120 results on '"A. Namakydoust"'
Search Results
2. Standard-of-care systemic therapy with or without stereotactic body radiotherapy in patients with oligoprogressive breast cancer or non-small-cell lung cancer (Consolidative Use of Radiotherapy to Block [CURB] oligoprogression): an open-label, randomised, controlled, phase 2 study
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Berger, Michael, Bromberg, Jacqueline, Chen, Linda, Dang, Chau, Das, Jeeban P, Drullinsky, Pamela, Eng, Julianna, Flynn, Jessica, Gelblum, Daphna Y, Gillespie, Erin F, Girshman, Jeffrey, Gomez, Daniel R, Gucalp, Ayca, Guttmann, David, Hajj, Carla, Higginson, Daniel, Iqbal, Afsheen, Khan, Atif J, LaPlant, Quincey, Lee, Nancy Y, Mann, Justin M, Modi, Shanu, Namakydoust, Azadeh, Ng, Kenneth, Patel, Juber, Powell, Simon N, Preeshagul, Isabel, Reis-Filho, Jorge S, Reyngold, Marsha, Riaz, Nadeem, Rimner, Andreas, Robson, Mark E, Rudin, Charles M, Sanford, Rachel, Seidman, Andrew D, Shah, Ronak, Shaverdian, Narek, Shepherd, Annemarie F, Shin, Jacob Y, Sugarman, Steven, Traina, Tiffany A, Tsai, Chiaojung Jillian, Wu, Abraham J, Xu, Amy J, Yang, Jonathan T, Yeh, Randy, Zhang, Zhigang, Zhi, Wanqing, Eng, Juliana, Seidman, Andrew, and Traina, Tiffany
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- 2024
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3. Overall survival with circulating tumor DNA-guided therapy in advanced non-small-cell lung cancer
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Jee, Justin, Lebow, Emily S., Yeh, Randy, Das, Jeeban P., Namakydoust, Azadeh, Paik, Paul K., Chaft, Jamie E., Jayakumaran, Gowtham, Rose Brannon, A., Benayed, Ryma, Zehir, Ahmet, Donoghue, Mark, Schultz, Nikolaus, Chakravarty, Debyani, Kundra, Ritika, Madupuri, Ramyasree, Murciano-Goroff, Yonina R., Tu, Hai-Yan, Xu, Chong-Rui, Martinez, Andrés, Wilhelm, Clare, Galle, Jesse, Daly, Bobby, Yu, Helena A., Offin, Michael, Hellmann, Matthew D., Lito, Piro, Arbour, Kathryn C., Zauderer, Marjorie G., Kris, Mark G., Ng, Kenneth K., Eng, Juliana, Preeshagul, Isabel, Victoria Lai, W., Fiore, John J., Iqbal, Afsheen, Molena, Daniela, Rocco, Gaetano, Park, Bernard J., Lim, Lee P., Li, Mark, Tong-Li, Candace, De Silva, Madhawa, Chan, David L., Diakos, Connie I., Itchins, Malinda, Clarke, Stephen, Pavlakis, Nick, Lee, Adrian, Rekhtman, Natasha, Chang, Jason, Travis, William D., Riely, Gregory J., Solit, David B., Gonen, Mithat, Rusch, Valerie W., Rimner, Andreas, Gomez, Daniel, Drilon, Alexander, Scher, Howard I., Shah, Sohrab P., Berger, Michael F., Arcila, Maria E., Ladanyi, Marc, Levine, Ross L., Shen, Ronglai, Razavi, Pedram, Reis-Filho, Jorge S., Jones, David R., Rudin, Charles M., Isbell, James M., and Li, Bob T.
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- 2022
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4. A Phase 1 Safety Study of Avelumab Plus Stereotactic Body Radiation Therapy in Malignant Pleural Mesothelioma
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Rimner, Andreas, Adusumilli, Prasad S., Offin, Michael D., Solomon, Stephen B., Ziv, Etay, Hayes, Sara A., Ginsberg, Michelle S., Sauter, Jennifer L., Gelblum, Daphna Y., Shepherd, Annemarie F., Guttmann, David M., Eichholz, Jordan E., Zhang, Zhigang, Ritter, Erika, Wong, Phillip, Iqbal, Afsheen N., Daly, Robert M., Namakydoust, Azadeh, Li, Henry, McCune, Megan, Gelb, Emily H., Taunk, Neil K., von Reibnitz, Donata, Tyagi, Neelam, Yorke, Ellen D., Rusch, Valerie W., and Zauderer, Marjorie G.
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- 2023
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5. A Phase 1 Safety Study of Avelumab Plus Stereotactic Body Radiation Therapy in Malignant Pleural Mesothelioma
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Andreas Rimner, MD, Prasad S. Adusumilli, MD, Michael D. Offin, MD, Stephen B. Solomon, MD, Etay Ziv, MD, Sara A. Hayes, MD, Michelle S. Ginsberg, MD, Jennifer L. Sauter, MD, Daphna Y. Gelblum, MD, Annemarie F. Shepherd, MD, David M. Guttmann, MD, Jordan E. Eichholz, MS, Zhigang Zhang, PhD, Erika Ritter, BS, Phillip Wong, PhD, Afsheen N. Iqbal, MD, Robert M. Daly, MD, Azadeh Namakydoust, MD, Henry Li, BS, Megan McCune, BS, Emily H. Gelb, BS, Neil K. Taunk, MD, Donata von Reibnitz, MD, Neelam Tyagi, PhD, Ellen D. Yorke, PhD, Valerie W. Rusch, MD, and Marjorie G. Zauderer, MD
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Malignant pleural mesothelioma ,Stereotactic body radiation therapy ,Avelumab ,Safety ,Phase I Study ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Introduction: Single-agent monoclonal antibody therapy against programmed death-ligand 1 (PD-L1) has modest effects in malignant pleural mesothelioma. Radiation therapy can enhance the antitumor effects of immunotherapy. Nevertheless, the safety of combining anti-PD-L1 therapy with stereotactic body radiation therapy (SBRT) is unknown. We present the results of a phase 1 trial to evaluate the safety of the anti-PD-L1 antibody avelumab plus SBRT in patients with malignant pleural mesothelioma. Methods: This was a single-arm, investigator-initiated trial in patients who progressed on prior chemotherapy. Avelumab was delivered every other week, and SBRT was delivered to one lesion in three to five fractions (minimum of 30 Gy) followed by continuation of avelumab up to 24 months or until disease progression. The primary end point of the study was safety on the basis of grade 3+ nonhematologic adverse events (AEs) within 3 months of SBRT. Results: Thirteen assessable patients received a median of seven cycles (range: 2–26 cycles) of avelumab. There were 27 grade 1, 17 grade 2, four grade 3, and no grade 4 or 5 avelumab-related AEs. The most common were infusion-related allergic reactions (n = 6), anorexia or weight loss (n = 6), fatigue (n = 6), thyroid disorders (n = 5), diarrhea (n = 3), and myalgia or arthralgias (n = 3). There were 10 grade 1, four grade 2, one grade 3, and no grade 4 or 5 SBRT-related AEs. The most common were diarrhea (n = 3), chest pain/myalgia (n = 2), fatigue (n = 2), cough (n = 2), dyspnea (n = 2), and nausea/vomiting (n = 2). Conclusions: Combination avelumab plus SBRT seems tolerable on the basis of the prespecified toxicity end points of the first stage of this Simon two-stage design phase 1 study.
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- 2023
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6. Clinical utility of next-generation sequencing-based ctDNA testing for common and novel ALK fusions
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Mondaca, Sebastian, Lebow, Emily S., Namakydoust, Azadeh, Razavi, Pedram, Reis-Filho, Jorge S., Shen, Ronglai, Offin, Michael, Tu, Hai-Yan, Murciano-Goroff, Yonina, Xu, Chongrui, Makhnin, Alex, Martinez, Andres, Pavlakis, Nick, Clarke, Stephen, Itchins, Malinda, Lee, Adrian, Rimner, Andreas, Gomez, Daniel, Rocco, Gaetano, Chaft, Jamie E., Riely, Gregory J., Rudin, Charles M., Jones, David R., Li, Mark, Shaffer, Tristan, Hosseini, Seyed Ali, Bertucci, Caterina, Lim, Lee P., Drilon, Alexander, Berger, Michael F., Benayed, Ryma, Arcila, Maria E., Isbell, James M., and Li, Bob T.
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- 2021
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7. COVID-19 in patients with lung cancer
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Luo, J., Rizvi, H., Preeshagul, I.R., Egger, J.V., Hoyos, D., Bandlamudi, C., McCarthy, C.G., Falcon, C.J., Schoenfeld, A.J., Arbour, K.C., Chaft, J.E., Daly, R.M., Drilon, A., Eng, J., Iqbal, A., Lai, W.V., Li, B.T., Lito, P., Namakydoust, A., Ng, K., Offin, M., Paik, P.K., Riely, G.J., Rudin, C.M., Yu, H.A., Zauderer, M.G., Donoghue, M.T.A., Łuksza, M., Greenbaum, B.D., Kris, M.G., and Hellmann, M.D.
