Non-cancer Pts Research Articles

Comparing the characteristics and outcomes of hospitalizations between cancer and non-cancer survivors.

12138 Background: Cancer prevalence is rising, with a corresponding increase in hospitalizations across the cancer continuum. However, little is known about how in-hospital patterns of care and outcomes of cancer survivors compare with non-cancer survivors as administrative data may not capture in-hospital details (e.g., investigations and medications) required for characterization. Understanding differences in how cancer and non-cancer inpatients are managed and their outcomes can help optimize their acute care delivery. Methods: In a multicenter registry of all patients (pts) admitted to medical wards across 26 hospitals (Ontario, Canada) from 2015-2022, we deterministically linked population-level administrative data, including ambulatory oncology data for cancer survivors, with each hospital’s electronic information (pharmacy, orders, notes, laboratory, imaging) at the patient level. Multivariable regression models compared resource use and outcomes between cancer and non-cancer pts for the top 5 discharge diagnoses among non-cancer pts. Results: Of 1,221,067 hospitalizations belonging to 666,569 pts, 30% of medical ward hospitalizations were for pts with a cancer history, with median admission date 4 years post-diagnosis; most common cancer sites were genitourinary (21%), gastrointestinal (20%), breast (12%), lung (10%). Most common discharge diagnoses among cancer pts were heart failure (HF) (5%), palliative care (5%), urinary tract infection (UTI) (2%), pneumonia (2%) renal failure (2%); while for non-cancer pts were HF (5%), myocardial infarction (3%), coronary artery disease (3%), COPD (2%) and UTI (2%). Compared to non-cancer pts, cancer pts were older (72 vs 66), had greater length of stay (LOS; 10 vs 8.7 days), in-hospital mortality (11% vs 6%) and 30 day re-admission rates (16% vs 11%) and were more likely to receive CTs (21% vs 15%), MRIs (9% vs 8%) and interventional procedures (6% vs 4%) (p < 0.001, all comparisons). When evaluating the top 5 discharge diagnoses among non-cancer patients, cancer survivors had higher LOS (aOR=1.06 95% [1.05-1.07] p<0.001), in-hospital mortality (aOR=1.20 [1.14-1.26] p<0.001), and 30 day re-admission rates (aOR=1.24 [1.14-1.35] p<0.001) and were more likely to receive CTs (aOR=1.25 [1.21-1.30] p<0.001), MRIs (aOR=1.36 [1.25-1.48] p<0.001) and interventional procedures (aOR=1.36 [1.25-1.47] p<0.001). Subgroup analyses focusing on cancer survivors admitted 3 and 5 years out from their diagnosis showed resource use and outcomes were closer to non-cancer patients. Conclusions: Cancer survivors represent a unique population on medical wards and have higher resource use, mortality and LOS compared to non-cancer patients, even for the same non-cancer diagnoses. Specialized models of care for hospitalized cancer survivors may be warranted, in particular for those admitted closer to their diagnosis date.

Abstract C139: The robustness of a targeted methylation-based multi-cancer early detection (MCED) test to population differences in self-reported ethnicity

