32 results on '"Dudnik, J."'
Search Results
2. EP08.02-047 The Impact of CGP on the Decision-making Process in ALK+ aNSCLC After Failure of 2nd/3rd-Generation ALK TKIs
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Dudnik, E., primary, Raphael, A., additional, Holtzman, L., additional, Dudnik, J., additional, Urban, D., additional, Kian, W., additional, Cohen, A., additional, Moskovitz, M., additional, Zer, A., additional, Bar, J., additional, Maimon Rabinovich, N., additional, Grynberg, S., additional, Oedegaard, C., additional, Agbarya, A., additional, Peled, N., additional, Shochat, T., additional, and Onn, A., additional
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- 2022
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3. 951P Induction osimertinib followed by definitive sequential radiation therapy and/or surgery in unresectable EGFR-mutant stage III NSCLC: An open-label, single-arm, phase II study
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Peled, N., primary, Roisman, L.C., additional, Dudnik, J., additional, Dudnik, E., additional, Chernomordikov, E., additional, Keren Rosenberg, S., additional, Shalata, W., additional, Hannes, V., additional, Tsuriel, S., additional, Lichtenburg, R., additional, Allen, A., additional, Hershkovitz, D., additional, Blumenfeld, P., additional, Lavrenkov, K., additional, and Kian, W., additional
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- 2022
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4. 120O Pembrolizumab (Pembro) with or without lenvatinib (Lenva) in first-line metastatic NSCLC with PD-L1 TPS ≥1% (LEAP-007): A phase III, randomized, double-blind study
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Yang, J.C-H., primary, Luft, A., additional, De La Mora Jiménez, E., additional, Lee, J.S., additional, Koralewski, P., additional, Karadurmus, N., additional, Sugawara, S., additional, Livi, L., additional, Basappa, N.S., additional, Quantin, X., additional, Dudnik, J., additional, Moran Ortiz, D., additional, Mekhail, T., additional, Okpara, C.E., additional, Zimmer, Z., additional, Samkari, A., additional, Bhagwati, N., additional, and Csőszi, T., additional
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- 2021
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5. 476P Open-label phase I/II study evaluating the tolerability and antitumor activity of selinexor (SEL) and pembrolizumab (pembro) in colorectal cancer (CRC)
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Kutiel, T. Shentzer, primary, Golan, T., additional, Geva, R., additional, Gottfried, M., additional, Zick, A., additional, Shai, A., additional, Dudnik, J., additional, Netiv, E., additional, Yang, F., additional, Sharoni, S., additional, Meng, C., additional, Duic, P., additional, Michel, D., additional, Sbar, E., additional, Shah, J., additional, Kauffman, M.G., additional, Shacham, S., additional, and Zer, A., additional
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- 2021
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6. 1331P Open-label phase I/II study evaluating the tolerability and anti-tumor activity of selinexor (SEL) and docetaxel (DTX) in non-small cell lung cancer (NSCLC)
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Zer, A., primary, Dudnik, J., additional, Shamai, S., additional, Gottfried, M., additional, Zick, A., additional, Shai, A., additional, Kutiel, T. Shentzer, additional, Netiv, E., additional, Yang, F., additional, Sharoni, S., additional, Meng, C., additional, Duic, P., additional, Michel, D., additional, Sbar, E., additional, Shah, J., additional, Kauffman, M.G., additional, Shacham, S., additional, and Golan, T., additional
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- 2021
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7. 1173P Induction osimertinib in EGFR-mutant stage IIIA/B NSCLC
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Kian, W., primary, Roisman, L.C., additional, Dudnik, J., additional, Chernomordikov, L., additional, Allen, A.M., additional, Corn, B., additional, Dudnik, E., additional, Rosenberg, S.K., additional, Zemel, M., additional, Lavrenkov, K., additional, and Peled, N., additional
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- 2021
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8. 133TiP Neoadjuvant osimertinib followed by sequential definitive radiotherapy and/or surgery in stage III EGFR-mutant NSCLC: An open-label, single-arm, phase II study
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Kian, W., Peled, N., Roisman, L.C., Levison, E., Dudnik, J., Chernomordikov, E., Dudnik, E., Keren-Rosenberg, S., Tsuriel, S., Hannes, V., Hershkovitz, D., Lichtenberg, R., Granot, I., Krayim, B., Shalata, W., Allen, A.M., Blumenfeld, P., and Lavrenkov, K.
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- 2023
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9. The usage of low-voltage AC plasma torch for polystyrene gasification
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Obraztsov, N V, primary, Safronov, A A, additional, Subbotin, D I, additional, Ivanov, D, additional, and Dudnik, J D, additional
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- 2019
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10. P2.06-14 BAP1 Mutant Malignant Pleural Mesothelioma (MPM): Outcomes with Chemotherapy, ICPi and PARPi
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Dudnik, E., primary, Bar, J., additional, Kuznetsov, T., additional, Moskovitz, M., additional, Dudnik, J., additional, Shochat, T., additional, Zer, A., additional, and Urban, D., additional
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- 2019
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11. Plasma synthesis of Al2O3 from related nitrate
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Subbotin, D I, primary, Surov, A V, additional, Kuznetsov, V E, additional, Pavlova, E A, additional, Azartsova, V V, additional, Kuchina, J A, additional, and Dudnik, J D, additional
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- 2018
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12. Erosion of rod electrodes of the air AC plasma torch
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Subbotin, D I, primary, Surov, A V, additional, Kuznetsov, V.E., additional, Popov, V.E., additional, Dudnik, J D, additional, Kuchina, J D, additional, and Obraztsov, N V, additional
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- 2018
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13. 150P Correlation between erlotinib-induced rash and efficacy in first-line therapy of patients with advanced non-small cell lung cancer (NSCLC) expressing epidermal growth factor receptor (EGFR)-mutation: A prospective, multi-center, open-label, single-arm, phase II study
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Gottfried, M., primary, Rosenberg, S. Keren, additional, Dudnik, J., additional, Wollner, M., additional, Bar, J., additional, Onn, A., additional, Frenkel, O., additional, and Maimon, N., additional
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- 2018
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14. Analysis of Physics Processes in the AC Plasma Torch Discharge under High Pressure
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Safronov, A A, primary, Vasilieva, O B, additional, Dudnik, J D, additional, Kuznetsov, V E, additional, Kuchina, J A, additional, Shiryaev, V N, additional, and Pavlov, A V, additional
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- 2017
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15. Investigation of the AC Plasma Torch Working Conditions for the Plasma Chemical Applications
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Safronov, A A, primary, Vasilieva, O B, additional, Dudnik, J D, additional, Kuznetsov, V E, additional, Shiryaev, V N, additional, Subbotin, D I, additional, and Pavlov, A V, additional
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- 2017
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16. 9094 Concurrent chemoradiotherapy for locally advanced non-small cell lung cancer: community hospital experience
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Rouvinov, K., primary, Dudnik, J., additional, Charkovski, T., additional, Ariad, S., additional, and Lavrenkov, K., additional
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- 2009
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17. Acute Myocardial Infarction in a Young Man Receiving Chemotherapy for Testicular Cancer: Case Report
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Mermershtain, W., primary, Dudnik, J., additional, Gusakova, I., additional, and Ariad, S., additional
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- 2001
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18. 150P Correlation between erlotinib-induced rash and efficacy in first-line therapy of patients with advanced non-small cell lung cancer (NSCLC) expressing epidermal growth factor receptor (EGFR)-mutation: A prospectivemulti-center, open-label, single-arm, phase II study
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Gottfried, M., Rosenberg, S. Keren, Dudnik, J., Wollner, M., Bar, J., Onn, A., Frenkel, O., and Maimon, N.
