bluuebunny/crossref_metadata_2025 huggingface dataset:
Prevalence and predictors of active surveillance management for black males diagnosed with low risk prostate cancer.
Authors: Taku Nicolette , Narayan Vivek , Bellamy Scarlett , Vapiwala Neha
Published: September 2018

e18019

Background: Consensus guidelines recommend that active surveillance (AS) be considered in the management of men with low risk prostate cancer (LRPC). The evidence supporting this recommendation is largely derived from studies in which men of African descent were underrepresented; thus, the appropriate implementation of AS in this population remains controversial. The objective of our study was to evaluate the prevalence and clinical predictors of an AS approach in black men (BM) diagnosed with LRPC following the 2010 inclusion of AS in LRPC management consensus guidelines. Methods: BM (N = 15,242) and non-Hispanic white men (WM) (N = 86,655) diagnosed with LRPC (as defined by PSA ≤ 10 ng/ml, Gleason score ≤ 6, clinical stage T1 – T2a) between 2010 and 2013 were identified from the National Cancer Database. Logistic regression models were used to assess the likelihood of pursuing an AS strategy over time, as well as to examine associations between sociodemographic characteristics (SDCs) and the receipt of AS. Results: Overall, 9% of BM with LRPC were managed with AS. On univariate analysis, the likelihood of BM undergoing AS increased from 2010 and was statistically significant ( p < 0.001) for all subsequent years (2011: OR = 1.54, 95% CI 1.30-1.82; 2012: OR = 2.19, 95% CI 1.82-2.60; 2013: OR = 2.55, 95% CI 2.15-3.02). Uninsured BM were twice as likely as those with private insurance to pursue AS (OR 1.97, 95% CI 1.51-2.58, p < 0.001). BM seen at academic cancer programs were also more likely to be managed with AS, when compared to those seen at community cancer centers (OR 1.47, 95% CI 1.37-1.60, p < 0.001). BM were less likely than WM to receive AS (OR = 0.82, 95% CI 0.77 to 0.87, p < 0.001). On multivariate analysis adjusted for SDCs, there was no significant difference in AS utilization between the two ethnic groups. Conclusions: The utilization of AS for BM with LRPC appears to be increasing, may be influenced by SDCs, and may not differ from the AS utilization for WM with LRPC. Given the observed elevated rates of post-prostatectomy adverse pathologic features among BM, further evaluation of the determinants of AS utilization and scrutinous consideration of the appropriateness of AS in this population is warranted.
Written care plan and patient enablement: Pre-implementation data from the 4R in Oncology Project.
Authors: Trosman Julia Rachel , Weldon Christine B. , Perez Claudia B. , Kulkarni Swati , Khan Seema Ahsan , Hansen Nora , Nelson Valerie , Stein Jennifer , Simon Melissa A. , Strauss Jonathan Blake , Benson Al Bowen , Espino Sasa M. , Bunce Mikele , Pan Wayne , Friedewald Sarah M. , Gradishar William John
Published: September 2018

e18032

Background: The IOM ’11 and ’13 reports recommend a written care plan (WCP) at cancer diagnosisto enable teamwork and patient (pt) engagement. Standardized multimodality WCP is a key part of the 4R model of care planning and pt engagement proposed under “NCI ASCO Teams” Project (Trosman JOP 2016). 4R (Right Information / Care / Patient / Time) is under implementation at 3 centers: academic, community and safety net. As current state assessment prior to implementing 4R and standard multimodality WCP, we surveyed pts not impacted by 4R on care planning, enablement and whether they received any WCP. Methods: Survey of breast cancer stage I-III pts who received care at the three sites Jan ’15 - Mar ’16, prior to 4R. We used simple frequencies and Fisher’s exact test in analysis. Results: Survey response rate: 47%, 241/515. Gaps of > 30% were reported in 7 of 8 aspects of care planning and pt enablement - Table. A non standard WCP was received by 46% of pts. Receiving a WCP impacted whether pts were clear about care (85% with WCP vs 52% without, p < .0001), able to manage own care (79% with WCP vs 58% without, p = .0005) and overwhelmed (35% with WCP vs 49% without, p = .04). Care complexity was a significant factor for feeling overwhelmed by pts without WCP (49% of pts receiving > 6 care services felt overwhelmed vs. 30% of pts receiving < = 6 services, p = .04), but not a significant factor in pts with WCP (45% vs 41%, p = .7). More pts with WCP reported well managed care by providers than pts without WCP (77%, 62%, P = .02). Conclusions: Serious gaps found in care planning and pt enablement at our sites support the need for 4R implementation. Even pre-4R, non standard WCPs improve pt understanding of care and ability to manage it, and reduce the impact of care complexity on pts. Providers using WCP appear to also coordinate care, but WCP itself may be an important factor of patient enablement. [Table: see text]
Racial disparities in receipt of guideline care and cancer deaths for women with ovarian cancer.
Authors: Warren Joan , Cronin Kathleen A , Stevens Jennifer , Howlader Nadia , Trimble Edward Lloyd , Harlan Linda C
Published: September 2018

