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Chemotherapy-induced peripheral neuropathy (henceforth, neuropathy) is often dose limiting and is generally managed by empirical dose modifications. We aimed to (1) identify an early time point that is predictive of future neuropathy using a patient-reported outcome and (2) propose a dose-adjustment algorithm based on simulated data to manage neuropathy. In previous work, a dose-neuropathy model was developed using dosing and patient-reported outcome data from Cancer and Leukemia Group B 40502 (Alliance), a randomized phase III trial of paclitaxel, nanoparticle albumin-bound paclitaxel or ixabepilone as first-line chemotherapy for locally recurrent or metastatic breast cancer. In the current work, an early time point that is predictive of the future severity of neuropathy was identified based on predictive accuracy of the model. Using the early data and model parameters, simulations were conducted to propose a dose-adjustment algorithm for the prospective management of neuropathy in individual patients. The end of the first 3 cycles (12 weeks) was identified as the early time point based on a predictive accuracy of 75% for the neuropathy score after 6 cycles. For paclitaxel, nanoparticle albumin-bound paclitaxel, and ixabepilone, simulations with the proposed dose-adjustment algorithm resulted in 61%, 48%, and 35% fewer patients, respectively, with neuropathy score ≥8 after 6 cycles compared to no dose adjustment. We conclude that early patient-reported outcome data on neuropathy can be used to guide dose adjustments in individual patients that reduce the severity of future neuropathy. Prospective validation of this approach should be undertaken in future studies.

10541 Background: It is well known that estrogen exposure is a major risk factor for breast cancer (BC). Estrogen levels can be affected by the gut microbiome through enterohepatic circulation. No studies regarding gut microbiome changes in BC have examined the colonic mucosal microbiome; and there is no data on which types of gut microbiome studies would be most relevant to the study of the microbiome in BC. Methods: We examined differences in the gut microbiome composition in BC and control subjects using the following sample types: Home-collected stool, endoscopically collected stool, and colonic biopsy samples (for all groups, n=48 total, n=24 BC, n=24 controls). Here, we used both operational taxonomic unit (OTU) and amplicon sequence variant (ASV) based approaches in QIIME2 for 16S rDNA sequencing analysis. Alpha diversity metrics (Chao1, Pielou’s Evenness, Faith PD, Shannon, and Simpson) and beta diversity metrics (Bray-Curtis, Weighted and Unweighted Unifrac) were calculated. LefSe was used to analyze differences in the abundance of various taxa between sample types. Results: Alpha and beta diversity metrics were different between the three sample types when using both OTU or ASV-based analysis, however there were some minor differences between analysis types in these samples. Comparing the 3 sample types, Actinobacteria and Firmicutes (Log10 LDA score >4) were the predominant phyla in home stool samples, while Bacteroidetes and Proteobacteria (Log10 LDA score >4) were higher in abundance in the colonic biopsy samples. Conclusions: Our data shows that alpha and beta diversity metrics differ between sampling methods (home-collected stool, endoscopically collected stool, and colonic biopsies) when looking at the composition of the gut microbiome in BC. Results remained the same regardless of ASV or OTU-based analysis. [Table: see text]

Background The Adjuvant Zoledronic Acid (ZA) study in early breast cancer (AZURE) showed correlation between a non-amplified MAF gene in the primary tumor and benefit from adjuvant zoledronic acid (ZA). Adverse ZA outcomes occurred in MAF-amplified patients. NSABP B-34 is a validation study. Methods A retrospective analysis of MAF gene status in NSABP B-34 was performed. Eligible patients were randomly assigned to standard adjuvant systemic treatment plus 3-years oral clodronate (1600mg/daily) or placebo. Tumors were tested for MAF gene amplification, and analyzed for their relationship to clodronate for disease-free survival (DFS) and overall survival (OS) in MAF non-amplified patients. All statistical tests were 2-sided. Results . MAF status was assessed in 2,533 available primary tumor samples from 3,311 patients. Of these, 37 withdrew consent; in 77 samples no tumor was found; 536 assays did not meet quality standards, leaving 1,883 (77.8%) evaluable for MAF assay by fluorescence in situ hybridization (947 from placebo, and 936 from clodronate arms). At 5 years, in MAF non-amplified patients receiving clodronate, DFS improved by 30% (hazard ratio =0.70, 95% confidence interval = 0.51-0.94, P=0.02). OS improved at 5 years (hazard ratio =0.59, 95% confidence interval = 0.37–0.93, P=0.02) remaining statistically significant for clodronate throughout study follow-up. Conversely, adjuvant clodronate in women with MAF-amplified tumors was not associated with benefit, but possible harm in some subgroups. Association between MAF status and menopausal status was not seen. Conclusions Non-amplified MAF showed statistically significant benefits (DFS and OS) with oral clodronate, supporting validation of the AZURE study.

Background Upfront docetaxel (UD) with androgen deprivation therapy (ADT) has been demonstrated to improve survival outcomes in metastatic castration-sensitive prostate cancer (mCSPC). However, existing studies have included predominantly Caucasian patients. Study question To compare the efficacy of addition of UD to ADT in mCSPC to ADT alone among minority patients. Study design Retrospective study of mCSPC patients. Measures and outcomes Patients treated with UD and ADT between January 2014 and December 2017 (UD + ADT, n = 44) were compared with those treated with ADT alone between January 2008 and January 2017 (ADT, n = 38); patients of Caucasian ethnicity were excluded. The outcome of interest was progression-free survival (PFS), which was estimated using Kaplan-Meier analysis and Cox proportional hazard analysis. Results Overall, 63 (76.8%) patients were African American and 16 (19.5%) were Hispanic. Fifty-five (67%) patients had high-volume mCSPC. The median follow-up was 14 months [95% confidence interval (CI): 10.4-16.5] for UD + ADT and 42 months (95% CI: 17-66.9) for ADT. Median PFS did not differ between groups: UD + ADT: 16 versus ADT: 18 months [hazard ratio (HR) for UD + ADT = 0.88, 95% CI: 0.48-1.62; P = 0.70]. In patients with high-volume disease, median PFS remained similar (UD + ADT: 16 vs. ADT: 14 months (HR for UD + ADT = 0.64, 95% CI: 0.33-1.25; P = 0.19). On multivariable analysis, prolonged time to nadir PSA, HR = 0.83 (95% CI: 0.76-0.90), was independently associated with PFS. The most common toxicities in UD + ADT were anemia and fatigue. Major limitations include small sample size and potential for selection bias due to the retrospective study design. Conclusions In this retrospective review of a minority mCSPC cohort, UD + ADT was not associated with improved PFS compared with ADT alone. Although further study with larger sample size is needed, these results underscore the importance of ensuring accrual of minorities in clinical trials, reflective of the real-world setting.

