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8. A Comparison of Different Approaches to Bayesian Hierarchical Models in a Basket Trial to Evaluate the Benefits of Increasing Complexity.

Author

Broglio, Kristine R., Zhang, Fanni, Yu, Binbing, Marshall, Jayne, Wang, Fujun, Bennett, Maxine, and Viele, Kert

Subjects
*BASKETS
Abstract

A basket trial is a trial that investigates a single experimental therapy simultaneously across multiple different patient population groups. When groups are heterogeneous, the optimal analysis is independence but when groups are homogeneous the optimal analysis strategy is pooling. A Bayesian Hierarchical Model (BHM) analysis strategy offers a compromise between independence and pooling. There are multiple different parameterizations of BHMs in the literature offering different ways to account for possible lack of exchangeability and heterogeneity across the groups in the basket. We selected 4 different BHMs that fit under the same general structure but have increasing levels of complexity to accommodate group heterogeneity for comparison. Because the choice of prior for a BHM affects the behavior of the model, we first optimize each model's prior selection in terms of maximizing the expected number of correct decisions across six efficacy scenarios. After optimization, differences between the performance of the models were small. In the context we evaluated, a simpler model may provide similar operating characteristics to a more complex model even when groups are truly heterogeneous. [ABSTRACT FROM AUTHOR]

Published
2022
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20. High Rate of Durable Remissions After Treatment of Newly Diagnosed Aggressive Mantle-Cell Lymphoma With Rituximab Plus Hyper-CVAD Alternating With Rituximab Plus High-Dose Methotrexate and Cytarabine

Author

Romaguera, Jorge E., Fayad, Luis, Rodriguez, Maria A., Broglio, Kristine R., Hagemeister, Frederick B., Pro, Barbara, McLaughlin, Peter, Younes, Anas, Samaniego, Felipe, Goy, Andre, Sarris, Andreas H., Dang, Nam H., Wang, Michael, Beasley, Virginia, Medeiros, L Jeffrey, Katz, Ruth L., Gagneja, Harish, Samuels, Barry I., Smith, Terry L., and Cabanillas, Fernando F.

Published
2005
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22. Central nervous system metastases in patients with high-risk breast carcinoma after multimodality treatment

Author

Gonzalez-Angulo, Ana M., Cristofanilli, Massimo, Strom, Eric A., Buzdar, Aman U., Kau, Shu-Wan, Broglio, Kristine R., Smith, Terry L., and Hortobagyi, Gabriel N.

Subjects
Metastasis -- Research, Metastasis -- Statistics, Metastasis -- Diagnosis, Breast cancer -- Care and treatment, Breast cancer -- Complications and side effects, Breast cancer -- Prognosis, Health
Published
2004

24. Age and Associated Fibrocystic Changes are Prognostically Significant in Patients with Small Node-Negative (T1a,bN0) Invasive Breast Cancer

Author

Hanrahan, Emer O., Sahin, Aysegul A., Hunt, Kelly K., Hortobagyi, Gabriel N., Gonzalez-Angulo, Ana M., Valero, Vicente, GÜRAY DURAK, MERİH, and Broglio, Kristine R.

Abstract

Some patients with small (50%), and 30% had grade 3 DCIS. Nonproliferative FCC and proliferative FCC with/without atypia were present in 80%, 36%, and 38% of patients, respectively. In univariate analysis, age at diagnosis (p < 0.0001), grade (p = 0.015), and percent (p = 0.046) of DCIS were significantly associated with DFS; presence of FCC was associated with longer DFS and OS. In multivariable models, age and presence of FCC remained significantly associated with survival. Age at diagnosis and associated FCC are significant factors in predicting recurrence in patients with T1a,bN0 IBC. Adjuvant systemic therapy should be discussed with and considered for young patients with T1a,bN0 IBC.

Published
2011

29. High risk of recurrence for patients with breast cancer who have human epidermal growth factor receptor 2-positive, node-negative tumors 1 cm or smaller.