e18081

Background: Receipt of guideline care improves survival for women with ovarian cancer yet care may vary by race. We assessed the receipt of guideline care and cancer deaths by race for women with incident ovarian cancer. Methods: This retrospective cohort analysis used the National Cancer Institute’s Patterns of Care data for black and white women diagnosed with all stages of ovarian cancer in 2002 and 2011 (n = 5356) with follow-up through 12/31/14. Data included patient characteristics, type of surgery and chemotherapy, and provider factors. Multivariate logistic regression was used to create the standardized percentages (predictive margins) of women receiving guideline treatment by race group. Cox proportional hazards models were used to assess the unadjusted and adjusted risk of ovarian cancer death by race. Results: At diagnosis, for black women, 35.6% had Stage III and 37.2% had Stage IV disease compared with 44.1% Stage III and 24.2% Stage IV for white women. More black women had surgery in large teaching hospitals (47.6%) than white women (39.7%) but use of gynecologic oncologists (GO) was similar for black women and white women- (62.1% vs 58.8%). In regression models, the standardized percent of black women receiving guideline care was significantly lower than for white women (29.2% vs 38.5%). The unadjusted hazards ratio (HR) for death was significantly higher in black women (HR = 1.32) yet after controlling for patient and provider factors and receipt of guideline care, black women did not have a significantly higher risk of death (HR = 1.08). Conclusions: Rates of guideline care are very low for all women with ovarian cancer, significantly more so for black patients. Low use of guideline care among black women cannot be explained by provider factors as a large percent of black women consulted a GO or received care in large teaching hospitals. Research is needed to address how to increase guideline care among black patients as we found that race was not associated with the risk of death when guideline care was included as a factor in multivariate survival models.
Real world experience of palbociclib in hormone receptor-positive metastatic breast cancer.
Authors: Malik Faizan , Ali Naveed , Jafri Syed Imran Mustafa , Sundermeyer Mark L. , Seidman Michael Jeffrey , Fidler Christian Joseph
Published: September 2018

e18094

Background: Palbociclib has been approved as a first line therapy in hormone-receptor positive (HR+) and HER-2 negative metastatic breast cancer(MBC) manifesting significant improvement in progression free survival (PFS). We studied this drug in a community setting. The endpoints were estimated PFS, objective response, toxicities and patient outcomes. Methods: This was a single-center, retrospective study of HR+MBC patients receiving palbociclib after its FDA approval. 22 patients were selected Results: A total of 22 patients were included (Male = 2, Female = 20). Median age was 60-years (range, 49-84). About 90% patients had received at least one previous therapy and the median number was 1.5. 13% patients were on fulvestrant, 86% on letrozole and 4.5% on exemestane. About 64% of patients had ECOG status of ≥ 1. Median duration of palbociclib treatment was 5-months, therefore, an estimated PFS at 18-months was 50%. 4.5% patients attained complete response. 22% patients achieved partial response, 22% had stable disease and 50% patients demonstrated disease progression. 72% patients had neutropenia, of which 45% were grade ≥ 3. Thrombocytopenia and anemia were common (63% and 58%, respectively) but grade ≥ 3 thrombocytopenia or anemia was not observed. 50% patients required dose reductions and 18% required drug cessation owing to side effects. Conclusions: PFS was much lower as compared to actual trials in our real-world experience. Despite, several interesting observations were good objective response rates in males and HER-2+ patients underscoring its potential clinical efficacy in these subsets. Furthermore, apart from myelosuppressive side effects, pneumonitis was observed in one patient necessitating vigilance in clinical practice
Hospitalization trends and outcomes for adults with metastatic cancers in the United States: 2004-2013.
Authors: Akinboro Oladimeji , Olorunfemi Odunayo , Pomerantz Daniel , Jesmajian Stephen , Ogunbayo Gbolahan , Saheed Deola , Phillips Elizabeth
Published: September 2018

e18111

Background: Metastatic cancer accounts for 90% of cancer deaths. However, the impact of metastatic cancer on hospitalization patterns and in-hospital mortality is unknown. We sought to examine trends in hospitalizations and mortality among adults with metastatic cancers in the United States. Methods: We obtained data from the National Inpatient Sample for hospitalized adults, aged ≥18 years, with metastatic cancer listed as a discharge diagnosis from 2004 to 2013. We estimated and trended the following: i) proportion of hospitalized adults with metastatic cancers; ii) leading causes of hospitalization for adults with metastatic cancer; and iii) in-hospital mortality among adults with metastatic cancer. Independent associations of in-hospital mortality with age, gender, race/ethnicity, payment source, and hospital type were examined with multivariable logistic regression. Survey weights were applied in estimating the population-based rates, odds ratios, and confidence intervals (CI). Results: 3.0% (95% CI 2.9-3.1%) and 3.2% (95% CI 3.0-3.3%) of hospitalized adults had metastatic cancers in 2004 and 2013, respectively ( P for trend 0.07). The leading causes of hospitalization from 2004 to 2013 were: maintenance chemotherapy/radiotherapy – 3.5% (95% CI 3.2-3.8%); pneumonia – 3.2% (95% CI 3.1-3.3%); complications of surgery, medical care, devices, and implants – 2.8% (95% CI 2.8-2.9%); fluid/electrolyte abnormalities – 2.4% (95% CI 2.4-2.5%); and heart failure/pulmonary circulation diseases – 2.2% (95% CI 2.1-2.2%). In-hospital mortality for patients with metastatic cancer declined from 10.3% (95% CI 9.9-10.7%) in 2004 to 8.1% (95% CI 7.8-8.3%) in 2013 ( P for trend < 0.01). Higher odds of in-hospital mortality were consistently seen each year with increasing age, non-Hispanic blacks, self-payment, and admissions at hospitals other than urban teaching hospitals. Conclusions: The relative hospitalization rates for adults with metastatic cancer remain stable. Significant declines in in-hospital mortality for these patients are noted but disparities are seen for certain groups. The economic burden and policy implications of these findings for end-of-life care warrant further investigation.
Metformin use in diabetic patients with multiple myeloma (MM): A SEER-Medicare study.
Authors: Manjappa Shivaprasad , Fiala Mark A , Vij Ravi , Stockerl-Goldstein Keith , Schroeder Mark A. , Wildes Tanya Marya
Published: September 2018

