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54. Phase Ib trial of inhaled iloprost for the prevention of lung cancer with predictive and response biomarker assessment

Author

Miller, York E., primary, Ghosh, Moumita, additional, Merrick, Daniel T., additional, Kubala, Brandi, additional, Szabo, Eva, additional, Bengtson, Lisa, additional, Kocherginsky, Masha, additional, Helenowski, Irene B., additional, Benante, Kelly, additional, Schering, Tia, additional, Kim, Jihye, additional, Kim, Hyunmin, additional, Ha, Duc, additional, Bergan, Raymond C., additional, Khan, Seema A., additional, and Keith, Robert L., additional

Published
2023
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55. Phase I/II Trial of Carboplatin, Nab-paclitaxel, and Pembrolizumab for Advanced Non–Small Cell Lung Cancer: Hoosier Cancer Research Network LUN13-175

Author

Gentzler, Ryan D, primary, Mohindra, Nisha A, additional, Jalal, Shadia I, additional, Reckamp, Karen L, additional, Hall, Richard D, additional, Hanna, Nasser H, additional, Chae, Young Kwang, additional, Koczywas, Marianna, additional, Helenowski, Irene B, additional, and Patel, Jyoti D, additional

Published
2023
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60. Phase I/II Trial of Carboplatin, Nab-paclitaxel, and Pembrolizumab for Advanced Non–Small Cell Lung Cancer: Hoosier Cancer Research Network LUN13-175.

Author

Gentzler, Ryan D, Mohindra, Nisha A, Jalal, Shadia I, Reckamp, Karen L, Hall, Richard D, Hanna, Nasser H, Chae, Young Kwang, Koczywas, Marianna, Helenowski, Irene B, and Patel, Jyoti D

Subjects
LUNG cancer, CARBOPLATIN, PROGRAMMED death-ligand 1, CONFIDENCE intervals, CANCER chemotherapy, IMMUNOHISTOCHEMISTRY, ANTINEOPLASTIC agents, TREATMENT effectiveness, RESEARCH funding, DESCRIPTIVE statistics, PACLITAXEL, PROGRESSION-free survival, IMMUNOTHERAPY, OVERALL survival
Abstract

Background Combination chemotherapy and immunotherapy regimens have significantly improved survival for patients with previously untreated advanced non–small cell lung cancer (NSCLC). Improvements in overall survival (OS) in two separate pembrolizumab trials have demonstrated survival improvements over chemotherapy alone, regardless of PD-L1 status. The optimal chemotherapy backbone for combination with immunotherapy is unknown. We hypothesized nab -paclitaxel may be a well-suited platinum partner to use in combination with checkpoint inhibitor therapy for both adenocarcinoma and squamous histology and conducted a phase I/II trial to assess the efficacy of this regimen in advanced NSCLC. Methods Adult patients with previously untreated, stage IIIB/IV NSCLC (any histology) with an Eastern Cooperative Oncology Group performance status of 0-1, any PD-L1 expression, and no EGFR mutations or ALK translocations, received carboplatin area under the curve (AUC) 6 day 1, nab -paclitaxel 100 mg/m2 days 1, 8, 15, and pembrolizumab 200 mg day 1 q21 days for 4 cycles followed by maintenance pembrolizumab q3w. Co-primary endpoints were progression-free survival (PFS) and overall response rate (ORR). Results Forty-six evaluable patients enrolled, 14 in phase I and 32 in phase II, from June 2015 to July 2018 with a median duration of follow-up of 35.4 months. Median time from enrollment to data lock was 42 months. In the ITT population, the ORR was 35%, median PFS was 5.6 months (95% CI, 4.6-8.2), and median OS was 15.4 months (CI, 12.4-28.1). There were no statistical differences in PFS or OS by PD-L1 status. The 2- and 3-year landmark OS rates were 33% and 24%, respectively. Conclusion Carboplatin, nab -paclitaxel, and pembrolizumab are a safe and effective regimen for patients with both squamous and nonsquamous NSCLC. Although this study did not meet the prespecified endpoints, the median and landmark OS results are consistent with durable benefit of this regimen as seen in phase III trials for first-line treatment of advanced NSCLC. [ABSTRACT FROM AUTHOR]

Published
2024
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63. Contribution of symmetric dimethylarginine to GFR decline in pediatric chronic kidney disease

