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PURPOSE: As the largest integrated health care system in the United States, the Veterans Health Administration (VA) is a leader in telehealth-delivered care. All 10 million Veterans cared for within the VA are eligible for telehealth. The VA cares for approximately 46,000 Veteran patients with newly diagnosed cancer and an estimated 400,000 prevalent cases annually. With nearly 38% of VA health care system users residing in rural areas and only 44% of rural counties having an oncologist, many Veterans lack local access to specialized cancer services. METHODS: We describe the VA's National TeleOncology (NTO) Service. NTO was established to provide Veterans with the opportunity for specialized treatment regardless of geographical location. Designed as a hub-and-spoke model, VA oncologists from across the country can provide care to patients at spoke sites. Spoke sites are smaller and rural VA medical centers that are less able to independently provide the full range of services available at larger facilities. In addition to smaller rural spoke sites, NTO also provides subspecialized oncology care to Veterans located in larger VA medical facilities that do not have subspecialties available or that have limited capacity. RESULTS: As of fiscal year 2021, 23 clinics are served by or engaged in planning for delivery of NTO and there are 24 physicians providing care through the NTO virtual hub. Most NTO physicians continue to provide patient care in separate traditional in-person clinics. Approximately 4,300 unique Veterans have used NTO services. Approximately half (52%) of Veterans using NTO lived in rural areas. Most of these Veterans had more than one remote visit through NTO. CONCLUSION: NTO is a state-of-the-art model that has the potential to revolutionize the way cancer care is delivered, which should improve the experience of Veterans receiving cancer care.

PURPOSE Telegenetics services can expand access to guideline-recommended cancer genetic testing. However, access is often not distributed equitably to all races and ethnicities. We evaluated the impact of an on-site nurse-led cancer genetics service in a diverse Veterans Affairs Medical Center (VAMC) oncology clinic on likelihood of germline testing (GT) completion. METHODS We conducted an observational retrospective cohort study of patients who were referred for cancer genetics services at the Philadelphia VAMC between October 1, 2020, and February 28, 2022. We evaluated the association between genetics service (on-site v telegenetics) and likelihood of GT completion in a subcohort of new consults, excluding patients with prior consults and those referred for known history of germline mutations. RESULTS A total of 238 Veterans, including 108 (45%) seen on site, were identified for cancer genetics services during the study period, with the majority referred for a personal (65%) or family (26%) history of cancer. In the subcohort of new consults, 121 Veterans (54% self-identified race/ethnicity [SIRE]-Black), including 60 (50%) seen on site, were included in the analysis of germline genetic testing completion. In a univariate analysis, patients who were seen by the on-site genetics service had 3.2-fold higher likelihood of completing GT (relative risk, 3.22; 95% CI, 1.89 to 5.48) compared with the telegenetics service. In multivariable regression analysis, the on-site genetics service was associated with higher likelihood of GT completion, but this association was only statistically significant in SIRE-Black compared with SIRE-White Veterans (adjusted RR, 4.78; 95% CI, 1.53 to 14.96; P < .001; P-interaction of race × genetics service = .016). CONCLUSION An on-site nurse-led cancer genetics service embedded in a VAMC Oncology practice was associated with higher likelihood of germline genetic testing completion than a telegenetics service among self-identified Black Veterans.

PURPOSE Increasing utilization of comprehensive genomic profiling (CGP) and a growing number of targeted agents (TAs) have led to substantial improvements in outcomes among patients with cancer with actionable mutations. We sought to evaluate real-world experience with off-label TAs among Veterans who underwent CGP. METHODS The National Precision Oncology Program database and VA Corporate Data Warehouse were queried to identify patients who underwent CGP between February 2019 and December 2021 and were prescribed 1 of 73 TAs for malignancy. OncoKB annotations were used to select patients who received off-label TAs based upon CGP results. Chart abstraction was performed to review response, toxicities, and time to progression. RESULTS Of 18,686 patients who underwent CGP, 2,107 (11%) were prescribed a TA and 169 (0.9%) were prescribed a total of 183 regimens containing off-label TAs for variants in 31 genes. Median age was 68 years and 83% had prior systemic therapy, with 28% receiving three or more lines. Frequency of off-label TA prescriptions was highest for patients undergoing CGP for thyroid (8.6%) and breast (7.6%) cancers. Most patients harbored alterations in BRCA1/BRCA2/ATM (22.5%), ERBB2 (19.5%), and BRAF (19.5%). Among the 160 regimens prescribed > 4 weeks, 43 (27%) led to response. Median progression-free survival and overall survival were 5.3 (4.2-6.5) and 9.7 (7.5-11.9) months, respectively. Patients with OncoKB level 2/3A/3B annotations had longer median progression-free survival (5.8 [4.5-7] months v 3.7 [1.6-7.7] months; hazard ratio, 0.45; 95% CI, 0.24 to 0.82; P = .01) compared with those receiving level 4 treatments. CONCLUSION Although administration of off-label TAs is infrequent after CGP, more than one quarter of treatment regimens led to response. TAs associated with level 4 annotations lead to worse outcomes than TAs bearing higher levels of evidence.

PURPOSEAdvances in precision oncology, including RAS testing to predict response to epidermal growth factor receptor monoclonal antibodies (EGFR mAbs) in colorectal cancer (CRC), can extend patients’ lives. We evaluated uptake and clinical use of KRAS molecular testing, guideline recommended since 2010, in the Veterans Affairs Healthcare System (VA).MATERIALS AND METHODSWe conducted a retrospective cohort study of patients with stage IV CRC diagnosed in the VA 2006-2015. We gathered clinical, demographic, molecular, and treatment data from the VA Corporate Data Warehouse and 29 commercial laboratories. We performed multivariable analyses of associations between patient characteristics, KRAS testing, and EGFR mAb treatment.RESULTSAmong 5,943 patients diagnosed with stage IV CRC, only 1,053 (17.7%) had KRAS testing. Testing rates increased from 2.3% in 2006 to 28.4% in 2013. In multivariable regression, older patients (odds ratio, 0.17; 95% CI, 0.09 to 0.32 for ≥ age 85 v < 45 years) and those treated in the Northeast and South regions were less likely, and those treated at high-volume CRC centers were more likely to have KRAS testing (odds ratio, 2.32; 95% CI, 1.48 to 3.63). Rates of potentially guideline discordant care were high: 64.3% (321/499) of KRAS wild-type (WT) went untreated with EGFR mAb and 8.8% (401/4,570) with no KRAS testing received EGFR mAb. Among KRAS-WT patients, survival was better for patients who received EGFR mAb treatment (29.6 v 18.8 months; P < .001).CONCLUSIONWe found underuse of KRAS testing in advanced CRC, especially among older patients and those treated at lower-volume CRC centers. We found high rates of potentially guideline discordant underuse of EGFR mAb in patients with KRAS-WT tumors. Efforts to understand barriers to precision oncology are needed to maximize patient benefit.

PURPOSE: Next-generation sequencing (NGS) gene panels are frequently completed for patients with advanced non–small-cell lung cancer (NSCLC). Patients with highly actionable gene variants have improved outcomes and reduced toxicities with the use of corresponding targeted agents. We sought to identify barriers to targeted agent use within the Veterans Health Affairs' National Precision Oncology Program (NPOP). METHODS: A retrospective evaluation of patients with NSCLC who underwent NGS multigene panels through NPOP between July 2015 and February 2019 was conducted. Patients who were assigned level 1 or 2A evidence for oncogenic gene variants by an artificial intelligence offering (IBM Watson for Genomics [WfG]) and NPOP staff were selected. Antineoplastic drug prescriptions and provider notes were reviewed. Reasons for withholding targeted treatments were categorized. RESULTS: Of 1,749 patients with NSCLC who successfully underwent NGS gene panel testing, 112 (6.4%) patients were assigned level 1 and/or 2A evidence for available targeted treatments by WfG and NPOP staff. All highly actionable gene variants were within ALK, BRAF, EGFR, ERBB2, MET, RET, and ROS1. Of these, 36 (32.1%) patients were not prescribed targeted agents. The three most common reasons were (1) patient did not carry a diagnosis of metastatic disease (33.3%), (2) treating provider did not comment on the NGS results (25.0%), and (3) provider felt that patient could not tolerate therapy (19.4%). No patients were denied access to level 1 or 2A targeted drugs because of rejection of a nonformulary drug request. CONCLUSION: A substantial minority of patients with NSCLC bearing highly actionable gene variants are not prescribed targeted agents. Further provider- and pathologist-directed educational efforts and implementation of health informatics systems to provide real-time decision support for test ordering and interpretation are needed.

PURPOSE There are growing efforts to integrate patient-reported outcome (PRO) data into electronic health records (EHRs) to bring together disparate sources of patient information and improve medical care. PRO measures can be used to assess cancer symptom presence and severity. Integrating PRO tools in EHRs can alert providers to address symptoms, which is an essential component of comprehensive oncology care. METHODS We modified a PRO used to measure cancer and end-of-life symptoms, the Edmonton Symptom Assessment System to create the Veteran Symptom Assessment System (VSAS). VSAS was implemented as an integrated PRO as part of the Veterans Administration EHR system and was used at hematology-oncology clinics in Veteran Administration (VA) medical centers in the Southeast. RESULTS From 2013 to 2014, VSAS was introduced, underwent usability testing and modifications, and was finally implemented in the EHR. Between 2015 and 2019, VSAS was administered 43,883 times in 9,058 patients. Eighty-nine percent of Veterans were male, 11% were female, 52% identified as non-Hispanic White, and 43% identified as African American. Fatigue, shortness of breath with exertion, and pain were most frequently reported initially (68%, 48%, and 45%, respectively) and were most frequently rated as severe (27%, 16%, and 17%, respectively). In patients diagnosed with stage IV cancer, higher symptom burden was significantly associated with shorter overall survival. The majority of Veterans with longitudinal measurements experienced improvement in symptoms, most frequently in severe symptoms. CONCLUSION To our knowledge, this is the first large-scale implementation of a PRO system, integrated in the VA EHR, in ambulatory patients with cancer and blood disorders. The integration of VSAS within the VA EHR is a significant demonstration and a necessary requirement for current and future systemic initiatives in cancer symptom management.