Abstract Background: DNA methylation (Me) is known to vary by race and ethnicity; cell-free DNA-based MCED tests must detect cancer-specific Me in the presence of this variation to be useful as a screening tool. Clinical study cohorts, however, often do not reflect the screening population. Additionally, underserved populations who may benefit most from improved cancer screening are often underrepresented. We sought to evaluate the robustness of an MCED test to detect cancer-specific Me patterns across self-reported ethnicity (SRE) in the training (N = 4487) and validation (N = 5309) datasets from the 15254-participant (pts) Circulating Cell-free Genome Atlas (CCGA; NCT02889978) study. Methods: To understand MCED test performance across SRE, we assessed concordance between ancestry and SRE by genotype in CCGA. We then conducted two in silico experiments to assess the robustness of the MCED test to differences in SRE. First, MCED test classifier scores from 1254 non-cancer pts from the validation cohort were regressed against covariates of sex and SRE, with smoking status and age included as potential confounders. Two SRE groups were considered for the analysis: White, non-Hispanic (W; 996 pts) and all other non-White SRE (NW; 258 pts). Second, to evaluate classifier generalization across SRE, two experimental MCED test classifiers (single SRE, S; multiple SRE, M) were trained similarly to the MCED test with intentionally skewed SRE compositions: S with 100% W pts and M with all available NW pts (20% NW). The training sets for both classifiers further included pts from STRIVE (NCT03085888) and matched on demographics (age, sex, smoking status), number of pts, samples, cancer type and stage. Sensitivity (at 99.4% specificity) and accuracy of cancer signal origin (CSO) prediction for the two classifiers were assessed in a separate held out population of 507 NW cancer pts. Results: Ancestry and SRE by genotype were in good agreement with >95% concordance in CCGA study pts. Neither sex, smoking status, nor SRE were significantly correlated with MCED classifier scores; age was weakly (r2 < 0.01) associated. In the classifier training experiment, both S and M performed nearly identically for sensitivity (S: 57% [95% CI: 53-62], 290/507 vs M: 57% [52-61], 288/507; McNemar test, P > 0.5) and CSO prediction accuracy (S: 90% [86-93] 262/290 vs M: 91% [88-94] 263/288) in a diverse population of NW cancer pts, despite the relatively large difference in SRE training composition. Neither analysis detected a significant contribution from Me patterns associated with SRE on classifier performance. Conclusions: Though DNA Me differences are known to occur across SRE, MCED classifier scores were comparable across non-cancer pts in SRE groups. Similarly, cancer signal detection in a NW population was comparable regardless of classifier training exposure. These findings indicate that detection of invasive cancer by the MCED test is not strongly influenced by SRE. Ongoing interventional studies of the MCED test are targeting enrollment of population-representative SRE. Citation Format: Oliver Venn, Joerg Bredno, Alexis Thornton, Earl Hubbell, Kathryn Kurtzman, John Beausang, Charles Swanton. The robustness of a targeted methylation-based multi-cancer early detection (MCED) test to population differences in self-reported ethnicity [abstract]. In: Proceedings of the 16th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2023 Sep 29-Oct 2;Orlando, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2023;32(12 Suppl):Abstract nr C139.

216. A Comparison of Multidrug-Resistant Gram-negative Bacteremia in Cancer and Non-Cancer Patients

Abstract Background Multidrug-resistant gram-negative bacteremia (MDR-GNB) is a growing threat worldwide as it is associated with increased morbidity and mortality. We sought to describe the clinical features of MDR-GNB and outcomes in cancer and non-cancer Pts. Methods We performed a retrospective study of adult patients with MDR-GNB at the Ochsner LSU Health Shreveport between January 2018 and July 2022. We collected patients' demographics, medical comorbidities, cancer diagnosis, causative bacteria (MDROs), source of bacteremia, antibiotics therapy, and clinical outcomes. Results We identified 112 Pts with MDR-GNB. Pts were divided into 2 groups: cancer group (n=33, 29%) and non-cancer group (n=79, 71%). In the cancer group, the majority of Pts had solid tumors (n=20, 61%) vs liquid tumors (n=13, 39%). Mean age was 69 y in cancer compared to 57 y in the non-cancer group. Enterobacteriaceae were isolated in 28 cancer Pts (85%) including ESBL E. coli in 20 Pts (61%), Klebsiella s.p (CRE/ESBL) in 5 Pts (15%), and ESBL P. mirabilis in 3 Pts (9%). Pseudomonas aeruginosa CRO in 3 Pts (9%) and A. baumannii in 2 Pts (6%). In non-cancer Pts, Enterobacteriaceae were isolated in 65 Pts (82%) including ESBL E. coli in 40 Pts (51%), Klebsiella s.p (CRE/ESBL) in 18 Pts (23%) and ESBL P. mirabilis in 6 Pts (8%). P. aeruginosa CRO found in 6 Pts (8%) and A. baumannii in 8 Pts (10%). The sources of bacteremia in cancer group were UTI in 14 Pts (42.4%), osteoarticular infection (OAI) in 5 Pts (15%), pneumonia in 3 Pts (9%), CLABSI in 2 Pts (6%), endovascular in 1 Pt (3%) and unknown in 8 Pts (24%), whereas in non-cancer group, UTI was reported in 40 Pts (68%), pneumonia in 9 (27%), OAI in 1 (1.3%), endocarditis in 1 Pt (1.3%), and unknown in 20 Pts (25.3%). Mean duration of targeted antibiotics was 9 days in cancer vs 13.3 days in non-cancer group (p-value=0.4). Mean length of hospital stay was comparable, 34 d in cancer vs 31 d in non-cancer(p-value= 0.87). 9 Pts were admitted to ICU in cancer group (27%) vs 39 Pts (49%). Mortality rate was 39% in cancer (8 pts went to hospice) vs 16.4% in non-cancer. Conclusion Our data showed that the common source of MDR-GNB remains urinary tract infection in both groups and the bacterial epidemiology is comparable between the two groups. Further studies are warranted to assess the impact of resistant organisms on cancer Pts. Disclosures All Authors: No reported disclosures

