ACORN Research LLC

Memphis, TN, United States

ACORN Research LLC

Memphis, TN, United States
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Stepanski E.J.,ACORN Research LLC | Reyes C.,Genentech | Walker M.S.,ACORN Research LLC | Satram-Hoang S.,Q.D. Research Inc | And 5 more authors.
Pancreas | Year: 2013

OBJECTIVES: This retrospective study examined pancreatic cancer patients who received combination gemcitabine and erlotinib to determine if the association between rash and outcomes observed in clinical trials would be observed in 'real-world' community oncology settings. METHODS: Medical records from 10 community oncology practices were used to identify eligible patients. Rash severity was classified as High (moderate/severe) versus Low (absent/mild) based on medical record review. Kaplan-Meier analysis assessed progression-free survival (PFS) and overall survival (OS) by rash status from a landmark of 42 days after treatment initiation. Cox regression with time-varying covariates tested whether high-severity rash predicted longer OS and PFS. RESULTS: The High Severity group (n = 34) had longer median OS from the landmark than the Low Severity group (n = 134; 7.58 months vs 5.03 months, P = 0.0339). Cox regression analysis (n = 174) confirmed a reduced risk of death with High Rash Severity (hazard ratio [HR] = 0.67, P = 0.0389). Progression-free survival results showed a similar pattern (median PFS 2.37 months from landmark vs 2.04 months for High vs Low Severity groups, P = 0.0485). CONCLUSIONS: Results from this community sample were consistent with findings from randomized clinical trials, showing that longer OS is predicted by high-severity rash in erlotinib-treated pancreatic cancer patients. Copyright © 2012 by Lippincott Williams & Wilkins.

Walker M.S.,ACORN Research LLC | Masaquel A.S.,Genentech | Kerr J.,ACORN Research LLC | Lalla D.,Genentech | And 3 more authors.
Breast Cancer Research and Treatment | Year: 2014

Treatment options for metastatic breast cancer (MBC) are complex, and some patients experience early discontinuation or switching of treatment (ETDS). We examined the relationship between ETDS and patient-reported symptom burden among patients receiving first-line treatment of MBC in community oncology settings. This retrospective observational study used the ACORN Data Warehouse, a comprehensive community oncology repository of medical records and patient-reported outcomes. Patients with first-line treatment for MBC who had Patient Care Monitor (PCM) surveys were eligible. ETDS was defined as: record stating ETDS, treatment duration < planned, and planned therapy <6 weeks. Symptom burden was measured by two PCM composite scores [continuous (0-22) and categorical (absent, mild, moderate, and severe)] computed from 22 PCM items with varying cut points to assess symptom burden over time. Cox regression with time-varying covariates was used to assess risk for ETDS controlling for patient characteristics and treatment type: chemo (chemotherapy without targeted therapy (±hormone therapy); targeted (chemotherapy plus targeted therapy (±hormone therapy); and hormone (hormone therapy only). Overall, 197 (24.7%) of a total sample of 797 patients had an ETDS event, of which 109 (55.3%) were switches rather than early discontinuation. ETDS rate was nominally lower in the hormone group (11.1%) versus chemo (27.6%) or targeted (26.1%). PCM continuous composite score predicted ETDS, controlling for other variables (HR = 1.132, p < 0.0001). ETDS was predicted by moderate and severe levels of PCM categorical composite score (HR = 4.135, and HR = 5.287 vs. absent, respectively, both p < 0.0001), with the pattern suggesting a threshold effect. Moderate or severe levels of a wide range of patient-reported symptoms and the accumulation of symptoms over time significantly predicted ETDS. Providers may better maintain patients on planned therapy if they attend to overall symptom burden patients experience over time. © Springer Science+Business Media 2014.

Henry D.H.,Pennsylvania Hospital | Langer C.J.,University of Pennsylvania | McKenzie R.S.,Janssen Scientific Affairs LLC | Piech C.T.,Janssen Scientific Affairs LLC | And 3 more authors.
Supportive Care in Cancer | Year: 2012

