Ca Pts Research Articles

Abstract PO4-27-01: COVID-19 Vaccination Behavior and Outcomes in Breast Cancer Patients in comparison with other Cancer types

Abstract Background: Cancer(ca) is a known risk factor for severe COVID-19 (C19) disease, related morbidity, and mortality. Ca patients (pts) were largely excluded from clinical trials evaluating the safety and efficacy of the 3 FDA-approved C19 vaccines (vax). Breast cancer (Bca) is the most commonly diagnosed non-skin ca, and accounts for ~ 30% of all new female cancers each year. The pandemic has led to disruptions in Bca care including screening, diagnosis, treatment, and follow-up which will likely have an impact on Bca mortality. We aim to study behavior and outcomes regarding C19 vax in Bca pts comparison to non-Bca pts. Methods: In our prospective and observational single center study; adult ca pts (18-89 years) seen in clinics from Nov 2021-Sept 2022 were randomly interviewed using telephone surveys after a verbal consent. Type of ca and therapy data were collected from medical records. The survey included C19 disease status, vax status positive (+) or negative (-), reason for vax status, side effects (s.e), and their perspective on impact on ca Rx or ca progression. The primary objective was to identify the rate of vaccination in adult ca pts. Secondary objectives were to quantify C19 vax acceptance vs. hesitance, identify s.e of C19 vax and effect of C19 vax on outcomes in Bca and non-Bca pts. Results: N=170 [Bca 45 (26.5%) and non-Bca 125 (73.5%)]. Among Bca pts: 40 (88.9%) were ER+, 34 (75.5%) PR+, and 9 (20%) HER2+. Of them, 20 (44.4%) pts received cytotoxic chemotherapy and 39 (86.7%) pts received hormonal therapy alone. Refer to Table 1 for key outcomes data. Top 3 risk factors for serious C19+ in Bca pts were age >65yr (42.2%), BMI >30 (42.2%) and smoking (24.4%); and in non Bca pts: age >65yr (52%), BMI >30 (34.4%) and immunocompromised state (23.2%). Top 3 reasons for C19 vax (+) in Bca pts: protection against C19+ for self (82.2%), for others (37.8%) and provider recommendation (46.7%). The main reasons for vax hesitancy in C19 vax (-) Bca pts: fear of side effects (4.4%), prior C19 infection (4.4%) and don’t trust the research behind it (2.2%). The common s.e of C19 vax in Bca pts were fatigue (40%), injection site inflammation (35.6%) and body aches (31.1%). Also, 13.3% of Bca pts developed lymphadenopathy. A total of 71.1% Bca pts developed ‘minor s.e’ from C19 vax, compared to 33.1% in non-Bca pts (p=0.0001). However, none of Bca pts reported progression of the disease or delay in cancer Rx or outcome due to C-19 vax. Conclusion: Majority of the Bca pts were vaccinated against C19 and tolerated it well. Even though significantly higher number of Bca pts had side effects, they were minor and did not impact Bca outcomes. Oncologists should discuss the importance of C19 vax in the context of ca. Table. Citation Format: Hyma Polimera, Emma Guare, Lauren Pomerantz, Monali Vasekar, Junjia Zhu, Monika Joshi. COVID-19 Vaccination Behavior and Outcomes in Breast Cancer Patients in comparison with other Cancer types [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO4-27-01.

COVID-19 vaccination in patients with cancer: Results from survey based observational study.

e18897 Background: COVID‐19 (C19) disproportionately affects those with comorbid medical conditions, leading to significantly higher mortality rate. Cancer(ca) is a well-studied risk factor for developing severe C19 disease. However, ca patients (pts) were largely excluded from clinical trials evaluating the safety and efficacy of 3 FDA-approved C19 vaccines (vax). We aim to study this highly vulnerable pts’ behavior and outcomes regarding C19 vax. Methods: A prospective and observational single center study. Adult ca pts (18-89 years) seen in clinics from Nov 2021-Sept 2022 were randomly interviewed using telephone surveys after a verbal consent. Type of ca and therapy data were collected from pts’ medical records. The survey included C19 disease status, vax status positive (vax+) or negative (vax-), reason for vax status, s.e, impact on ca Rx or ca progression. Our primary objectives were to assess the rate of vaccination in the adult ca pts and identify barriers to vaccination. Secondary objectives were determining factors associated with vax acceptance vs. hesitancy, identifying s.e of C19 vax, and effect of C19 vax on clinical outcomes in ca pts. Results: N = 170 [Males 82 (48.2%) and females 88 (51.8%)]. The median age was 65 years. Among 170 pts, 58.2% had solid malignancy, 40% had hematologic malignancy, and 1.8% had both solid and hematologic malignancy. Refer to Table 1 for outcomes data. Overall, 146 (85.9%) pts received C19 vax. C19 infection positive (C19+) in 49 (28.8%) pts. Of them 9 (18.4%) pts required hospitalization. The vax rate of prior C19+ pts was 73.5% compared to 90.9% in C19 infection negative (C19-) pts (p = 0.0013). Demographic factors were not significantly associated with vaccine uptake. A total of 50% pts developed s.e from vax. However only one patient (0.68%) reported a delay in ca treatment due to C19 vax and believed that vax affected the ca outcome. Conclusions: Our results demonstrate that majority of the ca pts were vaccinated against C19 and tolerated it well, with minimal side effects. Prior C19 infection significantly decreased vax uptake. Vaccination did not have notable adverse effect on ca outcomes. Oncologists should discuss the importance of C19 vax in the context of ca to avoid misconceptions and hesitancy. Clinical trial information: NCT04953065 . [Table: see text]

Socioeconomic and demographic disparities in rectal cancer treatment.

e15512 Background: Early treatment (tx) improves survival in rectal cancer (ca). We explored whether socioeconomic and demographic attributes are associated with time to tx initiation for rectal ca patients (pts) in New York's largest and most diverse healthcare system. Methods: 283 rectal ca pts were identified from three multidisciplinary tumor boards from 2019-2022. Time to tx was calculated as time from biopsy to first tx (surgery, chemotherapy, or radiation). Social work assistance was defined as an intervention by a social worker for home care, housing, or transportation assistance. Reasons for tx delay were assessed from physician and social work notes. Results: Median time to tx for all pts was 41 days. Time to tx was longer for Black/African American (BAA) (56.5 days; p < 0.001) and Medicare only (46.5 days; p = 0.005) pts. No differences were seen in time to tx for all pts when stratified by first tx modality (surgery, chemotherapy, or radiation). In a univariable linear regression, BAA pts (vs Asian or White; p < 0.001), Medicare only pts (vs Medicaid, Medicare with Supplemental, or Commercial Insurance; p = 0.001), and pts requesting social work assistance (p = 0.001) predicted longer time to tx. Employed pts (vs unemployed or retired; p = 0.034) predicted shorter time to tx. In a multivariable model, BAA (p = 0.013), Medicare (p = 0.022), and social work assistance (p = 0.029) predicted longer time to tx. The most common reasons identified for tx delay in BAA and Medicare pts were hospitalization during diagnosis (9%), evaluation of metastatic disease (9%), and tx hesitancy (7%). The odds ratio of being hospitalized during initial workup was 2.8 times higher for BAA than Asian or White pts (p = 0.007). Conclusions: Analysis of time to tx in rectal ca showed a notable delay for BAA pts, Medicare only pts, and pts requesting social work assistance. These findings may empower further studies to assess which factors are causal and to implement interventions that promote equity in timely tx for rectal ca pts. Reasons for tx delay were also not well documented and should be further elucidated. [Table: see text]