e18127

Background: Metformin, an oral hypoglycemic agent, has been linked to favorable outcomes among patients (pts) with cancer (Coyle et al. Ann Oncol 2016). Wu et al. demonstrated better overall survival (OS) with metformin use in pts with mm and Diabetes Mellitus (DM) (Br J Cancer 2014). They also found that patient with steroid-induced DM [SID] had worse outcomes than pts with pre-existing DM [PDM]. However, Keller et al. did not find these associations in a study of VA mm pts (Blood 2015 126:4502). We evaluated the impact of DM and metformin use on outcomes of pts with mm in the SEER-Medicare database. Methods: We used SEER-Medicare claims from 2007-2013 for pts with newly diagnosed MM. DM was identified using ICD-9 codes, antidiabetic medications by Medicare part D prescription claims. Multivariate analysis was performed by Cox proportional hazard modelling to evaluate (1) Association of DM type (PDM or SID) with mm outcomes and (2) Impact of metformin on outcomes of pts with mm and DM. Covariates included age, gender, transplant, CKD (chronic kidney disease), CCI (Charlson Comorbidity Index), and use of other antidiabetic medications. Potential smoldering mm cases in the dataset were controlled for using a pre-established algorithm (Fakhri, et al,Blood 2016 128:2348) Results: Out of 4708 mm pts, 45% had DM. Among the pts with DM, 28% were on metformin. Out of the 2112 pts with DM, 20% had SID. Median follow up was 26 months. We found no association between PDM (aHR 1.04, 95% CI 0.96-1.12) or SID (aHR 1.03, 0.91-1.17) with OS when compared to non-diabetic pts. Metformin use, female gender, transplant and CCI < 5 were significantly associated with improved OS. Metformin use was associated with an 18% decrease in mortality (aHR 0.82, 0.72-0.93, p = 0.002); controlling for CKD did not impact the association (aHR 0.83 (0.73- 0.94, p = 0.005). Other antidiabetic medications including insulin were not associated with OS. Conclusions: DM (PDM or SID) and insulin use were not associated with poorer outcomes. Metformin use was associated with improved OS among pts with mm and DM in the SEER-Medicare database. The impact of metformin on outcomes in mm pts should be further investigated in prospective clinical trials.
Oncology guidelines usage in a low and middle-income country.
Authors: Ismaila Nofisat , Salako Omolola , Oladeji Adebayo
Published: September 2018

e18211

Background: Healthcare providers often rely on clinical practice guidelines to help inform and optimize patient care. However, most of these guidelines are from reputable organizations that are based in developed countries. There is a paucity of data about the status of guidelines in low and middle-income countries (LMIC), specifically in terms of their availability, usage and quality. Objective: To determine utilization of oncology guideline and potential barriers to usage in a LMIC among clinical and radiation oncologist (RADONCS) Methods: A cross-sectional survey was conducted with the use of an online questionnaire that was administered to practicing RADONCS in Nigeria via the Association’s email and social media database. In addition, paper questionnaires were administered in person at regional clinical meetings. Results: Survey response rate was 53.4% in a sample of 101 RADONCS from the database. Sixty-nine percent of respondents were consultants and 30% were residents. About 17% had greater than ten years’ experience managing cancer patients, while 43% had less than five years’ experience. All of the respondents are involved in the chemotherapy administration while only about half are involved in the screening and diagnosis of cancer patients. Ninety-three percent report using guidelines in managing patients and the top 3 guidelines used were National Comprehensive Cancer Network (90%), American Society of Clinical Oncology (50%) and European Society of Medical Oncology (46%). The major three barriers to guideline utilization were inadequate facilities for proper guideline implementation, the guideline is not applicable to setting and information in guideline is overwhelming. Potential facilitators include providing adequate facilities, developing local guidelines and increase awareness on the use of guidelines. Almost all respondents are in favour of using guidelines that are adapted to their practice setting. Conclusions: Our study shows that clinicians involved in the management of cancer patients in a LMIC are aware of cancer treatment guidelines. However, issues like inadequate facilities, inapplicability of guideline to local setting and complexity of information in guidelines hinder their usage.
Cancer center clinic and clinical research team perceptions of identity and interactions.
Authors: Gerber David E. , Reimer Torsten , Garcia Sandra , Gill Mary , Duncan Tobi , Williams Erin Fenske , Lee Simon Craddock
Published: September 2018

