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2. Tissue-specific thresholds of mutation burden associated with anti-PD-1/L1 therapy benefit and prognosis in microsatellite-stable cancers

Author

Muquith, Maishara, Espinoza, Magdalena, Elliott, Andrew, Xiu, Joanne, Seeber, Andreas, El-Deiry, Wafik, Antonarakis, Emmanuel S., Graff, Stephanie L., Hall, Michael J., Borghaei, Hossein, Hoon, Dave S. B., Liu, Stephen V., Ma, Patrick C., McKay, Rana R., Wise-Draper, Trisha, Marshall, John, Sledge, George W., Spetzler, David, Zhu, Hao, and Hsiehchen, David

Published
2024
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3. Impact of gender and mutational differences in hormone receptor expressing non-small cell lung cancer

Author

Hsu, Robert, Chen, Denaly, Xia, Bing, Feldman, Rebecca, Cozen, Wendy, Raez, Luis E, Borghaei, Hossein, Kim, Chul, Nagasaka, Misako, Mamdani, Hirva, Vanderwalde, Ari M, Lopes, Gilberto, Socinski, Mark A, Wozniak, Antoinette J, Spira, Alexander I, Liu, Stephen V, and Nieva, Jorge J

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Estrogen, Cancer, Lung, Lung Cancer, Genetics, Good Health and Well Being, gender, hormone receptor, mutational differences, non-small cell lung cancer, disparities, Clinical sciences, Oncology and carcinogenesis
Abstract

BackgroundThe incidence of lung cancer in the US has been decreasing but a bigger decline has been observed in men despite similar declines in tobacco use between men and women. Multiple theories have been proposed, including exposure to exogenous estrogens. Our study seeks to understand the relationship between hormone receptors (HR), gender, and the genomic landscape of non-small lung cancer (NSCLC).Methods3,256 NSCLC tumor samples submitted for molecular profiling between 2013-2018 were retrospectively identified and assessed for HR expression. Hormone receptor (HR+) was defined as ≥ 1% nuclear staining of estrogen receptor-alpha (ER-a) or progesterone receptor (PR) by immunohistochemistry. DNA sequencing by NGS included cases sequenced by the Illumina MiSeq hot spot 47 gene panel (n=2753) and Illumina NextSeq 592 gene panel (n=503). An adjusted p-value (q-value)

Published
2023

6. A phase 1 study of nivolumab in combination with interferon-gamma for patients with advanced solid tumors

Author

Zibelman, Matthew, MacFarlane, IV, Alexander W., Costello, Kimberly, McGowan, Thomas, O’Neill, John, Kokate, Rutika, Borghaei, Hossein, Denlinger, Crystal S., Dotan, Efrat, Geynisman, Daniel M., Jain, Angela, Martin, Lainie, Obeid, Elias, Devarajan, Karthik, Ruth, Karen, Alpaugh, R. Katherine, Dulaimi, Essel Al-Saleem, Cukierman, Edna, Einarson, Margret, Campbell, Kerry S., and Plimack, Elizabeth R.

Published
2023
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7. A Phase 1/2 Study to Evaluate the Safety and Activity of Nivolumab in Combination With Vorolanib, a Vascular Endothelial Growth Factor Tyrosine Kinase Inhibitor, in Patients With Refractory Thoracic Tumors

Author

Beckermann, Kathryn E., Bestvina, Christine M., El Osta, Badi, Sanborn, Rachel E., Borghaei, Hossein, Lammers, Philip Edward, Selvaggi, Giovanni, Whisenant, Jennifer G., Heimann-Nichols, Ellen, Berry, Lynne, Hsu, Chih-Yuan, Shyr, Yu, Horn, Leora, and Wakelee, Heather

Published
2024
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9. SAPPHIRE: phase III study of sitravatinib plus nivolumab versus docetaxel in advanced nonsquamous non-small-cell lung cancer