357. A Comparison of Chest CT Findings in Cancer and Non-Cancer Patients with COVID-19

BackgroundThe purpose of this study was to compare chest computed tomography (CT) scan findings in cancer versus non-cancer patients with COVID-19 infection. We sought to assess the correlation between radiologic patterns of COVID-19 pneumonia, clinical course, and outcomes. MethodsWe performed a retrospective study of COVID-19 positive cancer and non-cancer pts who had chest CT scans at the time of diagnosis, at our hospital and 16 other centers in Asia, Australia, Europe, North America and South America, between March, 2020 and November, 2020. Patients’ age, underlying diseases, symptoms, laboratory studies, and radiologic findings consisting of bilateral ground-glass opacities (GGOs), multifocal organizing pneumonia (MOP) were collected in association with clinical outcomes. ResultsWe identified 426 pts with cancer and 622 non-cancer pts. Thereafter, cancer pts were analyzed into 3 distinct groups and similar to non-cancer pts: GGOs group (n=224, 54%), GGOs+MOP group (n=61, 14.6%), and a third group of neither GGOs or MOP (n=131, 31.4%) in cancer pts, and in non-cancer pts: GGOs group (n=387, 62.8%), GGOs +MOP group (n=100, 16.2%), and a third group of neither GGOs or MOP (n=129, 21%). The median patients’ age was 54 in non-cancer pts vs 62 in cancer pts (p< 0.001) and there were more males in the non-cancer group 57% vs 47% (p=0.001). Cough was more prevalent in non-cancer pts, 71% vs 59% (p< 0.001) and similar to fever (73% vs 57%, p< 0.001). Neutropenia < 0.5 k/µL and lymphocytopenia < 1 k/µL were more frequent in cancer pts (p< 0.001). In cancer pts, there was no statistically significance difference between the 3 groups (hospital admission, mechanical ventilation, readmission within 30 days, and mortality), except pts who required non-invasive (NI) ventilation were more frequent in the GGOs group, 55% (p=0.005). In non-cancer, pts with GGOs +MOP have higher hospital admission, ICU transfer, NI- and mechanical ventilation compared to the 2 other groups (p< 0.001). While readmission to hospital or mortality rate within 30 days were similar between the 3 groups. ConclusionThis study reveals that non-cancer pts tended to have more radiologic findings on chest CT scan compared to cancer pts at the time of COVID-19 diagnosis and were associated with more worrisome COVID-19-related clinical outcomes. Disclosures All Authors: No reported disclosures

1726P Expanding the role of medical oncologist in the management of COVID-19

Cancer patients (pts) have been associated with severe SARS-CoV2 infection and higher mortality compared with the general population. This could be related to the limitation of therapeutic effort based on their prognosis and healthcare prioritization towards non-cancer pts. The oncologist’s role could be crucial for providing high-quality care. We aim to assess the impact of oncologists (ONC) on COVID-19 management. Multicentre retrospective analysis of cancer pts diagnosed with COVID-19 between Mar-Apr 2020. We classified pts according to an estimated life expectancy (based on tumor/stage/line) in 3 groups: favourable group (FG) mOS >5 years (y), intermediate (IG) 1-5y and poor (PG) <1y. We studied COVID-19 management based on oncologist’s involvement: mainly-ONC vs. mainly other specialists (Other). Primary endpoint: COVID-19 30-day mortality (early-M). Secondary outcomes: intensive care unit admission (ICUa), the incidence of acute respiratory distress syndrome (ARDS) and antiretroviral treatment (ARVt) and immunomodulatory drugs (ImD) administered. 287 pts were enrolled, median age 69 (35-98), 52% male, 67% with an active tumor (of them 76% had advanced stage). Mostly thoracic tumors (26%), followed by gastrointestinal (21%) and breast (19%). Among 170 pts under treatment, 89 (52%) received chemotherapy (CHT). By prognostic group: 49% were included in FG (n=135), 40% in IG (n=113), and 11% in PG (n=30). Overall early-M rate was 27% (ONC 22% vs. Other 27%). Prognostic groups were associated with early-M: 19% (FG) vs. 31% (IG) vs. 37% (PG) (p=0.022). No significant differences regarding rate of ARDS (23% FG vs. 19% IG vs. 17% PG). The ONC-group (n=18) included 4 PG and 14 IG, 94% had an advanced stage disease, 83% receive CHT and 65% had PS≥2 (p=0.05 compared to Other group). In IG (ONC vs. Other): 7% vs. 2% ICUa, 100% vs. 34% ARVt and 57% vs. 7% ImD (all p<0.001). In PG (ONC vs. Other): 25% vs. 0% ICUa, 75% vs. 34% ARVt and 25% vs. 0% ImD (all p<0.001). Finally, FP managed only by Other: 13% ICUa; 33% ARVt and 13% ImD. Oncologist mostly treated complex pts compared to other specialists. During COVID-19 crisis, setting prognostic groups helped to individualized therapeutic approaches, reflected by less mortality rate and no differences in terms of complications.