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- 2018
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19. Alectinib versus Crizotinib in Untreated ALK-Positive Non–Small-Cell Lung Cancer
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Rafael Rosell, Alice T. Shaw, Ali Zeaiter, Shirish M. Gadgeel, Emmanuel Mitry, Bogdana Balas, Jin S. Ahn, Maurice Perol, Johannes Noe, Sai-Hong Ignatius Ou, Peter N. Morcos, D. Ross Camidge, Solange Peters, Tony Mok, Dong Wan Kim, Rafal Dziadziuszko, Sophie Golding, ALEX Trial Investigators, Nordman, I., Pittman, K., Dear, R., Lwin, Z., Briggs, P., Pavlakis, N., Ceric, T., Mehic, B., Stanetic, M., Franke, F.A., Castro, G., Santo Borges, G., Pereira, J., Brust, L., Santos, L., Cruz, M., Ribeiro, R., De Azevedo, S., Neron, Y.V., Sangha, R., Cohen, V., Burkes, R., Abdelsalam, M., Yadav, S., Cheema, P., Yanez, E., Aren, O., Zhou, C., Zhang, L., Liu, X., Corrales Rodriguez, L., Meldgaard, P., Soerensen, J.B., McCulloch, T., Rodriguez, N., Gaafar, R., Abdel Azeem, H., Coudert, B., Moro-Sibilot, D., Lena, H., Bennouna, J., Cortot, A., Veillon, R., Cadranel, J., Barlesi, F., Reck, M., Mezger, J., von Pawel, J., Fischer, J.R., Dickgreber, N.K., Zarogoulidis, K., Syrigos, K., Georgoulias, V., Agelaki, S., Castro-Salguero, H., Ho, J., Chan, S.H., Cheng, C.K., Ng, A., Stemmer, S., Wollner, M., Gottfried, M., Dudnik, J., Cyjon, A., Heching, N., Novello, S., Tiseo, M., Platania, M., Misino, A., Gridelli, C., Ciardiello, F., Favaretto, A., De Marinis, F., Longo, F., Bordonaro, R., Dazzi, C., Chiari, R., Mercuri, E., Macedo, E., Rodriguez Cid, J.R., McKeage, M., Vera, L., Morón Escobar, H.D., Rodriguez, M., Mas, L., Ramlau, R., Kowalski, D., Szczesna, A., Kazarnowicz, A., Milanowski, J., Luboch-Kowal, J., Oliveira, J., Barata, F., Almodovar, T., Lee, J.S., Cho, B.C., Kim, S.W., Han, J.Y., Karaseva, N., Stroyakovskii, D., Kuzmin, A., Smolin, A., Laktionov, K., Ragulin, Y., Filippov, A., Levchenko, E., Jovanovic, D., Perin, B., Andric, Z., Soo, R., Tan, E.H., De Castro Carpeno, J., Provencio Pulla, M., Garrido Lopez, P., Felip Font, E., Morano Bueno, T., Sanchez, A., Isla Casado, D., Ponce Aix, S., Reguart Aransay, N., Viteri Ramirez, S., Rodriguez Abreu, D., Sanchez Torres, J.M., Massuti Sureda, B., Ramos Vazquez, M., Tabernero, J.M., Curioni, A., Rothschild, S., Scherz, A., Chiu, C.H., Su, W.C., Yang, CHJ, Chang, G.C., Hsia, T.C., Yang, C.T., Tharavichitkul, E., Pongthai, P., Arpornwirat, W., Geater, S., Srimuninnimit, V., Sriuranpong, V., Demirkazik, A., Goker, E., Harputluoglu, H., Cicin, I., Kose, F., Erman, M., Bondarenko, I., Vinnyk, Y., Shparyk, Y., Golovko, Y., Lal, R., Forster, M., Califano, R., Skailes, G., Thompson, J., Mekhail, T., Polikoff, J., Spigel, D., Waqar, S., Hermann, R., Deo, E., Simon, G., Rybkin, I., Kaywin, P.R., Uyeki, J., Gubens, M., Limaye, S., Gerber, D.E., Leal, T., Spira, A.I., Bazhenova, L., Cetnar, J., Socinski, M., Jahanzeb, M., Kabbinavar, F., Lawler, W.E., Hancock, M.R., Raez, L.E., DiCarlo, B.A., Lowe, T.E., Fidler, M., Ross, H., Davidson, S.J., Sanchez, J.D., Hamm, J., Kerr, S., Belman, N., Baker, S., Naraev, B., Jung, G., Edelman, M., Feldman, L., Belani, C., and Pakkala, S.