PURPOSE: The aim of this study was to elucidate the prevalence of unmet supportive care needs in Hispanic/Latino cancer survivors and examine the association between unmet needs and patient-provider communication, satisfaction with cancer care, and cancer-specific symptom burden. METHODS: Hispanics/Latinos diagnosed with breast, prostate, or colorectal cancer within 15 months of treatment completion (N=288) completed questionnaires as part of an NCI-funded project. RESULTS: Hispanic/Latino cancer survivors reported greater unmet needs compared to previously published norms in primarily non-Hispanic/Latino white samples. Across the three cancer types, the two most common unmet needs were in the psychological domain: fear of metastasis (32.6%) and concern for close others (31.3%). However, unmet needs varied by cancer type. Factors associated with greater unmet needs included more recent cancer diagnosis (OR .98 [.96-.99]), younger age (OR .96-.97 [.93-.99]), female gender (OR 2.53–3.75 [1.53–7.36]), and being single (OR 1.82 [1.11–2.97]). Breast cancer survivors reported greater unmet needs than both prostate and colorectal cancer survivors (OR 2.33–5.86 [1.27–14.01]). Adjusting for sociodemographic and medical covariates, unmet needs were associated with lower patient-provider communication self-efficacy (B= −.18– −.22, p’s < .01) and satisfaction with cancer care (B= −2.05– −3.81, p’s < .05), and greater breast (B= −4.18– −8.30, p’s < .01) and prostate (B= −6.01– −8.13, p’s < .01) cancer-specific symptom burden. CONCLUSIONS: Findings document unmet supportive care needs in Hispanic/Latino cancer survivors and suggest that reducing unmet needs in Hispanic/Latino cancer survivors may improve not only satisfaction with care, but also health-related quality of life.

BACKGROUND The objective of the current study was to examine how modifiable factors such as satisfaction with cancer care and self-efficacy impact health-related quality of life (HRQOL) among Latino cancer survivors. METHODS Latinos previously diagnosed with breast, prostate, or colorectal cancer (N = 288) completed questionnaires (Patient Satisfaction with Cancer Care Scale, Stanford Chronic Disease Self-Management Measures, Functional Assessment of Cancer Therapy-General, and Short Acculturation Scale for Hispanics) within 2 years after receiving primary cancer treatment. RESULTS Path model analyses demonstrated that satisfaction with cancer care was associated with greater HRQOL and that this relationship was explained by several facets of self-efficacy (ie, confidence in managing psychological distress [z = 3.81; P

Objectives: To identify areas for improvement and design system-based strategies to address challenges in the provision of quality ovarian cancer care, we undertook a quality improvement (QI) program at 2 large US-based hospital systems. Methods: At baseline, between 9/2019 and 2/2020, we audited 200 EMR records (100 from each system) of adult patients with recurrent ovarian cancer for assessing physicians’ performance of quality-based and National Comprehensive Cancer Network (NCCN) guideline-directed biomarker testing, maintenance treatment, monitoring, and patient-centered practices. Multidisciplinary ovarian cancer teams in each center participated in QI interventions including feedback on baseline EMR results and development of action plans. Post-intervention, 200 additional recurrent ovarian cancer patient EMRs were retrospectively reviewed in each center between 2/2020 and 9/2020 to determine the effect of the intervention on ovarian cancer care. Results: At baseline, for 200 patients diagnosed with ovarian cancer who's EMR were audited, the mean age was 66 years and the average time since diagnosis was 3 years. In these patients, documentation of BRCA1/2 testing, use of maintenance therapy, patient follow-up, and shared decision-making (SDM) were sub-optimal (Table). Action plans, such as development of resources for guidance with regard to therapy sequencing and patient management strategies, development of a new adverse event management plan, and improvements in documentation and care coordination procedures, were implemented. In the post-intervention EMR audits, 200 patient's demographics were similar to baseline: the mean age was 62 years and the average time since diagnosis was 3 years. At follow-up, EMR audits demonstrated a significant 46% improvement in BRCA1/2 testing (P Download : Download high-res image (67KB) Download : Download full-size image Conclusions: These results demonstrate that aligning care with guidelines can be challenging; however, implementation of system- and team-based interventions can lead to improved documentation of care practices. These methods and findings from this program are relevant for the future design of intervention to improve the quality of recurrent ovarian cancer care.

e18649 Background: Molecular biomarker testing is integral to NSCLC cancer care, but adoption and testing practices in the community are varied and often suboptimal. Testing practices, such as standard testing protocols and results turnaround time (TAT), impact timely treatment decisions. We examined adoption and testing practices for guideline recommended NSCLC biomarkers among National Cancer Institute Community Research Program (NCORP) sites. The study was conducted in collaboration with Wake Forest NCORP Research Base. Methods: An online survey was administered to onsite labs affiliated with NCORP sites April 2019 – June 2020. We assessed testing practices for 7 NCCN recommended biomarkers, including 3 with category 1 recommendation (EGFR, ALK, PD-L1) and 4 with category 2 recommendations (BRAF, ROS1, MET, RET). Guideline concordant result TAT was defined as return of EGFR and ALK results in ≤ 10 days (Lindeman 2018) (see Table for other outcomes). We used proportions, including two-sided Fischer exact tests, to compare outcomes by site characteristics (safety net, practice size). Results: The survey response rate was 69% (58/85). All responding labs offered testing for category 1 biomarkers (EGFR, ALK and PD-L1); only 10% conducted these tests in-house (Table). The majority of labs also tested for category 2 biomarkers (67%). TAT varied, with most labs returning results in ≤ 10 days for EGFR and ALK (69%, but only a minority meet this TAT for all biomarkers. Larger practice size (> 1400 new cancer cases a year) was associated with in-house testing of EGFR, ALK, PD-L1 (p=0.03) and having standard testing protocols (p

Chemotherapy-induced peripheral neuropathy (CIPN) is a dose-limiting toxicity caused by several chemotherapeutic agents. Currently, CIPN is managed by empirical dose modifications at the discretion of the treating physician. The goal of this research is to quantitate the dose-CIPN relationship to inform the optimal strategies for dose modification. Data were obtained from the Cancer and Leukemia Group B (CALGB) 40502 trial, a randomized phase III trial of paclitaxel vs. nab-paclitaxel vs. ixabepilone as first-line chemotherapy for locally recurrent or metastatic breast cancer. CIPN was measured using a subset of the Functional Assessment of Cancer Therapy-Gynecologic Oncology Group Neurotoxicity (FACT-GOG-NTX) scale. A kinetic-pharmacodynamic (K-PD) model was utilized to quantitate the dose-CIPN relationship simultaneously for the three drugs. Indirect response models with linear and Smax drug effects were evaluated. The model was evaluated by comparing the predicted proportion of patients with CIPN (score ≥8 or score ≥12) to the observed proportion. An indirect response model with linear drug effect was able to describe the longitudinal CIPN data reasonably well. The proportion of patients that were falsely predicted to have CIPN or were falsely predicted not to have CIPN was 20% or less at any cycle. The model will be utilized to identify an early time point that can predict CIPN at later time points. This strategy will be utilized to inform dose adjustments to prospectively manage CIPN. Clinicaltrials.gov ID: NCT00785291