PURPOSE Poly ADP-ribose polymerase inhibitors (PARPi) are used for patients with advanced prostate cancer bearing alterations in homologous recombination repair (HRR) genes. We sought to characterize HRR gene variants and describe real-world outcomes for patients on PARPi. METHODS The US Department of Veterans Affairs’ National Precision Oncology Program’s database was reviewed to identify patients who underwent somatic DNA sequencing and were prescribed a PARPi before May 15, 2020. Somatic and germline variants within HRR genes were reported, and pathogenicity was reviewed via OncoKB. In patients treated with PARPi for > 4 weeks, the rate of those achieving a 30% decrease in prostate-specific antigen (PSA30) and composite progression-free survival (PFS) were compared between patients bearing pathogenic variants of BRCA2 and patients without these variants using Mann-Whitney and log-rank tests, respectively. RESULTS Forty-eight patients bearing 67 total HRR gene variants were prescribed PARPi for prostate cancer. Twenty-one patients (43.8%) were found to have at least one pathogenic HRR gene variant. Eight (16.6%) were referred to genetic counseling, and five (10.4%) were ultimately confirmed with germline variants. The median PFS was 4.0 months, and PSA30 was 25.6% (11 of 43) for all 43 evaluable patients. Patients with pathogenic BRCA2 variants (n = 13) had higher PSA30 (69.2% v 4.0%; P < .001) and longer PFS (7.2 v 2.8 months; P = .0291) than those without. CONCLUSION In a real-world setting, heavily pretreated patients with prostate cancer and pathogenic BRCA2 variants have a significant PSA response rate and a PFS > 7 months with PARPi. This work emphasizes the importance of determining pathogenicity and origin of HRR alterations to better inform clinical treatment decisions and highlights the need for provider education and other decision support tools.

PURPOSE Next-generation sequencing (NGS) multigene panel testing has become widespread, including the Veterans Affairs (VA), through the VA National Precision Oncology Program (NPOP). The interpretation of genomic alterations remains a bottleneck for realizing precision medicine. We sought to examine the concordance for pathogenicity determination and clinical actionability of annotation services in NPOP. METHODS Unique gene variants were generated from NGS gene panel results using two sequencing services. For each unique gene variant, annotations were provided through N-of-One (NoO), IBM Watson for Genomics (WfG), and OncoKB. Annotations for pathogenicity (all three sources) and actionability (WfG and OncoKB) were examined for concordance. Cohen’s kappa statistic was calculated to measure agreement between annotation services. RESULTS Among 1,227 NGS results obtained between 2015 and 2017, 1,388 unique variants were identified in 117 genes. The genes with the largest number of variants included TP53 (270), STK11 (92), and CDKN2A (81). The most common cancer type was lung adenocarcinoma (440), followed by colon adenocarcinoma (113). For pathogenic and likely pathogenic variants, there was 30% agreement between WfG and NoO (kappa, −0.26), 76% agreement between WfG and OncoKB (kappa, 0.22), and 42% agreement between NoO and OncoKB (kappa, −0.07). For level 1 drug actionability of gene variant–diagnosis combinations, there was moderate agreement between WfG and OncoKB (96.9%; kappa, 0.44), with 27 combinations identified as level 1 by both services, 58 by WfG alone, and 6 variants by OncoKB alone. CONCLUSION There is substantial variability in pathogenicity assessment of NGS variants in solid tumors by annotation services. In addition, there was only moderate agreement in level 1 therapeutic actionability recommendations between WfG and OncoKB. Improvement in the precision of NGS multigene panel annotation is needed.

PURPOSE The Veterans Health Administration (VHA) is the largest cancer care provider in the United States, with the added challenge of serving more than twice the percentage of patients with cancer in rural areas than the national average. The VHA established the National Precision Oncology Program in 2016 to implement and standardize the practice of precision oncology across the diverse VHA system. METHODS Tumor or peripheral blood specimens from veterans with advanced solid tumors who were eligible for treatment were submitted for next-generation sequencing (NGS) at two commercial laboratories. Annotated results were generated by the laboratories and independently using IBM Watson for Genomics. Levels-of-evidence treatment recommendations were based on OncoKB criteria. RESULTS From July 2016 to June 2018, 3,698 samples from 72 VHA facilities were submitted for NGS testing, of which 3,182 samples (86%) were successfully sequenced. Most samples came from men with lung, prostate, and colorectal cancers. Thirty-four percent of samples were from patients who lived in a rural area. TP53, ATM, and KRAS were among the most commonly mutated genes. Approximately 70% of samples had at least one actionable mutation, with clinical trials identified as the recommended option in more than 50%. Mutations in genes associated with a neuroendocrine prostate cancer phenotype were expressed at increased frequency among veterans than in the general population. The most frequent therapies prescribed in response to NGS testing were immune checkpoint inhibitors, EGFR kinase inhibitors, and PARP inhibitors. CONCLUSION Clinical implementation of precision oncology is feasible across the VHA health care system, including rural sites. Veterans have unique occupational exposures that might inform the nature of the mutational signatures identified here. Importantly, these results underscore the importance of increasing clinical trial availability to veterans.

394 Background: TeleOncology encompasses the delivery of care virtually though modalities such as electronic consultation (e-consult), telephone and video visits. The National TeleOncology (NTO) program was created by Veterans Affairs (VA) to address growing disparities in care across the VA network. Through NTO, subspecialty hematologists/oncologists can provide recommendations and care for patients located at VA centers across the county. We aimed to investigate differences in patient utilization of available forms of TeleOncology. Methods: NTO was started in 2020 and offers virtual care to over 20 VA sites. Patient visits were catalogued across different forms of TeleOncology including telephone, e-consult (chart review only), VA Video Connect (VVC, synchronous video visit with patient at home), and Clinical Video Telehealth (CVT, synchronous video visit with patient at local VA). Total and unique patient encounters were analyzed based on patient age, gender, race, care assessment need (CAN) score (predictor for identifying patients at high-risk for poor outcomes), and patient rurality. Modalities of telehealth were then compared. Results: 3008 unique patients and 5921 encounters were recorded (October 2019-May 2022). The majority of patients accessed care by CVT visit (n = 1915). Patient characteristics were statistically different between the modes of TeleOncology. Patients participating in CVT were older (Mean 70.5 (95% CI 69.97-70.97) vs 65.5 years old (95% CI 64.62-66.68) and had higher CAN scores (mean score 82 (95% CI 80.96-82.74) vs 69 (95% CI 66.76-70.74)), compared to patients assessed through e-consult. Conversely black and female patients were overrepresented in the e-consult group compared to the CVT group (Table). Patients receiving care by telephone were more often located in a rural or highly rural region compared to those seen through VVC (71.5% vs 52%). Conclusions: The NTO program offers unique insights into utilization patterns of different forms of virtual care. Patient characteristics were not similar across the e-consult, telephone, and video visit groups. Importantly racial and gender disparities were noted, with African American and female patients, being disproportionately cared for through chart review only compared to a video visit. These results represent a first step in understanding how patients’ interface with virtual care modalities. Future studies could investigate how patient and system factors might influence observed patterns.[Table: see text]

385 Background: Since the onset of COVID-19, oncology practices across the U.S. have integrated telemedicine (TM) and remote patient monitoring (RPM) into routine care and clinical trials. However, the extent of provider experience and comfort with TM/RPM in treatment trials is unknown. In this study, we surveyed oncology researchers to assess experience and comfort with TM/RPM. Methods: Between April 10 and June 1, 2022, we distributed email surveys to U.S.-based members of the American Society of Clinical Oncology (ASCO) whose member records indicated an interest or specialization in clinical research. We collected respondent demographic data, clinical trial experience, and workplace characteristics, as well as frequency and impression of TM/RPM use across trial components in phase 1, phase 2/3, and post-treatment trials. TM/RPM was defined as clinical trial-related health care and monitoring for patients geographically separated from the site administering the clinical trial. Results: There were 141 respondents. 53% identified as female. 39% were under 45 years old, and 25% were over 60. 70% identified as White. 90% were site or study PIs. 98% practiced in a non-rural site. Most respondents had enrolled patients on industry-sponsored trials (97%), NCI-sponsored trials (84%), and investigator-initiated trials (83%), across Phase 1 (92%), Phase 2/3 (100%), and post-approval trials (75%). About 41% of respondents had >20 years of trial experience. Regarding remote care in treatment trials, 75% reported using TM, RPM, or both. Among these individuals, 62% had never provided remote care to trial patients before the pandemic. For Phase 2/3 trials, while > 75% of respondents expressed comfort (C) using TM/RPM for some trial components, the corresponding experience (E) in these areas was lower. Specifically for Phase 2/3 trials, comfort levels exceeded experience for pre-screening (C = 91% vs. E = 47%), education and counseling (C = 95% vs. E = 52%), informed consent (C = 79% vs. E = 30%), routine lab testing (C = 81% vs. E = 37%), symptom monitoring for adverse events (C = 88% vs. E = 55%), PROs in real time (C = 87% vs. E = 20%), PROs as a study endpoint (C = 89% vs. E = 27%), and long-term outcome monitoring (C = 90% vs. E = 47%). Notably, 60% of respondents ranked patient access as the top advantage of providing TM/RPM in treatment trials. Top disadvantages included limited ability to monitor patients (34%) and disparities in patient technology access (23%). More than a quarter of respondents identified the top barrier to use of TM/TPM as trial regulations (29%) or cross-state licensure challenges (27%). Conclusions: COVID-19 spurred the rise of TM/RPM in cancer treatment trials. Among oncology researchers, higher levels of comfort compared to real-world experience with TM/RPM reveal opportunities for expanding TM/RPM policies and guidelines in oncology research.

