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1. Superior antitumor immune response achieved with proton over photon immunoradiotherapy is amplified by the nanoradioenhancer NBTXR3

Author

Hu, Yun, Paris, Sébastien, Sahoo, Narayan, Wang, Qi, Wang, Qianxia, Barsoumian, Hampartsoum B., Huang, Ailing, Da Silva, Jordan, Bienassis, Célia, Leyton, Claudia S. Kettlun, Voss, Tiffany A., Masrorpour, Fatemeh, Riad, Thomas, Leuschner, Carola, Puebla-Osorio, Nahum, Gandhi, Saumil, Nguyen, Quynh-Nhu, Wang, Jing, Cortez, Maria Angelica, and Welsh, James W.

Published
2024
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5. Inhibition of MER proto-oncogene tyrosine kinase by an antisense oligonucleotide enhances treatment efficacy of immunoradiotherapy

Author

Hu, Yun, Revenko, Alexey, Barsoumian, Hampartsoum, Bertolet, Genevieve, Fowlkes, Natalie Wall, Maazi, Hadi, Green, Morgan Maureen, He, Kewen, Sezen, Duygu, Voss, Tiffany A., Leyton, Claudia S Kettlun, Masrorpour, Fatemeh, Rafiq, Zahid, Puebla-Osorio, Nahum, Leuschner, Carola, MacLeod, Robert, Cortez, Maria Angelica, and Welsh, James W.

Published
2024
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7. Survival outcomes and toxicity of adjuvant immunotherapy after definitive concurrent chemotherapy with proton beam radiation therapy for patients with inoperable locally advanced non-small cell lung carcinoma

Author

Corrigan, Kelsey L., Xu, Ting, Sasaki, Yuki, Lin, Ruitao, Chen, Aileen B., Welsh, James W., Lin, Steven H., Chang, Joe Y., Ning, Matthew S., Gandhi, Saumil, O'Reilly, Michael S., Gay, Carl M., Altan, Mehmet, Lu, Charles, Cascone, Tina, Koutroumpakis, Efstratios, Sheshadri, Ajay, Zhang, Xiaodong, Liao, Li, Zhu, X. Ronald, Heymach, John V., Nguyen, Quynh-Nhu, and Liao, Zhongxing

Published
2024
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9. Stereotactic ablative radiotherapy with or without immunotherapy for early-stage or isolated lung parenchymal recurrent node-negative non-small-cell lung cancer: an open-label, randomised, phase 2 trial

Author

Chang, Joe Y, Lin, Steven H, Dong, Wenli, Liao, Zhongxing, Gandhi, Saumil J, Gay, Carl M, Zhang, Jianjun, Chun, Stephen G, Elamin, Yasir Y, Fossella, Frank V, Blumenschein, George, Cascone, Tina, Le, Xiuning, Pozadzides, Jenny V, Tsao, Anne, Verma, Vivek, Welsh, James W, Chen, Aileen B, Altan, Mehmet, Mehran, Reza J, Vaporciyan, Ara A, Swisher, Stephen G, Balter, Peter A, Fujimoto, Junya, Wistuba, Ignacio I, Feng, Lei, Lee, J Jack, and Heymach, John V

Published
2023
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10. Safety and clinical activity of intratumoral MEDI9197 alone and in combination with durvalumab and/or palliative radiation therapy in patients with advanced solid tumors.

Author

Siu, Lillian, Brody, Joshua, Gupta, Shilpa, Marabelle, Aurélien, Jimeno, Antonio, Munster, Pamela, Grilley-Olson, Juneko, Rook, Alain H, Hollebecque, Antoine, Wong, Rebecca KS, Welsh, James W, Wu, Yuling, Morehouse, Christopher, Hamid, Oday, Walcott, Farzana, Cooper, Zachary A, Kumar, Rakesh, Ferté, Charles, and Hong, David S

Subjects
CD8-positive t-lymphocytes, Th1-Th2 balance, combination, drug therapy, immunotherapy, radioimmunotherapy
Abstract