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Adult ,Male ,0301 basic medicine ,Oncology ,Alectinib ,medicine.medical_specialty ,Pathology ,Lung Neoplasms ,Brigatinib ,Pyridines ,medicine.drug_class ,Carbazoles ,Antineoplastic Agents ,Kaplan-Meier Estimate ,Aged, 80 and over ,Animals ,Antineoplastic Agents/adverse effects ,Antineoplastic Agents/therapeutic use ,Carbazoles/adverse effects ,Carbazoles/therapeutic use ,Carcinoma, Non-Small-Cell Lung/drug therapy ,Carcinoma, Non-Small-Cell Lung/mortality ,Central Nervous System Neoplasms/drug therapy ,Central Nervous System Neoplasms/secondary ,Disease-Free Survival ,Female ,Follow-Up Studies ,Humans ,Intention to Treat Analysis ,Lung Neoplasms/drug therapy ,Lung Neoplasms/mortality ,Middle Aged ,Piperidines/adverse effects ,Piperidines/therapeutic use ,Protein Kinase Inhibitors/adverse effects ,Protein Kinase Inhibitors/therapeutic use ,Pyrazoles/adverse effects ,Pyrazoles/therapeutic use ,Pyridines/adverse effects ,Pyridines/therapeutic use ,Receptor Protein-Tyrosine Kinases/analysis ,Receptor Protein-Tyrosine Kinases/antagonists & inhibitors ,Young Adult ,Central Nervous System Neoplasms ,03 medical and health sciences ,0302 clinical medicine ,Piperidines ,Carcinoma, Non-Small-Cell Lung ,hemic and lymphatic diseases ,Internal medicine ,medicine ,Anaplastic lymphoma kinase ,Lung cancer ,Protein Kinase Inhibitors ,Crizotinib ,Ceritinib ,business.industry ,Receptor Protein-Tyrosine Kinases ,General Medicine ,medicine.disease ,Lorlatinib ,ALK inhibitor ,030104 developmental biology ,030220 oncology & carcinogenesis ,Pyrazoles ,business ,medicine.drug - Abstract
Alectinib, a highly selective inhibitor of anaplastic lymphoma kinase (ALK), has shown systemic and central nervous system (CNS) efficacy in the treatment of ALK-positive non-small-cell lung cancer (NSCLC). We investigated alectinib as compared with crizotinib in patients with previously untreated, advanced ALK-positive NSCLC, including those with asymptomatic CNS disease. In a randomized, open-label, phase 3 trial, we randomly assigned 303 patients with previously untreated, advanced ALK-positive NSCLC to receive either alectinib (600 mg twice daily) or crizotinib (250 mg twice daily). The primary end point was investigator-assessed progression-free survival. Secondary end points were independent review committee-assessed progression-free survival, time to CNS progression, objective response rate, and overall survival. During a median follow-up of 17.6 months (crizotinib) and 18.6 months (alectinib), an event of disease progression or death occurred in 62 of 152 patients (41%) in the alectinib group and 102 of 151 patients (68%) in the crizotinib group. The rate of investigator-assessed progression-free survival was significantly higher with alectinib than with crizotinib (12-month event-free survival rate, 68.4% [95% confidence interval (CI), 61.0 to 75.9] with alectinib vs. 48.7% [95% CI, 40.4 to 56.9] with crizotinib; hazard ratio for disease progression or death, 0.47 [95% CI, 0.34 to 0.65]; P
- Published
- 2017
20. Pembrolizumab With or Without Lenvatinib for First-Line Metastatic NSCLC With Programmed Cell Death-Ligand 1 Tumor Proportion Score of at least 1% (LEAP-007): A Randomized, Double-Blind, Phase 3 Trial.
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Yang JC, Han B, De La Mora Jiménez E, Lee JS, Koralewski P, Karadurmus N, Sugawara S, Livi L, Basappa NS, Quantin X, Dudnik J, Ortiz DM, Mekhail T, Okpara CE, Dutcus C, Zimmer Z, Samkari A, Bhagwati N, and Csőszi T
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- Humans, Male, Female, Double-Blind Method, Middle Aged, Aged, Adult, B7-H1 Antigen metabolism, B7-H1 Antigen antagonists & inhibitors, Aged, 80 and over, Quinolines therapeutic use, Carcinoma, Non-Small-Cell Lung drug therapy, Carcinoma, Non-Small-Cell Lung pathology, Antibodies, Monoclonal, Humanized therapeutic use, Lung Neoplasms drug therapy, Lung Neoplasms pathology, Phenylurea Compounds therapeutic use, Antineoplastic Combined Chemotherapy Protocols therapeutic use
- Abstract
Introduction: Lenvatinib plus pembrolizumab was found to have antitumor activity and acceptable safety in previously treated metastatic NSCLC. We evaluated first-line lenvatinib plus pembrolizumab versus placebo plus pembrolizumab in metastatic NSCLC in the LEAP-007 study (NCT03829332/NCT04676412)., Methods: Patients with previously untreated stage IV NSCLC with programmed cell death-ligand 1 tumor proportion score of at least 1% without targetable EGFR/ROS1/ALK aberrations were randomized 1:1 to lenvatinib 20 mg or placebo once daily; all patients received pembrolizumab 200 mg every 3 weeks for up to 35 cycles. Primary end points were progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 and overall survival (OS). We report results from a prespecified nonbinding futility analysis of OS performed at the fourth independent data and safety monitoring committee review (futility bound: one-sided p < 0.4960)., Results: A total of 623 patients were randomized. At median follow-up of 15.9 months, median (95% confidence interval [CI]) OS was 14.1 (11.4‒19.0) months in the lenvatinib plus pembrolizumab group versus 16.4 (12.6‒20.6) months in the placebo plus pembrolizumab group (hazard ratio = 1.10 [95% CI: 0.87‒1.39], p = 0.79744 [futility criterion met]). Median (95% CI) PFS was 6.6 (6.1‒8.2) months versus 4.2 (4.1‒6.2) months, respectively (hazard ratio = 0.78 [95% CI: 0.64‒0.95]). Grade 3 to 5 treatment-related adverse events occurred in 57.9% of patients (179 of 309) versus 24.4% (76 of 312). Per data and safety monitoring committee recommendation, the study was unblinded and lenvatinib and placebo were discontinued., Conclusions: Lenvatinib plus pembrolizumab did not have a favorable benefit‒risk profile versus placebo plus pembrolizumab. Pembrolizumab monotherapy remains an approved treatment option in many regions for first-line metastatic NSCLC with programmed cell death-ligand 1 tumor proportion score of at least 1% without EGFR/ALK alterations., Competing Interests: Disclosure Dr. Yang reports receiving funding to institution for serving on advisory or consultancy services for Daiichi Sankyo, Eli Lilly, Merck KGaA, Darmstadt, Germany, Merck Sharp & Dohme, Novartis, Roche, Genentech, Takeda Oncology, Yuhan Pharmaceuticals, Janssen Pharmaceuticals, Puma Technology, Gilead Sciences Inc., GlaxoSmithKline, BeiGene, Blueprint Medicines Corporation, Regeneron Pharmaceutical, and Taiho Pharmaceutical; receiving grant from Roche/Genentech; and having advisory or consultancy services from Ono Pharmaceuticals and Pfizer. Dr. Han reports receiving study funding to the institution from Eisai Inc., Nutley, New Jersey, and Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, New Jersey, to support study conduct. Dr. Jiménez reports receiving study funding to the institution from Eisai Inc., Nutley, New Jersey, and Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, New Jersey, to support study conduct. Dr. Lee reports receiving study funding to the institution from Eisai Inc., Nutley, New Jersey, and Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, New Jersey, to support study conduct. Dr. Koralewski reports receiving study funding to the institution from Eisai Inc., Nutley, New Jersey, and Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, New Jersey, to support study conduct. Dr. Karadurmus reports receiving study funding to the institution from Eisai Inc., Nutley, New Jersey, and Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, New Jersey, to support study conduct. Dr. Sugawara reports receiving grants or contracts to their institution from AnHeart, AstraZeneca, Chugai Pharma, MSD, Daiichi Sankyo, Bristol-Myers Squibb, Nippon Boehringer