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  • 1
    In: Cancers, MDPI AG, Vol. 12, No. 9 ( 2020-08-21), p. 2375-
    Abstract: Background: Patients with cholangiocarcinoma often have indwelling biliary stents or catheters which are prone to obstructions and/or infections; studies show that 20–40% present with fever and/or jaundice requiring urgent treatment in the outpatient setting for which there are no uniform guidelines. The goal was to develop an expert panel consensus on this topic using the modified RAND/UCLA Delphi process to rate treatment appropriateness. Methods: Thirteen expert physicians from relevant specialties, geography, and practice settings were recruited for the panel. Patient scenarios were developed and panelists rated the therapies before and after a face-to-face discussion. The appropriateness of various therapies was rated on a scale from 1–9 and classified as appropriate, inappropriate, or uncertain. Scenarios with greater than 2 ( 〉 2) ratings of 1–3 (inappropriate) and greater than 2 ( 〉 2) ratings of 7–9 (appropriate) were considered to have disagreement and were not assigned an appropriateness rating. Results: Panelists were from all US regions and the UK (8%) and had practiced for a mean 16.5 years (4–33 years). Panelists rated 480 scenarios before the meeting and re-rated 288 of the clinical scenarios after the meeting. The panelists agreed that ongoing treatment with chemotherapy did not influence decision-making and, therefore, 192 scenarios were excluded from the final list. Disagreement decreased from 37.5% before to 10.4% after the meeting. Consensus on stent/tube manipulation and inpatient antibiotic therapy was obtained and summarized in patients as “appropriate” or “maybe appropriate” based on a patient’s bilirubin level at presentation. Conclusions: The Delphi process produced consensus guidelines to fill an unmet need in the urgent management of ascending cholangitis in patients with cholangiocarcinoma.
    Type of Medium: Online Resource
    ISSN: 2072-6694
    Language: English
    Publisher: MDPI AG
    Publication Date: 2020
    detail.hit.zdb_id: 2527080-1
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  • 2
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 35, No. 4_suppl ( 2017-02-01), p. 452-452
    Abstract: 452 Background: CC pts with biliary stents or catheters often present with fever and/or jaundice requiring urgent treatment for which there is no uniform guideline. We aimed to develop an expert panel consensus on this topic using the modified RAND/UCLA Delphi process to rate treatment appropriateness. Methods: We recruited 13 physician experts from relevant specialty, geography, and practice settings. Patient scenarios were developed based on a literature review, and therapies were rated by the experts before and after a face-to-face discussion. The appropriateness of various therapies was rated on a 1-9 scale and classified as appropriate, inappropriate, or uncertain. Scenarios with 〉 2 ratings of 1-3 (inappropriate) and 〉 2 ratings of 7-9 (appropriate) were considered to have disagreement and were not assigned an appropriateness rating. Results: Panelists were from all US regions (92%) and the UK (8%); had practiced for a mean 16.5 years (4-33 years) and reported seeing an average of 120 unique CC patients a year (0-900 pts). Panelists rated 288 clinical scenarios. Experts decided that ongoing treatment with chemotherapy did not influence decision-making. Disagreement decreased from 37.5% before the meeting to 10.4% after. Consensus statements are summarized in table 1. Conclusions: The Delphi process produced consensus guidelines to fill an unmet need in urgent management of ascending cholangitis in pts with CC. Studies of the impact of these guidelines on cost of care and pt outcomes are warranted. (Support: The Cholangiocarcinoma Foundation)[Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2017
    detail.hit.zdb_id: 2005181-5
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  • 3
    In: Journal of Surgical Oncology, Wiley, Vol. 111, No. 8 ( 2015-06), p. 935-940
    Abstract: Twenty percent of breast cancers are ductal carcinoma in situ (DCIS), with 15–60% having a local recurrence (LR) after surgery. Radiotherapy reduces LR by 50% but has not impacted survival. The validated Onco type DX ® 12‐gene assay (DCIS Score) provides individualized 10‐year LR estimates. This is the first study to assess whether DCIS Score impacts physicians' recommendations for radiation. Methods Ten sites enrolled women (9/2012–2/2014) with DCIS eligible for breast‐conserving therapy, excluding patients with invasive carcinoma and planned mastectomy. Prospective data collected included clinicopathologic factors, DCIS Score assay, and treatment recommendation before and after the assay result was known. Results In 115 patients (median age: 61 years; 74.8% postmenopausal), median DCIS size was 8 mm; 20% were nuclear grade 1, 46.1% grade 2; 64.4% reported necrosis. 86.1% were ER+, 79.1% PR+ (immunohistochemistry assay). Median DCIS Score: 29 (range: 0–85). Pre‐assay, 73% (95%CI: 64.0–80.9%) had radiotherapy recommendations vs. 59.1% (95%CI: 49.6–68.2%) post‐assay ( P = 0.008). Physicians rated DCIS Score as the most impactful factor in planning treatment. Conclusions The radiotherapy recommendation changed from pre‐assay to post‐assay 31.3% (95%CI: 23.0–40.6%) of the time—a clinically significant change. This study supports the clinical utility of the DCIS Score and indicates that the test provides additional, individualized information on LR risk. J. Surg. Oncol. 2015 111:935–940 . © 2015 Wiley Periodicals, Inc.