e18215

Background: As evidenced by the NCI-ASCO Teams in Cancer Care Delivery initiative, there is growing interest in applying an emerging science of teams to oncology clinical care. Treatment of patients on cancer clinical trials requires coordination and cooperation among research and clinic teams. However, little empirical research has examined issues of goal alignment, diffusion of responsibility, and perceived rivalries in this setting. Methods: We developed a survey incorporating modified components of the Adapted Team Climate Inventory, the Measure of Team Identification, and the Measure of In-group Bias. Surveys were administered to research staff and clinic staff. Survey responses were analyzed using t tests and ANOVAs. Results: Responses were received from 104 staff (54 clinic, 50 research). Median duration of professional experience was 8.3 years, and median time in current position was 2.0 years. Research staff identified more strongly with their own group ( P< 0.01) but less strongly with the Cancer Center ( P= 0.02) compared to clinic staff. Both clinic and research staff viewed their own group’s goals as clearer than those of the other group ( P< 0.01). Both clinic staff and research staff felt that members of their groups shared information among themselves more than the other group ( P< 0.01). Research staff felt information sharing occurred to a greater extent in both groups than did clinic staff ( P< 0.01). Similar results were noted regarding information sharing with the other group ( Ps< 0.01). Staff indicated that members of their own groups interacted more often with each other than did members of the other group ( P< 0.01), with research staff perceiving higher interaction rates in both teams than clinic staff ( P< 0.01). Research staff perceived daily outcomes to be more important than did clinic staff ( P =0.05), in particular research-related outcomes ( P =0.07). Conclusions: Clinical research staff and clinic staff identify more strongly with their own groups and feel that their own group’s goals are clearer than those of the other group. Further study of interactions, perceptions, and attitudes between research staff and clinic staff is essential to provision of quality care to patients on cancer clinical trials.
Integrating clinical pharmacy services into patient care in an early-phase clinical trial clinic.
Authors: Liu Dazhi , Dang Thu Oanh , Harnicar Stephen , Kargus Katherine , Evans Lauren A , So-Kwan Yat Yee , Hyman David Michael
Published: September 2018

e18228

Background: Early phase clinical trials have broadened treatment options for patients with cancer. Expert management of these new therapies is essential to positive patient outcomes. At Memorial Sloan Kettering Cancer Center, the Developmental Therapeutic Center (DTC) satisfies this need. Oncology clinical pharmacists collaborate with other healthcare professionals to maximize the benefits of drug therapy and minimize toxicities. The purpose of this project is to describe the interventions from a clinical pharmacist assigned to the DTC. Methods: A clinical pharmacist joined DTC to serve adult patients with cancer undergoing clinical trials. The clinical pharmacist acted as a liaison between pharmacy team and medical team, and sees patients during their trial eligibility screening and follow-up visits. The interventions were documented by the clinical pharmacist in patients’ medical charts and email communications. All interventions during 1 month were retrospectively collected and categorized into supportive care optimization, protocol violation prevention, and operational. Results: The oncology clinical pharmacist was involved in 115 patient visits for trial eligibility screening or protocol follow-up. A total of 769 interventions were addressed including supportive care optimization (40.2%), protocol violation prevention (24.7%), and operational (35.1%). Conclusions: The oncology clinical pharmacist is actively engaged in many aspects of cancer care at the early phase trial clinic. Our results demonstrate the vital role of an oncology clinical pharmacist. The impact of these categorized intervention areas would require a formal outcome and cost-saving analysis. [Table: see text]
Characteristics of patients (pts) receiving end of life treatment (EOLT) at an NCI-Designated Cancer Center.
Authors: Do Kevin , Sadeghi Sarmad , Matsuura Peggy , Lynch Gwendoyn , Barzi Afsaneh
Published: September 2018

e18245

Background: End of life treatment is identified as a high cost low return intervention and is under evaluation as a quality measure for providers. A 2012 ASCO expert panel acknowledged it as the most wasteful practice in oncology. However, characteristics of pts who receive EOLT is poorly described and so interventions to assist providers avoid such treatments are limited. Methods: We identified 299 pts with cancer diagnosis from 2008-2012 and confirmed deceased using our cancer registry. Pts charts were reviewed for last cancer-specific treatments, either chemotherapy (CTX) or radiation therapy (XRT). Characteristics of pts who received treatment within the last 90, 30, and 14 days of life was described. We compared the characteristics of those who received treatment with in the last 14 days of life (here defined as EOLT) to the rest of the population. Chi-squared tests were used to compare between groups. Results: 292 pts (98%) received CTX or XRT within the last 90 days of life, 167 (56%) received treatment within the last 30 days, and 78 (26%) within the last 14 days of life. The main modality of EOLT was CTX (99%). By cancer subtype, up to 50% of gastric and renal cell carcinoma patient received treatment in the last 14 days of life. Older pts, those on clinical trials, and those with longer period of time between diagnosis and death, were less likely to receive EOLT. There is a trend for receipt of EOLT for female pts and those younger than 65 years (p-value 0.059) Conclusions: Our data establishes that more than 25% of deceased pts received treatment in the last 14 days of life. Certain characteristics may influence providers to be aggressive and to deliver care when it is futile. Research to risk stratify pts who are good candidates for treatment is necessary and can improve the value of care delivered to these subjects.
Implementing a care model to enhance patient outcomes and limit liability in patients with incidental pulmonary nodules.
Authors: Raleigh Ruth , McCabe Vita , Soos Alisa , Pichan Alice , Lavasseur Beth Irene , Stella Philip J. , Swarup Rajeev , Fugenschuh David , Ferguson Eric , Griggs Jennifer J.
Published: September 2018

