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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.

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Eric J Roeland, Thomas W. LeBlanc, Kathryn J. Ruddy, Ryan Nipp, Rebecca Clark-Snow, Rita Wickham, Gary Binder, William L. Bailey, Ravi Potluri, Luke M. Schmerold, Eros Papademetriou and Rudolph M. Navari

Background: Avoiding acute care services can improve cancer care and reduce cost. The US Centers for Medicare and Medicaid Services’ (CMS) new oncology outcome measure (OP-35) defines 30-day post-chemotherapy inpatient (IP) and/or emergency department (ED) events (IP/ED) as “potentially avoidable” if involving any of 10 toxicities, including nausea or vomiting (NV). Evidence demonstrates meaningful gaps in oncologists’ adherence to antiemetic prophylaxis guidelines for highly emetogenic chemotherapy (HEC), and that NV-related IP use costs >$10,000; yet the incidence of avoidable acute care events involving NV is not well studied. Methods: We assessed chemotherapy courses using IBM Explorys electronic health records (4Q 2012–1Q 2018). We identified rates of IP/ED ≤30 days post-chemotherapy, and OP-35 toxicities (NV, anemia, dehydration, diarrhea, fever, neutropenia, pain, pneumonia, or sepsis) by ICD-9, ICD-10, procedure codes, and CMS criteria. We evaluated cisplatin, anthracycline + cyclophosphamide (AC), carboplatin (>14 days apart, as a proxy for AUC ≥4), oxaliplatin (OX), and other non-HEC chemotherapy. We assessed guideline adherence, defined as triple prophylaxis (NK1 RA + 5HT3 RA +dexamethasone) rates at HEC initiation. Results: In 17,609 HEC and 56,624 non-HEC courses, we observed 30-day IP/ED utilization in 29% and 19% of courses, respectively (Table 1). For HEC, 76% of IP/ED use involved ≥1 of the 10 CMS toxicities, most often anemia (42%), pain (41%), dehydration (24%), and NV (24%). Rates of all-cause IP/ED, IP/ED with OP-35 toxicity, and NV-related IP/ED were consistent for HEC and OX. Gaps in triple prophylaxis were common in HEC. Conclusion: Roughly one-third of patients receiving HEC or OX experienced IP/ED events ≤30 days after chemotherapy. Three-quarters of IP/ED events involved ≥1 of 10 OP-35 toxicities linked by CMS to potentially avoidable acute care; of these, one-third involved NV. NV-associated acute care use is considerable, costly, and potentially avoidable with better adherence to antiemesis guidelines.

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Yan Si, Jingsheng Cai, Hao Zhang, Haisheng Fang and Meiping Shen

Objective: To explore the anatomic features and the dissection technique of thyrothymic ligament (TTL) and to explore the clinical significance of protecting the inferior parathyroid gland (IPTG) with this structure. Method: Dissect the TTL of patients who receive initial thyroid surgery in our center, describe the structural features of TTL, and investigate the positional relationship of TTL and IPTG. Results: TTL is a kind of adipose connective tissue that is wide at the bottom and narrow at the top, accompanying with the inferior thyroid vein, from the thymus to the thyroid. Over 70% TTL are attached to the lower pole and the lower one-third dorsal of thyroid, containing fat and vessels. About 121 patients have undergone this dissection, totally dissected 194 sides, 143 sides had TTL (73.7%). About 63.4% IPTGs are located in the thymus-thyrothymic ligament-IPTG complex (TLIC), and nearly 70.6% IPTG can be proactively identified and located by the TTL during the operation. The incidence rate of postsurgical hypoparathyroidism is 14.9%. According to whether the dissection is successful, the IPTG can be described into 2 types, the ligament type (L) and the non-ligament type (N), and each type can be described into different subtypes.

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Vishal Vashistha, Pradeep J. Poonnen, Vimla L. Patel, Halcyon G. Skinner, Jane L. Snowdon, Victoria McCaffrey, Neil L. Spector, Bradley Hintze, Jill E. Duffy, Gretchen P. Jackson and Michael J. Kelley

