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52. Lung

Author

Kelsey, Christopher R., Vujaskovic, Zeljko, Jackson, Isabel Lauren, Riedel, Richard F., Marks, Lawrence B., Brady, Luther W., Series editor, Molls, Michael, Series editor, Heilmann, Hans-Peter, Series editor, Nieder, Carsten, Series editor, Rubin, Philip, editor, Constine, Louis S., editor, and Marks, Lawrence B., editor

Published
2014
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53. METFusions in NSCLC: Clinicopathologic Features and Response to MET Inhibition

Author

Riedel, Richard, Fassunke, Jana, Scheel, Andreas H., Scheffler, Matthias, Heydt, Carina, Nogova, Lucia, Michels, Sebastian, Fischer, Rieke N., Eisert, Anna, Scharpenseel, Heather, John, Felix, Ruge, Lea, Schaufler, Diana, Siemanowski, Janna, Ihle, Michaela A., Wagener-Ryczek, Svenja, Pappesch, Roberto, Rehker, Jan, Bunck, Anne, Kobe, Carsten, Keil, Felix, Merkelbach-Bruse, Sabine, Büttner, Reinhard, and Wolf, Jürgen

Abstract

METfusions have been described only rarely in NSCLC. Thus, data on patient characteristics and treatment response are limited. We here report histopathologic data, patient demographics, and treatment outcome including response to MET tyrosine kinase inhibitor (TKI) therapy in METfusion-positive NSCLC.

Published
2024
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55. NCCN Guidelines® Insights: Gastrointestinal Stromal Tumors, Version 2.2022

Author

von Mehren, Margaret, primary, Kane, John M., additional, Riedel, Richard F., additional, Sicklick, Jason K., additional, Pollack, Seth M., additional, Agulnik, Mark, additional, Bui, Marilyn M., additional, Carr-Ascher, Janai, additional, Choy, Edwin, additional, Connelly, Mary, additional, Dry, Sarah, additional, Ganjoo, Kristen N., additional, Gonzalez, Ricardo J., additional, Holder, Ashley, additional, Homsi, Jade, additional, Keedy, Vicki, additional, Kelly, Ciara M., additional, Kim, Edward, additional, Liebner, David, additional, McCarter, Martin, additional, McGarry, Sean V., additional, Mesko, Nathan W., additional, Meyer, Christian, additional, Pappo, Alberto S., additional, Parkes, Amanda M., additional, Petersen, Ivy A., additional, Poppe, Matthew, additional, Schuetze, Scott, additional, Shabason, Jacob, additional, Spraker, Matthew B., additional, Zimel, Melissa, additional, Bergman, Mary Anne, additional, Sundar, Hema, additional, and Hang, Lisa E., additional

Published
2022
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56. Corrigendum to “The development of a 6Li-based pixelated neutron detector for neutron reflectometry at the Spallation Neutron Source” [Nucl. Instrum. Methods Phys. Res. A 1039 (2022) 167052]

Author

Chong, Su-Ann, primary, Riedel, Richard, additional, Funk, Loren, additional, Visscher, Theodore, additional, Donahue, Cornelius, additional, Hannan, Bruce, additional, Montcalm, Christopher, additional, Beal, Justin, additional, Hayward, Jason, additional, and Doucet, Mathieu, additional

Published
2022
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60. A phase II trial of regorafenib in patients with advanced Ewing sarcoma and related tumors of soft tissue and bone: SARC024 trial results

Author

Attia, Steven, primary, Bolejack, Vanessa, additional, Ganjoo, Kristen N., additional, George, Suzanne, additional, Agulnik, Mark, additional, Rushing, Daniel, additional, Loggers, Elizabeth T., additional, Livingston, Michael B., additional, Wright, Jennifer, additional, Chawla, Sant P., additional, Okuno, Scott H., additional, Reinke, Denise K., additional, Riedel, Richard F., additional, Davis, Lara E., additional, Ryan, Christopher W., additional, and Maki, Robert G., additional

Published
2022
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62. Soft Tissue Sarcoma, Version 2.2022