Author

Abdel-Karim, Isam, Abdelsalam, Mahmoud, Addeo, Alfredo, Aguado, Carlos, Alexander, Patrick, Alt, Jürgen, Azzi, Georges, Balaraman, Rama, Biesma, Bonne, Blackhall, Fiona, Bohnet, Sabine, Boleti, Ekaterini, Borghaei, Hossein, Bradbury, Penelope, Brighenti, Matteo, Campbell, Nicholas, Campbell, Toby, Canon, Jean-Luc, Cappuzzo, Federico, Costa, Enric Carcereny, Cavanna, Luigi, Cetnar, Jeremy, Chella, Antonio, Chouaid, Christos, Christoph, Daniel, Castán, Javier Cortés, Dakhil, Shaker, de Castro Carpeño, Francisco Javier, de Marinis, Filippo, Delmonte, Angelo, Demedts, Ingel, Demey, Wim, Dits, Joyce, del Pilar Diz Taín, Maria, Gómez, Manuel Dómine, Dorius, Timothy, Dumoulin, Daphne, Duruisseaux, Michaël, Eaton, Keith, González, Emilio Esteban, Evans, Devon, Faehling, Martin, Farrell, Nicholas, Feinstein, Trevor, Font, Enriqueta Felip, Garcia Campelo, Maria Rosario, Garon, Edward, Garrido López, María Pilar, Germonpré, Paul, Gersten, Todd, Cao, Maria Gonzalez, Gopaluni, Srivalli, Greillier, Laurent, Grossi, Francesco, Guisier, Florian, Gurubhagavatula, Sarada, Calderón, Vanesa Gutiérrez, Hakimian, David, Hall, Richard, Jr., Hao, Desirée, Harris, Ronald, Hashemi, Sayed, He, Kai, Hendriks, Lizza, Huang, Chao, Ibrahim, Emad, Jain, Sharad, Johnson, Melissa, Jones, Benjamin, Jones, Monte, Juan Vidal, Óscar José, Juergens, Rosalyn, Kaderbhai, Courèche, Kastelijn, Elisabeth A (Lisanne), Keresztes, Roger, Kio, Ebenezer, Kokowski, Konrad, Konduri, Kartik, Kulkarni, Swati, Kuon, Jonas, Kurkjian, Carla, Labbé, Catherine, Lerner, Rachel, Lim, Farah, Madroszyk-Flandin, Anne, Marathe, Omkar, Martincic, Danko, McClay, Edward, McIntyre, Kristi, Mekhail, Tarek, Misino, Andrea, Molinier, Olivier, Morabito, Alessandro, Morócz, Éva, Müller, Veronika, Nagy, Tünde, Nguyen, Anthony V., Nidhiry, Emmanuel, Okazaki, Ian, Ortega-Granados, Ana Laura, Ostoros, Gyula, Oubre, David, Owen, Scott, Pachipala, Krishna, Park, David, Patel, Pareshkumar, Percent, Ivor, Pérol, Maurice, Peters, Solange, Piet, Berber, Planchard, David, Polychronis, Andreas, Aix, Santiago Ponce, Pons-Tostivint, Elvire, Popat, Sanjaykumar, Pulla, Mariano Provencio, Quantin, Xavier, Quéré, Gilles, Rafique, Noman, Ramaekers, Ryan, Reck, Martin, Reiman, Anthony, Reinmuth, Niels, Reynolds, Craig, Rodríguez-Abreu, Delvys, Romano, Gianpiero, Roque, Tammy, Salzberg, Matthew, Sanborn, Rachel, Sandiego, Sergio, Schaefer, Eric, Schreeder, Marshall, Seetharamu, Nagashree, Seneviratne, Lasika, Shah, Purvi, Shunyakov, Leonid, Slater, Dennis, Parra, Hector Soto, Stigt, Johannes, Stilwill, Joseph, Su, Jingdong, Surmont, Veerle, Swink, Alicia, Szalai, Zsuzsanna, Talbot, Toby, Garcia, Alvaro Taus, Theelen, Willemijn, Thompson, Jonathan, Tiseo, Marcello, Uprety, Dipesh, Uyeki, James, van der Leest, Kornelius Cor, Van Ho, Anthony, van Putten, John, Estévez, Sergio Vázquez, Veatch, Andrea, Vergnenègre, Alain, Ward, Patrick, Weise, Amy, Weiss, Matthias, Whitehurst, Matthew, Zai, Silvia, Zalcman, Gérard, Zuniga, Richard, Borghaei, H., de Marinis, F., Dumoulin, D., Reynolds, C., Theelen, W.S.M.E., Percent, I., Gutierrez Calderon, V., Johnson, M.L., Madroszyk-Flandin, A., Garon, E.B., He, K., Planchard, D., Reck, M., Popat, S., Herbst, R.S., Leal, T.A., Shazer, R.L., Yan, X., Harrigan, R., and Peters, S.

Published
2024
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10. Characterization of KRAS Mutation Subtypes in Non-small Cell Lung Cancer.

Author

Judd, Julia, Abdel Karim, Nagla, Khan, Hina, Naqash, Abdul, Baca, Yasmine, Xiu, Joanne, VanderWalde, Ari, Mamdani, Hirva, Raez, Luis, Nagasaka, Misako, Pai, Sachin, Socinski, Mark, Nieva, Jorge, Kim, Chul, Wozniak, Antoinette, Ikpeazu, Chukwuemeka, de Lima Lopes, Gilberto, Spira, Alexander, Korn, W, Kim, Edward, Liu, Stephen, and Borghaei, Hossein

Subjects
Carcinoma, Non-Small-Cell Lung, High-Throughput Nucleotide Sequencing, Humans, Lung Neoplasms, Microsatellite Instability, Mutation, Prognosis, Proto-Oncogene Proteins p21(ras)
Abstract

KRAS is the most commonly mutated oncogene in NSCLC and development of direct KRAS inhibitors has renewed interest in this molecular variant. Different KRAS mutations may represent a unique biologic context with different prognostic and therapeutic impact. We sought to characterize genomic landscapes of advanced, KRAS-mutated non-small cell lung cancer (NSCLC) in a large national cohort to help guide future therapeutic development.Molecular profiles of 17,095 NSCLC specimens were obtained using DNA next-generation sequencing of 592 genes (Caris Life Sciences) and classified on the basis of presence and subtype of KRAS mutations. Co-occurring genomic alterations, tumor mutational burden (TMB), and PD-L1 expression [22C3, tumor proportion score (TPS) score] were analyzed by KRAS mutation type.Across the cohort, 4,706 (27.5%) samples harbored a KRAS mutation. The most common subtype was G12C (40%), followed by G12V (19%) and G12D (15%). The prevalence of KRAS mutations was 37.2% among adenocarcinomas and 4.4% in squamous cell carcinomas. Rates of high TMB (≥10 mutations/Mb) and PD-L1 expression varied across KRAS mutation subtypes. KRAS G12C was the most likely to be PD-L1 positive (65.5% TPS ≥ 1%) and PD-L1 high (41.3% TPS ≥ 50%). STK11 was mutated in 8.6% of KRAS wild-type NSCLC but more frequent in KRAS-mutant NSCLC, with the highest rate in G13 (36.2%). TP53 mutations were more frequent in KRAS wild-type NSCLC (73.6%).KRAS mutation subtypes have different co-occurring mutations and a distinct genomic landscape. The clinical relevance of these differences in the context of specific therapeutic interventions warrants investigation.

