Background: Achieving and maintaining effective testosterone (T) suppression is key to treatment of advanced prostate cancer (PCa), for which LHRH agonists are standard of care. Increasing evidence suggests maintaining very low T levels to <20 ng/dL with androgen deprivation therapy (ADT) is desirable and correlates with disease-specific survival in patients with advanced PCa. Consistent drug delivery is important in providing continuous T suppression throughout the course of treatment without T rising above castrate level (T breakthrough). However, T breakthrough may occur between administrations, especially if a subsequent dose is delayed. Contributing factors to late administrations may include scheduling challenges, shortage of available appointments, and increasing number of patients. While FDA approvals for ADT drugs are based on a 28-day month, insurers may mandate full calendar months between doses for reimbursement. This study explored timeliness of subsequent LHRH agonist administrations and its relationship with T breakthrough. Methods: A retrospective review of electronic medical records from January 1, 2007 and June 30, 2016 of 85,030 LHRH agonist administrations for PCa treatment was conducted to evaluate the percentage of late subsequent dosing and impact on frequencies of T breakthrough, defined as T>50 ng/dL. Late administrations were defined as those on or after day 33, 98, 129, and 195 for 1, 3, 4, and 6 month formulations, respectively. Results: 26.9% of all subsequent LHRH agonist administrations were late: 14.4% were ≤1 week late, 3.1% were between 1–2 weeks late, and 9.4% were >2 weeks late. While only 4% of T values exceeded 50 ng/dL when doses were administered early/on time, 21% of T values exceeded 50 ng/dL when administrations were late. Conclusions: Over a quarter of subsequent administrations were defined as late, leading to >20% incidence of T values exceeding 50 ng/dL. Considering the clinical benefits of maintaining effective T suppression throughout a course of ADT, clinicians should administer treatments within approved dosing instructions, routinely monitor T levels, and consider prescribing treatments with proven efficacy through the dosing interval to maintain T at castrate levels.
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Stuart Atkinson, Raoul S. Concepcion, John A. McLane, Deborah Boldt-Houle and Eleni Efstathiou
David da Silva Dias, Catarina Jorge, Mafalda Baptista, Ana Júlia Arede, Paulo Luz, Tânia Madureira and Beatriz Gosalbez
Introduction: Febrile neutropenia (FN) induced by chemotherapy (ChT) arises until 6 weeks after the last cycle, usually between 5 and 10 days post-ChT. Infection risk is 20%–30%. It is difficult to stratify patients with low risk of complications due to FN. MASCC index is useful but has limitations. This correlates with unnecessary hospital admissions, complications, and costs. Methods: Retrospective study of patients with diagnosis of FN induced by ChT, admitted to our center between 2012 and 2016. Primary goal was to describe this population. Secondary goal was to re-stratify the risk of FN using MASCC and CISNE indexes, clinical judgement, and social/logistic factors. SPSS v23 was used for statistical analysis. Results: 211 patients were included; median age, 66 years. Median hospital stay was 6 days (1–89). 25% were nosocomial admissions. At admission 46% of patients presented with stage IV cancer. 75% were solid neoplasms and 25% were hematologic. Profound neutropenia was observed in 43% and severe neutropenia in 36%. Overall mortality rate was 13%. Sepsis was diagnosed in 24 patients (11%), with a mortality rate of 54%. Only 12.3% of patients had prophylaxis with granulocyte-colony stimulating factor. At admission, 64% of patients had no obvious focal infection; 20% had probable focus; and in 16% a microorganism was identified, most commonly gram-negative Enterobacteriaceae. Most used antibiotics were piperacillin/tazobactam (44%) and its combination with aminoglycoside (34%). This combination showed benefit against some extended-spectrum beta-lactamase (ESBL)–producing strains and multiresistant (MR) Pseudomonas aeruginosa (2.8%). MASCC index identified 31% of patients with low risk FN. After applying the CISNE index, clinical judgement, and social/logistic factors, only 11% were identified as low-risk FN and did not benefit from admission. This translates to an avoidable cost of €48,000 according to the center’s annual report. Conclusion: The combination of β-lactam and aminoglycoside is overused in our practice. It is not recommended in hemodynamically stable patients and contradictory in unstable ones; still it shows some effect versus MR and ESBL strains. A study to evaluate their incidence in our center is now in progress. Low risk FN was observed in 11% of admitted patients. Our center has an internal protocol and has been able to provide a good overall response.