Author

Brooks, Ellen R., Haymond, Shannon, Rademaker, Alfred, Pierce, Christopher, Helenowski, Irene, Passman, Rod, and Vicente, Faye

Subjects
Children -- Health aspects, Chromatography -- Usage, Chronic kidney failure -- Development and progression, Health
Abstract

Background In pediatric chronic kidney disease (pCKD), traditional factors (proteinuria, etiology, and race) do not fully explain disease progression. The levels of methylated arginine derivatives (MADs: asymmetric and symmetric dimethylarginine, respectively) rise in CKD and increase with CKD progression. The impact of MADs on glomerular filtration rate (GFR) decline has not been examined in pCKD. The aim of this study was to examine the additive impact of baseline (BL) levels of MADs on directly measured GFR (mGFR) decline per year (ml/min/1.73 m.sup.2/year) for a period of up to 4 years. Methods Plasma and data, including mGFR by plasma iohexol clearance, were provided by the prospective, observational Chronic Kidney Disease in Children study. BL MADs were analyzed by high-performance liquid chromatography-tandem mass spectrometry. Results For 352 pCKD subjects, the median [interquartile range] BL mGFR was 45 [35, 57] ml/min/1.73 m.sup.2. The levels of BL MADs were inversely related to the initial mGFR and its decline over time (p < 0.0005) but not to the rate of decline. Covariates, non-glomerulopathy and Tanner stage of [greater than or equal to] 3 demonstrated weaker relationships between BL levels and beginning mGFR (p = 0.004 and p = 0.002, respectively). Conclusions In pCKD, higher concentrations of BL MADs were inversely related to BL mGFR. MADs did not affect the CKD progression rate. Quantification of this relationship is novel to the pCKD literature., Author(s): Ellen R. Brooks [sup.1] [sup.2] , Shannon Haymond [sup.1] [sup.3] , Alfred Rademaker [sup.1] [sup.4] , Christopher Pierce [sup.5] , Irene Helenowski [sup.1] [sup.4] , Rod Passman [sup.1] [sup.6] [...]

Published
2018
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67. Data from Soy Isoflavone Supplementation for Breast Cancer Risk Reduction: A Randomized Phase II Trial

Author

Khan, Seema A., primary, Chatterton, Robert T., primary, Michel, Nancy, primary, Bryk, Michelle, primary, Lee, Oukseub, primary, Ivancic, David, primary, Heinz, Richard, primary, Zalles, Carola M., primary, Helenowski, Irene B., primary, Jovanovic, Borko D., primary, Franke, Adrian A., primary, Bosland, Maarten C., primary, Wang, Jun, primary, Hansen, Nora M., primary, Bethke, Kevin P., primary, Dew, Alexander, primary, Coomes, Margerie, primary, and Bergan, Raymond C., primary

Published
2023
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69. Supplementary Table 2 from Soy Isoflavone Supplementation for Breast Cancer Risk Reduction: A Randomized Phase II Trial

Author

Khan, Seema A., primary, Chatterton, Robert T., primary, Michel, Nancy, primary, Bryk, Michelle, primary, Lee, Oukseub, primary, Ivancic, David, primary, Heinz, Richard, primary, Zalles, Carola M., primary, Helenowski, Irene B., primary, Jovanovic, Borko D., primary, Franke, Adrian A., primary, Bosland, Maarten C., primary, Wang, Jun, primary, Hansen, Nora M., primary, Bethke, Kevin P., primary, Dew, Alexander, primary, Coomes, Margerie, primary, and Bergan, Raymond C., primary

Published
2023
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70. Supplementary Figure 1 from Soy Isoflavone Supplementation for Breast Cancer Risk Reduction: A Randomized Phase II Trial

Author

Khan, Seema A., primary, Chatterton, Robert T., primary, Michel, Nancy, primary, Bryk, Michelle, primary, Lee, Oukseub, primary, Ivancic, David, primary, Heinz, Richard, primary, Zalles, Carola M., primary, Helenowski, Irene B., primary, Jovanovic, Borko D., primary, Franke, Adrian A., primary, Bosland, Maarten C., primary, Wang, Jun, primary, Hansen, Nora M., primary, Bethke, Kevin P., primary, Dew, Alexander, primary, Coomes, Margerie, primary, and Bergan, Raymond C., primary

Published
2023
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72. Supplementary Table 1 from Soy Isoflavone Supplementation for Breast Cancer Risk Reduction: A Randomized Phase II Trial