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- 2020
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8. SMARCA4-Deficient Thoracic Sarcomatoid Tumors Represent Primarily Smoking-Related Undifferentiated Carcinomas Rather Than Primary Thoracic Sarcomas
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Rekhtman, Natasha, Montecalvo, Joseph, Chang, Jason C., Alex, Deepu, Ptashkin, Ryan N., Ai, Ni, Sauter, Jennifer L., Kezlarian, Brie, Jungbluth, Achim, Desmeules, Patrice, Beras, Amanda, Bishop, Justin A., Plodkowski, Andrew J., Gounder, Mrinal M., Schoenfeld, Adam J., Namakydoust, Azadeh, Li, Bob T., Rudin, Charles M., Riely, Gregory J., Jones, David R., Ladanyi, Marc, and Travis, William D.
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- 2020
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9. Yttrium-90 Transarterial Radioembolization of Primary Lung Cancer Metastases to the Liver
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Alexander, Erica S., primary, Petre, Elena N., additional, Zhao, Ken, additional, Sotirchos, Vlasios, additional, Namakydoust, Azadeh, additional, Moussa, Amgad, additional, Yuan, Gavin, additional, Sofocleous, Constantinos T., additional, Solomon, Stephen B., additional, and Ziv, Etay, additional
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- 2023
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10. Standard-of-care systemic therapy with or without stereotactic body radiotherapy in patients with oligoprogressive breast cancer or non-small-cell lung cancer (Consolidative Use of Radiotherapy to Block [CURB] oligoprogression): an open-label, randomised, controlled, phase 2 study
- Author
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Tsai, Chiaojung Jillian, Yang, Jonathan T, Shaverdian, Narek, Patel, Juber, Shepherd, Annemarie F, Eng, Juliana, Guttmann, David, Yeh, Randy, Gelblum, Daphna Y, Namakydoust, Azadeh, Preeshagul, Isabel, Modi, Shanu, Seidman, Andrew, Traina, Tiffany, Drullinsky, Pamela, Flynn, Jessica, Zhang, Zhigang, Rimner, Andreas, Gillespie, Erin F, Gomez, Daniel R, Lee, Nancy Y, Berger, Michael, Robson, Mark E, Reis-Filho, Jorge S, Riaz, Nadeem, Rudin, Charles M, Powell, Simon N, Berger, Michael, Bromberg, Jacqueline, Chen, Linda, Dang, Chau, Das, Jeeban P, Drullinsky, Pamela, Eng, Julianna, Flynn, Jessica, Gelblum, Daphna Y, Gillespie, Erin F, Girshman, Jeffrey, Gomez, Daniel R, Gucalp, Ayca, Guttmann, David, Hajj, Carla, Higginson, Daniel, Iqbal, Afsheen, Khan, Atif J, LaPlant, Quincey, Lee, Nancy Y, Mann, Justin M, Modi, Shanu, Namakydoust, Azadeh, Ng, Kenneth, Patel, Juber, Powell, Simon N, Preeshagul, Isabel, Reis-Filho, Jorge S, Reyngold, Marsha, Riaz, Nadeem, Rimner, Andreas, Robson, Mark E, Rudin, Charles M, Sanford, Rachel, Seidman, Andrew D, Shah, Ronak, Shaverdian, Narek, Shepherd, Annemarie F, Shin, Jacob Y, Sugarman, Steven, Traina, Tiffany A, Tsai, Chiaojung Jillian, Wu, Abraham J, Xu, Amy J, Yang, Jonathan T, Yeh, Randy, Zhang, Zhigang, and Zhi, Wanqing
- Abstract
Most patients with metastatic cancer eventually develop resistance to systemic therapy, with some having limited disease progression (ie, oligoprogression). We aimed to assess whether stereotactic body radiotherapy (SBRT) targeting oligoprogressive sites could improve patient outcomes.
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- 2024
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11. A Case of Tracheostomy Decannulation During Withdrawal of Life-Sustaining Technologies (CS308)
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Daube, Ariel, primary, Herbst, Leah, additional, Wexler, Tina S., additional, Donnelly, Luke, additional, Namakydoust, Pouyan, additional, and Eti, Serife, additional
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- 2023
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12. Figure S2 from The Genomic Landscape of SMARCA4 Alterations and Associations with Outcomes in Patients with Lung Cancer
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Schoenfeld, Adam J., primary, Bandlamudi, Chai, primary, Lavery, Jessica A., primary, Montecalvo, Joseph, primary, Namakydoust, Azadeh, primary, Rizvi, Hira, primary, Egger, Jacklynn, primary, Concepcion, Carla P., primary, Paul, Sonal, primary, Arcila, Maria E., primary, Daneshbod, Yahya, primary, Chang, Jason, primary, Sauter, Jennifer L., primary, Beras, Amanda, primary, Ladanyi, Marc, primary, Jacks, Tyler, primary, Rudin, Charles M., primary, Taylor, Barry S., primary, Donoghue, Mark T.A., primary, Heller, Glenn, primary, Hellmann, Matthew D., primary, Rekhtman, Natasha, primary, and Riely, Gregory J., primary
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- 2023
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13. Supplementary Legend from The Genomic Landscape of SMARCA4 Alterations and Associations with Outcomes in Patients with Lung Cancer
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Gregory J. Riely, Natasha Rekhtman, Matthew D. Hellmann, Glenn Heller, Mark T.A. Donoghue, Barry S. Taylor, Charles M. Rudin, Tyler Jacks, Marc Ladanyi, Amanda Beras, Jennifer L. Sauter, Jason Chang, Yahya Daneshbod, Maria E. Arcila, Sonal Paul, Carla P. Concepcion, Jacklynn Egger, Hira Rizvi, Azadeh Namakydoust, Joseph Montecalvo, Jessica A. Lavery, Chai Bandlamudi, and Adam J. Schoenfeld
- Abstract
Supplementary Legend
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- 2023
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14. Figure S2 from The Genomic Landscape of SMARCA4 Alterations and Associations with Outcomes in Patients with Lung Cancer
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Gregory J. Riely, Natasha Rekhtman, Matthew D. Hellmann, Glenn Heller, Mark T.A. Donoghue, Barry S. Taylor, Charles M. Rudin, Tyler Jacks, Marc Ladanyi, Amanda Beras, Jennifer L. Sauter, Jason Chang, Yahya Daneshbod, Maria E. Arcila, Sonal Paul, Carla P. Concepcion, Jacklynn Egger, Hira Rizvi, Azadeh Namakydoust, Joseph Montecalvo, Jessica A. Lavery, Chai Bandlamudi, and Adam J. Schoenfeld
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Overall survival by combination of STK11, KEAP1, and SMARCA4 alteration status.
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- 2023
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15. Data from The Genomic Landscape of SMARCA4 Alterations and Associations with Outcomes in Patients with Lung Cancer
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Gregory J. Riely, Natasha Rekhtman, Matthew D. Hellmann, Glenn Heller, Mark T.A. Donoghue, Barry S. Taylor, Charles M. Rudin, Tyler Jacks, Marc Ladanyi, Amanda Beras, Jennifer L. Sauter, Jason Chang, Yahya Daneshbod, Maria E. Arcila, Sonal Paul, Carla P. Concepcion, Jacklynn Egger, Hira Rizvi, Azadeh Namakydoust, Joseph Montecalvo, Jessica A. Lavery, Chai Bandlamudi, and Adam J. Schoenfeld
- Abstract
Purpose:SMARCA4 mutations are among the most common recurrent alterations in non–small cell lung cancer (NSCLC), but the relationship to other genomic abnormalities and clinical impact has not been established.Experimental Design:To characterize SMARCA4 alterations in NSCLC, we analyzed the genomic, protein expression, and clinical outcome data of patients with SMARCA4 alterations treated at Memorial Sloan Kettering.Results:In 4,813 tumors from patients with NSCLC, we identified 8% (n = 407) of patients with SMARCA4-mutant lung cancer. We describe two categories of SMARCA4 mutations: class 1 mutations (truncating mutations, fusions, and homozygous deletion) and class 2 mutations (missense mutations). Protein expression loss was associated with class 1 mutation (81% vs. 0%, P < 0.001). Both classes of mutation co-occurred more frequently with KRAS, STK11, and KEAP1 mutations compared with SMARCA4 wild-type tumors (P < 0.001). In patients with metastatic NSCLC, SMARCA4 alterations were associated with shorter overall survival, with class 1 alterations associated with shortest survival times (P < 0.001). Conversely, we found that treatment with immune checkpoint inhibitors (ICI) was associated with improved outcomes in patients with SMARCA4-mutant tumors (P = 0.01), with class 1 mutations having the best response to ICIs (P = 0.027).Conclusions:SMARCA4 alterations can be divided into two clinically relevant genomic classes associated with differential protein expression as well as distinct prognostic and treatment implications. Both classes co-occur with KEAP1, STK11, and KRAS mutations, but individually represent independent predictors of poor prognosis. Despite association with poor outcomes, SMARCA4-mutant lung cancers may be more sensitive to immunotherapy.
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- 2023
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16. Table S1 from The Genomic Landscape of SMARCA4 Alterations and Associations with Outcomes in Patients with Lung Cancer
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Gregory J. Riely, Natasha Rekhtman, Matthew D. Hellmann, Glenn Heller, Mark T.A. Donoghue, Barry S. Taylor, Charles M. Rudin, Tyler Jacks, Marc Ladanyi, Amanda Beras, Jennifer L. Sauter, Jason Chang, Yahya Daneshbod, Maria E. Arcila, Sonal Paul, Carla P. Concepcion, Jacklynn Egger, Hira Rizvi, Azadeh Namakydoust, Joseph Montecalvo, Jessica A. Lavery, Chai Bandlamudi, and Adam J. Schoenfeld
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Frequency of altered individual genes within SMARCA4 Class 1 vs SMARCA4 Class 2 subgroups.