1763P - The reality of critical cancer patients in a polyvalent intensive care unit

BackgroundWith increased incidence and survival of cancer patients (pts), more oncological candidates are considered for admission in Intensive Care Unit (ICU). Trials demonstrated no significant difference in the outcome of cancer pts compared to non-cancer pts. Our study describes characteristics and outcomes of cancer pts in a polyvalent ICU in Portugal. MethodsSingle-centre retrospective cohort study of consecutive oncological pts admitted to a polyvalent ICU (January 2013 to December 2017). Only pts with active cancer were included. A Cox model was fit with time to death within 6 months as the dependent variable and type of cancer and organ support therapy as the independent ones. Covariate Cox regressions were performed. ROC curve analysis was used to determine the sensitivity of prognostic scores. ResultsTwo hundred and thirty-six pts included (1400 ICU admissions), mean age of 53.5±15.3 years and 65% were male. Median length of stay was 3 days (IQR 5). Central nervous system (CNS - 31%), gastrointestinal (18%), genitourinary (17%) and hematological (H - 15%) were the main types of cancer. Curative/diagnostic surgeries (49%) and sepsis (17%) were the main reasons for admission. Vasopressors (VP), invasive mechanical ventilation (IMV) and renal replacement therapy (RRT) >24h were required in 31, 33 and 14% of pts. ICU mortality was 16%, those requiring VP, IMV or RRT were 45, 43 and 67%. Overall survival (OS) was 5.7 months, survival rate at 6 months was 48%. APACHE II and SAPS II scores in H-pts vs solid tumors (ST): 30 vs 20 and 63 vs 38, respectively, p<0.005; ROC curve analysis with AUC > 0.72. VP, IMV, and RRT were more used in H-pts rather than ST-pts - excluding CNS - (71% vs 35%, p<0.005; 63% vs 39%, p=0.013; 29% vs 8%, p=0.002; 46% vs 13% p<0.005). Length of stay was longer in H-pts vs ST-pts (12.8 vs 7 days, p=0.002) as ICU mortality (57% vs 14%, p<0.005). Median OS in H-pts was 3.1 months and in ST-pts 13.9 months (p<0.005). ConclusionsSurvival rate at 6 months was better than described in literature. Prolonged ICU stay was associated to worse prognosis, as use of support therapies. A better OS was documented in ST-pts. Both SAPS II and APACHE II scores were reasonably sensible predicting mortality, demonstrating their value in cancer pts. Legal entity responsible for the studyTiago Cruz Tomás. FundingHas not received any funding. DisclosureAll authors have declared no conflicts of interest.

Cell-free DNA (cfDNA) mutations from clonal hematopoiesis: Implications for interpretation of liquid biopsy tests.