e17031 Background: Liquid biopsy with plasma circulating tumor DNA (ctDNA) is a noninvasive alternative to tissue genomic profiling. The yield of ctDNA is largely dependent upon the total amount and proportion of ctDNA in the total circulating DNA pool. Factors that predict successful genomic profiling via liquid biopsy amongst Veterans with prostate cancer are unknown. Methods: 764 veterans with prostate cancer who received liquid biopsy testing between February 2019-2021 were selected from the VA National Precision Oncology Program (NPOP) database. Baseline patient variables including age at specimen collection date, race, PSA, PSA doubling time (PSADT), sites of metastatic involvement (i.e., bone, brain, liver, lung, and lymph nodes), number of metastatic sites, Gleason score, and Gleason grade group were extracted from the VA Corporate Data Warehouse (CDW). Two independent approaches were used to define a successful liquid biopsy: Approach 1: Liquid biopsies with an alteration detected in one or more prostate cancer related genes ( AR, CDK12, SPOP, MED12, CCND1, BRAF, AKT1, TMPRSS2) (n = 337); Approach 2: Liquid biopsies with alterations detected in any gene detected by the Foundation One Liquid CDx assay (n = 670). We performed univariate and multivariate logistic regression analysis for Odds Ratio (OR), 95% confidence interval (CI), and conducted statistical significance tests to investigate associations between clinical factors and liquid biopsy test outcome. P-value < 0.05 was considered significant. Results: In Approach 1, the OR by univariate analysis was 4.80 (P < 0.001; 95% CI [3.09, 7.47]) for 4th PSA quantile group versus 1st PSA quantile group. The OR was 3.61 (P < 0.001; 95% CI [2.0, 6.5]) for PSADT less than 3 months versus PSADT more than 60 months; brain metastasis had the highest OR value among metastatic sites of 2.47 (P = 0.008; 95% CI [1.27. 4.8]). In multivariate analysis, PSA, PSADT and sites of metastasis remained significant risk factors. Statistical significance tests indicated PSA, PSADT, and sites of metastasis were significantly different between the success and failure groups. In Approach 2, no statistically significant associations were observed between the studied variables and any outcome. Conclusions: Factors such as PSA, PSADT, and metastatic site were significantly associated with a successful liquid biopsy of detecting prostate cancer related gene mutations, while the outcome of detecting any gene mutations was not statistically significant associated with studied variables in this study population. Given the likelihood that a significant number of non-prostate cancer mutations are likely due to clonal hematopoiesis, this finding is expected. Our findings may facilitate clinical decisions around genomic profiling by liquid biopsies in the absence of tumor tissue, thereby increasing the success rate of sequencing efforts for treatment selection.

3534 Background: Clinical trials have demonstrated improvements in survival with immune checkpoint inhibitors (ICIs) for advanced colorectal cancer patients with MSI-H/dMMR detected using PCR-based assays (PCR) or immunohistochemistry (IHC), respectively. MSI-H can also be assessed by next-generation sequencing (NGS). Evaluation of real-world outcomes among MSI-H patients by NGS treated with ICIs are warranted, particularly when results are discordant between these tests. Methods: The VA National Precision Oncology Program Database was accessed to select veterans with colorectal cancer and an MSI-H biomarker by NGS. Baseline patient variables, disease characteristics, and duration of ICI treatment were obtained from the VA’s Corporate Data Warehouse. Concordance between NGS and IHC or PCR testing was computed, and the response rate and duration of ICI treatment in patients with discordant test results were recorded from chart review. Results: Among 1,276 colorectal cancer patients, 71 (5.6%) were found to have MSI-H by NGS. Of these, 22 (30.1%) received ICI. Among 49 patients who did not receive ICI, 36 had stage I-III disease, 5 had limited performance status, 5 were actively being treated with chemotherapy and 3 had completely resected stage IV disease. Of the 71 patients, 29 had dMMR IHC testing, 8 had MSI-H PCR testing, 1 had both IHC and PCR testing, and 34 patients had only NGS testing. No PCR tests were discordant with NGS but 8 of 29 IHC tests were discordant. Among these 8 patients with discordant IHC MMR and MSI-H by NGS, 5 received pembrolizumab. There were 3 partial responses, 1 stable disease and 1 progressive disease. Durable responses were seen with 3 of 5 patients remaining on therapy without progression at the time of this analysis at a median follow up of 8.5 months. Conclusions: In a cohort of NGS MSI-H colorectal cancer patients, there was a high rate of discordant IHC results. Clinical benefit is seen in patients treated with ICI with discordant testing results, suggesting that NGS testing identifies patients with false negative dMMR IHC testing in the real-world clinical setting.

e18676 Background: The increasing availability of comprehensive genomic profiling (CGP) and a growing number of targeted agents (TAs) has led to substantial improvements in outcomes among cancer pts with actionable mutations. CGP has led to identification of both on-label (level 1) variants, for which TAs have known efficacy, and off-label variants with lesser strength of supporting data. We sought to evaluate real-world prescription patterns and outcomes of off-label TA prescriptions among pts who underwent CGP. Methods: The NPOP database and VA Corporate Data Warehouse were queried to identify pts who had underwent CGP between February 2019 and December 2021 and were prescribed at least 1 of 73 TAs before January 2022. TAs prescribed for FDA-approved indications not relying on CGP as a companion diagnostic were excluded. OncoKB was used to annotate gene variants and evaluated against prescriptions to select pts who received off-label TAs. The frequency of off-label TA use, and for those treated > 4 weeks, rate of pts treated for 6 months or longer, median treatment duration and overall survival (OS) were computed. Results: Of the 18686 patients who underwent CGP, 2107 (11%) were prescribed any TA, and 191 (1%) were prescribed off-label TAs, with 31 receiving multiple concurrent or sequential off-label TAs. Mean age was 65.5 years, and 88% were male. TAs were most often prescribed for cancers of unknown primary (CUP, 29), NSCLC (24), and colorectal cancer (22). Frequency of off-label prescriptions was highest for pts who completed CGP for thyroid cancer (9%), breast cancer (8%), and CUP (2%). Most common variants involved BRAF (21%), ERBB2 (18%), BRCA1/BRCA2/ATM (9%), and PIK3CA (6%). Among all 164 pts treated > 4 weeks, 40% received TAs for 6 months or longer, including 50%, 47%, and 46% of pts bearing BRAF-, ERBB2-, and PIK3CA-mutant disease, respectively. Median therapy duration and OS was 141 [78.5 – 317, IQR] days and 181 [96.5 – 304.5, IQR] days, respectively. Conclusions: Though overall use of off-label TAs following CGP is low, nearly 10% of advanced thyroid and breast cancer patients are prescribed TAs for off-label indications. Forty percent of all pts receiving off-label TAs continue for at least 6 months, with higher rates for pts bearing BRAF-, ERBB2-, and PIK3CA-mutant disease. CGP-guided off-label treatment approaches offer unique options for advanced stage cancer with amenable molecular profiles.

186 Background: Distinct molecular subgroups of colorectal cancer (CRC) have been afforded with use of next-generation sequencing (NGS) as standard in clinical practice for advanced disease. We have previously demonstrated that disease bulk predicts clinical resistance to EGFR inhibition in RAS/RAF-wildtype (WT) CRC. We hypothesized bulky disease would predict advanced subclonal heterogeneity by circulating tumor DNA (ctDNA) in RAS/RAFWT CRC. Methods: Following IRB-approval, a retrospective review of molecular profiles in advanced CRC (n = 965) were compiled from the Veteran Administration’s (VA) National Precision Oncology Program (NPOP) and University of Wisconsin Precision Medicine Molecular Tumor Board (MTB). Disease bulk was defined as the longest diameter of metastatic disease or short axis for advanced lymphadenopathy. Molecular profiling was performed using commercially available platforms including Strata Oncology (MTB) and FoundationOne (NPOP). Bulky was compared as categorical (> 35 cm) and continuous variable against the count of pathologic variants. Results: The population was largely representative of advanced CRC with alterations in TP53 (80.5%), KRAS (44.8%), PIK3CA (22.0%) and BRAF (12.8%). Veterans had increased frequency of alterations in PIK3CA (22.7% v. 13.0%, p < 0.02) and BRAF (13.3% v. 6.9%, p < 0.05). There was no difference in metastatic bulk at the time of NGS for tissue biopsy between MTB and NPOP populations (t = 0.80). Disease bulk did not predict the number of pathologic variants from tissue sampling in RAS/RAFWT CRC (n = 96, t = 0.24). RAS/RAFMT cancers had increased frequency of subclonal alterations by ctDNA (9.1±4.0) v. RAS/RAFWT (4.5±3.4, p < 0.0001). Using ctDNA, bulky disease in RAS/RAFMT CRC was not predictive of increased pathologic variants (8.8±3.5 v. 9.5±4.8, t = 0.62). Bulky disease (> 35mm) in RAS/RAFWT CRC predicted increased subclonal variants (6.2±3.6 v. 3.5±2.9, p < 0.02). As a continuous variable, disease bulk predicted the number of pathologic variants in RAS/RAFWT CRC (R = 0.51). Conclusions: These data indicate that metastatic bulk is a predictor of subclonal heterogeneity by ctDNA in RAS/RAFWT CRC. Molecular profiling of tissue alone did not predict differences in subclonal heterogeneity when stratified by disease bulk in RAS/RAFWT CRC. Limited subclonal heterogeneity in non-bulky cancers support ongoing prospective investigations to select non-bulky cancers for early incorporation of anti-EGFR inhibition (NCT04587128).

12130 Background: Patients diagnosed with cancer are at an increased risk of adverse mental health outcomes including suicidal behavior. Suicide rates among Veterans are 50 percent greater than for non-Veteran US adults. To inform Veterans Affairs (VA) suicide prevention initiatives, it is important to understand associations between cancer and suicide risk among Veterans receiving VA healthcare from the Veterans Health Administration (VHA). Study aims were to assess associations between new cancer diagnoses and suicide among Veterans in VHA care to identify high risk diagnostic subgroups and risk-periods. Methods: We used a cohort study design, identifying 4,926,373 Veterans with VHA use in 2011 and either 2012 or 2013 and without a VHA cancer diagnosis in 2011. Incident cancer diagnoses, assessed between first VHA use in 2012-2013 and 12/31/2018, were characterized by subtype and stage using the VHA Oncology Raw Data. Data from the VA/Department of Defense Mortality Data Repository identified date and cause of death. Cox proportional hazards regression, accounting for time-varying cancer diagnosis, was used to evaluate associations between a new cancer diagnosis and suicide risk. An initial model adjusted for VHA regional network and patient age and sex. Cancer subtypes with significant associations with suicide were further assessed using a model that also adjusted for suicide attempts and mental health, tobacco use disorder, and other substance use disorder diagnoses in the prior year. Crude suicide rates following a new cancer diagnoses were calculated among Veterans with new diagnoses, 2012-2018 (N = 240,410). Rates were assessed up to 84 months following diagnosis. Results: On average, Veteran VHA users were followed for 6.0 years after their first VHA use in 2012-2013 and for 2.7 years following a new cancer diagnosis. Receipt of a new cancer diagnosis corresponded to a 43% (Adjusted Hazard Ratio [AHR] = 1.43, 95% CI: 1.29, 1.58) higher suicide risk, adjusting for covariates. The cancer subtype associated with the highest suicide risk was esophageal cancer (AHR = 5.93, 95% CI: 4.05, 10.51) and other significant subtypes included head and neck (AHR = 3.44, 95% CI: 2.65, 4.46) and lung cancer (AHR = 2.28, 95% CI: 1.79, 2.90). Cancer stages 3 (AHR = 2.29, 95% CI: 1.75, 3.01) and 4 (AHR = 3.45, 95% CI: 2.75, 4.34) at diagnosis were also positively associated with suicide risk. Suicide rates were highest in the first three months following a diagnosis (Rate = 128.3 per 100,000 person-years, 95% CI: 100.4, 161.6) and remained elevated through the first 12 months. Conclusions: Among Veteran VHA users, suicide risk was elevated following a new cancer diagnosis and was especially high in the initial 3 months. Additional screening and suicide prevention efforts may be warranted for VHA Veterans newly diagnosed with cancer, particularly among those diagnosed with esophageal, head and neck, or lung cancer or at stages 3 or 4.