Background Capecitabine is an oral fluoropyrimidine that is used to treat various malignancies. Hand-foot syndrome (HFS) is a dose-limiting toxicity of capecitabine that can limit the use of this agent in some patients. Some investigators have observed that pyridoxine (vitamin B6) can ameliorate HFS that is caused by capecitabine. We designed a prospective trial to determine if pyridoxine can prevent HFS in patients who receive capecitabine. Methods In our double-blind, placebo-controlled trial, we randomly assigned eligible patients who were treated with capecitabine to receive either daily pyridoxine 100 mg or placebo along with their capecitabine-containing chemotherapy regimen. Patients were observed during the first 4 cycles of capecitabine treatment. The primary endpoint was the incidence and grade of HFS that occurred in both study arms. Results Between 2008 and 2011, 77 patients were randomly assigned to receive either pyridoxine (n = 38) or placebo (n = 39). Dosages of capecitabine were equally matched between both arms of the study. HFS occurred after a median of 2 chemotherapy cycles in both groups. HFS developed in 10 of 38 (26%) patients in the pyridoxine group and in 8 of 39 (21%) patients in the placebo group (P = .547). Therefore, the risk of HFS was 5 percentage points higher in pyridoxine group (95% confdence interval [CI] for difference, -13 percentage points to +25 percentage points). Given our study results, a true benefit from pyridoxine can be excluded. No difference in HFS grades was observed. Limitations Single-institution study. Conclusion Prophylactic pyridoxine (vitamin B6), given concomitantly with capecitabine-containing chemotherapy, was not effective for the prevention of HFS.

e14134 Background: Immune-related endocrine dysfunction is unique to immunotherapy (IT). We aimed to explore the clinical parameters associated with development of thyroid disorder (TD) in patients receiving IT and their outcome. Methods: We designed a retrospective study of patients treated with anti-CTLA4 and/or anti-PD1/PDL1 IT at Cook County Hospital, Chicago between January 2015 to January 2018. Patients with incomplete charts and those who received less than two cycles of IT were excluded. Demographics, clinical and pathologic data were recorded at the time of diagnosis and prior to start of IT. Pearson Chi-square, independent sample t-test and logistic regression were used for data analysis. Results: We included 104 patients in the study, out of whom 66 were male and 38 were female. Most common diagnosis was non-small cell lung cancer (42.4%) followed by squamous cell cancer of head and neck (21.2%), renal cell cancer (12.5%), small cell lung cancer (12.5%) and melanoma (8.7%). Majority of patients (91.4%) had metastasized and were treated with either Nivolumab (71.1%) or Pembrolizumab (21.2%) in the 2nd (50%) or 3rd line (29.8%) setting. Twenty-eight patients developed TD while on IT, out of whom, 13 developed hypothyroidism, 12 developed hyperthyroidism followed by hypothyroidism and 3 developed hyperthyroidism. TD developed between 1st to 6th cycle of IT in 96.5% patients. Older age (p-0.009), history of radiation (RT) to neck (p-0.007), history of RT to chest (p-0.015), history of venous thrombosis (p-0.007) and higher thyroid stimulating hormone (TSH) level (17.76±35.67) prior to starting IT (p-0.029) were significantly associated with TD. Multivariate logistic regression showed that history of RT to neck was a significant predictor of developing TD after adjustment for age, race and sex (adjusted OR 9.64, 95% CI 1.88-49.36, p-0.007). No patient reported thyroid related symptom and IT was continued uninterrupted in all patients. Levothyroxine was the drug of choice for treating hypothyroidism. No patient received steroids or antithyroid medications. Conclusions: History of radiation therapy to neck is significantly associated with development of thyroid dysfunction in patients receiving immunotherapy. Thyroid replacement therapy is sufficient to bring down the levels of TSH and immunotherapy need not be interrupted.

e12093 Background: The Recurrence Score (RS) result based on the 21-gene Oncotype DX Breast Recurrence Score assay is standard of care in deciding adjuvant chemo-hormonal therapy versus hormone therapy alone in hormone-receptor positive (HR+), HER 2 negative, node–negative breast cancer. This study explores the role of RS result in predicting the response to neoadjuvant chemotherapy (NACT). Methods: In this retrospective single institution cohort study, electronic medical records of 148 women with HR+, HER 2 negative, non-metastatic breast cancer who received NACT from 2006 onward were screened. 38 patients were excluded due to lack of tissue for testing. Pretreatment biopsy blocks were sent to Genomic Health, Inc. for Oncotype Dx testing. Low RS result was defined as ≤25. Pathologic complete response (pCR) was defined as no residual tumor. Partial response (PR) was residual tumor with > 25% decrease in the largest dimension. No response (NR) was defined as < 25% decrease in the tumor post NACT. Progression (PD) was defined as increase in size of original tumor or new site(s) of disease. Results: Of the 110 patients studied, 58% were postmenopausal women. Fifty percent were African American, 12% were Caucasian and 27% were Hispanic. Invasive ductal carcinoma was the predominant histology (86%). Most patients had > T2 disease (97%) with 73% being clinically node positive. Adriamycin based NACT regimen was used in treating 86.3% of the women. Forty patients (36.4%) had tumor with RS≤25. NR/PD was significantly higher in tumors with RS≤25 (27/40) vs RS > 25 (13/70) (OR: 9.1, 95% CI: 3.7-22.2, P< 0.001). pCR was seen in 16% with RS > 25 and 0% with RS ≤25. Response to NACT (pCR/PR) was 32.5% in RS≤25 vs 81.4% in RS > 25. In tumors with response, RS > 25 was associated with a greater percent decrease in the tumor size compared to RS≤25 (median decrease of 71% vs 52%, P= 0.033). Conclusions: HR+, HER 2 negative, RS≤25 breast cancer is associated with increased rates of NR/PD and is unlikely to respond to NACT. Recurrence Score result determination in pretreatment breast cancer biopsy samples can be an effective tool to select patients with non-metastatic breast cancer for NACT. Studies are needed to determine novel neoadjuvant therapeutic approaches in patients who are candidates for neoadjuvant therapy but are unlikely to benefit from NACT.