    Type of Medium: Online Resource
    ISSN: 0022-4790 , 1096-9098
    URL: Issue
    Language: English
    Publisher: Wiley
    Publication Date: 2015
    detail.hit.zdb_id: 1475314-5
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  • 4
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 32, No. 15_suppl ( 2014-05-20), p. 11050-11050
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2014
    detail.hit.zdb_id: 2005181-5
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  • 5
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 39, No. 15_suppl ( 2021-05-20), p. e18584-e18584
    Abstract: e18584 Background: Cancer progression rates following diagnosis are readily measured. However, the progression rate of cancer during the preclinical sojourn time is generally unobserved. Understanding the duration of preclinical stages (“dwell time”) would allow clinicians to better identify appropriate screening intervals for cancer. We therefore elicited estimates of progression rate during the preclinical sojourn time for a wide variety of malignancies from a panel of clinical experts. Methods: We used a validated consensus methodology (RAND/UCLA modified Delphi panel method) to elicit per-stage dwell time estimates for 20 solid cancers and lymphoma from experts. Eleven experienced oncologists (general and subspecialists) from community and academic centers reviewed literature on the natural history of disease and estimated in number of years ( 〈 1 to 9+ years) how long it would take each cancer to progress from the beginning of clinically detectable Stage I/II/III to the beginning of the next stage in untreated adults. Cancer histological subtypes were grouped and experts were asked to provide an overall rating. Ratings were completed before and after a discussion of areas of disagreement. Results: Expert estimates and range of dwell time for 21 cancer types are provided in Table. Prostate and thyroid cancer were estimated to be the slowest growing, taking approximately 7 and 5 years respectively to progress through Stage I (range 4-8), 5 years to progress through Stage II (range 3-7), and 3 and 4 (range 2-5) years respectively to progress through Stage III. Esophageal, lung, liver/intrahepatic bile-duct, gallbladder, and pancreatic cancers were estimated to progress quickly through all three stages (1-2 years per stage). Conclusions: These findings summarize practicing oncologists’ estimates of dwell time in preclinical disease. Experts agreed on dwell times although ranges were large and differences in cancer subtypes were not captured. Generally, estimates trend with published data on survival with treatment: cancers with higher survival (e.g., prostate, thyroid) were estimated to grow slower, while cancers with lower survival (e.g., pancreatic, liver/intrahepatic bile-duct, gallbladder) were estimated to grow faster. These estimates could be useful when determining screening intervals for these or any subset of these cancers. [Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2021
    detail.hit.zdb_id: 2005181-5
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  • 6
    In: Neurology and Therapy, Springer Science and Business Media LLC, Vol. 9, No. 2 ( 2020-12), p. 473-482
    Type of Medium: Online Resource
    ISSN: 2193-8253 , 2193-6536
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2020
    detail.hit.zdb_id: 2682228-3
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  • 7
    Online Resource
    Online Resource
    American Society of Clinical Oncology (ASCO) ; 2013
    In:  Journal of Clinical Oncology Vol. 31, No. 15_suppl ( 2013-05-20), p. e22124-e22124
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 31, No. 15_suppl ( 2013-05-20), p. e22124-e22124
