Linking the NETSARC+ National Sarcoma Database With the SNDS to Evaluate Adjuvant and/or Neoadjuvant Therapy: Report on the Linkage Process and Result (Health Data Hub's DEEPSARC Pilot Project)

Background: TNBC constitutes an aggressive and heterogeneous group of tumors with variable response to neoadjuvant therapy (NAT) that currently lacks clinically available profiling strategies for prediction. We aimed to develop an integrated model based on imaging, pathological and clinical data capable to predict NAT response in TNBC early during therapy. METHOD AND MATERIALS:125 Stage I-III TNBC patients enrolled in an IRB approved prospective clinical trial (NCT02276433) who had DCE-MRI at baseline (BL) and post 2 cycles (C2) of NAT, and had surgery were included in this analysis. Tumor volume was calculated using 3D measurements at BL and C2 time points DCE-MRI. Percent tumor volume reduction (TVR) between BL and C2 was calculated. Demographic, clinical, and pathological data (age, T and N stage, histology, androgen receptor expression, Ki-67, stromal tumor infiltrating lymphocytes level (sTIL), and PD-L1 expression), and treatment response at surgery (pCR vs non-pCR) were documented. Recursive partitioning was used to identify TVR cutoff value. Multivariate logistic regression and ROC analysis were used to assess associations and build and evaluate predictive models. RESULTS: 61 (49%) TNBC pts showed pCR at surgery, and 64 (51%) non-pCR. Recursive partitioning analysis identified ≥ 55% TVR as the optimal cutoff values for pCR prediction at C2. TVR, N stage and sTIL were significantly associated with pCR in the multivariate analyses (p<0.002, p<0.01, p<0.001, respectively). Integrated model containing TVR (≥55% vs <55%), N stage (N0 vs N+) and sTIL (≥20% vs <20%) was predictive of pCR with AUC 0.84 (95% CI:0.77-0.91). Integrated model performance was significantly better than TVR only or clinical only (sTIL, and N stage) models (p<0.001). CONCLUSION: Integrated model that included imaging (DCE-MRI TVR), clinical (N stage) and pathological (sTIL) data showed high accuracy for prediction of NAT response in TNBC patients early during treatment. Validation of these results in a large prospective study is ongoing. Citation Format: Gaiane Margishvili Rauch, Rosalind P. Candelaria, Mary Saber Guirguis, Medine Boge, Rania M. M. Mohamed, Nabil Elshafeey, Jia Sun, Gary J Whitman, Jessica Leung, Huong C Le-Petross, Lumarie Santiago, Deanna Lane, Marion Scoggins, David Spak, Miral M Patel, Frances Perez, Jason B. White, Elizabeth Ravenberg, Wei Peng, Debu Tripathy, Vicente Valero, Jennifer Litton, Lei Huo, Clinton Yam, Alastair Thompson, Jingfei Ma, Stacy L. Moulder, Wei Yang, Beatriz E. Adrada. Integrated model for early prediction of neoadjuvant systemic therapy response in triple negative breast cancer [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr PD11-07.

Validation of an indirect linkage algorithm to combine registry data with Medicare claims

The purpose of this study was to determine the rate of complete pathologic response in axillary lymph nodes after neoadjuvant therapy and the clinicopathologic factors associated with a complete response. Clinical, demographic, and pathologic data from all patients with breast cancer treated at our institution are prospectively recorded in a database. We reviewed this database from 2000 to 2007 and identified 90 patients who were node-positive before neoadjuvant therapy based on image-guided fine needle aspiration biopsy; all 90 patients underwent axillary lymph node dissection (ALND) after neoadjuvant therapy. Data were compared using chi-square and Fisher's exact test. Of 90 patients with breast cancer who were node-positive before neoadjuvant therapy, 71 (79%) had positive nodal disease on final ALND pathology and 19 (21%) had a complete nodal pathologic response. Age, race, tumor grade, clinical T and N stage, and estrogen/progesterone receptor and Her-2neu status were not predictive of a complete nodal response. The only factor predictive of a complete nodal response was the type of neoadjuvant therapy used; all 19 patients with a complete response received neoadjuvant chemotherapy and none received neoadjuvant endocrine therapy (P < 0.05). Twenty-five percent of patients who underwent neoadjuvant chemotherapy had a complete pathologic response in the nodal basin, whereas no patient who underwent neoadjuvant endocrine therapy experienced a complete nodal response. Twenty-five percent of patients who underwent neoadjuvant chemotherapy had a complete pathological response in the nodal specimen, whereas no patient who underwent neoadjuvant endocrine therapy experienced a complete nodal response.