Ingelheim, Ono Pharmaceuticals, AbbVie, Amgen, Taiho Pharmaceutical, Takeda, and Clinipace; payment or honoraria from AstraZeneca, Chugai Pharma, Ono Pharmaceutical, Bristol-Myers Squibb, MSD, Nippon Boehringer Ingelheim, Pfizer, Taiho Pharmaceutical, Eli Lilly and Company, Novartis, Kyowa Kirin, Takeda, Nippon Kayaku, Merck Biopharma Japan, Amgen, AbbVie, Otsuka, Thermo Fisher Scientific, and Towa Pharmaceutical. Dr. Livi reports receiving study funding to the institution from Eisai Inc., Nutley, New Jersey, and Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, New Jersey, to support study conduct. Dr. Basappa reports receiving grants or contracts from Ipsen; receiving payment or honoraria from Bayer, Astellas, and Janssen; receiving support for attending meetings from Eisa, Ipsen, and Janssen; having participation on data safety monitoring board or advisory board with Eisai, Ipsen, Pfizer, Bristol-Myers Squibb, Roche, Janssen, AstraZeneca, EMD Serono, Bayer, Astellas, and MSD. Dr. Quantin reports receiving payment or honoraria to their institution from Sanofi, Bristol-Myers Squibb, and AstraZeneca; receiving support for attending meetings from Janssen Cilag, Sanofi, and Pfizer; and having participation on data safety monitoring board or advisory board with Bristol-Myers Squibb. Dr. Dudnik reports receiving study funding to the institution from Eisai Inc., Nutley, New Jersey, and Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, New Jersey, to support study conduct. Dr. Moran reports receiving support for present manuscript from MSD; grants or contracts from Abbott; consulting fees from Bristol-Myers Squibb and MSD; honoraria from Bristol-Myers Squibb, MSD, AstraZeneca, GlaxoSmithKline, Novartis, and Bayer; support for attending meetings from Tecnofarma, Roche, Pfizer, Bayer, and Janssen; and having participation on data safety monitoring board or advisory board with MSD. Dr. Mekhail reports receiving payment for speakers bureau from MSD. Drs. Okpara and Dutcus are employees of Eisai Ltd., Hatfield, UK. Drs. Zimmer, Samkari, and Bhagwati are employees of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, New Jersey, and own stock in Merck & Co., Inc., Rahway, New Jersey. Dr. Csőszi reports receiving study funding to the institution from Eisai Inc., Nutley, New Jersey, and Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, New Jersey, to support study conduct., (Copyright © 2024 Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA, The Author(s). Published by Elsevier Inc. All rights reserved.)
- Published
- 2024
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21. Neoadjuvant Osimertinib Followed by Sequential Definitive Radiation Therapy and/or Surgery in Stage III Epidermal Growth Factor Receptor-Mutant Non-Small Cell Lung Cancer: An Open-Label, Single-Arm, Phase 2 Study.
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Peled N, Roisman LC, Levison E, Dudnik J, Chernomordikov E, Heching N, Dudnik E, Keren-Rosenberg S, Nechushtan H, Salhab A, Hershkovitz D, Tsuriel S, Hannes V, Rotem O, Lazarev I, Lichtenberg R, Granot IS, Krayim B, Shalata W, Levin D, Krutman Y, Allen AM, Blumenfeld P, Lavrenkov K, and Kian W
- Subjects
- Humans, Female, Aged, Neoadjuvant Therapy, Prospective Studies, ErbB Receptors genetics, Mutation, Carcinoma, Non-Small-Cell Lung genetics, Carcinoma, Non-Small-Cell Lung therapy, Lung Neoplasms genetics, Lung Neoplasms therapy
- Abstract
Purpose: The treatment for unresectable, locally advanced stage III non-small cell lung cancer (NSCLC) is concurrent chemoradiation therapy (CRT) followed by consolidation durvalumab. This study aimed to evaluate the benefit of neoadjuvant osimertinib as an alternative therapy to this approach with the aim of reducing the radiation field., Methods and Materials: This investigation was a nonrandomized, open-label, single-arm, phase 2, prospective, proof-of-concept study. Eligible patients were classified as having treatment-naïve, nonoperable, stage III epidermal growth factor receptor-mutant NSCLC. Patients received 80 mg of oral osimertinib daily for 12 weeks before definitive radiation therapy (RT) and/or surgery. The response was assessed at weeks 6 and 12. For responders, sequential definitive RT and/or surgery were planned. Nonresponders were started on standard CRT. After RT ± surgery or CRT, patients were followed for 2 years without adjuvant therapy. The primary endpoint was the objective response rate (ORR), with September 20, 2022, set as the cut-off for data collection. Secondary endpoints were safety and the gross tumor volume (GTV), planned tumor volume (PTV), and the percentage of total lung volume minus GTV exceeding 20 Gy (V20%) before versus after osimertinib. Exploratory analyses included assessments of the presence of plasma circulating tumor-free DNA (ctDNA) before osimertinib treatment, at weeks 6 and 12, at the end of RT, and 6 weeks post-RT., Results: Twenty-four patients were included (19 women; median age, 73 years; range, 51-82 years). Nineteen of 24 had never smoked, 20 of 24 had adenocarcinoma, 16 of 24 had exon 19 deletions, and 8 of 24 had exon 21 mutations. Participants had stage IIIA (10), IIIB (9), or IIIC (5) disease. Three patients were excluded from the analysis (1 dropped out and 2 were still undergoing osimertinib treatment at the cut-off date). The ORR to induction osimertinib was 95.2% (17 partial response, 3 complete response, and 1 progressive disease). After induction osimertinib, 13 of 20 patients were definitively radiated, 3 of 20 underwent surgery, and 5 of 20 were excluded. Four patients were restaged as stage IV (contralateral ground-glass opacities responded to osimertinib), and 1 patient withdrew informed consent. Three patients underwent surgery, one of whom was treated with RT. Two patients achieved pT1aN0, and one achieved pathologic complete response. The median GTV, PTV, and V20% before osimertinib treatment were 47.4 ± 76.9 cm
3 (13.5-234.9), 227.0 ± 258.8 cm3 (77.8-929.2), and 27.1 ± 16.4% (6.2-60.3), respectively. The values after osimertinib treatment were 27.5 ± 42.3 cm3 (2.99-137.7; -48 ± 20%; P = .02), 181.9 ±198.4 cm3 (54-718.1; -31 ± 20%; P = .01), and 21.8 ± 11.7% (9.1-44.15; -24 ± 40%; P = .04), respectively. PTV/GTV/V20% reduction was associated with tumor size and central location. The median follow-up time was 28.71 months (range, 0.4-45.1 months), and median disease-free survival was not reached (mean, 30.59; standard error, 3.94; 95% confidence interval, 22.86-38.31). ctDNA was detected in 5 patients; 4 of 5 were positive for ctDNA at baseline and became negative during osimertinib induction but were again positive after osimertinib treatment was terminated. Interestingly, 3 patients who were ctDNA negative at baseline became weakly positive after RT and then were negative at follow-up. No significant adverse events were reported during the osimertinib or radiation phases., Conclusions: Neoadjuvant osimertinib therapy is feasible in patients with stage III lung cancer NSCLC, followed by definitive radiation and/or surgery, with an ORR of 95.2% and an excellent safety profile. Osimertinib induction for 12 weeks before definitive radiation (chemo-free) significantly reduced the radiation field by nearly 50% with a linear association with tumor size. Further studies are needed to test this chemo-free approach for long-term outcomes before practices are changed., (Copyright © 2023 Elsevier Inc. All rights reserved.)- Published
- 2023
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22. The Impact of Comprehensive Genomic Profiling (CGP) on the Decision-Making Process in the Treatment of ALK-Rearranged Advanced Non-Small Cell Lung Cancer (aNSCLC) After Failure of 2 nd /3 rd -Generation ALK Tyrosine Kinase Inhibitors (TKIs).