Efrat Dotan, Elizabeth Handorf, Caitlin R. Meeker, Bianca Lewis, Kelly Filchner, Jennifer S. Winn and Lori J. Goldstein
Introduction: Geriatric assessment (GA) is recommended for evaluating an older cancer patient’s fitness for treatment; however, it is underutilized in the community. We sought to define the gaps that exist in community oncology practices in the assessment and management of older MBC patients through implementation and training on the use of GA for the care of older MBC patients. Methods: The first phase evaluated community oncology providers using questionnaires regarding their assessment and management of older MBC patients. The second phase included training through implementation of a patient self-administered GA among patients ≥65-years-old with MBC. The providers were blinded to the results of the GA and provided their assessment. Comparison of the 2 evaluations was conducted. The GA was ultimately shared with the providers, who were questioned about the effect of the results on care recommendations. Results: 43 providers from 10 practices were enrolled. Phase I revealed the majority (77%) of providers recognized the utility of GA, yet only 42% routinely conducted a GA pretreatment. Most providers (77%) reported evaluating various GA domains through patient interview rather than validated assessments. Validated scales were used in low rates to evaluate cognition (23%), psychosocial status (12%), and toxicity risk (9%). The limited use of validated assessment tools was not influenced by the provider’s demographics or their views of GA utility. Eighty patients took part in the training phase of the study to date, with average age 74 (range, 65–90) and 84% Caucasian. The majority of patients had subtype ER/PR+, HER2- (75%) and 46% were on first-line therapy. 277 recommended interventions were identified: 174 immediate interventions and 103 suggested interventions. Following review of these results, providers reported being surprised in 40% of the cases, mainly with lower than expected cognitive or social support scores. The providers reported plans for change in management in 44% of the patients as a result of the GA findings. Conclusion: Despite acknowledgement of the value associated with pretreatment GA, it is rarely used in the community. Furthermore, interview rather than validated assessment tools are used to identify age-related concerns. In our preliminary results, the GA identified a large number of deficient areas that had not been identified through the provider’s assessment, and resulted in management change. Additional updated results will be presented at the conference.
Lori L. DuBenske, Sarina B. Schrager, Terry A. Little and Elizabeth S. Burnside
Background: National health organizations offer contrasting guidelines for women aged 40–49 regarding when to begin and how often to use mammography screening for breast cancer. The ACS recommends average risk women aged 40–44 receive annual screening “if they wish to do so” and annual screening for women aged 45–54. The United States Preventive Services Task Force recommends individualized screening for average-risk women before age 50 advised by risk assessment and shared decision-making (SDM). Clinicians lack guidance on how to conduct and what elements to include in mammography SDM. Our prior work identified core elements via scoping review applied to a modified Delphi consensus process involving patients, primary care physicians (PCP), and healthcare decision scientists (HDS). This study examines stakeholder group differences in endorsing core SDM elements. Methods: The Delphi consensus included 10 patients, 10 PCP, and 10 HDS and fielded 48 items to codify core elements of mammography SDM. A threshold of 80% agreement across all participants was set to establish consensus for retaining or dropping an item. In this study, separate stakeholder groups’ endorsement rates for each item were calculated. Items were deemed to have stakeholder discrepancy if one group differed from the 2 others in either meeting or not meeting the 80% threshold criteria. Results: 16 items (13 retained, 3 dropped in Delphi) had a discrepant group. For all retained items, the discrepant group fell below 80% criteria for retaining. For 2 of the dropped items, discrepant groups achieved threshold for retaining the item. One item was dropped despite most participants voting to retain it (>80%) due to the discrepant group’s rating <80%. Patients rated less importance to educating women about risks and recommendations. PCPs rated lower importance to training PCPs and women for discussions about mammograms and having discussions on a regular basis. HDSs rated greater importance to considering mammogram procedures and costs in SDM. Discussion: Leading healthcare organizations are increasingly recommending SDM in breast cancer screening, among other decisions. Guidelines enumerating core elements of SDM are needed to effectively direct clinicians. This study, by illuminating differences between stakeholder group perspectives, highlights the importance of eliciting varied perspectives in identifying core elements of SDM when informing healthcare practices and policy.
