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PURPOSE: Oncology care reimbursement has been shifting from a traditional fee-for-service model to either 1- or 2-sided risk models during the past 5 years. A major expense associated with the total cost of care is hospitalization cost. The study set out to investigate whether the creation of an Advanced Community Care Model (ACCM) of home health care would affect 60-day hospitalization and 30-rehospitalization rates in a community oncology setting. METHODS: In conjunction with a single home health care organization, an ACCM was modified for oncology care to include intervention protocols to address antiemetic issues, pain control, dehydration, shortness of breath, diarrhea, and fever. Weekly and monthly joint management meetings began. Quality metrics were defined. RESULTS: Overall, 457 unique home health care admissions were evaluated. Hospitalization associated with intervention protocols was evaluated. Sixty-day hospitalization rates decreased from 14% to 8%. Thirty-day rehospitalization rates decreased from 25% to 10%. CONCLUSION: An oncology ACCM, as created in this study, appears to have reduced both 60-day hospitalization and 30-day rehospitalization rates.

The classification of germline variants may differ between labs and change over time. We apply a variant harmonization tool, Ask2Me VarHarmonizer, to map variants to ClinVar and identify discordant variant classifications in a large multipractice variant dataset. A total of 7496 variants sequenced between 1996 and 2019 were collected from 11 clinical practices. Variants were mapped to ClinVar, and lab-reported and ClinVar variant classifications were analyzed and compared. Of the 4798 unique variants identified, 3699 (77%) were mappable to ClinVar. Among mappable variants, variants of unknown significance (VUS) accounted for 74% of lab-reported classifications and 60% of ClinVar classifications. Lab-reported and ClinVar discordances were present in 783 unique variants (21.2% of all mappable variants); 121 variants (2.5% of all unique variants) had within-practice lab-reported discordances; and 56 variants (1.2% of all unique variants) had lab-reported discordances across practices. The unmappable variants were associated with a higher proportion of lab-reported pathogenic classifications (50% vs. 21%, p

49 Background: Oncology providers and patients benefit from evidence-based nutritional resources to support cancer care. For patients, proper nutrition care can prevent inappropriate weight loss, improve treatment tolerance, and improve quality of life. Recent literature has noted the lack of both adequate dietitian resources at outpatient centers and comprehensive nutrition guidelines in cancer care. At a large community practice with 210 locations across Texas and Oklahoma, a survey was developed and administered to assess nutrition practices. Methods: Clinic directors in the practice completed a survey to assess for the presence or absence of a malnutrition screen; how nutrition concerns are addressed; and the availability of a dietitian. Results: A total of 26 responses detailed the nutrition processes at 50 unique locations. At 37 (74%) locations, a malnutrition screening tool was utilized and of these, 30 (81%) locations reported utilizing the Malnutrition Screening Tool (MST), a brief, validated tool for outpatient settings including oncology. Seven (19%) sites did not specify what tool was used. Of the clinics that reported completing a malnutrition screen for patients, the screen was completed by the advanced practice provider (APP)/physician in 18 (49%) clinics, a nurse in 4 (11%) clinics, a dietitian in 4 (11%) clinics and a medical assistant in 1 (3%) clinic. At 10 sites more than one provider type was responsible for completing the screen. Nutrition issues were addressed by physicians, APPs, and nurses in 15 (50%), 35 (70%), and 9 (14%) sites respectively (see table). Twenty-two locations (44%) reported referring patients to a dietitian and 10 sites (20%) had a dietitian available in clinic. Forty-one (82%) clinics employed more than one method for addressing nutrition issues. Sixteen of 26 respondents (62%) reported that increased dietitian access would be helpful; this included respondents whose locations already had a dietitian available. Conclusions: Overall, 74% of reporting locations used a malnutrition screening tool and 20% had access to a dietitian on site. Forty-four percent of sites referred to a dietitian if there was a need. This indicates that multiple providers are involved in the nutritional care of oncology patients. In response to these findings, the multidisciplinary PECAN Taskforce was created to develop comprehensive malnutrition screening, implement a referral process for all at-risk patients, enhance nutrition education, and expand dietitian services. Further study will measure the impact of expanded nutrition access on patient outcomes.[Table: see text]