Published
2021

11. Impact of XPO1 mutations on survival outcomes in metastatic non-small cell lung cancer (NSCLC).

Author

Nagasaka, Misako, Asad, Mohammad, Al Hallak, Mohammed, Uddin, Md, Sukari, Ammar, Baca, Yasmine, Xiu, Joanne, Magee, Dan, Mamdani, Hirva, Uprety, Dipesh, Kim, Chul, Xia, Bing, Liu, Stephen, Nieva, Jorge, Lopes, Gilberto, Bepler, Gerold, Borghaei, Hossein, Demeure, Michael, Raez, Luis, Ma, Patrick, Puri, Sonam, Korn, W, and Azmi, Asfar

Subjects
NGS, NSCLC, Nuclear Protein Transport, Tumor Mutational Burden, XPO1, Carcinoma, Non-Small-Cell Lung, Humans, Karyopherins, Lung Neoplasms, Mutation, Receptors, Cytoplasmic and Nuclear
Abstract

BACKGROUND: Nuclear protein transport is essential in guiding the traffic of important proteins and RNAs between the nucleus and cytoplasm. Export of proteins from the nucleus is mostly regulated by Exportin 1 (XPO1). In cancer, XPO1 is almost universally hyperactive and can promote the export of important tumor suppressors to the cytoplasm. Currently, there are no studies evaluating XPO1 amplifications and mutations in NSCLC and the impact on outcomes. METHODS: Tumor samples were analyzed using next-generation sequencing (NGS) (NextSeq, 592 Genes), immunohistochemistry (IHC), and whole transcriptome sequencing (WTS, NovaSeq) (Caris Life Sciences, Phoenix, AZ). Survival was extracted from insurance claims data and calculated from time of tissue collection to last contact using Kaplan-Meier estimate. RESULTS: Among 18,218 NSCLC tumors sequenced, 26 harbored XPO1 mutations and 24 had amplifications. XPO1 mutant tumors were more likely to have high TMB (79% vs. 52%, p = 0.007) and less likely to have high PD-L1 (32% vs. 68%, p = 0.03). KRAS co-mutations were seen in 19% (n = 5) and EGFR co-mutations were rare (n = 2). Among the 17,449 NSCLC tumors with clinical data, there were 24 XPO1 mutant. Comparison of survival between XPO1 mutant and WT showed a negative association with a hazard ratio (HR) of 1.932 (95% CI: 1.144-3.264 p = 0.012). XPO1 amplification was not associated with survival. CONCLUSIONS: XPO1 pathogenic mutations were associated with a poor survival in NSCLC. Although XPO1 mutations are rare in NSCLC, further studies to assess its associations with treatment responses are warranted.

Published
2021

14. Systemic and Intracranial Outcomes With First-Line Nivolumab Plus Ipilimumab in Patients With Metastatic NSCLC and Baseline Brain Metastases From CheckMate 227 Part 1

Author

Reck, Martin, Ciuleanu, Tudor-Eliade, Lee, Jong-Seok, Schenker, Michael, Zurawski, Bogdan, Kim, Sang-We, Mahave, Mauricio, Alexandru, Aurelia, Peters, Solange, Pluzanski, Adam, Caro, Reyes Bernabe, Linardou, Helena, Burgers, Jacobus A., Nishio, Makoto, Martinez-Marti, Alex, Azuma, Koichi, Axelrod, Rita, Paz-Ares, Luis G., Ramalingam, Suresh S., Borghaei, Hossein, O’Byrne, Kenneth J., Li, Li, Bushong, Judith, Gupta, Ravi G., Grootendorst, Diederik J., Eccles, Laura J., and Brahmer, Julie R.

Published
2023
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15. SWOG S1400D (NCT02965378), a Phase II Study of the Fibroblast Growth Factor Receptor Inhibitor AZD4547 in Previously Treated Patients With Fibroblast Growth Factor Pathway–Activated Stage IV Squamous Cell Lung Cancer (Lung-MAP Substudy)

Author

Aggarwal, Charu, Redman, Mary W, Lara, Primo N, Borghaei, Hossein, Hoffman, Philip, Bradley, Jeffrey D, Newman, Alfred J, Feldman, Marvin J, Minichiello, Katherine, Miao, Jieling, Mack, Philip C, Papadimitrakopoulou, Vassiliki A, Herbst, Roy S, Kelly, Karen, and Gandara, David R

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Cancer, Lung, Lung Cancer, Clinical Trials and Supportive Activities, Clinical Research, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Aged, Aged, 80 and over, Antineoplastic Agents, Benzamides, Biomarkers, Tumor, Carcinoma, Non-Small-Cell Lung, Carcinoma, Squamous Cell, Female, Follow-Up Studies, Gene Amplification, Humans, Lung Neoplasms, Male, Middle Aged, Neoplasm Staging, Piperazines, Pyrazoles, Receptor, Fibroblast Growth Factor, Type 1, Receptor, Fibroblast Growth Factor, Type 3, Salvage Therapy, Survival Rate, LUNG-MAP, SWOG1400, FGFR inhibitor, Cardiorespiratory Medicine and Haematology, Oncology & Carcinogenesis, Clinical sciences, Oncology and carcinogenesis
Abstract