Eric Gratias, David Spangler and Margaret Rausa
Background: eviCore healthcare uses the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) to support its proprietary program for medical oncology drug management. All treatment regimens assigned NCCN Category of Evidence 1, 2A, or 2B are considered NCCN-adherent treatment selections in the eviCore program. The purpose of this study was to evaluate the pattern of NCCN adherence during the first year following program launch in regional payer markets. Methods: All cancer drug treatment authorization requests submitted in month 1 and month 12 following program launch for 4 regional third-party payers representing 13 different states were included, each of whom had management of high cost oncology drugs in place prior to eviCore program launch. Month 1 data were used as a surrogate for pre-program NCCN adherence, which is an overestimate as there is significant eviCore program impact on patients initiating therapy during that time. Requests with incomplete clinical data were excluded from analysis. Included requests were stratified by month 1 or month 12 from initial program launch date for each health plan. NCCN adherence was assigned based on the results of the clinical decision support and peer consultation processes utilized by eviCore to adjudicate the treatment request. NCCN adherence rate was calculated for each subgroup and a cumulative NCCN adherence rate for all included cases was calculated using weighted average accounting for volume differences by market. Results: There were 2,028 treatment regimen requests that were fully evaluable, with 1,285 occurring in month 1 and 743 occurring in month 12 following program launch. The rate of NCCN adherence increased for each health plan during the first program year, ranging from 69%–84% in month 1 and rising to 79%–91% in month 12. The weighted cumulative NCCN adherence during month 1 for all included plans was 75% and rose to 88% at month 12 following program launch. Conclusions: Use of clinical decision support supplemented by peer consultation is an effective means of increasing oncologists’ adherence to NCCN-recommended therapies across a broad range of regional provider markets. Additional study is warranted to determine whether this methodology can be applied to NCCN Categories of Preference to direct more patients toward preferred regimens with superior efficacy, safety, and affordability to further improve quality of care and lower total medical costs.
Bridgett Harr, Joanna Bodmann and Helen Tackitt
Background: Survivorship care (SC) has evolved since its inception, as there are many approaches to provide care for the cancer survivor. In review of disease-specific programs offered, it was determined there were varying levels of commitment and resources within the same institution. Due to Commission on Cancer (CoC) requirements for eligible patients to be offered SC, a project was undertaken to standardize SC by: (1) establishing a comprehensive, standardized assessment for SC, (2) delivering consistent SC across disease groups, (3) encouraging evidence-based multidisciplinary management, and (4) meeting CoC standards of SC plan (SCP) delivery. Methods: SC is delivered by embedded, disease-specific advanced practice providers (APPs). All patients receive a personalized SCP, along with general survivorship education. Due to differences in resources and survivorship expertise, not all patients receive the same care quality. An APP committee was created to review the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Survivorship and develop a comprehensive program. A questionnaire was created to address survivorship-specific concerns. An order set was created to highlight available resources. Additionally, evidence-based practice guidelines were created for each survivorship concern to assist the provider in identification and management. This was added to standard materials, and tailored education is given based on concerns identified during the visit. Referrals and orders are placed as appropriate. Results: Across the institution, SCP delivery is on track to meet CoC standards for 2018. A database has been developed to track and audit completion of SCP delivery. The standardized survivorship questionnaire was implemented to enhance the meaningfulness of the survivorship visit. This was executed during the 4th quarter of this year with review and revision underway. Conclusions: Standardized delivery of SC is improving with positive feedback from the patients. The survivorship questionnaire and supporting materials have been well-received by APP staff to assist in quality care. Some areas continue to lack adequate resources for implementation and will pose challenges in the future to meet accrual metrics. Future goals include creating pre-visit electronic questionnaires and repeat assessments to address survivors’ evolving needs. Prospective data will be collected on survivors to assess unmet needs and population differences.