525 Background: Exposure to cytotoxic chemotherapy (CC) has been observed to be associated with significant changes in body composition, namely marked lean muscle mass losses, with implications for treatment-related toxicity and oncologic outcomes. However, prior studies predominately include elderly patients who, a priori, are at risk for sarcopenia or severe skeletal muscle deficiency. To date, the impact of CC on body composition in young men with testicular cancer remains undefined. Methods: A retrospective analysis of 19 patients with metastatic testicular cancer treated with CC was performed (2015-17). Lumbar skeletal muscle index (SMI), visceral (VAI), subcutaneous (SCAI), and intramuscular adipose (IMAI) indices (cm2/m2), as well as fat-free mass (FFM, kg) and fat mass (FM, kg) were calculated using cross-sectional soft tissue area measurements on pre- and post-CC computed tomography (CT) axial scans and compared using paired Wilcoxon Signed Rank Tests. Results: Median age was 29 years. According to the NHANES FMI-based classification, 5 (26.3%), 9 (47.4%), 4 (21.1%), and 1 (5.3%) patients had normal, excess, class I, and class II obesity, respectively. Median pre- and post-CC BMI was 27.7 vs. 29.6 kg/m2(p = 0.03). Median pre- and post-CC SMI, VAI, SAI, and IAI were 63.5 vs 57.8 (p = 0.14), 19.9 vs 30.8 (p = 0.01), 47.9 vs 58.2 (p = 0.03), and 3.0 vs 5.2 (p = 0.002), respectively. Median muscle density pre- and post-CC were 47.0 vs 43.6 HU (p = 0.002). Pre- and post-chemotherapy FFM were 21.5 vs 19.5 kg, representing an overall median loss of 2.8%, (IQR -10.1, +4.7; Range -49.5 - +16.3; p = 0.14). Conversely, pre- and post-CC FM were 6.6 vs 7.5 kg, representing an overall median gain of 13.3% (IQR -3.3, +17.0; -24.9 - +50; p = 0.01). Median time between imaging assessments was 121 days. Specific median measures of adiposity each increased significantly, such that VIA increased by 29% (p = 0.01), SCAI increased by 39.7% (p = 0.03), and IMIA increased by 39.7% (p = 0.002). Conclusions: While lean muscularity remained stable, we observed significant increases in total body adipose mass with decreased muscle density in this consecutive case series of testicular cancer patients following CC.

Erlotinib is one of the most widely used tyrosine kinase inhibitor targeting human epidermal growth factor receptor. Since its introduction, it has revolutionized the treatment of advanced non-small cell lung cancer. Skin rashes and diarrhea are the most often reported side effects of erlotinib however it is also associated with interstitial pneumonitis or interstitial lung disease, which often turns out to be fatal complication of using this medicine. Though reported scarcely in the western world, the association of interstitial lung disease with epidermal growth factor receptor has attracted a lot of attention in the recent times. Various researches working with murine models of bleomycin-induced pulmonary fibrosis have found a pro and con role of the receptor in development of the interstitial lung disease. We present the case of a patient diagnosed with stage IV adenocarcinoma of the lung with metastasis to brain. He was found to be positive for the human epidermal growth factor mutation and was hence started on erlotinib. Within a few weeks of starting the medicine the patient was admitted with diarrhea. During the course of this admission he developed acute shortness of breath diagnosed as interstitial pneumonitis. The purpose of this case report is to review the literature associated with erlotinib induced interstitial pneumonitis and make the practicing oncologists aware of this rare yet fatal complication of erlotinib. Here we will also review literature, pertaining to the role of epidermal growth factor receptor in development of interstitial lung disease.

e21104Background: Clinical stage at diagnosis determines prognosis in lung cancer. One third of patients are metastatic at diagnosis with median survival of 1 year. Lately, survival has improved wi...

e17038Background: Upfront docetaxel (UD) in castration-sensitive metastatic prostate cancer (CSPC) has improved failure-free and overall survival in the CHAARTED, GETUG-AFU 15 and STAMPEDE trials, ...

e20039Background: Carfilzomib (Ky) is an irreversible proteasome inhibitor. Phase III trials, ASPIRE and ENDEAVOR reported cardiovascular adverse events (CvAE) associated with Ky. We performed this...

e17020Background: Sarcopenia refers to the functional decline associated with severe deficiency of skeletal muscle mass (lumbar skeletal muscle index (SMI) < 55cm2/m2 for males). The objective of t...

359 Background: Upfront docetaxel (UD) in castration-sensitive metastatic prostate cancer (CSPC) has improved failure-free and overall survival in the CHAARTED, GETUG-AFU 15 and STAMPEDE trials, resulting in a paradigm shift in practice patterns. However, the impact of docetaxel-based chemotherapy regimens in minorities and in real-world practice remains to be described. The objective of this study is to evaluate tolerability and response to UD in an inner-city ethnically diverse CSPC cohort. Methods: We retrospectively reviewed clinical data for CSPC patients at Cook County Hospital. Patients treated with UD and androgen deprivation (UD, n = 49, 2013-17) were compared to those receiving androgen deprivation alone (ADT, n = 42, 2010-17) using descriptive statistics and Cox Proportional Hazards analysis. Results: Median age was 59 and 60 years in UD and ADT, respectively. African Americans, Hispanics and Caucasians formed 69%, 18%, and 10% in UD and 64%, 9.5% and 26% in ADT. Median PSA at diagnosis was: UD 536 [72-1110] ng/ml, ADT 229 [54-999] ng/ml (p = 0.3). Gleason score > 7 was present in 89.8% [UD] and 92.8% [ADT]. UD and ADT had similar frequency of bone (91% vs. 95%, p = 0.5), visceral (12.2% vs. 11.9%, p = 0.9) and retroperitoneal nodal metastases (55% vs. 45.2%, p = 0.3). UD was initiated a median of 8 weeks from diagnosis. 94% in UD received > 3 cycles of chemotherapy. CTCAE grade > 3 events included anemia (6%); neutropenia (6%); infection (4%); diarrhea (4%); peripheral neuropathy (6%), and fatigue (2%). Median PSA nadir was 3.2 [0.5-40.1] vs. 3.45 [0.1-36.4] ng/ml and time to nadir was 20 [13-27] vs. 41 [19-69] weeks in UD vs. ADT. Biochemical progression was observed in 34.7% [UD] vs. 40.5% [ADT]. Median time to castration-resistance was UD: 39 [31-67] vs. ADT: 65 [34-76] weeks [HR: 0.9; 95% CI 0.4-1.8; p = 0.7]. There were 12 deaths [UD: 4; ADT: 8] during a median follow-up of 46 [23-86, UD] and 111 [68-157, ADT] weeks. Conclusions: In a diverse underserved population with CSPC, UD was well tolerated but was not associated with improvement in time to castration compared to ADT. These results warrant validation and underscore the importance of ensuring accrual of minorities in clinical trials.