123 Background: Identifying individuals with inherited cancer susceptibility is critical to cancer treatment and prevention in patients and families. While the identification and management of inherited susceptibility to cancer is the standard of care, genetic testing rates are low; 1.2 million women with breast and/or ovarian cancer who qualify have yet to undergo genetic testing (Childers et al 2017). The Genetic Risk Evaluation and Testing Program (GREAT) formed to improve access to genetic evaluations and testing in Texas Oncology, a large, state-wide community oncology practice. Methods: The GREAT program is a collaborative service delivery model, utilizing 4 certified genetic counselors (CGC) to lead advanced practice providers and physicians in offering pre and post-test evaluations to oncology patients in their own community. Training involves 8-12 weeks of didactic lectures, precepting, and ongoing education and support. GREAT-trained providers then offer comprehensive genetic evaluations and testing to established oncology patients as well as at-risk individuals from the surrounding community. Results: The GREAT program has trained 72 providers at 52 cancer centers. Rates of genetic evaluations increased each year from 2012 to 2018. Overall findings: 19,129 unique patients received an evaluation; 17,305 genetic tests were completed; 2,597 pathogenic/likely pathogenic variants (P/VLP) have been identified. Conclusions: Despite guidelines recommending genetic evaluations for hereditary cancer syndromes, most patients are not receiving this service. A hybrid service delivery model utilizing regional CGCs to train providers in community oncology offices can significantly increase access to genetic services. The model described is an effective and expansive mechanism for the delivery of high-quality cancer genetics care. The GREAT program plans to hire additional CGCs to train more providers across Texas Oncology with the goal of expanding access. [Table: see text]

273 Background: Unplanned hospital admissions or hospital re-admissions in cancer patients after discharge cost in excess of 16 billion dollars. Oncology patients are a very high risk of hospitalization despite the involvement of a home healthcare agency. The 30-day medical oncology re-hospitalization rates are reported to be 21.6%. Unplanned hospitalization rates in selected oncology patients over a 12 month period have been reported to be as high as 58%. Methods: A large home health agency and a community based medical oncology practice created a delivery model referred to as the Advanced Community Care Model (ACCM). We are reporting our initial 14 month experience. The initial pilot involved three of the medical group’s six cancer centers. The ACCM created standing intervention orders regarding hydration, nausea/vomiting, central line management, antiemetic and diarrhea and a continuum of monthly management meetings with the agency and the practice. Navigation services by a designated RN were provided. Enhanced interventions with either telephone communication or home visits took place when deemed appropriate. Results: ACCM impacted 60-day hospitalization rates fell a baseline at 6 months into the program from 43% to 22% by the end of the 18 month pilot. Avoidable hospitalizations and re-hospitalizations related to N/V, pain, SOB and infection were less than 10%. The initial program has involved 310 unique patients. Conclusions: The reduction in the 60 day hospitalization rates and the low hospitalization and re-hospitalization rates related to pain control, infection, SOB and infection were below published national averages. The results were felt to be encouraging and the ACCM will be expanded to involve all 7 cancer centers in the practice.

Introduction: The identification of patients with an inherited cancer syndrome is becoming increasingly relevant in the treatment and prevention of cancer. Testing with a panel of genes provides the opportunity to rapidly identify or rule out deleterious mutations in several genes simultaneously and, thus, has the potential to streamline the testing process and more efficiently and accurately provide results. We report on the experience of panel-based testing in the community oncology setting. Objectives: To evaluate the performance of a 25-gene hereditary cancer test in the community oncology setting and describe the patient characteristics and test findings. Methods: We retrospectively evaluated the 25-gene panel testing data obtained between September 2013 and February 2014 in 6 large community oncology practices. The gene panel was based on next generation sequencing and rearrangement analysis of 25 genes with cancer risk data: BRCA1, BRCA2, MLH1, MSH2, MSH6, PMS2, EPCAM, APC, MUTYH, CDKN2A, CDK4, PALB2, CHEK2, SMAD4, BMPR1A, STK11, TP53, CDH1, PTEN, ATM, NBN, BARD1, BRIP1, RAD51C, and RAD51D. Personal and family history was obtained by health care provider report on test requisition forms. Results: The panel test was performed on 359 individuals during the time period. 69.9% of these patients had a phx of at least one of the eight panel cancers: breast, ovarian, colorectal, endometrium, pancreas, melanoma, prostate, and/or stomach. cancer diagnosis. 97.8% of the patients tested met the 2013 NCCN guideline criteria for HBOC, 2012 NCCN guideline criteria for Lynch Syndrome, or both. 37 pathogenic mutations were found in 34 distinct patients. The variant rate in this population was 35.4%. Mutations were identified in 16 different genes, and only 20 of the 37 mutations (54.1%) were found to be in the 6 genes included in HBOC and Lynch Syndrome testing (BRCA1, BRCA2, MSH6, MLH1, MSH2, PMS2). Conclusion: The 25-gene hereditary cancer panel increased the identification of deleterious mutations which would otherwise not have been detected. The variant rate in this setting is similar to the rate reported previously in both community and academic centers where panel testing is used. Use of a hereditary cancer panel in the community oncology practice may improve detection rates and provide an opportunity for enhanced cancer management. Citation Format: Sami Diab, Patricia Rodriguez, Anna Leininger, Lisa Clark, Mike F Janicek, Ellen B Smith, John Sandbach, Jennifer Saam, Lucy Langer. Experience in the community oncology practice with a 25-gene hereditary cancer panel [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr P1-03-03.