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Raphael A, Onn A, Holtzman L, Dudnik J, Urban D, Kian W, Cohen AY, Moskovitz M, Zer A, Bar J, Rabinovich NM, Grynberg S, Oedegaard C, Agbarya A, Peled N, Shochat T, and Dudnik E
- Abstract
Background: The use of CGP in guiding treatment decisions in aNSCLC with acquired resistance to ALK TKIs is questionable., Methods: We prospectively assessed the impact of CGP on the decision-making process in ALK-rearranged aNSCLC patients following progression on 2
nd /3rd -generation ALK TKIs. Physician's choice of the most recommended next-line systemic treatment (NLST) was captured before and after receival of CGP results; the percentage of cases in which the NLST recommendation has changed was assessed along with the CGP turnaround time (TAT). Patients were divided into groups: patients in whom the NLST was initiated after (group 1) and before (group 2) receival of the CGP results. Time-to-treatment discontinuation (TTD) and overall survival (OS) with NLST were compared between the groups., Results: In 20 eligible patients (median [m]age 63 years [range, 40-89], females 75%, adenocarcinoma 100%, failure of alectinib 90%, FoundationOne Liquid CDx 80%), CGP has altered NLST recommendation in 30% of cases. CGP findings were as follows: ALK mutations 30% (l1171X 10%, G1202R, L1196M, G1269A, G1202R+l1171N+E1210K 5% each), CDKN2A/B mutation/loss 10%, c-met amplification 5%. CGP mTAT was 2.9 weeks [IQR, 2.4-4.4]. mTTD was 11.3 months (95% CI, 2.1-not reached [NR]) and 5.4 months (95% CI, 2.0-NR) in groups 1 and 2, respectively (p-0.34). mOS was 13.2 months (95% CI, 2.9-NR) and 13.0 months (95% CI, 6.0-NR) in groups 1 and 2, respectively (p-0.86)., Conclusion: CGP has a significant impact on the decision-making process in ALK-rearranged aNSCLC following progression on 2nd /3rd -generation ALK TKIs., Competing Interests: Author TS was employed by the company Statistical Consulting Unit. Disclosure (all outside of the submitted work): AR reported personal fees from Roche, Astra Zeneca, Merck Sharpe & Dohme, Novartis, Takeda, Elli Lilly, support for attending meetings from Bristol Myers Squibb, Roche, Boehringer Ingelheim. AO reported advisory fees from Merck Sharpe & Dohme, Bristol Myers Squibb, Roche, Astra Zeneca, Novartis, Boehringer Ingelheim. Damien Urban reported personal and consulting fees from Roche, Merck Sharpe & Dohme, Takeda, Astra Zeneca, Rhenium Oncotest, Bristol Myers Squibb. MM reported consulting fees from Boehringer Ingelheim, Roche, Astra Zeneca, MSD, BMS, Abbvie, Takeda, Pomicell. AZ reported grants from Bristol Myers Squibb, personal fees from Roche, Merck Sharpe & Dohme, Bristol Myers Squibb, Astra Zeneca, Takeda. JB reported grants and personal fees from Merck Sharpe & Dohme, Bristol Myers Squibb, Astra Zeneca, Roche, Abbvie, Takeda, OncoHost, ImmuneAI, Bayer, Novartis. AA reported research funding from Bristol Myers Squibb, personal and consulting fees from Bristol Myers Squibb, Roche, Pfizer, Astra Zeneca, Takeda, Novartis. NP reported research funding from Bristol-Myers Squibb, Eli Lilly, Foundation Medicine, Gaurdant360, Merk, MSD, Novartis, NovellusDx, Pfizer, Roche, Takeda, IP: Volatile Organic Compounds For Detecting Cell Dysplasia And Genetic Alterations Associated With Lung Cancer, WO2012023138; Breath Analysis of Pulmonary Nodules, US20130150261 A1; Apparatus for treating a target site of a body, WO/2015/059646 - all outside of the submitted work. ED reported grants from Astra Zeneca, Boehringer Ingelheim, personal fees from Boehringer Ingelheim, Roche, Astra Zeneca, Pfizer, Merck Sharpe & Dohme, Bristol Myers Squibb, Novartis, Takeda, Sanofi, Merck Serono, Medison Pharma, Janssen Israel- all outside of the submitted work. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Raphael, Onn, Holtzman, Dudnik, Urban, Kian, Cohen, Moskovitz, Zer, Bar, Rabinovich, Grynberg, Oedegaard, Agbarya, Peled, Shochat and Dudnik.)- Published
- 2022
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23. BAP1-Altered Malignant Pleural Mesothelioma: Outcomes With Chemotherapy, Immune Check-Point Inhibitors and Poly(ADP-Ribose) Polymerase Inhibitors.