Weight loss (WL) as a predictive factor for immune oncology (IO).

e14528 Background: WL is an adverse prognostic factor/symptom reported in ~40% cancer (ca) patients (pts) at diagnosis agnostic to site or histologic grade. The mechanism of WL in ca, however, remains elusive. The role of energetic waste in ca WL is doubtful (it neglects likely dietary compensation). On the other hand, lymphocytic activation, a clonal, energetically demanding process is accompanied with anorexia limiting caloric intake which leads frequently to WL if protracted over months as seen in lymphoma (B-symptom) or indecisive immune engagement (Eng) with tuberculosis. WL of > 5% of body weight, was an adverse prognosticator and exclusion criterion in non-small cell lung cancer (NSCLC) chemotherapy (CT) trials, likely due to CT or steroids' abrogation of the putative, limited immune ca containment. We hypothesized that WL in ca reflects months of immune Eng, ineffective as it may be at containing the tumor, but nevertheless representing immune Eng with the ca. Such cases stand the best chance for IO benefit. Notably, IO impact in ca mirrors the 40% of WL in ca pts. Methods: Tumor registry retrieved data from all stage 4 cancers treated with monotherapy IO in our institution. We dichotomized pts to beneficiaries (B) or non-beneficiaries (NB). Bs survive longer than median survival for the respective stage/line of therapy in each ca derived from published trials. To account for missing WL data prior to IO, we reasoned that weight gain of ≥10 lbs (reliably charted over 1 year from IO infusions) is acceptable surrogate for WL and met our criteria. Results: WL in our cohort (n = 53) of Melanoma, NSCLC, renal cell carcinoma, and bladder ca was 43% of B; 10% in NB (ratio > 4:1) rejecting the null hypothesis (p < 0.05). PDL-1, Tumor Mutation Burden, both inconclusive in identifying durable benefit, were limited in our set precluding further analysis. Conclusions: Our results support, though do not prove, that WL identifies the appropriate IO pts. Improved outcome despite a historically-adverse prognosticator (WL); the fact that IO was the only ca therapy used, both support our interpretation. We hope to stimulate others to examine independent larger datasets to confirm this notion and to allow comprehensive subset analyses. For WL to be utilized properly the relevant clinical context is crucial, accounting for GI obstructing ca (esophageal ca), enzymatic anomalies (pancreatic ca), volume fluctuations (cirrhosis), catabolism (prolonged hospitalization), or dental issues, to name a few. Additionally, factors such as tumor bulk, perhaps discerned from the T of TNM staging, deserve examination since more vigorous immune activation against larger targets could produce more impact on appetite and caloric intake. Finally, available clinical trial datasets, not tumor registries, might provide a more crisp, reliable source as we continue this investigation. WL can, with confirmatory work, be clinically incorporated as a predictive factor for IO benefit.

COVID-19 vaccination behavior and outcomes in patients with genitourinary cancer in comparison with other cancer types.

134 Background: Cancer(ca) and old age are risk factors for developing severe COVID-19 (C19+) disease, related morbidity and mortality. These patients (pts) were excluded from clinical trials evaluating the safety and efficacy of 3 FDA approved C19 vaccines (vax). Genitourinary (GU) ca-prostate, bladder and kidney ca contribute to the majority of non-skin ca and median age of these pts range from 65-75 yrs. We aimed to study these highly vulnerable pts behavior and outcomes regarding C19 vax in comparison to non-GU ca pts (18-89 years). Methods: A prospective and observational single center study. Adult ca pts seen in clinics from Nov 2021-Sept 2022 were randomly interviewed using telephone surveys after a verbal consent. Type of ca and therapy data were collected from pts’ medical records. The survey included C19 disease status, vax status positive (+) or negative (-), reason for vax status, side effects (s.e), impact on ca Rx or ca progression. Data was entered on REDCap. The primary end point was rate of vaccination in adult ca pts. Secondary end points were to quantify C19 vax acceptance vs. hesitance, identify s.e of C19 vax and effect of C19 vax on outcomes in GU and non-GU Ca pts. Results: N=172; GU ca 21 (12.2%) and non-GU ca 151 (87.8%). Among GU ca pts- 9 had prostate ca, 7 had bladder ca and 5 had renal ca. C19+ in 4 (19%) GU and 45 (30.2%) non-GU pts. GU pts: 90.5% received C19 vax (Pfizer 47.6%; Moderna 42.9%, J & J 0%); 9.5% were not vaxed. Non-GU pts: 85.2% received C19 vax (Pfizer 39.1%; Moderna 43%, J & J 2.6%); 14.8% were not vaxed. The top 3 risk factors for serious C19+ were age >65yr (76.2%), heart disease (61.9%) and BMI>30 (42.9%) in GU ca pts and age >65yr (46.4%), BMI>30 (35.1%) and smoking (19.9%) in non-GU ca pts. The top 3 reasons for C19 vax (+) in GU ca pts: protection against C19+ for self (81%), for others (47.6%) and provider recommendation (38.1%). The main reasons for vax hesitancy in C19 vax (-) GU ca pts: concern for allergy to the vax (4.8%) and prior C19 infection (4.8%). The common s.e of C19 vax reported in GU ca pts were injection site inflammation (19%), headache (4.8%), muscle/body aches (4.8%) but no lymphadenopathy. None of GU ca pts reported delay in Rx or progression of the disease due to C-19 vax. Conclusions: C19 vax were overall well tolerated and did not impact ca outcomes in pts with GU malignancies. Oncologists should discuss the importance of C19 vax in the context of ca. Clinical trial information: NCT04953065 . [Table: see text]

Differences in the tumor genomic landscape between African Americans (AA) and Caucasians (CA) advanced prostate cancer (aPC) patients (pts) by comprehensive genomic profiling (CGP) of cell-free DNA (cfDNA).