BACKGROUND As panel testing becomes more common in clinical practice, it is important to understand the prevalence and trends associated with the pathogenic variants (PVs) identified. This is especially true for genetically heterogeneous cancers, such as breast cancer (BC), in which PVs in different genes may be associated with various risks and cancer subtypes. The authors evaluated the outcomes of genetic testing among women who had a personal history of BC. METHODS A total of 35,409 women with a single diagnosis of BC who underwent clinical genetic testing with a 25-gene panel were included in the current analysis. Women with multiple BCs and men with BC were excluded. The frequency and distribution of PVs were assessed for the overall cohort, among women with triple-negative BC (TNBC) (n = 4797), and by age at diagnosis. RESULTS PVs were identified in 9.3% of women tested; 51.5% of PVs were identified in genes other than breast cancer 1 (BRCA1) and BRCA2, including checkpoint kinase 2 (CHEK2) (11.7%), ataxia telangiectasia mutated (ATM; ATM serine/threonine kinase) (9.7%), and partner and localizer of BRCA2 (PALB2) (9.3%). The prevalence of PVs in BRCA1, PALB2, BRCA1-associated RING domain 1 (BARD1), BRCA1-interacting protein C-terminal helicase 1 (BRIP1), and RAD51 paralog C (RAD51C) was statistically higher among women with TNBC. The PV rate was higher among women aged 59 years, and relatively constant (8.5%-9.0%) among women who were diagnosed between ages 40 and 59 years. CONCLUSIONS These results demonstrate that panel testing increased the number of women identified as carrying a PV in this cohort compared with BRCA testing alone. Furthermore, the proportion of women identified who carried a PV in this cohort did not decrease between ages 40 and 59 years. Cancer 2017;123:1721–1730. © 2017 American Cancer Society.

Background: Genetic risk assessment is an important component of the care of the community oncology breast cancer patient. However, identification of at-risk patients is largely an ad-hoc process and practices lack a systematic approach to genetic risk evaluation. The US Oncology Network Genetic Risk Evaluation and Testing (USON GREAT) Program provides a structured approach to implementation of genetic risk evaluation, testing, and triage for appropriate intervention. Methods: In 2009, our multi-disciplinary community oncology practice implemented the USON GREAT Program. The practice's program has a single dedicated nurse practitioner and physician lead, trained in part through a core educational curriculum and utilizing US Oncology Network-wide genetics resources (web-based MD, midlevel, and genetic counselor conferencing; discussion Portal; published guidelines and office procedures). NCCN guidelines were used to guide testing recommendations. Sequential risk evaluations were documented prospectively. We retrospectively analyzed how evaluation patterns changed over a 4 year time period. We also sought to capture descriptive characteristics of the evaluated population. Results: Overall, between 2008 and 2011, our practice evaluated 1018 patients at potential risk for a BRCA mutation (mut), based on personal history of breast cancer under age 50; ovarian, fallopian or peritoneal cancer; known family history of malignancy; or known BRCA mutation in the family. In 2008, 6% of potential at-risk individuals were identified vs 35% in 2011. NCCN guideline exclusions for BRCA testing in invasive breast cancer were 8% in 2008 and 3% in 2010. 150 deleterious mut and variants of uncertain significance (VUS) were identified. There was an 14.7% overall identification rate for BRCA1/2 (B1, B2) mut and VUS. Among mut and VUS identified by cancer type, B1 mut was more commonly identified in patients with a gynecologic malignancy (53% B1 vs 30% B2, 17% VUS); mut in invasive breast cancer were more likely to be in B2 (42% B2 vs 32% B1, 26% VUS). 7% of all tests for individuals with malignancy were declined or cancelled due to insurance or finances, vs 37% for unaffecteds, despite their high risk of mutation carrier status. Conclusions: We report a single practice's four-year experience with implementation of the USON GREAT Program. The results from this experience demonstrate that the USON GREAT Program results in higher rates of identification of at-risk individuals, and promotes more appropriate guidelines-based testing in the community oncology setting. The relative frequency of BRCA2 vs BRCA1 in invasive breast cancer is of unclear significance at this time and warrants further analysis. Cost of testing remains a barrier to appropriate utilization. Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr P4-11-04.

