Dan Sayam Zuckerman

American Society of Clinical Oncology Executive Summary of the Clinical Practice Guideline Update on the Role of Bone-Modifying Agents in Metastatic Breast Cancer

PURPOSE To update the recommendations on the role of bone-modifying agents in the prevention and treatment of skeletal-related events (SREs) for patients with metastatic breast cancer with bone metastases. METHODS A literature search using MEDLINE and the Cochrane Collaboration Library identified relevant studies published between January 2003 and November 2010. The primary outcomes of interest were SREs and time to SRE. Secondary outcomes included adverse events and pain. An Update Committee reviewed the literature and re-evaluated previous recommendations. RESULTS Recommendations were modified to include a new agent. A recommendation regarding osteonecrosis of the jaw was added. RECOMMENDATIONS Bone-modifying agent therapy is only recommended for patients with breast cancer with evidence of bone metastases; denosumab 120 mg subcutaneously every 4 weeks, intravenous pamidronate 90 mg over no less than 2 hours, or zoledronic acid 4 mg over no less than 15 minutes every 3 to 4 weeks is recommended. There is insufficient evidence to demonstrate greater efficacy of one bone-modifying agent over another. In patients with a calculated serum creatinine clearance of more than 60 mg/min, no change in dosage, infusion time, or interval of bisphosphonate administration is required. Serum creatinine should be monitored before each dose. All patients should receive a dental examination and appropriate preventive dentistry before bone-modifying agent therapy and maintain optimal oral health. Current standards of care for cancer bone pain management should be applied at the onset of pain, in concert with the initiation of bone-modifying agent therapy. The use of biochemical markers to monitor bone-modifying agent use is not recommended.

Comprehensive Survivorship Care With Cost and Revenue Analysis

PURPOSE The 2015 Commission on Cancer standards require that cancer survivors receive an individualized survivorship care plan (SCP). To meet this new standard, St Lukes Mountain States Tumor Institute (MSTI), with support from the National Community Cancer Centers Program, implemented a successful survivorship model. PATIENTS AND METHODS At MSTI, the patients SCP is prepared in the electronic health record by a registered health information technician. This document is reviewed during an appointment with a nurse practitioner and social worker. The providers dictation is mailed to the primary care physician with the SCP. From August 2011 to Oct 2012, 118 patients with breast cancer were seen for survivorship appointments. Medical record audit and follow-up telephone call were completed to evaluate patient survivorship needs and satisfaction with the appointment. Patient accounts were reviewed for reimbursement. RESULTS From medical record review, the most common patient concerns were weight management (35%), fatigue (30%), sexuality (27%), anxiety (23%), caregiver stress (17%), and depression (16%). Telephone calls showed high patient satisfaction and understanding. Patients rated the following statements on a Likert scale from 1 (strongly disagree) to 5 (strongly agree): I understand my treatment summary and care plan (88% strongly agree or agree), and I feel the survivorship visit met my survivorship needs (86% strongly agree or agree). At 1 month, 80% of participants were still working on wellness goals. Patient accounts analysis showed revenue covered costs. CONCLUSION Survivorship care at MSTI meets new standards, allows for patient engagement and satisfaction, and improves care coordination. Costs are covered by reimbursement.

Oral chemotherapy: A focus on interventions and access.

44 Background: Oral chemotherapies are becoming more predominant with 40% of the currently available oral agents being approved in the last 7 years. Patient self-administration and the costs of these medications raise concerns about monitoring and access. As a result, nonfulfillment rates in the literature have been reported to range from 10-24% with rates directly correlated with cost of the medication. METHODS Patients who utilized the pharmacist-managed oral chemotherapy program were included for evaluation. Patients were excluded if they utilized external mail order pharmacies. Patient charts were audited for documented pharmacist-initiated interventions such as drug-interactions, lab monitoring, and dose adjustments. Patient nonfulfillment rates were evaluated by evaluating percentage of patients referred to number of prescriptions filled. Patients were classified as either filled, mail order, financial assistance or never started. Financial assistance patients were divided into free drug or co-pay assistance. Total amount of free drug obtained was assessed by multiplying the average number of cycles obtained by patients by the average wholesale price (AWP). RESULTS A total of 702 patients were served by the Oral Chemotherapy program between August 2009 and October 2011. In those patients, 82 drug-drug interactions and 24 patients required dose adjustments up front, mostly due to renal dysfunction. Compared to the 10-24% nonfulfillment rates in the literature, this program was able to keep rates less than 1% for patients who were unable to obtain medication for financial reasons. In this time period, underinsured patients were able to obtain >

Medication therapy management (MTM) in a multidisciplinary supportive oncology clinic.

1 million in free drug and >

Driving improvement in oncofertility.

200,000 in co-pay assistance funds thanks to our financial advocates. CONCLUSIONS Collaboration within one health system between oncologists, pharmacists, nurses and social workers/financial advocates was able to ensure better quality of care by helping address medication issues upfront with minimal delays in access. In addition, this program was able to ensure that most patients were able to obtain their medication within a reasonable time period at a reasonable cost, reducing non-fulfillment rates compared to what has previously been reported in the literature.