    Abstract: e22124 Background: Many stage II and most stage I non-small cell lung cancer (NSCLC) patients forgo adjuvant chemotherapy, despite the likely presence of occult metastasis in the 30-60% of these patients who die within 5 years of surgery, and despite demonstration that patients with undetected, i.e. very early, metastasis can achieve long-term survival with this intervention. A multi-gene assay using quantitative RT-PCR and run on formalin-fixed, paraffin-embedded samples (Pervenio Lung RS) has been independently validated in two large international studies to better differentiate high- and low-risk non-squamous NSCLC patients than either traditional risk assessment criteria or conventional staging. A survey of physicians who used this multi-gene assay probed whether better risk discrimination changed post-operative management. Methods: Physicians were queried via a web-based survey on practice patterns, patient characteristics and treatment recommendations. The survey was developed through cognitive interviews with oncologists and thoracic surgeons. Physicians were allowed to respond regarding up to 4 patients (stage I or II) for whom the multi-gene test was ordered. Results: Forty-one physicians (12 surgeons, 29 oncologists/internists) of 61 contacted (67%) provided responses on 77 patients. Community practices accounted for 83%, and the average years in practice was 15. Seventy-one percent provided responses on either 1 or 2 patients. Mean patient age was 66±10 years, with stage I and stage II comprising 73% and 27%, respectively. Prior to obtaining assay results, chemotherapy was recommended in 30% of patients, including 5 stage I patients. The assay characterized 5-year mortality risk as high, intermediate and low in 52%, 23% and 25% of patients, respectively. Treatment recommendations were changed post-assay in 36% of patients, including 73% of high-risk patients for whom observation was recommended initially. Change in treatment intensity correlated with the degree of assay-assessed risk. Conclusions: Refinement of risk assessment achieved via a multi-gene prognostic assay resulted in changes in treatment recommendations for a substantial number of early stage NSCLC patients.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2013
    detail.hit.zdb_id: 2005181-5
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  • 8
    In: Blood, American Society of Hematology, Vol. 128, No. 22 ( 2016-12-02), p. 395-395
    Abstract: Introduction:MDS are characterized by dysplastic blood cell production and anemia, neutropenia, and thrombocytopenia. Anemia may be managed by red blood cell transfusions, but risks of infection, iron overload, and end-organ damage can limit use. Disease progression is defined, in part, by dependence on transfusions. Active treatment with chemotherapy or biotherapy directed at the underlying dysplastic cells can reduce transfusion requirements, although optimum timing for initiation is not fully understood. Methods:This retrospective cohort study analyzed 2006-2012 linked Surveillance, Epidemiology, and End Results (SEER) registry and Medicare claims to estimate the impact of treatment timing on the likelihood of reaching transfusion independence (TI) among transfusion-dependent (TD) lower-risk MDS patients (International Classification of Diseases [ICD]-O-3: 9980-9989) ≥ 60 years of age receiving active treatment (azacitidine, decitabine, or lenalidomide). The start of TD (≥ 1 blood transfusion in each of 2 consecutive 8-week periods, without a transfusion-free gap of ≥ 56 days) for the first time between 1/1/2007 and 12/31/2011 was defined as the index date. Patients not continuously enrolled for 12 months before index (baseline) or 6 months after (follow-up) were excluded. Patients were followed from index either until achieving TI or to the end of follow-up in the database. We compared early (treatment initiated ≤ 3 months from index date) vs late ( 〉 3 months) initiators of active treatment for all outcomes. The primary outcome, TI (defined as a ≥ 56-day transfusion-free gap), was examined using multivariate Cox regression and Kaplan-Meier survival estimates. Cox models adjusted for patient demographics, treatment exposure threshold (≥ 3 prescription fills for lenalidomide or ≥ 6 administration cycles of hypomethylating agents [HMAs], based on clinical trial experience for response), and other disease characteristics such as MDS pathological categories. Components of the previously published SEER-Medicare MDS Risk Score (SMMRS) were used to categorize pathological or disease severity. Results:We identified 508 actively treated TD patients with MDS (351 early