Sin-Ho Jung

Overview:

Design of Clinical Trials
Survival Analysis
Longitudinal Data Analysis
Clustered Data Analysis
ROC Curve Analysis
Design and Analysis of Microarray Studies

Positions:

Professor of Biostatistics and Bioinformatics

Biostatistics & Bioinformatics
School of Medicine

Member of the Duke Cancer Institute

Duke Cancer Institute
School of Medicine

Education:

Ph.D. 1992

University of Wisconsin - Madison

Grants:

Role of the tumor NLRP3 inflammasome in the generation of anti-PD-1 antibody immunotherapy-associated toxicities

Administered By
Medicine, Medical Oncology
Awarded By
National Institutes of Health
Role
Biostatistician
Start Date
End Date

Alliance NCORP Research Base - Clinical Trials - CALGB 70807

Administered By
Duke Cancer Institute
Awarded By
Mayo Clinic
Role
Principal Investigator
Start Date
End Date

ETIOLOGY OF COPD AMONG CONSTRUCTION WORKERS

Administered By
Family Medicine & Community Health,Occupational & Environmental Medicine
Awarded By
National Institute for Occupational Safety and Health
Role
Biostatistician
Start Date
End Date

Publications:

Survival outcomes in sinonasal carcinoma with neuroendocrine differentiation: A NCDB analysis.

BACKGROUND: Sinonasal carcinoma with neuroendocrine differentiation (SCND) is a rare group of tumors with poor prognosis. Treatment and sequence of therapies are still unclear. The goal of this study is to analyze treatment outcomes in SCND using a national database. METHODS: The National Cancer Database was queried for SCND from 2004 to 2014. Patient demographics, tumor characteristics and treatment paradigms were tabulated. Multivariable Cox proportional hazards regression was performed for statistical analysis of treatment regimen on overall survival (OS). RESULTS: A total of 415 patients were identified. Most patients were male (61.2%), with a median age of 58 years and the most common primary site was the nasal cavity (52.5%). T4 tumors were observed in 67.7% of cases. Unimodality (41.9%) and bimodality (43.9%) therapies were the most common treatment modalities. Radiation therapy was the only treatment administered in 30% of the patients, while 27.2% received definitive chemoradiation (CRT) and 11.6% had surgery with adjuvant CRT. In our Cox-PH model, age (HR = 1.04, p < 0.001), T4 (HR = 2.6, p = 0.004) and N2/N3 (HR = 2.18, p = 0.001) were associated with worse survival. Trimodality (HR = 0.49, p = 0.005) and bimodality (HR = 0.65, p = 0.009) therapies had a better OS compared to unimodality. Patients treated with definitive CRT or surgery with adjuvant CRT had a significant increase in OS (p = 0.01 and 0.002 respectively). CONCLUSION: SCND appears to be best treated using a multimodality approach with definitive CRT or surgery followed by CRT. Neoadjuvant chemotherapy could be helpful in selecting the best treatment strategy.
Authors
Issa, K; Ackall, F; Jung, S-H; Li, J; Jang, DW; Rangarajan, SV; Abi Hachem, R
MLA Citation
Issa, Khalil, et al. “Survival outcomes in sinonasal carcinoma with neuroendocrine differentiation: A NCDB analysis.Am J Otolaryngol, vol. 42, no. 2, Mar. 2021, p. 102851. Pubmed, doi:10.1016/j.amjoto.2020.102851.
URI
https://scholars.duke.edu/individual/pub1470948
PMID
33385873
Source
pubmed
Published In
Am J Otolaryngol
Volume
42
Published Date
Start Page
102851
DOI
10.1016/j.amjoto.2020.102851

Predictive Model for Neoplastic Potential of Gallbladder Polyp.

GOAL: To provide the statistical predictive model for neoplastic potential of gallbladder polyp (GBP). BACKGROUND: Many studies have attempted to define the risk factors for neoplastic potential of GBP. It remains difficult to precisely adapt the reported risk factors for the decision of surgery. Estimating the probability for neoplastic potential of GBP using a combination of several risk factors before surgical resection would be useful in patient consultation. STUDY: We collected data of patients confirmed as GBP through cholecystectomy at Samsung Medical Center between January 1997 and March 2015. Those with a definite evidence for malignancy, such as adjacent organ invasion, metastasis on preoperative imaging studies, polyp >15 mm, and absence of proper preoperative ultrasonographic imaging were excluded. A total of 1976 patients were enrolled. To make and validate the predictive model, we divided the cohort into the modeling group (n=979) and validation group (n=997). Clinical information, ultrasonographic findings, and blood tests were retrospectively analyzed. RESULTS: Clinical factors of older age, single lesion, sessile shape, and polyp size showed statistical significance for neoplastic potential of GBP in the modeling group. A predictive model for neoplastic potential of GBP was constructed utilizing the statistical outcome of the modeling group. Statistical validation was performed with the validation group to determine the optimal clinical sensitivity and specificity of the predictive model. Optimal cut-off value for neoplastic probability was 7.4%. CONCLUSIONS: The predictive model for neoplastic potential of GBP may support clinical decisions before cholecystectomy.
Authors
Yang, J-I; Lee, JK; Ahn, DG; Park, JK; Lee, KH; Lee, KT; Chi, SA; Jung, S-H
MLA Citation
Yang, Ju-Il, et al. “Predictive Model for Neoplastic Potential of Gallbladder Polyp.J Clin Gastroenterol, vol. 52, no. 3, Mar. 2018, pp. 273–76. Pubmed, doi:10.1097/MCG.0000000000000900.
URI
https://scholars.duke.edu/individual/pub1269321
PMID
28742730
Source
pubmed
Published In
J Clin Gastroenterol
Volume
52
Published Date
Start Page
273
End Page
276
DOI
10.1097/MCG.0000000000000900