Design of a prospective, longitudinal cohort of people living with type 1 diabetes exploring factors associated with the residual cardiovascular risk and other diabetes-related complications: The SFDT1 study

Lymphocytic infiltration and Chemotherapy Response Score as prognostic markers in ovarian cancer patients treated with Neoadjuvant chemotherapy

346 Background: Several research findings indicate that some patients with locally advanced gastric cancer (LAGC) who undergo neoadjuvant therapy followed by curative surgery can achieve pathological complete response (pCR). Whether pCR is equivalent to cure, serves as a good prognostic indicator for long-term survival, and whether patients achieving pCR require subsequent adjuvant therapy are still unknown. Therefore, we conducted a nationwide multicenter retrospective study to investigate the long-term efficacy of patients with LAGC who achieved pCR after neoadjuvant therapy. Methods: Clinical and pathological data were collected from 351 patients with locally advanced gastric cancer who achieved pCR after neoadjuvant therapy between January 2018 and October 2023 at 14 medical centers in China. These patients were matched 1:1 with non-pCR patients based on age, gender, clinical T stage, and N stage. This study evaluated general clinical data, neoadjuvant treatment regimens, cycles, surgical outcomes, and follow-up information including postoperative adjuvant therapy, recurrence, metastasis, and survival status up to November 2023. Results: Negative Serum tumor markers, non-signet ring cell carcinoma and neoadjuvant treatment regimens were closely associated with pCR. Patients achieving pCR were more likely to reach ypN0 status after neoadjuvant therapy compared to non-pCR patients. Survival analysis showed significantly higher overall survival (OS) and disease-free survival (DFS) in pCR patients compared to matched non-pCR patients. Moreover, OS and DFS were significantly higher in ypN0 patients within the pCR group compared to non-pCR patients. However, there was no significant difference in OS and DFS between ypN+ patients in the pCR group and non-pCR patients. Additionally, postoperative adjuvant chemotherapy did not significantly impact OS and DFS in the pCR group. Conclusions: pCR is an independent prognostic factor for OS and DFS. However, survival benefits from pCR are limited to patients achieving ypT0N0 status, while ypT0N+ patients do not benefit from pCR. Furthermore, adjuvant chemotherapy may not improve the prognosis of patients achieving pCR after neoadjuvant therapy.