5058 Background: Emerging data suggest differences in the tumor genomic profile of AA compared with CA men with aPC. We hypothesized that there will be significant differences in the tumor genomic landscape between AA and Ca pts as detected by cfDNA CGP. Methods: Pts with aPC and available cfDNA CGP by the Guardant (G360) 73 gene panel were included. In addition, G360 74 gene panel was used to identify CDK12 mutation (not detected in 73 gene panel) in an independent cohort of aPC pts. Barnard’s test was used to evaluate the association between genetic mutation and gene. Genomic landscape was also compared by a Bayesian Network (BN) machine learning approach. Results: A total of 552 pts (125 AA, 427 CA) tested by G360 73 gene panel were included. Multiple genomic aberrations were enriched in AA patients (Table). In the independent cohort of 261 aPC patients (AA=106 pts, CA=155 pts) tested by G360 74 gene panel, CDK12 mutation was significant enriched in AA pts. (9.4% vs. 1.9%, p=0.006). Machine learning analysis supported these results, and will be presented at the meeting. Conclusions: These hypothesis generating data suggest significant differences in the tumor genomic profile between AA and CA pts with aPC. Identification of molecular drivers of tumor progression enriched in AA pts may allow development of tailored systemic therapy for these men, and decrease disparities in disease related outcomes. Data need external validation. PB,RR,MAB contributed equally to this work.[Table: see text]

Association of total neoadjuvant therapy with favorable clinical outcomes in patients with locally advanced esophageal and gastroesophageal junction adenocarcinomas (LA-GEJ CA).

231 Background: Both peri-operative chemotherapy and neoadjuvant chemoradiation have been shown to improve outcomes in patients (pts) with LA-GEJ CA compared to surgery alone. Rates of post-operative chemotherapy delivery remain suboptimal. Total neo-adjuvant therapy (TNT) in LA-GEJ CA - induction chemotherapy (IC) followed by concurrent chemoradiation (CRT) - may improve systematic delivery of neoadjuvant therapy and result in favorable clinical outcomes. Methods: We retrospectively reviewed medical records of 135 pts with LA-GEJ CA at our institution between 2/2007 and 11/2019; pertinent clinical data were abstracted with Institutional Review Board approval. Patients treated with IC and curative-intent CRT with ≥40 Gy dose of radiation for adenocarcinoma were included in this analysis (N = 59). Doublet or triplet IC regimens utilizing 5-Flurouracil(5-FU), Cisplatin/Oxaliplatin and Docetaxel were commonly administered while combinations of Carboplatin +Paclitaxel or 5-FU + Oxaliplatin were used in CRT. Clinical complete response (CCR) was defined as metabolic imaging and endoscopic biopsies negative for residual malignancy after completion of TNT. Patients were followed from diagnosis to recurrence and overall survival. Survival probabilities were estimated using the Kaplan-Meier method and compared between groups using a log-rank test. Results: Out of 59 evaluable pts, 69% were clinical stage T3, 71% were node positive. 37 pts (63%) underwent surgery, R0 resection rate was 89% (33/37), pathologic complete response (pCR) rate was 19% (7/37). Among the pts who did not undergo surgery, 41% (9/22) opted to forego surgery since they attained a CCR. For the entire cohort, median Disease-Free Survival (mDFS), median Overall Survival (mOS), and 3-yr OS were 2.4 yrs, 4.7 yrs, and 67% respectively. Pts who did not undergo surgery had a mDFS, mOS, and 3-yr OS of 1.5 yrs, 4.2 yrs, and 59% respectively. Median DFS, mOS, and 3-yr OS of patients who underwent surgery were 3.5 yrs, 5.8 yrs and 72% respectively. Patients who achieved a CCR and opted to forego surgery (N = 9) had a 3 -yr DFS of 42% vs 83% for pts (N = 7) who demonstrated a pCR after curative intent tri-modality therapy. (P = 0.0099) Interestingly, the same group that achieved CCR and opted out of surgery had 3yr OS of 89% vs 83% of those who demonstrated a pCR (p = 0.0042). Conclusions: TNT for pts with LA-GEJ CA is associated with high rates of R0 resection as well as excellent DFS and OS compared to historical controls, warranting prospective evaluation. The remarkable DFS and OS in patients who opted to forego surgery due to achieving CCR is reflective of the local and systemic control rendered by this approach. Careful characterization and close longitudinal follow-up of patients who achieve CCR may help identify a subgroup of LA-GEJ CA pts who may benefit from surgery sparing approaches.

First year outcomes of an initiative to increase BRCA testing among NCCN guideline-eligible breast cancer patients within a large community OCM practice.

1540 Background: Pathogenic variants in BRCA1/BRCA2 can affect a breast CA pts care: preventative interventions, surgical decisions, medical treatments, screening, and family counseling. National data suggests significant non-adherence to NCCN testing guidelines, with only 1/3 of eligible pts referred for genetic services. In 2018, OHC (Cincinnati) launched an APP-centric genetics program. Specially trained APPs carry out genetic counseling and order NCCN-compliant testing. Early data suggested a significant deficit in physician-driven referrals. From 1/01/18 - 07/31/18, 138 new breast pts were estimated to be NCCN guideline-eligible. Only 28 (20%) pts received genetic services. Methods: In 2019, the OHC genetics team implemented a standardized screening process for every new breast CA pt. An EMR template (iKnowMed G2) that included NCCN guidelines was created for initial breast CA consultation and Oncology Care Model (OCM) treatment planning. All pts, not just OCM pts, are subject to OCM treatment planning. This automated screening method ensured all breast CA pts were screened, drastically increasing compliance. Through integration of genetics screening into the templates, pts meeting NCCN criteria for testing are reflexively referred for genetic counseling. With USON/McKesson, integrated data fields were developed in the EMR to automate data collection. Results: From 01/01/19 – 12/31/19, 717 new breast CA pts were seen at OHC. 676/717 (94%) were screened. Of those screened, 279 new breast CA pts met NCCN criteria for BRCA testing. 140 (50%) eligible new pts had appts with the genetics team. Another 50 (18%) had confirmed testing outside of OHC. 57 (20%) refused appts and/or testing. 32 (11%) did not have appts, representing screen fails. Referrals in non-breast CA pts also increased by 127%; 604 (2019) vs 264 (2018) suggesting a halo effect. Analyses suggest the program to be economically viable, with a financial growth rate of 127%. Conclusions: EMR templates embedded with the NCCN guidelines for reflex genetics referral can appropriately increase the utilization of genetic services. Breast genetics screening and resultant appt/testing rates increased significantly 2019 vs 2018. Success in BRCA testing in breast CA will lead to expansion to other cancers and genes. Implementation of structured EMR genetics data fields can automate data collection and measure compliance. Integration of genetics screening into universal OCM treatment planning is feasible, economically viable and scalable.