BackgroundMEDI9197 is an intratumorally administered toll-like receptor 7 and 8 agonist. In mice, MEDI9197 modulated antitumor immune responses, inhibited tumor growth and increased survival. This first-time-in-human, phase 1 study evaluated MEDI9197 with or without the programmed cell death ligand-1 (PD-L1) inhibitor durvalumab and/or palliative radiation therapy (RT) for advanced solid tumors.Patients and methodsEligible patients had at least one cutaneous, subcutaneous, or deep-seated lesion suitable for intratumoral (IT) injection. Dose escalation used a standard 3+3 design. Patients received IT MEDI9197 0.005-0.055 mg with or without RT (part 1), or IT MEDI9197 0.005 or 0.012 mg plus durvalumab 1500 mg intravenous with or without RT (part 3), in 4-week cycles. Primary endpoints were safety and tolerability. Secondary endpoints included pharmacokinetics, pharmacodynamics, and objective response based on Response Evaluation Criteria for Solid Tumors version 1.1. Exploratory endpoints included tumor and peripheral biomarkers that correlate with biological activity or predict response.ResultsFrom November 2015 to March 2018, part 1 enrolled 35 patients and part 3 enrolled 17 patients; five in part 1 and 2 in part 3 received RT. The maximum tolerated dose of MEDI9197 monotherapy was 0.037 mg, with dose-limiting toxicity (DLT) of cytokine release syndrome in two patients (one grade 3, one grade 4) and 0.012 mg in combination with durvalumab 1500 mg with DLT of MEDI9197-related hemorrhagic shock in one patient (grade 5) following liver metastasis rupture after two cycles of MEDI9197. Across parts 1 and 3, the most frequent MEDI9197-related adverse events (AEs) of any grade were fever (56%), fatigue (31%), and nausea (21%). The most frequent MEDI9197-related grade ≥3 events were decreased lymphocytes (15%), neutrophils (10%), and white cell counts (10%). MEDI9197 increased tumoral CD8+ and PD-L1+ cells, inducing type 1 and 2 interferons and Th1 response. There were no objective clinical responses; 10 patients in part 1 and 3 patients in part 3 had stable disease ≥8 weeks.ConclusionIT MEDI9197 was feasible for subcutaneous/cutaneous lesions but AEs precluded its use in deep-seated lesions. Although no patients responded, MEDI9197 induced systemic and intratumoral immune activation, indicating potential value in combination regimens in other patient populations.Trial registration numberNCT02556463.

Published
2020

13. Salvage Reirradiation with Proton Beam Therapy for Locoregionally Recurrent Non-Small Cell Lung Cancer.

Author

Ning, Matthew S., Odwuor, Abigael, Chang, Joe Y., Gandhi, Saumil, Liao, Zhongxing, Lin, Steven H., Chen, Aileen, Welsh, James W., Nguyen, Quynh-Nhu, O'Reilly, Michael S., Chun, Stephen G., Bronk, Julianna, Qian, David, and Lee, Percy

Subjects
PROTON therapy, CANCER relapse, SALVAGE therapy, LOGISTIC regression analysis, TREATMENT effectiveness, DESCRIPTIVE statistics, MANN Whitney U Test, RETROSPECTIVE studies, KAPLAN-Meier estimator, LUNG cancer, DATA analysis software, CONFIDENCE intervals, PROPORTIONAL hazards models
Abstract