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- 2023
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17. Final Analysis of Consolidative Use of Radiotherapy to Block (CURB) Oligoprogression Trial - A Randomized Study of Stereotactic Body Radiotherapy for Oligoprogressive Metastatic Lung and Breast Cancers
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Tsai, C.J., primary, Yang, J.T., additional, Guttmann, D.M., additional, Shaverdian, N., additional, Eng, J., additional, Yeh, R., additional, Girshman, J., additional, Das, J., additional, Gelblum, D., additional, Xu, A.J., additional, Namakydoust, A., additional, Iqbal, A., additional, Mann, J.M., additional, Preeshagul, I., additional, Hajj, C., additional, Gillespie, E.F., additional, Modi, S., additional, Dang, C., additional, Drullinsky, P., additional, Zhi, W., additional, LaPlant, Q., additional, Rimner, A., additional, Shin, J.Y., additional, Wu, A.J., additional, Ng, K., additional, Gucalp, A., additional, Khan, A.J., additional, Sanford, R., additional, Bromberg, J., additional, Seidman, A.D., additional, Traina, T.A., additional, Gomez, D.R., additional, Flynn, J., additional, Zhang, Z., additional, Patel, J.A., additional, Berger, M., additional, Reis-Filho, J.S., additional, Lee, N.Y., additional, Riaz, N., additional, Robson, M.E., additional, Rudin, C.M., additional, and Powell, S.N., additional
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- 2022
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18. Targeting NFE2L2/KEAP1 Mutations in Advanced NSCLC With the TORC1/2 Inhibitor TAK-228
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Paik, Paul K., primary, Fan, Pang-Dian, additional, Qeriqi, Besnik, additional, Namakydoust, Azadeh, additional, Daly, Bobby, additional, Ahn, Linda, additional, Kim, Rachel, additional, Plodkowski, Andrew, additional, Ni, Ai, additional, Chang, Jason, additional, Fanaroff, Rachel, additional, Ladanyi, Marc, additional, de Stanchina, Elisa, additional, and Rudin, Charles M., additional
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- 2022
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19. 1018P Phase I/II trial of rigosertib and nivolumab for KRAS mutated non-small cell lung cancer (NSCLC) patients
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Veluswamy, R., primary, Bhalla, S., additional, Samstein, R., additional, Marron, T., additional, Gomez, J.E., additional, Doroshow, D.B., additional, Sabari, J., additional, Shum, E., additional, Saxena, A., additional, Namakydoust, A., additional, Chachoua, A., additional, Wisnivesky, J., additional, Mandeli, J., additional, Bhardwaj, N., additional, Hirsch, F.R., additional, Merad, M., additional, and Reddy, E., additional
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- 2022
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20. A Case of Tracheostomy Decannulation During Withdrawal of Life-Sustaining Technologies (CS308)
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Ariel Daube, Leah Herbst, Tina S. Wexler, Luke Donnelly, Pouyan Namakydoust, and Serife Eti
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Anesthesiology and Pain Medicine ,Neurology (clinical) ,General Nursing - Published
- 2023
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21. 169P Phase I dose escalation trial combining olaparib and thoracic radiation therapy in extensive-stage small cell lung cancer
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A. Rimner, B. Lok, D.Y. Gelblum, R.R. Kotecha, F. Albrecht, J.Y. Shin, Q. Laplant, A. Namakydoust, A. Shepherd, D. Gomez, N. Shaverdian, A. Wu, C.B. Simone, H.A. Yu, K. Ng, R. Daly, M.D. Offin, M. Ginsberg, Z. Zhang, and C.M. Rudin
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Pulmonary and Respiratory Medicine ,Oncology - Published
- 2023
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22. The Genomic Landscape of SMARCA4 Alterations and Associations with Outcomes in Patients with Lung Cancer
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Schoenfeld, Adam J., Bandlamudi, Chai, Lavery, Jessica A., Montecalvo, Joseph, Namakydoust, Azadeh, Rizvi, Hira, Egger, Jacklynn, Concepcion, Carla P., Paul, Sonal, Arcila, Maria E., Daneshbod, Yahya, Chang, Jason, Sauter, Jennifer L., Beras, Amanda, Ladanyi, Marc, Jacks, Tyler, Rudin, Charles M., Taylor, Barry S., Donoghue, Mark T.A., Heller, Glenn, Hellmann, Matthew D., Rekhtman, Natasha, Riely, Gregory J., Schoenfeld, Adam J., Bandlamudi, Chai, Lavery, Jessica A., Montecalvo, Joseph, Namakydoust, Azadeh, Rizvi, Hira, Egger, Jacklynn, Concepcion, Carla P., Paul, Sonal, Arcila, Maria E., Daneshbod, Yahya, Chang, Jason, Sauter, Jennifer L., Beras, Amanda, Ladanyi, Marc, Jacks, Tyler, Rudin, Charles M., Taylor, Barry S., Donoghue, Mark T.A., Heller, Glenn, Hellmann, Matthew D., Rekhtman, Natasha, and Riely, Gregory J.
- Abstract
Purpose: SMARCA4 mutations are among the most common recurrent alterations in non-small cell lung cancer (NSCLC), but the relationship to other genomic abnormalities and clinical impact has not been established. Experimental Design: To characterize SMARCA4 alterations in NSCLC, we analyzed the genomic, protein expression, and clinical outcome data of patients with SMARCA4 alterations treated at Memorial Sloan Kettering. Results: In 4,813 tumors from patients with NSCLC, we identified 8% (n ¼ 407) of patients with SMARCA4-mutant lung cancer. We describe two categories of SMARCA4 mutations: class 1 mutations (truncating mutations, fusions, and homozygous deletion) and class 2 mutations (missense mutations). Protein expression loss was associated with class 1 mutation (81% vs. 0%, P < 0.001). Both classes of mutation co-occurred more frequently with KRAS, STK11, and KEAP1 mutations compared with SMARCA4 wild-type tumors (P < 0.001). In patients with metastatic NSCLC, SMARCA4 alterations were associated with shorter overall survival, with class 1 alterations associated with shortest survival times (P < 0.001). Conversely, we found that treatment with immune checkpoint inhibitors (ICI) was associated with improved outcomes in patients with SMARCA4-mutant tumors (P ¼ 0.01), with class 1 mutations having the best response to ICIs (P ¼ 0.027). Conclusions: SMARCA4 alterations can be divided into two clinically relevant genomic classes associated with differential protein expression as well as distinct prognostic and treatment implications. Both classes co-occur with KEAP1, STK11, and KRAS mutations, but individually represent independent predictors of poor prognosis. Despite association with poor outcomes, SMARCA4-mutant lung cancers may be more sensitive to immunotherapy.
- Published
- 2022
23. Targeting NFE2L2/KEAP1 Mutations in Advanced NSCLC With the TORC1/2 Inhibitor TAK-228.
- Author
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Paik, Paul K., Fan, Pang-Dian, Qeriqi, Besnik, Namakydoust, Azadeh, Daly, Bobby, Ahn, Linda, Kim, Rachel, Plodkowski, Andrew, Ni, Ai, Chang, Jason, Fanaroff, Rachel, Ladanyi, Marc, de Stanchina, Elisa, and Rudin, Charles M.
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- 2023
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24. COVID-19 in patients with lung cancer
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Alexander Drilon, David Hoyos, M. Offin, Jia Luo, Paul K. Paik, A. Iqbal, Chaitanya Bandlamudi, Kathryn C. Arbour, Matthew D. Hellmann, Marjorie G. Zauderer, Benjamin D. Greenbaum, Marta Łuksza, Mark T.A. Donoghue, Kenneth K.-S. Ng, Bob T. Li, R.M. Daly, Adam J. Schoenfeld, Hira Rizvi, Helena A. Yu, Isabel Ruth Preeshagul, Caroline G. McCarthy, Jamie E. Chaft, Charles M. Rudin, Gregory J Riely, Juliana Eng, Jacklynn V. Egger, Azadeh Namakydoust, W.V. Lai, Mark G. Kris, Christina Falcon, and Piro Lito
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Male ,0301 basic medicine ,Lung Neoplasms ,immunotherapy/ checkpoint blockade ,medicine.medical_treatment ,chemotherapy ,B7-H1 Antigen ,law.invention ,0302 clinical medicine ,law ,Intubation ,Aged, 80 and over ,Hematology ,Middle Aged ,Intensive care unit ,Hospitalization ,medicine.anatomical_structure ,Oncology ,030220 oncology & carcinogenesis ,Female ,Lung cancer ,Coronavirus Infections ,Hydroxychloroquine ,Adult ,medicine.medical_specialty ,Pneumonia, Viral ,macromolecular substances ,Article ,Betacoronavirus ,03 medical and health sciences ,Internal medicine ,medicine ,Humans ,Pandemics ,Aged ,Retrospective Studies ,Lung ,SARS-CoV-2 ,business.industry ,COVID-19 ,Cancer ,Retrospective cohort study ,Odds ratio ,medicine.disease ,Confidence interval ,COVID-19 Drug Treatment ,small molecule agents ,030104 developmental biology ,business ,Follow-Up Studies - Abstract
Structured Abstract Background Patients with lung cancers may have disproportionately severe COVID-19 outcomes. Understanding the patient-specific and cancer-specific features that impact severity of COVID-19 may inform optimal cancer care during this pandemic. Patients and methods We examined consecutive patients with lung cancer and confirmed diagnosis of COVID-19 (n=102) at a single center from March 12-May 6, 2020. Thresholds of severity were defined a priori as hospitalization, ICU/intubation/DNI (a composite metric of severe disease including ICU stay, intubation and invasive mechanical ventilation, and/or transition to do not intubate [DNI]), or death. Recovery was defined as >14 days from COVID-19 test and >3 days since symptom resolution. HLA alleles were inferred from MSK-IMPACT (n=46) and compared to controls with lung cancer and no known non-COVID-19 (n=5166). Results COVID-19 was severe in patients with lung cancer (62% hospitalized, 25% died). Although severe, COVID-19 accounted for a minority of overall lung cancer-deaths during the pandemic (11% overall). Determinants of COVID-19 severity were largely patient-specific features, including smoking status and chronic obstructive pulmonary disease (Odds ratios for severe COVID-19 2.9, 95% CI 1.07-9.44 comparing the median [23.5 pack-years] to never and 3.87, 95% CI 1.35-9.68, respectively). Cancer-specific features, including prior thoracic surgery/radiation and recent systemic therapies did not impact severity. HLA supertypes were generally similar in mild or severe cases of COVID-19 compared to non-COVID-19 controls. Most patients recovered from COVID-19, including 25% patients initially requiring intubation. Among hospitalized patients, hydroxychloroquine did not improve COVID-19 outcomes. Conclusion COVID-19 is associated with high burden of severity in patients with lung cancer. Patient-specific features, rather than cancer-specific features or treatments, are the greatest determinants of severity., Highlights • COVID-19 is associated with high burden of severity in patients with lung cancer. • Patient-specific features, rather than cancer-specific features or treatments, are the greatest determinants of severity.