11526 Background: A large fraction of cfDNA fragments are derived from hematopoietic sources. Somatic alterations in cfDNA can be tumor-derived but also could represent somatic changes associated with clonal hematopoiesis. We performed deep sequencing of both plasma cfDNA and matched white blood cell (WBC) genomic DNA (gDNA) to determine the contribution of clonal hematopoiesis to the variants observed in cfDNA. Four cohorts were investigated: metastatic breast (BC), non-small cell lung (NSCLC), castration-resistant prostate cancer (CRPC), and non-cancer participants (pts). Methods: Metastatic cancer pts with de novo or progressive disease were prospectively enrolled. Non-cancer pts were blood bank donors. Plasma cfDNA and matched WBC gDNA were sequenced using a targeted 508-gene panel (2 Mb) to &gt; 60,000X raw depth. Variant calling used a novel pipeline that employed molecular barcoding for error suppression followed by de novo assembly and graph-based variant calling. Results: Of 151 metastatic cancer pts (48 BC, 49 NSCLC, 54 CRPC), median age was 64 (30-87) with 53% female and 33% treatment naive. Of 47 non-cancer pts, median age was 61 (20-78) with 51% female. Analysis of cfDNA identified 1072 variants (AF &gt; 0.1%, &gt; 2 mutant reads, passing bioinformatic quality filters) which were also detected in WBC gDNA as non-germline ( &lt; 35% allele frequency [AF]) non-synonymous variants. For these cfDNA variants, AF ranged from 0.1-14.4% and correlated with AF in WBC gDNA (r2 = 0.47, p &lt; 0.001). Mutated genes were consistent with clonal hematopoiesis, with the most frequently mutated genes being DNMT3A, TET2, PPM1D, and TP53 (215, 77, 45, and 36 variants, respectively). For both cancer and non-cancer pts (age &gt; 45), median number of overlapping variants was 5 per pt (range 0-22). The number of WBC gDNA and cfDNA variants per individual was positively associated with age (p &lt; 0.001) in both cancer and non-cancer pts (interaction p = 0.08). Conclusions: Somatic cfDNA variants are frequently derived from clonal hematopoiesis and increase with age. Accurate assessment of somatic alterations in cfDNA should account for this phenomenon to distinguish between tumor-derived and WBC-derived variants.

Development and validation of a Medicare health outcomes survey (MHOS) frailty index in multiple myeloma (MM).

e21519 Background: Increasing age is associated with poorer outcomes in MM. However, biological aging (BA) is heterogeneous and does not correlate perfectly with chronological age (CA). A recently developed frailty of CA, functional status, and comorbidities is more predictive of toxicity, progression-free and overall survival (OS) than CA alone (Palumbo et al Blood 2015). We sought to apply the Rockwood Accumulation of Deficits approach to develop and validate a frailty index (FI) for older adults with MM. Methods: MHOS, a random survey of HRQOL (health related quality of life) in Medicare Advantage HMO enrollees, data were obtained from 1,747,042 non-cancer patients (pts) and 340 with newly diagnosed MM 1997-2011 from the SEER-MHOS linked dataset. In creating the FI, we considered only variables available throughout all 4 survey versions used since its initiation in 1998. We identified 34 variables including items related to function/mobility, comorbidities, and mental health. The FI was calculated as the number of deficits present, divided by the number total number of possible deficits, with possible scores ranging from 0 to 1 and higher values indicating more frail. Missing data points were excluded from the FI calculation. Cox regression analysis was performed to determine the association of the FI with OS, controlling for CA, gender, and race. The FI was first derived in the non-cancer cohort then applied in the MM cohort. Results: The median age was 72 for non-cancer pts and 75 for pts with MM; the median FI was 0.308 and 0.368, respectively. Among non-cancer pts, each 10% increase in FI (~3-4 more deficits) was associated with a 35% increased risk for death (aHR 1.352, 95% CI 1.350-1.354, p &lt; 0.001); among pts with MM it was associated with a 15% increased risk (aHR 1.147, 1.065-1.236, p &lt; 0 .001). Median OS for pts with MM in the lowest tertile of FI was 48 months (95% CI 42-56) compared to 23 months (17-33) for the highest tertile. Conclusions: Here we present a MHOS-based FI. The FI was more prognostic among non-cancer pts than among pts with MM, presumably because stage and tumor characteristics also contribute to OS in MM pts. Further exploration of the MHOS-FI in MM and other cancers is warranted.

International Clinical Practice Guidelines for the Treatment and Prophylaxis of Thrombosis Associated with Central Venous Catheters in Patients with Cancer