The value of a genetic counselor for patient identification.

30 Background: Patients with advanced cancer experience significant symptom burden and psychosocial distress from the onset of their diagnosis and throughout treatment shifting the paradigm of supportive care. In addition, most cancer patients have multiple co-morbidities and are at high risk of poly-pharmacy. One in three ambulatory cancer patients are at risk of drug-drug interactions. METHODS In June 2010, a multidisciplinary supportive oncology clinic, modeled after the Massachusetts General Hospital article by Temel et al., was started and staffed by a pharmacist, a nurse, a social worker and a dietitian and lead by a nurse practitioner. A chart audit was conducted for all patients seen in the clinic between June 2010 and March 2012. Pharmacy assessment entries were evaluated for diagnosis, medication issues and total time spent with patients. Duplicate therapy was defined as an unnecessary duplication in therapy for a single symptom and/or two medications in the same class. Drug-Interactions were assessed utilizing Micromedex 2.0 Drug-Interaction Checker and Lexicomp Lexi-Interact Online drug-interaction analysis program. All major kinetic interactions were recorded and pharmacodynamic interactions were recorded if they required intervention. RESULTS From June 2010 to May 2012, 153 patients were seen in the clinic. The most common diagnoses were pancreatic, lung, breast and head and neck. Use of a standardized pharmacy assessment identified duplicate therapies in 45.1% of patients, drug-drug interactions in 35.3%, side-effects in 83%, lack of efficacy in 88.9% and untreated conditions 68.6%. The pharmacists spent an average of 44.1 minutes (range 15-90 min) with patients. CONCLUSIONS Pharmacist-initiated MTM identifies a higher rate of poly-pharmacy, drug-drug interactions and side effects than found in literature. Identification allows for referral to other disciplines within the clinic for work-up. Gastrointestinal related issues were referred to a dietitian, psychosocial issues including adherence issues to a social worker and medication related issues to the nurse practitioner for follow-up. Initial identification of these issues has allowed for more long-term follow-up in these patients.

Patient-reported outcomes on integrative therapies for pain, tension, and level of comfort.

183 Background: In 2006 the American Society of Clinical Oncology (ASCO) recommended that oncologists discuss infertility as a result of cancer treatment with patients of reproductive age and provide referrals to specialists as needed. Despite these guidelines the majority of cancer centers are not in compliance. Mountain States Tumor Institute (MSTI) piloted a process to improve quality of oncofertility preservation (OP) through identification, documentation, and referral to reproductive specialists. METHODS A physician survey in 2010 indicated that perceived barriers to OP discussion were a lack of accessible materials as well as oversight on the part of the provider. Random chart audits of the Quality Oncology Practice Initiative (QOPI) measures (infertility risks discussed prior to treatment and fertility preservation options discussed/referral to a specialist) occurred biannually at that time. To increase awareness of the data chart audits and reporting shifted to quarterly and included all patients that met OP criteria. Additionally, a committee was formed in 2011 to develop patient/provider packets, collaborate with the local reproductive specialists, and create an OP process. The committee established an OP algorithm involving support staff to flag patients of reproductive age at initial medical oncology consultation and utilizing genetic counselors (GC) and social workers (SW) to expedite and facilitate referrals to reproductive specialists. GC/SW were chosen due to sensitivity with psychosocial issues and to share the additional workload. The OP program was launched in October of 2012. RESULTS Baseline assessment in 2009 revealed MSTI was compliant 6% and 6%. Six months after program initiation the OP measures improved to 47% and 45% respectively. Notably March and April 2013 showed dramatic improvements with 100% and 75% compliance for both OP measures. CONCLUSIONS It is well known that OP has been a challenge for many cancer centers. This multipronged approach is an example of a novel process implementation that demonstrated significant improvement with the QOPI oncofertility measures. Continued work is needed on improving physician documentation and consistency of OP patient identification.

Comprehensive and financially sustainable survivorship care.

97 Background: Advances in genetics are rapidly changing cancer care and requiring institutions to maximize the unique skills of genetics professionals. The identification of genetic syndromes is vital for prevention and management of families with high cancer risks. Despite this high risk patients and families who qualify for genetic counseling are not referred; this is due to increasing responsibilities on physicians. Genetic counselors could be utilized to review new oncology charts to improve identification. METHODS A genetics assessment tool developed by NCI Community Cancer Centers Program generated baseline measurements of 2010 tumor registry data of patients meeting NCCN guidelines for genetics evaluation. A weekly list of new oncology patients was provided to a genetic counselor who reviewed each H&P dictation focusing on the pathology, age, and family history sections. The genetic counselor notified the oncologist by email or through the EMR system, and the physician discussed genetic counseling with patient or approved the order. Post implementation of the chart review program was measured using 2011 tumor registry data. RESULTS In 2010 58% of total applicable patients were offered a genetics evaluation. In 2011 this improved to 70%. Based on disease type: 69% (breast), 59% (colon), 29% (ovary), and 20% (uterine) were offered a genetics evaluation in 2010. In 2011 these numbers were 76% (breast), 64% (colon), 91% (ovary), and 20% (uterine). Over a 10-month period a total of 122 patients were identified through the chart review program by the genetic counselor. Three of these were confirmed to have a genetic mutation for one of the hereditary cancer syndromes. An average week included review of 73 charts for 10 medical oncologists, 4 radiation oncologists, 4 pediatric oncologists, which generated 60 to 80 minutes of work weekly for the counselor. CONCLUSIONS This program improved patient identification and allowed physicians to become more aware of opportunities for genetic consultation that led to a streamlined referral process and allowed more applicable patients to receive counseling and testing. Project funded in whole or part with Federal Funds from the National Cancer Institute, National Institutes of Health, Contract No. HHSN261200800001E.

