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2. Characteristics of Lung Cancer Patients With Asymptomatic or Undiagnosed SARS-CoV-2 Infections

Author

Somisetty, Medha, Mack, Philip C., Hsu, Chih-Yuan, Huang, Yuanhui, Gomez, Jorge E., Rodilla, Ananda M., Cagan, Jazz, Tavolacci, Sooyun C., Carreño, Juan Manuel, Brody, Rachel, Moore, Amy C., King, Jennifer C., Rohs, Nicholas C., Rolfo, Christian, Bunn, Paul A., Minna, John D., Bhalla, Sheena, Krammer, Florian, García-Sastre, Adolfo, Figueiredo, Jane C., Kazemian, Elham, Reckamp, Karen L., Merchant, Akil A., Nadri, Maimoona, Ahmed, Rafi, Ramalingam, Suresh S., Shyr, Yu, Hirsch, Fred R., and Gerber, David E.

Published
2024
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6. A phase II clinical trial evaluating the safety and efficacy of durvalumab as first line therapy in advanced and metastatic non-small cell lung cancer patients with Eastern Cooperative Oncology Group performance status of 2

Author

Shaverdashvili, Khvaramze, Reyes, Vincent, Wang, Hong, Mehta, Dhaval, Marsh, Christopher, Waas, John K., VanderWeele, Robert A., Peracha, Sajid M., Liang, Hongmei, Socinski, Mark A., Gerber, David E., Dowell, Jonathan E., and Villaruz, Liza C.

Published
2023
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8. Tumor Treating Fields therapy with standard systemic therapy versus standard systemic therapy alone in metastatic non-small-cell lung cancer following progression on or after platinum-based therapy (LUNAR): a randomised, open-label, pivotal phase 3 study

Author

Leal, Ticiana, Kotecha, Rupesh, Ramlau, Rodryg, Zhang, Li, Milanowski, Janusz, Cobo, Manuel, Roubec, Jaromir, Petruzelka, Lubos, Havel, Libor, Kalmadi, Sujith, Ward, Jeffrey, Andric, Zoran, Berghmans, Thierry, Gerber, David E, Kloecker, Goetz, Panikkar, Rajiv, Aerts, Joachim, Delmonte, Angelo, Pless, Miklos, Greil, Richard, Rolfo, Christian, Akerley, Wallace, Eaton, Michael, Iqbal, Mussawar, and Langer, Corey

Published
2023
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11. EGFR ligand shifts the role of EGFR from oncogene to tumour suppressor in EGFR-amplified glioblastoma by suppressing invasion through BIN3 upregulation

Author

Guo, Gao, Gong, Ke, Beckley, Nicole, Zhang, Yue, Yang, Xiaoyao, Chkheidze, Rati, Hatanpaa, Kimmo J., Garzon-Muvdi, Tomas, Koduru, Prasad, Nayab, Arifa, Jenks, Jennifer, Sathe, Adwait Amod, Liu, Yan, Xing, Chao, Wu, Shwu-Yuan, Chiang, Cheng-Ming, Mukherjee, Bipasha, Burma, Sandeep, Wohlfeld, Bryan, Patel, Toral, Mickey, Bruce, Abdullah, Kalil, Youssef, Michael, Pan, Edward, Gerber, David E., Tian, Shulan, Sarkaria, Jann N., McBrayer, Samuel K., Zhao, Dawen, and Habib, Amyn A.

Published
2022
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22. Phase II Study of Immunotherapy With Tecemotide and Bevacizumab After Chemoradiation in Patients With Unresectable Stage III Non-Squamous Non–Small-Cell Lung Cancer (NS-NSCLC): A Trial of the ECOG-ACRIN Cancer Research Group (E6508)

Author

Patel, Jyoti D., Lee, Ju-Whei, Carbone, David P., Wagner, Henry, Shanker, Anil, de Aquino, Maria Teresa P., Horn, Leora, Johnson, Melissa L., Gerber, David E., Liu, Jane Jijun, Das, Millie S., Al-Nsour, Mohammed Ali, Dakhil, Christopher S.R., Ramalingam, Suresh, and Schiller, Joan H.

Published
2020
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24. Time-Dependent Effects of Clinical Interventions on SARS-CoV-2 Immunity in Patients with Lung Cancer.