BACKGROUND: This study assessed BRCA1 and BRCA2 mutation prevalence in an unselected cohort of patients with triple-negative breast cancer (BC). METHODS: One hundred ninety-nine patients were enrolled. Triple negativity was defined as

1067 Background: Although triple-negative breast cancer (TNBC) accounts for 15% to 20% of all breast cancers diagnosed in the US, its epidemiology is not well understood. Previous studies have show...

590 Background: Some ER-negative (ER-) breast cancers express low levels of estrogen receptors and approximately 12% express androgen receptors (Traina, T, et al. ASCO, 2012). Whether young premenopausal women (age 40yrs and by ER status. Results: In the two studies combined, ER- patients ≤40 had a superior DFS (84%) than ER- patients >40 (80%), while ER+ patients ≤40 had a worse 5-yr DFS (83%) than ER+ patients >40 (89%), although these findings were of borderline significance (see Table below). In 99-016, omitting C did not adversely affect outcomes in either age group, regardless of ER status. Conclusions: We did not observe worse outcomes in ER- patients ≤40 years compared to those >40 years in 2 US Oncology adjuvant chemotherapy trials, suggesting no adverse impact of assumed greater ovarian function following adjuvant chemotherapy in patients ≤40yrs. ER+ patients ≤40 had a worse DFS than ER+ patients >40. Omitting C in ER- patients ≤40 or >40 did not adversely affect outcome. [Table: see text]

One hundred thirty-three patients with advanced metastatic cancer were randomized to receive single-agent chemotherapy selected by either a medical oncologist or an in vitro capillary cloning system. Thirty-six of the 65 patients (55%) who were randomly assigned to selection of a drug by the clinician actually received a drug; these patients were able to be evaluated for clinical response. Of these 36 patients, one had a partial tumor response (3%). Only 19 of the 68 patients (28%) who were randomly assigned to selection of a drug by the capillary system actually received a drug; these patients were able to be evaluated for clinical response. Of these 19 patients, four (21%) had partial tumor responses. In the assessable patients (36 in the clinician's choice group, 19 in the capillary cloning group), the partial response rate was superior for drug selection by the capillary cloning system (P = .04). For all patients randomly assigned to a group (65 in the clinician's choice group, 68 in the capillary cloning group), the response rate was not significantly different (1.5% and 5.9%, respectively; P = .37). When overall survival rates for patients in the two groups were compared, there was no difference. We conclude that drug sensitivity testing in capillary tubes can improve the response rate for patients with advanced malignancies. This improved response rate, however, does not translate into improved survival times for these patients.

517 Background: This study compared the disease-free survival (DFS) obtained with 2 regimens of adjuvant therapy for patients (pts) with high-risk breast cancer Methods: Women PS 0–1 with local, operable, confirmed stage I-III adenocarcinoma were eligible. Pts may have had primary surgery, with no residual tumor. Therapy was as follows:Arm 1 (AC→T) - doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 repeated every 3 weeks for 4 cycles → paclitaxel 175 mg/m2 repeated every 3 weeks for 4 cycles; Arm 2 (AT→T) - doxorubicin 50 mg/m2 plus paclitaxel 200 mg/m2 repeated every 3 weeks for 4 cycles → paclitaxel 80 mg/m2 weekly ×12. Results: 1,830 pts were enrolled and treated; n=915 Arm 1 (AC→T) and n=915 Arm 2 (AT→T). Pts were: PS=0 (70%/Arm), ER+/PR+ (54% and 50%, Arms 1 and 2 respectively), ER-/PR- (35% and 34%) with 0 positive nodes (N+) (28% and 27%), 1–3 (N+) (44% and 46%), 4–9 (N+) (21% and 18%) and 10+ (N+) (7% and 8.5%). Most were postmenopausal (57%/Arm); median age was 52 years/Arm. To date 1,655 pts (90%) are alive. 5-year DFS was 80% vs 81% for Arms 1 and 2 Overall 5-year survival was 86% vs 89%, in Arms 1 and 2. Cause of death was recurrence for 76 pts in Arm 1 and 56 pts in Arm 2. The main reasons for pts being taken off study treatment were toxicity (85 pts Arm 1 vs 128 pts Arm 2), recurrence (79 pts Arm 1 vs 52 pts Arm 2), and consent withdrawal (18 pts Arm 1 vs 30 pts Arm 2). The most frequent toxicities were neutropenia, leukopenia, neuropathy, febrile neutropenia, nausea, vomiting, arthralgia, and myalgia. GI toxicities were more frequent in Arm 1. Alopecia occurred in both Arms (77%). Conclusions: At 5-years, the AT→T produced significantly better OS (p=0.054) and improved DFS (p=0.19). Clinically important toxicities were more frequent with AC→T. Given this, AT→T in the adjuvant treatment of breast cancer is well tolerated and warranted in place of AC→T in these pts. Research support provided by Bristol-Myers Squibb (Princeton, NJ). No significant financial relationships to disclose.