e20635 Background:Metastatic lung cancer with systemic chemotherapy has a median progression-free survival (PFS) of 5-6 months and median overall survival time (OS) of around 12 months. In Epidermal Growth Factor Receptor gene (EGFR) mutated metastatic lung cancer the use of EGFR Tyrosine Kinase Inhibitors (EGFR-TKIs) has increased the median PFS to12 months and the median OS to 30 months. The objective of this study is to evaluate the response to TKIs in EGFR mutated metastatic lung cancer in racially diverse inner city population with high smoking rates. Methods:Consecutive patients diagnosed with EGFR mutant metastatic lung adenocarcinoma and treated with TKIs in John H. Stroger Jr. Hospital of Cook County in Chicago, IL between January 2009 to June 2016 were retrospectively evaluated. Demographic data was collected and PFS and OS were analyzed. Results:35 patients with EGFR mutated metastatic lung cancer received EGFR-TKI during the study period. There was a female preponderance (63%). Hispanics formed the most common racial group (37%), followed by Asians (26%), African Americans (AA) (20%) and Caucasians (17%). Mean age of diagnosis of metastatic disease was 56.5± 11.5 years. 20% of the patients were ever smokers. Stage 4 disease at presentation was seen in 88.6 %. Sites of metastatic disease included lungs/pleura (60%), bone (60%), brain (22.9%) and liver (14.3%). 82.9% had TKI as first line treatment. Median PFS and OS were 9.89 (95% CI: 7.8-11.9) months and 19.3 (95% CI: 1.9-36.8) months respectively. The median PFS and OS were 12.88 and 17 months for Asians, 10.8 and 24.4 months for Caucasians and 9.2 and 33 months for Hispanics respectively. Among AA, PFS at 19 months and OS at 35 months was 0.58%, not reaching the median. Patients who continued to smoke had a median OS of 8.5 months vs 19.3 months in nonsmokers/ex-smokers. Conclusions: In an underserved population, patients treated with EGFR mutated metastatic lung adenocarcinoma with EGFR-TKI have similar survival compared previously known data. Race of the patient does not appear to alter response to EGFR-TKI therapy. Active smokers had a lower OS. Studies in minority populations with larger samples are required to further validate the above findings.

Summary Background 9-Aminocamptothecin (9-AC) is a synthetic analogue of camptothecin. Phase I studies, identified the maximum tolerated dose as 1416 μg/m2/day × 3 as continuous intravenous infusion (CVI) with dose-limiting neutropenia. Patients and methods Eligible patients had stage IIIB or IV non-small-cell lung cancer (NSCLC) with measurable disease. Patients were initially treated at 1416 μg/m2/d × 3 by CVI followed by granulocyte-colony stimulating factor (G-CSF) support. This dose was decreased to 1100 μg/m2/d after the first 13 patients. Cycles were repeated every 14 days until tumor progression. Results Fifty-eight patients were treated, thirteen at 1416 μg/m2/d and 45 at 1100 μg/m2/d. Fifty percent had adenocarcinoma and 17% squamous cell carcinoma. Seventy-one percent had stage IV disease. Five patients had a partial response (response duration 9–28 weeks) for an overall response rate of 8.6%, (95% confidence intervals (CI): 2.9%–19%). Median time to progression was 2.3 months and the median survival for the entire study population 5.4 months with a one-year survival rate of 30%. The one-year survival rate for 27 patients who received second line chemotherapy was 56.7%. Toxicities at 1416 μg/m2/d included grade 4 neutropenia and thrombocytopenia in six and five of 13 patients, respectively; at 1100 μg/m2/d these toxicities were observed in 12 and three of 45 patients, respectively. Conclusion 9-AC has modest single-agent activity in previously untreated NSCLC. Its further evaluation at the dose and schedule employed in this study does not seem indicated. Exploration of more prolonged administration schedules may be warranted.

Purpose The purpose of this study is to determine whether primary treatment with both radiotherapy and chemotherapy is superior to radiotherapy alone in patients with squamous cell carcinoma of the esophagus. Patients and methods From January 1980 to December 1988, 77 patients from two Veterans Affairs hospitals with clinically staged nonmetastatic squamous cell carcinoma of the esophagus received either radiotherapy alone (RT group) or concomitant radiotherapy and chemotherapy (RT + CT group) with curative intent. Each group originated at a different hospital, but all patients were irradiated in the same radiotherapy department. Chemotherapy consisted of cisplatin and 5-fluorouracil. Forty-two patients received RT alone, and 35 received RT + CT. Locoregional control, disease-free survival, and overall survival rates were compared. Results Locoregional control, disease-free survival, and overall survival rates were significantly higher in the RT + CT group when compared to RT group, 26% vs 5%, 20%, vs 2%, and 29% vs 7%, respectively, at 2 years (P = .01, 0.02 and 0.02, respectively). The median survival was 14 months for the RT + CT group and 7.5 months for the RT group. There was no difference in the incidence of distant metastases except for bone metastases. No one in the RT + CT group developed bone metastases compared to nine patients in the RT group (P = .01). Conclusion This retrospective analysis shows improved locoregional control, disease-free survival, and survival when chemotherapy consisting of cisplatin and 5-FU is given in addition to radiation for patients with squamous cell carcinoma of the esophagus. Bony metastases were absent in those who received chemotherapy.

Amonafide (nafidimide), a synthetic organic compound with an inhibitory effect on cellular replication, was used in a phase II study conducted by the Illinois Cancer Center in order to assess its efficacy and toxicity in advanced or recurrent squamous cell cancer of the head and neck. Eligible patients had received no more than one prior adjuvant or neoadjuvant chemotherapy, had normal bone marrow, renal and hepatic function, ECOG performance status of 0–2, and bidimensionally measurable disease. Eligible patients were administered amonafide at a starting dose of 300 mg/m2 for five consecutive days every 3 weeks with dose escalation or de-escalation according to established hematologic criteria in the absence of disease progression. Nineteen of 22 entered patients were evaluable for response and all patients were evaluable for toxicity. Eleven of 19 patients achieved stable disease. Median time to progression after start of treatment was 57 days, for the 18 patients for whom the date of progression is known. There were no partial or complete responses. Hematologic toxicity was dose limiting with grade 3–4 neutropenia in 50 percent of patients and 4 deaths associated with neutropenic sepsis. Non-hematologic toxicity was mild to moderate with nausea and vomiting predominating. In this study, amonafide was a myelotoxic, inactive treatment in advanced/ recurrent head and neck cancer. Further use in head and neck cancer appears unwarranted.

e18195Background: John Stroger Hospital is one of the largest public hospitals in the country, providing chemotherapy to 60-70 patients a day. Over 2014-2015, we designed, built and now use 285 ele...