Simple Summary: Roughly 25% of non-small cell lung cancer (NSCLC) patients subsequently experience isolated locoregional recurrence following definitive radiation therapy (RT). For these scenarios, thoracic reirradiation (re-RT) has become an increasingly common consideration, with improved feasibility due to technological advancements that have made it safer to deliver high doses of RT in the retreatment setting. Proton beam therapy (PBT) is an attractive choice for re-RT due to its ability to spare radiation to adjacent previously treated normal tissues. Here, we evaluate outcomes with PBT for the definitive re-RT of recurrent NSCLC within the previously irradiated thorax. Background/Objectives: This retrospective study evaluates outcomes of 66 patients who underwent reirradiation (re-RT) with proton beam therapy (PBT) for recurrent non-small cell lung cancer. Methods: Toxicity was scored via the CTCAE v5.0, and outcomes estimated using the Kaplan–Meier method, with associations evaluated via Cox proportional hazards and logistic regression analyses. Results: Patients were treated to a median re-RT prescription of 66 Gy/33 fxs (BED10 = 79 Gy; IQR: 71–84 Gy) at an interval of 1.4 years from prior RT. Half (50%) received concurrent chemotherapy. At 14 months follow-up, the median OS and PFS were 5 months (95%CI: 13–17) and 12.5 months (95%CI: 10–15), respectively. On multivariable analysis, a higher RT dose (BED10 > 70 Gy) [HR0.37; 95%CI: 0.20–0.68, p = 0.001] and concurrent chemotherapy (HR0.48; 95%CI: 0.28–0.81, p = 0.007) were associated with improved PFS, while treatment site overlap was adversely associated (HR1.78; 95%CI: 1.05–3.02, p = 0.031). The median PFS for definitive RT with concurrent chemotherapy (n = 28), definitive RT alone (BED10 > 70 Gy) [n = 22], and lower prescription RT (BED10 < 70 Gy) [n = 16] was 15.5 months (95%CI: 7.3–23.7), 14.1 months (95%CI: 10.9–17.3), and 3.3 months (95%CI: 0–12.3), respectively (log-rank, p = 0.006), with corresponding 2-year estimates of 37% (±9), 18% (±8), and 12.5% (±8), respectively. The incidence of Grade 3+ toxicity was 10.5% (6% pulmonary; 3% esophageal; and 1.5% skin), including one Grade 4 bronchopulmonary hemorrhage but no Grade 5 events. Cases with central site overlap had higher composite Dmax to the esophagus (median 87 Gy [IQR:77–90]), great vessels (median 120 Gy [IQR:110–138]), and proximal bronchial tree (median 120 Gy [IQR:110–138]) as compared to other cases (p ≤ 0.001 for all). However, no significant associations were identified with Grade 3+ events. Conclusions: Thoracic re-RT with PBT is an option for recurrent NSCLC with acceptable outcomes and toxicity for select patients. When feasible, higher prescription doses (BED10 > 70 Gy) should be delivered for definitive intent, and concurrent chemotherapy may benefit individual cases. [ABSTRACT FROM AUTHOR]

Published
2024
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14. Combining a nanoparticle-mediated immunoradiotherapy with dual blockade of LAG3 and TIGIT improves the treatment efficacy in anti-PD1 resistant lung cancer

Author

Hu, Yun, Paris, Sébastien, Bertolet, Genevieve, Barsoumian, Hampartsoum B., He, Kewen, Sezen, Duygu, Chen, Dawei, Wasley, Mark, SILVA, Jordan DA, Mitchell, Joylise A., Voss, Tiffany A., Masrorpour, Fatemeh, Leyton, Claudia Kettlun, Yang, Liangpeng, Leuschner, Carola, Puebla-Osorio, Nahum, Gandhi, Saumil, Nguyen, Quynh-Nhu, Cortez, Maria Angelica, and Welsh, James W.