Author

Gonzalez-Angulo, Ana Maria, Litton, Jennifer K, Broglio, Kristine R, Meric-Bernstam, Funda, Rakkhit, Ronjay, Cardoso, Fatima, Peintinger, Florentia, Hanrahan, Emer O, Sahin, Aysegul, Guray, Merih, Larsimont, Denis, Feoli, Francesco, Stranzl, Heidi, Buchholz, Thomas A, Valero, Vicente, Theriault, Richard, Piccart-Gebhart, Martine, Ravdin, Peter, Berry, Donald A, Hortobagyi, Gabriel N., Gonzalez-Angulo, Ana Maria, Litton, Jennifer K, Broglio, Kristine R, Meric-Bernstam, Funda, Rakkhit, Ronjay, Cardoso, Fatima, Peintinger, Florentia, Hanrahan, Emer O, Sahin, Aysegul, Guray, Merih, Larsimont, Denis, Feoli, Francesco, Stranzl, Heidi, Buchholz, Thomas A, Valero, Vicente, Theriault, Richard, Piccart-Gebhart, Martine, Ravdin, Peter, Berry, Donald A, and Hortobagyi, Gabriel N.

Abstract

PURPOSE: To evaluate the risk of recurrence in women diagnosed with T1a and T1b, node-negative, human epidermal growth factor receptor 2 (HER2) -positive breast cancer. METHODS: We reviewed 965 T1a,bN0M0 breast cancers diagnosed at our institution between 1990 and 2002. Dedicated breast pathologists confirmed HER2 positivity if 3+ by immunohistochemistry or if it had a ratio of 2.0 or greater by fluorescence in situ hybridization (FISH). Patients who received adjuvant chemotherapy or trastuzumab were excluded. Kaplan-Meier product was used to calculate recurrence-free survival (RFS) and distant recurrence-free survival (DRFS). Cox proportional hazard models were fit to determine associations between HER2 status and survival after adjustment for patient and disease characteristics. Additionally, 350 breast cancers from two other institutions were used for validation. RESULTS: Ten percent of patients had HER2-positive tumors. At a median follow-up of 74 months, there were 72 recurrences. The 5-year RFS rates were 77.1% and 93.7% in patients with HER2-positive and HER2-negative tumors, respectively (P < .001). The 5-year DRFS rates were 86.4% and 97.2% in patients with HER2-positive and HER2-negative tumors, respectively (P < .001). In multivariate analysis, patients with HER2-positive tumors had higher risks of recurrence (hazard ratio [HR], 2.68; 95% CI, 1.44 to 5.0; P = .002) and distant recurrence (HR, 5.3; 95% CI, 2.23 to 12.62; P < .001) than those with HER2-negative tumors. Patients with HER2-positive tumors had 5.09 times (95% CI, 2.56 to 10.14; P < .0001) the rate of recurrences and 7.81 times (95% CI, 3.17 to 19.22; P < .0001) the rate of distant recurrences at 5 years compared with patients who had hormone receptor-positive tumors. CONCLUSION: Patients with HER2-positive T1abN0M0 tumors have a significant risk of relapse and should be considered for systemic, anti-HER2, adjuvant therapy., Journal Article, Research Support, N.I.H. Extramural, Research Support, Non-U.S. Gov't, info:eu-repo/semantics/published

Published
2009

30. Factors predicting additional disease in the axilla in patients with positive sentinel lymph nodes after neoadjuvant chemotherapy Presented in part at the Annual Meeting of the American Society of Clinical Oncology, Atlanta, Georgia, June 2???6, 2006.