Author

von Mehren, Margaret, Kane, John M., Agulnik, Mark, Bui, Marilyn M., Carr-Ascher, Janai, Choy, Edwin, Connelly, Mary, Dry, Sarah, Ganjoo, Kristen N., Gonzalez, Ricardo J., Holder, Ashley, Homsi, Jade, Keedy, Vicki, Kelly, Ciara M., Kim, Edward, Liebner, David, McCarter, Martin, McGarry, Sean V., Mesko, Nathan W., Meyer, Christian, Pappo, Alberto S., Parkes, Amanda M., Petersen, Ivy A., Pollack, Seth M., Poppe, Matthew, Riedel, Richard F., Schuetze, Scott, Shabason, Jacob, Sicklick, Jason K., Spraker, Matthew B., Zimel, Melissa, Hang, Lisa E., Sundar, Hema, and Bergman, Mary Anne

Subjects
Humans, Extremities, Sarcoma, Soft Tissue Neoplasms, Medical Oncology, Article
Abstract

Soft tissue sarcomas (STS) are rare malignancies of mesenchymal cell origin that display a heterogenous mix of clinical and pathologic characteristics. STS can develop from fat, muscle, nerves, blood vessels, and other connective tissues. The evaluation and treatment of patients with STS requires a multidisciplinary team with demonstrated expertise in the management of these tumors. The complete NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Soft Tissue Sarcoma provide recommendations for the diagnosis, evaluation, and treatment of extremity/superficial trunk/head and neck STS, as well as retroperitoneal/intra-abdominal STS, desmoid tumors, and rhabdomyosarcoma. This portion of the NCCN Guidelines discusses general principles for the diagnosis and treatment of retroperitoneal/intra-abdominal STS, outlines treatment recommendations, and reviews the evidence to support the guidelines recommendations.

Published
2022

67. Screening of FGFR patients for FGFR directed clinical trials in Network Genomic Medicine (NGM): Real-world data.

Author

Scharpenseel, Heather, primary, Malchers, Florian, additional, Terjung, Inken, additional, Hillmer, Axel, additional, Merkelbach-Bruse, Sabine, additional, Scheel, Andreas H., additional, Siemanowski, Janna, additional, Scheffler, Matthias, additional, Riedel, Richard, additional, Eisert, Anna, additional, Michels, Sebastian Yves Friedrich, additional, Fischer, Rieke Nila, additional, Weber, Jan-Philip, additional, Westphal, Theresa, additional, Kron, Anna, additional, Sueptitz, Juliane, additional, Thomas, Roman K., additional, Buettner, Reinhard, additional, Wolf, Juergen, additional, and Nogova, Lucia, additional

Published
2022
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68. Metastatic patterns plus clinical and molecular characteristics of ROS1 aberrations in non-small cell lung cancer patients without rearrangements.

Author

Glaser, Moritz, primary, von Levetzow, Cornelia, additional, Michels, Sebastian Yves Friedrich, additional, Nogova, Lucia, additional, Katzenmeier, Marianna, additional, Wompner, Claudia, additional, Schmitz, Jaqueline, additional, Bitter, Elisabeth, additional, Terjung, Inken, additional, Passmann, Elke, additional, Schaufler, Diana, additional, Eisert, Anna, additional, Fischer, Rieke Nila, additional, Riedel, Richard, additional, Weber, Jan-Phillip, additional, Hahne, Sabine, additional, Merkelbach-Bruse, Sabine, additional, Büttner, Reinhard, additional, Wolf, Juergen, additional, and Scheffler, Matthias, additional

Published
2022
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69. Age as a factor in the molecular landscape and the tumor-microenvironmental signature of osteosarcoma.

Author

Seeber, Andreas, primary, Elliott, Andrew, additional, Modiano, Jaime, additional, Untergasser, Gerold, additional, von Mehren, Margaret, additional, Rosenberg, Andrew, additional, Khushman, Moh'd, additional, Dizon, Don S., additional, Riedel, Richard F., additional, Trent, Jonathan C., additional, Zimmer, Kai, additional, Lagos, Galina, additional, DeNardo, Bradley, additional, Sarver, Aaron, additional, Puccini, Alberto, additional, Walker, Phillip, additional, Oberley, Matthew James, additional, Korn, Wolfgang Michael, additional, Wolf, Domink, additional, and Kocher, Florian, additional

Published
2022
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70. nab-Sirolimus for patients with advanced malignant PEComa with or without prior mTOR inhibitors: Biomarker results from AMPECT and an expanded access program.