BackgroundS1400D is a biomarker-driven therapeutic substudy of Lung-MAP evaluating the fibroblast growth factor (FGF) receptor (FGFR) inhibitor AZD4547 in patients with FGF pathway-activated squamous cell. This is the first phase II trial to evaluate AZD4547 as a targeted approach in patients with previously treated FGFR-altered squamous cell NSCLC and is the first demonstration of successful implementation and conduct of a national umbrella protocol in this disease setting.MethodsEligible patients had tumoral FGFR alteration or mutation and had progressive disease after at least one line of platinum-based systemic therapy. Patients received AZD4547 80 mg twice daily orally. Primary endpoint was response by Response Evaluation Criteria in Solid Tumors version 1.1; secondary endpoints included progression-free survival, overall survival, and duration of response (DoR).ResultsNinety-two patients were assigned to S1400D, 43 were enrolled, and 27 AZD4547-treated patients were evaluable. Evaluable patients were predominantly white (n = 24, 89%), median age 66 years (range, 49-88 years old), and female (n = 7, 26%). FGFR alterations included FGFR1 amplification (n = 23; 85%), FGFR3 amplification (n = 2; 7%), FGFR3 S249C (n = 2; 7%), and FGFR3 fusion (n = 1; 4%). Treatment with ADZ4547 was well tolerated; grade 3 adverse events occurred in six patients, and one patient had grade 4 sepsis. Of 27 response-evaluable patients, 1 patient with FGFR3 S249C had unconfirmed partial response with a DoR of 1.5 months and 1 patient with FGFR1 amplification had a confirmed partial response with a DoR of 2.9 months (7%, 95% confidence interval [CI]: 0%-17%). Median progression-free survival and overall survival for the AZD4547-treated cohort were 2.7 months (95% CI: 1.4- 4.5 months) and 7.5 months (95% CI: 3.7-9.3 months).ConclusionsAZD4547 had an acceptable safety profile but minimal activity in this predominantly FGFR1/FGFR3-amplified cohort. Evaluation of other targeted agents in Lung-MAP is ongoing.

Published
2019

16. Safety of First-Line Nivolumab Plus Ipilimumab in Patients With Metastatic NSCLC: A Pooled Analysis of CheckMate 227, CheckMate 568, and CheckMate 817

Author

Paz-Ares, Luis G., Ciuleanu, Tudor-Eliade, Pluzanski, Adam, Lee, Jong-Seok, Gainor, Justin F., Otterson, Gregory A., Audigier-Valette, Clarisse, Ready, Neal, Schenker, Michael, Linardou, Helena, Caro, Reyes Bernabe, Provencio, Mariano, Zurawski, Bogdan, Lee, Ki Hyeong, Kim, Sang-We, Caserta, Claudia, Ramalingam, Suresh S., Spigel, David R., Brahmer, Julie R., Reck, Martin, O’Byrne, Kenneth J., Girard, Nicolas, Popat, Sanjay, Peters, Solange, Memaj, Arteid, Nathan, Faith, Aanur, Nivedita, and Borghaei, Hossein

Published
2023
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17. Sotorasib versus pembrolizumab in combination with platinum doublet chemotherapy as first-line treatment for metastatic or locally advanced, PD-L1 negative, KRAS G12C-mutated NSCLC (CodeBreaK 202).

Author

Barlesi, Fabrice, primary, Felip, Enriqueta, additional, Popat, Sanjay, additional, Solomon, Benjamin J., additional, Wolf, Juergen, additional, Li, Bob T., additional, Wu, Yi-Long, additional, Kerr, Keith, additional, Akamatsu, Hiroaki, additional, Camidge, David Ross, additional, Gupta, Ravi G., additional, Meloni, Alison, additional, Dai, Tian, additional, and Borghaei, Hossein, additional

Published
2024
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18. TRITON: Phase 3b study of tremelimumab (T) + durvalumab (D) vs pembrolizumab (P), in combination with chemotherapy (CT), in non-squamous (NSQ) metastatic NSCLC (mNSCLC) with STK11and/or KEAP1 and/or KRAS mutations.

Author

Skoulidis, Ferdinandos, primary, Borghaei, Hossein, additional, Garon, Edward B., additional, Leal, Ticiana, additional, Liu, Stephen V., additional, Nadler, Eric S., additional, Patel, Sandip Pravin, additional, Velcheti, Vamsidhar, additional, Gautam, Ashish, additional, Emeribe, Ugochinyere, additional, Luciani-Silverman, Luisa, additional, and Heymach, John, additional

Published
2024
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29. A process to reanalyze clinical DNA sequencing data for biomarker matching in the Lung-MAP Master Protocol

Author

Neal, Joel W, primary, Minichiello, Katherine, additional, Brennick, Ryan, additional, Huang, Richard S P, additional, Hiemenz, Matthew C, additional, Amler, Cornel, additional, Patel, Jyoti, additional, Herbst, Roy, additional, Reckamp, Karen L, additional, Borghaei, Hossein, additional, Highleyman, Louise, additional, Redman, Mary W, additional, Pasquina, Lincoln W, additional, and Kozono, David E, additional

Published
2024
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30. First-Line Nivolumab Plus Ipilimumab in Advanced NSCLC: 4-Year Outcomes From the Randomized, Open-Label, Phase 3 CheckMate 227 Part 1 Trial

Author

Paz-Ares, Luis G., Ramalingam, Suresh S., Ciuleanu, Tudor-Eliade, Lee, Jong-Seok, Urban, Laszlo, Caro, Reyes Bernabe, Park, Keunchil, Sakai, Hiroshi, Ohe, Yuichiro, Nishio, Makoto, Audigier-Valette, Clarisse, Burgers, Jacobus A., Pluzanski, Adam, Sangha, Randeep, Gallardo, Carlos, Takeda, Masayuki, Linardou, Helena, Lupinacci, Lorena, Lee, Ki Hyeong, Caserta, Claudia, Provencio, Mariano, Carcereny, Enric, Otterson, Gregory A., Schenker, Michael, Zurawski, Bogdan, Alexandru, Aurelia, Vergnenegre, Alain, Raimbourg, Judith, Feeney, Kynan, Kim, Sang-We, Borghaei, Hossein, O'Byrne, Kenneth John, Hellmann, Matthew D., Memaj, Arteid, Nathan, Faith Ellen, Bushong, Judith, Tran, Phuong, Brahmer, Julie R., and Reck, Martin

Published
2022
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31. The Effects of HER2 Alterations in EGFR Mutant Non-small Cell Lung Cancer

Author

Nagasaka, Misako, Singh, Vijendra, Baca, Yasmine, Sukari, Ammar, Kim, Chul, Mamdani, Hirva, Spira, Alexander I., Uprety, Dipesh, Bepler, Gerold, Kim, Edward S., Raez, Luis E., Pai, Sachin Gopalkrishna, Ikpeazu, Chukwuemeka, Oberley, Matthew, Feldman, Rebecca, Xiu, Joanne, Korn, W. Michael, Wozniak, Antoinette J., Borghaei, Hossein, and Liu, Stephen V.