- Author
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Dudnik E, Bar J, Moore A, Gottfried T, Moskovitz M, Dudnik J, Shochat T, Allen AM, Zer A, Rotem O, Peled N, and Urban D
- Abstract
Objectives: Little is known regarding the outcomes of systemic treatments in BAP1-altered malignant pleural mesothelioma (MPM)., Materials and Methods: Forty five patients with MPM [group A: eight MPM patients with BAP1 inactivating mutation/copy number loss (FoundationOne
® CDx/TEMPUSxT), selected from the electronic databases of four Israeli cancer centers (ICC); group B: 37 consecutive (years 2016-2018) MPM patients selected from the electronic databases of two ICC-of those six patients without a BAP1 alteration (group B1) and 31 patients not tested for BAP1 (group B2)] were analyzed for ORR, PFS (mRECIST), and OS with 1st -line platinum/pemetrexed+/-antiangiogenic drug (CT, n-28), immune check-point inhibitors (ICPi, n-16) and poly (ADP-ribose) polymerase inhibitors (PARPi, n-4). OS since diagnosis (OSDx) was assessed., Results: There were no differences in ORR or mPFS with CT between the groups: ORR-50% vs . 47% vs . 50% vs . 47% (p>0.9), mPFS-9.1mo (95% CI, 1.2-16.1) vs . 9.2mo (95% CI, 2.9-13.3) vs . 7.2mo (95% CI, 2.3-NR) vs . 10.9mo (95% CI, 2.9-20.3) (p>0.8) in groups A, B, B1, and B2, respectively. There were no differences in ORR or mPFS with ICPi between the groups: ORR-0% vs . 27% vs . 33% vs . 25% (p>0.2), mPFS-2.5mo (95% CI, 1.4-3.7) vs . 3.0mo (95% CI, 1.3-10.5) vs . 2.0mo (95% CI, 1.9-NR) vs . 4.5mo (95% CI, 0.3-10.5) (p>0.3) in groups A, B, B1, and B2, respectively. In group A, no responses were seen with PARPi; mPFS with PARPi was 1.8mo (95% CI, 1.8-NR). OSDx was 98.3mo (95% CI, 9.7-98.3) vs . 19.4mo (95% CI, 9.7-47.3) vs . 18.8mo (95% CI, 8.5-NR) vs . 19.5mo (95% CI, 8.3-82.2) in groups A, B, B1, and B2, respectively (p>0.3)., Conclusions: BAP1-altered MPM, as compared to non-selected MPM, is characterized by similar efficacy of CT and ICPi. Numerically longer OS in BAP1-altered MPM may reflect favorable tumor biology. No responses were observed with PARPi., Competing Interests: ED reported grants from Boehringer Ingelheim, personal fees for consulting or advisory services from Boehringer Ingelheim, Roche, Astra Zeneca, Pfizer, MSD, BMS, Novartis, Takeda. JB reported grants from MSD, Roche, Boehringer Ingelheim, AstraZeneca and Pfizer, and personal fees for consulting or advisory services from MSD, Roche, Boehringer Ingelheim, AstraZeneca, Pfizer, BMS, Novartis, Takeda, Bayer, Vascular Biogenics, and Abbvie. AM reported honoraria from Merck, Roche. MM reported personal fees for consulting or advisory services from Boehringer Ingelheim, Roche, Astra Zeneca, MSD, BMS, and Takeda. AZ reported grants from BMS, personal fees for consulting or advisory services from Roche, MSD, BMS, Astra Zeneca. NP reported grants and personal fees for consulting or advisory services from Astra Zeneca, Boehringer Ingelheim, BMS, Eli Lilly, MSD, Roche, Pfizer, Novartis, NovellusDx, FMI, Gaurdant360. DU reported personal fees for consulting or advisory services from Boehringer Ingelheim, Roche, Astra Zeneca, MSD, BMS, Takeda. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Dudnik, Bar, Moore, Gottfried, Moskovitz, Dudnik, Shochat, Allen, Zer, Rotem, Peled and Urban.)- Published
- 2021
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24. The impact of osimertinib' line on clonal evolution in EGFRm NSCLC through NGS-based liquid biopsy and overcoming strategies for resistance.
- Author
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Fuchs V, Roisman L, Kian W, Daniel L, Dudnik J, Nechushtan H, Goldstein I, Dvir A, Soussan-Gutman L, Grinberg R, Gillis R, and Peled N
- Subjects
- Acrylamides, Aniline Compounds, Clonal Evolution, Drug Resistance, Neoplasm genetics, Humans, Liquid Biopsy, Mutation, Protein Kinase Inhibitors pharmacology, Protein Kinase Inhibitors therapeutic use, Retrospective Studies, ErbB Receptors genetics, Lung Neoplasms drug therapy, Lung Neoplasms genetics
- Abstract
Background: Resistance mechanisms following 1st line therapy with osimertinib in EGFR + NSCLC have become focus of investigation. This retrospective study aims to deepen the understanding and clarify possible mechanisms of osimertinib 1st line resistance in comparison to the 2nd line by examining NGS results of 30 patients who developed resistance to osimertinib. Furthermore, we followed clinical outcomes of select patients who received combined therapy following EGFR resistance, a novel strategy not yet widely tested., Methods: Liquid biopsy technique (Guardant360) was used to monitor tumor dynamics in patients who were treated with osimertinib as 1st-line therapy (Group A, N = 15) and patients who received osimertinib as 2nd-line therapy (Group B, N = 15)., Results: At the time of progression under osimertinib all but one patient preserved the primary EGFR mutation. While the C797S mutation was relatively common in the 2nd-line osimertinib setting (5/15), it did not develop in group A patients. TP53 was the most common detected mutation among all patients accounting for 11/15 in group A (73.33 %) and 10/15 in group B (66.67 %). In group A MET amplification was found in 3/15 patients (20 %) whereas MET mutation appeared in only one patient from group B. The outcomes of different treatment approaches post osimertinib resistance is reported including chemotherapy with/without osimertinib for maintaining control of brain metastases, drug combination such as osimertinib with crizotinib, chemo-immunotherapy and others. Overall survival in this cohort ranged from 12 to80 months., Conclusions: Mechanisms of resistance to osimertinib as 1st-line therapy differ from those which develop in the 2nd-line setting and commonly include MET amplification. C797S is not a main resistance mechanism in the 1st-line setting, whereas it is more common in the 2nd-line setting. Combined therapy was effective and well tolerated, making it an acceptable choice in patients for whom there is a reasonable rationale for such treatment, however this approach deserves further investigation., (Copyright © 2021. Published by Elsevier B.V.)
- Published
- 2021
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25. Long term follow-up of EGFR mutated NSCLC cases.