Author

Mack, Philip C., Hsu, Chih-Yuan, Rodilla, Ananda M., Gomez, Jorge E., Cagan, Jazz, Huang, Yuanhui, Tavolacci, Sooyun, Valanparambil, Rajesh M., Rohs, Nicholas, Brody, Rachel, Nichols, Brittney, Carreño, Juan Manuel, Bhalla, Sheena, Rolfo, Christian, Gerber, David E., Moore, Amy, King, Jennifer C., Ahmed, Rafi, Minna, John D., and Bunn Jr., Paul A.

Subjects
SARS-CoV-2, COVID-19 vaccines, BOOSTER vaccines, GENERALIZED estimating equations, INFLUENZA vaccines
Abstract

In patients with lung cancer (LC), understanding factors that impact the dynamics of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) anti-spike antibody (SAb) titers over time is critical, but challenging, due to evolving treatments, infections, vaccinations, and health status. The objective was to develop a time-dependent regression model elucidating individual contributions of factors influencing SAb levels in LC patients using a prospective, longitudinal, multi-institutional cohort study initiated in January 2021. The study evaluated 296 LC patients—median age 69; 55% female; 50% stage IV. Blood samples were collected every three months to measure SAb levels using FDA-approved ELISA. Asymptomatic and unreported infections were documented through measurement of anti-nucleocapsid Ab levels (Meso Scale Discovery). Associations between clinical characteristics and titers were evaluated using a time-dependent linear regression model with a generalized estimating equation (GEE), considering time-independent variables (age, sex, ethnicity, smoking history, histology, and stage) and time-dependent variables (booster vaccinations, SARS-CoV-2 infections, cancer treatment, steroid use, and influenza vaccination). Significant time-dependent effects increasing titer levels were observed for prior SARS-CoV-2 infection (p < 0.001) and vaccination/boosters (p < 0.001). Steroid use (p = 0.043) and chemotherapy (p = 0.033) reduced titer levels. Influenza vaccination was associated with increased SAb levels (p < 0.001), independent of SARS-CoV-2 vaccine boosters. Prior smoking significantly decreased titers in females (p = 0.001). Age showed no association with titers. This GEE-based linear regression model unveiled the nuanced impact of multiple variables on patient anti-spike Ab levels over time. After controlling for the major influences of vaccine and SARS-CoV-2 infections, chemotherapy and steroid use were found to have negatively affected titers. Smoking in females significantly decreased titers. Surprisingly, influenza vaccinations were also significantly associated, likely indirectly, with improved SARS-CoV-2 titers. [ABSTRACT FROM AUTHOR]

Published
2024
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35. Highly variable timing renders immunotherapy efficacy and toxicity impractical biomarkers of one another in clinical practice.

Author

von Itzstein, Mitchell S., Yuqiu Yang, Yiqing Wang, Hsiehchen, David, Sheffield, Thomas Y., Fattah, Farjana, Popat, Vinita, Ahmed, Murtaza, Homsi, Jade, Dowell, Jonathan E., Rashdan, Sawsan, Lohrey, Jay, Hammers, Hans J., Hughes, Randall S., Tao Wang, Yang Xie, and Gerber, David E.

Subjects
DRUG side effects, ACNEIFORM eruptions, IMMUNE checkpoint inhibitors, IMMUNOTHERAPY, BIOMARKERS, FISHER exact test
Abstract

Background: A useful clinical biomarker requires not only association but also a consistent temporal relationship. For instance, chemotherapy-induced neutropenia and epidermal growth-factor inhibitor-related acneiform rash both occur within weeks of treatment initiation, thereby providing information prior to efficacy assessment. Although immune checkpoint inhibitor (ICI)-associated immune-related adverse events (irAE) have been associated with therapeutic benefit, irAE may have delayed and highly variable onset. To determine whether ICI efficacy and irAE could serve as clinically useful biomarkers for predicting each other, we determined the temporal relationship between initial efficacy assessment and irAE onset in a diverse population treated with ICI. Methods: Using two-sided Fisher exact and Cochran-Armitage tests, we determined the relative timing of initial efficacy assessment and irAE occurrence in a cohort of 155 ICI-treated patients (median age 68 years, 40% women). Results: Initial efficacy assessment was performed a median of 50 days [interquartile range (IQR) 39-59 days] after ICI initiation; median time to any irAE was 77 days (IQR 28-145 days) after ICI initiation. Median time to first irAE was 42 days (IQR 20-88 days). Overall, 58% of any irAE and 47% of first irAE occurred after initial efficacy assessment. For clinically significant (grade =2) irAE, 60% of any and 53% of first occurred after initial efficacy assessment. The likelihood of any future irAE did not differ according to response (45% for complete or partial response vs. 47% for other cases; P=1). In landmark analyses controlling for clinical and toxicity follow-up, patients demonstrating greater tumor shrinkage at initial efficacy assessment were more likely to develop future grade =2 (P=0.05) and multi-organ (P=0.02) irAE. Conclusions: In contrast to that seen with chemotherapy and molecularly targeted therapies, the temporal relationship between ICI efficacy and toxicity is complex and bidirectional. In practice, neither parameter can be routinely relied on as a clinical biomarker to predict the other. [ABSTRACT FROM AUTHOR]