e18247

Background: Patients with incidental pulmonary nodules are at risk for loss to follow-up due to fragmented health care delivery systems. The purpose of this study is to describe implementation of a care model to eliminate gaps in care for these patients. Methods: A multifaceted intervention was implemented to improve follow-up of incidental pulmonary nodules in at-risk patients. The intervention included education of all patients with incidental nodules in the emergency room and inpatient setting upon discharge. Other key steps included: (i) engagement of physician leadership, (ii) development of a patient tracking database, (iii) designation of a nurse navigator to ensure timely notification of radiological findings, (iv) ensuring patients received timely follow-up and (v) coordination communication with the primary care physician (PCP) or assistance in establishing a relationship with a PCP. Finally, smoking history was added to all CT body radiology reports to stratify risk and determine follow-up intervals using nationally accepted guidelines. The study was reviewed by the St Joseph Mercy Health System Institutional Review Board and was considered exempt. Results: Over the course of 36 months, 7,962 patients with incidental pulmonary nodules were identified by radiologists and flagged for entry into the follow-up program. 2.6% of patients enrolled were found to have lung neoplasms (68% of which were stage I, II or III non-small cell lung cancer). Conclusions: Integrated care models with a seamless combination of nurse navigation and optimal use of health information technology improves care and outcomes for patients with incidental pulmonary nodules while simultaneously mitigating liability for physicians and health care institutions.
Study on compliance with breakthrough cancer pain guidelines by medical oncologists in Spain.
Authors: Lopez Rafael , Camps Carlos , Khosravi-Shahi Parham , Guillem Vicente , Carrato Alfredo , Garcia-Foncillas Jesus , Cruz Juan J. , Gascon Pedro , Anton Antonio , Diaz-Rubio Eduardo , Feyjoo Margarita , Aranda Enrique
Published: September 2018

e18260

Background: Breakthrough cancer pain (BTcP) has been shown to be a prevalent and poor prognostic factor for cancer patients, which remains undertreated and underdiagnosed. The Spanish Society for Medical Oncology (SEOM) developed a clinical practice guideline (CPG) for the treatment of cancer pain which specifically addressed the management of BTcP. Methods: With the objective of evaluate compliance with SEOM’ guideline, Fundación ECO designed a survey to identify awareness, perceptions, implementation and gaps, among Spanish medical oncologists. Results: A total of 83 oncologists with a median experience of 13 years responded. Although 87% of oncologists considered their clinical practice complied with SEOM recommendations, there were discrepancies between what oncologists agreed to do versus how they do in clinical practice, as shown in the table. Main barriers identified in our study were time pressure together with vague statements in some recommendations, and the need to regularly update to reflect the most recent knowledge on therapeutic management. Conclusions: Nonetheless, this nationwide survey reflects that oncologist’s clinical practice is increasingly guided by GPC, and thus, the evaluation process is necessary, both to gauge the true application of the GPC by the professionals and to evaluate their impact on health care. [Table: see text]
Retrospective review of pegfilgrastim on-body injector delivery rates in a large health system.
Authors: Stuessy Peter , Sanchez Federico Augusto , Schober Madeline
Published: September 2018

e18273

Background: Pegfilgrastim is used in patients at significant risk for febrile neutropenia following myelosuppresive chemotherapy. Labeling for pegfilgrastim requires administration the day after administration of chemotherapy. The pegfilgrastim on-body injector allows for delivery at home, without having to return to the clinic. Rates of appropriate delivery of pegfilgrastim via the on-body injector have not been studied in large scale outside of controlled environments. This retrospective review investigates the rate of appropriate delivery of pegfilgrastim via the on-body injector in a large heath system. Methods: Reports were created listing monthly clinic administration of the pegfilgrastim on-body injector at nineteen outpatient cancer care clinics from July 1st, 2016 to December 31st, 2016. Patient charts were reviewed for reported non-delivery of the medication. Results: Three hundred eighty-nine injections from 149 patient charts were reviewed. Of these injections, eight were not delivered (non-delivered rate = 2.1%). Four other administrations resulted in only partial dose delivery or unknown if dose was delivered (partial/unknown rate = 1%), leading to a failure rate of 3.1 with an appropriate delivery rate of 96.9%. Conclusions: In one health system’s experience, 96.9% of pegfilgrastim on-body injector administrations were delivered as planned. A process for real time evaluation of delivery rates should be created to address the 3-4% non-delivered dosing.
Accountable care organizations and the use of prostate cancer screening and breast cancer screening.
Authors: Trinh Quoc-Dien , Meyer Christian , Krasnova Anna , Sammon Jesse , Lipsitz Stuart R. , Weissman Joel S. , Sun Maxine
Published: September 2018

e18308

Background: Accountable Care Organizations (ACOs) were established under the Affordable Care Act as a new payment model intended to impose greater responsibility on all stakeholders for cost control and quality improvement. Preventive services are an ideal target to monitor the effectiveness of new health care delivery models. We sought to examine and compare the prevalence of breast cancer screening (BCa-S), and prostate cancer screening (PCa-S) between ACO and traditional Medicare beneficiaries. We hypothesized that the use of BCa-S is higher among beneficiaries attributed to an ACO, whereas the use of PCa-S, a non-recommended test, would be unaffected by ACO assignment. Methods: Using a random 20% sample of Medicare beneficiaries, we assessed BCa-S in women aged < 75, (evidence-based cancer screening), and PCa-S in men < 75 (non-recommended cancer screening) between January 1, 2013 and December 31, 2013 with appropriate exclusion criteria following the review of guideline recommendations. ACO coverage was ascertained from the quarterly assignment in the Shared Savings Program ACO Beneficiary-level file. Propensity-score weighting was performed to balance out patient and sociodemographic covariates. Results: Following propensity-score weighting, our final cohorts of ACO and traditional Medicare beneficiaries included 52,987 and 526,063 women for BCa-S; 86,936 and 814,221 men for PCa-S, respectively. The prevalence of screening in ACO vs. traditional Medicare were 35.0% vs. 25.2% for BCa-S, and 54.6% vs. 41.7% for PCa-S (all p < 0.001) Conclusions: The ACO model appears to have a salutary effect on preventive service utilization. Our findings vis-à-vis PCa-S among ACOs are likely a reflection of improved health care access rather than vetted screening practices. There is hope that such nonrecommended screening will decrease if more ACOs are required to move towards a “two-sided” risk shared savings and loss model.
The delivery of value-based healthcare for children with osteosarcoma at Children’s Cancer Hospital Egypt.
Authors: Soliman Ranin , Eweida Wael , Zamzam Manal , Elhaddad Alaa , Abouelnaga Sherif
Published: September 2018