There is a major focus in health reform in Australia and internationally on monitoring and reporting organisational performance measures, such as standardised mortality rates, in different clinical areas. Given the increasing reliance on existing data for measuring mortality rates, it is important that the accuracy and validity of data are high. Yet, researchers have demonstrated limitations in measuring in-hospital mortality to evaluate intensive care, as it can lead to skewed measurements depending on the discharge practices of different organisations. In Australia, the intensive care clinical registry does not currently measure survival outcomes of patients after hospital discharge but there is interest in doing so. While administrative data sources have the ability to assess outcomes of intensive care patients after hospital discharge, these data may not have sufficient clinical detail to enable robust risk adjustment. Data linkage can be used to link clinical registry and administrative data to enable the measurement of long-term outcomes while using clinical variables to enhance risk-adjustment. However, linkage must be conducted in a robust fashion so that additional error introduced from sub-optimal linkage processes will not bias results. The main aim of the thesis is to assess the utility of linked administrative and clinical data compared to administrative alone and clinical data alone for monitoring long term survival outcomes of ICU patients. The objectives of the thesis are: 1) to define key attributes of linked data for assessing the quality of study results; and 2) to compare the use of linked data to administrative data alone and clinical data alone for a) predicting survival of intensive care patients at 180 days after discharge and b) assessing systematic variation between observed and expected deaths. There were two projects involved in this thesis to address aims 1 and 2, respectively. The first project involved a Delphi consensus process including Australian experts to develop standardised reporting guidelines for assessing the quality of data linkage studies. The resulting guidelines included a list of fourteen items. The guidelines were then applied by two researchers to a stratified selection of data linkage studies to assess their inter-rater reliability (k=0.6). The second project involved the linkage of the Victorian Admitted Episodes Dataset to the Australian/New Zealand Intensive Care Society clinical database of adult critical care patient episodes in the state of Victoria. The linkage procedure was validated to determine whether sources of bias were introduced into the dataset through linkage processes. The added predictive capabilities of the full linked dataset were compared to a model using the administrative data only (C=0.85 v 0.75), a model using the clinical data only (C=0.85 v. 0.84) and a model using a limited sub-set of linked data (C=0.85 v 0.83). Variable Life Adjusted Display (VLAD) charts were developed using both of the linked, administrative and clinical predictive models to determine whether the linked data enhanced the capacity for detecting systematic variation in mortality ratios. It was found that the use of data linkage can enhance the measurement of long-term mortality indicators in intensive care by improving the accuracy of data, risk prediction models and methods for displaying systematic variation in death ratios. Yet, these benefits must be considered together with the limitations of the data, which can influence the accuracy of the linkage process. Identifying and reporting these issues will help to improve data quality and linkage in the future.

Objectives: To construct a nomogram for prediction of intrahepatic cholangiocarcinoma (ICC) lymph node metastasis based on inflammation-related markers,and to conduct its clinical verification. Methods: Clinical and pathological data of 858 ICC patients who underwent radical resection were retrospectively collected at 10 domestic tertiary hospitals in China from January 2010 to December 2018. Among the 508 patients who underwent lymph node dissection,207 cases had complete variable clinical data for constructing the nomogram,including 84 males,123 females,109 patients≥60 years old,98 patients<60 years old and 69 patients were pathologically diagnosed with positive lymph nodes after surgery. Receiver operating characteristic curve was drawn to calculate the accuracy of preoperative imaging examinations to determine lymph node status,and the difference in overall survival time was compared by Log-rank test. Partial regression squares and statistically significant preoperative variables were screened by backward stepwise regression analysis. R software was applied to construct a nomogram,clinical decision curve and clinical influence curve,and Bootstrap method was used for internal verification. Moreover,retrospectively collecting clinical information of 107 ICC patients with intraoperative lymph node dissection admitted to 9 tertiary hospitals in China from January 2019 to June 2021 was for external verification to verify the accuracy of the nomogram. 80 patients with complete clinical data but without lymph node dissection were divided into lymph node metastasis high-risk group and low-risk group according to the score of the nomogram among the 858 patients. Log-rank test was used to compare the overall survival of patients with or without lymph node metastasis diagnosed by pathology. Results: The area under the curve of preoperative imaging examinations for lymph node status assessment of 440 patients was 0.615,with a false negative rate of 62.8% (113/180) and a false positive rate of 14.2% (37/260). The median survival time of 207 patients used to construct a nomogram with positive or negative postoperative pathological lymph node metastases was 18.5 months and 27.1 months,respectively (P<0.05). Five variables related to lymph node metastasis were screened out by backward stepwise regression analysis,which were combined calculi,neutrophil/lymphocyte ratio,albumin,liver capsule invasion and systemic immune inflammation index,according to which a nomogram was constructed with concordance index(C-index) of 0.737 (95%CI: 0.667 to 0.806). The C-index of external verification was 0.674 (95%CI:0.569 to 0.779). The calibration prediction curve was in good agreement with the reference curve. The results of the clinical decision curve showed that when the risk threshold of high lymph node metastasis in the nomogram was set to about 0.32,the maximum net benefit could be obtained by 0.11,and the cost/benefit ratio was 1∶2. The results of clinical influence curve showed that when the risk threshold of high lymph node metastasis in the nomogram was set to about 0.6,the probability of correctly predicting lymph node metastasis could reach more than 90%. There was no significant difference in overall survival time between patients with high/low risk of lymph node metastasis assessed by the nomogram and those with pathologically confirmed lymph node metastasis or without lymph node metastasis (Log-rank test:P=0.082 and 0.510,respectively). Conclusion: The prediction accuracy of preoperative nomogram for ICC lymph node metastasis based on inflammation-related markers is satisfactory,which can be used as a supplementary method for preoperative diagnosis of lymph node metastasis and is helpful for clinicians to make personalized decision of lymph node dissection for patients with ICC.