Author

Department of Surgery, University of Michigan Medical School, Ann Arbor, Michigan, Department Surgical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas, Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, Tennessee, Department of Breast Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas, Division of Quantitative Sciences, The University of Texas M. D. Anderson Cancer Center, Houston Texas, Department Surgical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas ; Fax: (713) 792-4689 ; Department of Surgical Oncology, The University of Texas M. D. Anderson Cancer Center, 1515 Holcombe Boulevard, Unit 444, Houston, TX 77030, Jeruss, Jacqueline S., Newman, Lisa A., Ayers, Gregory D., Cristofanilli, Massimo, Broglio, Kristine R., Meric-Bernstam, Funda, Yi, Min, Waljee, Jennifer F., Ross, Merrick I., Hunt, Kelly K., Department of Surgery, University of Michigan Medical School, Ann Arbor, Michigan, Department Surgical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas, Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, Tennessee, Department of Breast Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas, Division of Quantitative Sciences, The University of Texas M. D. Anderson Cancer Center, Houston Texas, Department Surgical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas ; Fax: (713) 792-4689 ; Department of Surgical Oncology, The University of Texas M. D. Anderson Cancer Center, 1515 Holcombe Boulevard, Unit 444, Houston, TX 77030, Jeruss, Jacqueline S., Newman, Lisa A., Ayers, Gregory D., Cristofanilli, Massimo, Broglio, Kristine R., Meric-Bernstam, Funda, Yi, Min, Waljee, Jennifer F., Ross, Merrick I., and Hunt, Kelly K.

Abstract

BACKGROUND. The utility of sentinel lymph node (SNL) biopsy (SLNB) as a predictor of axillary lymph node status is similar in patients who receive neoadjuvant chemotherapy and patients who undergo surgery first. The authors of this study hypothesized that patients with positive SLNs after neoadjuvant therapy would have unique clinicopathologic factors that would be predictive of additional positive non-SLNs distinct from patients who underwent surgery first. METHODS. One hundred four patients were identified who received neoadjuvant chemotherapy, had a positive SLN, and underwent axillary dissection between 1997 and 2005. At the time of presentation, 66 patients had clinically negative lymph nodes by ultrasonography, and 38 patients had positive lymph nodes confirmed by fine-needle aspiration. Eighteen factors were assessed for their ability to predict positive non-SLNs using chi-square and logistic regression analysis with a bootstrapped, backwards elimination procedure. The resulting nomogram was tested by using a patient cohort from another institution. RESULTS. Patients with clinically negative lymph nodes at presentation were less likely than patients with positive lymph nodes to have positive non-SLNs (47% vs 71%; P = .017). On multivariate analysis, lymphovascular invasion, the method for detecting SLN metastasis, multicentricity, positive axillary lymph nodes at presentation, and pathologic tumor size retained grouped significance with a bootstrap-adjusted area under the curve (AUC) of 0.762. The resulting nomogram was validated in the external patient cohort (AUC, 0.78). CONCLUSIONS. A significant proportion of patients with positive SLNs after neoadjuvant chemotherapy had no positive non-SLNs. The use of a nomogram based on 5 predictive variables that were identified in this study may be useful for predicting the risk of positive non-SLNs in patients who have positive SLNs after chemotherapy. Cancer 2008. ?? 2008 American Cancer Society.

Published
2008

34. Using Bayesian Adaptive Trial Designs for Comparative Effectiveness Research: A Virtual Trial Execution.

Author

Luce, Bryan R., Connor, Jason T., Broglio, Kristine R., Mullins, C. Daniel, Ishak, K. Jack, Saunders, Elijah, Davis, Barry R., and RE-ADAPT (REsearch in ADAptive methods for Pragmatic Trials) Investigators

Subjects
BAYESIAN analysis, CLINICAL trials, COMPARATIVE studies, ANTIHYPERTENSIVE agents, DRUG efficacy, ANTILIPEMIC agents, MYOCARDIAL infarction, EXPERIMENTAL design, MEDICAL care research, PROBABILITY theory, STATISTICAL sampling, RANDOMIZED controlled trials, PREVENTION
Abstract