A human tumor cloning system has been utilized to grow human breast carcinoma. A total of 225 specimens have been placed in culture. One hundred thirty-two were from primary chest cancer specimens and 93 were from metastatic lesions. Of these, 71% of the primary breast carcinomas and 75% of metastases formed greater than or equal to 5 colonies per 500,000 cells plated. Forty-five percent of the primary breast carcinomas and 52% of the metastases formed enough colonies (greater than or equal to 30 colonies per 500,000 cells plated) to perform meaningful in vitro drug testing. Estrogen receptor status did not influence the percentage of tumors which formed colonies in vitro. Histologic and nude mouse studies provided confirmatory evidence the colonies were composed of breast cancer cells. In 176 in vitro chemotherapeutic drug tests, the anticancer agents commonly used clinically for treatment of breast cancer, i.e., Adriamycin, 5-fluorouracil, etc., showed some in vitro activity. This activity was not as dramatic as is seen in the clinic with these conventional agents. Future work should concentrate on improving the number of colonies which form from breast cancer specimens and on prospective use of the system for screening for new agents for the treatment of human breast cancer.

A human tumor cloning system has been utilized to culture 431 patients' breast cancer specimens. Overall, 288 or 67% of the specimens formed colonies in soft agar. Of the primary lesions 188/260 (72%) formed colonies and 100/171 (58%) of the metastatic lesions formed colonies. The median number of colonies per 500,000 nucleated cells plated was 47 for the primary lesions and 30 for the metastatic lesions. Growth from a variety of metastatic sites ranged from 22% for intradermal lesions to 77% for solid visceral metastases. Methods to increase the number of colonies from a specimen are reported including increasing the number of nucleated cells plated and making a variety of changes in the growth media. None of these methods has had a major impact on colony growth. The antitumor activity of standard anticancer agents such as adriamycin and medroxyprogesterone in the assay is presented. In addition, in vitro results with two new anthracene derivatives demonstrate good antitumor activity for the derivatives. The cloning assay represents a new model for both the basic and clinical studies of human breast cancer.

Nine of ninety-three patients receiving Bisantrene on an every three week schedule developed an anaphylactoid reaction with a variety of symptoms. Most reactions occurred in patients who had multiple exposures to Bisantrene. Investigatiors utilizing Bisantrene in ongoing clinical trials should be aware of this life threatening toxicity.

An in vitro tumor colony-forming assay was utilized to measure the sensitivity of 800 individual patients' tumors to a variety of antineoplastic agents. Thirty-six separate histologic types of cancer were represented. Only 199 of the 800 patients' tumors (25 percent) both formed colonies in vitro and had enough cells in the biopsy or fluid specimen to perform drug sensitivity assays. In 123 instances the drug tested in vitro against the tumor was also used clinically to treat the patient. The clinician caring for the patient did not know the results of the in vitro test. When analyzed in a retrospective manner, the probability of a positive prediction from the assay, given the patient responded clinically, was 0.88. The probability for a negative prediction of the assay given the patient did not respond, was 0.94. Associations of in vitro and in vivo results in the 123 correlations were highly significant (p less than 0.001). We conclude that, as now constituted, the human tumor colony-forming assay can provide useful sensitivity information for only about 25 percent of the general oncology patients. Secondly, a prospective clinical trial of the assay is needed to insure that the assay is indeed predictive of which drug will produce a patient response and that it is not merely an indicator that a particular patient's tumor is highly responsive in vivo.