e18310

Background: Aim of the study was to develop a system to measure the value of health care services delivered to osteosarcoma patients, through developing a standardized set of patient-centered outcomes for Osteosarcoma and using a consistent approach to measure the costs of Osteosarcoma care throughout all care cycles. Methods: The Porter’s Outcomes Measurement Hierarchy was used to define the domains of outcomes reporting for Osteosarcoma, which included three levels of measuring outcomes; health status achieved or retained, process of recovery, and sustainability of health. Time-driven activity-based costing (TDABC) approach was used a guide to determine the actual costs of healthcare services delivered to Osteosarcoma patients throughout their journey of cure. Results: Osteosarcoma outcome measurement tools and questionnaires were standardized based on the following domains: survival, degree of health or recovery, time to recovery and return to normal activities, disutility of care and treatment processes, sustainability of health and nature of recurrences, and the long-term consequences of therapy. The standardized outcome reporting tools under each domain included: toxicity reporting using NCI-Common Toxicity Criteria version 4.0, Pediatric Quality of Life Inventory (PedsQL) Cancer module, Musculoskeletal Tumour Society Score (MSTS) for functional outcome assessment, Palliative Care Outcomes Scale (POS). Process mapping was done for each step involved in the delivery of health care services to children with Osteosarcoma at Children’s Cancer hospital Egypt (57357 Hospital). Conclusions: Developing a standardized system for measuring the health outcomes of Osteosarcoma and the total costs for delivering the health care services is fundamental to measure and improve the value of health care delivered to Osteosarcoma patients.
Hospitalization for patients in the United States (US) and European Union (EU) treated with inotuzumab ozogamicin (InO) vs standard of care (SOC) for relapsed/refractory acute lymphoblastic leukemia (R/R ALL) in a global phase 3 trial.
Authors: Su Yun , van Oostrum Ilse , Vandendries Erik , Welch Verna , Loberiza Fausto Rodriguez
Published: September 2018

e18500

Background: InO, an anti-CD22 antibody-calicheamicin conjugate, with its once a week, 1-hour infusion schedule, has demonstrated lower hospital utilization in association with superior clinical activity, favorable patient-reported outcomes (PROs), and a generally manageable safety profile versus SOC (intensive chemotherapy) for R/R ALL in the phase 3 INO-VATE trial. Here, regional-specific hospitalizations in the trial are presented. Methods: Patients receiving study treatment and recruited from the US and the EU were included in the analyses. The total number of days hospitalized for each patient was calculated. Hospital days prior to randomization and those after the end of study treatment were excluded. Due to different treatment durations for InO and SOC (median 1 vs 3 cycles), calculations were reported for cycle 1 treatment period (randomization to end of cycle 1) and for the entire treatment period (all cycles - randomization to end of treatment). Results: A total of 281 patients were available for the analyses. 154 were from the US and 127 from 11 of the EU countries. The median and mean hospitalization days were shorter for patients in the InO arm compared to the SOC arm across both regions (Table). The difference between the two treatment arms appear to be greater in the US compared to the EU. Hospitalizations in the US appear to be shorter than in the EU, particularly for patients receiving InO. Conclusions: InO treatment in R/R ALL is associated with less hospitalization across both the US and EU compared to SOC, consistent with InO’s better efficacy, tolerability, PRO and dosing schedule. The finding that US has lower hospitalization than the EU might be explained by different patient care practices in the two regions. Given that hospitalization is the biggest cost driver in cancer care, the discrepancy may lead to greater cost-savings in healthcare systems where hospitalizations are strictly managed. Clinical trial information: NCT01564784. [Table: see text]
Cytogenetic evolution between diagnosis and relapse and impact on acute myeloid leukemia (AML) reinduction outcomes.
Authors: Brunner Andrew Mark , Werner Lillian , Lombardi Story Jennifer , Hobbs Gabriela , Amrein Philip C. , Hasserjian Robert P , Neuberg Donna S. , Fathi Amir Tahmasb
Published: September 2018