Published
2022
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32. Durvalumab with platinum-pemetrexed for unresectable pleural mesothelioma: survival, genomic and immunologic analyses from the phase 2 PrE0505 trial

Author

Forde, Patrick M., Anagnostou, Valsamo, Sun, Zhuoxin, Dahlberg, Suzanne E., Kindler, Hedy L., Niknafs, Noushin, Purcell, Thomas, Santana-Davila, Rafael, Dudek, Arkadiusz Z., Borghaei, Hossein, Lanis, Mara, Belcaid, Zineb, Smith, Kellie N., Balan, Archana, White, James R., Cherry, Christopher, Ashok Sivakumar, I. K., Shao, Xiaoshan M., Chan, Hok Yee, Singh, Dipika, Thapa, Sampriti, Illei, Peter B., Pardoll, Drew M., Karchin, Rachel, Velculescu, Victor E., Brahmer, Julie R., and Ramalingam, Suresh S.

Published
2021
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35. Incidence, Correlates, and Prognostic Significance of Mixed Response in Advanced Non-small Cell Lung Cancer.

Author

Gerber, David E, Wang, Yating, Ramalingam, Suresh S, Bhalla, Sheena, Sun, Zhuoxin, Borghaei, Hossein, Brahmer, Julie R, and Schiller, Joan H

Subjects
THERAPEUTIC use of antineoplastic agents, PEARSON correlation (Statistics), RISK assessment, BEVACIZUMAB, TREATMENT effectiveness, CARBOPLATIN, MANN Whitney U Test, CHI-squared test, MULTIVARIATE analysis, LOG-rank test, CANCER chemotherapy, CANCER cells, LUNG cancer, TUMOR classification, PACLITAXEL, CONFIDENCE intervals, SURVIVAL analysis (Biometry), OVERALL survival, PROPORTIONAL hazards models
Abstract

Background Mixed response (MR), a scenario featuring discordant tumor changes, has been reported primarily with targeted therapies or immunotherapy. We determined the incidence and prognostic significance of MR in advanced non–small cell lung cancer (NSCLC) treated with cytotoxic chemotherapy. Patients and Methods We analyzed patient-level data from ECOG-ACRIN E5508 (carboplatin-paclitaxel + bevacizumab induction followed by randomization to maintenance therapy regimens). For patients with at least 2 target lesions and available measurements after cycle 2, we characterized response as homogeneous response (HR, similar behavior of all lesions), MR (similar behavior but >30% difference in magnitude of best and least responding lesions), or true mixed response (TMR, best and least responding lesions showing different behavior: ≥10% growth versus ≥10% shrinkage). We compared category characteristics using Mann-Whitney U and Chi-square tests, and overall survival (OS) using log-rank test and Cox models. Results Among 965 evaluable patients, HR occurred in 609 patients (63%), MR in 208 (22%), and TMR in 148 (15%). Median OS was 13.6 months for HR, 12.0 months for MR, and 7.6 months for TMR (P  < .001). Compared to HR, TMR had inferior OS among stable disease cases (HR 1.62; 95% CI, 1.23-2.12; P  < .001) and a trend toward inferior OS among progressive disease cases (HR 1.39; 95% CI, 0.83-2.33; P  = .2). In multivariate analysis, TMR was associated with worse OS (HR 1.48; 95% CI, 1.22-1.79; P  < .001). Conclusion True mixed response occurs in a substantial minority of lung cancer cases treated with chemotherapy and independently confers poor prognosis. [ABSTRACT FROM AUTHOR]

Published
2024
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37. NCCN Guidelines Insights: Malignant Pleural Mesothelioma, Version 3.2016.

Author

Ettinger, David S, Wood, Douglas E, Akerley, Wallace, Bazhenova, Lyudmila A, Borghaei, Hossein, Camidge, David Ross, Cheney, Richard T, Chirieac, Lucian R, D'Amico, Thomas A, Dilling, Thomas, Dobelbower, Michael, Govindan, Ramaswamy, Hennon, Mark, Horn, Leora, Jahan, Thierry M, Komaki, Ritsuko, Lackner, Rudy P, Lanuti, Michael, Lilenbaum, Rogerio, Lin, Jules, Loo, Billy W, Martins, Renato, Otterson, Gregory A, Patel, Jyoti D, Pisters, Katherine M, Reckamp, Karen, Riely, Gregory J, Schild, Steven E, Shapiro, Theresa A, Sharma, Neelesh, Swanson, Scott J, Stevenson, James, Tauer, Kurt, Yang, Stephen C, Gregory, Kristina, and Hughes, Miranda

Subjects
Lung Cancer, Rare Diseases, Lung, Cancer, Detection, screening and diagnosis, 4.2 Evaluation of markers and technologies, Humans, Lung Neoplasms, Mesothelioma, Mesothelioma, Malignant, Pleural Neoplasms, Oncology & Carcinogenesis
Abstract

These NCCN Guidelines Insights focus on recent updates to the NCCN Guidelines for Malignant Pleural Mesothelioma (MPM). These NCCN Guidelines Insights discuss systemic therapy regimens and surgical controversies for MPM. The NCCN panel recommends cisplatin/pemetrexed (category 1) for patients with MPM. The NCCN panel also now recommends bevacizumab/cisplatin/pemetrexed as a first-line therapy option for patients with unresectable MPM who are candidates for bevacizumab. The complete version of the NCCN Guidelines for MPM, available at NCCN.org, addresses all aspects of management for MPM including diagnosis, evaluation, staging, treatment, surveillance, and therapy for recurrence and metastasis; NCCN Guidelines are intended to assist with clinical decision-making.