Author

Dickson, Mark Andrew, primary, Ravi, Vinod, additional, Riedel, Richard F., additional, Ganjoo, Kristen N., additional, Van Tine, Brian Andrew, additional, Chugh, Rashmi, additional, Cranmer, Lee D., additional, Gordon, Erlinda Maria, additional, Chen, James Lin, additional, Murphy, Martina Cathryn, additional, Schmid, Anita N., additional, Desai, Neil, additional, Alonzo Palma, Norma, additional, Kwiatkowski, David J., additional, and Wagner, Andrew J., additional

Published
2022
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72. Phase II Randomized Study of CMB305 and Atezolizumab Compared With Atezolizumab Alone in Soft-Tissue Sarcomas Expressing NY-ESO-1

Author

Chawla, Sant P., primary, Van Tine, Brian A., additional, Pollack, Seth M., additional, Ganjoo, Kristen N., additional, Elias, Anthony D., additional, Riedel, Richard F., additional, Attia, Steven, additional, Choy, Edwin, additional, Okuno, Scott H., additional, Agulnik, Mark, additional, von Mehren, Margaret, additional, Livingston, Michael B., additional, Keedy, Vicki L., additional, Verschraegen, Claire F., additional, Philip, Tony, additional, Bohac, G. Chet, additional, Yurasov, Sergey, additional, Yakovich, Adam, additional, Lu, Hailing, additional, Chen, Michael, additional, and Maki, Robert G., additional

Published
2022
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73. Dual-Energy CT Vital Iodine Tumor Burden for Response Assessment in Patients With Metastatic GIST Undergoing TKI Therapy: Comparison With Standard CT and FDG PET/CT Criteria

Author

Meyer, Mathias, primary, Hohenberger, Peter, additional, Overhoff, Daniel, additional, Bartsch, Anna, additional, Henzler, Thomas, additional, Haubenreisser, Holger, additional, Ronald, James, additional, Schmidt, Bernhard, additional, Flohr, Thomas, additional, Sedlmair, Martin, additional, Ota, Hideki, additional, Messiou, Christina, additional, Schoenberg, Stefan O., additional, Riedel, Richard F., additional, Nelson, Rendon C., additional, and Marin, Daniele, additional

Published
2022
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78. nab-Sirolimus for Patients With Malignant Perivascular Epithelioid Cell Tumors

Author

Wagner, Andrew J., primary, Ravi, Vinod, additional, Riedel, Richard F., additional, Ganjoo, Kristen, additional, Van Tine, Brian A., additional, Chugh, Rashmi, additional, Cranmer, Lee, additional, Gordon, Erlinda M., additional, Hornick, Jason L., additional, Du, Heng, additional, Grigorian, Berta, additional, Schmid, Anita N., additional, Hou, Shihe, additional, Harris, Katherine, additional, Kwiatkowski, David J., additional, Desai, Neil P., additional, and Dickson, Mark A., additional

Published
2021
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79. A phase II trial of regorafenib in patients with advanced Ewing sarcoma and related tumors of soft tissue and bone: SARC024 trial results.

Author

Attia, Steven, Bolejack, Vanessa, Ganjoo, Kristen N., George, Suzanne, Agulnik, Mark, Rushing, Daniel, Loggers, Elizabeth T., Livingston, Michael B., Wright, Jennifer, Chawla, Sant P., Okuno, Scott H., Reinke, Denise K., Riedel, Richard F., Davis, Lara E., Ryan, Christopher W., and Maki, Robert G.