Combination immunotherapy with ipilimumab and nivolumab in patients with advanced biliary tract cancers.

4588 Background: Patients (pts) with advanced biliary tract cancers (BTC) have a poor prognosis with first and second line chemotherapy resulting in modest survival benefits. Immunotherapy using single agent anti-PD-1 therapy has also shown low activity with an objective response rate (ORR) of less than 10%. Combined CTLA-4/PD-1 blockade using ipilimumab (ipi) and nivolumab (nivo) has demonstrated superior efficacy compared to single agent anti-PD-1 therapy in pts with advanced melanoma and renal cell carcinoma. To date, no trials in BTC pts with ipi/nivo therapy have been reported. Methods: 39 pts with metastatic BTCs were enrolled into the CA 209-538 clinical trial for rare cancers. Patients received nivo 3mg/kg and ipi 1mg/kg q 3 weekly for 4 doses, followed by nivo 3mg/kg q 2 weekly. Treatment continued for up to 96 weeks, or until disease progression or the development of unacceptable toxicity. Response (RECIST 1.1) was assessed every 12 weeks. The primary endpoint was clinical benefit rate (CBR = CR +PR + SD). Exploratory endpoints include correlation of efficacy with biomarkers including PD-L1 expression and tumour mutation burden. Results: 39 pts with BTC were enrolled and 33 pts (85%) had received at least one prior line of systemic treatment (0-2 lines). The ORR was 24% and the CBR 45% with the median duration of response not been reached (range 2-26+months). Responses were observed in 3/14 intrahepatic, 1/10 extrahepatic, 0/2 unspecified cholangiocarcinoma and 5/13 gallbladder ca pts. None of the responding pts had a microsatellite instable tumour. 2 pts with durable partial responses were subsequently rendered surgically free of disease. Median OS and PFS were 6.1 and 3.1 months respectively. 22 (56%) pts experienced an immune –related adverse event (irAE) with grade3/4 irAEs being observed in 8 (20%) pts. Conclusions: Combination immunotherapy with ipi/nivo demonstrates significant clinical activity in a subset of patients with advanced microsatellite stable BTC. The response rate compares favourably to clinical trials investigating single agent anti-PD-1 therapy. Clinical trial information: NCT02923934 .

Abstract 3129: Investigating the importance of prostate tumor location and symmetry in a racially diverse, military cohort

Abstract Introduction and objective Prostate cancer (CaP) tumor location (TL) and symmetry (TS), may help forecast CaP outcomes in radical prostatectomy (RP) patients. The study aim was to examine associations between CaP TL and TS with disease pathology and progression, including biochemical recurrence (BCR)-free survival especially whether such associations differ across race. Methods This retrospective cohort study included 1140 patients enrolled at the Walter Reed National Military Medical Center who underwent RP between 1993 and 2008. TL and TS were recorded for index tumors (i.e, largest/highest grade) in whole-mounted RP specimen sections. TLs were divided into coronal versus axial planes. For coronal plane, TL was sub-divided into anterior (A), antero-lateral (AL), lateral (L), postero-lateral (PL), posterior (P) and diffuse (D) (includes A, AL, L, PL and P). The axial plane locations included base (B), mid (M) and apex (A). Kaplan Meier (KM) estimation curves were used to model BCR-free and DM-free survival. Results Mean age at diagnosis was 59.3 years, 27.1% were African-American (AA) and 76.7% were non-symmetric (NST). According to KM analysis patients with NST experienced significantly worse BCR-free survival (p=0.003) with no racial differences found (CA: p=0.02, AA: p=0.04). Tumor location (coronal plane) distribution by race was: A and AL tumors (CA: 9.6%, 7.5% vs. AA: 9.5%, 5.5% respectively), D tumors (CA: 6.9% vs. AA: 9.4%, respectively), L tumors (CA: 9.3% vs. AA: 6.5%, respectively), P and PL tumors (CA: 21.2%, 45.6% vs. AA: 22.7%, 46.3%, respectively) (p=0.36). In the axial plane exclusively A or B tumors are rare (CA: 3.1%, 1.3% vs. AA: 2.6%, 0%, respectively) while exclusively M tumors are more frequent (CA: 27.9% vs. AA: 23%, respectively). Tumors spanning two axial location categories MA and BM tumors were (CA: 27.6%, 15.6% vs. AA: 34%, 8.4%, respectively). Tumors spanning three axial location categories BMA were (CA: 21.8% vs. AA: 30.7%, respectively) (p<.0001). No racial differences in BCR-free survival were observed for D (CA: p<.0001, AA: p=.07) or BMA (CA p<.0001; AA p=0.0004) tumors. The share of tumors with nuclear grade III in D or BMA location categories was (10.5% and 7.2%, respectively; p<.0001) while the difference in NST and ST was (4.2% vs. 0.8%, p=.0002). Conclusions In this longitudinal, racially diverse cohort of RP patients, TL and TS were informative features in predicting BCR. However, this study did not find evidence of racial differences in these associations with the exception of axial tumor location. These findings have implications for treatment stratification at time of RP. Citation Format: William Gesztes, Grant Williams, Jennifer Cullen, Allen Burke, Denise Young, Justin Mygatt, Yongmei Chen, Huai-Ching Kuo, Shiv Srivastava, Kevin Rice, Inger Rosner, Isabell Sesterhenn. Investigating the importance of prostate tumor location and symmetry in a racially diverse, military cohort [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2019; 2019 Mar 29-Apr 3; Atlanta, GA. Philadelphia (PA): AACR; Cancer Res 2019;79(13 Suppl):Abstract nr 3129.

Association of polybromo-associated BAF (PBAF) complex mutations with overall survival (OS) in cancer patients (pts) treated with checkpoint inhibitors (ICIs).