Anne K. Hubben, Nathan Pennell, Marc Shapiro, Craig Savage and James P. Stevenson
Purpose: National guidelines do not include routine pGCSF as primary prophylaxis (PP) for patients receiving chemotherapy associated with a low risk for febrile neutropenia (FN). Inappropriate pGCSF can increase patient morbidity, financial burden, and overall health care costs. In 2013, an interdisciplinary group at TCI implemented a QI project to reduce inappropriate PP pGCSF in patients with lung cancer; this included prescriber education and modification of chemotherapy orders by risk of FN in the electronic medical record (EMR). Inappropriate pGCSF was reduced from 28% to 4%. In this 5-year follow up study we analyzed pGCSF use in lung cancer patients. Methods: We conducted a review of lung cancer patients who received pGCSF with chemotherapy initiated between January 2016 and August 2018. PP pGCSF use was appropriate if prescribed with chemotherapy regimens with a high risk (>20%) for FN, or intermediate risk (10%–20%) if other accepted FN risk factors were present. PP use with FN low-risk (<10%) chemotherapy was considered inappropriate. Treating physicians were anonymously surveyed about their practices. Results: 294 patients with lung cancer received 1,353 doses of pGCSF during the study period. 58 (20%) were treated at TCI by subspecialty thoracic oncologists and 236 (80%) were treated at regional network sites. 100/294 (34%) patients received low-risk regimens. 62/100 (62%) patients treated with low-risk regimens received 311 doses of PP pGCSF (inappropriate use). 5/62 (8%) of inappropriate use occurred at TCI; 57/62 (92%) at network sites. Of 130 patients who received an intermediate risk regimen, 99 (76%) received PP pGCSF. At least one risk factor for FN was identified in 80/99 (80%) of these patients; age >65 and prior chemotherapy or radiation were the top-cited factors. 33/294 (11%) patients were hospitalized for FN during the study period; 7/100 (7%) received low-risk regimens, 15/130 (11.5%) intermediate-risk, and 11/46 (24%) high-risk regimens. All physicians responding to the survey indicated awareness of guidelines and EMR risk identification. Conclusion: After initial success at our center, we found that guideline-based alignment of pGCSF prescribing in lung cancer patients was not sustained. Despite reported familiarity with guidelines for PP pGCSF use, this analysis suggests an opportunity for re-education and further EMR modification. Based on July 2018 CMS average sales price, reduction in inappropriate use presents a potential cost savings of $1.5 million during the study.
Nancy Kassem, Halima El Omri, Mohamed Yassin and Shereen Elazzazy
Introduction: Rasburicase is a urate oxidase enzyme used for prophylaxis and treatment of hyperuricemia associated with TLS. The recommended dose of rasburicase is 0.2 mg/kg/day for 5 days; however, recent studies have demonstrated the effectiveness of a single rasburicase dose in prophylaxis and management of hyperuricemia associated with TLS. Our institution’s TLS guideline was updated to recommend the use of a single rasburicase dose (0.2 mg/kg). The primary objective of this study was to assess the efficacy of a single rasburicase dose in controlling uric acid (UA); the secondary objective was to evaluate the impact of the institutional TLS guidelines update on consumption and cost of rasburicase. Methods: This is a single center retrospective cohort study including all patients who received rasburicase from August 2012 to March 2016 at the National Center for Cancer Care and Research (NCCCR) in Qatar. Patients were divided into 2 groups based on the prescribed number of rasburicase doses (single dose vs multiple doses). Collected data included patients’ diagnosis, laboratory parameters rasburicase dose, duration, and number of dispensed vials. UA levels within 24 hours and on day 5 of initial rasburicase dose were evaluated. Risk stratification was determined according to institutional guidelines based on disease, white blood cell count, lactate dehydrogenase level, renal function, and UA level. Results: A total of 103 patients who received rasburicase were evaluated retrospectively; rasburicase was prescribed as single dose for 65 patients (63%) and multiple doses for 38 patients (37%). The majority of patients who received rasburicase as single or multiple doses were at high risk of developing TLS, representing 68% and 84%, respectively. Baseline mean UA levels were similar in both groups: 5.4±2.9 mg/dL vs 4.7±3.2 mg/L respectively (P=.7). Normal or undetectable UA levels were observed within 24 hours in 98% of patients in the single dose group and 100% of patients in the multiple doses group. All patients in both groups had normal UA on day 5 of rasburicase with relatively similar UA levels: 1.5±1.2 mg/dL vs 0.8±1 mg/dL (P=.18). Rasburicase consumption and cost were reduced by 42.5% after the guidelines update. Conclusion: The single rasburicase dose demonstrated efficacy in controlling serum UA levels. Updating the institutional TLS guidelines had a significant impact on rasburicase consumption and led to significant cost reduction.