Author

Khan, Seema A., primary, Chatterton, Robert T., primary, Michel, Nancy, primary, Bryk, Michelle, primary, Lee, Oukseub, primary, Ivancic, David, primary, Heinz, Richard, primary, Zalles, Carola M., primary, Helenowski, Irene B., primary, Jovanovic, Borko D., primary, Franke, Adrian A., primary, Bosland, Maarten C., primary, Wang, Jun, primary, Hansen, Nora M., primary, Bethke, Kevin P., primary, Dew, Alexander, primary, Coomes, Margerie, primary, and Bergan, Raymond C., primary

Published
2023
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74. Supplementary Table 3 from Soy Isoflavone Supplementation for Breast Cancer Risk Reduction: A Randomized Phase II Trial

Author

Khan, Seema A., primary, Chatterton, Robert T., primary, Michel, Nancy, primary, Bryk, Michelle, primary, Lee, Oukseub, primary, Ivancic, David, primary, Heinz, Richard, primary, Zalles, Carola M., primary, Helenowski, Irene B., primary, Jovanovic, Borko D., primary, Franke, Adrian A., primary, Bosland, Maarten C., primary, Wang, Jun, primary, Hansen, Nora M., primary, Bethke, Kevin P., primary, Dew, Alexander, primary, Coomes, Margerie, primary, and Bergan, Raymond C., primary

Published
2023
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75. 381 Repeated Opening of the Blood-Brain Barrier With the Skull-implantable SonoCloud-9 (SC9) Device: Phase 1 Trial of Nab-Paclitaxel and SC9 in Recurrent Glioblastoma

Author

Sonabend, Adam M., primary, Gould, Andrew, additional, Luan, Yu, additional, Hou, Ye, additional, Chen, Le, additional, Kobayashi, Mikoto, additional, Castro, Brandyn, additional, Zhang, Daniel, additional, Korobova, Farida, additional, Amidei, Christina, additional, Youngblood, Mark William, additional, Bebawy, John Patrick, additional, Liu, Benjamin P., additional, Horbinski, Craig, additional, Desseaux, Carole, additional, Helenowski, Irene, additional, Zhang, Hui, additional, Muzzio, Miguel, additional, Yue, Feng, additional, Caney, Michael, additional, and Stupp, Roger, additional

Published
2023
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76. Supplementary Table S2 from Predicting Relapse in Favorable Histology Wilms Tumor Using Gene Expression Analysis: A Report from the Renal Tumor Committee of the Children's Oncology Group

Author

Huang, Chiang-Ching, primary, Gadd, Samantha, primary, Breslow, Norman, primary, Cutcliffe, Colleen, primary, Sredni, Simone T., primary, Helenowski, Irene B., primary, Dome, Jeffrey S., primary, Grundy, Paul E., primary, Green, Daniel M., primary, Fritsch, Michael K., primary, and Perlman, Elizabeth J., primary

Published
2023
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77. Supplementary Figure 1 from Selective Progesterone Receptor Modulators in Early-Stage Breast Cancer: A Randomized, Placebo-Controlled Phase II Window-of-Opportunity Trial Using Telapristone Acetate

Author

Lee, Oukseub, primary, Sullivan, Megan E., primary, Xu, Yanfei, primary, Rogers, Chiara, primary, Muzzio, Miguel, primary, Helenowski, Irene, primary, Shidfar, Ali, primary, Zeng, Zexian, primary, Singhal, Hari, primary, Jovanovic, Borko, primary, Hansen, Nora, primary, Bethke, Kevin P., primary, Gann, Peter H., primary, Gradishar, William, primary, Kim, J. Julie, primary, Clare, Susan E., primary, and Khan, Seema A., primary

Published
2023
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78. Supplementary Figure 5 from Selective Progesterone Receptor Modulators in Early-Stage Breast Cancer: A Randomized, Placebo-Controlled Phase II Window-of-Opportunity Trial Using Telapristone Acetate

Author

Lee, Oukseub, primary, Sullivan, Megan E., primary, Xu, Yanfei, primary, Rogers, Chiara, primary, Muzzio, Miguel, primary, Helenowski, Irene, primary, Shidfar, Ali, primary, Zeng, Zexian, primary, Singhal, Hari, primary, Jovanovic, Borko, primary, Hansen, Nora, primary, Bethke, Kevin P., primary, Gann, Peter H., primary, Gradishar, William, primary, Kim, J. Julie, primary, Clare, Susan E., primary, and Khan, Seema A., primary