Published
2016

38. NCCN Guidelines Insights: Non-Small Cell Lung Cancer, Version 4.2016.

Author

Ettinger, David S, Wood, Douglas E, Akerley, Wallace, Bazhenova, Lyudmila A, Borghaei, Hossein, Camidge, David Ross, Cheney, Richard T, Chirieac, Lucian R, D'Amico, Thomas A, Dilling, Thomas J, Dobelbower, M Chris, Govindan, Ramaswamy, Hennon, Mark, Horn, Leora, Jahan, Thierry M, Komaki, Ritsuko, Lackner, Rudy P, Lanuti, Michael, Lilenbaum, Rogerio, Lin, Jules, Loo, Billy W, Martins, Renato, Otterson, Gregory A, Patel, Jyoti D, Pisters, Katherine M, Reckamp, Karen, Riely, Gregory J, Schild, Steven E, Shapiro, Theresa A, Sharma, Neelesh, Stevenson, James, Swanson, Scott J, Tauer, Kurt, Yang, Stephen C, Gregory, Kristina, and Hughes, Miranda

Subjects
Lung Cancer, Cancer, Lung, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Good Health and Well Being, Antibodies, Monoclonal, Antibodies, Monoclonal, Humanized, Antineoplastic Agents, Carcinoma, Non-Small-Cell Lung, Carcinoma, Squamous Cell, Docetaxel, Humans, Immunosuppressive Agents, Immunotherapy, Lung Neoplasms, Nivolumab, Practice Guidelines as Topic, Survival Rate, Taxoids, Oncology & Carcinogenesis
Abstract

These NCCN Guidelines Insights focus on recent updates in the 2016 NCCN Guidelines for Non-Small Cell Lung Cancer (NSCLC; Versions 1-4). These NCCN Guidelines Insights will discuss new immunotherapeutic agents, such as nivolumab and pembrolizumab, for patients with metastatic NSCLC. For the 2016 update, the NCCN panel recommends immune checkpoint inhibitors as preferred agents (in the absence of contraindications) for second-line and beyond (subsequent) therapy in patients with metastatic NSCLC (both squamous and nonsquamous histologies). Nivolumab and pembrolizumab are preferred based on improved overall survival rates, higher response rates, longer duration of response, and fewer adverse events when compared with docetaxel therapy.

Published
2016

40. Tarlatamab for Patients with Previously Treated Small-Cell Lung Cancer

Author

Ahn, Myung-Ju, primary, Cho, Byoung Chul, additional, Felip, Enriqueta, additional, Korantzis, Ippokratis, additional, Ohashi, Kadoaki, additional, Majem, Margarita, additional, Juan-Vidal, Oscar, additional, Handzhiev, Sabin, additional, Izumi, Hiroki, additional, Lee, Jong-Seok, additional, Dziadziuszko, Rafal, additional, Wolf, Jürgen, additional, Blackhall, Fiona, additional, Reck, Martin, additional, Bustamante Alvarez, Jean, additional, Hummel, Horst-Dieter, additional, Dingemans, Anne-Marie C., additional, Sands, Jacob, additional, Akamatsu, Hiroaki, additional, Owonikoko, Taofeek K., additional, Ramalingam, Suresh S., additional, Borghaei, Hossein, additional, Johnson, Melissa L., additional, Huang, Shuang, additional, Mukherjee, Sujoy, additional, Minocha, Mukul, additional, Jiang, Tony, additional, Martinez, Pablo, additional, Anderson, Erik S., additional, and Paz-Ares, Luis, additional

Published
2023
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41. Phase II Randomized Trial of Carboplatin, Pemetrexed, and Bevacizumab With and Without Atezolizumab in Stage IV Nonsquamous Non–Small-Cell Lung Cancer Patients Who Harbor a Sensitizing EGFR Mutation or Have Never Smoked

Author

Bodor, J. Nicholas, primary, Patel, Jyoti D., additional, Wakelee, Heather A., additional, Levy, Benjamin P., additional, Borghaei, Hossein, additional, Pellini, Bruna, additional, Costello, Michael R., additional, Dowell, Jonathan E., additional, Finley, Gene, additional, Huang, Chao H., additional, Neal, Joel W., additional, Nieva, Jorge J, additional, Puri, Sonam, additional, Socinski, Mark A., additional, Thomas, Christian, additional, Ross, Eric A., additional, Litwin, Samuel, additional, Clapper, Margie L., additional, and Treat, Joseph, additional

Published
2023
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42. Validation of a Molecular Diagnostic Test for Circulating Tumor DNA by Next-Gen Sequencing

Author

Fernandez, Sandra V., primary, Tan, Yin Fei, additional, Rao, Shilpa, additional, Fittipaldi, Patricia, additional, Sheriff, Fathima, additional, Borghaei, Hossein, additional, Dotan, Efrat, additional, Winn, Jennifer S., additional, Edelman, Martin J., additional, Treat, Joseph, additional, Judd, Julia, additional, Alpaugh, R. Katherine, additional, Wang, Y. Lynn, additional, Yu, Jian Q., additional, Wasik, Mariusz, additional, and Baldwin, Don A., additional

Published
2023
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43. SAPPHIRE: phase III study of sitravatinib plus nivolumab versus docetaxel in advanced nonsquamous non-small-cell lung cancer