- Author
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Rennert G, Gottfried M, Rennert HS, Lejbkowicz F, Frank M, Cohen I, Kelt S, Agbarya A, Dudnik E, Dudnik J, Katznelson R, Mishali M, Maimon Rabinovich N, Nechushtan H, Onn A, Keren Rosenberg S, Wollner M, Zer A, Bar J, and Gronich N
- Abstract
Purpose: A substantial fraction of all non-small cell lung cancers(NSCLC) carry a mutation in the EGFR gene for which an effective treatment with anti-tyrosine kinases(TKIs) is available. We studied the long term survival of these patients following the introduction of TKIs., Experimental Design: All consecutive cases of NSCLC newly diagnosed with advanced disease were referred for free tumor EGFR mutation testing at Clalit's national personalized medicine laboratory. Mutations and deletions in target codons 18-21 of EGFR were sought using RT-PCR and fragment analysis. Comprehensive EMRs were used to collect full data on treatments and clinical status., Results: A cohort of 3,062 advanced NSCLC cases, included 481(15.7%) somatic EGFR mutation carriers (17.5% of all adenocarcinomas, 26.7% of females with adenocarcinomas). TKIs treatment to EGFR mutation carriers was provided to 85% of all eligible. After a median follow up period of 15.9 months for EGFR mutated cases the hazard ratio for overall survival of EGFR-mutated NSCLC treated with TKIs was 0.55(0.49-0.63, p<0.0001) when compared with EGFR wild-type(WT) tumors under usual care. After adjusting for age, sex, ethnicity, smoking history and tumor histology, all of which had an independently significant effect on survival, the HR for TKI-treated, EGFR-mutated tumors, was 0.63 (0.55-0.71, p<0.0001). Treating EGFR-WT cases with TKIs yielded a high HR=1.32 (1.19-1.48)., Conclusions: TKIs given to EGFR mutated advanced NSCLC demonstrated a substantial survival benefit for at least five years. Squamous histology, smoking, male sex and Arab ethnicity were associated with higher NSCLC mortality hazard. Treating non-EGFR-mutated NSCLC with TKIs seems detrimental. Statement of Significance: • TKIs given to EGFR mutated advanced NSCLC demonstrated a substantial survival benefit for at least five years but not much longer. • Treating non-EGFR-mutated NSCLC with TKIs seems detrimental and should probably be avoided. • Squamous histology of non-small cell lung cancer, smoking history, male sex and Arab ethnicity were associated with altogether higher NSCLC mortality hazard., Competing Interests: Declaration of Competing Interest None of the authors has any conflict of interests to report., (Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.)
- Published
- 2021
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26. Rising Incidence of Lung Cancer in Arab Females, Jewish Females, and Arab Males from 1990 to 2014 in Israel.
- Author
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Bar J, Perelman M, Urban D, Gottfried M, Moskovitz M, Nechushtan H, Dudnik J, Zer A, Dudnik E, Merimsky O, Onn A, and Silverman B
- Subjects
- Adenocarcinoma epidemiology, Adenocarcinoma ethnology, Age Factors, Aged, Carcinoma, Large Cell epidemiology, Carcinoma, Large Cell ethnology, Carcinoma, Squamous Cell epidemiology, Carcinoma, Squamous Cell ethnology, Female, Humans, Incidence, Israel epidemiology, Lung Neoplasms ethnology, Male, Middle Aged, Registries, Sex Factors, Small Cell Lung Carcinoma epidemiology, Small Cell Lung Carcinoma ethnology, Arabs statistics & numerical data, Jews statistics & numerical data, Lung Neoplasms epidemiology
- Abstract
Background: Lung cancer is the most common cause of cancer-related death., Objectives: To identify changing patterns of lung cancer and its histologic subtypes among different population groups in Israel over a 25 year period., Methods: Primary lung cancers, all types and all stages, diagnosed during 1990-2014 were recorded in the Israel National Cancer Registry database. Demographic information was retrieved from the National Population Register. Age-standardized rates for the different subgroups were calculated for each year. Joinpoint software was used to analyze trends in incidence., Results: We identified 42,672 lung cancer cases. The most common histology was adenocarcinoma (34%), followed by squamous cell carcinoma (19%), large cell/not-otherwise-specified (19%), other histologies (15%), and small cell lung cancer (11%). The adenocarcinoma incidence rose from 25.7% to 48.2% during the examined period. Large cell/not-otherwise-specified incidence peaked around 2005-2006 and declined after. Lung cancer incidence increased significantly for the population overall and specifically in Arab females, followed by Jewish females and by Arab males. Adenocarcinoma and small cell lung cancer increased in Jewish females and in Arab males. A younger age of diagnosis was seen in Arab compared to Jewish patients., Conclusions: Jewish females and Arab males and females living in Israel demonstrated a constant increase in lung cancer incidence, mostly in adenocarcinoma and small cell lung cancer incidence. In addition, a younger age of diagnosis in Arabs was noted. Smoking reduction interventions and screening should be implemented in those populations.
- Published
- 2020
27. Dose escalation of osimertinib for intracranial progression in EGFR mutated non-small-cell lung cancer with brain metastases.
- Author
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Goldstein IM, Roisman LC, Keren-Rosenberg S, Dudnik J, Nechushtan H, Shelef I, Fuchs V, Kian W, and Peled N
- Abstract
Background: Osimertinib is a selective irreversible epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) with increased penetration across the blood-brain barrier compared with previous EGFR-TKIs, and thus, a 52% reduction in the risk of intracranial disease progression is seen when it is used as a first line of therapy compared with gefitinib and erlotinib. It is also efficient as second-line therapy for patients who developed the T790M resistance mutation following treatment with previous generation TKIs. Here, we report 11 patients who were treated by an increasing dose of osimertinib from 80 mg to 160 mg QD orally following intracranial progression in either first- or second-line setting., Methods: This is a subcohort analysis from a larger nonrandomized, phase 2, open-label trial, evaluating the efficacy of osimertinib dose escalation from 80 mg to 160 mg in EGFR-mutated advanced non-small-cell lung cancer (NSCLC) patients with intracranial progression in either first- (arm A) or second-line setting (arm B for T790M+ and C for T790M-)., Results: Eleven patients, 5 in arm A, 4 in arm B, and 2 in arm C were reported in this study. The mPFS of osimertinib before dose escalation was 11.4 ± 8.9 (6.6-30.7) months for arm A, 8.7 ± 1.8 (6.3-11.2) for arm B, and 14.5 ± 7.8 (6.7-22.3) for arm C. Intracranial response rate to dose escalation was 54% (6 of 11) with 2 of 11 having intracranial stability. Median iPFS was 4.3 ± 7.4 (0.7-25.5) months; 3.8 ± 6.4 (1.8-18.9), 5.6 ± 9.7 (0.7-25.5), and 7.0 ± 2.7 (4.3-9.6) for arms A/B/C, respectively. Dose escalation was well tolerated with diarrhea and paronychia as the main dose-limiting symptoms., Conclusions: Osimertinib 160 mg is feasible and may offer a therapeutic alternative for patients with isolated intracranial progression on osimertinib standard (80 mg) dose. Further studies on CNS osimertinib pharmacokinetics are needed to test this hypothesis., (© The Author(s) 2020. Published by Oxford University Press, the Society for Neuro-Oncology and the European Association of Neuro-Oncology.)
- Published
- 2020
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28. 68Ga-DOTATATE PET/CT in Focal Fatty Sparing of the Liver.