Published
2023
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79. Data from Selective Progesterone Receptor Modulators in Early-Stage Breast Cancer: A Randomized, Placebo-Controlled Phase II Window-of-Opportunity Trial Using Telapristone Acetate

Author

Lee, Oukseub, primary, Sullivan, Megan E., primary, Xu, Yanfei, primary, Rogers, Chiara, primary, Muzzio, Miguel, primary, Helenowski, Irene, primary, Shidfar, Ali, primary, Zeng, Zexian, primary, Singhal, Hari, primary, Jovanovic, Borko, primary, Hansen, Nora, primary, Bethke, Kevin P., primary, Gann, Peter H., primary, Gradishar, William, primary, Kim, J. Julie, primary, Clare, Susan E., primary, and Khan, Seema A., primary

Published
2023
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80. Supplementary Figure 4 from Selective Progesterone Receptor Modulators in Early-Stage Breast Cancer: A Randomized, Placebo-Controlled Phase II Window-of-Opportunity Trial Using Telapristone Acetate

Author

Lee, Oukseub, primary, Sullivan, Megan E., primary, Xu, Yanfei, primary, Rogers, Chiara, primary, Muzzio, Miguel, primary, Helenowski, Irene, primary, Shidfar, Ali, primary, Zeng, Zexian, primary, Singhal, Hari, primary, Jovanovic, Borko, primary, Hansen, Nora, primary, Bethke, Kevin P., primary, Gann, Peter H., primary, Gradishar, William, primary, Kim, J. Julie, primary, Clare, Susan E., primary, and Khan, Seema A., primary

Published
2023
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81. Supplementary Figure 2 from Selective Progesterone Receptor Modulators in Early-Stage Breast Cancer: A Randomized, Placebo-Controlled Phase II Window-of-Opportunity Trial Using Telapristone Acetate

Author

Lee, Oukseub, primary, Sullivan, Megan E., primary, Xu, Yanfei, primary, Rogers, Chiara, primary, Muzzio, Miguel, primary, Helenowski, Irene, primary, Shidfar, Ali, primary, Zeng, Zexian, primary, Singhal, Hari, primary, Jovanovic, Borko, primary, Hansen, Nora, primary, Bethke, Kevin P., primary, Gann, Peter H., primary, Gradishar, William, primary, Kim, J. Julie, primary, Clare, Susan E., primary, and Khan, Seema A., primary

Published
2023
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82. Supplemental Materials from Selective Progesterone Receptor Modulators in Early-Stage Breast Cancer: A Randomized, Placebo-Controlled Phase II Window-of-Opportunity Trial Using Telapristone Acetate

Author

Lee, Oukseub, primary, Sullivan, Megan E., primary, Xu, Yanfei, primary, Rogers, Chiara, primary, Muzzio, Miguel, primary, Helenowski, Irene, primary, Shidfar, Ali, primary, Zeng, Zexian, primary, Singhal, Hari, primary, Jovanovic, Borko, primary, Hansen, Nora, primary, Bethke, Kevin P., primary, Gann, Peter H., primary, Gradishar, William, primary, Kim, J. Julie, primary, Clare, Susan E., primary, and Khan, Seema A., primary

Published
2023
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83. Supplemental Table 1 from Selective Progesterone Receptor Modulators in Early-Stage Breast Cancer: A Randomized, Placebo-Controlled Phase II Window-of-Opportunity Trial Using Telapristone Acetate

Author

Lee, Oukseub, primary, Sullivan, Megan E., primary, Xu, Yanfei, primary, Rogers, Chiara, primary, Muzzio, Miguel, primary, Helenowski, Irene, primary, Shidfar, Ali, primary, Zeng, Zexian, primary, Singhal, Hari, primary, Jovanovic, Borko, primary, Hansen, Nora, primary, Bethke, Kevin P., primary, Gann, Peter H., primary, Gradishar, William, primary, Kim, J. Julie, primary, Clare, Susan E., primary, and Khan, Seema A., primary

Published
2023
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84. Supplemental Table 2 from Selective Progesterone Receptor Modulators in Early-Stage Breast Cancer: A Randomized, Placebo-Controlled Phase II Window-of-Opportunity Trial Using Telapristone Acetate