Background: Genomic sequencing of tumor samples is often considered for patients diagnosed with metastatic malignancies. In July 2016, the Veterans Health Administration (VHA) created the VA National Precision Oncology Program (NPOP) to offer next generation sequencing (NGS) multigene panels for veterans with advanced solid tumors. We sought to assess the perceptions of NPOP among medical oncologists across VHA. Methods: Semi-structured interviews were designed to evaluate the following concepts: expectations for NGS testing, required workflow to conduct testing, applicability of testing results, and summative views of genomic sequencing. VHA medical oncologists who had previously sent at least one sample for testing through NPOP were solicited to participate for an in-person or telephonic conversation. Interviews were analyzed by an inductive narrative approach to code responses, which was then followed by thematic analysis for key findings that emerged. Results: 17 medical oncologists were interviewed from 16 different VA medical centers (VAMCs) in 12 states. 16 (94.1%) oncologists reported sending at least 5 samples for NGS testing; 4 (23.5%) oncologists practiced at VAMCs that sent over 100 samples. Clinicians collectively expected that testing would determine all clinically relevant genomic alterations in a reasonable time. Testing was expedited for oncologists who maintained a collaborative relationship with their local pathologists and proceduralists. 8 (47.1%) oncologists felt that testing reports should provide greater insight into the clinical significance of uncommon gene variants. 6 (35.3%) respondents expressed that educational efforts are warranted to describe optimal sample processing, indications for testing, and/or relevance of rare mutations. Twelve (70.6%) respondents felt strongly that NGS testing would improve outcomes for their patients, while 3 (17.6%) oncologists were wary that the current number of actionable mutations is too limited to offer widespread benefit. Conclusions: VHA medical oncologists opined that NGS testing through VA NPOP improved outcomes. The testing process is expedited with multidisciplinary involvement. Designed approaches to semi-algorithmically report testing results may improve efficiency of clinical decision-making. More education is warranted to detail the procedural requirements to conduct testing, indications for test ordering, and interpretation of results.

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Ashwaq Mohammed Alanazi, Rawan Alshalhoub, Maha Meshal Alrasheed, Nora Abanamy, Dana Bakheet and Nduna Dzimiri

Background: Patients with differentiated thyroid cancer (DTC) are usually managed with total thyroidectomy and subsequent radioiodine ablation of the remnant thyroid tissue. L-thyroxine (L-T4) therapy (about 2 µg/kg) is required for life, with a wide variation in patient dose requirements. The iodothyronine deiodinase types I, II, and III (DIO1, DIO2, and DIO3, respectively) regulate the activity of the thyroid hormone via removal of specific iodine moieties from the precursor molecule T4. During LT4 replacement, the active hormone triiodothyronine (T3) levels strictly depend on DIO2-mediated activation of LT4. Therefore, the aims of this study were to investigate the association of DIO1 and DIO2 polymorphisms with DTC and L-T4 dose requirement in the Saudi population. Methods: A total of 1,067 (560 controls and 507 DTC thyroidectomized cases) Saudi Arabs were included. Serum free thyroxine and TSH levels were measured in the cases. We genotyped 1 DIO1 variant rs2294512_G and 3 DIO2 SNPs, rs1388378_T, rs12885300_T, rs225013_T, by TaqMan assay. Results: The DIO1 and DIO2 genotyping revealed an association between L-T4 dose requirement and rs1388378_T. Patients carrying the rs1388378_T allele required a lower l-T4 dose (145.91±33.31; P=.035). No significant association was found for these SNPs with cancer risk. Conclusions: Our study identified 1 DIO2 variant associated with L-T4 dose requirement. Thyroidectomized patients carrying T allele of rs1388378 need lower L-T4 dose to maintain normal TSH level thus providing evidence in favor of customized treatment of hypothyroidism in athyreotic patients.

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Yamini V. Ananth and Karisa Schreck

Background: Glioblastoma remains incurable, but detailed molecular characterization has revealed different genomic subtypes have differential survival and sensitivity to therapies. Correlating clinical with molecular data has proven challenging, however, limiting the field’s insight into the effect of specific mutations. BRAF V600E, a targetable mutation with important therapeutic implications, is not well studied in adults with high-grade gliomas. With this study we sought to establish a consolidated clinical-molecular database in order to ascertain the range of primary brain tumors with BRAF V600E mutations that occur in adults, and the clinical and histopathological features of these tumors. Methods: We created a secure, web-based database using the REDCap tool. We analyzed data from 29 adults with primary brain tumors containing the BRAF V600E mutation, recording gender, age at diagnosis, tumor pathology, molecular tumor information, dates of surgeries, time to progression, treatments received, response to treatment, and survival. Results: The patient cohort’s median age at diagnosis was 33 ± 3.2 years. These patients were followed for a median of 4.2 ± 1.5 years. Tumor grades ranged from WHO I to IV, with 59% (n=17) of tumors classified as high grade by WHO criteria (III or IV). Of the patients with high-grade gliomas, 60% (n=6) received chemotherapy and radiation within 4 months of diagnosis. Three patients were treated at progression: 1 received standard therapy, the other 2 received an experimental targeted therapy of dabrafenib and trametinib (BRAF/MEK inhibitors). Overall, the high-grade glioma cohort received a median of one treatment (range 0–4) with a median follow up of 1.2 ± 0.9 years. Conclusion: Understanding the natural history of different genomic subtypes of glioblastoma is critical for the appropriate application of novel therapeutics. Here we demonstrate that a clinical-pathological database consisting of clinical and molecular data from patients with an uncommon mutation in brain tumors (BRAF V600E) is useful for understanding the prevalence, distribution, and natural history of this disease. This novel database tool also creates a systematic manner in which to track the clinical outcome in cohorts of patients with specific mutations, which is of broad interest for patients with glioblastoma and other potentially targetable mutations.