Distress management in a community oncology center.

58 Background: The 2007 National Health Interview Survey (NHIS) reported more than one-third of adults used some form of complementary and alternative medicine (CAM). An analysis of 2002 NHIS data found CAM use to be more prevalent among people with a prior diagnosis of cancer. In 1999, St. Lukes Mountain States Tumor Institute (MSTI) began an integrative therapies program to meet this growing interest and provide evidence-based, safe CAM modalities for patients. The program continues to grow and offers programs such as massage, acupuncture, and pediatric music therapy. METHODS Patient reported outcomes are collected from patients using pre/post treatment assessments. Outpatient massage and acupuncture programs measure comfort levels pre/post treatment using a 0-10 scale (0 = very comfortable; 10 = worst discomfort). The inpatient massage program measures pre/post treatment pain and tension using a 0-10 scale (0 = no pain/tension; 10 = worst pain/tension). Finally, the MSTI pediatric music therapy program collects pre/post treatment pain outcomes using a FLACC scale, where each of the five categories Face (F), Legs (L), Activity (A), Cry (C) and Consolability (C) are scored from 0-2, which results in a total score 0-10. RESULTS Assessments from outpatient acupuncture and massage collected between July 1, 2011 to July 1, 2012 showed that patients had an average comfort score of 3.6 before acupuncture and 2.0 after acupuncture and an average comfort score of 3.4 before massage and 0.77 after massage (n=1300 estimate). Inpatient massage outcomes collected between Dec. 2011 - June 2012 showed an average pain score of 2.53 before massage and 0.41 after massage and an average tension score of 4.73 before massage and 0.52 after massage (n=52). MSTI pediatric music therapy outcomes collected from January-April 2012 showed an average FLACC score of 3.0 before music therapy and 0.72 after music therapy (n=68). CONCLUSIONS Integrative therapies such as massage, acupuncture and pediatric music therapy show significant benefits in providing comfort and decreasing pain and tension in MSTI cancer patients. Opportunities remain to conduct research and set a standard of practice with integrative therapies.

SUNSHINE: Randomized double-blind phase II trial of vitamin D supplementation in patients with previously untreated metastatic colorectal cancer.

32 Background: New 2015 Commission on Cancer (CoC) standards require that all patients who complete treatment receive an individualized survivorship care plan (SCP). To meet this new standard St. Lukes Mountain States Institute (MSTI), with support from the NCCCP, implemented a process that is multidisciplinary, efficient and sustainable. METHODS At MSTI, the patients SCP is a modified ASCO template with a comprehensive care plan and is prepared in the EMR by a Registered Health Information Technician (RHIT). This document is reviewed during a one hour visit with a nurse practitioner and a social worker. The patient participates in the discussion and sets wellness goals for healthy survivorship. The providers dictation is mailed to the PCP with the SCP. From Aug. 2011 - June 2012, 53 breast cancer patients were seen in 1 hour joint nurse practitioner/social work survivorship visits. A chart audit was conducted for these patients and follow-up phone calls were done with 36 patients at one month post-visit to evaluate patient understanding and satisfaction. Financial analysis was also completed to determine return on investment (ROI). RESULTS From chart review, the most common patient concerns were nutrition and weight loss (36%), anxiety (23%), fatigue (21%), depression (17%), caregiver stress (19%) and sexuality (17%). Phone calls showed high patient satisfaction and understanding. Patients rated the following statements on a Likert scale from 5=strongly agree to 1= strongly disagree: I understand my treatment summary and care plan 92% strongly agree or agree, I feel the survivorship visit met my survivorship needs, 97% strongly agree or agree, and 76% of participants were still working on wellness goals at one month. Patient accounts were reviewed showing approximately 50% ROI. CONCLUSIONS It is possible to implement sustainable and comprehensive survivorship care that meets the new CoC standards. The model at MSTI provides increased patient engagement, patient satisfaction, and improved patient provider communication in addition to ROI. Opportunities remain to measure long term health outcomes and downstream revenues associated with this survivorship model. Project funded with Federal funds from the NCI, Contract No HHSN261200800001E.