103 Background: ICIs have shown benefit across several metastatic carcinomas, yet predictive biomarkers are still lacking. 20% of malignancies harbor alterations in ≥1gene that is part of PBAF complex. With recent data suggesting an association between PBRM1 mutations (mts) and outcomes in renal cell carcinoma (RCC) pts treated with ICIs (Miao, Science, 2018), we examined the association between PBAF mts and OS in ICI-treated patients across several solid cancer (ca) types. Methods: Of 6007 pts with different ca histologies and targeted exome sequencing (Oncopanel) at Dana Farber Cancer institute (DFCI), 138 pts had truncating mts in any PBAF gene (SMARCA4, PBRM1, and ARID2) or oncogenic missense mts in SMARCA4 and were treated with ICIs. 138 histology-matched DFCI pts had none. A publicly-available cohort (2:1 histology matched) from Memorial Sloan Kettering (MSKCC) (Samstein et al., Nature Genetics, 2019) of 621 ca pts (PBAF mutant [MT] = 207, PBAF wild type [WT] = 414) treated with ICIs was analyzed for association between PBAF mts and OS. OS was defined from time from ICI initiation. OS was compared by Cox regression between PBAF MT and PBAF WT. Hazard ratio (HR) was derived using univariable and multivariable analysis (MVA) adjusted for ICI regimen (single vs combination) and age. Results: Median (Md) follow-up for the combined cohort (n = 897) was 27 months (m). Major histologies were non-small cell lung ca (268; 29.9%), melanoma (220; 24.5%), RCC (181; 20.2%), and bladder ca (65; 7.2%). Results on univariable and MVA analyses from individual and combined cohorts are presented below. Conclusions: PBAF mts are associated with survival in ICI-treated ca pts. Work in progress with non-ICI treated pts will determine if this is prognostic or predictive of response. [Table: see text]

Aberrations in androgen receptor ctDNA varies by race in metastatic castrate-resistant prostate cancer.

247 Background: Characterization of circulating free DNA (ctDNA) may aid understanding of the pathophysiology of metastatic castrate resistant prostate cancer (mCRPC). The goal of this study was to evaluate and compare somatic alterations in ctDNA between African-American (AA) and Caucasian (C) mCRPC patients. Methods: 24 AA were retrospectively case-matched by prior treatment with 45 CA mCRPC; ctDNA was assessed with Guardant360 assay (Guardant Health, Redwood City, CA). Mutant allelic fraction, mutations, and gene amplification were compared. Results: Prior to testing, 6 AA pts and 12 CA pts had 0 lines of CRPC therapy, 7 AA pts and 10 CA pts had 1-2 lines, 5 AA and 17 CA had 3-4 lines, 5 AA and 2 CA had 5-6 lines, and 1 AA pt and 4 CA pts had >6 lines. The median Gleason score was 8, regardless of race. The median ctDNA mutant allelic fraction was 0.40% for AA pts and 0.60% for the CA pts. Mutations and/or amplifications in individually assessed genes are shown in the Table. No statistically significant differences were detected except for the androgen receptor (AR) gene where alterations (mutations and/or amplifications) were more frequent in AA as compared to C (p=0.04). Conclusions: AR alterations were more commonly detected in ctDNA in AA men as compared to C suggesting that AR driven pathophysiology may predominate in this setting. Additional analyses with a larger cohorts are warranted. Data from prospective trials in mCRPC using abiraterone/prednisone (George et al. LBA 5009, ASCO 2018) similarly suggest that mCRPC may be comparatively more AR driven in this racial setting. Alterations in ctDNA compared between AA and C men with mCRPC. [Table: see text]

Increased access for and enhancement of cancer (ca) patients (pts) participation (par) in clinical trials (cts) by alleviation of financial toxicity.

24 Background: Prognosis for pts is increasing as a result of advances in cts. However, the degree to which cancer caused financial problems may influence ca pts par in cts and negatively impact quality of life. Excess financial burden of cts par, may include finding an appropriate trial, traveling to the trial site, travel costs, lodging and medical expenses. The Lazarex Cancer Foundation (LCF) was founded in 2006 with mission to improve care, giving hope, dignity, and life to advanced ca pts by providing assistance with options and costs to cts par, community outreach, and education. LCF developed processes to removing the barriers to cts par by improving equitable access to cancer care, increasing cts enrollment, retention and minority par, and increasing cts referrals. Methods: To determine the extent of benefit of LCF, we conducted a retrospective analysis of LCF beneficiaries participating in cts by reviewing and summarizing the number of pts, states and countries of residence, age, type of cancer, location and distance to cts site, type of assistance, and number of advocacy/outreach. Results: From 1/01/2010 – 12/31/2016 2179 pts were assisted financially; age range 1-102 yrs, median 50-60; (43%) male, (53%) female, (3.4%) undeclared. (6.4%) were African American, 10.3% Hispanic, 3.6 Asian Pacific Islander, other minority 2.1, and Caucasian 72.7%;total minority 22.5%. Pts resided in 50 states with largest CA , TX , MA , and FL. Cts were at 199 sites – 43 NCI CCC, 7 NCI DCC and 149 other cancer centers. Most common diagnoses were breast, leukemia, colorectal cancers. type tumors. Median household income was $75,000. Financial assistance to travel to and living expenses at the cts site was the most frequently identified need. Conclusions: Relieving pts of financial burden allows greater access to and participation in cancer clinical trials. Further research and greater resources are needed to define patient needs and determine methods to eliminate barriers to enrollment and retention investigate coverage thresholds that minimize adverse financial outcomes and identify ca pts at greatest risk for financial toxicity to increase par in cts.

Abstract P6-10-04: Determining the optimal vaccination strategy using a combination of the folate binding protein (FBP) peptide vaccine (E39+GM-CSF) and an attenuated version (E39') to maximize the immunologic response in breast cancer patients