Published
2022
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15. Stereotactic ablative radiotherapy for operable stage I non-small-cell lung cancer (revised STARS): long-term results of a single-arm, prospective trial with prespecified comparison to surgery

Author

Antonoff, Mara, Hofstetter, Wayne, Rajaram, Ravi, Rice, David, Sepesi, Boris, Swisher, Stephen, Vaporciyan, Ara, Walsh, Garrett, DeGraaf, Craig, Correa, Arlene, Chen, Aileen, Gandhi, Saumil, Komaki, Ritsuko, Lee, Percy, Nguyen, Quynh-Nhu, Ning, Matthew, Gao, Song, Pollard-Larkin, Julianne, Nitsch, Paige, Sadagopan, Ramaswamy, Wang, Xiaochun, Chang, Joe Y, Mehran, Reza J, Feng, Lei, Verma, Vivek, Liao, Zhongxing, Welsh, James W, Lin, Steven H, O'Reilly, Michael S, Jeter, Melenda D, Balter, Peter A, McRae, Stephen E, Berry, Donald, Heymach, John V, and Roth, Jack A

Published
2021
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16. High-dose irradiation in combination with non-ablative low-dose radiation to treat metastatic disease after progression on immunotherapy: Results of a phase II trial

Author

Patel, Roshal R., He, Kewen, Barsoumian, Hampartsoum B., Chang, Joe Y., Tang, Chad, Verma, Vivek, Comeaux, Nathan, Chun, Stephen G., Gandhi, Saumil, Truong, Mylene T., Erasmus, Jeremy J., Hong, David S., Lee, Percy P., Ning, Matthew S., Nguyen, Quynh-Nhu, Heymach, John V., Altan, Mehmet, Blumenschein, George, Fossella, Frank V., Sezen, Duygu, Chen, Dawei, Carter, Brett W., Davies, Michael A., Glitza, Isabella C., Diab, Adi, Ferrarotto, Renata, Cabanillas, Maria E., Yuan, Ying, Shah, Shalin J., Parra, Edwin R., Sun, Baohua, Cortez, Maria Angelica, and Welsh, James W.

Published
2021
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18. Pembrolizumab with or without radiotherapy for metastatic non-small-cell lung cancer: a pooled analysis of two randomised trials

Author

Theelen, Willemijn S M E, Chen, Dawei, Verma, Vivek, Hobbs, Brian P, Peulen, Heike M U, Aerts, Joachim G J V, Bahce, Idris, Niemeijer, Anna Larissa N, Chang, Joe Y, de Groot, Patricia M, Nguyen, Quynh-Nhu, Comeaux, Nathan I, Simon, George R, Skoulidis, Ferdinandos, Lin, Steven H, He, Kewen, Patel, Roshal, Heymach, John, Baas, Paul, and Welsh, James W

Published
2021
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23. Phase 1/2 Trial of Pembrolizumab and Concurrent Chemoradiation Therapy for Limited-Stage SCLC

Author

Welsh, James W., Heymach, John V., Guo, Chunxiao, Menon, Hari, Klein, Katherine, Cushman, Taylor R., Verma, Vivek, Hess, Kenneth R., Shroff, Girish, Tang, Chad, Skoulidis, Ferdinandos, Jeter, Melenda, Comeaux, Nathan, Patel, Roshal R., Chen, Dawei, Ozgen, Tugce, Nguyen, Quynh-Nhu, Chang, Joe Y., Altan, Mehmet, Zhang, Jianjun, Papadimitrakopoulou, Vassiliki A., Simon, George R., Byers, Lauren A., and Glisson, Bonnie

Published
2020
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26. Stereotactic ablative radiation therapy for pulmonary metastases: Improving overall survival and identifying subgroups at high risk of local failure

Author

Pasalic, Dario, Lu, Yi, Betancourt-Cuellar, Sonia L., Taku, Nicolette, Mesko, Shane M., Bagley, Alexander F., Chance, William W., Allen, Pamela K., Tang, Chad, Antonoff, Mara B., Balter, Peter A., Mehran, Reza J., Welsh, James W., Liao, Zhongxing, Gomez, Daniel, Erasmus, Jeremy J., and Nguyen, Quynh-Nhu

Published
2020
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27. Phase I Trial of Pembrolizumab and Radiation Therapy after Induction Chemotherapy for Extensive-Stage Small Cell Lung Cancer

Author

Welsh, James W., Heymach, John V., Chen, Dawei, Verma, Vivek, Cushman, Taylor R., Hess, Kenneth R., Shroff, Girish, Tang, Chad, Skoulidis, Ferdinandos, Jeter, Melenda, Menon, Hari, Nguyen, Quynh-Nhu, Chang, Joe Y., Altan, Mehmet, Papadimitrakopoulou, Vassiliki A., Simon, George R., Raju, Uma, Byers, Lauren, and Glisson, Bonnie

Published
2020
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32. Is Single-Site Radiation Therapy Enough to Augment the Immune System and Enhance Immunotherapy for Metastatic Disease?