Author

Borghaei, H., primary, de Marinis, F., additional, Dumoulin, D., additional, Reynolds, C., additional, Theelen, W.S.M.E., additional, Percent, I., additional, Gutierrez Calderon, V., additional, Johnson, M.L., additional, Madroszyk-Flandin, A., additional, Garon, E.B., additional, He, K., additional, Planchard, D., additional, Reck, M., additional, Popat, S., additional, Herbst, R.S., additional, Leal, T.A., additional, Shazer, R.L., additional, Yan, X., additional, Harrigan, R., additional, Peters, S., additional, Abdel-Karim, Isam, additional, Abdelsalam, Mahmoud, additional, Addeo, Alfredo, additional, Aguado, Carlos, additional, Alexander, Patrick, additional, Alt, Jürgen, additional, Azzi, Georges, additional, Balaraman, Rama, additional, Biesma, Bonne, additional, Blackhall, Fiona, additional, Bohnet, Sabine, additional, Boleti, Ekaterini, additional, Borghaei, Hossein, additional, Bradbury, Penelope, additional, Brighenti, Matteo, additional, Campbell, Nicholas, additional, Campbell, Toby, additional, Canon, Jean-Luc, additional, Cappuzzo, Federico, additional, Costa, Enric Carcereny, additional, Cavanna, Luigi, additional, Cetnar, Jeremy, additional, Chella, Antonio, additional, Chouaid, Christos, additional, Christoph, Daniel, additional, Castán, Javier Cortés, additional, Dakhil, Shaker, additional, de Castro Carpeño, Francisco Javier, additional, de Marinis, Filippo, additional, Delmonte, Angelo, additional, Demedts, Ingel, additional, Demey, Wim, additional, Dits, Joyce, additional, del Pilar Diz Taín, Maria, additional, Gómez, Manuel Dómine, additional, Dorius, Timothy, additional, Dumoulin, Daphne, additional, Duruisseaux, Michaël, additional, Eaton, Keith, additional, González, Emilio Esteban, additional, Evans, Devon, additional, Faehling, Martin, additional, Farrell, Nicholas, additional, Feinstein, Trevor, additional, Font, Enriqueta Felip, additional, Garcia Campelo, Maria Rosario, additional, Garon, Edward, additional, Garrido López, María Pilar, additional, Germonpré, Paul, additional, Gersten, Todd, additional, Cao, Maria Gonzalez, additional, Gopaluni, Srivalli, additional, Greillier, Laurent, additional, Grossi, Francesco, additional, Guisier, Florian, additional, Gurubhagavatula, Sarada, additional, Calderón, Vanesa Gutiérrez, additional, Hakimian, David, additional, Hall, Richard, additional, Hao, Desirée, additional, Harris, Ronald, additional, Hashemi, Sayed, additional, He, Kai, additional, Hendriks, Lizza, additional, Huang, Chao, additional, Ibrahim, Emad, additional, Jain, Sharad, additional, Johnson, Melissa, additional, Jones, Benjamin, additional, Jones, Monte, additional, Juan Vidal, Óscar José, additional, Juergens, Rosalyn, additional, Kaderbhai, Courèche, additional, Kastelijn, Elisabeth A (Lisanne), additional, Keresztes, Roger, additional, Kio, Ebenezer, additional, Kokowski, Konrad, additional, Konduri, Kartik, additional, Kulkarni, Swati, additional, Kuon, Jonas, additional, Kurkjian, Carla, additional, Labbé, Catherine, additional, Lerner, Rachel, additional, Lim, Farah, additional, Madroszyk-Flandin, Anne, additional, Marathe, Omkar, additional, Martincic, Danko, additional, McClay, Edward, additional, McIntyre, Kristi, additional, Mekhail, Tarek, additional, Misino, Andrea, additional, Molinier, Olivier, additional, Morabito, Alessandro, additional, Morócz, Éva, additional, Müller, Veronika, additional, Nagy, Tünde, additional, Nguyen, Anthony V., additional, Nidhiry, Emmanuel, additional, Okazaki, Ian, additional, Ortega-Granados, Ana Laura, additional, Ostoros, Gyula, additional, Oubre, David, additional, Owen, Scott, additional, Pachipala, Krishna, additional, Park, David, additional, Patel, Pareshkumar, additional, Percent, Ivor, additional, Pérol, Maurice, additional, Peters, Solange, additional, Piet, Berber, additional, Planchard, David, additional, Polychronis, Andreas, additional, Aix, Santiago Ponce, additional, Pons-Tostivint, Elvire, additional, Popat, Sanjaykumar, additional, Pulla, Mariano Provencio, additional, Quantin, Xavier, additional, Quéré, Gilles, additional, Rafique, Noman, additional, Ramaekers, Ryan, additional, Reck, Martin, additional, Reiman, Anthony, additional, Reinmuth, Niels, additional, Reynolds, Craig, additional, Rodríguez-Abreu, Delvys, additional, Romano, Gianpiero, additional, Roque, Tammy, additional, Salzberg, Matthew, additional, Sanborn, Rachel, additional, Sandiego, Sergio, additional, Schaefer, Eric, additional, Schreeder, Marshall, additional, Seetharamu, Nagashree, additional, Seneviratne, Lasika, additional, Shah, Purvi, additional, Shunyakov, Leonid, additional, Slater, Dennis, additional, Parra, Hector Soto, additional, Stigt, Johannes, additional, Stilwill, Joseph, additional, Su, Jingdong, additional, Surmont, Veerle, additional, Swink, Alicia, additional, Szalai, Zsuzsanna, additional, Talbot, Toby, additional, Garcia, Alvaro Taus, additional, Theelen, Willemijn, additional, Thompson, Jonathan, additional, Tiseo, Marcello, additional, Uprety, Dipesh, additional, Uyeki, James, additional, van der Leest, Kornelius Cor, additional, Van Ho, Anthony, additional, van Putten, John, additional, Estévez, Sergio Vázquez, additional, Veatch, Andrea, additional, Vergnenègre, Alain, additional, Ward, Patrick, additional, Weise, Amy, additional, Weiss, Matthias, additional, Whitehurst, Matthew, additional, Zai, Silvia, additional, Zalcman, Gérard, additional, and Zuniga, Richard, additional

Published
2023
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44. Four-year survival with nivolumab in patients with previously treated advanced non-small-cell lung cancer: a pooled analysis

Author

Antonia, Scott J, Borghaei, Hossein, Ramalingam, Suresh S, Horn, Leora, De Castro Carpeño, Javier, Pluzanski, Adam, Burgio, Marco A, Garassino, Marina, Chow, Laura Q M, Gettinger, Scott, Crinò, Lucio, Planchard, David, Butts, Charles, Drilon, Alexander, Wojcik-Tomaszewska, Joanna, Otterson, Gregory A, Agrawal, Shruti, Li, Ang, Penrod, John R, and Brahmer, Julie

Published
2019
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47. Influence of TP53 Comutation on the Tumor Immune Microenvironment and Clinical Outcomes With Immune Checkpoint Inhibitors in STK11 -Mutant Non–Small-Cell Lung Cancer.