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- 2020
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25. SMARCA4-Deficient Thoracic Sarcomatoid Tumors Represent Primarily Smoking-Related Undifferentiated Carcinomas Rather Than Primary Thoracic Sarcomas
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Mrinal M. Gounder, Ni Ai, Natasha Rekhtman, Joseph Montecalvo, Andrew J. Plodkowski, Patrice Desmeules, Amanda Beras, William D. Travis, Marc Ladanyi, Achim A. Jungbluth, Gregory J. Riely, Adam J. Schoenfeld, Justin A. Bishop, Azadeh Namakydoust, Bob T. Li, Deepu Alex, Charles M. Rudin, Jennifer L. Sauter, Brie Kezlarian, Ryan Ptashkin, Jason C. Chang, and David R. Jones
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0301 basic medicine ,Pulmonary and Respiratory Medicine ,Pathology ,medicine.medical_specialty ,Lung Neoplasms ,Thoracic ,Cell ,medicine.disease_cause ,Article ,03 medical and health sciences ,BRG1 ,0302 clinical medicine ,SMARCA4 ,Rhabdoid ,Biomarkers, Tumor ,Humans ,Medicine ,Lung ,Thoracic Neoplasm ,Mutation ,business.industry ,Lineage markers ,Carcinoma ,Smoking ,DNA Helicases ,Nuclear Proteins ,Sarcoma ,Thoracic Neoplasms ,Sarcomatoid ,030104 developmental biology ,medicine.anatomical_structure ,Oncology ,030220 oncology & carcinogenesis ,Immunohistochemistry ,Undifferentiated carcinoma ,business ,Transcription Factors - Abstract
Introduction: Highly aggressive thoracic neoplasms characterized by SMARCA4 (BRG1) deficiency and undifferentiated round cell or rhabdoid morphology have been recently described and proposed to represent thoracic sarcomas. However, it remains unclear whether such tumors may instead represent sarcomatoid carcinomas, and how their clinicopathologic characteristics compare with those of nonsarcomatoid SMARCA4-deficient non–small cell lung carcinomas (SD-NSCC). Methods: We identified 22 SMARCA4-deficient thoracic sarcomatoid tumors (SD-TSTs) with round cell and/or rhabdoid morphology and 45 SD-NSCCs, and comprehensively analyzed their clinicopathologic, immunohistochemical, and genomic characteristics using 341–468 gene next-generation sequencing and other molecular platforms. Results: The relationship of SD-TSTs with NSCC was supported by (1) the presence of NSCC components juxtaposed with sarcomatoid areas in five cases, (2) focal expression of NSCC lineage markers TTF1 or p40 in four additional cases, (3) smoking history in all except one patient (mean = 51 pack-years), accompanied by genomic smoking signature, and (4) high tumor mutation burden (mean = 14.2 mutations per megabase) and mutations characteristic of NSCC in a subset. Compared with SD-NSCCs, SD-TSTs exhibited considerably larger primary tumor size (p < 0.0001), worse survival (p = 0.004), and more frequent presentation at younger age (30–50 years) despite heavier smoking history. Distinctive pathologic features of SD-TSTs included consistent lack of adhesion molecule claudin-4, SMARCA2 (BRM) codeficiency, and frequent expression of stem cell markers. Conclusions: SD-TSTs represent primarily smoking-associated undifferentiated/de-differentiated carcinomas rather than primary thoracic sarcomas. Despite their histogenetic relationship with NSCC, these tumors have unique clinicopathologic characteristics, supporting their recognition as a distinct entity. Further studies are warranted to determine therapeutic approaches to this novel class of exceptionally aggressive thoracic tumors.
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- 2020
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26. Targeting NFE2L2/KEAP1 Mutations in Advanced NSCLC With the TORC1/2 Inhibitor TAK-228
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Paul K. Paik, Pang-Dian Fan, Besnik Qeriqi, Azadeh Namakydoust, Bobby Daly, Linda Ahn, Rachel Kim, Andrew Plodkowski, Ai Ni, Jason Chang, Rachel Fanaroff, Marc Ladanyi, Elisa de Stanchina, and Charles M. Rudin
- Subjects
Pulmonary and Respiratory Medicine ,Oncology - Abstract
Increased insight into the mutational landscape of squamous cell lung cancers (LUSCs) in the past decade has not translated into effective targeted therapies for patients with this disease. NRF2, encoded by NFE2L2, and its upstream regulator, KEAP1, control key aspects of redox balance and are frequently mutated in NSCLCs.Here, we describe the specific potent activity of TAK-228, a TORC1/2 inhibitor, in NSCLC models harboring NRF2-activating alterations and results of a phase 2 clinical trial of TAK-228 in patients with advanced NSCLC harboring NRF2-activating alterations including three cohorts (NFE2L2-mutated LUSC, KEAP1-mutated LUSC, KRAS/NFE2L2- or KEAP1-mutated NSCLC).TAK-228 was most efficacious in a LUSC cohort with NFE2L2 alterations; the overall response rate was 25% and median progression-free survival was 8.9 months. Additional data suggest that concurrent inhibition of glutaminase with the glutaminase inhibitor CB-839 might overcome metabolic resistance to therapy in these patients.TAK-228 has single-agent activity in patients with NRF2-activated LUSC. This study reframes oncogenic alterations as biologically relevant based on their downstream effects on metabolism. This trial represents, to the best of our knowledge, the first successful attempt at metabolically targeting NSCLC and identifies a promising targeted therapy for patients with LUSC, who are bereft of genotype-directed therapies.
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- 2022
27. Overall survival with circulating tumor DNA-guided therapy in advanced non-small-cell lung cancer
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Justin Jee, Emily S. Lebow, Randy Yeh, Jeeban P. Das, Azadeh Namakydoust, Paul K. Paik, Jamie E. Chaft, Gowtham Jayakumaran, A. Rose Brannon, Ryma Benayed, Ahmet Zehir, Mark Donoghue, Nikolaus Schultz, Debyani Chakravarty, Ritika Kundra, Ramyasree Madupuri, Yonina R. Murciano-Goroff, Hai-Yan Tu, Chong-Rui Xu, Andrés Martinez, Clare Wilhelm, Jesse Galle, Bobby Daly, Helena A. Yu, Michael Offin, Matthew D. Hellmann, Piro Lito, Kathryn C. Arbour, Marjorie G. Zauderer, Mark G. Kris, Kenneth K. Ng, Juliana Eng, Isabel Preeshagul, W. Victoria Lai, John J. Fiore, Afsheen Iqbal, Daniela Molena, Gaetano Rocco, Bernard J. Park, Lee P. Lim, Mark Li, Candace Tong-Li, Madhawa De Silva, David L. Chan, Connie I. Diakos, Malinda Itchins, Stephen Clarke, Nick Pavlakis, Adrian Lee, Natasha Rekhtman, Jason Chang, William D. Travis, Gregory J. Riely, David B. Solit, Mithat Gonen, Valerie W. Rusch, Andreas Rimner, Daniel Gomez, Alexander Drilon, Howard I. Scher, Sohrab P. Shah, Michael F. Berger, Maria E. Arcila, Marc Ladanyi, Ross L. Levine, Ronglai Shen, Pedram Razavi, Jorge S. Reis-Filho, David R. Jones, Charles M. Rudin, James M. Isbell, and Bob T. Li
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Lung Neoplasms ,Carcinoma, Non-Small-Cell Lung ,Mutation ,Biomarkers, Tumor ,Humans ,High-Throughput Nucleotide Sequencing ,General Medicine ,General Biochemistry, Genetics and Molecular Biology ,Circulating Tumor DNA - Abstract
Circulating tumor DNA (ctDNA) sequencing guides therapy decisions but has been studied mostly in small cohorts without sufficient follow-up to determine its influence on overall survival. We prospectively followed an international cohort of 1,127 patients with non-small-cell lung cancer and ctDNA-guided therapy. ctDNA detection was associated with shorter survival (hazard ratio (HR), 2.05; 95% confidence interval (CI), 1.74-2.42; P 0.001) independently of clinicopathologic features and metabolic tumor volume. Among the 722 (64%) patients with detectable ctDNA, 255 (23%) matched to targeted therapy by ctDNA sequencing had longer survival than those not treated with targeted therapy (HR, 0.63; 95% CI, 0.52-0.76; P 0.001). Genomic alterations in ctDNA not detected by time-matched tissue sequencing were found in 25% of the patients. These ctDNA-only alterations disproportionately featured subclonal drivers of resistance, including RICTOR and PIK3CA alterations, and were associated with short survival. Minimally invasive ctDNA profiling can identify heterogeneous drivers not captured in tissue sequencing and expand community access to life-prolonging therapy.