AbstractAbstract 4357 BackgroundUse of long term indwelling central venous catheter (CVC) is associated with symptomatic (Σ) events in up to 30% of cancer patients (pts), which may lead to pulmonary embolism (PE) and loss of the CVC. Lack of consensus on management of CVC related thrombosis (CVCT) and heterogeneity in clinical practices worldwide led us to establish international Good Clinical Practices Guidelines (GCPG) for the management of CRT in cancer pts. MethodsThe international working group (WG) met 4 times and worked 2 years with the methodological support and quality control of the French institute of Cancer (INCa). All studies on cancer, venous thromboembolism (VTE, including pulmonary embolism PE), and anticoagulant drugs (AC) published from 1996 to 2011 weree searched using MEDLINE®database. Meta-analyses, systematic reviews, randomized or non-randomized prospective or retrospective studies in the absence of randomized clinical trials, and abstracts only if a full paper had been accepted in a peer-reviewed medical journal were included in the analysis. The included studies concerned the prophylaxis and treatment of CVC in cancer pts. Studies in non-cancer pts, pts with a peripheral or dialysis catheter, or with a history of cancer in remission for more than 5 years were not considered. The main study outcomes were rates of proven catheter related thrombosis (CRT), extension of CRT, PE associated with CRT, major and minor bleeding, thrombocytopenia, and death. Quality of the studies was evaluated in a double-blind manner by the methodologists using the GRADE appraisal grids. Extracted data were entered in evidence tables, subsequently validated by all the WG. The level of evidence (High A, Moderate B, Low C, Very low D) depended on study design, limitations, inconsistency, indirectness, imprecision and publication bias. For each question, results analysis were summarized and discussed by the WG. Overall conclusions and recommendations were classified as Strong (Grade 1 Guideline) or Weak (Grade 2 Guideline) based on evidence levels, the balance between desirable/undesirable effects, values and preferencesand costs. In the absence of scientific evidence, judgment based on consensus within the WG was defined as Best Clinical Practice (BCP). The GCP were reviewed and evaluated using a specific grid in February 2012 by 45 independent experts in managing cancer pts worldwide and 3 pt representatives. Results1.For the treatment of established CVC in cancer pts, we found no prospective randomized study, only 2 non-randomized prospective studies and 1 retrospective study examining the efficacy and safety of LMWH+VKA. One retrospective study evaluated the benefit of CVC removal and 2 retrospective studies, with few patients assessing the thrombolytic drugs values. We recommend A) For the treatment of Σ CRT in cancer pts, AC is recommended for a minimum of months; in this setting, LMWH are suggested. Oral VKA can be used [BCP]. B) The CVC can be kept in place if it is functional, well-positioned, non-infected and shows good evolution under close surveillance; whether the CVC is kept or removed, no standard approach in term of duration of anticoagulation is established [BCP].2.For the prophylaxis of CVCRT in cancer pts, 6 randomized studies investigated the efficacy and safety of VKA vs. placebo or no treatment, 1 the efficacy and safety of UFH, 6 the value of LMWH and one double-blind randomized study the thrombolytic drugs in the prevention of CVC-RT. Six meta-analyses of AC and CVC thromboprophylaxis have been performed. The type of catheter (open-ended, such as the Hickman® catheter, versus closed-ended catheter with a valve, such as the Groshong®catheter), its position (above, below or at the junction of the superior vena cava and the right atrium), and the method of placement may influence the onset of CVCT on the basis of 6 retrospective, 4 prospective non-randomized trials, 3 randomized trials and 1 meta-analysis. In light of these data,A.Use of AC for routine prophylaxis of CRT is not recommended [1A];B.CVC should be inserted on the right side, in the jugular vein, and distal extremity of the central catheter should be located at the junction of the superior vena cava and the right atrium [1A]. ConclusionDissemination and implementation of these international GCPG on the prevention and treatment of CRT in cancer ptsat each national level is a major public health priority, necssitating world wide collaboration. Disclosures:No relevant conflicts of interest to declare.

Out-of-pocket (OOP) health care expenditure burden for Medicare beneficiaries with cancer.

6075 Background: Concern is increasing about the OOP burden faced by cancer patients (pts). Medicare beneficiaries have multiple comorbidities, have limited financial resources, and may face substantial cost sharing under traditional Medicare if they do not have generous supplemental coverage. We examined OOP spending and burden relative to income for Medicare beneficiaries with cancer, compared to a non-cancer comparison group. Methods: We used Medicare Current Beneficiary Survey data (1997-2007). Newly diagnosed cancer pts were selected using ICD-9CM codes on claims after a 12 mos washout period. OOP spending was assessed using self report for the index(diagnosis) and subsequent year. Pt characteristics were self reported. Generalized Linear Models estimated effects of pt characteristics on OOP spending; logistic regression identified pt characteristics associated with high burden, defined as OOP spending &gt;20% of income. Results: The cohort included 1,869 beneficiaries with, and 10,057 beneficiaries without cancer. Relative to the non-cancer cohort, cancer pts were older, had greater comorbidities, and were more likely to lack supplemental coverage (22 vs 16%) (all at p&lt;0.01).OOP spending was $4,727 or 11.4% of total spending for cancer pts. The unadjusted difference between cancer and non-cancer pts in OOP spending was $1,518 (p&lt;.001); with adjustment for patient characteristics, cancer patients faced an incremental $956 (p&lt;.01) in OOP spending. Median[mean] OOP/income was 10%[24%] for beneficiaries with, compared to 6%[14%] without cancer (p&lt;.001). Over ¼ (28%) of beneficiaries with cancer spent 20% of their income OOP, compared to 16% of beneficiaries without cancer (p&lt;.001). Supplemental insurance and higher income were protective against high OOP burden, whereas assets, comorbidity, and receipt of cancer-directed radiation and antineoplastic therapy were associated with higher OOP burden. Conclusions: Medicare beneficiaries with cancer face higher OOP burden than their counterparts without cancer; some of the higher burden was explained by higher comorbidity burden and lack of supplemental insurance. Financial pressures may discourage some elderly patients from pursuing treatment.