e17033 Background: PARP inhibitors (PARPis) were approved by the FDA for the treatment of advanced prostate cancer (PC) among patients (pts) harboring mutations in genes responsible for homologous DNA repair. Increasing evidence has suggested that pts with BRCA2 gene alterations may derive the most benefit from these drugs. Study objectives were to evaluate real-world treatment outcomes among Veterans prescribed PARPis for PC and to compare outcomes between pts with BRCA2 gene variants and those with variants in other homologous DNA repair genes. Methods: The U.S. Department of Veterans Affairs (VA) National Precision Oncology Program database was reviewed to identify PC pts who successfully underwent tumor DNA sequencing and were prescribed olaparib, rucaparib, niraparib or talazaporib prior to FDA approval for PARPi use in PC (May 15, 2020). Only pts who received a PARPi for > 4 weeks were included in outcome assessments The VA’s Corporate Data Warehouse was reviewed to obtain clinical and disease characteristics, laboratory and imaging reports, and treatments administered. Assessed outcomes included PSA30, defined as the percentage of pts achieving 30% reduction in prostate-specific antigen (PSA) level, and composite progression-free survival (PFS), which included time to radiographic progression per RECIST criteria, discontinuation of therapy, and/or death. Pts who discontinued therapy due to toxicity were censored for PFS analyses. PSA30 and PFS were compared between pts bearing BRCA2 gene variants and those with variants in other homologous DNA repair genes using t-testing and log-rank testing, respectively. Results: 48 pts were prescribed a PARPi for PC; 43 (89.6%) received therapy for > 4 weeks. BRCA2 gene variants (43.8%) were most commonly observed followed by ATM (23.0%) and BRCA1 (16.7%). Forty-two pts (87.5%) received prior systemic therapy beyond androgen deprivation. Forty (83.3%) pts received olaparib, 6 (12.5%) received rucaparib, and 2 (4.2%) received both. Eleven (22.9%) discontinued therapy due to toxicity, with anemia being most common toxicity. Of the 43 pts treated for > 4 weeks, pts with BRCA2 variants had a higher rate of PSA30 than those without (47.9% vs. 4.5%; p = 0.004). The median PFS for all pts was 4.0 months. Pts with BRCA2 gene variants had longer PFS than those without BRCA2 gene variants (7.2 vs 3.3 months; p = 0.037). Pts with BRCA2 gene variants also had longer PFS than those with BRCA1 variants (7.2 vs 3.3, p = 0.031). No difference was observed in PFS between those with BRCA2 variants and those with ATM variants ( p = 0.51). Conclusions: Approximately one-quarter of PC pts with variants in homologous DNA repair genes treated with PARPis achieve a 30% reduction in PSA, and the median PFS is 4 months. Pts harboring BRCA2 gene variants have a significantly higher rate of PSA30 and a longer PFS than those with variants in other homologous DNA repair genes.

11029 Background: Genetic testing has become essential to delivery of cancer treatment, risk assessment, surveillance, and prevention. We sought to understand the use of genetic tests by clinicians in the Department of Veterans Affairs (VA). Methods: We administered a web-based survey to clinicians at 20 VA facilities with precision oncology programs. We excluded respondents if they were: not at one of the 20 VA facilities; not seeing patients in VA; not a physician, nurse practitioner (NP), physician assistant (PA), or pharmacist; a medical geneticist or specialty was not reported; or if the survey was incomplete. Using multiple logistic regression, we assessed the association between genetic test ordering, genetics referral, and clinician characteristics. Results: There were 909 (909/11,442, 8%) eligible respondents with 61% women and 64% under age 55. There were 571 physicians (63%), 200 NPs (22%), 93 pharmacists (10%), and 45 PAs 5(%). There were 361 (40%) primary care providers (PCPs), 90 (10%) cancer specialists, and 458 (50%) non-cancer specialists. Only 21% of clinicians reported feeling prepared to use genetic tests in their practice. In the past year, only 8% had ordered at least one multi-gene cancer test (germline, tumor or both), 12% a pharmacogenetic test, and 0.2%, an exome. Compared to physicians, NPs were 60% less likely (OR = 0.42, 0.23-0.77, p = 0.005), pharmacists, 80% less likely (OR = 0.22, 0.08-0.62, p = 0.005), and PAs, 90% less likely (OR = 0.08, 0.01-0.58, p = 0.01) to have ordered a genetic test. Compared to PCPs, cancer specialists were almost 5 times more likely to order a genetic test (OR = 4.74, 2.57-8.73, p < 0.0001); there was no difference in genetic test ordering between PCPs and non-cancer specialists. Among clinicians (n = 72) who had ordered cancer genetic tests, only about two-thirds were confident in knowing the indications for testing; discussing the potential benefits, harms and limitations of testing; understanding the test report; and knowing implications of results on disease management and prevention. Clinicians (n = 106) who had ordered pharmacogenetic tests had lower frequencies of confidence in these tasks. About half (52%) of the cancer specialists had referred patients to genetics in the past year; they were 1.8 times more likely than PCPs to refer (OR = 1.82, 1.10-3.03, p = 0.02), and non-cancer specialists were about 50% less likely than PCPs to refer (OR = 0.46, 0.33-0.64, p < 0.0001). Conclusions: In the VA, cancer specialists are integrating genetic testing and genetics referral into their practice more than PCPs and other specialists. However, genetic testing is underutilized, and many clinicians remain unprepared to use genetic tests in their practice. These results will inform workforce planning, clinician education, and development of clinical decision support to facilitate genetic risk assessment, informed consent, and ordering of genetic tests.

2005 Background: Next-Generation Sequencing (NGS) gene panels are often completed to guide therapeutic decisions for patients with advanced stage non-small cell lung cancer (NSCLC). Patients with highly-actionable gene variants may experience improved therapeutic treatments and reduced toxicities with use of targeted agents. Ensuring appropriate prescription of targeted therapies is therefore of high importance. We sought to identify barriers to targeted agent use within the Veterans Health Affairs’ (VHA) National Precision Oncology Program (NPOP). Methods: A retrospective evaluation examined the cohort of NSCLC patients who underwent NGS multi-gene panels through NPOP between July 2015 and February 2019. A level of evidence for drug actionability was assigned to each observed oncogenic gene variant using an artificial intelligence offering (IBM Watson for Genomics: WfG). WfG level 1 and 2A evidence was reviewed by NPOP staff to exclude gene variants that did not conform to NPOP level 1 and 2A definitions. Anti-neoplastic drug prescriptions and oncology provider notes were obtained for all included patients from the VHA Corporate Data Warehouse. Review of clinical notes of patients who did not receive targeted agents was performed to categorize the reason(s). Results: Of 1764 NSCLC patients who successfully underwent NGS gene panel testing, 156 (8.9%) received therapeutic level 1 (7.3%) or 2A (1.6%) options for targeted agents based on WfG evidence analysis. In total, 117 (6.6%) patients had NPOP level 1 and 2A gene variants, all within ALK, BRAF, EGFR, ERBB2, MET, and RET. Of these, 49 (41.2%) patients were not prescribed available targeted agents. The three most common reasons were: (1) treating provider did not comment on NGS results (30.7%), (2) patient did not carry a diagnosis of advanced stage disease (18.4%), and (3) patient had begun an alternative systemic therapy prior to completion of sequencing (16.3%). No patient was denied access to a level 1 or 2A targeted drug due to utilization-management review. Conclusions: A substantial minority of patients with advanced NSCLC bearing highly-actionable gene variants are not prescribed available targeted agents. Further provider- and pathologist-directed educational effort are needed, as well as implementation of health informatics systems to provide near real-time decision support for test ordering and interpretation.

e19295 Background: Immunotherapy (IO) has revolutionized the treatment paradigm for patients with advanced non-small cell lung cancer (NSCLC). Study objectives were to evaluate utilization of IO as first-line (1L) therapy and compare clinical characteristics between patients receiving IO and those receiving CT in 1L setting. Methods: Using the U.S. Department of Veterans Affairs corporate data warehouse, patients with stage IV NSCLC diagnosed 2012-2017 and initiated non-targeted systemic therapy within 120 days of diagnosis were selected. Unadjusted descriptive statistics were used to compare patient characteristics, inpatient and outpatient clinic visits, and prevalence of select adverse events (AE) between patients receiving IO monotherapy and CT. Kaplan-Meier and Cox regression approaches with and without propensity score matching (PSM) were used for overall survival (OS) analyses. OS was calculated from treatment initiation date to death or end of study period in June 2019. Results: 4609 patients were included in the analysis: 3.4% (n = 156) received IO monotherapy, 96% (n = 4426) received CT, and 0.6% (n = 27) received IO+CT (IO+CT not included in analysis). IO patients were older than CT patients (median age 69 vs. 66 years, p < 0.0001) and more frequently resided in the Midwest and West regions whereas CT patients were more likely to live in the Northeast and South (p = 0.0024). There were no significant differences in IO and CT by other demographic and clinical characteristics. Estimated median OS was 7.5 months (95% CI 7.2-7.7) for CT and 7.9 months (95% CI 5.3-12.6) for IO patients. The unadjusted HR for IO compared to CT patients was 0.81 (95% CI 0.67-0.98). With 1:4 PSM (144 and 559 patients matched in the IO and CT groups, respectively), the HR was 0.75 (95% CI 0.60-0.93). The mean number of outpatient visits for IO and CT patients were 47 and 36, respectively (p = 0.003). No difference in number of hospitalizations or length of hospital stays between the two groups was observed. Common AEs in the IO group were dyspnea (58%), colitis/enterocolitis (42%), and anemia (30%). Common AEs among CT patients were colitis/enterocolitis (36%), anemia (32%), and nausea/vomiting (31%). Conclusions: In a real-world 1L setting among veterans with NSCLC, improvement in OS was observed among patients receiving IO monotherapy compared to those receiving CT, and IO patients had a greater number of outpatient visits. Continued assessment of treatment patterns and impact of IO are needed as the use of IO continues to expand.