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Kristi Maxwell, Eric A. Severson, Meagan Montesion, Ingrid Marino, Rachel Anhorn and Bethany Sawchyn

Comprehensive genomic profiling (CGP) for patients with advanced solid tumors is on the trajectory of becoming standard of care through incorporation into clinical practice, professional society guidelines, availability of an FDA-approved assay, and a national coverage determination from Medicare. For hematologic malignancies, the clinical utility of CGP can be diagnostic, prognostic, or predictive depending on the type of malignancy. Molecular testing has been standard of care for many years for hematologic malignancies, and payer coverage of the CGP approach must now be considered to keep pace with advances in the field of hematology-oncology. Based on American Medical Association CPT coding definitions, molecular testing for hematologic malignancies is categorized as testing for individual genes and gene panels of 5–50 genes or >50 genes. Our review of payer coverage policies from the Policy Reporter database in October 2018 demonstrated that payer coverage for >50 genes in hematologic malignancies is limited. As an example of coverage limitations, a recently updated Medicare Local Coverage Determination limits coverage to 50 genes or less. Coverage decisions such as these are being made during a time of increasing demand for an expanded approach. Data from the Foundation Medicine, Inc. database shows that as of April 2018, over 3,600 patients with AML, MDS, and MPN have undergone clinical testing with FoundationOne Heme, a CGP assay for hematologic malignancies. In an analysis of over 1,300 AML cases tested with FoundationOne Heme, 62% had an alteration that is included in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines), and 91% had a clinically relevant alteration identified that could inform diagnosis, prognosis, or treatment selection. In an analysis of over 1,300 MDS cases tested, 70% had at least one clinically relevant alteration identified. In an analysis of over 200 MPN cases tested, 48% were triple negative for CALR, JAK2, and MPL, and of those triple negative cases, 55% had another clinically relevant alteration. These data demonstrate that FoundationOne Heme is a clinically important assay for patients with hematologic malignancies including AML, MDS, and MPN, and stakeholders within the system must now come together to further refine the clinical utility, improve payer coverage, and ensure patient access to this impactful testing as the field advances.

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Zin W. Myint, Rani Jayswal, Ranjana Arora, Gregory P. Monohan, Amit Goldberg, Roger Fleischman, Roger Herzig, Hayder Saeed, Gerhard C. Hildebrandt and Reshma Ramlal

Purpose: Acute myeloid leukemia (AML) is characterized by multiple somatically acquired mutations that affect genes of different functional categories. It has been well established in myelodysplastic syndrome (MDS) that the cumulative number of somatic mutations has an impact on overall survival. However, no such data exist for AML. In this study, we sought to determine the number of clinically significant somatic mutations for each cytogenetically defined risk group of AML and to determine whether this had an impact on overall survival (OS). Methods: In this retrospective, single-center study, all adult patients diagnosed with AML from August 2016–December 2017 were reviewed. Baseline characteristics, somatic mutations in the diagnostic bone marrow as detected by Next Generation Sequencing (NGS), and survival outcomes were analyzed. NGS panel was done in-house and could identify 94 genes. Patients were divided into favorable, intermediate, and poor risk groups based on cytogenetics, and molecular abnormalities using NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for AML, version 1.2018. Kaplan-Meier plots and Cox regression analyses were utilized. Results: A total of 105 AML patients were included; baseline characteristics and frequency of identified clinically significant (CS) mutations are described in the presentation. The FLT3 mutation occurred in the highest frequency (22%) followed by DNMT3A & ASXL1 (15%). 17 (16%) patients were favorable risk, 33 (31%) intermediate risk, and 55 (52%) were poor risk. 67.6% of patients were male, and the median age was 64 (20–79) years. There was a difference in the number of CS mutations between the intermediate risk group and favorable risk group (P=.007), but not between the favorable risk and poor risk groups (P=.221) or between the intermediate risk group and poor risk group (P=.093). Increased number of CS mutations (≥ 5) was seen with equal frequency across risk groups and predicted for shorter overall survival in both univariate (HR=2.80; P=.039) and by multivariate Cox regression analysis (P=.001) independently from assigned risk group. There were no differences in age, gender, smoke, geographic, and different risk groups by multivariate analyses. Conclusion: Our study shows that ≥ 5clinically significant somatic mutations were associated with adverse outcomes and decreased survival, independent of risk groups and induction regimen. Thus, it may be a useful prognostic factor. This finding needs to be validated using a larger sample size.