and 157 late treatment initiators). Median age was 77 years (range 38-91); 45.5% were female; and all US geographic regions were represented. Six percent of patients had deletion 5q [del(5q)] syndrome (6.3%). Disease severity varied between early and late initiators (P 〈 0.001), although in each group 〉 70% of patients had MDS of a higher severity. For early treatment initiators, mean time ± standard deviation to active treatment was 28 ± 25 days, vs 187 ± 114 days for late treatment initiators. Proportions of patients receiving an HMA (azacitidine 56.1%, decitabine 22.8%) or lenalidomide (21.1%) were similar for early vs late initiators (P = 0.221). Most patients (65.4%) received an erythropoiesis-stimulating agent (ESA) during their TD period; however, a smaller proportion of early initiators used ESAs vs late initiators (61.5% vs 73.9%; P = 0.007). A similar proportion of early and late initiators met the minimum treatment exposure threshold for assessing response to their chosen active treatment (≥ 6 cycles of HMA or ≥ 3 cycles of lenalidomide) (37.4%; P = 0.886). The median time to reach TI was significantly shorter in early initiators vs late initiators (284 days vs 682 days; P 〈 0.001) (Figure). The unadjusted rate of achieving TI was higher in early vs late initiators (0.72 per patient year [PPY] vs 0.40 PPY). This difference was observed irrespective of the minimum treatment exposure threshold being met. The proportion of patients reaching TI over time was higher in early initiators vs late initiators at nearly all time points (P 〈 0.001; Figure). In adjusted analyses, early treatment initiation was a significant predictor of reaching TI during the study period vs late initiation (hazard ratio [HR] 1.69; P 〈 0.001). Patients who met the minimum treatment exposure were also more likely to reach TI vs those who did not (HR 2.12; P 〈 0.001). Conclusions:Patients with TD MDS who began active treatment ≤ 3 months of becoming TD achieved TI earlier and at a higher rate than those who initiated active treatment after 〉 3 months. Further study of MDS clonal evolution is needed to understand how early vs late treatment exposure impacts the subclonal architecture of MDS. Disclosures Reddy: Celgene Corporation: Other: Other I am an employee of the Partnership for Health Analytic Research, LLC, a health services research firm paid by Celgene to conduct the research described in this abstract.. Chang:Celgene Corporation: Other: Other I am an employee of the Partnership for Health Analytic Research, LLC, a health services research firm paid by Celgene to conduct the research described in this abstract.. Papoyan:Celgene Corporation: Other: Other I am an employee of the Partnership for Health Analytic Research, LLC, a health services research firm paid by Celgene to conduct the research described in this abstract.. Broder:Celgene Corporation: Other: Other I am an employee of the Partnership for Health Analytic Research, LLC, a health services research firm paid by Celgene to conduct the research described in this abstract.. McGuire:Celgene Corporation: Employment, Equity Ownership. Binder:Celgene Corporation: Employment, Equity Ownership.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2016
    detail.hit.zdb_id: 1468538-3
    detail.hit.zdb_id: 80069-7
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  • 9
    In: Blood, American Society of Hematology, Vol. 124, No. 21 ( 2014-12-06), p. 6008-6008
    Abstract: Background: The myelodysplastic syndromes (MDS) include a group of malignancies characterized by myeloid stem cell origin and increasing incidence with age. Although treatment is available with hypomethylating agents (HMAs), 80% of patients fail to achieve remission and nearly all patients eventually develop chemoresistant disease. The incidence of MDS 1st-line HMA treatment failures has not been previously reported. Methods: We examined US commercial health insurance claims data to estimate the annual incidence of MDS and the number of MDS patients potentially eligible for 2nd-line therapy. We conducted a retrospective cohort study of patients with an MDS-associated medical claim (ICD-9-CM diagnosis code 238.7x) in the identification (ID) period (calendar year 2009). The subgroup of newly diagnosed patients had no prior MDS diagnosis in the pre-ID period (calendar year 2008); patients newly treated with HMA had a claim for HMA in the ID but not pre-ID periods. Using expert input, we defined MDS patients as potential candidates for 2nd-line therapy if they used an HMA in the ID period and stopped for ≥2 months, switched to another HMA, or remained on the first HMA for 〉 7 months. MDS incidence rates were stratified by age (≤49, 50-64, 65-74, and ≥75 years) and sex. Results: We identified 9,209 patients with an MDS-associated claim. There were 4,151 patients newly diagnosed with MDS, yielding an overall MDS incidence of 69.9/100,000 enrollees (Table). Incidence was slightly higher among women (75.7/100,000) than men (63.1/100,000). Women between the ages of 50 and 64 years had the highest incidence (111.5/100,000) among all newly diagnosed patients stratified by age and sex. The incidence of newly treated MDS patients was 2.8/100,000 enrollees. Among this group, incidence was higher among men (3.6/100,000) than women (2.1/100,000), and when stratified by age and sex the incidence was highest among men aged 75 years or older (10.5/100,000). For each 100,000 enrollees, there were 3 new 2nd-line therapy candidates. Conclusions: The estimated incidence of MDS in the United States was 69.9 per 100,000 insured enrollees in 2009, similar to results found in other epidemiological databases (Cogle et al, Blood 2011; Goldberg et al, J Clin Oncol 2010). The incidence of MDS patients identified as eligible for 2nd-line therapy was 3/100,000. In this commercially insured patient population we estimate that approximately 9,500 people per year in the United States may be candidates for 2nd-line therapy for MDS. These data can be used to inform population-based estimates that would include Medicare patients in addition to those commercially insured of the medical and economic burden of disease faced by MDS patients. Table: Incidence of MDS Stratified by Age and Gender Gender Age Group, years Newly Diagnosed Patients Newly Treated Patients Potential 2nd Line Treatment Candidates Female All ages 75.7 2.1 2.0 ≤49 56.6 0.1 0.0 50-64 111.5 2.1 1.1 65-74 101.2 4.0 5.3 ≥75 68.5 4.4 4.4 Male All ages 63.1 3.6 4.1 ≤49 29.6 0.2 0.1 50-64 86.5 2.5 3.8 65-74 106.1 8.5 8.5 ≥75 97.1 10.5 11.7 All All ages 69.9 2.8 3.0 Note: Results are expressed as number of cases per 100,000 enrollees. Disclosures Cogle: Partnership for Health Analytic Research (PHAR): Consultancy, I was paid as a consultant for my expert opinion while developing the analyses Other. Kurtin:Celgene, Millenium, Onyx, TEVA, Onconova, Incyte: Consultancy. Bentley:Partnership for Health Analytic Research (PHAR): Employment, I am an employee of PHAR, LLC, which was paid by Onconova Therapeutics to conduct the analyses described in this abstract. Other. Broder:Partnership for Health Analytic Research (PHAR): Employment, I am an employee of PHAR, LLC, which was paid by Onconova Therapeutics to conduct the analyses described in this abstract. Other. Chang:Partnership for Health Analytic Research (PHAR): Employment, I am an employee of PHAR, LLC, which was paid by Onconova Therapeutics to conduct the analyses described in this abstract. Other. Lawrence:Onconova Therapeutics, Inc. : Employment. McKearn:Onconova Therapeutics, Inc. : Employment. Megaffin:Onconova Therapeutics, Inc. : Employment. Percy:Onconova Therapeutics, Inc. : Employment. Petrone:Onconova Therapeutics, Inc. : Employment, Stock Options Other. Sun:Partnership for Health Analytic Research (PHAR): Employment, I am an employee of PHAR, LLC, which was paid by Onconova Therapeutics to conduct the analyses described in this abstract. Other.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2014
    detail.hit.zdb_id: 1468538-3
    detail.hit.zdb_id: 80069-7
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  • 10
    In: Blood, American Society of Hematology, Vol. 140, No. Supplement 1 ( 2022-11-15), p. 13129-13131
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2022
    detail.hit.zdb_id: 1468538-3
    detail.hit.zdb_id: 80069-7
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