7075 Background: Tumor profiling identifies patients who are eligible for targeted anticancer therapies. Common tumor profiling approaches include targeted gene panel testing (TGPT), which tests for common mutations in select genes, and multigene panel sequencing (MGPS), which tests for a broad range of mutations in a comprehensive set of genes. Our objective was to determine the lifetime cost-effectiveness of MGPS and TGPT compared to no tumor profiling for Veterans with metastatic lung adenocarcinoma from the Veterans Health Administration’s (VHA) perspective. Methods: A decision analytic model was developed to simulate outcomes for a closed cohort of hypothetical Veterans with metastatic lung adenocarcinoma considering anticancer therapy. OncoKB genes with levels of evidence 1 and 2 for guiding therapy were included. Three profiling strategies were studied: TGPT ( ALK, EGFR, ROS1), MGPS ( ALK, BRAF, EGFR, HER2, MET, NTRK1, NTRK2, NTRK3, RET, ROS1), and no tumor profiling. We assumed 95% of patients with actionable mutations received targeted therapies. Non-targeted therapy options included chemotherapy and/or immunotherapy, and no anticancer therapy. Model inputs were derived from randomized trials (progression-free survival), VHA and Medicare (drug costs), published studies (non-drug cancer-related management costs, health care utilities), and VHA National Precision Oncology Program and cBioPortal for Cancer Genomics databases (mutation prevalence). Costs (2019 US$) and quality-adjusted life years (QALYs) were discounted at 3%/year. Base-case scenario, one-way sensitivity analyses, and probabilistic sensitivity analyses (PSA) using 1,000 Monte Carlo simulations were completed. Results: Base-case results and corresponding 95% credible intervals from the PSA indicated the cost/QALY gained was $309,399 ($280,371-$343,161) for TGPT and $324,707 ($296,086-$359,778) for MGPS compared to no tumor profiling. Of the 3 strategies, MGPS resulted in the highest number of QALYs. One-way sensitivity analyses revealed the cost/QALY estimates were most impacted by changes in health state utility on a targeted therapy (quality of life), costs of alectinib, and non-drug cancer-related costs in patients receiving targeted therapy. Compared to no tumor profiling, cost-effectiveness ratios for both profiling approaches surpassed the $150,000/QALY threshold in 100% of PSA simulations. Conclusions: Tumor profiling (TGPT or MGPS) can optimize anticancer therapy selection in patients with metastatic lung adenocarcinoma and improve quality-adjusted survival, but compared to no tumor profiling, is not cost-effective.

Purpose The optimal chemotherapy regimen to use with radiotherapy in stage III non–small-cell lung cancer is unknown. Here, we compare the outcome of patents treated within the Veterans Health Administration with either etoposide-cisplatin (EP) or carboplatin-paclitaxel (CP). Methods We identified patients treated with EP and CP with concurrent radiotherapy from 2001 to 2010. Survival rates were compared using Cox proportional hazards regression models with adjustments for confounding provided by propensity score methods and an instrumental variables analysis. Comorbidities and treatment complications were identified through administrative data. Results A total of 1,842 patients were included; EP was used in 27% (n = 499). Treatment with EP was not associated with a survival advantage in a Cox proportional hazards model (hazard ratio [HR], 0.97; 95% CI, 0.85 to 1.10), a propensity score matched cohort (HR, 1.07; 95% CI, 0.91 to 1.24), or a propensity score adjusted model (HR, 0.97; 95% CI, 0.85 to 1.10). In an instrumental variables analysis, there was no survival advantage for patients treated in centers where EP was used more than 50% of the time as compared with centers where EP was used in less than 10% of the patients (HR, 1.07; 95% CI, 0.90 to 1.26). Patients treated with EP, compared with patients treated with CP, had more hospitalizations (2.4 v 1.7 hospitalizations, respectively; P < .001), outpatient visits (17.6 v 12.6 visits, respectively; P < .001), infectious complications (47.3% v 39.4%, respectively; P = .0022), acute kidney disease/dehydration (30.5% v 21.2%, respectively; P < .001), and mucositis/esophagitis (18.6% v 14.4%, respectively; P = .0246). Conclusion After accounting for prognostic variables, patients treated with EP versus CP had similar overall survival, but EP was associated with increased morbidity.

e23120 Background: Cancer patients experience symptoms which may precede diagnosis, occur during therapy, and persist into survivorship. Symptom assessments and patient reported outcomes have been shown to improve quality of life and extend survival in cancer patients. The Veterans Administration Symptom Assessment Scale (VSAS) is a clinical tool to document cancer-related symptoms. Here, we report VSAS adoption in five Veterans Health Administration (VHA) hematology-oncology sites during a five-year period. Methods: Data was collected from the Corporate Data Warehouse (CDW): VSAS data, date of birth, gender, race, ethnicity, vital status, year of cancer diagnosis, ICD-O-3, VHA facility, and clinic stop codes. Descriptive analyses of patient demographics, disease characteristics, and VSAS utilization was performed. VSAS is comprised of 13 symptoms, rated on a 0 to 10 scale. A VSAS visit was defined as the date the VSAS was administered to a patient. Results: From January 2013 through June 2018, there were 41,917 instances of VSAS administered to 9,409 unique patients at five VHA facilities: 8,512 (90.5%) were male; 5,241 (56%) were non-Hispanic White, 3,743 (40%) were Black, and 297 (3%) were other racial categories or not available. The median age at the first VSAS visit was 67 years. In patients whose oncologic diagnosis was recorded by a cancer registrar (4,536), the most common diagnoses were prostate cancer, lung cancer (all histologies), colon cancer, and multiple myeloma. The number of VSAS administrations increased annually, from 866 in 2013 to 12,775 in 2017, which may be attributed to increased adoption of VSAS across and within VHA facilities. Individual patients completed the VSAS 1-57 times (median 2). At the five VHA facilities utilizing VSAS in 2017, VSAS was administered at 56% of hematology-oncology clinic visits. Conclusions: VSAS is a tool to measure and document patient symptom burden, and has been successfully adopted in the last five years at select VHA facilities. Expanded use of VSAS throughout the VHA is an important step in improving the quality of life and extending survival of veterans with cancer and blood disorders.

193 Background: Progress in understanding molecular changes in advanced prostate cancer has led to promising precision oncology opportunities; to date, most have been concentrated at tertiary research centers and urban centers and unequally available to patients. The VHA is the largest integrated healthcare system in the U.S. and provides medical care to >6 million veterans (~40% living in rural areas). The VHA has implemented a system-wide National Precision Oncology Program (NPOP) to offer tumor NGS testing to veterans with cancer. Methods: VHA patients with advanced stage cancers were offered targeted NGS gene panels (Personalis ACE Extended Cancer Panel; PGDx CancerSELECT/PlasmaSELECT) as part of clinical care. Annotated sequence data is collected by NPOP. We report preliminary findings of the participating veterans with prostate cancer. Results: 372 veterans from 81 sites underwent NGS sequencing of their prostate tumors (n=311) or cfDNA (n=61). Tumors from 165 (44%) were found to have mutations (allelic ratio ≥5%) in 47 genes. Of 372, 62 harbored mutations in TP53 (17%), 9 in NOTCH1 (2%), 16 in PTEN (4%), 16 in AR (4%), 13 in ATM (4%), 11 in BRCA2 (3%), 2 in MSH2 (0.5%), 1 in NBN (0.3%), and 1 in PALB2 (0.3%). 7 men (1.8%) had adequate tumor, but no identifiable somatic mutations. NPOP findings were compared to the existing databases SU2C/PCF (of metastatic biopsies in metastatic castration resistant disease) and TCGA (of primary tumors in localized disease), see table. Findings will be updated at presentation. Conclusions: The VA NPOP has been successfully implemented, and prostate tumors from veterans were found to carry potentially actionable mutations, including BRCA2 and ATM, for which there are precision treatment trials. The program will be expanded and will facilitate more diverse and equitable distribution of access to precision oncology diagnostics and therapeutic opportunities, in alignment with the Cancer Moonshot Initiative. (e.g. VA-ABCD clinicaltrials.gov; NCT02985021). [Table: see text]

A growing set of quality measures is being implemented to evaluate all components of cancer care, from diagnosis through the end of life. We investigated the Quality Oncology Practice Initiative (QOPI) quality measures portfolio. Additionally, we explored the effect of quality measure type on conformance.We performed QOPI data collections twice per year from fall 2007 through fall 2010 and spring 2012, using chart review of the Durham Veterans Administration outpatient oncology clinic. We categorized QOPI measures as nontreatment-related supportive care (NTSC), treatment-related supportive care (TSC), diagnostic, or therapeutic. Descriptive statistics and χ(2) were used to compare longitudinal conformance.The majority of QOPI measures in spring 2012 assess processes of chemotherapy treatment (therapeutic, 54.3%; TSC, 8.7%) or diagnostic modalities (19.6%). Measures targeting NTSC are few (17.4%) but increased from three measures in fall 2007 to eight measures in spring 2012. During those 5 years, average conformance to NTSC, TSC, diagnostic, and therapeutic measures was 71.4%, 86.1%, 89.3%, and 75.4%, respectively (P.001). Within the NTSC measures, emotional well-being and constipation assessment were least documented (41.0% and 46.3%, respectively). In spring 2012, NTSC measure conformance (75.8%) remained significantly lower than diagnostic measure conformance (91.5%; P.001).Most QOPI quality measures assess diagnosis or treatment processes of care and not supportive care. Aggregate conformance to the NTSC measures was lower than that of other categories. The differential conformance demonstrates the necessity of standardized documentation methods and quality improvement efforts that remain commensurate with the increasing portfolio of supportive care measures.