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- 2022
28. 1018P Phase I/II trial of rigosertib and nivolumab for KRAS mutated non-small cell lung cancer (NSCLC) patients
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R. Veluswamy, S. Bhalla, R. Samstein, T. Marron, J.E. Gomez, D.B. Doroshow, J. Sabari, E. Shum, A. Saxena, A. Namakydoust, A. Chachoua, J. Wisnivesky, J. Mandeli, N. Bhardwaj, F.R. Hirsch, M. Merad, and E. Reddy
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Oncology ,Hematology - Published
- 2022
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29. Final Analysis of Consolidative Use of Radiotherapy to Block (CURB) Oligoprogression Trial - A Randomized Study of Stereotactic Body Radiotherapy for Oligoprogressive Metastatic Lung and Breast Cancers
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C.J. Tsai, J.T. Yang, D.M. Guttmann, N. Shaverdian, J. Eng, R. Yeh, J. Girshman, J. Das, D. Gelblum, A.J. Xu, A. Namakydoust, A. Iqbal, J.M. Mann, I. Preeshagul, C. Hajj, E.F. Gillespie, S. Modi, C. Dang, P. Drullinsky, W. Zhi, Q. LaPlant, A. Rimner, J.Y. Shin, A.J. Wu, K. Ng, A. Gucalp, A.J. Khan, R. Sanford, J. Bromberg, A.D. Seidman, T.A. Traina, D.R. Gomez, J. Flynn, Z. Zhang, J.A. Patel, M. Berger, J.S. Reis-Filho, N.Y. Lee, N. Riaz, M.E. Robson, C.M. Rudin, and S.N. Powell
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Cancer Research ,Radiation ,Oncology ,Radiology, Nuclear Medicine and imaging - Published
- 2022
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30. Clinical utility of next-generation sequencing-based ctDNA testing for common and novel ALK fusions
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Alex Makhnin, David R. Jones, Hai-Yan Tu, Michael F. Berger, Charles M. Rudin, Pedram Razavi, Malinda Itchins, Bob T. Li, Michael Offin, Tristan Shaffer, Jorge S. Reis-Filho, Caterina Bertucci, Ryma Benayed, Sebastian Mondaca, Nick Pavlakis, Andres Martinez, Stephen Clarke, Gregory J. Riely, Chongrui Xu, James M. Isbell, Yonina R. Murciano-Goroff, Gaetano Rocco, Emily S. Lebow, Maria E. Arcila, Daniel R. Gomez, Seyed Ali Hosseini, Mark Li, Alexander Drilon, Lee P. Lim, Andreas Rimner, Adrian Lee, Azadeh Namakydoust, Jamie E. Chaft, and Ronglai Shen
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Pulmonary and Respiratory Medicine ,Cancer Research ,Treatment response ,Lung Neoplasms ,DNA sequencing ,Article ,Circulating Tumor DNA ,Acquired resistance ,Carcinoma, Non-Small-Cell Lung ,hemic and lymphatic diseases ,Humans ,Medicine ,Prospective Studies ,Liquid biopsy ,Lung cancer ,Aryldialkylphosphatase ,business.industry ,Breakpoint ,High-Throughput Nucleotide Sequencing ,Receptor Protein-Tyrosine Kinases ,medicine.disease ,Oncology ,Circulating tumor DNA ,Mutation ,Cancer research ,CLTC ,business - Abstract
OBJECTIVES: Liquid biopsy for plasma circulating tumor DNA (ctDNA) next-generation sequencing (NGS) can detect ALK fusions, though data on clinical utility of this technology in the real world is limited. MATERIALS AND METHODS: Patients with lung cancer without known oncogenic drivers or who had acquired resistance to therapy (n = 736) underwent prospective plasma ctDNA NGS. A subset of this cohort (n = 497) also had tissue NGS. We evaluated ALK fusion detection, turnaround time (TAT), plasma and tissue concordance, matching to therapy, and treatment response. RESULTS: ctDNA identified an ALK fusion in 21 patients (3%) with a variety of breakpoints and fusion partners, including EML4, CLTC, and PON1, a novel ALK fusion partner. TAT for ctDNA NGS was shorter than tissue NGS (10 vs. 20 days; p
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- 2021
31. Corrigendum to “Clinical utility of next-generation sequencing-based ctDNA testing for common and novel ALK fusions” [Lung Cancer 159 (2021) 66–73]
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Mondaca, Sebastian, primary, Lebow, Emily S., additional, Namakydoust, Azadeh, additional, Razavi, Pedram, additional, Reis-Filho, Jorge S., additional, Shen, Ronglai, additional, Offin, Michael, additional, Tu, Hai-Yan, additional, Murciano-Goroff, Yonina, additional, Xu, Chongrui, additional, Makhnin, Alex, additional, Martinez, Andres, additional, Pavlakis, Nick, additional, Clarke, Stephen, additional, Itchins, Malinda, additional, Lee, Adrian, additional, Rimner, Andreas, additional, Gomez, Daniel, additional, Rocco, Gaetano, additional, Chaft, Jamie E., additional, Riely, Gregory J., additional, Rudin, Charles M., additional, Jones, David R., additional, Li, Mark, additional, Shaffer, Tristan, additional, Hosseini, Seyed Ali, additional, Bertucci, Caterina, additional, Lim, Lee P., additional, Drilon, Alexander, additional, Berger, Michael F., additional, Benayed, Ryma, additional, Arcila, Maria E., additional, Isbell, James M., additional, and Li, Bob T., additional
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- 2021
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32. Consolidative Use of Radiotherapy to Block (CURB) Oligoprogression ― Interim Analysis of the First Randomized Study of Stereotactic Body Radiotherapy in Patients With Oligoprogressive Metastatic Cancers of the Lung and Breast
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Tsai, C.J., primary, Yang, J.T., additional, Guttmann, D.M., additional, Shaverdian, N., additional, Shepherd, A.F., additional, Eng, J., additional, Gelblum, D., additional, Xu, A.J., additional, Namakydoust, A., additional, Iqbal, A., additional, Mann, J.M., additional, Preeshagul, I., additional, Hajj, C., additional, Gillespie, E.F., additional, Sugarman, S., additional, Modi, S., additional, Dang, C., additional, Drullinsky, P., additional, Yeh, R., additional, Girshman, J., additional, Das, J., additional, Zhi, W., additional, LaPlant, Q., additional, Reyngold, M., additional, Rimner, A., additional, Shin, J.Y., additional, Wu, A.J., additional, Ng, K., additional, Gucalp, A., additional, Sanford, R., additional, Khan, A.J., additional, Bromberg, J., additional, Seidman, A.D., additional, Comen, E., additional, Traina, T.A., additional, Gomez, D.R., additional, Zhang, Z., additional, Robson, M.E., additional, Rudin, C.M., additional, and Powell, S.N., additional
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- 2021
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33. Targeting NFE2L2/KEAP1Mutations in Advanced NSCLC With the TORC1/2 Inhibitor TAK-228
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Paik, Paul K., Fan, Pang-Dian, Qeriqi, Besnik, Namakydoust, Azadeh, Daly, Bobby, Ahn, Linda, Kim, Rachel, Plodkowski, Andrew, Ni, Ai, Chang, Jason, Fanaroff, Rachel, Ladanyi, Marc, de Stanchina, Elisa, and Rudin, Charles M.
- Abstract
Increased insight into the mutational landscape of squamous cell lung cancers (LUSCs) in the past decade has not translated into effective targeted therapies for patients with this disease. NRF2, encoded by NFE2L2, and its upstream regulator, KEAP1, control key aspects of redox balance and are frequently mutated in NSCLCs.
