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Jeremy Lund, Angela Pearson and Georgia Keriazes

Purpose: The goal of this study was to develop a method for practitioners to evaluate both quality of care delivered to patients receiving chemotherapy and illicit risk factors for 30-day chemotherapy-related readmissions (CRR). Methods: Midas+ DataVision Readmission Tool Pack (Version 2.x) was used to retrospectively identify patients who received inpatient chemotherapy from April 2010 through May 2013. The population was screened for unscheduled admissions within 30 days after discharge. A multidisciplinary team was used to attribute readmissions to chemotherapy administration. Demographic information and oncology-specific characteristics were collected. The CRR rate and relative risk for readmission were calculated for each characteristic. Results: A baseline CRR rate of 11.1% was established. Risk factors associated with an increased risk for experiencing a CRR included age of 65 years or older, hematologic cancer diagnosis, first cycle chemotherapy, Medicare coverage, discharge to a skilled nursing facility, and anthracycline administration. Conclusions: A baseline CRR rate was established. Institution-specific 30-day CRR risk factors were elucidated. Modifiable risk factors included discharge to a skilled nursing facility and administration of an anthracycline. Further investigation for opportunities for quality improvement in these 2 risk factors is a topic for future research. Expanded research into chemotherapy-related toxicities requiring inpatient admission/readmission outside of clinical trials is warranted.

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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.

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Chizoba Nwankwo, Shelby L. Corman, Ruchit Shah and Youngmin Kwon

Background: An estimated 12,820 women in the United States will be diagnosed with CxCa in 2018, with 4,210 deaths from the disease. The economic burden of CxCa, both in terms of healthcare costs and lost productivity, has not been adequately studied. Methods: This was a mixed-methods study that evaluated the direct and indirect costs of CxCa using data from the Medical Expenditure Panel Survey (MEPS) for prevalent CxCa cases and the National Center for Health Statistics (NCHS) for deaths due to CxCa. Total healthcare costs and number of work days missed were compared between CxCa cases and controls in MEPS, using propensity scores calculated from baseline demographics and comorbidities. Missed work was converted to costs using the average hourly wage for women in 2015. Per-patient incremental healthcare and lost work productivity costs were then multiplied by the number of prevalent cases of CxCa in 2015 obtained from the Surveillance, Epidemiology, and End Results Program (SEER). NCHS data on the age-stratified number of CxCa deaths per year (1935–2015) and life expectancy data from the Social Security Administration were then used to calcluate the number of women who would be alive in 2015 if they had not died from CxCa and the lost earnings resulting from early mortality. The primary study outcome was the total direct and indirect cost of CxCa in 2015, calculated as the sum of the incremental direct healthcare costs, incremental lost productivity costs due to missed work, and lost productivity costs resulting from early death due to CxCa. Results: An estimated 257,524 women were alive with CxCa in 2015. Total healthcare costs were $4,221 higher, and an additional 0.37 work days were missed in women with CxCa compared to propensity-matched controls. Of the 488,475 women who died of CxCa prior to 2015, 108,832 would be alive in 2015 and 38,540 would be part of the workforce. Lost earnings in 2015 attributable to these deaths totaled $2.19 billion. The total economic burden of CxCa in the United States in 2015 was thus estimated at $3.3 billion (Table 1). Conclusions: CxCa was responsible for nearly $3.3 billion in direct and indirect costs in 2015. Early death among women with CxCa was the biggest driver of total economic burden.

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Olivia G. Fahey, Elizabeth N. Dow, Jennifer K. Piccolo and Ticiana A. Leal