Abstract BACKGROUND FBP is overexpressed in 20-50% of breast(B) cancers(Ca) and roughly 90% of endometrial(E) and ovarian (Ov) Ca. E39 (FBP191-199, EIWTHSYKV)+GM-CSF is an HLA-A2 restricted FBP peptide vaccine, which has been shown to generate significant in vivo immunologic response(IR) in a phase I/IIa trial in E Ca and Ov Ca patients (pts). There is a risk of inducing immunologic tolerance after multiple inoculations with a highly immunogenic vaccine. Thus, we are investigating a novel vaccination series using combinations of E39 and E39' (EIWTFSTKV, an attenuated version of E39) in a phase Ib, randomized, single-center trial. We are assessing short and long-term IR. Here, we present the initial IR analysis to the primary vaccination series (PVS) within B Ca pts. METHODS HLA-A2 positive B or Ov Ca pts were enrolled after completion of standard of care therapy and randomized into three arms: EE (6 inoculations of E39); EE'(3 inoculations of E39, then 3 of E39'); or E'E(3 of E39', then 3 of E39). Theoretically, due to lower FBP expression and less aggressive chemotherapy regimens, B Ca pts are more antigen naïve and have a less suppressed immune system. Thus, only B Ca pts were included in this analysis. The PVS includes 6 inoculations total (R1-R6), one every 3-4 weeks, and containing 250mcg GM-CSF+500mcg peptide in the first 5 pts per arm and 1000mcg of peptide in second 5 pts. To assess the in vivo IR, local reaction(LR) was measured 48 hours after each inoculation (R1-R6), and delayed type hypersensitivity(DTH) was measured pre-PVS (R0), 1, and 6-months post-PVS (RC1, RC6). Ex vivo IR was measured via dextramer assay for E39-specific CD8+ T-cells at R0, RC1, and RC6. Statistical analyses were completed using appropriate tests. RESULTS Thirty-five B Ca pts were enrolled, with 27 completing the PVS (EE n=10, EE' n=8, E'E n=9). No clinicopathologic differences between groups or significant toxicities > grade 2 were appreciated. LR increased from R1 to R6 in all groups (ΔEE= 24.80mm, p=0.14; ΔEE'=38.13mm, p=0.07; ΔE'E=8.05mm, p=0.38), the greatest increase approaching statistical significance in the EE' arm. The only arm with a statistically significant increase for in vivo DTH from R0-RC1-RC6 was in the EE' arm (ΔEE=-6.17mm, p=0.27; ΔEE'= 44.58mm, p<0.05; ΔE'E=-1.42, p=0.37). Ex vivo analysis of IR revealed no significant difference between groups at R0(p=0.45) or RC6(p=0.72), nor within groups over time (EE p=0.32, EE' p=0.47, E'E p=0.30). CONCLUSION In this phase Ib trial analyzing the IR of B Ca pts receiving a different vaccination strategy, both peptides were noted to be safe and immunogenic. While no difference was seen in E39-specific CD8+ T cells between groups, the in vivo response was enhanced with the use of E39' after E39; this may indicate expansion of more effective clonal populations of CD8+ T cells with this strategy. These results may be specific to B Ca pts who are relatively antigen-naïve with relatively intact immune systems. Further analysis of these pts as this trial continues will determine the optimal vaccination strategy capable of stimulating and maintaining an IR to prevent B Ca recurrence. Citation Format: Jackson DO, Qiao N, Peace KM, Hale DF, Vreeland TJ, Greene JM, Berry JS, Trappey AF, Clifton GT, Ibrahim N, Toms A, Peoples GE, Mittendorf EA. Determining the optimal vaccination strategy using a combination of the folate binding protein (FBP) peptide vaccine (E39+GM-CSF) and an attenuated version (E39') to maximize the immunologic response in breast cancer patients [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P6-10-04.

Clinical Impact of KMT2C and SPRY4 Expression Levels in Intensively Treated Younger Adult Acute Myeloid Leukemia Patients

Background:Recent publications suggest important roles of lysine methyltransferase 2C (KMT2C, located on 7q) and sprouty 4 (SPRY4, located on 5q) as candidate genes in leukemogenesis of acute myeloid leukemia (AML). The prognostic impact of the gene expression levels (ELs) of both genes on outcome in AML patients (pts) is currently unclear.Aim:To evaluate the prognostic impact of KMT2C and SPRY4 expression in correlation to clinical characteristics and genetic abnormalities assessed at diagnosis in a cohort of intensively treated adult AML pts.Methods: We retrospectively studied 268 AML pts (median age, 48 years; range, 17-60 years) who had been enrolled on 2 AML SHG trials (0295 and 0199, n=148; only normal cytogenetics pts (CN)) and the SAL-AML2003 trial (n=120; only abnormal cytogenetics pts (CA)). Acute promyelocytic and core-binding factor leukemia pts were excluded. Type of AML was de novo in 235 (88%), secondary in 19 (7%) and therapy-related in 14 (5%) of the 268 pts. Regarding baseline characteristics, CN pts had significantly higher white blood counts (WBC; p=0.001) and blast cells in peripheral blood (p=0.02) as compared to CA pts; all other factors were comparable. Cytogenetic analyses could be performed in 263 (98%) of the 268 pts. Cytogenetic risk classification according to ELN guidelines was intermediate-II in 55 (47%) and adverse in 63 (53%) of the CA pts, respectively. Abnormalities (abn) of 5q were present in 21 (18%) and abn of 7q in 16 (14%) of the CA pts. NPM1 and FLT3-ITD were analyzed in 145 (98%) of the CN pts. Of those, 59 (41%) were only NPM1 positive (pos), 12 (8%) were only FLT3-ITD pos, 34 (23%) were double pos and 40 (28%) were double negative (neg).KMT2C and SPRY4 ELs, normalized to ABL1and log2-transformed for analysis, were measured in triplets on cDNA obtained at diagnosis by RT-qPCR. Based on cDNA availability, KMT2C ELs could be analyzed in 143 (97%) of the CN and in all of the 120 CA pts, respectively. SPRY4 ELs could be measured in 30 (21%) of the CN and 107 (89%) of the CA pts, respectively.Results: KMT2C ELs were significantly lower in CN pts with de novo as compared to secondary AML (p= 0.02), whereas there was no difference in CA pts. No significant association was found for SPRY4 and type of AML. KMT2C ELs were significantly lower in FLT3-ITD pos as compared to FLT3-ITD neg CN pts (p=0.046), whereas there was no difference for SPRY4 ELs between the two groups (p=0.57). In addition, there was a significantly lower KMT2C expression in CN pts with intermediate-I risk as compared to NPM1 pos / FLT3-ITD neg pts (p=0.01). Regarding CA pts, there was no difference of KMT2C or SPRY4 ELs in adverse as compared to intermediate-II risk pts (p=0.08; p=0.20, respectively). When focusing on specific subgroups, KMT2C ELs were significantly lower in abn7q CA pts as compared to those without abn7q (p=0.002), whereas there was no difference of SPRY4 ELs in CA pts with or without abn5q (p=0.27). In univariate analysis higher SPRY4 ELs showed a significant favorable impact on relapse-free (RFS, p=0.03) and a trend towards a beneficial impact on overall survival (OS, p=0.06) for CA patients. A similar effect for KMT2C was not observed (RFS, p=0.96; OS, p=0.92). In subgroup analyses of pts with adverse risk cytogenetics, there was no impact of KMT2C or SPRY4 ELs on RFS (p=0.73; p=0.39) or OS (p=0.49; p=0.46), respectively. The same was true for FLT3-ITD pos CN pts (RFS, p=0.73; p=0.37; OS, p=0.91; p=0.36, respectively). In multivariate analyses on RFS and OS in CA pts including age, gender, KMT2C and SPRY4 ELs, logarithm of WBC, blast cells in bone marrow and cytogenetic risk group as variables, only higher age (OS, Hazard ratio (HR),1.28 per 10 years; 95%-confidence interval (CI): 1.02-1.59; p=0.03) and complex karyotype as compared to intermediate-II risk cytogenetics (RFS, HR: 2.25; 95%-CI: 1.20-4.22; p=0.01; OS, HR: 2.97; 95%-CI: 1.65-5.35; p<0.001) had an adverse impact. An effect of KMT2C or SPRY4 on RFS (p=0.84; p=0.16) or OS (p=0.85; p=0.45) was not found in the multivariate setting. In addition, in a multivariate model on CN pts (risk class according to NPM1 and FLT3-ITD mutational status instead of cytogenetic risk class) neither KMT2C nor SPRY4 had an impact on RFS (p=0.13; p=0.39, respectively) or OS (p=0.36; p=0.56, respectively).Conclusions:Lower KMT2C and SPRY4 ELs are associated with distinct genetic risk groups. An impact on prognosis was evident in univariable analyses for SPRY4 but not for KMT2C ELs in CA pts. DisclosuresKayser:Novartis: Consultancy. Platzbecker:Amgen: Honoraria, Research Funding; Novartis: Honoraria, Research Funding; TEVA Pharmaceutical Industries: Honoraria, Research Funding; Janssen-Cilag: Honoraria, Research Funding; Celgene Corporation: Honoraria, Research Funding. Heuser:Tetralogic: Research Funding; Novartis: Consultancy, Research Funding; Celgene: Honoraria; Bayer Pharma AG: Research Funding; Pfizer: Research Funding; Karyopharm Therapeutics Inc: Research Funding; BerGenBio: Research Funding. Thiede:AgenDix: Employment, Other: Ownership.

