cytostatic agents. When recommended guidelines are considered suboptimal, sponsors are encouraged to seek regulatory scientific advice. No significant financial relationships to disclose.
Unrelated donor hematopoietic cell transplantation (HCT) as treatment for acute myeloid leukemia (AML) in first remission
Authors: Pagel J. M. , Gooley T. , Sandmaier B. M. , Drouet L. , Petersdorf E. W. , Sorror M. L. , Hansen J. A. , Deeg H. J. , Martin P. J. , Storb R. , Appelbaum F. R. 
Published: March 2020

7000 Background: Unrelated donor HCT has been used with increasing frequency for the treatment of AML patients in first remission. Methods: Between 1990 and 2005, 105 adult patients with AML [66 (62%) primary and 39 (38%) secondary] received T- cell-replete HCT from unrelated donors in Seattle. Results: Median age was 44 (range, 18–74) years. Seventy-nine patients received ablative conditioning for HCT (57% conditioned with cyclophosphamide plus total body irradiation (TBI), 43% with chemotherapy alone). Non- myeloablative doses of fludarabine (FLU; 25 mg/m2 daily for 3 days) and TBI (200 cGy) were delivered to 26 patients. Ninety-six percent of patients who underwent reduced-intensity conditioning received unrelated peripheral blood stem cells (PBSC) while 59% of myeloablative HCT patients received PBSC as their source of stem cells. For all patients, the leukemia-free survival (LFS) and non-relapse mortality estimated at 2 years were 53%, and 26%, respectively, as 27 patients died of transplant-related causes (pulmonary-6, cardiac-1, graft versus host disease (GVHD)-6, infection-5, and unknown-9). Twenty-two patients (21%) relapsed 2 to 83 months (median 5) post-transplant, and 56 patients are surviving disease-free 1 to 168 months (median 27) post-transplant. For 90 patients (86%) with intermediate-risk cytogenetics, 51 (57%) are surviving disease-free, with 16 (18%) relapsing. Fourteen patients (13%) were considered high risk based on unfavorable cytogenetics; 4 of these 14 (29%) are surviving disease-free and 6 (43%) have relapsed. The probability of grade 3/4 acute GVHD was 19% while the probability of clinical extensive chronic GVHD was 54% one year after transplant. Unfavorable cytogenetics (HR=2.16, p=.08), secondary leukemia (HR=1.71, p=.10), higher co-morbidity score (p<.0001), and HLA mismatching (HR=2.35, p=.02) were associated with an increased hazard of mortality. After controlling for these factors, non-ablative conditioning was not statistically worse than ablative conditioning (HR=1.21, p=.61). Conclusions: These data suggest that HCT using unrelated allografts has the potential to provide significant LFS for patients undergoing HCT for AML in first remission when an HLA family match is not available. No significant financial relationships to disclose.
Bosutinib (SKI-606) exhibits clinical activity in patients with Philadelphia chromosome positive CML or ALL who failed imatinib
Authors: Gambacorti-Passerini C. , Brummendorf T. , Kantarjian H. , Martinelli G. , Liu D. , Fisher T. , Hewes B. , Volkert A. , Abbas R. , Cortes J. 
Published: March 2020

7006 Background: Bosutinib (SKI-606) is an orally available, dual Src/Abl kinase inhibitor. To assess safety and preliminary clinical activity of bosutinib, we conducted a phase 1/2 study in patients (pts) with Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML) or acute lymphocytic leukemia (ALL) who were imatinib resistant/intolerant. Methods: In part 1, 18 pts with imatinib- relapsed/refractory chronic phase (CP) CML received bosutinib 400 mg/day (3 pts), 500 mg/day (3 pts), or 600 mg/day (12 pts). Part 2 was an expanded cohort of 51 pts with all phases of Ph+ CML and ALL dosed at 500 mg daily. Timed blood samples were collected on days 1–3, 15 for PK analysis. Results: Of 69 pts, median age was 59 yrs; 48 were CP; 90% imatinib resistant. Drug-related grade 1/2 adverse events (AEs) occurring in =10% of CP pts: diarrhea (69%), nausea (44%), vomiting (19%), abdominal pain (13%), rash (13%). Grade 3/4 AEs occurring in =5% of CP pts: rash (6%), thrombocytopenia (6%). 17 pts required dose reductions. In evaluable imatinib-resistant CP-CML pts with no prior exposure to other Abl inhibitors, 16/19 (84%) had complete hematologic response (CHR); 4/21 had partial and 7/21 had complete cytogenetic responses for major cytogenetic response (MCyR) rate of 52%. Of 58 pts evaluable for mutations, 13 different imatinib-resistant mutations were found in 32 pts. 12/14 CP pts with non-P-loop mutations and 3/3 with P-loop mutations achieved CHR. 5/11 CP pts with non-P- loop mutations and 1/1 with P-loop mutation achieved MCyR. 4/9 evaluable advanced leukemia pts had CHR, 2 had MCyR. After oral administration, steady state exposure of bosutinib was nearly 2-fold higher than single-dose exposure. Mean elimination half-life was approximately 22–27 hours, supporting a once-daily dosing regimen. Conclusions: Bosutinib was well tolerated in pts with CML, with primarily low-grade gastrointestinal and dermatologic AEs. Bosutinib showed clinical activity in imatinib-resistant pts with cytogenetic responses and CHR across a range of mutations. Durability of response continues to be assessed. [Table: see text]