Resolution of venous thrombo-emboli (VTE) with a factor Xa inhibitor: Initial safety and efficacy results of a randomized, phase III trial of anticoagulation plus inferior vena cava (IVC) filter versus anticoagulation alone in patients with cancer and VTE

20544 Background: Cancer-associated thrombosis is a major cause of death in patients (pts) with cancer. The 1-year survival in pts with cancer with VTE is 12% (vs. 36% without VTE). More than 20% of pts have VTE propagation and re-thrombosis on standard therapeutic anticoagulation (AC) (Prandoni 2007). The role of IVC filters in terms of efficacy, safety, prevention of pulmonary embolism (PE), and impact on survival remains controversial. Resolution of DVT takes an average of 6 months in non-cancer pts (Asbeutah 2004) and thrombi remain detectable in half of pts after a year (Kearon 2004). Methods: Pts with malignancy were eligible if they had an acute VTE (DVT and/or PE), and were randomized to standard fondaparinux sodium (FS) alone [5mg SC for pts <50 kg, 7.5mg SC for pts 50–100 kg and 10mg SC for pts >100 kg] vs FS+IVC filter. A total of 106 pts are planned. The primary endpoint is survival without recurrent VTE. Secondary endpoints include safety and clot resolution, given in this report. Due to safety review in pts ≥ 65 yrs, the dose of FS was reduced to 5mg during the conduct of the study. Pts were evaluated q 2 weeks for 4 weeks then q 4 weeks. Results: To date 33 pts were randomized and treated. All have stage IV extent, 94% are on chemotherapy; median age 67 (range 38–89%). Diagnoses include: lung (25%), GI (22%), and breast (19%); 9% have brain metastases. Of pts re-evaluated with DVTs: 15/20, 75% [95% CI: 44–90%] had complete clot resolution at an average of 45 days. Of those with PE: 8/9, 89% [95% CI: 52–100%] had complete clot resolution. Toxicities were more prominent in pts ≥ 65, 1 with marked ecchymosis and 1 with fatal hemorrhage into a brain metastasis. Conclusions: This study is ongoing and remains blinded as to treatment arm; however, current observations are important: 1) complete clot resolution has been observed in many, despite past studies using low molecular weight heparins not reporting such resolution in cancer patients; 2) the factor Xa inhibition may be responsible for this clot resolution effect; 3) the FS was well tolerated and appears safe in those over age 65 at a lower dose. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration GlaxoSmithKline

DNR patterns in cancer patients (pts) 16 years after the Patient Self Determination Act (PSDA)

6582 Background: In 1991, the PSDA required institutions receiving federal funding to inform pts about the right to refuse life prolonging treatments such as CPR. Studies conducted around 1991 suggest that most DNR orders are written by oncologists less than 3 days prior to death in hospitalized pts, raising ethical concerns. 16 years later, are oncology clinicians writing DNR orders earlier in cancer pts’ hospital course compared to non-cancer pts? Methods: We conducted a chart review of 284 of the 296 total adult deaths during 2005 at Indiana University Hospital. Demographic, diagnostic, and attending service info was collected from hospital billing records. Pts’ DNR status, timing of DNR orders, and presence of a written advanced directive (AD) were assessed through chart review. Results: 76 of 284 (26.8%) patients had cancer diagnoses. Of these, 59 had documented DNR orders. There was no difference in presence or absence of DNR orders at the time of death for cancer vs. non-cancer pts (77.6 vs 72.7%, p=0.35). Mean time from writing of the DNR order to death was 3.51 ± 4.61 days for cancer pts compared to 3.26 ±3.81 days for non-cancer pts (p=0.40), however, the majority of DNR orders written by oncologists were written less than 2 days prior to death. We calculated a ratio of the time between DNR order writing and death to the overall length of stay for cancer and non-cancer pts, excluding pts with very short lengths of stay ( = 5 days). In univariate analyses, this ratio trended toward statistical significance (p=0.08). In multivariate analyses, cancer pts had a higher ratio of the time between DNR order and death to LOS (0.30 vs 0.21, p=0.05). Existence of an AD had no significant impact on this ratio. Surgical specialists wrote DNR orders less frequently (64.2 vs 77.3%, p=0.02) and later than non-surgical specialists (mean 21 vs 10 days from admission, p=0.0008). Conclusions: In this study, DNR ordering patterns among hospitalized cancer and non-cancer pts have changed little since the PSDA. Although cancer pts on average had DNR orders written relatively earlier in their terminal hospital stay than non-cancer pts, the timing varied little from pts in prior studies. Although the majority of hospitalized pts in this sample died with DNR orders, these orders were written very late in their hospital stay. No significant financial relationships to disclose.