3 Background: It is imperative to provide quality end of life (EOL) care for cancer patients. This entails minimizing aggressive measures at the EOL. Although rates of hospice utilization within the Veteran’s Health Administration have improved, chemotherapy administration and intensive care unit (ICU) admission at the EOL, indicators of aggressive care, are not clearly declining over recent years. Methods: We identified 32,665 veterans diagnosed with stage IV lung, colorectal, or pancreatic cancer who died between 2009-2016 using VA cancer registry and Corporate Data Warehouse data through a novel EOL Dashboard Tool, which has been validated at multiple VA sites. This EOL tool reports three indicators; incidence of chemotherapy use in the last 14 days of life, ICU admission in the last 30 days of life and hospice admission or consult. Change over time, 2009-2016, was assessed using a repeated measures one-way ANOVA with post hoc test for linear trend of time for individual cancers and two-way ANOVA for all cancers combined. Results: Chemotherapy use in the last 14 days of life declined from 6.8% in 2009 to 4.4% in 2016 (p < 0.05). ICU admission in the last 30 days did not change significantly, from 13.3% in 2009 to 14.7% in 2016. The exception was stage IV lung cancer patients in whom ICU admissions increased from 12.9% to 16.2% (p = 0.01). Patients utilizing hospice services increased from 32.4% to 52.6% (p < 0.01). When combined for all years in an unadjusted analysis by VA regional network (VISN), chemotherapy use ranged geographically from 4.2% to 8.1% and for ICU admission from 8.4% to 18.0%. Conclusions: While chemotherapy administration at the EOL is declining for veterans with stage IV cancer, ICU admissions are unchanged and becoming more common in stage IV lung cancer despite increasing hospice utilization. Compared to prior Medicare reports, veterans have similar rates of EOL chemotherapy use and fewer EOL ICU admissions, adding to a growing body of literature showing that despite veterans having poorer health and utilizing more medical resources, the VA performs at or above non-veteran health care institutions on end of life cancer care. There is notable geographic variation in aggressive EOL care.

Purpose The Veterans Affairs (VA) healthcare system treats approximately 3% of patients with cancer in the United States each year. We measured the quality of nonmetastatic colorectal cancer (CRC) care in VA as indicated by concordance with National Comprehensive Cancer Network practice guidelines (six indicators) and timeliness of care (three indicators). Patients and Methods A retrospective medical record abstraction was done for 2,492 patients with incident stages I to III CRC diagnosed between October 1, 2003, and March 31, 2006, who underwent definitive CRC surgery. Patients were treated at one or more of 128 VA medical centers. The proportion of patients receiving guideline-concordant care and time intervals between care processes were calculated. Results More than 80% of patients had preoperative carcinoembryonic antigen determination (ie, stages II to III disease) and documented clear surgical margins (ie, stages II to III disease). Between 72% and 80% of patients had appropriate referral to a medical oncologist (ie, stages II to III disease), preoperative computed tomography scan of the abdomen and pelvis (ie, stages II to III disease), and adjuvant fluorouracil-based chemotherapy (ie, stage III disease). Less than half of patients with stages I to III CRC (43.5%) had a follow-up colonoscopy 7 to 18 months after surgery. The mean number of days between major treatment events included the following: 26.6 days (standard deviation [SD], 38.2; median, 20 days) between diagnosis and initiation of treatment (in stages II to III disease); 64.9 days (SD, 54.9; median, 50 days) between definitive surgery and start of adjuvant chemotherapy (in stages II to III disease); and 444.1 days (SD, 182.1; median, 393 days) between definitive surgery and follow-up colonoscopies (in stages I to III disease). Conclusion Although there is opportunity for improvement in the area of cancer surveillance, the VA performs well in meeting established guidelines for diagnosis and treatment of CRC.

e20571Background: Accurate staging for small cell lung cancer (SCLC) is critical to selecting appropriate therapy. The impact of positron emission tomography (PET) and stage migration are well-desc...

e24274Background: Immune checkpoint inhibitors (CPIs) induce prolonged tumor responses in a minority of patients with solid tumors including those with MSI-high, melanoma and NSCLC. Established pre...

4 Background: The growing number of colorectal cancer (CRC) survivors often have multiple chronic conditions. Comparing CRC survivors and matched non-cancer controls, our objectives were to determine the odds of CRC survivors being diagnosed with CVD-related chronic conditions and their likelihood of control during the year after CRC diagnosis. Methods: We retrospectively identified patients diagnosed with non-metastatic CRC in the Veterans Affairs (VA) healthcare system from fiscal years 2009-2012 and matched each with up to 3 non-cancer control patients. We used logistic regression to assess differences in the likelihood of being diagnosed with CVD-related chronic conditions and control between CRC survivors and non-cancer controls. Results: We identified 9,758 CRC patients and matched them to 29,066 non-cancer controls. At baseline, 69.4% of CRC survivors and their matched controls were diagnosed with hypertension, 52.4% with hyperlipidemia, and 36.7% with diabetes. Compared to matched non-cancer controls, CRC survivors had 57% higher odds of being diagnosed with hypertension (OR = 1.57, 95% CI = 1.49-1.64) and 12% higher odds of poor blood pressure control (OR = 1.12, 95% CI 1.06-1.18) in the subsequent year. Compared to matched non-cancer control patients, CRC survivors had half the odds of being diagnosed with hyperlipidemia (OR = 0.50, 95% CI = 0.48-0.52) and higher odds of LDL control (OR 1.14, 95% CI 1.06-1.23). There were no significant differences between groups for diabetes diagnoses or control. Conclusions: Compared to non-cancer controls, CRC survivors have: 1) greater likelihood of being diagnosed with hypertension and worse blood pressure control in the year following diagnosis; 2) lower likelihood of being diagnosed with hyperlipidemia or LDL control; and 3) comparable diabetes diagnoses and control. There may be a need for hypertension control interventions targeting cancer survivors.

741 Background: Adjuvant chemotherapy (AC) following chemoradiation (CRT) and total mesorectal excision (TME) for locoregionally advanced rectal cancer (LARC) is a standard of care in the United States despite limited data. The purpose of this study was to examine the role, optimal regimen, and duration of AC in the mandatory, prospectively collected cancer registry of the largest integrated health system in the US. Methods: Using the VA Central Cancer Registry, stage II-III rectal cancer patients diagnosed between 1/2001-4/2011 were included if they received neoadjuvant CRT followed by TME with or without AC. Adequate chemotherapy was defined as at least 4 months of therapy. Kaplan-Meier and Log-Rank tests were used to assess survival. Propensity score (PS) adjustment was performed to compare survival outcomes while adjusting for baseline characteristics, including AJCC stage, age, gender, race, smoking status, and comorbidity. Results: 649 patients were identified; 323 received AC while 326 did not (OBS). Median follow-up was 66 months. Mean age was 63 years. 85.1% were white; 98.8% were male. 49.2% had stage II disease. Median overall survival (OS) for all patients was 92 months; 6-year OS was 56.8%. Median OS was 72 months for the OBS group and not reached (NR) for the AC group (p < 0.001). OS at 6 years was 49.5% for OBS and 64.1% for AC (p < 0.0001). On PS matched analysis, OS was improved favoring AC (p < 0.0001). Median disease-specific survival (DSS) was NR for the whole group and NR for the OBS and AC groups. 6-year DSS was 73.6% for the whole group and 67.9% for OBS vs. 79.2% for AC (p < 0.001). PS matched analysis for DSS favored AC (p = 0.0004). There was no significant difference in OS (p = 0.554) or DSS (p = 0.680) when comparing single versus multi-agent chemotherapy and no significant difference in OS (p = 0.766) or DSS (p = 0.271) when comparing adequate ( > / = 4 months) versus inadequate chemotherapy ( < 4 months). Conclusions: In this VA population of LARC patients treated with neoadjuvant CRT followed by TME, the addition of AC was found to improve both OS and DSS compared to OBS. There was no improvement in OS or DSS with the addition of a multi-agent over single-agent chemotherapy.

Purpose Standard therapy for unresectable stage III non–small-cell lung cancer includes concomitant chemoradiotherapy. In Cancer and Leukemia Group B 39801, we evaluated whether induction chemotherapy before concurrent chemoradiotherapy would result in improved survival. Patients and Methods Between July 1998 and May 2002, 366 patients were randomly assigned to arm A, which involved immediate concurrent chemoradiotherapy with carboplatin area under the concentration-time curve (AUC) of 2 and paclitaxel 50 mg/m2 given weekly during 66 Gy of chest radiotherapy, or arm B, which involved two cycles of carboplatin AUC 6 and paclitaxel 200 mg/m2 administered every 21 days followed by identical chemoradiotherapy. The accrual goal was 360 patients. Results Thirty-four percent of patients were female, 66% were male, and the median age was 63 years. Grade 3 or 4 toxicities during induction chemotherapy on arm B consisted mainly of neutropenia (18% and 20%, respectively). During concurrent chemoradiotherapy, there was no difference in severity of in-field toxicities of esophagitis (grade 3 and 4 were, respectively, 30% and 2% for arm A v 28% and 8% for arm B) and dyspnea (grade 3 and 4 were, respectively, 11% and 3% for arm A v 15% and 4% for arm B). Survival differences were not statistically significant (P = .3), with a median survival on arm A of 12 months (95% CI, 10 to 16 months) versus 14 months (95% CI, 11 to 16 months) on arm B and a 2-year survival of 29% (95% CI, 22% to 35%) and 31% (95% CI, 25% to 38%). Age, weight loss before therapy, and performance status were statistically significant predictive factors. Conclusion The addition of induction chemotherapy to concurrent chemoradiotherapy added toxicity and provided no survival benefit over concurrent chemoradiotherapy alone. The median survival achieved in each of the treatment groups is low, and the routine use of weekly carboplatin and paclitaxel with simultaneous radiotherapy should be re-examined.

PurposeTo determine the ability to induce tumor-specific immunity with individual mutant K-ras–or p53-derived peptides and to monitor clinical outcome.Patients and MethodsPatients in varying stages of disease underwent genetic analysis for mutations in K-ras and p53. Thirty-nine patients were enrolled. Seventeen-mer peptides were custom synthesized to the corresponding mutation. Baseline immunity was assessed for cytotoxic T-lymphocyte (CTL) response and interferon gamma (IFN-γ) release from mutant peptide-primed lymphocytes. Patients' peripheral-blood mononuclear cells were pulsed with the corresponding peptide, irradiated, and applied intravenously. Patients were observed for CTL, IFN-γ, interleukin (IL) -2, IL-5, and granulocyte-macrophage colony-stimulating factor responses, for treatment-related toxicity, and for tumor response.ResultsNo toxicity was observed. Ten (26%) of 38 patients had detectable CTL against mutant p53 or K-ras, and two patients were positive for CTL at baseline. Positive IFN-γ responses occurred in 16 patients (42%) after vaccination, whereas four patients had positive IFN-γ reaction before vaccination. Of 29 patients with evident disease, five experienced a period of stable disease. Favorable prognostic markers were detectable CTL activity and a positive IFN-γ reaction but not IL-5 release. Median survival times of 393 v 98 days for a positive versus negative CTL response (P = .04), respectively, and of 470 v 88 days for a positive versus negative IFN-γ response (P = .02), respectively, were detected.ConclusionCustom-made peptide vaccination is feasible without any toxicity. CTL and cytokine responses specific to a given mutation can be induced or enhanced with peptide vaccines. Cellular immunity to mutant p53 and K-ras oncopeptides is associated with longer survival.