- Author
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Hod N, Levin D, Anconina R, Taragin BH, Dudnik J, and Lantsberg S
- Subjects
- Aged, Biological Transport, False Positive Reactions, Fatty Liver complications, Female, Humans, Liver Neoplasms secondary, Lung Neoplasms complications, Lung Neoplasms pathology, Magnetic Resonance Imaging, Neuroendocrine Tumors pathology, Fatty Liver diagnostic imaging, Fatty Liver metabolism, Organometallic Compounds, Positron Emission Tomography Computed Tomography
- Abstract
Ga-DOTATATE imaging is commonly used for the detection of metastatic disease in neuroendocrine tumors. We present a case of a 69-year-old woman postsurgery for lung carcinoid tumor in which sequential follow-up Ga-DOTATATE PET/CT studies identified focal hepatic uptake that was presumed to represent a liver metastasis. However, correlative imaging with MRI revealed a focal fatty sparing of the liver composed of benign hepatic parenchyma at that area accompanied with diffuse liver steatosis in the background of the "pseudolesion." This report demonstrates a potential "false-positive" hepatic finding that can strikingly mimic a metastasis in neuroendocrine tumor imaging.
- Published
- 2019
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29. FDG PET/CT of Mediastinal Epithelioid Hemangioendothelioma.
- Author
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Hod N, Anconina R, Levin D, Delgado B, Dudnik J, and Lantsberg S
- Subjects
- Aged, Biological Transport, Female, Hemangioendothelioma, Epithelioid metabolism, Hemangioendothelioma, Epithelioid pathology, Humans, Mediastinal Neoplasms metabolism, Mediastinal Neoplasms pathology, Neoplasm Staging, Fluorodeoxyglucose F18 metabolism, Hemangioendothelioma, Epithelioid diagnostic imaging, Mediastinal Neoplasms diagnostic imaging, Positron Emission Tomography Computed Tomography
- Abstract
Epithelioid hemangioendothelioma is a rare low- to intermediate-grade malignant vascular neoplasm with a variable clinical course and currently no standardized treatment. We present a case of a 65-year-old woman diagnosed as having mediastinal epithelioid hemangioendothelioma, a location which is very exceptional. FDG PET/CT was more sensitive than CT for staging, revealing intense FDG uptake in the primary tumor and in the metastatic disease. Despite high FDG uptake, the disease was stable with no further specific treatment. Only few reports utilizing FDG PET/CT are available; review of the literature on this subject is included.
- Published
- 2019
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30. Semi-automatic volumetric measurement of response to chemotherapy in lung cancer patients: How wrong are we using RECIST?
- Author
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Greenberg V, Lazarev I, Frank Y, Dudnik J, Ariad S, and Shelef I
- Subjects
- Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols adverse effects, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Female, Humans, Lung Neoplasms drug therapy, Male, Middle Aged, Response Evaluation Criteria in Solid Tumors, Tomography, X-Ray Computed methods, Treatment Outcome, Tumor Burden, Lung Neoplasms diagnostic imaging, Lung Neoplasms pathology
- Abstract
Objectives: Lung cancer typically starts as a near-spherical lesion, but as it grows it may acquire an irregular radiologic formation. RECIST is based on the assumption that tumors are spherical, and consequently, proportional changes of tumor volume and parallel changes in tumor diameter, and vice versa. Hence, a 30% decrease in diameter (2r) implies a 65% decrease of volume, and a 20% increase in diameter implies a 73% increase of volume., Materials and Methods: We compared volumetric measurement based on multi-detector CT technology with calculated volume (CV) according to RECIST in a cohort of 43 patients with advanced, non-squamous cell type, lung cancer treated with a combination of platinum and pemetrexed., Results: CV was larger than SMV in most patients both at baseline and at best overall response (BOR). The difference between the sum of volumes based on volumetric measurement (SMV) and CV was larger for higher sum of diameters. The Lin's concordance correlation coefficient between the percent changes in SMV and CV at BOR was 0.757. Of note, four patients (4/43, 9.5%) were categorized as PD according to the method of CV, but SD according to the method of SMV., Conclusion: Our study highlights the importance of volumetric measurement for assessing response to treatment in lung cancer patients particularly showing large, irregular lesions., (Copyright © 2017 Elsevier B.V. All rights reserved.)
- Published
- 2017
- Full Text
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31. EGFR mutation testing practice in advanced non-small cell lung cancer.
- Author
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Bar J, Cyjon A, Flex D, Sorotsky H, Biran H, Dudnik J, Peylan-Ramu N, Peled N, Nechushtan H, Gips M, Katsnelson R, Rosenberg SK, Merimsky O, Onn A, and Gottfried M
- Subjects
- Antineoplastic Agents therapeutic use, Biopsy, Carcinoma, Non-Small-Cell Lung drug therapy, Carcinoma, Non-Small-Cell Lung enzymology, Carcinoma, Non-Small-Cell Lung pathology, DNA Mutational Analysis statistics & numerical data, Genetic Predisposition to Disease, Health Care Surveys, Humans, Internet, Israel, Lung Neoplasms drug therapy, Lung Neoplasms enzymology, Lung Neoplasms pathology, Molecular Targeted Therapy, Phenotype, Precision Medicine, Predictive Value of Tests, Surveys and Questionnaires, Carcinoma, Non-Small-Cell Lung genetics, DNA Mutational Analysis trends, ErbB Receptors genetics, Lung Neoplasms genetics, Mutation, Practice Patterns, Physicians' trends
- Abstract
Purpose: Testing tumor samples for the presence of a mutation in the epithelial growth factor receptor (EGFR) gene is recommended for advanced non-squamous non-small cell lung cancer (NSCLC) patients. We aimed to collect data about common practice among Medical Oncologists treating lung cancer patients, regarding EGFR mutation testing in advanced NSCLC patients., Methods: An internet-based survey was conducted among members of the Israeli Society for Clinical Oncology and Radiotherapy involved in the treatment of lung cancer patients., Results: 24 Oncologists participated in the survey. The participants encompass the Oncologists treating most of the lung cancer patients in Israel. 79% of them use EGFR testing routinely for all advanced NSCLC patients. Opinions were split regarding the preferable biopsy site for EGFR testing material. 60% of participants recommend waiting for EGFR test results prior to initiation of first-line therapy., Conclusions: EGFR testing is requested in Israel routinely by most treating Oncologists for all advanced NSCLC patients, regardless of histology. In most cases, systemic treatment is deferred until the results of this test are received.
- Published
- 2014
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32. Leukemoid reaction in lung cancer patients.
- Author
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Shalom G, Sion-Vardy N, Dudnik J, and Ariad S
- Subjects
- Adult, Antineoplastic Agents therapeutic use, Carcinoma, Large Cell diagnosis, Carcinoma, Large Cell therapy, Carcinoma, Squamous Cell diagnosis, Carcinoma, Squamous Cell therapy, Diagnosis, Differential, Fatal Outcome, Female, Humans, Leukocytosis etiology, Lung Neoplasms diagnosis, Lung Neoplasms therapy, Male, Middle Aged, Radiotherapy, Adjuvant, Carcinoma, Large Cell complications, Carcinoma, Squamous Cell complications, Leukemoid Reaction etiology, Lung Neoplasms complications
- Published
- 2010
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