Background In advanced non–small-cell lung cancer (NSCLC), reducing symptoms can be a meaningful treatment outcome. This study characterizes the pulmonary symptoms of patients receiving second- and third-line systemic therapies for NSCLC and assesses the content validity of the 4-item Pulmonary Symptom Index (PSI) of the Functional Assessment of Cancer Therapy—Lung (FACT-L). Methods Twenty patients with advanced NSCLC undergoing second- and third-line treatment (“qualitative sample”) completed semistructured interviews regarding their NSCLC symptoms and the importance of pulmonary symptoms. Results were mapped to the PSI. In addition, existing PSI data from 912 patients with cancer (“validation sample”) was analyzed to evaluate the scalability of the 4 PSI items. Results In the qualitative sample, mean age was 62 years (range 30-79 years); 80% had nonsquamous histologic type, and 25% had comorbid chronic obstructive pulmonary disease (COPD). A core set of pulmonary symptoms emerged in the data—shortness of breath, cough, and chest tightness. These mapped to 3 PSI items. A quarter of the patients reported an absence of pulmonary symptoms, which supports the inclusion of the final PSI item, “breathing is easy.” In the validation sample, for the shortness of breath/breathing ease item pair, weighted kappa representing chance-adjusted agreement ranged from 0.39 to 0.54 and percent agreement from 44% to 49% (both considered moderate), supporting a distinct contribution of each item. Conclusion The PSI captures the most important and relevant symptoms reported by patients with NSCLC receiving second- and third-line treatment. Our results suggest that the PSI may provide a clinically useful method to measure patient benefit from lung cancer therapies.

Fourteen patients with squamous cell carcinoma of the head and neck received 9-AC/DMA infusions of 850 mg/M2/day over 72 hours. Eligibility criteria included good performance status, advanced disease incurable by conventional means, no prior treatment of metastatic disease, and measurable lesions for objective response assessment. The infusions were repeated at 21 day intervals until progression or prohibitive toxicity occurred. A median of 3 cycles (range 1-7) was given. No objective responses were observed. Median survival of the group was 6 months. Toxicity was hematologic which was modest and promptly reversible. 9-AC/DMA is inactive against this tumor type at the dose and schedule employed in this study.

Patient-reported outcomes (PROs), such as symptom scales or more broad-based health-related quality-of-life measures, play an important role in oncology clinical trials. They frequently are used to help evaluate cancer treatments, as well as for supportive and palliative oncology care. To be most beneficial, these PROs must be relevant to patients and clinicians, valid, and easily understood and interpreted. The Patient-Reported Outcomes Measurement Information System (PROMIS) Network, part of the National Institutes of Health Roadmap Initiative, aims to improve appreciably how PROs are selected and assessed in clinical research, including clinical trials. PROMIS is establishing a publicly available resource of standardized, accurate, and efficient PRO measures of major self-reported health domains (eg, pain, fatigue, emotional distress, physical function, social function) that are relevant across chronic illnesses including cancer. PROMIS is also developing measures of self-reported health domains specifically targeted to cancer, such as sleep/wake function, sexual function, cognitive function, and the psychosocial impacts of the illness experience (ie, stress response and coping; shifts in self-concept, social interactions, and spirituality). We outline the qualitative and quantitative methods by which PROMIS measures are being developed and adapted for use in clinical oncology research. At the core of this activity is the formation and application of item banks using item response theory modeling. We also present our work in the fatigue domain, including a short-form measure, as a sample of PROMIS methodology and work to date. Plans for future validation and application of PROMIS measures are discussed.

6593 Background: RT-related early adverse skin reactions (EASR) are common in BC patients. EASR occur during/within 2 months post-RT. Predictive biomarkers for EASR are under active investigation. ...

Bisphosphonates reduce the incidence of skeletal-related events (fractures, pain, hypercalcemia) in patients (pts) with bone metastases from breast cancer. By inhibiting osteoclast function and subsequent bone turnover they may inhibit the growth of bone (and other) metastases. Their role in preventing or delaying the development of bone (or other) metastases in pts with early breast cancer is uncertain. Three previous trials of oral clodronate have given mixed results. The largest trial (placebo-controlled) and a smaller open-label trial suggested that oral clodronate benefitted pts with improved bone metastases-free survival (BMFS) and overall survival (OS), but a third open-label study showed no benefit with an apparent detrimental effect on survival. Studies of IV zoledronate in open-label trials in early breast cancer have also shown mixed results: the AZURE trial in pts with node positive breast cancer showed no benefit in disease-free survival (DFS) or OS with a possible effect in pts aged over 60. The ABCSG-12 trial in GnRH (plus tamoxifen or anastrozole) treated women with early breast cancer showed a small DFS benefit for those receiving IV zoledronate but no BMFS or OS benefit. Methods: B-34 is a prospective, randomized, double-blind, phase III clinical trial in pts with stage 1, 2 or 3 breast cancer assessing oral clodronate 1600mg daily for 3 years compared to placebo given alone or in addition to adjuvant chemo- or hormone therapy. Stratification is by age ( Results: 3323 patients were accrued — 1662 in Group A and 1661 in Group B. As of March 31, 2011, 54 pts were declared ineligible: 23 in Group A and 31 in Group B. The average time on study is 101.3 months. Patient characteristics were evenly distributed throughout both groups. Approximately 75% of pts in each group had negative axillary lymph nodes and some 78% in each group were ER and/or PR positive. About 64% of pts were age 50 or over. Oral clodronate was generally tolerable, toxicities observed being mainly due to the concomitant systemic chemotherapy. One pt in Group A had a 1 mm area of osteonecrosis on the palatal taurus. Compliance, as expected with trials of oral medications, has been a problem. 1910 pts completed 3 years of therapy. Event rates were slower than anticipated. This final analysis assesses a total of 598 events in the two arms. Conclusions: This trial is the largest placebo-controlled study of an oral bisphosphonate in patients with early breast cancer and will provide further information on the role of bisphosphonates in breast cancer management. Supported for NSABP by NCI U10CA12027, −37377, 69651, 69974; and Bayer Schering Pharma Oy; for ECOG by U10CA021115; for NCCTG by U10CA25224; for SWOG by U10CA38926. Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr S2-3.