Purpose: In July 2007, the Centers for Medicare andMedicaid Services (CMS) limited coverage of erythropoiesisstimulating agents (ESAs) in cancer patients with chemotherapy-induced anemia (CIA) through a National Coverage Determination (NCD). The primary objective of this study was to compare transfusion rates in patients with CIAwith lung, breast, or colorectal cancer before and after the NCD. Methods: Adult Medicare patients with CIA treated at 49 community oncology clinics were selected from two time periods based on clinics' NCD implementation date. Chart data were abstracted for 12 weeks post-CIA episode start, defined as hemoglobin (Hb) level <11 g/dL while receiving chemotherapy or within 60 days of the last chemotherapy dose. Multivariate analyses were used to calculate the odds of transfusion and to assess the units of blood transfused, controlling for differences in demographics, clinical history, and chemotherapy. Results: Eight hundred pre-NCD and 994 post-NCD patients from 49 sites were selected. Of the patients, 56% used ESAs post-NCD vs. 88% pre-NCD (p<0.0001). The duration of ESA use decreased in the post-NCD (32.1 days) vs. pre-NCD (48.4 days, p<0.0001) group. The post-NCD group reported significantly lower Hb levels, higher odds of receiving a transfusion (odds ratio: 1.41, 95% CI 1.05-1.89, p=0.0238) and inc:reased blood utilization of 53% (units transfused: OR 1.53, 95% CI 1.15-2.04, p=0.0034). Conclusions: Decreased frequency and duration of ESA administration were reported in the post-NCD vs. pre-NCD period. Findings were accompanied by a modest but statistically significant increase in transfusions and a decrease in Hb values. © Springer-Verlag 2011.

Edinger J.D.,Veterans Affairs Medical Center | Edinger J.D.,Duke University | Wyatt J.K.,Rush University Medical Center | Stepanski E.J.,ACORN Research LLC | And 12 more authors.
Archives of General Psychiatry | Year: 2011

Context: Distinctive diagnostic classification schemes for insomnia diagnoses are available, but the optimal insomnia nosology has yet to be determined. Objectives: To test the reliability and validity of insomnia diagnoses listed in the American Psychiatric Association's DSM-IV-TR and the International Classification of Sleep Disorders, second edition (ICSD-2). Design: Multitrait-multimethod correlation design. Setting: Two collaborating university medical centers, with recruitment from January 2004 to February 2009. Participants: A total of 352 adult volunteers (235 of whom were women) who met research diagnostic criteria for insomnia disorder. Main Outcome Measures: Goodness-of-fit ratings of 10 DSM-IV-TR and 37 ICSD-2 insomnia diagnoses for each patient. Ratings were provided by 3 clinician pairs who used distinctive assessment methods to derive diagnostic impressions. Correlations computed within and across clinician pairs were used to test reliability and validity of diagnoses. Results: Findings suggested that the best-supported DSMIV- TR insomnia categories were insomnia related to another mental disorder, insomnia due to a general medical condition, breathing-related sleep disorder, and circadian rhythm sleep disorder. The category of primary insomnia appeared to have marginal reliability and validity. The best-supported ICSD-2 categories were the insomnias due to a mental disorder and due to a medical condition, obstructive sleep apnea, restless legs syndrome, idiopathic insomnia, and circadian rhythm sleep disorder-delayed sleep phase type. Psychophysiological insomnia and inadequate sleep hygiene received much more variable support across sites, whereas the diagnosis of paradoxical insomnia was poorly supported. Conclusions: Both the DSM-IV-TR and ICSD-2 provide viable insomnia diagnoses, but findings support selected subtypes from each of the 2 nosologies. Nonetheless, findings regarding the frequently used DSM-IV-TR diagnosis of primary insomnia and its related ICSD-2 subtypes suggest that their poor reliability and validity are perhaps due to significant overlap with comorbid insomnia subtypes. Therefore, alternate diagnostic paradigms should be considered for insomnia classification. ©2011 American Medical Association. All rights reserved.

Tillmanns T.D.,West Clinic | Lowe M.P.,Northwestern University | Lowe M.P.,Advocate Christ Medical Center | Walker M.S.,ACORN Research LLC | And 2 more authors.
Gynecologic Oncology | Year: 2013

Objective: We examined the safety and efficacy of combining bevacizumab with albumin-bound (ab-) paclitaxel to treat patients with recurrent, platinum-resistant primary epithelial ovarian or peritoneal carcinoma. Methods: Patients had measurable disease per RECIST guidelines, progressing within 6 months after a prior course of platinum-based treatment. Patients received ab-paclitaxel 100 mg/m2 given by intravenous infusion over 30 min on days 1, 8, and 15 of a 28-day cycle with bevacizumab 10 mg/kg given on days 1 and 15. Results: Forty-eight patients with an average 1.8 prior lines of treatment participated. The overall response rate was 50% (24/48) (95% CI, 34.8% - 65.1%), with 4 complete and 20 partial responses. Fourteen patients (29%) had stable disease, whereas eight (17%) had progressive disease, and two (4%) were not evaluable. Patients received a median of 6 treatment cycles (range, 1 - 31 cycles). The median progression-free survival was 8.08 months (95% CI, 5.78 - 10.15 months); 6 month progression-free rate was 62.5% (95% CI, 47.8%-77.2%); median overall survival was 17.15 months (95% CI, 13.57 - 23.82 months). Grade 3-4 adverse events included gastrointestinal disorders (18.8%), neutropenia (8.3%), and hypertension (6.3%). Conclusions: Ab-paclitaxel with bevacizumab clearly demonstrates antitumor activity and manageable toxicity profile in patients with recurrent, platinum-resistant ovarian carcinoma. This regimen should be evaluated in a larger randomized trial. © 2012 Elsevier Inc. All rights reserved.