Impact of financial burden on information and opportunity for cancer (ca) patients' (pts) participation (par) in clinical trials (cts).

166 Background: The degree to which cancer caused financial problems may influence ca pts par in cts and negatively impact quality of life (QoL). Financial burden of cts par, may include finding an appropriate trial, traveling to the trial site, paying for travel, lodging and some medical expenses. The Lazarex Cancer Foundation (LCF) was founded in 2006 with mission to improve care, giving hope, dignity, and life to advanced ca pts by providing assistance with options and costs to cts par, community outreach, and education. LCF developed processes to removing the barriers to cts par by improving equitable access to cancer care, increasing cts enrollment, retention and minority par, and increasing cts referrals. Methods: To determine the extent of benefit of LCF, we conducted a retrospective analysis of LCF beneficiaries participating in cts by reviewing and summarizing the #pts, states and countries of residence, age, type of cancer, location and distance to cts site, type of assistance, and #of advocacy/outreach. Results: From 1/01/2010 – 12/31/2015 1479 pts were assisted; age range 4-86 yrs, median 50-60; 638(43%) male, 790 (53%) female, 51 (3.4%) undeclared. 434 did not give racial/ethnic identity; of 1045, 67 (6.4%) were African American, 108 (10.3%) Hispanic, 38 (3.6) Asian Pacific Islander, other 22 (2.1), and Caucasian 760 (72.7%) –total minority 235 (22.5%). Pts resided in 49 states with largest CA-280, TX-131, MA-119, FL-81. Cts were at 115 sites; 38 NCI CCC, 8 NCI DCC. The most common diagnoses were breast-116, leukemia-87, colorectal-48 and many rare type tumors. The median household income was $75,000. Financial assistance to travel to and living expenses at the cts site was the most frequently identified need. Conclusions: Relieving pts of financial burden allows greater access to and participation in cancer clinical trials. Further research and greater resources are needed to define the patient needs and determine methods to eliminate and remove barriers to enrollment and retention. Future research should investigate coverage thresholds that minimize adverse financial outcomes and identify ca pts at greatest risk for financial toxicity to increase par in cts and enhance QoL.

Phase I/II trial of IMMU-132 (isactuzumab govitecan), an anti-Trop-2-SN-38 antibody drug conjugate (ADC): Results in patients with metastatic gastrointestinal (GI) cancers.

703 Background: Trop-2 is a tumor-associated glycoprotein highly expressed in many epithelial cancers. Elevated expression has been linked to more aggressive disease and a poorer prognosis. IMMU-132 is an ADC comprising a humanized mAb binding to Trop-2 and conjugated to SN-38 (drug: Ab ratio = 7.6), the active metabolite of irinotecan. After finding potent activity in human tumor xenografts, a phase I/II trial was undertaken (NCT01631552). Methods: Pts with relapsed/refractory metastatic cancers were enrolled, starting at a dose of 8 mg/kg given on days 1 and 8 of a 3-week cycle. Dose levels of 8 and 10 mg/kg were chosen for phase II (N=47). Results: Sixty pts with advanced GI cancers were enrolled in phase I/II. Neutropenia was the principal dose-limiting toxicity, with fatigue, diarrhea, nausea, and vomiting as other reported toxicities. In the phase II pts with median prior therapies of 3 (range 1-7), the following moderate/severe drug-related toxicities occurred: neutropenia (Gr 3, 18.8%; Gr 4, 10.4%); fatigue (Gr 3, 14.6%; Gr 4, 0%), anemia (Gr 3, 10.4%; Gr 4, 0%); diarrhea (Gr 3, 4.2%; Gr 4, 0%). Of 29 CRC pts (10 mg/kg [N=9], 8 mg/kg [N=20]), 1 had a PR and 14 had SD as the best response by RECIST, with a time to progression (TTP) of 11.5+ months (mo) for the PR (65% shrinkage) and a median of 4.8+ mo for the SD pts (5 ongoing). This is a disease control rate (DCR) of 51.7%. Thirteen CRC pts had KRAS mutations, 7 with SD (median TTP = 4.4+ mo [range, 2.8-7.8 mo; 3 ongoing]). Of 15 pts with pancreatic ca, 8 had SD as best RECIST response (median TTP = 3.4 mo); DCR=53.3%. Among 11 pts with esophageal ca, 7 had CT assessments with 1 PR (TTP, 6.9+ mo), and 4 SD (TTP, 4.0+, 5.0, 6.0, and 6.9 mo) as best response; DCR=62.5%. Of 5 gastric ca pts, only 3 had post-baseline CT assessments, all with SD (1 with 19% target lesion reduction and an ongoing TTP of 6.7+ mo). Conclusions: IMMU-132 is a novel anti-cancer therapeutic, conjugating a topoisomerase I inhibitor to an internalizing, cancer-selective mAb. This ADC can be given safely and repeatedly over many months to heavily pretreated patients. Encouraging activity in pts with several metastatic gastrointestinal tumors has been observed. Clinical trial information: NCT01631552.

Clinical efficacy of accelerated partial-breast irradiation in treatment of ER-negative breast cancer: Results of a matched pair analysis.