Background: Bayesian and adaptive clinical trial designs offer the potential for more efficient processes that result in lower sample sizes and shorter trial durations than traditional designs.Objective: To explore the use and potential benefits of Bayesian adaptive clinical trial designs in comparative effectiveness research.Design: Virtual execution of ALLHAT (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial) as if it had been done according to a Bayesian adaptive trial design.Setting: Comparative effectiveness trial of antihypertensive medications.Patients: Patient data sampled from the more than 42 000 patients enrolled in ALLHAT with publicly available data.Measurements: Number of patients randomly assigned between groups, trial duration, observed numbers of events, and overall trial results and conclusions.Results: The Bayesian adaptive approach and original design yielded similar overall trial conclusions. The Bayesian adaptive trial randomly assigned more patients to the better-performing group and would probably have ended slightly earlier.Limitations: This virtual trial execution required limited resampling of ALLHAT patients for inclusion in RE-ADAPT (REsearch in ADAptive methods for Pragmatic Trials). Involvement of a data monitoring committee and other trial logistics were not considered.Conclusion: In a comparative effectiveness research trial, Bayesian adaptive trial designs are a feasible approach and potentially generate earlier results and allocate more patients to better-performing groups.Primary Funding Source: National Heart, Lung, and Blood Institute. [ABSTRACT FROM AUTHOR]

Published
2016
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38. High Risk of Recurrence for Patients With Breast Cancer Who Have Human Epidermal Growth Factor Receptor 2–Positive, Node-Negative Tumors 1 cm or Smaller

Author

Gonzalez-Angulo, Ana M., primary, Litton, Jennifer K., additional, Broglio, Kristine R., additional, Meric-Bernstam, Funda, additional, Rakkhit, Ronjay, additional, Cardoso, Fatima, additional, Peintinger, Florentia, additional, Hanrahan, Emer O., additional, Sahin, Aysegul, additional, Guray, Merih, additional, Larsimont, Denis, additional, Feoli, Francesco, additional, Stranzl, Heidi, additional, Buchholz, Thomas A., additional, Valero, Vicente, additional, Theriault, Richard, additional, Piccart-Gebhart, Martine, additional, Ravdin, Peter M., additional, Berry, Donald A., additional, and Hortobagyi, Gabriel N., additional

Published
2009
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41. Circulating Tumor Cells in Metastatic Breast Cancer: Biologic Staging Beyond Tumor Burden

Author

Cristofanilli, Massimo, primary, Broglio, Kristine R., primary, Guarneri, Valentina, primary, Jackson, Summer, primary, Fritsche, Herbert A., primary, Islam, Rabiul, primary, Dawood, Shaheenah, primary, Reuben, James M., primary, Kau, Shu-Wan, primary, Lara, Juanita M., primary, Krishnamurthy, Savitri, primary, Ueno, Naoto T., primary, Hortobagyi, Gabriel N., primary, and Valero, Vicente, primary

Published
2007
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44. Neoadjuvant Therapy with Paclitaxel followed by 5-Fluorouracil, Epirubicin, and Cyclophosphamide Chemotherapy and Concurrent Trastuzumab in Human Epidermal Growth Factor Receptor 2–Positive Operable Breast Cancer: An Update of the Initial Randomized Study Population and Data of Additional Patients Treated with the Same Regimen

Author

Buzdar, Aman U., primary, Valero, Vicente, additional, Ibrahim, Nuhad K., additional, Francis, Deborah, additional, Broglio, Kristine R., additional, Theriault, Richard L., additional, Pusztai, Lajos, additional, Green, Marjorie C., additional, Singletary, Sonja E., additional, Hunt, Kelly K., additional, Sahin, Aysegul A., additional, Esteva, Francisco, additional, Symmans, William F., additional, Ewer, Michael S., additional, Buchholz, Thomas A., additional, and Hortobagyi, Gabriel N., additional

Published
2007
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50. Abstract TP236.

Author

Broglio, Kristine R, Connor, Jason T, Meurer, William J, Durkalski, Valerie L, and Johnston, Karen C

Published
2013

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