Effect of household smoking exposure in childhood on lung cancer risk in Korea: A case-control study

9598 Background: Smoking is the major cause of lung cancer and the duration rather than the amount of smoking has much greater impact on lung cancer risk. Thus, exposure to household smoking in childhood may be much more harmful than currently appreciated. We conducted this study to examine the impact of passive exposure to household smoking in childhood on the risk of lung cancer. Methods: Using a pre-tested interview questionnaire, we collected demographic and socioeconomic data and the information on smoking status, both personal and exposure to environmental smoking in childhood from 2499 patients (pts) who visited National Cancer Center (NCC) between 5/2002 and 7/2003. There were 699 lung cancer cases (M/F: 498/201), 854 non-cancer pts (M/F: 388/466) who visited NCC for other than cancer including those who had cancer prevention and screening evaluation (Control I) and 946 cancer pts (M/F: 344/602) other than lung cancer (Control II). Results: For male lung cancer cases, the proportion of lifetime non-smokers were only 7.2%, which was significantly (p<0.001) different from 15.0%, and 15.7% of the controls I and II. However, the corresponding figures for females were 86.1%, 86.0%, and 88.2%, respectively, which was not statistically significant. By univariate analysis, age, <12 years of education, low income, and rural residence in childhood were associated with higher risk of lung cancer. When the groups are stratified by age (<50 vs. 50+), paternal smoking was an important risk factor for the 50+ age group, both for females (OR=1.515, p=0.198; OR=1.781, p=0.043) and for males (OR=2.151, p=0.006; OR=1.711, p=0.044) as compared with controls I and II, respectively. There was also a trend toward increased risk with maternal smoking for young (< 50 yrs) smoking males (OR=3.861, p=0.013) as compared with control I. Spouse smoking was not associated with any increased risk in this analysis, even for the non-smoking females. Conclusions: While more in-depth analyses are needed, these results strongly suggest that environmental exposure to household smoking in childhood is an important risk factor for lung cancer development. (Supported by NCC Grant 0210040). Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration National Cancer Center, Goyang, Gyeonggi, Korea

1139 DIFFERENCES IN SILASTIC CATHETER RELATED INFECTION CANCER PATIENTS VS NON-CANCER PATIENTS

Infection of indwelling silastic central venous catheters (SCVC) in pediatric patients is a common complication. A retrospective study involving 86 patients was performed to compare SCVC associated infections between children receiving chemotherapy and children without cancer. All underwent SCVC placement in the OR between 6/81-12/83. Data subsequent to the placement of 102 catheters was analyzed. Exit site swelling, previous catheter repair or occlusion were found to increase the incidence of SCVC related infection. No statistically significant differences were found in either the incidence or the location (exit site or blood) of infection in either group. The 53 pts receiving cRX exhibited a 27% (17 infect/62 catheters) infection rate (13/17 were bacteremic). There were 8.1 bacteremic episodes and 2.5 exit site infections per 100 catheter days. Similarly, the 33 non-cancer pts exhibited a 22% (9 infect/40 catheters) infection rate (6/9 were bacteremic). These pts had 8 bacteremic episodes and 4 exit site infections per 100 catheter days. However, the organisms causing sepsis in each group were different. In children without cancer, sepsis was caused only by fungus and gram positive organisms: Staph species (50%) C. albicans (33%), enterococeus and Candida (17%). Gram negative bacteremia occurred only in cancer pts: Gram negatives (23%), Staph species (46%), Strep (23%), Candida and S. aureus (8%). These data demonstrate that SCVC placement is associated with similar infection risks in both cancer and non-cancer pts, although the spectrum of organisms causing infection differs between the two groups.