Background: Hepatocellular cancer (HCC) is the fifth most frequently diagnosed cancer in the world and the second leading cause of cancer-related death across the globe. There are few small and old studies that tried to correlate levels of alpha-fetoprotein (AFP) with patient outcomes. Currently with more screening there is early diagnosis of HCC and the therapeutic options for non-surgical candidates have also improved in the past decade. We undertook this study to see if the level of elevation of AFP is related to patient prognosis in the current era.

e20544 Background: Poor sleep is common, and is linked to impaired cognitive, psychological, and physical functioning and a lower quality of life. The purpose of this study is to measure quality of sleep in cancer patients and determine the relationship between quality of sleep and performance status. Methods: Patients with cancer (n=139) were recruited at the public hospital between November 2011 and January 2012 and asked to complete the Pittsburgh Sleep Quality Index (PSQI) and the Eastern Cooperative Oncology Group (ECOG) performance status (PS) questionnaires. Twenty patients repeated the questionnaires after 3 months. For the purpose of this study PSQI global score >5 was considered insomnia. PS score 0-1 was considered good, and PS 2-4 was considered poor. Results: The mean age of participants was 55±11 years, 56% were women, 78% were ethnic minority, 77% had advanced cancer, and 71% were undergoing cancer treatment. Among all patients, 73% reported good PS. Median PSQI score was 7 (IQR 4; 11) and 62% had insomnia. Sleep medication was used by 25%. Patients with poor PS had worse PSQI score (Mann-Whitney test, p< 0.0001), and 7.34 (95%CI 2.11-25.49) higher odds of insomnia (p=0.0002) compared to patients with good PS.(Table1) No significant correlation was found between insomnia and gender, ethnicity, primary tumor type, tumor stage, or treatment status. Conclusions: The incidence of insomnia among cancer patients is high. There is a higher incidence of sleep disturbance and worse sleep quality among patients with poorer performance status. [Table: see text]

African Americans are more likely to develop lung cancer and die from it than any other ethnic group. Complex biological, environmental, political and cultural factors contribute to this disparity. The purpose of the current project is to examine the relationship between epigenetic factors, gender, ethnicity and outcome in a retrospective study of patients with surgically-treated early stage lung cancer. Fixed primary tumor tissues from a private (RMC) and a public (JHS-CCH) institution were analyzed in this study. The RMC group consisted of 132 patients with stage Ib, IIa and IIb NSCLC, 22% African-American (AA) and 52% female. The JHS-CCH group consisted of 88 patients, 62% AA and 43% female. Five year survival was achieved by 85% of women vs 67% of men in the RMC group (Chi square p=0.022). 68% of Caucasians vs 53% AA survived five years in the RMC group (p=0.186). To investigate the role of epigenetic influences on survival, promoter methylation of Ras association domain family protein 1, RASSF1A, was investigated. Associations between inactivation of the RASSF1A tumor suppressor and poor outcome in lung and other cancers have been reported in several studies. Promoter methylation was quantified using pyrosequencing. Percent methylation of RASSF1 at cytosine position –36 (A of ATG=+1) was more frequent in AA (41% of cases) than in Caucasians (20% of cases) in the RMC group (p=0.023) compared to 69% of cases in the JHS-CCH group. Methylation levels of RASSF1 at all CpG sites tested were higher in the JHS-CCH group than in the RMC group. Kaplan-Meier analysis was performed on dichotomized hypermethylation status compared to five-year survival (5YS). Promoter hypermethylation of RASSF1 was significantly associated with shortened 5YS in AA (p=0.005), compared to Caucasians (p=0.197) in the RMC group. Although 5YS was marginally shortened with hypermethylation of RASSF1 in men in the RMC group (p=0.123), no significant effects were seen with regard to gender. These results suggest that biomarkers can have differential effects, based on genetic background and support analysis of epigenetic biomarkers to address disparities and develop more personalized treatment strategies for individual patients. Citation Format: {Authors}. {Abstract title} [abstract]. In: Proceedings of the 103rd Annual Meeting of the American Association for Cancer Research; 2012 Mar 31-Apr 4; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2012;72(8 Suppl):Abstract nr 3586. doi:1538-7445.AM2012-3586

Thirty-three patients with advanced colorectal carcinoma were entered on a phase II trial of weekly IV aminothiadiazole (175 mg/m2 escalated to 200 mg/m2) with concomitant allopurinol and non-steroidal anti-inflammatory agents (NSAID's). Toxicity was predominantly GI, cutaneous, and chest pain/dyspnea. Twenty-five percent of patients had grade 3 or 4 toxicity. There were no responses in 27 evaluable patients. Median survival was 12 months. Aminothiadiazole, at higher doses than used in previous reports, when given with NSAID's, had no significant activity against large bowel cancer.

10590 Background: We previously identified p53 as an independent marker of prognosis in African-American (AA) women with breast cancer. However, it is unclear whether the influence of p53 is unique...

7558 Background: Lung cancer is the leading cause of cancer death. Response and survival of patients (pts) with stage III lung cancer in minority population is not well studied. Methods: 79 pts treated between 2001 and 2006 were studied as a retrospective cohort. Clinical and survival data were analyzed using fisher's test, chi square test, Kaplan Meier analyses. Results: 33 Pts had Stage IIIA; Median age at diagnosis was 58 yrs (37–75). 14 were males (42.4%) 19 females (57.6%) 26 African American (78.8%) and 7 Caucasians (21.2%). Median number of co morbidities 2 (0–4). Mean follow up was 25 months (mo) (2 - 93), 19 had surgery (12 Lobectomy (36.4%), 7 Pneumonectomy (21.2%)) and 14 were unresectable (42.4%). All pts received adjuvant chemotherapy. Unresectable pts received chemotherapy and radiation, 8 carboplatin and gemcitabine and 6 cisplatin and etoposide. Median time to progression in resectable IIIA was 23 mo (2- 67), unresectable IIIA was 12 mo (3–93). Median survival in pts with resection was 26 mo (2 - 67), unresectable was 12 mo (5 - 93). Overall survival and time to progression was not influenced by sex, race, tumor type. 46 pts had stage IIIB, median age at diagnosis 57.5 yrs (40–68). 31 were males (67.4%) 15 females (32.6%) 29 African Americans (63%) 11 Caucasians (23.9) 3 Asians (6.5%) and 3 Hispanics (6.5%). Median follow up was 10 mo (3–97). All pts received chemotherapy and radiation. 23 received cisplatin and etoposide (50%), 14 carboplatin and gemcitabine (30%), 5 carboplatin and etoposide (9%), 5 carboplatin and paclitaxel (9%). 13 had complete response (28.3%), 15 partial response (32.6%), 2 stable disease (4.3%) and 10 Progression (21.7%). Median time to progression was 9 mo (3–97). Median overall survival was 10 mo (3–97). Overall survival and time to progression was not influenced by sex, race, tumor type, chemotherapy regimen. Conclusions: In this minority based cohort response, time to progression, overall survival in both IIIA and IIIB pts is much lower then historical controls. The overall survival and time to progression in both IIIA and IIIB is not influenced by race, sex, tumor type and type of chemotherapy regimen. Further investigations of disease and healthcare disparities in the underserved minority population, are warranted. No significant financial relationships to disclose.