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- 2023
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34. Lesion-Level Response Dynamics to Programmed Cell Death Protein (PD-1) Blockade
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Andrew J. Plodkowski, Dung T. Le, Juan C. Osorio, Jennifer N. Durham, Hira Rizvi, Helena A. Yu, Michelle S. Ginsberg, Gregory J. Riely, Jamie E. Chaft, Luis A. Diaz, Peter Sawan, Joseph G. Crompton, Azadeh Namakydoust, Kathryn C. Arbour, Matthew D. Hellmann, Darragh Halpenny, and Barzin Y. Nabet
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Adult ,Male ,0301 basic medicine ,Cancer Research ,Programmed cell death ,Lung Neoplasms ,Programmed Cell Death 1 Receptor ,Lesion ,03 medical and health sciences ,Antineoplastic Agents, Immunological ,0302 clinical medicine ,Text mining ,Carcinoma, Non-Small-Cell Lung ,Biology of Neoplasia ,Protein PD-1 ,Programmed cell death 1 ,Humans ,Medicine ,Aged ,Aged, 80 and over ,Antitumor immunity ,biology ,business.industry ,Middle Aged ,Blockade ,030104 developmental biology ,Oncology ,030220 oncology & carcinogenesis ,Disease Progression ,Cancer research ,biology.protein ,Female ,medicine.symptom ,business - Abstract
PURPOSE Response to programmed cell death protein 1 (PD-1) blockade is often conceptualized as resulting from reinvigoration of tumor-infiltrating lymphocytes. However, recruited antitumor immunity from the periphery may also be an important contributor to response. A detailed assessment of the response dynamics of individual metastasis could provide insight to the systemic and local features that mediate response and resistance to immunotherapy. MATERIALS AND METHODS Patients with metastatic non–small-cell lung cancer (NSCLC) or mismatch repair deficiency (MMRD) carcinoma treated with PD-1 monotherapy were evaluated independently. Absolute and percent change of each target lesion were quantified at each computed tomography scan using RECIST. Patterns of progression were predefined as systemic or mixed and were correlated with clinical outcomes. RESULTS A total of 761 individual lesions from 214 patients with NSCLC and 290 lesions from 78 patients with MMRD carcinoma were examined. Individual target lesion responses aligned with best overall response of each patient (85% NSCLC and 93% MMRD lesions responded in patients with partial response/complete response). In responding patients, timing of response was uniform (73% NSCLC and 76% MMRD lesions responded synchronously), and deeper responses were associated with prolonged progression-free survival and overall survival. By contrast, at progression, mixed progression was common (45% of NSCLC and 53% of MMRD) and associated with improved survival compared with those who experienced systemic progression (NSCLC hazard ratio [HR], 0.58; P = .001; MMRD HR, 0.40; P = .07). Organ sites had differential responses, with lymph node and liver metastasis among the most and least responsive, respectively. CONCLUSION Temporal-spatial patterns of response across individual metastases tend to be uniform, favoring the role of peripheral, clonally directed antitumor immunity as a key mediator of response to PD-1 blockade. In contrast, progression is more heterogeneous, potentially revealing the clinical importance of local features and intertumoral heterogeneity.
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- 2019
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35. Consolidative Use of Radiotherapy to Block (CURB) Oligoprogression ― Interim Analysis of the First Randomized Study of Stereotactic Body Radiotherapy in Patients With Oligoprogressive Metastatic Cancers of the Lung and Breast
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Chau T. Dang, J. Das, J. Bromberg, Quincey LaPlant, Atif J. Khan, Daniel R. Gomez, D.M. Guttmann, Annemarie F. Shepherd, Tiffany A. Traina, Steven Sugarman, Charles M. Rudin, Isabel Ruth Preeshagul, C.J. Tsai, J.M. Mann, Erin F. Gillespie, Shanu Modi, Carla Hajj, Elizabeth A. Comen, Rachel Ann Sanford, M.E. Robson, Wanqing Iris Zhi, Marsha Reyngold, Pamela Drullinsky, A. Iqbal, A.J. Xu, Ayca Gucalp, Jeffrey Girshman, Azadeh Namakydoust, Kenneth K.-S. Ng, Narek Shaverdian, R. Yeh, J.T. Yang, Zhigang Zhang, Simon N. Powell, Daphna Y. Gelblum, Juliana Eng, J.Y. Shin, Andreas Rimner, Andrew D. Seidman, and Abraham J. Wu
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Oncology ,Cancer Research ,medicine.medical_specialty ,Radiation ,business.industry ,medicine.medical_treatment ,Cancer ,medicine.disease ,Interim analysis ,Primary tumor ,Radiation therapy ,Breast cancer ,Internal medicine ,Clinical endpoint ,medicine ,Radiology, Nuclear Medicine and imaging ,Lung cancer ,business ,Tumor marker - Abstract
Purpose/Objective(s) We hypothesize that there is an oligoprogressive state in metastatic cancer, in which disease control can be improved with local therapy to progressive lesions only. This study therefore evaluated the impact of stereotactic body radiotherapy (SBRT) to sites of oligoprogression in patients with metastatic non-small-cell lung cancer (NSCLC) and breast cancer with 1-5 progressive lesions. Materials/Methods We enrolled patients with metastatic NSCLC or breast cancer who received ≥ 1 line of systemic therapy and had oligoprogressive lesions amenable to SBRT. There was no upper limit of non-progressive lesions. Oligoprogression was defined as Response Evaluation or Positron Emission Tomography Response Criteria in Solid Tumors documented progression ≤ 5 individual lesions. Stratification factors included number of progressive sites (1 vs. 2-5), prior systemic therapy (immunotherapy vs. other), primary tumor (NSCLC vs. breast), and tumor marker status (driver mutation and hormone receptor status). Patients were randomized 1:1 between SBRT to all progressive sites plus palliative standard of care (SOC) vs. palliative SOC only. Systemic therapy was per physician's discretion. The primary endpoint was progression-free survival (PFS). We used a randomized phase II design with a one-sided alpha of 0.05 and a power of 0.80, yielding a target accrual of 160 patients. PFS was compared using one-sided stratified log-rank test. One interim analysis was planned. Results From January 2019 to May 2021, 102 patients were randomized - 58 NSCLC (30 in the SBRT arm) and 44 breast (22 in each arm). Median age was 67. Most patients (75%) had > 1 site of oligoprogression and 47% had > 5 total metastatic lesions. Fifty-five (54%) patients received immunotherapy. The majority of NSCLC (86%) did not harbor an actionable driver mutation and 32% of breast cancer were triple negative. Baseline factors were balanced between arms. At a median follow-up of 51 weeks, 71 patients progressed and 30 died. Median PFS was 22 weeks in the SBRT arm vs. 10 weeks in the palliative SOC arm (p=0.005). This was driven entirely by the PFS benefit from SBRT in the NSCLC patients (44 weeks with SBRT vs. 9 weeks with SOC; p=0.004). No difference in median PFS was seen in the breast cohort (18 weeks with SBRT vs. 17 weeks with SOC; p=0.5). In multivariable Cox model inclusive of stratification factors, age, sex, lines of systemic therapy, and change of systemic therapy, the PFS benefit of SBRT remained substantial in the NSCLC cohort (Hazard Ratio: 0.38; 95% CI: 0.18-77; p=0.007). Grade ≥2 adverse events occurred in 8 patients in the SBRT arm, including 1 grade 3 pneumonitis. Conclusion Inthis pre-planned interim analysis of the first and largest randomized trial of radiotherapy for oligoprogressive metastatic NSCLC and breast cancer, we demonstrated the benefit of SBRT to sites of oligoprogression on overall PFS, meeting the primary endpoint. The mechanism of the differential benefits between NSCLC and breast cohorts merits further evaluation.
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- 2021
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36. The Genomic Landscape of SMARCA4 Alterations and Associations with Outcomes in Patients with Lung Cancer
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Schoenfeld, Adam J, Bandlamudi, Chai, Lavery, Jessica A, Montecalvo, Joseph, Namakydoust, Azadeh, Rizvi, Hira, Egger, Jacklynn, Concepcion, Carla P, Paul, Sonal, Arcila, Maria E, Daneshbod, Yahya, Chang, Jason, Sauter, Jennifer L, Beras, Amanda, Ladanyi, Marc, Jacks, Tyler, Rudin, Charles M, Taylor, Barry S, Donoghue, Mark TA, Heller, Glenn, Hellmann, Matthew D, Rekhtman, Natasha, Riely, Gregory J, Schoenfeld, Adam J, Bandlamudi, Chai, Lavery, Jessica A, Montecalvo, Joseph, Namakydoust, Azadeh, Rizvi, Hira, Egger, Jacklynn, Concepcion, Carla P, Paul, Sonal, Arcila, Maria E, Daneshbod, Yahya, Chang, Jason, Sauter, Jennifer L, Beras, Amanda, Ladanyi, Marc, Jacks, Tyler, Rudin, Charles M, Taylor, Barry S, Donoghue, Mark TA, Heller, Glenn, Hellmann, Matthew D, Rekhtman, Natasha, and Riely, Gregory J
- Abstract
Purpose: SMARCA4 mutations are among the most common recurrent alterations in non-small cell lung cancer (NSCLC), but the relationship to other genomic abnormalities and clinical impact has not been established. Experimental Design: To characterize SMARCA4 alterations in NSCLC, we analyzed the genomic, protein expression, and clinical outcome data of patients with SMARCA4 alterations treated at Memorial Sloan Kettering. Results: In 4,813 tumors from patients with NSCLC, we identified 8% (n ¼ 407) of patients with SMARCA4-mutant lung cancer. We describe two categories of SMARCA4 mutations: class 1 mutations (truncating mutations, fusions, and homozygous deletion) and class 2 mutations (missense mutations). Protein expression loss was associated with class 1 mutation (81% vs. 0%, P < 0.001). Both classes of mutation co-occurred more frequently with KRAS, STK11, and KEAP1 mutations compared with SMARCA4 wild-type tumors (P < 0.001). In patients with metastatic NSCLC, SMARCA4 alterations were associated with shorter overall survival, with class 1 alterations associated with shortest survival times (P < 0.001). Conversely, we found that treatment with immune checkpoint inhibitors (ICI) was associated with improved outcomes in patients with SMARCA4-mutant tumors (P ¼ 0.01), with class 1 mutations having the best response to ICIs (P ¼ 0.027). Conclusions: SMARCA4 alterations can be divided into two clinically relevant genomic classes associated with differential protein expression as well as distinct prognostic and treatment implications. Both classes co-occur with KEAP1, STK11, and KRAS mutations, but individually represent independent predictors of poor prognosis. Despite association with poor outcomes, SMARCA4-mutant lung cancers may be more sensitive to immunotherapy.