e18509

Background: Changes in the subclonal composition of AML may occur after diagnosis and be a mechanism of relapse. Cytogenetic changes between diagnosis and relapse may reveal evolution in clonal composition. We sought to determine whether evolution of patient cytogenetics impacts the response to salvage chemotherapy among AML patients who relapse after first remission. Methods: We identified adults with relapsed AML between 2001-2015. Studied patients received induction at diagnosis, achieved remission, relapsed, and received intensive salvage. APL and primary refractory AML were excluded. We identified cytogenetic abnormalities at relapse, and any clonal changes from diagnosis (gain/loss/no change). Associations with CR2 were analyzed by Fisher’s exact test. OS was from salvage therapy to death or censored at last known alive, with Kaplan Meier estimates. Results: 69 patients (median 54 yo, 58% male) received salvage therapy for relapsed AML. Most (81%) had de novoAML. Patients had favorable (7%), intermediate (70%), and adverse risk (23%) cytogenetics at diagnosis; 51% were normal karyotype. 94% received 7+3-based induction. 42% underwent allo-HCT in CR1. Salvage included 7+3 (n = 22), MEC (n = 36), HiDAC (n = 4), or other regimens (n = 7). Median time from CR1 to relapse was 10 mo (IQR 5, 18). At relapse, 29 patients (42%) gained cytogenetic abnormalities, 8 (12%) lost abnormalities, and 31 (45%) were unchanged. The most common acquired abnormalities involved chromosomes 7, 11, or 17 (each n = 6). 55% achieved CR2/CRi2 (CR2 w/ chromosome gain 48%, loss 38%, no change 65%). Longer CR1 duration was associated with greater likelihood of achieving CR2/CRi2 (p = 0.003). Accounting for CR1 duration, cytogenetic evolution from diagnosis to relapse was not significantly associated with CR2. Improved OS was seen with non-adverse diagnosis cytogenetics (p = 0.0003), longer CR1 (p = 0.035), and transplant in CR1 (p = 0.04). Conclusions: Although AML evolution frequently occurs between diagnosis and relapse (54% of this cohort had cytogenetic changes at relapse), this did not impact CR2 or overall survival. Rather, duration of CR1, likely a surrogate for depth of remission, significantly impacted outcomes.
Hospital readmission rate for febrile neutropenia (FN) following high dose cytarabine (HiDAC) consolidation chemotherapy for acute myeloid leukemia (AML).
Authors: Siebenaller Caitlin , Radivoyevitch Tomas , Cheng Connie , Carraway Hetty , Mukherjee Sudipto , Advani Anjali S. , Gerds Aaron Thomas , Nazha Aziz , Maciejewski Jaroslaw P. , Earl Marc A. , Waldron Madeline , Sekeres Mikkael A.
Published: September 2018

e18513

Background: FN is an anticipated complication of consolidation with HiDAC for AML, though precise descriptions of incidence, type, and severity of infection leading to FN are lacking. Since AML patients (pts) with FN after HiDAC are routinely readmitted to the hospital, there is a likely impact on measures of quality and value in this population. Methods: Our primary aim was to define the rate of FN inpatient readmissions among all HiDAC cycles. Secondary aims included: estimating rates of all-cause readmissions, clinical (e.g., probable pneumonia per imaging) and microbiologically-documented infections, and identify pts-specific risk factors associated with readmission. Readmission per patient were modeled using Poisson regression, with means proportional to total cycles exposed, and logistic regression for the probability of FN per treatment cycle. Results: We identified 150 AML pts ≥ 18 years of age, who received at least one cycle of HiDAC consolidation (1000-3000 mg/m2 for six doses) in 2009-2016. The median age was 50 (range 19-69); 55% were female and 45% were male. For 417 HiDAC cycles analyzed (87% at 3000 mg/m2), all pts received flouroquinalone prophylaxis and the overall readmission rate was 49% (203/417), of which 86% (174/203) were for FN. Median time to FN hospital admission was 18 days (range 10-22) from the start of HiDAC. Of the 174 FN readmissions, 60% had documented infections. Of these infections, 35% were bacteremia, 29% other bacterial, 24% fungal, 6% sepsis, and 6% viral. Females had higher FN readmission rates (RR 1.7 (1.3, 2.4) p = 0.007), as did pts with higher BMI (RR 1.06 (1.01, 1.09) p = 0.005), while age and HiDAC dose were not associated with readmission. Only 34% of all readmissions were in the absence of a documented infection. Conclusions: The majority of FN readmissions were associated with clinical or microbiologically documented infections and are not avoidable. Females and pts with higher BMI were more likely to be readmitted. Readmission of AML pts following HiDAC is expected, and therefore, should be excluded from measures of value and quality.
Association of CDKN2A/2B deletion with homozygous deletion of TCR- γ gene in T-ALL.
Authors: Chopra Anita , Singh Jay , Verma Deepak , Rajput Nishi , Bakhshi Sameer , Singh Amar Ranjan , Kumar Rajive
Published: September 2018

e18516

Background: T-lineage acute lymphoblastic leukemia (T-ALL) is a genetically heterogeneous disease that arises in a multistep fashion through acquisition of several genetic aberrations. Absence of biallelic deletion of TCR-γ (ABD), a marker of immaturity, and CDKN2A/2B deletion have been identified as poor predictors of outcome in T-ALL treated with contemporary protocols. The aim of this study was to determine the correlation between ABD and CDKN2A/2B in Indian T-ALL patients. Methods: A total of 31 cases of T-ALL, diagnosed on morphology, cytochemistry and immunophenotyping, were included in the study. The age of the patients ranged from 1-50 years. The patients were investigated for CDKN2A/2B deletion by multiplex ligation dependent probe amplification (MLPA) using the commercially available probe set P383 (MRC Holland). The status of the deletion of TCR- γ was determined using quantitative assay described by Gutierrez et al.1 Results: Absence of biallelic deletion of TCR- γ gene were found in 14 (45.16%) patients. Homozygous deletion was seen in 13 (41.93%) patients while monoallelic deletion was seen in 5 (16.12%) patients. CDKN2A/2B deletions were found in (48.38%) patients. On correlation of CDKN2A/2B deletion and TCR- γ deletion, it was found that CDKN2A/2B deletion was found in 2/14 (14.28%) patients with ABD and 10/13 (76.92%) patients with homozygous deletion. Conclusions: CDKN2A/2B deletion are more common in patients with homozygous deletion of TCR- γ gene.
Treatment of adolescents and young adults with Philadelphia negative acute lymphoblastic leukemia (AYA Ph-ALL) using a risk and response based protocol with extended intensification and high dose methotrexate: A report from a single center in Saudi Arabia.
Authors: Eldadah Saleem , Jastaniah Wasil , Alsaeed Ahmad , Abrar Mohammed Burhan , Abdelaal Mohamed A. , Alzahrani Zayed , Rajkhan Walaa , Warsi Ashraf , Alsobhi Enaam , Alahmadi Majed , Ibrahim Amro , Higazi Ahmad , Ahmed Ayoub , El-Hemaidi Ihab , Absi Ahmed A.
Published: September 2018