Differences between the efficacy of HER2(2+)/FISH-positive and HER2(3+) in breast cancer during dual-target neoadjuvant therapy.

To explore the factors influencing the prognosis of endometrial cancer (EC) patients and assess their quality of life. A retrospective study was conducted involving 190 patients with EC who underwent surgical treatment in the Department of Obstetrics and Gynecology at Beijing Chao-Yang Hospital Affiliated to Capital Medical University between January 2008 and December 2018. Clinical and pathologic data were collected, and all patients received appropriate follow-up. Univariate analysis and Cox proportional hazards regression models were used to identify the factors related to EC prognosis and independent predictors of outcome. Additionally, the predictive performance of the serum biomarkers carcinoembryonic antigen (CEA), cancer antigen 125 (CA125), and CA199 for patient prognosis were evaluated. All 190 EC patients had complete clinical, pathologic, and follow-up data. The median survival time was 88.95 months, with a 5-year survival rate of 94.4%. Univariate analysis showed that older age, postmenopausal status, higher FIGO stage, deeper myometrial invasion, poorer tissue differentiation, lymph node metastasis, and receipt of postoperative chemotherapy and combined radiotherapy were significantly associated with worse prognosis (P<0.05). The sensitivities of CEA, CA125, and CA199 for predicting adverse prognosis were 86.7%, 97.6%, and 82.4%, respectively; specificities were 72.0%, 68.0%, and 80.0%, respectively. The areas under the receiver operating characteristic curves (AUCs) were 0.681, 0.867, and 0.853, respectively. Postoperative prognosis in patients with endometrial cancer is influenced by multiple clinical and pathological factors. Serological markers CEA, CA125, and CA199 demonstrated favorable predictive value.