Subjects
SOFT tissue tumors, EWING'S sarcoma, REGORAFENIB, PROGRESSION-free survival, KINASE inhibitors
Abstract

Background: Regorafenib is one of several FDA‐approved cancer therapies targeting multiple tyrosine kinases. However, there are few subtype‐specific data regarding kinase inhibitor activity in sarcomas. We report results of a single arm, phase II trial of regorafenib in advanced Ewing family sarcomas. Methods: Patients with metastatic Ewing family sarcomas (age ≥ 18, ECOG 0–2, good organ function) who had received at least one line of therapy and experienced progression within 6 months of registration were eligible. Prior kinase inhibitors were not allowed. The initial dose of regorafenib was 160 mg oral days 1–21 of a 28‐day cycle. The primary endpoint was estimating progression‐free rate (PFR) at 8 weeks employing RECIST 1.1. Results: Thirty patients (median age, 32 years; 33% women [10 patients]; bone primary, 40%; extraskeletal primary, 60%) enrolled at 14 sites. The most common grade 3 or higher toxicities were hypophosphatemia (5 grade 3, 1 grade 4), hypertension (2 grade 3), elevated ALT (2 grade 3). Sixteen patients required dose reductions, most often for hypophosphatemia (n = 7 reductions in 6 patients); two stopped regorafenib for toxicity. There was one death unrelated to treatment in the 30‐day post‐study period. Median progression‐free survival (PFS) was 14.8 weeks (95% CI 7.3–15.9); PFR at 8 weeks by Kaplan–Meier analysis was 63% (95% CI 46–81%). The RECIST 1.1 response rate was 10%. Median OS was 53 weeks (95% CI 37–106 weeks). Conclusions: Regorafenib has modest activity in the Ewing family sarcomas. Toxicity was similar to that seen in approval studies. [ABSTRACT FROM AUTHOR]

Published
2023
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81. Health-related quality of life and pain with selinexor in patients with advanced dedifferentiated liposarcoma

Author

Gounder, Mrinal, primary, Abdul Razak, Albiruni R, additional, Gilligan, Adrienne M, additional, Leong, Hoyee, additional, Ma, Xiwen, additional, Somaiah, Neeta, additional, Chawla, Sant P, additional, Martin-Broto, Javier, additional, Grignani, Giovanni, additional, Schuetze, Scott M, additional, Vincenzi, Bruno, additional, Wagner, Andrew J, additional, Chmielowski, Bartosz, additional, Jones, Robin L, additional, Shah, Jatin, additional, Shacham, Sharon, additional, Kauffman, Michael, additional, Riedel, Richard F, additional, and Attia, Steven, additional

Published
2021
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82. Bone Sarcomas

Author

Larrier, Nicole, primary, Eward, William C., additional, and Riedel, Richard F., additional

Published
2014
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85. Large scale multiomic analysis suggests mechanisms of resistance to immunotherapy in leiomyosarcoma.

Author

Lagos, Galina, primary, Groisberg, Roman, additional, Dizon, Don S., additional, Elliott, Andrew, additional, Copeland, Tabitha, additional, Seeber, Andreas, additional, Gibney, Geoffrey Thomas, additional, von Mehren, Margaret, additional, Cardona, Kenneth, additional, Demeure, Michael J., additional, Riedel, Richard F., additional, Florou, Vaia, additional, Chou, Alexander J., additional, Kumar, Abhijeet, additional, Modiano, Jaime, additional, Khushman, Moh'd M., additional, D'Amato, Gina Z., additional, Espejo Freire, Andrea P., additional, Korn, W. Michael, additional, and Trent, Jonathan C., additional

Published
2021
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86. TK216 for relapsed/refractory Ewing sarcoma: Interim phase 1/2 results.

Author

Ludwig, Joseph Aloysius, primary, Federman, Noah C., additional, Anderson, Peter Meade, additional, Macy, Margaret E, additional, Riedel, Richard F., additional, Davis, Lara E., additional, Daw, Najat C., additional, Wulff, Jade, additional, Kim, AeRang, additional, Ratan, Ravin, additional, Baskin-Bey, Edwina S, additional, Toretsky, Jeffrey A., additional, Breitmeyer, James Bradley, additional, and Meyers, Paul A., additional

Published
2021
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87. KEAP1 mutations in squamous cell lung cancer.