Safety and tolerability of idelalisib, lenalidomide, and rituximab in relapsed and refractory lymphoma: the Alliance for Clinical Trials in Oncology A051201 and A051202 phase 1 trials.

BACKGROUND: A new generation of biological and targeted agents might potentially replace traditional cytotoxic agents in lymphoma. Lenalidomide plus rituximab was felt to be a safe and promising backbone based on available data. Idelalisib is an oral phosphatidylinositol 3-kinase delta (PI3Kδ) inhibitor that has promising activity as a monotherapy in refractory indolent lymphomas. The primary objective of these two trials was to determine the maximum tolerated dose of lenalidomide in combination with rituximab and idelalisib in relapsed follicular and mantle cell lymphoma. METHODS: A051201 (mantle cell lymphoma) and A051202 (follicular lymphoma) were phase 1 trials. Patients with histologically documented relapsed mantle cell lymphoma who had not received previous lenalidomide or idelalisib (A051201) were started with oral lenalidomide 15 mg on days 1-21 in a 28 day cycle, oral idelalisib 150 mg twice a day with continuous 28-day cycles, and intravenous rituximab 375 mg/m2 weekly during cycle 1. Patients with histologically documented relapsed follicular lymphoma and time to progression 6 months or longer from last rituximab-containing regimen (A051202) were started with oral lenalidomide 10 mg on days 1-21 every 28 days and oral idelalisib 150 mg twice a day with continuous 28-day cycles, and intravenous rituximab 375 mg/m2 on cycle 1, day 8, day 15, day 22, and cycle 2, day 1. The primary endpoints of the studies were safety and tolerability of combining idelalisib with lenalidomide and rituximab in patients with relapsed mantle cell lymphoma (A051201) and relapsed follicular lymphoma (A051202). All analyses were by intention to treat. The trials were registered at ClinicalTrials.gov, number NCT01838434 (A051201) and number NCT01644799 (A051202). FINDINGS: Between July 9, 2013, and Sept 30, 2014, 11 patients (three with mantle cell lymphoma and eight with follicular lymphoma) were enrolled. Among the first eight patients, four experienced unexpected dose-limiting toxicities: grade 4 sepsis syndrome, grade 4 hypotension with grade 3 rash and fevers, grade 4 aspartate aminotransferase (AST) or alanine aminotransferase (ALT) elevation with fevers, and grade 3 pulmonary infection with grade 3 maculopapular rash. Symptom onset was 9-20 days after treatment initiation, coinciding with rituximab infusions. Both studies were amended to remove rituximab, but two of three additional patients had grade 3 rashes and one had grade 3 AST elevation. Both trials were permanently closed. The most common grade 3-4 adverse events were ALT elevation (two [67%] of three) and rash (two [67%] of three) for patients with mantle cell lymphoma and neutropenia (five [63%] of eight) and rash (four [50%] of eight) for patients with follicular lymphoma. The primary endpoint of safety and tolerability was not met. INTERPRETATION: The combination of idelalisib, lenalidomide, and rituximab in these trials is excessively toxic, and these trials serve as cautionary notes as new combinations are proposed. Off-target effects, drug-drug interactions, and emerging toxicities should be carefully assessed when investigating biological agents in combination and should never be done outside of a clinical trial setting. FUNDING: National Cancer Institute of the National Institutes of Health.
Authors
Smith, SM; Pitcher, BN; Jung, S-H; Bartlett, NL; Wagner-Johnston, N; Park, SI; Richards, KL; Cashen, AF; Jaslowski, A; Smith, SE; Cheson, BD; Hsi, E; Leonard, JP
MLA Citation
Smith, Sonali M., et al. “Safety and tolerability of idelalisib, lenalidomide, and rituximab in relapsed and refractory lymphoma: the Alliance for Clinical Trials in Oncology A051201 and A051202 phase 1 trials.Lancet Haematol, vol. 4, no. 4, Apr. 2017, pp. e176–82. Pubmed, doi:10.1016/S2352-3026(17)30028-5.
URI
https://scholars.duke.edu/individual/pub1244294
PMID
28314699
Source
pubmed
Published In
The Lancet Haematology
Volume
4
Published Date
Start Page
e176
End Page
e182
DOI
10.1016/S2352-3026(17)30028-5

Safety of Percutaneous Biopsy for Hepatic Angiosarcoma: Results of a Multicenter Korean Survey.