Background: Sentinel lymph node (SLN) biopsy accurately stages the axilla, but is time consuming and resource intensive. Nomograms and scoring systems have been developed, based on clinical and pathologic data available before surgery, to attempt to predict the likelihood of lymph node metastasis before surgery. As the management of the axilla in patients with low nodal burden changes, it is also important to predict whether there will be further axillary disease in patients with a positive SLN. Aim: To explore the risk factors for SLN and non-SLN metastasis in Indian women with breast cancer, by analysis of clinical and pathologic data. To assess the validity and clinical utility of two MSKCC nomograms that predicts axillary lymph node status for Western patients. Methods: Clinical data, and pathologic data available from core biopsy, for a consecutive series of women having SLNB was analyzed, and was plotted on two MSKCC nomograms. Univariate analysis was done by χ2 and Fischer exact tests and multivariate analysis was done by logistic regression method. A receiver-operating characteristic (ROC) curve was drawn and predictive accuracy was assessed by calculating the area under the ROC curve (AUC). Results: 34% (89 out of 256) of our patients had SLN positivity. When correlated with SLN metastasis by univariate analysis, LVI (χ2 = 80, P ≤ 0.001), PNI (χ2 = 13.36, P ≤ 0.001), ER+ (χ2 = 6.85, P = 0.009), PR+ (χ2 = 7.1, P = 0.008) and age ( P = 0.03) were significant. However, multivariate analysis showed that age (OR=1.04, P = 0.007) and LVI (OR=0.07, P ≤ 0.001) were identified as independent predictors for SLN metastasis. The area under the ROC curve was 0.772 and it fairly correlated with MSKCC nomogram. Patients with MSKCC scores lower than 38% had a frequency of SLN metastasis of 7.7% (5/65) and this cut-off could be used as a guide for not doing frozen section analysis in this subgroup. Further axillary dissection showed 41% (38 out of 92) had non-sentinel nodes positive. When correlated with non-SLN metastasis by univariate analysis, LVI (χ2 = 8.8, P = 0.003), PNI (χ2 = 6.85, P = 0.009), and extracapsular extension (χ2 = 4.18, P = 0.04) were significant. Number of SLN negative ( P = 0.01), SLN ratio (number of SLN positive/total number of SLN removed) ( P = 0.01) and size of SLN metastasis ( P = 0.002) were significant. However, multivariate analysis showed that only size of SLN metastasis (OR=0.845, P = 0.02) was identified as independent predictor for non-SLN metastasis. The area under the ROC curve was 0.66 and it poorly correlated with MSKCC nomogram. Conclusion: The MSKCC nomogram can provide a fairly accurate prediction of the probability of SLN metastasis, but is not for non-SLN metastasis. An institutional nomogram for non-SLN metastasis, including additional factors such as size of SLN metastasis, may improve prediction.

e21044 Background: Identification of the tissue-of-origin (ToO) of a brain metastatic tumor is vital to its management. Carcinoma of unknown primary (CUP) is common in oncology, representing 4-6% of all invasive malignancies. A qRT-PCR-based test that measures the expression of 48 microRNAs was employed to identify the ToO of metastatic tumors of known origin as well as of CUP cases resected from brain or spine. Methods: A microRNA-based qRT-PCR diagnostic assay to identify the ToO of metastatic tumors was tested on 2 cohorts of resected brain and spinal metastatic lesions. The first cohort included 104 resected tumors with known origin (“reference diagnosis”), previously classified based on the patient's clinical history and pathological data. The second cohort included 57 tumors that had been originally diagnosed as CUP, for some of which additional clinical and pathological data was gathered following the original diagnosis. The majority of the samples were processed successfully (3 samples/cohort failed QA). Results: In this blinded study, the test predictions correctly identified the reference diagnosis of the samples with the known origin in 84% of the 89 cases (excluding prostate samples). In the second cohort, for 6 cases out of the 54 true CUP patients the diagnosis of the origin remained unknown clinically and after full pathological review. In 81% out of the remaining 48 CUP cases, the test prediction was in agreement with the diagnosis which was later confirmed clinically or with pathological data. In 19% out of the remaining CUP cases, the test results showed some discordance with the pathology or with clinical data. Additional clinical and pathological analysis of the CUP cases is currently ongoing. Conclusions: In a cohort of brain and spinal metastases, a previously developed qRT-PCR test based on the expression profile of 48 microRNAs allowed accurate identification of ToO in most of the cases. The high accuracy of this test in identifying the ToO of metastasis of unknown primary has been validated by this study and demonstrates its clinical utility. The test was also able to suggest origins in cases in which the pathological review was insufficient, suggesting additional clinical utility in those hard-to-resolve cases. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Rosetta Genomics Rosetta Genomics Rosetta Genomics