- Published
- 2021
37. Overall survival with circulating tumor DNA-guided therapy in advanced non-small cell lung cancer.
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Jee, Justin, primary, Lebow, Emily S., additional, Murciano-Goroff, Yonina R., additional, Jayakumaran, Gowtham, additional, Shen, Ronglai, additional, Brannon, Angela Rose, additional, Benayed, Ryma, additional, Namakydoust, Azadeh, additional, Offin, Michael, additional, Paik, Paul K., additional, Yu, Helena Alexandra, additional, Donoghue, Mark, additional, Zehir, Ahmet, additional, Drilon, Alexander E., additional, Solit, David B., additional, Jones, David Randolph, additional, Rudin, Charles M., additional, Berger, Michael F., additional, Isbell, James M., additional, and Li, Bob T., additional
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- 2021
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38. The Genomic Landscape of
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Adam J, Schoenfeld, Chai, Bandlamudi, Jessica A, Lavery, Joseph, Montecalvo, Azadeh, Namakydoust, Hira, Rizvi, Jacklynn, Egger, Carla P, Concepcion, Sonal, Paul, Maria E, Arcila, Yahya, Daneshbod, Jason, Chang, Jennifer L, Sauter, Amanda, Beras, Marc, Ladanyi, Tyler, Jacks, Charles M, Rudin, Barry S, Taylor, Mark T A, Donoghue, Glenn, Heller, Matthew D, Hellmann, Natasha, Rekhtman, and Gregory J, Riely
- Subjects
Male ,Kelch-Like ECH-Associated Protein 1 ,Genome, Human ,DNA Helicases ,Nuclear Proteins ,Genomics ,Middle Aged ,Protein Serine-Threonine Kinases ,Prognosis ,Disease-Free Survival ,Article ,Gene Expression Regulation, Neoplastic ,Proto-Oncogene Proteins p21(ras) ,Treatment Outcome ,AMP-Activated Protein Kinase Kinases ,Carcinoma, Non-Small-Cell Lung ,Mutation ,Humans ,Female ,Immunotherapy ,Aged ,Transcription Factors - Abstract
PURPOSE: SMARCA4 mutations are among the most common recurrent alterations in NSCLC, but the relationship to other genomic abnormalities and clinical impact has not been established. EXPERIMENTAL DESIGN: To characterize SMARCA4 alterations in NSCLC, we analyzed the genomic, protein expression, and clinical outcome data of patients with SMARCA4 alterations treated at Memorial Sloan Kettering. RESULTS: In 4813 tumors from patients with NSCLC, we identified 8% (n= 407) patients with SMARCA4-mutant lung cancer. We describe two categories of SMARCA4 mutations: Class 1 mutations (truncating mutations, fusions and homozygous deletion) and Class 2 mutations (missense mutations). Protein expression loss was associated with Class 1 mutation (81% vs 0%, (P < 0.001)). Both classes of mutation co-occured more frequently with KRAS, STK11, and KEAP1 mutations compared to SMARCA4 wildtype tumors (P < 0.001). In patients with metastatic NSCLC, SMARCA4 alterations were associated with shorter overall survival, with Class 1 alterations associated with shortest survival times (P < 0.001). Conversely, we found that treatment with immune checkpoint inhibitors was associated with improved outcomes in patients with SMARCA4-mutant tumors (P = 0.01), with Class 1 mutations having the best response to ICIs (p = 0.027). CONCLUSIONS: SMARCA4 alterations can be divided into two clinically relevant genomic classes associated with differential protein expression as well as distinct prognostic and treatment implications. Both classes co-occur with KEAP1, STK11, and KRAS mutations, but individually represent independent predictors of poor prognosis. Despite association with poor outcomes, SMARCA4-mutant lung cancers may be more sensitive to immunotherapy.
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- 2020
39. The Genomic Landscape of SMARCA4 Alterations and Associations with Outcomes in Patients with Lung Cancer
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Tyler Jacks, Maria E. Arcila, Jason C. Chang, Jessica A. Lavery, Jacklynn V. Egger, Carla P. Concepcion, Matthew D. Hellmann, Chaitanya Bandlamudi, Amanda Beras, Jennifer L. Sauter, Gregory J. Riely, Glenn Heller, Barry S. Taylor, Adam J. Schoenfeld, Marc Ladanyi, Yahya Daneshbod, Mark T.A. Donoghue, Joseph Montecalvo, Hira Rizvi, Natasha Rekhtman, Charles M. Rudin, Sonal Paul, and Azadeh Namakydoust
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0301 basic medicine ,Oncology ,Cancer Research ,medicine.medical_specialty ,Mutation ,Lung ,business.industry ,medicine.medical_treatment ,STK11 ,Immunotherapy ,medicine.disease_cause ,medicine.disease ,03 medical and health sciences ,030104 developmental biology ,0302 clinical medicine ,medicine.anatomical_structure ,030220 oncology & carcinogenesis ,Internal medicine ,medicine ,SMARCA4 ,Missense mutation ,KRAS ,business ,Lung cancer - Abstract
Purpose: SMARCA4 mutations are among the most common recurrent alterations in non–small cell lung cancer (NSCLC), but the relationship to other genomic abnormalities and clinical impact has not been established. Experimental Design: To characterize SMARCA4 alterations in NSCLC, we analyzed the genomic, protein expression, and clinical outcome data of patients with SMARCA4 alterations treated at Memorial Sloan Kettering. Results: In 4,813 tumors from patients with NSCLC, we identified 8% (n = 407) of patients with SMARCA4-mutant lung cancer. We describe two categories of SMARCA4 mutations: class 1 mutations (truncating mutations, fusions, and homozygous deletion) and class 2 mutations (missense mutations). Protein expression loss was associated with class 1 mutation (81% vs. 0%, P < 0.001). Both classes of mutation co-occurred more frequently with KRAS, STK11, and KEAP1 mutations compared with SMARCA4 wild-type tumors (P < 0.001). In patients with metastatic NSCLC, SMARCA4 alterations were associated with shorter overall survival, with class 1 alterations associated with shortest survival times (P < 0.001). Conversely, we found that treatment with immune checkpoint inhibitors (ICI) was associated with improved outcomes in patients with SMARCA4-mutant tumors (P = 0.01), with class 1 mutations having the best response to ICIs (P = 0.027). Conclusions: SMARCA4 alterations can be divided into two clinically relevant genomic classes associated with differential protein expression as well as distinct prognostic and treatment implications. Both classes co-occur with KEAP1, STK11, and KRAS mutations, but individually represent independent predictors of poor prognosis. Despite association with poor outcomes, SMARCA4-mutant lung cancers may be more sensitive to immunotherapy.
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- 2020
40. MA06.08 A Safety Study of Avelumab plus SBRT in Malignant Mesothelioma
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Rimner, A., primary, Yorke, E., additional, Gelblum, D., additional, Shepherd, A., additional, Guttmann, D., additional, Iqbal, A., additional, Daly, R., additional, Offin, M., additional, Fiore, J., additional, Namakydoust, A., additional, Li, H., additional, Mccune, M., additional, Gelb, E., additional, Taunk, N., additional, Von Reibnitz, D., additional, Adusumilli, P., additional, Center, M.S.K., additional, and Zauderer, M., additional
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- 2021
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41. 169P Phase I dose escalation trial combining olaparib and thoracic radiation therapy in extensive-stage small cell lung cancer
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Rimner, A., Lok, B., Gelblum, D.Y., Kotecha, R.R., Albrecht, F., Shin, J.Y., Laplant, Q., Namakydoust, A., Shepherd, A., Gomez, D., Shaverdian, N., Wu, A., Simone, C.B., Yu, H.A., Ng, K., Daly, R., Offin, M.D., Ginsberg, M., Zhang, Z., and Rudin, C.M.