70 Background: To assess outcomes of ER-negative breast CA pts treated with APBI, a matched-pair analysis was performed to determine efficacy of APBI vs whole breast RT (WBRT) from a single institution. Methods: From over 1650 pts treated with BCT from 1980-2013, a cohort of ER[-] pts treated with APBI or WBRT were investigated. Matched-pair analysis with a 1:1 ratio paired 79 APBI with 79 WBRT pts, all ER[-] (total:158). Match criteria included follow-up (FU) &gt; 1.0 yr, stage, &amp; age +/- 5 yrs. Outcomes analyzed included local recurrence (LR), true recurrence/marginal miss (TRMM), regional recurrence (RR), distant metastases (DM), disease-free (DFS), cause-specific (CSS), and overall survivals (OS). Results: As for clinical-pathological traits, no significant differences were noted for age (p=0.302), T-stage (p=1.000), tumor size (p=0.721), N-stage (p=0.062), use of chemoRx (p=0.747), endocrine Rx(p=0.408) or Herceptin (p=1.00). Per ASTRO Guidelines, no differences were seen in cautionary or unsuitable [UnS] groups between APBI &amp; WBRT (p=0.333). With a mean FU of 8.0 yrs (10.1 yrs APBI; 8.4 yrs WBRT p&lt;0.001), no differences were seen in the 10-yr actuarial rates of LR (9.3% vs 22.1% p=0.094), RR (1.3% vs 8.1% p=0.299), DM (7.1% vs 13.0% p=0.429), DFS (83.9% vs. 72.5% p=0.214), CSS (93.5% vs. 89.0 % p=0.677), or OS (79.6% vs. 80.1% p=0.573) between APBI &amp; WBRT. Only TRMM was significantly different (0% APBI vs 12.5% p=0.011). In stratifying patients based on ER% (0%, 1-3%, 4-8%) no outcome differences were noted. Of the 158 ER[-] pts, 124 were cautionary with similar 10-yr outcomes except for TRMM (0% APBI;WBRT 14.4% p=0.017) &amp; CLBF (0% APBI;WBRT17.1% p=0.019). For the 34 UnS patients, no endpoint differences were seen APBI vs WBRT. But, when the entire 158 ER[-] patients were analyzed for # of UnS factors, increasing UnS factors led to significant risk of RR (p&lt;0.001) &amp; DM (p=0.002). Conclusions: With 10-year FU of APBI for ER[-], the clinical results were equivalent to WBRT. No differences were noted based on ER%. Increasing number of unsuitable factors had more RR and DM. Maturation of randomized trial data will be needed to provide Class I evidence for equivalence of APBI to WBRT in ER[-] patients.

Comparison of predictors of survival in colon and rectal cancer patients.

e14681 Background: We studied comorbidity and other predictors of survival for patients (pts) with colorectal cancer (CRC) and compared pts with colon (C) vs rectal (R) cancer (ca). Methods: In an IRB-approved protocol, we reviewed the records of pts diagnosed with CRC at a VA medical center from 01/01/2003 to 12/31/2011 for demographics, stage, grade, ECOG performance status (PS), CEA, Hemoglobin (HGB), and Albumin (ALB) at diagnosis (dx). Comorbidity was assessed with the Charlson Comorbidity Index (CCI), the Cumulative Illness Rating Scales (CIRS), and the Kaplan-Feinstein Index (KFI). Statistical analyses were performed with SAS 9.2/Stata 11.0. We compared the pts with C vs R ca. Results: There were 279 men. 191 pts (68.5%) had C ca and 88 pts (31.5%) had R Ca. The two groups were similar for stage, grade, age, HGB, CEA, ALB, and ECOG PS. For R ca pts, Median (M) CCI is 3.7 (0.4-13.9), M CIRS15 2.5 (0-5), M CIRS16 5 (0-13), M CIRS 17 2.0 (0-8), M CIRS18 0 (0-1), M CIRS19 0 (0-1), and M KFI 1 (0-3). For C ca pts, M CCI is 4.3 (0.9-19.6), M CIRS15 3.0 (0-6), M CIRS16 6.0 (0-13), M CIRS17 2.0 (0-9), M CIRS18 0 (0-1), M CIRS19 0 (0-2), and M KFI 2 (0-3). In univariate analysis, stage, ECOG PS, HGB, and ALB were significant survival predictors in R ca pts. Age, stage, grade, ECOG PS, HGB, CCI, CIRS16, CIRS17, CIRS19 and KFI were significant for C ca pts. Other significant multivariate predictors are summarized in the table. R ca pts are more likely to die (P=0.003, HR=0.51). Conclusions: In this larger population of pts with CRC, we confirmed our previous findings (ASCO 2012 e14125). Grade, stage, ECOG PS, and CIRS 19 are important independent survival predictors for veterans with CRC. Age, grade, stage, ECOG PS, CCI, CIRS 16 and CIRS 19 are independent predictors for colon ca pts. Only Stage and ECOG PS are independent predictors for rectal ca pts. Rectal ca pts are at increased risk of dying. More research is needed to confirm this. Supported by New Jersey Commission for Cancer Research. [Table: see text]

Standardizing quality breast cancer care throughout all New York university facilities.

160 Background: NYU physicians provide breast cancer care (BCC) at several locations throughout New York. The NYU Clinical Cancer Center (NYUCCC) is a private, university-based facility while Bellevue and Woodhull Hospitals are city hospitals. The diversity of BCC provided to patients (pts) in city hospitals can vary greatly from that of private centers and intra-center physician variability also diversifies care. This variability can impact on pt satisfaction and outcomes. Breast cancer (Br Ca) pts make up the greatest number of pts seen and treated at all NYU affiliated sites, therefore, a "Br Ca Quality of Care Program" will be incorporated into the electronic medical record (EMR) at all facilities. A treatment algorithm based on the pt’s stage and a simple "drop-down menus" will simplify use. It will encompass diagnostic imaging, pathology, biopsy procedures, surgery, radiation, chemo, and hormonal therapy as well as survivorship guidelines for maintaining wellness. Methods: Leaders of each Br Ca program have identified potential barriers to care and rectifiable issues. Algorithms and “drop down menus” in the EMR will be presented to the NYUCCC Br Ca physicians for feedback. This tool will then be refined and launched at NYUCCC. After evaluating this program at NYUCCC, the data will be presented to the all NYUCCC faculty. Achieving the city hospitals to adopt this EMR program will be the ultimate success and standardized quality care will be the result. Results: An assessment of the endpoints of physician adherence to guidelines, cost effectiveness and pt/provider satisfaction will be conducted 6 months later. Random audits of breast cancer pt charts will evaluate provider compliance. A cost analysis of this care will be done and compared to a random sampling of previously treated pt charts. Review and analysis of this data would be presented to the NYUCCC faculty, then programs launched at both city-hospitals. Conclusions: If the endpoints of quality standardized care, cost effectiveness and pt/provider satisfaction are met, incorporation of similar programs into other high volume oncologic disease entities seen at all NYU facilities would be developed.