e18527

Background: Studies have shown superior outcomes of AYA Ph-ALL when treated with pediatric or pediatric-inspired protocol. Since 2003 we used a modified Children’s Oncology Group (COG) protocol to treat AYA Ph-ALL aiming to improve outcomes. Methods: This study involved 67 consecutive patients aged 14-35 years with Ph-ALL diagnosed between October 2003 and March 2016. Patients with precursor B ALL, CNS1/CNS2, and negative day 29 minimal residual disease (MRD-) received single interim maintenance (IM) and delayed intensification (DI) (Arm B). While CNS3 or MRD+ patients received double IM and DI (Arm C). Patients with T cell ALL received double IM with high dose methotrexate (HDMTX) in IM#1, and double DI (Arm C+HDMTX). Dexamethasone was used in all patients but prophylactic cranial irradiation was not utilized. Results: Median age at diagnosis was 17 years with 24 (35.8%) 18 years and older. CR rate, induction death, relapse rate, 4 year event free survival (EFS) and overall survival (OS) were 93.7%, 4.5%, 19.4%, 71.4%±6.0 and 81.8%±5.0; respectively. Of the 57 patients with available MRD, 44 (77.2%) were MRD-. Day 29 MRD status significantly impacted the outcomes (EFS: 78.6%±6.8 vs. 49.2%±15.4; p = 0.007 and OS: 90.5%±4.5 vs. 49.4%±22.0; p = 0.04) for MRD- vs. MRD+ patients; respectively). Outcomes were not different for T (n = 21) vs. B (n = 46) phenotypes (EFS: 69.2%±7.6 vs. 75.6%±9.5; p = 0.57 and OS: 79.8%±6.5 vs. 85.7%±7.6; p = 0.98; respectively). Grade 3 and above toxicities were venous thromboembolism (VTE) in 9 (13.4 %), avascular necrosis (AVN) in 9 (13.4 %) and pancreatitis in 3 (4.5 %) patients. Four patients (6%) died in CR and 2 died with secondary AML. Conclusions: Improved outcomes were observed with OS rate exceeding 90% for MRD negative patients. Therapy was tolerated relatively well, however, AVN and VTE occurred frequently. This suggests that utilizing a modified COG backbone in AYA Ph-ALL patients up to 35 years of age is feasible, however, further modification is warranted to reduce toxicity and improve outcomes in MRD positive patients.
Burden of illness in patients with acute myeloid leukemia aged ò65 years ineligible for intensive chemotherapy.
Authors: Lafeuille Marie-Helene , Sundaram Murali , Lefebvre Patrick , Emond Bruno , Romdhani Hela , Senbetta Mekre
Published: September 2018

e18529

Background: Management of older patients with acute myeloid leukemia (AML) is challenging due to a higher comorbidity burden, poorer performance status and less favorable biology. This study assessed treatment patterns and healthcare resource utilization (HRU) in the US in patients diagnosed with AML aged ≥65 years who did not receive intensive chemotherapy. Methods: Patients aged ≥65 years with ≥2 diagnoses for AML were identified from the Truven Health MarketScan Analytics Databases (01/01/2011-07/31/2016). Patients had ≥1 bone marrow diagnosis procedure (BX; first AML diagnosis following BX defined as the index date), ≥12 months of continuous eligibility pre-index, no treatment with intensive chemotherapy at any time, no diagnosis for AML relapse or remission or stem cell transplant before BX, and <2 diagnoses for other blood cancers pre-index. Post-index treatment patterns and HRU were reported. Results: 1,492 patients with AML were identified (mean [standard deviation] age: 76.8 [7.0] years; 61% males). Mean post-index follow-up was 212 (255) days and 43% were treated with antineoplastic agents (AA). Most common first-line treatments were azacitidine (35%), decitabine (32%) and hydroxyurea (16%). 4% received low-dose cytarabine. Patients with ≥1 blood transfusion (61%) received 8.9 (9.5) transfusions per month during 177 (244) days on average. A total of 3% received stem cell transplant. Patients had a mean of 3.7 (5.3; pre-index: 0.4 [0.7]) days of hospitalization, 0.2 (1.4; pre-index: 0.0 [0.2]) days of hospice care, and 5.2 (4.5; pre-index: 2.6 [2.4]) office visits per month post-index. Compared to treated patients, untreated patients (32%; i.e., patients with no AA, blood transfusion or stem cell transplant) had fewer days of post-index follow-up (106 vs. 263), more days of hospitalization (4.8 vs. 3.2), and of hospice care (0.4 vs. 0.1), and fewer office visits (3.8 vs. 5.8) per month (all P<0.01). Conclusions: Patients ≥65 years diagnosed with AML not receiving intensive chemotherapy incurred more HRU after AML diagnosis. About a third was untreated and had higher HRU than treated patients. This suggests major unmet needs for well-tolerated treatment options for these patients.