Background: Use of immune checkpoint inhibitors (ICPi) in oncology continues to rapidly expand. ICPis have a unique toxicity profile and can lead to immune related adverse events (irAEs), some serious and potentially life-threatening. Early detection and appropriate treatment may limit the morbidity and mortality of irAEs and allow patients who are deriving benefit from ICPi to continue treatment. Pharmacists practicing in UW Health Carbone Cancer Center clinics are uniquely positioned to educate patients about common ICPi toxicities and ensure appropriate, early recognition and management of irAEs in collaboration with the multidisciplinary team. Methods: Within lung, melanoma, and gastrointestinal medical oncology clinics, a program was implemented involving pharmacists educating patients and families prior to the start of treatment as well as contacting patients at regular intervals to assess for any signs or symptoms of irAEs. The primary outcome is the number of patients experiencing Common Terminology Criteria for Adverse Events version 5.0 (CTCAE) grade 1 or 2 irAEs identified by a pharmacist enrolled in the program. Secondary outcomes include grade ≥ 3 irAEs identified by a pharmacist, the total number of patients enrolled in the program with any irAE, reason for discontinuation of ICPi, emergency department visits, and hospital admissions during the study period. Results: Between November 14, 2017 and October 15, 2018, a total of 81 patients were enrolled in the program with 49 of those patients still enrolled at the end of the study period. These patients experienced a total of 39 grade 1 and 13 grade 2 irAEs, of which 53.8% (n=28) were identified by pharmacists. The most common grade 1 or 2 toxicities identified by pharmacists were gastrointestinal (n=15) and dermatologic (n=6). Endocrine (n=7) and dermatologic (n=7) were the most common grade 1 or 2 irAEs identified by other providers. There were 4 grade 3 irAEs (endocrine, fatigue, liver, and pneumonitis) identified by other providers, and there were no grade 4 irAEs. Conclusion: Proactive pharmacist contact at regular intervals during ICPi treatment resulted in the early discovery of grade 1 or 2 irAEs experienced by patients. This pharmacist-driven approach may allow for earlier treatment of any toxicities experienced after ICPi treatment and reduce the rates of serious irAEs. Current efforts are focused on expanding these services to all UW Health Carbone Cancer Center clinics.

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Andrew D. Zelenetz, Islah Ahmed, Edward Louis Braud, James D. Cross, Nancy Davenport-Ennis, Barry D. Dickinson, Steven E. Goldberg, Scott Gottlieb, Philip E. Johnson, Gary H. Lyman, Richard Markus, Ursula A. Matulonis, Denise Reinke, Edward C. Li, Jessica DeMartino, Jonathan K. Larsen and James M. Hoffman

Biologics are essential to oncology care. As patents for older biologics begin to expire, the United States is developing an abbreviated regulatory process for the approval of similar biologics (biosimilars), which raises important considerations for the safe and appropriate incorporation of biosimilars into clinical practice for patients with cancer. The potential for biosimilars to reduce the cost of biologics, which are often high-cost components of oncology care, was the impetus behind the Biologics Price Competition and Innovation Act of 2009, a part of the 2010 Affordable Care Act. In March 2011, NCCN assembled a work group consisting of thought leaders from NCCN Member Institutions and other organizations, to provide guidance regarding the challenges health care providers and other key stakeholders face in incorporating biosimilars in health care practice. The work group identified challenges surrounding biosimilars, including health care provider knowledge, substitution practices, pharmacovigilance, naming and product tracking, coverage and reimbursement, use in off-label settings, and data requirements for approval.

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David S. Ettinger, Debra K. Armstrong, Sally Barbour, Michael J. Berger, Philip J. Bierman, Bob Bradbury, Georgianna Ellis, Steve Kirkegaard, Dwight D. Kloth, Mark G. Kris, Dean Lim, Michael Anne Markiewicz, Lida Nabati, Carli Nesheiwat, Hope S. Rugo, Steven M. Sorscher, Lisa Stucky-Marshal, Barbara Todaro and Susan Urba

Antiemesis Clinical Practice Guidelines in Oncology NCCN Categories of Evidence and Consensus Category 1: The recommendation is based on high-level evidence (e.g., randomized controlled trials) and there is uniform NCCN consensus. Category 2A: The recommendation is based on lowerlevel evidence and there is uniform NCCN consensus. Category 2B: The recommendation is based on lowerlevel evidence and there is nonuniform NCCN consensus (but no major disagreement). Category 3: The recommendation is based on any level of evidence but reflects major disagreement. All recommendations are category 2A unless otherwise noted. Clinical trials: The NCCN believes that the best management for any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged. Overview Chemotherapy-induced vomiting (emesis) and nausea can significantly affect a patient's quality of life, leading to poor compliance with further chemotherapy treatment. Nausea and vomiting can also result in metabolic imbalances, degeneration of self-care and functional ability, nutrient depletion, anorexia, decline of performance and mental status, wound dehiscence, esophageal tears, and withdrawal from potentially useful or curative anticancer treatment.1–4 The incidence and severity of nausea and/or vomiting in patients undergoing chemotherapy are affected by numerous factors, including 1) the specific chemotherapeutic agents used, 2) dosage of the agents, 3) schedule and route of administration of the agents, and 4) individual patient variability (e.g., age, sex, prior chemotherapy, history of alcohol use). Approximately 70% to 80% of all patients undergoing chemotherapy experience nausea and/or vomiting,5,6 whereas 10% to 44% experience anticipatory nausea and/or vomiting;7–10 patients often experience more...
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Philip E. Johnson, George Dahlman, Kirby Eng, Rekha Garg, Scott Gottlieb, James M. Hoffman, Peyton Howell, Mohammad Jahanzeb, Shirley Johnson, Emily Mackler, Mark Rubino, Brenda Sarokhan, F. Marc Stewart, Tim Tyler, Julie M. Vose, Sharon Weinstein, Edward C. Li and Jessica DeMartino