Author

Koleczko, Sophia, primary, Hillmer, Axel, additional, Bayarassou, Abdel Hakim, additional, Grohé, Christian, additional, Buchenroth, Martin, additional, Kaminsky, Britta, additional, Schulte, Clemens, additional, Michels, Sebastian Yves Friedrich, additional, Schaufler, Diana, additional, Kron, Anna, additional, Riedel, Richard, additional, Westphal, Theresa, additional, Weber, Jan-Phillip, additional, Fischer, Rieke Nila, additional, Merkelbach-Bruse, Sabine, additional, Nogova, Lucia, additional, Buettner, Reinhard, additional, Wolf, Juergen, additional, and Scheffler, Matthias, additional

Published
2021
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88. P10015/SARC033: A phase 2 trial of trametinib in patients with advanced epithelioid hemangioendothelioma (EHE).

Author

Schuetze, Scott, primary, Ballman, Karla V., additional, Ganjoo, Kristen N., additional, Davis, Elizabeth J., additional, Morgan, Jeffrey A., additional, Tinoco, Gabriel, additional, Burgess, Melissa Amber, additional, Van Tine, Brian Andrew, additional, Choy, Edwin, additional, Shepard, Dale Randall, additional, Kelly, Ciara Marie, additional, Riedel, Richard F., additional, von Mehren, Margaret, additional, Siontis, Brittany L, additional, Attia, Steven, additional, Schwartz, Gary K., additional, Deshpande, Hari Anant, additional, Kozlowski, Erin, additional, Chen, Helen X., additional, and Rubin, Brian, additional

Published
2021
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89. Phase II study of atezolizumab in advanced alveolar soft part sarcoma (ASPS).

Author

Naqash, Abdul Rafeh, primary, O'Sullivan Coyne, Geraldine Helen, additional, Moore, Nancy, additional, Sharon, Elad, additional, Takebe, Naoko, additional, Fino, Kristin K., additional, Ferry-Galow, Katherine V., additional, Hu, James S., additional, Van Tine, Brian Andrew, additional, Burgess, Melissa Amber, additional, Read, William L., additional, Riedel, Richard F., additional, George, Suzanne, additional, Glod, John, additional, Conley, Anthony Paul, additional, Foster, Jared C., additional, Fogli, Laura K., additional, Parchment, Ralph E., additional, Doroshow, James H., additional, and Chen, Alice P., additional

Published
2021
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90. Multiomic analysis to reveal distinct molecular profiles of uterine and nonuterine leiomyosarcoma.

Author

Copeland, Tabitha, primary, Groisberg, Roman, additional, Dizon, Don S., additional, Elliott, Andrew, additional, Lagos, Galina, additional, Seeber, Andreas, additional, von Mehren, Margaret, additional, Cardona, Kenneth, additional, Demeure, Michael J., additional, Riedel, Richard F., additional, Florou, Vaia, additional, Chou, Alexander J., additional, Kumar, Abhijeet, additional, Modiano, Jaime, additional, Khushman, Moh'd M., additional, D'Amato, Gina Z., additional, Espejo Freire, Andrea P., additional, Korn, W. Michael, additional, and Trent, Jonathan C., additional

Published
2021
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92. Lung

Author

Kelsey, Christopher R., primary, Vujaskovic, Zeljko, additional, Jackson, Isabel Lauren, additional, Riedel, Richard F., additional, and Marks, Lawrence B., additional

Published
2013
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93. Lorlatinib in pretreated ALK- or ROS1-positive lung cancer and impact of TP53 co-mutations: results from the German early access program

Author

Frost, Nikolaj, Christopoulos, Petros, Kauffmann-Guerrero, Diego, Stratmann, Jan, Riedel, Richard, Schaefer, Monica, Alt, Jurgen, Gutz, Sylvia, Christoph, Daniel C., Laack, Eckart, Faehling, Martin, Fischer, Richard, Fenchel, Klaus, Haen, Sebastian, Heukamp, Lukas, Schulz, Christian, Griesinger, Frank, Frost, Nikolaj, Christopoulos, Petros, Kauffmann-Guerrero, Diego, Stratmann, Jan, Riedel, Richard, Schaefer, Monica, Alt, Jurgen, Gutz, Sylvia, Christoph, Daniel C., Laack, Eckart, Faehling, Martin, Fischer, Richard, Fenchel, Klaus, Haen, Sebastian, Heukamp, Lukas, Schulz, Christian, and Griesinger, Frank