Although many studies have investigated the impact of chronic hepatitis B virus (HBV) infection and nonalcoholic fatty liver disease (NAFLD) on liver disease, few have investigated the relationship between nonalcoholic steatohepatitis (NASH) defined by liver pathology and the prognosis of chronic HBV infection. Most patients were followed up for a short time. This study aimed to further explore the impact of NAFLD and the pathological changes confirmed by liver pathology in patients with chronic HBV infection. To study the effect of NAFLD confirmed using liver pathology on the outcomes of long-term serious adverse events [cirrhosis, hepatocellular carcinoma (HCC), and death] in patients with chronic hepatitis B (CHB) virus infection. We enrolled patients with chronic hepatitis B virus (HBV) infection who underwent liver biopsy at the Third People's Hospital of Zhenjaing Affiliated Jiangsu University between January 2005 and September 2020. Baseline clinical and pathological data on liver pathology and clinical data at the end of follow-up were collected. Propensity score matching (PSM) was used to balance baseline parameters, Kaplan-Meier (K-M) survival analysis was used to evaluate the risk of clinical events, and Cox regression was used to analyze the risk factors of events. Overall, 456 patients with chronic HBV infection were included in the study, of whom 152 (33.3%) had histologically confirmed NAFLD. The median follow-up time of the entire cohort was 70.5 mo. Thirty-four patients developed cirrhosis, which was diagnosed using ultrasound during the follow-up period. K-M survival analysis showed that NAFLD was not significantly associated with the risk of cirrhosis (log-rank test, P > 0.05). Patients with CHB with fibrosis at baseline were more prone to cirrhosis (log-rank test, P = 0.046). After PSM, multivariate analysis showed that diabetes mellitus, ballooning deformation (BD), and platelet (PLT) were independent risk factors for cirrhosis diagnosed using ultrasound (P < 0.05). A total of 10 patients (2.2%) developed HCC, and six of these patients were in the combined NAFLD group. K-M survival analysis showed that the cumulative risk of HCC in the NAFLD group was significantly higher (log-rank test, P < 0.05). Hepatocyte ballooning, and severe liver fibrosis were also associated with an increased risk of HCC (log-rank test, all P < 0.05). Cox multivariate analysis revealed that hepatocyte ballooning, liver fibrosis, and diabetes mellitus were independent risk factors for HCC. There was no significant correlation between chronic HBV infection and the risk of cirrhosis in patients with NAFLD. Diabetes mellitus, BD, and PLT were independent risk factors for liver cirrhosis. Patients with chronic HBV infection and NASH have an increased risk of HCC. BD, liver fibrosis, and diabetes mellitus are independent risk factors for HCC.

The quantitative accuracy of MRI in predicting the intraosseous extent of primary sarcoma of bone has not been definitively confirmed, although MRI is widely accepted as an accurate tool to plan limb salvage resections. Because inaccuracies in MRI determination of tumor extent could affect the ability of a tumor surgeon to achieve negative margins and avoid local recurrence, we thought it important to assess the accuracy of MR-determined tumor extent to the actual extent observed pathologically from resected specimens in pediatric patients treated for primary sarcomas of bone. (1) Does the quantitative pathologic bony margin correlate with that measured on preoperative MRI? (2) Are T1- or T2-weighted MRIs most accurate in determining a margin? (3) Is there a difference in predicting tumor extent between MRI obtained before or after neoadjuvant chemotherapy and which is most accurate? We retrospectively studied a population of 211 potentially eligible patients who were treated with limb salvage surgery between August 1999 and July 2015 by a single surgeon at a single institution for primary sarcoma of bone. Of 131 patients (62%) with disease involving the femur or tibia, 107 (51%) were classified with Ewing's sarcoma or osteosarcoma. Records were available for review in our online database for 79 eligible patients (37%). Twenty-six patients (12%) were excluded because of insufficient or unavailable clinical or pathology data and 17 patients (8%) were excluded as a result of inadequate or incomplete MR imaging, leaving 55 eligible participants (26%) in the final cohort. The length of the resected specimen was superimposed on preresection MRI sequences to compare the margin measured by MRI with the margin measured by histopathology. Arithmetic mean differences and Pearson r correlations were used to assess quantitative accuracy (size of the margin). All MR imaging types were positively associated with final histopathologic margin. T1-weighted MRI after neoadjuvant chemotherapy and final histopathologic margin had the strongest positive correlation of all MR imaging and time point comparisons (r = 0.846, p < 0.001). Mean differences existed between the normal marrow margin on T1-weighted MRI before neoadjuvant chemotherapy (t = 8.363; mean, 18.883 mm; 95% confidence interval [CI], 14.327-23.441; p < 0.001), T2-weighted MRI before neoadjuvant chemotherapy (t = 8.194; mean, 17.204 mm; 95% CI, 12.970-21.439; p < 0.001), T1-weighted after neoadjuvant chemotherapy (t = 10.808; mean, 22.178 mm; 95% CI, 18.042-26.313; p < 0.001), T2-weighted after neoadjuvant chemotherapy (t = 10.702; mean, 20.778 mm; 95% CI, 16.865-24.691; p < 0.001), and the final histopathologic margin. T1-weighted MRI after neoadjuvant chemotherapy compared with the final histopathologic margin had the smallest mean difference in MRI-measured versus histopathologic margin size (mean, 5.9 mm; SD = 4.5 mm). T1 MRI after neoadjuvant chemotherapy exhibited the strongest positive correlation and smallest mean difference compared with histopathologic margin. When planning surgical resections based on MRI obtained after neoadjuvant chemotherapy, for safety, one should account for a potential difference between the apparent margin of a tumor on an MRI and the actual pathologic margin of that tumor of up to 1 cm. Level III, diagnostic study.