Schwartzberg L.S.,West Clinic | Wang G.,Advanced Medical Specialties | Somer B.G.,West Clinic | Blakely L.J.,Tennessee Oncology | And 4 more authors.
Clinical Breast Cancer | Year: 2014

Background In this phase II study, we explored efficacy and toxicity of combined endocrine and low-dose metronomic chemotherapy therapy consisting of fulvestrant and capecitabine in estrogen and/or progesterone receptor-positive, HER2-negative MBC. Patients and Methods Patients with ≤ 1 previous hormonal treatment in the metastatic setting received an injection fulvestrant loading dose 500 mg on day 1, 250 mg on days 15 and 29 followed by 250 mg every 28 days along with continuous oral capecitabine in divided doses. The total fixed daily dose of capecitabine was either 1500 mg or 2000 mg, depending on the patient's weight (< 80 kg vs. ≥ 80 kg). Primary end points were PFS and TTP. Toxicity was assessed by continuous evaluations of treatment-emergent adverse events (AEs) and changes from baseline in laboratory values. Results Forty-one women, with a mean age of 64.5 years, were enrolled. Patients completed a median of 11 monthly treatment cycles. Median PFS was 14.98 months (95% confidence interval [CI], 7.26-upper limit [UL] not estimated) and median TTP was 26.94 months (95% CI, 7.26-UL not estimated). Median overall survival was 28.65 months (95% CI, 23.95-UL not estimated). Treatment was well tolerated with < 10% Grade 3 palmar-plantar erythrodysesthesia. Overall, the most frequent AEs were palmar-plantar erythrodysesthesia, fatigue, and nausea. Conclusion Fulvestrant with metronomic capecitabine demonstrates substantial activity in hormone receptor-positive MBC and is well tolerated. Combined chemoendocrine approaches should be further explored considering the low toxicity of the combination with meaningful TTP. © 2014 Elsevier Inc. All rights reserved.

Walker M.S.,ACORN Research LLC | Miller P.J.E.,ACORN Research LLC | Namjoshi M.,Novartis | Houts A.C.,ACORN Research LLC | And 2 more authors.
Journal of Medical Economics | Year: 2013

Objective This retrospective observational study describes treatment patterns and longitudinal health-related quality-of-life (HRQoL) among metastatic breast cancer patients with bone metastasis from nine community oncology clinics. Methods For description of treatment patterns, patients were classified as treated if they started zoledronic acid within 60 days of diagnosis of bone metastasis, were considered untreated if they had not, and were considered unclassified if they died or experienced fracture before 60 days had elapsed. Medical record review provided demographic and disease characteristics as well as history of treatment. Patients completed Patient Care Monitor (PCM) assessments of patient reported outcomes during routine care for up to 2 years from the date of bone metastasis diagnosis. Results The overall rate of fracture in the sample was 17.4%. Of the 321 patients enrolled, 160 were treated as of 60 days after diagnosis of bone metastasis, 147 were untreated, and 14 were unclassified. Of the 147 untreated as of 60 days, 82 did eventually receive zoledronic acid. More than half of all patients treated with zoledronic acid delayed the start of treatment by more than 30 days after diagnosis of bone metastasis. Patients who had a fracture showed decreased mobility and increased pain and anxiety at fracture, with recovery taking ∼16 months. Limitations: Key limitations included: convenience sample with information limited to medical record content, low rate of observed fractures possibly due to limited 2-year follow-up, and exclusion of non-zoledronic acid bisphosphonate use. Conclusions Whereas the proportion of patients experiencing a fracture was small, the impact of fracture on HRQoL was significant and was more prominently seen to impact specific dimensions of HRQoL. © 2013 Informa UK Ltd.