Abstract

Introduction: We report on the results of the German early access program (EAP) with the third-generation ALK- and ROS1-inhibitor lorlatinib. Patients and Methods: Patients with documented treatment failure of all approved ALK/ROS1-specific therapies or with resistance mutations not covered by approved inhibitors or leptomeningeal carcinomatosis were enrolled and analyzed. Results: In total, 52 patients were included [median age 57 years (range 32-81), 54% female, 62% never smokers, 98% adenocarcinoma]; 71% and 29% were ALK- and ROS1-positive, respectively. G1202R and G2032R resistance mutations prior to treatment with lorlatinib were observed in 10 of 26 evaluable patients (39%), 11 of 39 patients showed TP53 mutations (28%). Thirty-six patients (69%) had active brain metastases (BM) and nine (17%) leptomeningeal carcinomatosis when entering the EAP. Median number of prior specific TKIs was 3 (range 1-4). Median duration of treatment, progression-free survival (PFS), response rate and time to treatment failure were 10.4 months, 8.0 months, 54% and 13.0 months. Calculated 12-, 18- and 24-months survival rates were 65, 54 and 47%, overall survival since primary diagnosis (OS2) reached 79.6 months. TP53 mutations were associated with a substantially reduced PFS (3.7 versus 10.8 month, HR 3.3, p = 0.003) and were also identified as a strong prognostic biomarker (HR for OS2 3.0 p = 0.02). Neither prior treatments with second-generation TKIs nor BM had a significant influence on PFS and OS. Conclusions: Our data from real-life practice demonstrate the efficacy of lorlatinib in mostly heavily pretreated patients, providing a clinically meaningful option for patients with resistance mutations not covered by other targeted therapies and those with BM or leptomeningeal carcinomatosis.

Published
2021

94. KEAP1 mutations in squamous cell lung cancer.

Author

Koleczko, Sophia, Hillmer, Axel, Bayarassou, Abdel Hakim, Grohe, Christian, Buchenroth, Martin, Kaminsky, Britta, Schulte, Clemens, Michels, Sebastian Yves Friedrich, Schaufler, Diana, Kron, Anna, Riedel, Richard, Westphal, Theresa, Weber, Jan-Phillip, Fischer, Rieke Nila, Merkelbach-Bruse, Sabine, Nogova, Lucia, Buettner, Reinhard, Wolf, Juergen, Scheffler, Matthias, Koleczko, Sophia, Hillmer, Axel, Bayarassou, Abdel Hakim, Grohe, Christian, Buchenroth, Martin, Kaminsky, Britta, Schulte, Clemens, Michels, Sebastian Yves Friedrich, Schaufler, Diana, Kron, Anna, Riedel, Richard, Westphal, Theresa, Weber, Jan-Phillip, Fischer, Rieke Nila, Merkelbach-Bruse, Sabine, Nogova, Lucia, Buettner, Reinhard, Wolf, Juergen, and Scheffler, Matthias

Published
2021

95. Health-related quality of life and pain with selinexor in patients with advanced dedifferentiated liposarcoma

Author

Karyopharm Therapeutics, Daiichi-Sankyo, Amgen, Bayer, National Cancer Institute (US), National Institutes of Health (US), Merck & Co, AstraZeneca, Eli Lilly and Company, Roche, GlaxoSmithKline, Janssen Biotech, Gounder, Mrinal, Abdul Razak, Albiruni R., Gilligan, Adrienne M., Leong, Hoyee, Ma, Xiwen, Somaiah, Neeta, Chawla, Sant P., Martín-Broto, Javier, Grignani, Giovanni, Schuetze, Scott M., Vincenzi, Bruno, Wagner, Andrew J., Chmielowski, Bartosz, Jones, Robin L., Shah, Jatin, Shacham, Sharon, Kauffman, Michael, Riedel, Richard F., Attia, Steven, Karyopharm Therapeutics, Daiichi-Sankyo, Amgen, Bayer, National Cancer Institute (US), National Institutes of Health (US), Merck & Co, AstraZeneca, Eli Lilly and Company, Roche, GlaxoSmithKline, Janssen Biotech, Gounder, Mrinal, Abdul Razak, Albiruni R., Gilligan, Adrienne M., Leong, Hoyee, Ma, Xiwen, Somaiah, Neeta, Chawla, Sant P., Martín-Broto, Javier, Grignani, Giovanni, Schuetze, Scott M., Vincenzi, Bruno, Wagner, Andrew J., Chmielowski, Bartosz, Jones, Robin L., Shah, Jatin, Shacham, Sharon, Kauffman, Michael, Riedel, Richard F., and Attia, Steven