To study the histological features, diagnosis, differential diagnoses of aggressive B-cell lymphomas of the gastrointestinal tract and to correlate clinical prognosis with pathologic parameters and immunophenotypes with an emphasis on c-myc, Tcl-1 and CD38 expression and their values in predicting the status of c-myc gene translocation. Fifty-four cases of aggressive B-cell lymphomas of the gastrointestinal tract with complete clinical and pathologic data were retrospectively collected. The clinical data, histologic and immunohistochemical findings and follow-up results were analyzed. Predictive immunohistochemical stains including c-myc, Tcl-1 and CD38 were performed and ROC curve analysis was used to confirm the accuracy of these markers in predicting c-myc translocation. Of 54 cases, there were 33 males and 21 females with median age of 56 years. Histological types of lymphomas included 49 cases of DLBCL (11 cases of germinal central B cell like and 38 cases of activated B cell like by Hans classification), 4 cases of DLBCL/BL and 1 case of BL. Eleven of 54 patients died within 97 months, with median survival of 42 months. Histologically, full-thickness infiltration of the gastrointestinal tract by large atypical cells with evident phagocytosis of karyorrhexis by macrophages ("starry sky") were seen in 18/54 cases. The lymphoma cells were positive for CD20 (54/54), CD79a (54/54), CD43 (4/54), CD5 (7/54), bcl-2 (26/54), Tcl-1 (17/54) and CD38 (15/54), but all negative for CD3 and CD30. The proliferative index by Ki-67 ranged from 40% to 100%. The univariate survival analysis indicated that B symptoms, general performance, high LDH, high IPI, distant metastasis, high clinical stage and tumors with over 90% of cells positive for c-myc were negative predictors for the patient's survival. In addition, cases of DLBCL positive for CD5 had an unfavorable prognosis. Cox regression analysis showed c-myc translocation, distant metastasis and high LDH were independent predictors for unfavorable prognosis. ROC curve revealed the percentage of c-myc positivity predicted the presence of c-myc gene translocation, with 75% as the optimal threshold. Aggressive B-cell lymphomas of the gastrointestinal tract with a prognosis influenced by variable clinicopathologic factors. DLBCL and DLBCL/BL may possess c-myc translocation and tend to be Burkitt-like or atypical Burkitt lymphoma. As independent prognostic indicator, c-myc expression may be used for selection of therapeutic regimens and prognostication. High percentage of tumor cells with c-myc positivity may be used to predict the presence of c-myc gene translocation.