PURPOSE: To evaluate the incidence of severe bleeding and mortality associated with percutaneous biopsy for hepatic angiosarcoma in a multicenter retrospective cohort. MATERIALS AND METHODS: A retrospective review of 33 patients with biopsy-proven hepatic angiosarcoma (29 male; median age, 57 y; age range, 24-96 y) was performed at seven tertiary academic hospitals between January 1998 and March 2015. The mean maximum tumor size was 5.5 cm (range, 1.7-20 cm). An 18-gauge automated cutting biopsy needle was used with a freehand technique in all patients who underwent ultrasonography-guided percutaneous core needle biopsy on an inpatient basis. The incidences of severe bleeding and procedure-related mortality were evaluated per Society of Interventional Radiology (SIR) guidelines. RESULTS: There was a mean of 2.8 needle passes per patient during the procedure (range, 1-6). The overall incidence of severe bleeding events (SIR grade C/D) was 9.1% (3 of 33). Two patients were managed with blood transfusion, and one patient underwent embolization for bleeding control. No other major complications were encountered. There were no cases of mortality associated with the biopsy. CONCLUSIONS: Severe bleeding was not a frequent complication after percutaneous biopsy for hepatic angiosarcoma. The majority of bleeding complications could be controlled with conservative management.
Authors
Kang, TW; Lee, MW; Choi, D; An, C; Kim, M-J; Joo, I; Lee, SJ; Lim, S; Park, JG; Seo, JW; Jung, S-H
MLA Citation
Kang, Tae Wook, et al. “Safety of Percutaneous Biopsy for Hepatic Angiosarcoma: Results of a Multicenter Korean Survey.J Vasc Interv Radiol, vol. 27, no. 6, June 2016, pp. 846–51. Pubmed, doi:10.1016/j.jvir.2016.01.148.
URI
https://scholars.duke.edu/individual/pub1488853
PMID
27080009
Source
pubmed
Published In
J Vasc Interv Radiol
Volume
27
Published Date
Start Page
846
End Page
851
DOI
10.1016/j.jvir.2016.01.148

Subcentimeter hypervascular nodule with typical imaging findings of hepatocellular carcinoma in patients with history of hepatocellular carcinoma: natural course on serial gadoxetic acid-enhanced MRI and diffusion-weighted imaging.

OBJECTIVES: To evaluate the natural course of subcentimeter hypervascular nodules at high risk for developing into hepatocellular carcinomas (SHNHR) using serial magnetic resonance imaging (MRI) in patients with a history of hepatocellular carcinoma (HCC). METHODS: An SHNHR was defined as a subcentimeter hypervascular nodule having typical imaging findings of HCC on gadoxetic acid-enhanced MRI and diffusion-weighted imaging. We included 39 patients with 46 SHNHRs (mean size ± standard deviation, 6.1 ± 1.6 mm; range, 3.2 - 9.0 mm). Overt HCC was defined as pathology proven HCC or a nodule larger than 1 cm with typical imaging findings of HCC. The cumulative rate and the independent predictive factors for progression to overt HCC were evaluated. RESULTS: The median follow-up period was 139 days (range, 64 - 392 days). The cumulative progression rate to overt HCC at 3, 6, 9, and 12 months was 13.9%, 61.7%, 83.2%, and 89.9%. The initial size of SHNHR was a significant predictor of progression to overt HCC, with an optimal cut-off value of 5.5 mm. CONCLUSION: The progression rate of SHNHR to overt HCC within 12 months was high (89.9%) in patients with history of HCC. The initial size of SHNHR was an important predictor for progression to overt HCC. KEY POINTS: • Most SHNHRs (89.9%) progressed to overt HCCs within 12 months. • Initial size was an important predictor for progression to overt HCCs. • The optimal cut-off value for initial nodule size was 5.5 mm.
Authors
Song, KD; Kim, SH; Lim, HK; Jung, S-H; Sohn, I; Kim, HS
URI
https://scholars.duke.edu/individual/pub1102860
PMID
25735515
Source
pubmed
Published In
Eur Radiol
Volume
25
Published Date
Start Page
2789
End Page
2796
DOI
10.1007/s00330-015-3680-9