Abstract

[Objective] Compare health-related quality of life (HRQoL) of selinexor versus placebo in patients with dedifferentiated liposarcoma., [Materials & methods] HRQoL was assessed at baseline and day 1 of each cycle using the European Organization for Research and Treatment of Cancer 30-item core quality of life questionnaire. Results were reported from baseline to day 169 (where exposure to treatment was maximized while maintaining adequate sample size)., [Results] Pain scores worsened for placebo versus selinexor across all postbaseline visits, although differences in HRQoL at some visits were not significant. Other domains did not exhibit significant differences between arms; however, scores in both arms deteriorated over time., [Conclusion] Patients treated with selinexor reported lower rates and slower worsening of pain compared with patients who received placebo.

Published
2021

97. A Randomized, Double-Blind, Placebo-Controlled, Phase II Study of Regorafenib Versus Placebo in Advanced/Metastatic, Treatment-Refractory Liposarcoma: Results from the SARC024 Study

Author

Riedel, Richard, Ballman, Karla, Lu, Yao, Attia, Steven, Loggers, Elizabeth, Ganjoo, Kristen, Livingston, Michael, Chow, Warren, Wright, Jennifer, Ward, John, Rushing, Daniel, Okuno, Scott, Reed, Damon, Liebner, David, Keedy, Vicki, Mascarenhas, Leo, Davis, Lara, Ryan, Christopher, Reinke, Denise, and Maki, Robert

Subjects
Adult, Male, Treatment Outcome, Double-Blind Method, Pyridines, Phenylurea Compounds, Humans, Female, Liposarcoma, Middle Aged, Protein Kinase Inhibitors, Aged
Abstract

LESSONS LEARNED: The results from the liposarcoma cohort of SARC024 confirm previously published data and do not support the routine use of regorafenib in this patient population. Continued exploration of novel therapies, including combination approaches, is warranted for a patient population in whom limited treatment options exist. BACKGROUND: Regorafenib is a multitargeted kinase inhibitor with a kinase profile overlapping, but distinct from, pazopanib, an agent approved for recurrent and metastatic non-gastrointestinal stromal tumor (GIST), non-adipocytic soft tissue sarcoma. We conducted a randomized, phase II study of regorafenib versus placebo in refractory liposarcoma patients. METHODS: Patients with advanced or metastatic, treatment-refractory liposarcoma were randomized 1:1 to receive regorafenib 160 mg or placebo once daily (3 weeks on, 1 week off). Patients with well-differentiated liposarcoma only were excluded. Crossover for placebo was allowed upon progression. The primary endpoint was progression-free survival (PFS), according to RECIST version 1.1. RESULTS: Forty-eight subjects with liposarcoma (34 dedifferentiated, 12 myxoid/round cell, 2 pleomorphic) were enrolled. Median PFS was 1.87 (95% confidence interval [CI], 0.92-3.67) months for regorafenib versus 2.07 (95% CI, 1.64-3.44) months for placebo; stratified hazard ratio [HR], 0.85 (95% CI, 0.46, 1.58), p = .62. No responses were seen on regorafenib. One PR was observed on placebo. Median overall survival was 6.46 (95% CI, 4.16-23.48) months for regorafenib and 4.89 (95% CI, 3.02-9.77) months for placebo, stratified HR, 0.66 (95% CI, 0.31-1.40), p = .28). Treatment-related adverse events were similar to the known safety profile of regorafenib. CONCLUSION: Regorafenib did not appear to improve PFS in treatment-refractory liposarcoma. No new significant safety signals were observed.

Published
2020

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