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- 2023
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42. Corrigendum to 'Clinical utility of next-generation sequencing-based ctDNA testing for common and novel ALK fusions' [Lung Cancer 159 (2021) 66–73]
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Jamie E. Chaft, Yonina R. Murciano-Goroff, Stephen Clarke, Daniel R. Gomez, Malinda Itchins, Ronglai Shen, Seyed Ali Hosseini, Gregory J. Riely, Chongrui Xu, Ryma Benayed, Emily S. Lebow, Hai-Yan Tu, Charles M. Rudin, Michael F. Berger, Maria E. Arcila, Lee P. Lim, David R. Jones, Jorge S. Reis-Filho, Andreas Rimner, Andres Martinez, Alex Makhnin, Caterina Bertucci, Sebastian Mondaca, Mark Li, Pedram Razavi, Tristan Shaffer, Adrian Lee, Azadeh Namakydoust, Nick Pavlakis, James M. Isbell, Michael Offin, Bob T. Li, Gaetano Rocco, and Alexander Drilon
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Pulmonary and Respiratory Medicine ,Cancer Research ,Oncology ,business.industry ,medicine ,MEDLINE ,Computational biology ,Lung cancer ,medicine.disease ,business ,DNA sequencing - Published
- 2021
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43. The Genomic Landscape of SMARCA4 Alterations and Associations with Outcomes in Patients with Lung Cancer
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Schoenfeld, Adam J., primary, Bandlamudi, Chai, additional, Lavery, Jessica A., additional, Montecalvo, Joseph, additional, Namakydoust, Azadeh, additional, Rizvi, Hira, additional, Egger, Jacklynn, additional, Concepcion, Carla P., additional, Paul, Sonal, additional, Arcila, Maria E., additional, Daneshbod, Yahya, additional, Chang, Jason, additional, Sauter, Jennifer L., additional, Beras, Amanda, additional, Ladanyi, Marc, additional, Jacks, Tyler, additional, Rudin, Charles M., additional, Taylor, Barry S., additional, Donoghue, Mark T.A., additional, Heller, Glenn, additional, Hellmann, Matthew D., additional, Rekhtman, Natasha, additional, and Riely, Gregory J., additional
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- 2020
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44. A07 The Genomic Landscape of SMARCA4 Alterations and Association with Patient Outcomes in Lung Cancer
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Schoenfeld, A.J., primary, Montecalvo, J., additional, Namakydoust, A., additional, Lavery, J., additional, Bandlamudi, C., additional, Rizvi, H., additional, Paul, S., additional, Arcila, M., additional, Chang, J., additional, Sauter, J., additional, Beras, A., additional, Ladanyi, M., additional, Taylor, B., additional, Donoghue, M., additional, Heller, G., additional, Hellmann, M., additional, Rekhtman, N., additional, and Riely, G., additional
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- 2020
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45. Overall survival with circulating tumor DNA-guided therapy in advanced non-small cell lung cancer
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Charles M. Rudin, Mark T.A. Donoghue, Paul K. Paik, Michael F. Berger, James M. Isbell, Michael Offin, Angela Rose Brannon, Ryma Benayed, Gowtham Jayakumaran, Bob T. Li, David B. Solit, David R. Jones, Azadeh Namakydoust, Yonina R. Murciano-Goroff, Emily S. Lebow, Alexander Drilon, Ahmet Zehir, Ronglai Shen, Helena Alexandra Yu, and Justin Jee
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Oncology ,Cancer Research ,medicine.medical_specialty ,business.industry ,Circulating tumor DNA ,Internal medicine ,medicine ,Overall survival ,Non small cell ,business ,Lung cancer ,medicine.disease - Abstract
9009 Background: The effectiveness of circulating tumor DNA (ctDNA) at matching patients to life prolonging therapy has been studied mostly in small cohorts with limited follow up. The prognostic value of ctDNA alterations, particularly those absent on tissue, is also unclear. To address these questions, we studied survival outcomes in a prospective cohort of patients (N = 1002) with non-small cell lung cancer (NSCLC). Methods: Adults with metastatic or recurrent NSCLC were eligible if they had no known driver mutation or a known driver with progression following targeted therapy. Patients were enrolled at Memorial Sloan Kettering Cancer Center (New York, NY) starting October 21, 2016; analysis here is from a snapshot November 1, 2020. All patients had ctDNA sequenced via the Resolution ctDx Lung platform. To reduce inclusion of incidental germline mutations, we excluded non-functionally significant mutations with an allele frequency 35-65% that were present in gnomAD. Patients could also receive, at their provider’s discretion, tissue sequencing with MSK-IMPACT, which filters germline and clonal hematopoietic (CH) mutations with matched white blood cell sequencing. We performed survival analyses using Cox proportional hazards models from time of diagnosis of advanced disease to death, left truncating at time of study entry. Results: Of 1002 patients, 348 (35%) were treated with targeted therapy; in 181 of these (52%) the targetable alteration was detected in ctDNA. Patients treated with targeted therapy had prolonged survival whether matched by tissue-based methods (HR 0.39, 95%CI 0.30-0.51) or ctDNA (HR 0.47, 95%CI 0.37-0.61). These benefits persisted across multiple subgroups. ctDNA alterations themselves were associated with worse survival (HR 2.2, 95%CI 1.8-2.8), in a manner that scaled with allele fraction and burden. Of 401 patients with time-matched tissue sampling, 62 (15%) had ctDNA alterations that were absent on IMPACT (“unique” ctDNA alterations). Three such patients had unique ctDNA EGFR T790M mutations leading to changes in therapy. However, unique ctDNA alterations were generally associated with worse survival than no ctDNA alterations (HR 2.5, 95%CI 1.7-3.7) and even tissue-matched ctDNA alterations (HR 1.7, 95%CI 1.1-2.4). Of 98 unique ctDNA mutations, 48 (49%) were detectable in tissue at subthreshold levels, 12 (12%) were filtered by IMPACT as CH or germline, and 38 mutations (39%) were absent even at subthreshold levels. ctDNA alteration burden correlated with radiographic disease extent. In multivariate models with radiographic disease extent and other clinical variables, ctDNA alterations were the strongest independent predictor of worse survival. Conclusions: Our results show that ctDNA may match patients to life-prolonging targeted therapy and have prognostic importance. ctDNA may provide data about a patient’s cancer missed by spatially restricted tissue sequencing. Clinical trial information: NCT01775072.
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- 2021
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46. MA06.08 A Safety Study of Avelumab plus SBRT in Malignant Mesothelioma
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A. Rimner, E. Yorke, D. Gelblum, A. Shepherd, D. Guttmann, A. Iqbal, R. Daly, M. Offin, J. Fiore, A. Namakydoust, H. Li, M. Mccune, E. Gelb, N. Taunk, D. Von Reibnitz, P. Adusumilli, M.S.K. Center, and M. Zauderer
- Subjects
Pulmonary and Respiratory Medicine ,Oncology ,Avelumab ,medicine.medical_specialty ,business.industry ,Internal medicine ,Medicine ,Mesothelioma ,business ,medicine.disease ,medicine.drug - Published
- 2021
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- View/download PDF
47. A07 The Genomic Landscape of SMARCA4 Alterations and Association with Patient Outcomes in Lung Cancer
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Jason C. Chang, Matthew D. Hellmann, Azadeh Namakydoust, Hira Rizvi, G. J. Riely, Chaitanya Bandlamudi, Maria E. Arcila, B.S. Taylor, S. Paul, Adam J. Schoenfeld, Amanda Beras, G. Heller, M. Ladanyi, M. Donoghue, J. Lavery, Natasha Rekhtman, Joseph Montecalvo, and Jennifer L. Sauter
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Pulmonary and Respiratory Medicine ,Oncology ,medicine.medical_specialty ,business.industry ,Association (object-oriented programming) ,Internal medicine ,SMARCA4 ,medicine ,business ,Lung cancer ,medicine.disease - Published
- 2020
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48. Lesion-Level Response Dynamics to Programmed Cell Death Protein (PD-1) Blockade
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Osorio, Juan C., primary, Arbour, Kathryn C., additional, Le, Dung T., additional, Durham, Jennifer N., additional, Plodkowski, Andrew J., additional, Halpenny, Darragh F., additional, Ginsberg, Michelle S., additional, Sawan, Peter, additional, Crompton, Joseph G., additional, Yu, Helena A., additional, Namakydoust, Azadeh, additional, Nabet, Barzin Y., additional, Chaft, Jamie E., additional, Riely, Gregory J., additional, Rizvi, Hira, additional, Diaz, Luis A., additional, and Hellmann, Matthew D., additional
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- 2019
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49. P1.01-122 A Clinical Utility Study of Plasma DNA Next Generation Sequencing Guided Treatment of Uncommon Drivers in Advanced Non-Small-Cell Lung Cancers
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Tu, H., primary, Xu, C., additional, Tong-Li, C., additional, Offin, M., additional, Razavi, P., additional, Schapira, E., additional, Namakydoust, A., additional, Lee, A., additional, Pavlakis, N., additional, Clarke, S., additional, Diakos, C., additional, Chan, D., additional, Myers, M., additional, Makhnin, A., additional, Jain, H., additional, Martinez, A., additional, Iqbal, Z., additional, Adamski, A., additional, Li, H., additional, Hernandez, J., additional, Watford, S., additional, Hosseini, A., additional, Shaffer, T., additional, Lim, L., additional, Li, M., additional, Drilon, A., additional, Ladanyi, M., additional, Arcila, M., additional, Rusch, V., additional, Jones, D., additional, Rudin, C., additional, Rimner, A., additional, Isbell, J., additional, and Li, B., additional
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- 2019
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50. P1.01-122 A Clinical Utility Study of Plasma DNA Next Generation Sequencing Guided Treatment of Uncommon Drivers in Advanced Non-Small-Cell Lung Cancers
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M. Ladanyi, Z. Iqbal, Alex Makhnin, Mackenzie L. Myers, Adrian Lee, Azadeh Namakydoust, Maria E. Arcila, Michael Offin, H. Jain, Stephen Clarke, Connie I. Diakos, Andres Martinez, Jennifer Hernandez, E. Schapira, David Chan, Chongrui Xu, S. Watford, Pedram Razavi, David R. Jones, H. Li, Mark Li, A. Hosseini, Tristan Shaffer, James M. Isbell, Ariana Adamski, Charles M. Rudin, Hai-Yan Tu, Lee P. Lim, Andreas Rimner, C. Tong-Li, A. Drilon, Bob T. Li, V. Rusch, and Nick Pavlakis
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Pulmonary and Respiratory Medicine ,Lung ,medicine.anatomical_structure ,Oncology ,business.industry ,Plasma dna ,Cancer research ,Medicine ,Non small cell ,business ,DNA sequencing - Published
- 2019
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