Published
2024
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36. 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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38. Increasing Numbers and Reported Adverse Events in Patients with Lung Cancer Undergoing Inpatient Lung Biopsies: A Population-Based Analysis

Author

von Itzstein, Mitchell S., Gupta, Arjun, Mara, Kristin C., Khanna, Sahil, and Gerber, David E.

Subjects
Clinical trials -- Analysis, Lung cancer -- Diagnosis -- Risk factors, CT imaging -- Usage, Pneumothorax -- Diagnosis -- Risk factors, Health
Abstract

Introduction The use of molecular biomarkers to guide lung cancer management has led to increasing frequency and amounts of tissue required for repeat lung biopsies. While patient safety and reporting of adverse events has been increasingly emphasized in recent decades, the safety of lung biopsies in patients with lung cancer has only been studied in small cohorts. We therefore analyzed adverse events in patients with lung cancer undergoing lung biopsies in the National Hospital Discharge Survey (NHDS) database. Methods Data were abstracted using ICD-9 lung cancer diagnosis (162.X) and lung biopsy procedure codes (33.20, 33.24, 33.25, 33.26, 33.27, 33.28) from 2001 to 2010. Agency for Healthcare Research and Quality (AHRQ) Patient-Safety Indicators (PSI) were used to identify hospital-acquired adverse events. Weighted analyses were performed using SAS version 9.4. Results A total of 540,747 patients were included for analysis. The number of biopsies increased over time, from 51,221 in 2001, to 63,239 in 2010 (P < 0.001). Overall, 159,683 (30%) patients suffered [greater than or equal to] 1-PSI event during their hospitalization. Incidence of PSI varied by biopsy type: bronchoscopic (26%), percutaneous (34%), surgical (39%). The proportion of patients with [greater than or equal to] 1 PSI event increased from 24% in 2001 to 38% in 2010 (P < 0.001). Patients with [greater than or equal to] 1 PSI had longer length of stay (mean, 11.6 vs 8.1 days; P < 0.001) and higher in-hospital mortality (adjusted odds ratio, 5.9, 95% CI 3.9-8.9; P < 0.001). Conclusions The frequency of lung biopsies performed and rate of documented adverse events in hospitalized lung cancer patients have increased. These findings have policy, funding, research, and practice implications., Author(s): Mitchell S. von Itzstein [sup.1] , Arjun Gupta [sup.1] [sup.6] , Kristin C. Mara [sup.2] , Sahil Khanna [sup.3] , David E. Gerber [sup.1] [sup.4] [sup.5] [sup.7] Author Affiliations: [...]

Published
2019
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43. Nivolumab plus ipilimumab as first-line treatment for advanced non-small-cell lung cancer (CheckMate 012): results of an open-label, phase 1, multicohort study

Author

Hellmann, Matthew D, Rizvi, Naiyer A, Goldman, Jonathan W, Gettinger, Scott N, Borghaei, Hossein, Brahmer, Julie R, Ready, Neal E, Gerber, David E, Chow, Laura Q, Juergens, Rosalyn A, Shepherd, Frances A, Laurie, Scott A, Geese, William J, Agrawal, Shruti, Young, Tina C, Li, Xuemei, and Antonia, Scott J

Published
2017
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46. Concerning Safety and Efficacy of Concurrent and Consolidative Durvalumab With Thoracic Radiation Therapy in PDL1-Unselected Stage III Non-Small Cell Lung Cancer: Brief Report

Author

Zhang, Yuanyuan, Iyengar, Puneeth, Montalvo, Steven, Westover, Kenneth D., Rashdan, Sawsan, Donthireddy, Kavitha, Kim, James, Dowell, Jonathan E., Drapkin, Benjamin, Bhalla, Sheena, Chukwuma, Christian, Nadeem, Urooba, Ahn, Chul, Timmerman, Robert D., and Gerber, David E.