8544 Background: The goal of this study was to determine patient factors associated with short- vs long-term survival after surgery for stage I/II NSCLC and assess the distribution of causes of death over time. Methods: Using the VA Central Cancer Registry, we identified patients diagnosed 2001-2005 with stage I/II NSCLC who had surgery and survived 30 days after resection. We used multivariate logistic regression models to determine the impact of patient characteristics on 1 year (1Y), 5 year (5Y), and 10 year (10Y) mortality. We compared causes of death at 1Y versus 5Y after diagnosis. Results: The analysis included 4,693 patients. Among these patients, the 1Y, 5Y, and 10Y overall survival (OS) rates were 87%, 45%, and 22%, respectively. 50% of patients alive at 5 year survived to 10 years. For each survival time period, highest survival rates were among patients who were younger (≤65), had stage I disease, had lobectomy, and had fewer comorbidities (all p < 0.0001). Significant differences in 1Y and 10Y OS were noted for histology, with highest 1Y OS among adenocarcinoma (88%) and squamous cell (87%) and highest 10Y OS among large cell (28%) and adenocarcinoma (25%). Racial differences were only observed in 10Y OS (whites 22%, blacks 26%, p = 0.01). In multivariate analyses, age > 65, stage II disease, surgery other than lobectomy, and ≥3 comorbidities were associated with increased likelihood of 1Y, 5Y, and 10Y mortality. Large cell and other histology were the only additional significant predictors of 1Y mortality [OR: 1.94 (1.33-2.84) and OR:1.36 (1.05-1.77), respectively], and squamous cell histology was a significant predictor of 10Y mortality [OR: 1.19 (1.02-1.40)] relative to adenocarcinoma. Among patients who died within 1 year of diagnosis (n = 616), the primary causes of death were lung cancer (63%), cardiovascular disease (10%), other cancer (8%), respiratory disease (3%), and other causes (15). The contribution of these causes of 5Y mortality (n = 2602) were 60%, 11%, 10%, 4%, and 12%, respectively. Conclusions: Half of patients alive at 5Y after resection of stage I/II NSCLC were alive at 10Y. 10Y survival is associated with younger age, earlier stage, non-squamous histology, lobectomy, and fewer comorbidities, but not race.

6507 Background: VHA is the US’s largest integrated healthcare system providing care to over 6 million Veterans (~40% in rural areas). Precision Oncology offers the promise of effective, low-toxicity targeted therapies tailored to individual tumor genomics but is unequally available to patients in the US. As part of the Cancer Moonshot, VHA is implementing a system-wide Precision Oncology Program (POP) including patients in rural areas, where specialty oncology care has historically had limited availability. Methods: Patients tested with multigene NGS tumor sequencing through 1 of 2 contracted vendors were identified from POP records and cancer characteristics were extracted from POP and medical records. Drug use data was obtained from the VA Corporate Data Warehouse. NGS testing results and annotations were extracted from POP records. Results: A total of 978 tumor samples were sent for NGS testing since program inception in 2015. The most common diagnoses are lung (464: adeno 314, squamous 107), GI (87), LN (75), liver (56), H&N (52), and prostate (43). The rate of sample test requests increased rapidly after national implementation in July 2016 (mean 23 samples/month prior to implementation to mean 126 samples/month 3 months later) as did the number of participating facilities (mean 8/month to 27/month). Sequencing success rate increased from 68% to 71% over the same interval while mean turn around time remained similar at 19.7 and 19.1 d, respectively. NGS results are available for a cohort of 344 patients including: lung 200 (adeno 138, squamous 51), skin 28, LN 20, liver 19, GI 16. 979 variants were found including TP53 278, KRAS 106, STK11, APC 38, PIK3CA 38, and CDKN2A 37. 228 patients had actionable results (on-label drug 24, off-label drug 165, clinical trial 213). To date, 8 patients received a recommended drug outside a clinical trial between 11 and 288 d after testing (median 82 d); 4 additional patients had received an NGS-recommended drug prior to testing. Conclusions: Implementation of tumor NGS testing as part of Precision Oncology Program in a US distributed healthcare system is feasible. Further program implementation and provision of appropriate targeted drugs both on and off study will be necessary to impact patient outcomes.

PURPOSE To determine the maximum-tolerated dose (MTD) of paclitaxel administered by 96-hour continuous infusion in combination with cisplatin, to determine if the addition of granulocyte colony-stimulating factor (G-CSF) permits significant paclitaxel dose escalation, and to assess the toxicity and preliminary activity of this combination in patients with advanced lung cancer. PATIENTS AND METHODS Fifty patients with untreated lung cancer were enrolled: 42 had advanced non-small-cell lung cancer (NSCLC) and eight had extensive-stage small-cell lung cancer (SCLC). Patients received paclitaxel doses of 100 to 180 mg/m2/96 hours and cisplatin doses of 60 to 80 mg/m2 as a single 30-minute bolus injection at the end of the paclitaxel infusion. RESULTS Two of six patients experienced dose-limiting neutropenia at a dose of paclitaxel 140 mg/m2/96 hours and cisplatin 80 mg/m2. With G-CSF support, one of three patients experienced both dose-limiting mucositis and fatal neutropenic sepsis at a dose of paclitaxel 180 mg/m2/96 hours and cisplatin 80 mg/m2. Significant peripheral neuropathy developed in five patients and occurred after six or more cycles of therapy. Thirty-three of 42 patients with NSCLC had measurable disease; the objective response rate was 55%, with two complete responses and 16 partial responses. For all 42 patients with NSCLC, the median time to progression and median survival duration were 5 months and 10 months, respectively. The actuarial 1-year survival rate was 41%. Of eight SCLC patients, four responded to therapy, and the median survival duration for all SCLC patients was 11 months. CONCLUSION The MTD without G-CSF is paclitaxel 120 mg/m2/96 hours and cisplatin 80 mg/m2, and the MTD with G-CSF is paclitaxel 160 mg/m2/96 hours and cisplatin 80 mg/m2. Infusional paclitaxel with cisplatin is well tolerated and active in patients with advanced NSCLC.

e267 Background: Our objective was to evaluate VA CRC incidence and survival and compare with the National Cancer Institute's Surveillance, Epidemiology, and End Results (SEER) data. Methods: Data were obtained from VACCR for veterans diagnosed/treated in VA for incident CRC during fiscal years (FY) 2009-2012. Using VHA Support Service Center information about the distribution of VA healthcare system enrollees for corresponding years, we adjusted incidence rates for age and gender to the underlying VA population. Survival data were available through January 2015; thus, patients in the analysis had 3-6 years of follow-up data and were censored accordingly. CRC incidence and survival among VA patients was compared to projected national 2014 CRC-specific SEER and supporting data sources. Results: From FY 2009-2012, 12,551 patients (2.6% women; 97.4% men) were in the analytic cohort. Among VACCR patients, the most common tumor location was proximal colon (38%), followed by rectum (31%), distal colon (26%), and other colon (5%). This is comparable to SEER, in which proximal colon and rectum are most common. Among patients in the VACCR, SEER summary stage distribution was: 44% local, 36% regional, 17% distant and 4% unknown. This also aligns with SEER, in which approximately 40% of CRC cases are diagnosed locally. Mirroring SEER, overall VA CRC incidence rate decreased from 0.22 to 0.16 cases per 1,000 veterans in FYs 2009 and 2012. Evaluating survival, median follow-up time was 3.3 years among veterans. The 3-year survival rate for VA patients was 65.9%. Overall 3-year survival is slightly higher for rectal (66.4%) than for colon (65.6%). This is comparable to 5-year SEER survival rates (66.5% and 64.2% for rectal and colon, respectively). Also consistent with SEER, VA CRC patients < 65 have higher rates of 3-year survival than patients > 65 years (74.6% vs. 58.5%, respectively). Conclusions: VACCR data indicate that CRC incidence and survival in FY 2009-2012 approximated SEER projections during a similar timeframe. This suggests that, although VA patients are more complex than the general population, they are diagnosed with comparable CRC locations and stages.

e17582 Background: Molecular profiling has resulted in new, targeted therapies that may improve survival for non-small cell lung cancer patients (NSCLC). Erlotinib is used in stage-IV patients and ...

e17510 Background: About 10% of Veterans seen in VA facilities are female, some of whom are diagnosed with breast cancer. In 2012, NCCN guidelines for BRCA1/BRCA2 testing criteria included offering...

e17511 Background: The number of Veterans diagnosed and treated for breast cancer within the Veterans Health Administration is increasing. The VA Central Cancer Registry (VACCR) reported 504 and 62...

7568 Background: The antidiabetic drug M may improve cancer-specific survival; however, little is known about the association between M use and survival among NSCLC pts. Methods: We retrospectively...

9612 Background: The objective of this analysis was to perform unbiased discovery of genetic variants that modulate neutropenia risk early in docetaxel treatment. Methods: Chemotherapy-naive metast...

201 Background: Yearly, 52,000 veterans are diagnosed with cancer. Minorities represent 18.5% (9,651) of these patients. The rapid and explosive growth of molecular diagnostics (MDx) has created challenges for large healthcare systems such as the Veterans Health Administration (VA) to integrate genomic data into the EMR. Yet, this is an important component of high quality cancer care. In 2011, the VA cancer registry (VACCR) began reporting molecular data. This presentation will describe one project to improve integration of genomics into the EMR and the VACCR. Methods: Using ICD diagnosis codes, we identified veterans diagnosed in 2011 with brain, breast, colon, gastrointestinal stromal, lung, and melanoma cancers. Administrative data was obtained to identify MDx testing. These data were then compared to random chart audits. Significant discrepancies between these sources of data prompted collaboration with national and proprietary reference labs (ARUP, LabCorp, Quest, Genomic Health) to obtain the volume of testing by each VAMC. These data were used to conduct targeted chart reviews to identify the location, processes of care, free and structured text information. These data informed the development of natural language processing (NLP) tools to automatically identify patients that underwent testing. Results: Laboratories had the most accurate source of data. Data from ARUP, Quest, and LabCorp identified a significantly higher volume of testing than reported by administrative data. Applying NLP tools to patients diagnosed with breast cancer identified 44 of the 116 tests ordered for the 21-gene risk score tests. Conclusions: Decision support systems are needed to link tumor SNOMED code to diagnostic testing. Until systems are developed, collaborations with reference labs may be an effective method for identifying molecular data. NLP tools may also serve as an adjunct method for capturing MDx tests ordered from smaller labs.