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Ahmed Abdalla, Amr Aref, Amer Alame, Mohamad Barawi, Danny Ma and Zyad Kafri

Background: The National Comprehensive Cancer Network (NCCN) Guidelines recently recognized total neoadjuvant therapy (TNT) as an acceptable option in patients with T3 and any N rectal cancer. Previous studies suggested that patients who received chemotherapy prior to conventional preoperative chemoradiation (CRT) and surgery allowed patients to receive more of their planned treatment with a better toxicity profile and increase in pathological response. However, those studies used a long course of FOLFOX or used capecitabine and oxaliplatin as an induction regimen. We are conducting a phase 2 prospective clinical trial to evaluate the use of 6 cycles of FOLFOX as TNT in patients with T2-T3/N0-N+. Patients and Methods: Patients with T2-T3/N0-N+ enrolled on our phase 2 prospective trial were included for this analysis. Patients received 6 cycles of FOLFOX (infusional fluorouracil, leucovorin, and oxaliplatin), which was administered every 2 weeks. After 3 weeks of recovery period, patients then received conventional CRT with 5FU or capecitabine. All patients got MRI and endorectal ultrasound (ERUS) at baseline, after completing FOLFOX 3-months regimen and after finishing conventional CRT. Patients underwent either full-thickness local excision or total mesorectal resection depending on their tumor response to neoadjuvant therapy. The time interval between completion of radiation therapy and surgery ranged between 7and 12 weeks. Results: A total of 10 patients completed the chemotherapy and CRT treatment regimen. 9 patients proceeded to surgery and the 10th patient is scheduled for surgery. Clinical downstaging by MRI or ERUS was shown in 9 of 10 patients with only 6 cycles of FOLFOX. Complete clinical response was achieved in 6 patients as evident by ERUS/MRI of the pelvis after 3 months of FOLFOX before CRT. Complete pathological response was found in 4 of 9 patients (44%). In addition, 4 other patients had significant albeit not complete pathological response. Conclusions: This study suggests that adding only 6 cycles of neoadjuvant FOLFOX before CRT improved clinical and pathological downstaging of T2-T3/N0-N+ rectal adenocarcinoma and may facilitate organ preservation surgery. This is strategy needs to be investigated in larger phase III trials to validate these findings.

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Nimesh Adhikari, Myo H. Zaw, Sriman Swarup, Anita Sultan, Upama Sharma, Wai P. Thi, Nay N. Yee, Khaing K. Htwe, Tun W. Naing and Kyaw Z. Thein

Background: Bruton’s tyrosine kinase (BTK), a kinase downstream of the B-cell receptor, involves in the B cell survival and proliferation and has become an attractive therapeutic target. Ibrutinib is an oral potent, covalent inhibitor of BTK and hence employed in many hematologic malignancies. We performed a systematic review and pooled analysis of randomized controlled trials (RCTs) to determine the risk of atrial fibrillation (AF) and pulmonary toxicities among patients treated with ibrutinib. Methods: We performed a comprehensive literature search using MEDLINE, EMBASE databases, and meeting abstracts through September 2018. Phase 3 RCTs that mention AF and pulmonary toxicities as adverse effects were incorporated in the analysis. Mantel-Haenszel method was used to calculate the estimated pooled risk ratio with 95% CI. Random effects model was applied. Results: 4 phase III RCTs with a total of 1,383 patients with chronic lymphocytic leukemia or small lymphocytic lymphoma were eligible. Studies comparing Ibrutinib (I) vs ofatumumab, I vs chlorambucil, I+ bendamustine (B)+ rituximab (R) vs placebo + B+ R, and I vs R were included in the analysis. The AF incidence was 41 (5.686%) in the ibrutinib group vs 8 (1.208%) in the control arm. The relative risk (RR) for AF was statistically significant at 3.825 (95% CI: 1.848–7.917; P<.0001) and RD was 0.041 (95% CI: 0.023–0.059; P<.0001). The RR of all-grade side effects was as follows: cough, 1.133 (95% CI: 0.724–1.773; P=.584); edema, 1.375 (95% CI: 0.943–2.006; P=.098); pneumonia, 1.227 (95% CI: 0.884–1.703; P=.221); and upper respiratory infections (URI), 1.075 (95% CI: 0.809–1.429; P=.616). The RR of high-grade side effects was as follows: cough, 0.373 (95% CI: 0.063–2.209; P=.277); edema, 1.232 (95% CI: 0.199–7.649; P=.822); pneumonia, 1.277 (95% CI: 0.847–1.926; P=.243); and URI, 1.555 (95% CI: 0.239–10.127; P=.644). Conclusion: Our meta-analysis demonstrated that patients on ibrutinib noted a significant increase in the risk of atrial fibrillation with a relative risk of 3.825. However, the risk of pulmonary toxicities was not statistically increased in the ibrutinib group.