Published
2024
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47. TNF-driven adaptive response mediates resistance to EGFR inhibition in lung cancer

Author

Gong, Ke, Guo, Gao, Gerber, David E., Gao, Boning, Peyton, Michael, Huang, Chun, Minna, John D., Hatanpaa, Kimmo J., Kernstine, Kemp, Cai, Ling, Xie, Yang, Zhu, Hong, Fattah, Farjana J., Zhang, Shanrong, Takahashi, Masaya, Mukherjee, Bipasha, Burma, Sandeep, Dowell, Jonathan, Dao, Kathryn, Papadimitrakopoulou, Vassiliki A., Olivas, Victor, Bivona, Trever G., Zhao, Dawen, and Habib, Amyn A.

Subjects
Gene mutations -- Research, Tumor necrosis factor -- Research, Lung cancer, Non-small cell -- Genetic aspects -- Care and treatment -- Research, Cellular signal transduction -- Research, Genetic transcription -- Research, Health care industry
Abstract

Although aberrant EGFR signaling is widespread in cancer, EGFR inhibition is effective only in a subset of non-small cell lung cancer (NSCLC) with EGFR activating mutations. A majority of NSCLCs express EGFR wild type (EGFRwt) and do not respond to EGFR inhibition. TNF is a major mediator of inflammation-induced cancer. We find that a rapid increase in TNF level is a universal adaptive response to EGFR inhibition in NSCLC, regardless of EGFR status. EGFR signaling actively suppresses TNF mRNA levels by inducing expression of miR-21, resulting in decreased TNF mRNA stability. Conversely, EGFR inhibition results in loss of miR-21 and increased TNF mRNA stability. In addition, TNF-induced NF-[kappa]B activation leads to increased TNF transcription in a feed-forward loop. Inhibition of TNF signaling renders EGFRwt-expressing NSCLC cell lines and an EGFRwt patient-derived xenograft (PDX) model highly sensitive to EGFR inhibition. In EGFR-mutant oncogene-addicted cells, blocking TNF enhances the effectiveness of EGFR inhibition. EGFR plus TNF inhibition is also effective in NSCLC with acquired resistance to EGFR inhibition. We suggest concomitant EGFR and TNF inhibition as a potentially new treatment approach that could be beneficial for a majority of lung cancer patients., Introduction Oncogene addiction has been described primarily in cancers that express oncogenes rendered constitutively active by mutation (1, 2). Constitutive activation results in a continuous and unattenuated signaling, resulting in [...]

Published
2018
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48. Phase 1 study of ARQ 761, a β-lapachone analogue that promotes NQO1-mediated programmed cancer cell necrosis

Author

Gerber, David E., Beg, M. Shaalan, Fattah, Farjana, Frankel, Arthur E., Fatunde, Oluwatomilade, Arriaga, Yull, Dowell, Jonathan E., Bisen, Ajit, Leff, Richard D., Meek, Claudia C., Putnam, William C., Kallem, Raja Reddy, Subramaniyan, Indhumathy, Dong, Ying, Bolluyt, Joyce, Sarode, Venetia, Luo, Xin, Xie, Yang, Schwartz, Brian, and Boothman, David A.

Published
2018
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49. Longitudinal nucleocapsid antibody testing reveals undocumented SARS-CoV-2 infections in patients with lung cancer

Author

Rodilla, Ananda M., Valanparambil, Rajesh M., Mack, Philip C., Hsu, Chih-Yuan, Cagan, Jazz, Tavolacci, Sooyun C., Carreño, Juan Manuel, Brody, Rachel, Moore, Amy, King, Jennifer C., Gomez, Jorge E., Rohs, Nicholas, Rolfo, Christian, Bunn, Paul A., Jr., Gerber, David E., Minna, John D., Krammer, Florian, Ramalingam, Suresh S., García-Sastre, Adolfo, Shyr, Yu, Ahmed, Rafi, and Hirsch, Fred R.

Published
2023
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