Elizabeth Reed, Robin M. Lally and Roksana Zak
Background: Nationally, gaps exist in the timely and appropriate care of young women with breast cancer. Few women receive genetic and fertility counseling, while contralateral prophylactic mastectomy rates rise. The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Breast Cancer direct breast cancer treatment and symptom management, but care of young newly diagnosed women requires providers to combine elements of several guidelines and consider an appropriate order of assessments and treatments utilizing multidisciplinary consultation. In Nebraska, fewer than 300 women under age 50 are diagnosed with breast cancer annually. One-third of these women live rurally, miles from the NCCN Member Institution. Thus, rural physicians encounter these patients infrequently and may lack local specialists with whom to consult and refer, thus challenging the provision of the highest quality care. Purpose: To improve the efficacy and efficiency with which rural oncology care providers recognize and address physical, psychosocial, and decision-making needs of young women with breast cancer through development and delivery of education, multidisciplinary consultation, and clinical pathways. Methods: Baseline, 2-year electronic medical record data on surgical, medical, and supportive oncology practice patterns for women with breast cancer under age 50 were collected from the University of Nebraska Medical Center and collaborating rural cancer centers. Records were hand searched for fertility and genetic data. The PROMIS Global Health Survey and Sexual Function Profile, the Brief Subjective Decision Quality Measure, and a project-specific care satisfaction survey were mailed to these patients. Data were entered into SPSS and descriptive statistics used to identify the project’s starting point. Results: To date, clinics (rural and urban) identified a 2-year total of 199 women with breast cancer, ages 21 to 49 years. Cancers were stage 0 (n=21), 1 (n=50), 2 (n=40), 3 (n=19), 4 (n=3), and unavailable (n=66). Eight clinical pathways based on ER, PR, and HER2 status were developed to guide treatment, considerations, evidence-based neoadjuvant and adjuvant therapy, and survivorship care. Pathways, with associated educational webinars and links to NCCN Guidelines, are accessible to providers and patients on the project-derived Pathway to Cure website. Website use and webinar views following program implementation will be reported as will comparison of baseline practice patterns with data at the first 3-month analysis.
Katherine Robinson, Amber Todd, Abu-Sayeef Mirza, Madeline Macdonald, Noura Ayoubi, Rahul Mhaskar, Richard Roetzheim, Laurie Woodard and Smitha Pabbathi
Background: There are limited studies documenting the prevalence of malignancies and the cancer screening practices of the uninsured population. Cancer survivors require continued cancer surveillance and screening for recurrence and second primaries. However, screening may be suboptimal among the uninsured. Our objective was to identify and document the screening rates and adherence to ACS guidelines in our local uninsured community. Methods: Demographic data, cancer history and associated cancer screening measures were extracted from electronic medical records of patients managed in 8 free clinics between January 2016 and December 2017 in the Tampa Bay Area. Frequencies, proportions, and Pearson correlation coefficients were used to describe the population and statistically significant relationships. Using the ACS cancer screening recommendations, the charts were reviewed for appropriate cancer screening. Results: From manual chart review, 6,958 charts were reviewed and 201 (2.89%) patients had a diagnosis of cancer. The average age was 55.58 years and 134 (66.67%) were women. Most common malignancies included breast cancer (49, 24.38%), prostate (18, 8.96%), colorectal (13, 6.47%), leukemia/lymphoma (11, 5.47%), cervical (10, 4.98%), melanoma (10, 4.98%), ovarian (9, 4.48%), thyroid (9, 4.48%), renal (6, 2.99%), bladder (5, 2.49%), and uterine (5, 2.49%). Of the 201 patients diagnosed with cancer, 104 (51.74%) met the guidelines for a screening mammogram; however, only 49 (47.12%) had this completed. 115 (57.21%) met the guidelines for a screening Papanicolaou smear; 28 (24.35%) had it completed. 145 (72.14%) met the guidelines for a screening colonoscopy; 23 (15.86%) had it completed. 39 (19.4%) met the guidelines for prostate screening; 3 (7.69%) had it completed. Of the 201 patients, 14 (6.97%) reported a greater than 30 pack smoking history but no patients were screened with a low-dose CT of the thorax. Of the 10 patients with melanoma, 3 (30%) mentioned having routine skin exams. Conclusions: The uninsured population have many barriers to obtaining health care and appropriate screening for malignancies. This retrospective chart review highlights the need for easier access to screening. Increasing screening rates in the uninsured population will decrease cancer mortality as well as being cost effective to the community. It is important for free clinic providers to emphasize guideline-directed cancer screening at every visit.