REMS are a particularly important issue for oncology and the National Comprehensive Cancer Network (NCCN). A disproportionate number of drugs with complex REMS are used in patients with cancer or hematologic disorders. REMS policies and processes within oncology may act as a model for other clinical areas. A breadth of experience and access to a wide knowledge base exists within oncology that will ensure appropriate development and consideration of the practical implications of REMS. NCCN is uniquely positioned to assume a leadership role in this process given its status as the arbiter of high-quality cancer care based on its world-leading institutions and clinicians. Notwithstanding the potential benefits, the successful design, implementation, and analysis of the FDA's recent requirement for REMS for some high-risk drugs and biologics will present significant challenges for stakeholders, including patients, providers, cancer centers, manufacturers, payors, health information technology vendors, and regulatory agencies. To provide guidance to these stakeholders regarding REMS challenges, the NCCN assembled a work group comprised of thought leaders from NCCN Member Institutions and other outside experts. The Work Group identified challenges across the REMS spectrum, including the areas of standardization, development and assessment of REMS programs, medication guides, provider knowledge and impact on prescribing, provider burden and compensation, and incorporation of REMS into clinical practice.

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Robert A. Swarm, Amy Pickar Abernethy, Doralina L. Anghelescu, Costantino Benedetti, Sorin Buga, Charles Cleeland, Oscar A. deLeon-Casasola, June G. Eilers, Betty Ferrell, Mark Green, Nora A. Janjan, Mihir M. Kamdar, Michael H. Levy, Maureen Lynch, Rachel M. McDowell, Natalie Moryl, Suzanne A. Nesbit, Judith A. Paice, Michael W. Rabow, Karen L. Syrjala, Susan G. Urba, Sharon M. Weinstein, Mary Dwyer and Rashmi Kumar

Pain is a common symptom associated with cancer and its treatment. Pain management is an important aspect of oncologic care, and unrelieved pain significantly comprises overall quality of life. These NCCN Guidelines list the principles of management and acknowledge the range of complex decisions faced in the management oncologic pain. In addition to pain assessment techniques, these guidelines provide principles of use, dosing, management of adverse effects, and safe handling procedures of pharmacologic therapies and discuss a multidisciplinary approach for the management of cancer pain.

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Robert Swarm, Amy Pickar Abernethy, Doralina L. Anghelescu, Costantino Benedetti, Craig D. Blinderman, Barry Boston, Charles Cleeland, Nessa Coyle, Oscar A. deLeon-Casasola, June G. Eilers, Betty Ferrell, Nora A. Janjan, Sloan Beth Karver, Michael H. Levy, Maureen Lynch, Natalie Moryl, Barbara A. Murphy, Suzanne A. Nesbit, Linda Oakes, Eugenie A. Obbens, Judith A. Paice, Michael W. Rabow, Karen L. Syrjala, Susan Urba and Sharon M. Weinstein

Overview Pain, defined as “a sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage,”1 is one of the most common symptoms associated with cancer. Cancer pain or cancer-related pain is distinct from pain experienced by patients without malignancies. Pain occurs in approximately one quarter of patients with newly diagnosed malignancies, one third of patients undergoing treatment, and three quarters of patients with advanced disease,2–4 and is one of the symptoms patients fear most. Unrelieved pain denies patients comfort and greatly affects their activities, motivation, interactions with family and friends, and overall quality of life. The importance of relieving pain and availability of effective therapies make it imperative that physicians and nurses caring for these patients be adept at the assessment and treatment of cancer pain.5–7 This requires familiarity with the pathogenesis of cancer pain; pain assessment techniques; common barriers to the delivery of appropriate analgesia; and pertinent pharmacologic, anesthetic, neurosurgical, and behavioral approaches to the treatment of cancer pain. The most widely accepted algorithm for the treatment of cancer pain was developed by the WHO.8,9 It suggests that patients with pain be started on acetaminophen or a nonsteroidal anti-inflammatory drug (NSAID). If this is not sufficient, patients should be escalated to a weak opioid, such as codeine, and then to a strong opioid, such as morphine. Although this algorithm has served as an excellent teaching tool, the management of cancer pain is considerably more complex than this 3-tiered “cancer pain ladder”...