Author

Naqash, Abdul Rafeh, Floudas, Charalampos S., Aber, Etan, Maoz, Asaf, Nassar, Amin H., Adib, Elio, Choucair, Khalil, Xiu, Joanne, Baca, Yasmine, Ricciuti, Biagio, Alessi, Joao V., Awad, Mark M., Kim, Chul, Judd, Julia, Raez, Luis E., Lopes, Gilberto, Nieva, Jorge J., Borghaei, Hossein, Takebe, Naoko, and Ma, Patrick C.

Subjects
IMMUNE checkpoint inhibitors, NON-small-cell lung carcinoma, GLUTAMINE, TUMOR microenvironment, GLUTAMINE synthetase, KILLER cells, METABOLIC reprogramming
Abstract

PURPOSE: Non–small-cell lung cancer (NSCLC) with STK11 mut has inferior outcomes to immune checkpoint inhibitors (ICIs). Using multiomics, we evaluated whether a subtype of STK11 mut NSCLC with a uniquely inflamed tumor immune microenvironment (TIME) harboring TP53 comutations could have favorable outcomes to ICIs. PATIENTS AND METHODS: NSCLC tumors (N = 16,896) were analyzed by next-generation sequencing (DNA-Seq/592 genes). A subset (n = 5,034) underwent gene expression profiling (RNA-Seq/whole transcriptome). Exome-level neoantigen load for STK11 mut NSCLC was obtained from published pan-immune analysis. Tumor immune cell content was obtained from transcriptome profiles using the microenvironment cell population (MCP) counter. ICI data from POPLAR/OAK (n = 34) and the study by Rizvi et al (n = 49) were used to model progression-free survival (PFS), and a separate ICI-treated cohort (n = 53) from Dana-Farber Cancer Institute (DFCI) was used to assess time to treatment failure (TTF) and tumor RECIST response for STK11 mut TP53 mut versus STK11 mut TP53 wt NSCLC. RESULTS: Overall, 12.6% of NSCLC tumors had a STK11 mut with the proportions of tumor mutational burden (TMB)-high (≥10 mut/Mb), PD-L1 ≥50%, and microsatellite instability-high being 38.3%, 11.8%, and 0.72%, respectively. Unsupervised hierarchical clustering of STK11 mut (n = 463) for stimulator of interferon-gamma (STING) pathway genes identified a STING-high cluster, which was significantly enriched in TP53 mut NSCLC (P <.01). Compared with STK11 mut TP53 wt, tumors with STK11 mut TP53 mut had higher CD8+T cells and natural killer cells (P <.01), higher TMB (P <.001) and neoantigen load (P <.001), and increased expression of MYC and HIF-1A (P <.01), along with higher expression (P <.01) of glycolysis/glutamine metabolism genes. Meta-analysis of data from OAK/POPLAR and the study by Rizvi et al showed a trend toward improved PFS in patients with STK11 mut TP53 mut. In the DFCI cohort, compared with the STK11 mut TP53 wt cohort, the STK11 mut TP53 mut tumors had higher objective response rates (42.9% v 16.7%; P =.04) and also had longer TTF (14.5 v 4.5 months, P adj =.054) with ICI. CONCLUSION: STK11 mut NSCLC with TP53 comutation is a distinct subgroup with an immunologically active TIME and metabolic reprogramming. These properties should be exploited to guide patient selection for novel ICI-based combination approaches. [ABSTRACT FROM AUTHOR]

Published
2024
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48. Impact of gender and mutational differences in hormone receptor expressing non-small cell lung cancer

Author

Hsu, Robert, primary, Chen, Denaly, additional, Xia, Bing, additional, Feldman, Rebecca, additional, Cozen, Wendy, additional, Raez, Luis E., additional, Borghaei, Hossein, additional, Kim, Chul, additional, Nagasaka, Misako, additional, Mamdani, Hirva, additional, Vanderwalde, Ari M., additional, Lopes, Gilberto, additional, Socinski, Mark A., additional, Wozniak, Antoinette J., additional, Spira, Alexander I., additional, Liu, Stephen V., additional, and Nieva, Jorge J., additional

Published
2023
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49. Musashi-2 (MSI2) regulates epidermal growth factor receptor (EGFR) expression and response to EGFR inhibitors in EGFR-mutated non-small cell lung cancer (NSCLC)

Author

Makhov, Petr, Bychkov, Igor, Faezov, Bulat, Deneka, Alexander, Kudinov, Alexander, Nicolas, Emmanuelle, Brebion, Rohan, Avril, Eleanor, Cai, Kathy Q., Kharin, Leonid V., Voloshin, Mark, Frantsiyants, Elena, Karnaukhov, Nikolay, Kit, Oleg I., Topchu, Iuliia, Fazliyeva, Rushaniya, Nikonova, Anna S., Serebriiskii, Ilya G., Borghaei, Hossein, Edelman, Martin, Dulaimi, Essel, Golemis, Erica A., and Boumber, Yanis

Published
2021
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