A phase II trial of 4′ Deoxydoxorubicin (DXDX) was conducted in unresectable previously untreated non-small cell lung cancer patients. DXDX was administered every 3 weeks by short intravenous infusion at a starting dose of 30 mg/m2, with dose escalation to 40 mg/m2 toxicity permitting. Four responses, all partial, were observed in 35 evaluable patients, for a response rate of 11% (95% confidence limits 3.2% and 26.7%). Myelosuppression was the dose-limiting toxicity. Cardiotoxicity was not seen. DXDX has minimal activity against non-small cell lung cancer as a single agent at the dosage used in this study.

Background: The phenotypic expression of Hodgkin lymphoma among different ethnic groups is not well described. We conducted a study to look at the characteristics and the clinical response of Hodgkin lymphoma patients of different ethnicities to standard treatment. Method: A retrospective analysis of 65 Hodgkin lymphoma patients diagnosed 2003 through 2006 was undertaken. Patients who have been compliant and completed assigned chemotherapy (ABVD) with or without Involved Field RT were evaluated for response to treatment using CT scan and PET scan. Data was analyzed using fisher exact test. Results: Patients with limited staged disease received 4 to 6 cycles of ABVD +/− RT while those with advanced staged disease received 6 to 8 cycles of ABVD +/− RT. All 50 patients achieved objective response. Complete response rates were 52% Hispanic, 68% African American, and 75% Caucasians. (p=0.4) Conclusion: Hodgkin lymphoma is as common in Hispanics as in African American. The mixed cellularity subtype is more common in the Hispanics; however the nodular sclerosis subtype remains the most common histological subtype. Though more Hispanics had an early clinical stage disease at diagnosis, they had a lower complete response rate compared to the other ethnic groups. How this observation will translate into a poorer survival outcome remains to be seen. Results: Hispanic African American Caucasians N=65 26 27 12 Median age 26 27 38 Nodular Sclerosis subtype 26 27 12 (P=0.08) Mixed Cellularity subtype 6 1 1 Clinical Stage 1–2 16 9 9 (P=0.03) Clinical Stage 3–4 10 18 3 Completed Treatment N=50 23 19 8

14155 Background: Chemotherapy-associated thrombotic thrombocytopenic purpura (TTP) has been described in the literature. However Cetuximab, a monoclonal antibody targeted to the EGF receptor, has not yet been associated with TTP. We report a case of an 85 year old woman with a resected squamous cell carcinoma of the lip who developed TTP after receiving cetuximab. Methods: A day after receiving Cetuximab, as part of an adjuvant concurrent cetuximab-radiotherapy regimen, the patient presented with gingival bleeding and confusion without fever but with significant petechial rash and jaundice.. Hemoglobin level was 6.9 g/dL WBC 3.9 k/uL Platelet count 4 k/uL Lactate dehydrogenase 1350 U/L Indirect bilirubin 3.8 mg/dL Haptoglobulin < 6 mg/dL Reticulocyte count 4.4 %. Serum creatinine, ANA, coagulation profile, coomb‘s test were normal. Peripheral blood smear showed 3+ schistocytes. TTP was diagnosed and daily plasmapheresis was initiated. TTP resolved after 8 sessions of plasmapheresis with platelet count increasing to 446 k/uL and sustained. Results: Competing etiologies for our patient’s TTP were cancer and cetuximab. Most reported cases of cancer-associated TTP occurred in patients with metastatic adenocarcinoma. Our patient had a non-metastatic resected squamous cell carcinoma with only residual microscopic disease. Since TTP developed closely following cetuximab administration and resolved with plasmapheresis after stopping cetuximab, we concluded that its development was most likely secondary to cetuximab or to antibody developed to it. Possible mechanisms for cetuximab-induced TTP are direct endothelial damage by cetuximab leading to platelet activation and aggregation or inhibition of metalloproteinase, resulting in accumulation of Ultra-large VWF multimers. Conclusions: Targeted-therapy is emerging as an effective treatment modality in medical-oncology. Further clinical experience is needed to ascertain the full extent of potentially fatal adverse events. To our knowledge this is the first case of cetuximab-induced TTP. No significant financial relationships to disclose.

13568 Background: Oxaliplatin and 5FU based regimens have become standard first line treatment for stage IV colorectal cancer. At our institution predominately the regimens FOLFOX6 (oxaliplatin/infusional 5FU via a central venous catheter) and XELOX (oxaliplatin/ capecitabine given orally) are used. We performed a retrospective review of 40 patients to see if any differences, primarily in toxicities, but also in response, emerged. Methods: . Twenty consecutive patients with Stage IV colorectal cancer who received FOLFOX6 as initial therapy and twenty consecutive patients who received initial XELOX, with the oxaliplatin given via a peripheral IV, were analyzed. The decision to administer FOLFOX6 or XELOX was not made for clinical reasons, but came about from logistical difficulties placing central venous catheters in our institution, due to cost and operating time. Comparisons were performed with a Mann Whitney test. The two groups were well matched in terms of sex, age, and performance status. Response evaluations were made based on RECIST criteria. Results: Toxicities compared in the two groups (FOLFOX6 v. XELOX) were gastrointestinal, >Gr. II (5 v. 20%); dermatologic, >Gr. III (0 v. 35%); bone marrow, > Gr. II (15 v. 20%); neurologic, >Gr. III peripheral neuropathy (10 v. 10%); and development of arm pain/discomfort (0 v. 30%). The two toxicities reaching a significant difference, with the higher incidence from XELOX, were > Grade II dermatitis (p= 0.03) and development of arm pain (p=0.05). The response rate of FOLFOX6 was 75% and that for XELOX was 55% (p value of 0.144). Conclusions: Our conclusions from this analysis are that the two regimens are comparable in terms of response, but that FOLFOX6 may be preferable in order to avoid severe dermatitis and if XELOX is the treatment choice, serious consideration should given to administer the oxaliplatin via a central catheter. No significant financial relationships to disclose.

Daniel H. Shevrin 1, Thomas E. Lad 2, Patrick Guinan 3, Lary J. Kilton 4, Alice Greenburg 5, Patricia Johnson 6, Richard R. Blough 7 and Holly Hoyer 7 1Evanston Hospital, Evanston, 1L; 2University of Illinois Hospital, Chicago, IL; SCook County Hospital, Chicago, IL; 4private practice, Barrington, IL; 5Decatur Memorial Hospital, Decatur, [L; 6Carle Clinic, Urbana, IL; 7Illinois Cancer Council, Chicago, IL, USA