Author

Verma, Vivek, Barsoumian, Hampartsoum B., and Welsh, James W.

Abstract

Despite the promise of combining immunotherapy and radiotherapy (RT) for metastatic cancers, existing randomized data have not been consistent on whether RT to a single irradiated site improves clinical outcomes. Mechanistically, this could result from a low quantity/diversity of tumor antigens released for immune detection, immunosuppressive molecules released by tumor masses, and the lack of immune infiltration into tumor bulk. Herein, multi-site RT is discussed as a potential solution, given that it can directly improve upon each of the mechanistic issues. Just as it is illogical to use systemic therapy alone in place of a dedicated local therapeutic option (e.g., RT) for most stage II-III malignancies, so too is illogical to irradiate one site only in case of metastatic neoplasms instead of implementing systemic therapy and/or multi-site RT. Although it may theoretically be possible to address all systemic disease with systemic therapy, that notion assumes that all areas of systemic disease will be responsive to systemic therapy in the first place. However, in reality, certain sites may develop innate or acquired resistance to systemic therapy, hence opening the door to multi-site localized treatment strategies. Further investigation is required to address whether multi-site RT would be effective in the setting of suboptimal immune function and/or resistance/refractoriness to multiple prior systemic therapies. Methods to improve the effectiveness of multi-site RT are also discussed, such as ablatively-/definitively-dosed RT, along with staggered timing of RT administration (pulsed RT). [ABSTRACT FROM AUTHOR]

Published
2024
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40. The inherited KRAS-variant as a biomarker of Cetuximab Response in NSCLC

Author

Weidhaas, Joanne B, primary, Hu, Chen, additional, Komaki, Ritsuko, additional, Masters, Gregory A, additional, Blumenschein, George R, additional, Chang, Joe Y., additional, Lu, Bo, additional, Dicker, Adam P., additional, Bogart, Jeffrey A, additional, Garces, Yolanda I, additional, Narayan, Samir, additional, Robinson, Clifford G., additional, Kavadi, Vivek S, additional, Greenberger, Joel S, additional, Koprowski, Christopher D, additional, Welsh, James W., additional, Gore, Elizabeth, additional, MacRae, Robert M, additional, Paulus, Rebecca, additional, and Bradley, Jeffrey, additional

Published
2023
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41. Abstract PR05: Changing the radiation and immune-oncology paradigm in patients with head and neck squamous cell carcinoma (HNSCC) with the radioenhancer NBTXR3: From bench to bedside

Author

Shen, Colette J., primary, Tourneau, Christophe Le, additional, Takacsi-Nagy, Zoltán, additional, Liem, Xavier, additional, Frakes, Jessica, additional, Niu, Jiaxin, additional, Weiss, Jared, additional, Caudell, Jimmy, additional, Hu, Yun, additional, Welsh, James W., additional, Paris, Sebastien, additional, Debard, Anais, additional, Said, Patricia, additional, Tyan, Pavel, additional, Seiwert, Tanguy Y., additional, Papai, Zsuzsanna, additional, Vivar, Omar I., additional, Farber, Leonard A., additional, and Rosenberg, Ari, additional

Published
2023
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43. Stereotactic radiosurgery of early melanoma brain metastases after initiation of anti-CTLA-4 treatment is associated with improved intracranial control