Author

Lee, Oukseub, primary, Sullivan, Megan E., primary, Xu, Yanfei, primary, Rogers, Chiara, primary, Muzzio, Miguel, primary, Helenowski, Irene, primary, Shidfar, Ali, primary, Zeng, Zexian, primary, Singhal, Hari, primary, Jovanovic, Borko, primary, Hansen, Nora, primary, Bethke, Kevin P., primary, Gann, Peter H., primary, Gradishar, William, primary, Kim, J. Julie, primary, Clare, Susan E., primary, and Khan, Seema A., primary

Published
2023
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85. Supplementary Figure 3 from Selective Progesterone Receptor Modulators in Early-Stage Breast Cancer: A Randomized, Placebo-Controlled Phase II Window-of-Opportunity Trial Using Telapristone Acetate

Author

Lee, Oukseub, primary, Sullivan, Megan E., primary, Xu, Yanfei, primary, Rogers, Chiara, primary, Muzzio, Miguel, primary, Helenowski, Irene, primary, Shidfar, Ali, primary, Zeng, Zexian, primary, Singhal, Hari, primary, Jovanovic, Borko, primary, Hansen, Nora, primary, Bethke, Kevin P., primary, Gann, Peter H., primary, Gradishar, William, primary, Kim, J. Julie, primary, Clare, Susan E., primary, and Khan, Seema A., primary

Published
2023
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86. Supplemental Table 3 from Selective Progesterone Receptor Modulators in Early-Stage Breast Cancer: A Randomized, Placebo-Controlled Phase II Window-of-Opportunity Trial Using Telapristone Acetate

Author

Lee, Oukseub, primary, Sullivan, Megan E., primary, Xu, Yanfei, primary, Rogers, Chiara, primary, Muzzio, Miguel, primary, Helenowski, Irene, primary, Shidfar, Ali, primary, Zeng, Zexian, primary, Singhal, Hari, primary, Jovanovic, Borko, primary, Hansen, Nora, primary, Bethke, Kevin P., primary, Gann, Peter H., primary, Gradishar, William, primary, Kim, J. Julie, primary, Clare, Susan E., primary, and Khan, Seema A., primary

Published
2023
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87. Supplementary Data from The Novel Expanded Porphyrin, Motexafin Gadolinium, Combined with [90Y]Ibritumomab Tiuxetan for Relapsed/Refractory Non-Hodgkin's Lymphoma: Preclinical Findings and Results of a Phase I Trial

Author

Evens, Andrew M., primary, Spies, William G., primary, Helenowski, Irene B., primary, Patton, David, primary, Spies, Stewart, primary, Jovanovic, Borko D., primary, Miyata, Sarah, primary, Hamilton, Elizabeth, primary, Variakojis, Daina, primary, Chen, Jun, primary, Naumovski, Louie, primary, Rosen, Steven T., primary, Winter, Jane N., primary, Miller, Richard A., primary, and Gordon, Leo I., primary

Published
2023
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99. Posttransplant Lymphoproliferative Disorder (PTLD) Following Transplantation at Northwestern University: Choice of Immunosuppressive Agents Does Not Impact Outcomes in PTLD

Author

Melody, Megan, primary, St. Pierre, Frederique, additional, Helenowski, Irene, additional, Pearse, William B, additional, Vakkalagadda, Chetan, additional, Leventhal, Joseph R., additional, Ho, Bing, additional, Friedewald, John, additional, Ganger, Daniel, additional, Winter, Jane N., additional, Gordon, Leo I., additional, Lin, Adam Yuh, additional, Karmali, Reem, additional, Ma, Shuo, additional, Pro, Barbara, additional, and Moreira, Jonathan, additional

Published
2022
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100. Impact of Extranodal Disease Involvement on Outcomes in Post-Transplant Lymphoproliferative Disorder

Author

Melody, Megan, primary, St. Pierre, Frederique, additional, Helenowski, Irene, additional, Pearse, William B, additional, Vakkalagadda, Chetan V, additional, Leventhal, Joseph R., additional, Friedewald, John, additional, Ho, Bing, additional, Ganger, Daniel, additional, Winter, Jane N., additional, Gordon, Leo I., additional, Lin, Adam Yuh, additional, Karmali, Reem, additional, Ma, Shuo, additional, Pro, Barbara, additional, and Moreira, Jonathan, additional

Published
2022
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