Rybarczyk B.,Virginia Commonwealth University | Mack L.,Virginia Commonwealth University | Harris J.H.,Southwestern University | Stepanski E.,Acorn Research LLC
Rehabilitation Psychology | Year: 2011

Objective: The present study tested two methods of self-help cognitive-behavioral therapy for insomnia (CBT-I) for 106 older adults (mean age = 68) with osteoarthritis (n = 33) or coronary artery disease (n = 33) or no significant medical condition (n = 40). The latter was employed as a comparison group to test the differential efficacy between primary and comorbid insomnia. Method: Self-help CBT-I has demonstrated efficacy in previous studies, so two treatments were compared rather than employing a no treatment control group. Participants were randomly assigned to a book version or an enhanced multimedia version of CBT-I. Results: Both versions of CBT-I demonstrated efficacy in improving all measures of sleep at posttreatment, using intent-to-treat analyses. These sleep improvements were maintained among 86 treatment completers who participated in 1-year follow-up assessment. There were no significant differences in treatment response between primary (no medical condition) and comorbid insomnia participants and no significant differences between the two types of self-help according to sleep log measure. However, multimedia participants compared to book participants showed more improvement on three global sleep measures administered at posttreatment only. Conclusions: Although outcomes were attenuated relative to those obtained in therapist led intervention studies, the results suggest that self-help CBT-I has good potential to serve as a first-line, cost-effective treatment for both primary and comorbid insomnia in older adults. © 2011 American Psychological Association.

PubMed | ACORN Research LLC, The West Clinic and Sanofi S.A.
Type: Journal Article | Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology | Year: 2017

118 Background: Cabazitaxel (C) and abiraterone (A) improve survival in mCRPC after progression on docetaxel (D). We examined whether mCRPC patients progressing on D received C and/or A, in which sequence, and how they compared with patients not receiving C or A.This retrospective study used medical records from the ACORN Data Warehouse. Eligible patients were: diagnosed with mCRPC, progressed after 1Screened out patients were: 60 with no progression on D; 41 absent records; 18 with another cancer. Table below shows patients by treatment sequence group. Age, PS, and PSA did not differ significantly. More patients appear to have received A after C (56.7%) than C after A (25.7%). In the 3-drug sequence groups, more patients received DCA in the 6-month period from April-October 2011 (n = 17/19) than in the 6-month period from June-December 2012 (n = 2/10), suggesting a drop-off in use of C immediately after D. Cox PFS treatment effect was not significant. Cox OS treatment effect was significant (DA vs DC, HR = 1.693 [95% CI: 1.066, 2.691], p = 0.0258).Patterns suggest comparable outcomes in PFS. Controlling for patient characteristics, OS may be longer in DC vs DA. Patients appear undertreated in third line with fewer receiving C after A than the opposite sequence. We hypothesize that DAC may not be as feasible as DCA. Reasons for underutilization of C are being examined. [Table: see text].

PubMed | EMOL Health, The West Clinic and ACORN Research LLC
Type: Journal Article | Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology | Year: 2017

159 Background: Giving chemotherapy (CTX) near the end of life is futile and costly in human and financial terms. We analyzed patterns of chemotherapy administered at the end of life (CAEOL) by disease, provider, and line of therapy as part of a broad quality initiative. We hypothesized that measuring CAEOL in our practice could identify modifiable practice patterns.All patients (pts) with an ICD-9 diagnosis of cancer who died between 1/09 and 6/10 were identified by EMR or by searching SSDI records. We focused on the cohort receiving CTX within 14 or 28 days (d) of death, stratified by tumor type, provider and line of therapy by electronic chart review. Initial results were distributed to practice physicians for review and discussion with a clinic-wide goal to be below 5% and 10% at 14 and 28d, respectively. Subsequent cohorts were then evaluated periodically with results disseminated.There was a 14.5% reduction in CAEOL within 14d and a 25% reduction within 28d over time (Table), meeting the clinic-wide standard. In the 2009-2010 cohort there was a difference in 1st line pts receiving CTX within 28 d for NSCLC (24/56 pts, 42.9%) or pancreas cancer (13/19, 68.4%) and the next 4 most common diagnoses: breast, colorectal, small cell lung, and head and neck cancer (15/84, 17.9%), p= .0024. CAEOL beyond 3rd line in non-breast, or >5th line in breast cancer was uncommon. In the 2013 cohort, 1st line accounted for 28/51 pts (54.9%) receiving CTX within 28 d with NSCLC (8/15), pancreas (3/3) and lymphoma (4/4) the most prevalent diagnoses.CAEOL is a relatively rare event in our practice, now meeting practice standards after measurement and delving into root causes. A certain irreducible number of pts will be treated at the end-of-life, including those with potentially life-prolonging intent. First line therapy represents the majority, so identifying inappropriate candidates at diagnosis remains a quality improvement opportunity. [Table: see text].

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