162 Background: Quality improvement measures are uniformly applied to all oncology providers, regardless of their positions. Little is known about differences in conformance to these measures between oncology fellows and attending physicians. In order to tailor improvement interventions to these groups, we investigated conformance across QOPI measures for oncology fellows and attending physicians at the Durham VA Medical Center (DVAMC). Methods: Using data collected from the Spring 2013 QOPI cycle, we abstracted information from patients who had received care at the DVAMC between 2011 and 2013 and separated them based on their provider. To validate the data, we abstracted a subset of patient charts, limited to oral chemotherapy quality measures. Descriptive statistics and the Chi square test were calculated for each measure between the two groups. Results: A total of 97 patients were reviewed at DVAMC. Of these, 21 had a fellow and 47 had an attending as their main provider. Fellows and attendings performed similarly on 119 of 125 QOPI measures (core, end of life, symptom, colorectal, and NSCLC modules). Fellows were less likely to assess pain on the most recent visits when compared to attendings (52% vs. 77%, p=0.046) but more likely to document a management plan if the patient had moderate or severe pain (86% vs 75%, p=0.09). Attendings documented the plan for oral chemotherapy more often (93% vs. 60%, p=0.07). However, after the chart audit, we found that fellows actually documented the plan for oral chemotherapy 80% of the time (p=0.21). Fellows were more likely to document smoking status (95% vs. 64%, p=0.007) and to address smoking cessation (86% vs. 62%, p=0.048). Conclusions: Patient care practices tend to be similar between attendings and fellows overall; some of the significant differences may not remain significant after chart audit. Fellows generally mirror behaviors of attending physicians, and attendings have an important role in modeling best practice behaviors for fellows. Different quality measure standards may not be necessary between fellows and attendings.

6562 Background: Data on implementation of genetic diagnostic (GDx) tests are lacking yet are crucial to evaluate population differences in access and outcomes. Previous studies identified substantial underuse of GDx tests. Greater access existed in states with NCI cancer centers. This pattern of diffusion may exacerbate disparities. Since 2008, the 21-gene recurrence score (21-gene RS), which assesses the 10-year risk of breast cancer (BC) recurrence in ER+, node-negative, early-stage disease, has been recommended by ASCO/NCCN to guide chemotherapy decisions. This study examines regional and site-of-care differences in use. We report national implementation rate and state-level differences in utilization. Methods: Hospital level data on 2011 orders for the test were provided by Genomic Health. We aggregated this dataset at the state-level and linked it to public datasets (Census and CDC State Cancer Profiles). Using Surveillance Epidemiology End Results (SEER) data, we estimated number of guideline-directed BC cases. The outcome variable, state utilization ratio, was calculated by dividing the number of tests ordered by guideline-directed BC cases. For some states utilization ratios may be higher than 1 because patients may have crossed state boundaries to obtain care. Results: Of approximately 101,702 guideline-directed BC cases nationally, 59,053 patients had the test; a utilization ratio of 0.58. Utilization ratio by state ranged from 0.21 to 1.71 (25th/75thpercentile range 0.48-0.64). The District of Columbia had the highest utilization ratio at 1.71 (8 institutions ordered 367 tests on an estimated 213 patients); Iowa had the lowest at 0.21 (39 institutions, 458 tests, 2094 patients). Only 7 states had utilization ratios

11053 Background: There are currently no effective methods for predicting, preventing, or treating chemotherapy-induced peripheral neuropathy. We performed a genome-wide association study in a clinical trial of castration-resistant prostate cancer (CRPC) to discover variants that may be useful for identifying patients at high risk of neuropathy during docetaxel treatment. Methods: Treatment and toxicity data were collected prospectively on the Cancer and Leukemia Group B (CALGB) 90401 trial of chemotherapy naïve CRPC patients treated with docetaxel and prednisone ± bevacizumab. Genotyping was performed by the RIKEN Institute using the Illumina HumanHap610-Quad platform. Genetically defined European subjects were included in the discovery analysis of all single nucleotide polymorphisms (SNPs) that passed quality control. The primary endpoint was the cumulative dose level triggering a grade 3+ sensory neuropathy. The inference was conducted within the framework of a competing risk model accounting for early treatment termination induced by death or progression, or other toxicities. SNPs that were highly associated with neuropathy were assessed for a broader taxane effect in a cohort of paclitaxel-treated patients from a breast cancer clinical trial, CALGB 40101. Results: 623 Caucasian patients and 498,022 SNPs were included in the discovery analysis. The incidence of grade 3 neuropathy was 8%. One intergenic SNP (rs11017056) was associated with increased risk of neuropathy (HR=2.83, p=4.7x10-7). This association surpassed the genome-wide significance threshold after covariate adjustment (p=7.2x10-8). However, none of the 7 SNPs selected for replication were associated with neuropathy in the paclitaxel-treated breast cancer cohort. Conclusions: Using a prospectively enrolled prostate cancer patient cohort we identified multiple SNPs that may identify risk of docetaxel-induced peripheral neuropathy, but not paclitaxel-induced neuropathy. However, since it is unknown whether the genetic factors that affect taxane neuropathy are drug-specific, further replication studies in docetaxel-treated cohorts are of great interest.

7538 Background: Clinical trials demonstrating improved survival with AC for stages I-III NSCLC are limited in their applicability to broader populations. We sought to describe the pattern of AC use and its correlation with survival in the population-based VA system. Methods: We conducted a retrospective analysis of pts with stages I-III NSCLC in the VA Central Cancer Registry. Descriptive statistics were used to examine patterns of AC use over an 8 yr period and to obtain survival rates associated with use of AC. Chi-square was used to compare distributions. Results: Among 28,173 pts with stages I-III NSCLC in 2001-2008, 10,043 had surgical resection. The proportion receiving AC was 9% (stage I), 34% (II), and 40% (III). Receipt of AC increased for each stage, with the greatest increase observed in stage II (2001-03: 12%; 2004-05: 41%; 2006-08: 50%). About 90% received a platinum agent; among these carboplatin was most common (77%) but by 2008 43% received cisplatin. For stages II and III in 2001-2003, the 3-year survival rate was similar irrespective of AC use. In latter time periods, survival rates were significantly higher for stage II AC pts (2004-2005: 53 vs 43%, p=0.03; 2006-2008: 58 vs 46%, p=0.001). Stage III AC pt diagnosed in 2006-2008 had a higher 3-yr survival (52 vs 36%, p

7539 Background: Adjuvant chemotherapy (AC) is considered standard of care in patients with resected stages 2 and 3 non-small cell lung cancer (NSCLC). However data regarding its utility in older patients are sparse. This analysis was conducted to evaluate the role of AC in older patients with early stage NSCLC. Methods: We conducted a retrospective analysis of patients with stages 1-3 NSCLC between 2001 and 2008 in the VA Central Cancer Registry. Patients were divided into two groups based on age

8090 Background: Second-line chemotherapy (2-L) improves overall survival (OS) in patients with metastatic NSCLC. In 2004, erlotinib and pemetrexed were approved as 2-L agents. In this study we analyze the utilization of anti-cancer agents and survival for patients with NSCLC who received 2-L treatment within the VHA. Methods: We identified from the VA Central Cancer Registry incident cases of metastatic NSCLC diagnosed between 2001 and 2008. We included patients who received their 1st cycle of chemotherapy within 120 days of diagnosis. A chemotherapy regimen included all chemotherapy agents prescribed during the next 28 days. We defined a subsequent line of therapy when a new agent was started after a period of more than the initial 28 days since the last drug. We divided our cohort into two based on whether they were diagnosed or treated before August of 2004 (the date pemetrexed was approved). Results: 5,893 patients fulfilled our eligibility criteria and were included for analysis. 2,200 patients were diagnosed before 2004 and 3,693 after. 2-L was administered in 35% (n=2052) of patients overall. Veterans diagnosed after 2004 were more frequently prescribed 2-L compared to those diagnosed earlier (30.2 vs. 37.6%, p

232 Background: Studies have documented racial differences along the lung cancer continuum and equity in care is essential to quality improvement. The purpose of this study was to investigate the influence of race on lung cancer treatment and survival among early-stage non-small cell lung cancer patients in an equal access healthcare system. We hypothesize that patients receiving similar treatment will have similar survival. Methods: Data were from the External Peer Review Program (EPRP) Lung Cancer Special Study, which was a cross-sectional study conducted to assess the quality of care among patients diagnosed with lung cancer and receiving care at a VA facility. All patients were diagnosed between October 1, 2006 and December 31, 2007. Analyses were restricted to patients with Stage I/II NSCLC (n=1,426; 1,229 whites, 197 blacks). Multivariate logistic regression was used to estimate odds ratios (OR) and 95% confidence intervals (95%CI). Results: The proportion of blacks who had surgery was significantly less than that among whites (OR: 0.56, 95% CI 0.39-0.79). There was no racial difference in receipt of adjuvant therapy (chemotherapy and/or radiation therapy) among patients who had surgery (p=0.08). Among patients who did not undergo surgery, blacks were more likely to refuse surgery (OR: 2.30, 95% CI 1.29-4.13); however, the proportion of patients with contraindications to surgery and those receiving palliative treatment were similar in both race groups. The 2-year survival rate was 69% and race was not a predictor of survival when controlling for receipt of surgery along with other covariates (p=0.76). The 2-year survival rate was 82% among patients who had surgery, and 48% among patients who did not have surgery. Specifically among patients who did not have surgery due to refusal, the survival rate was 55%. Conclusions: We observed a racial disparity in surgery, partially due to the greater rate of refusal among blacks, but not adjuvant or palliative treatment. Race did not have a major impact on 2-year survival for patients with early-stage lung cancer. These findings stress the need to better understand patient preferences regarding surgery and identify ways to reduce this variation in surgery to improve quality of lung cancer care.