Author

An, Yi, Jiang, Wen, Kim, Betty Y.S., Qian, Jack M., Tang, Chad, Fang, Penny, Logan, Jennifer, D'Souza, Neil M., Haydu, Lauren E., Wang, Xin A., Hess, Kenneth R., Kluger, Harriet, Glitza, Isabella C., Mahajan, Anita, Welsh, James W., Lin, Steven H., Yu, James B., Davies, Michael A., Hwu, Patrick, Sulman, Erik P., Brown, Paul D., Chiang, Veronica L.S., and Li, Jing

Published
2017
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45. Local Control and Toxicity of a Simultaneous Integrated Boost for Dose Escalation in Locally Advanced Esophageal Cancer: Interim Results from a Prospective Phase I/II Trial

Author

Welsh, James W., Seyedin, Steven N., Allen, Pamela K., Hofstetter, Wayne L., Ajani, Jaffer A., Chang, Joe Y., Gomez, Daniel R., Amini, Arya, Swisher, Stephen G., Blum, Mariela A., Younes, Ahmed I., Nguyen, Quynh-Nhu, Minsky, Bruce D., Erasmus, Jeremy J., Lee, Jeffrey H., Bhutani, Manoop, and Komaki, Ritsuko U.

Published
2017
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46. Bone morphogenetic protein 7 promotes resistance to immunotherapy

Author

Cortez, Maria Angelica, Masrorpour, Fatemeh, Ivan, Cristina, Zhang, Jie, Younes, Ahmed I., Lu, Yue, Estecio, Marcos R, Barsoumian, Hampartsoum B., Menon, Hari, Caetano, Mauricio da Silva, Ramapriyan, Rishab, Schoenhals, Jonathan E., Wang, Xiaohong, Skoulidis, Ferdinandos, Wasley, Mark D., Calin, George, Hwu, Patrick, and Welsh, James W.

Published
2020
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48. Translational Research and Immunotherapy in Lung Cancer

Author

Schoenhals, Jonathan E., Brooks, Eric D., Cortez, Maria A., Seyedin, Steven N., Niknam, Sharareh, Wang, Xiaohong, Cadena, Alexandra P., Li, Xuan Shirley, Gomez, Daniel R., Liao, Zhongxing, Welsh, James W., Ozyigit, Gokhan, editor, Selek, Ugur, editor, and Topkan, Erkan, editor

Published
2016
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49. WISP Genes are Members of the Connective Tissue Growth Factor Family that are Up-Regulated in Wnt-1-Transformed Cells and Aberrantly Expressed in Human Colon Tumors

Author

Pennica, Diane, Swanson, Todd A., Welsh, James W., Roy, Margaret A., Lawrence, David A., Lee, James, Brush, Jennifer, Taneyhill, Lisa A., Deuel, Bethanne, Lew, Michael, Watanabe, Colin, Cohen, Robert L., Melhem, Mona F., Finley, Gene G., Quirke, Phil, Goddard, Audrey D., Hillan, Kenneth J., Gurney, Austin L., Botstein, David, and Levine, Arnold J.

Published
1998

50. Nanoparticle-enhanced proton beam immunoradiotherapy drives immune activation and durable tumor rejection

Author

Hu, Yun, primary, Paris, Sébastien, additional, Sahoo, Narayan, additional, Bertolet, Genevieve, additional, Wang, Qi, additional, Wang, Qianxia, additional, Barsoumian, Hampartsoum B., additional, Da Silva, Jordan, additional, Huang, Ailing, additional, Doss, Denaha J., additional, Pollock, David P., additional, Hsu, Ethan, additional, Selene, Nanez, additional, Leyton, Claudia S. Kettlun, additional, Voss, Tiffany A., additional, Masrorpour, Fatemeh, additional, Ganjoo, Shonik, additional, Leuschner, Carola, additional, Pietz, Jordan T., additional, Puebla-Osorio, Nahum, additional, Gandhi, Saumil, additional, Nguyen, Quynh-Nhu, additional, Wang, Jing, additional, Cortez, Maria Angelica, additional, and Welsh, James W., additional

Published
2023
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