Full Text Journal Articles by
Author David E Gerber

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Statin Intolerance, Anti-HMGCR Antibodies, and Immune Checkpoint Inhibitor-Associated Myositis: A "Two-Hit" Autoimmune Toxicity or Clinical Predisposition?

Mitchell S von Itzstein, Shaheen Khan, Vinita Popat, Rong Lu, Saad A Khan, Farjana J Fattah, Jason Y Park, Bonnie L Bermas, David R Karp, Murtaza Ahmed, Jessica M Saltarski, Yvonne Gloria-McCutchen, Yang Xie, Quan-Zhen Li, Edward K Wakeland, David E Gerber,

Immune-related adverse events induced by immune checkpoint inhibitor (ICI) therapy may affect diverse organ systems, including skeletal and cardiac muscle. ICI-associated myositis may result in substantial morbidity and occasional mortality. We present a case of a patient with advanced non-small cell lung cancer who developed grade 4 myositis with concurrent ... Read more >>

Oncologist (The oncologist)
[2020, :]

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A randomized trial of mail and email recruitment strategies for a physician survey on clinical trial accrual.

Caitlin C Murphy, Simon J Craddock Lee, Ann M Geiger, John V Cox, Chul Ahn, Rasmi Nair, David E Gerber, Ethan A Halm, Katharine McCallister, Celette Sugg Skinner,

BACKGROUND:Patient participation in cancer clinical trials is suboptimal. A challenge to capturing physicians' insights about trials has been low response to surveys. We conducted a study using varying combinations of mail and email to recruit a nationally representative sample of medical, surgical, and radiation oncologists to complete a survey on ... Read more >>

BMC Med Res Methodol (BMC medical research methodology)
[2020, 20(1):123]

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Investigational Biomarkers for Checkpoint Inhibitor Immune-Related Adverse Event Prediction and Diagnosis.

Mitchell S von Itzstein, Shaheen Khan, David E Gerber,

BACKGROUND:Immune checkpoint inhibitors (ICIs) have revolutionized the treatment of multiple cancers. However, these promising therapies may also cause immune-related adverse events (irAEs) in a substantial proportion of patients. These autoimmune phenomena may affect almost any organ system and may occur at almost any point in therapy. In some instances, these ... Read more >>

Clin. Chem. (Clinical chemistry)
[2020, 66(6):779-793]

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Closing the gap: Contribution of surgical best practices to outcome differences between high- and low-volume centers for lung cancer resection.

Mitchell S von Itzstein, Rong Lu, Kemp H Kernstine, Ethan A Halm, Shidan Wang, Yang Xie, David E Gerber,

BACKGROUND:Clinical outcomes for resected early-stage non-small cell lung cancer (NSCLC) are superior at high-volume facilities, but reasons for these differences remain unclear. Understanding these differences and optimizing outcomes across institutions are critical to the management of the increasing incidence of these cases. We evaluated the extent to which surgical best ... Read more >>

Cancer Med (Cancer medicine)
[2020, :]

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Lack of Association Between Radiographic Tumor Burden and Efficacy of Immune Checkpoint Inhibitors in Advanced Lung Cancer.

Vinita Popat, Rong Lu, Murtaza Ahmed, Jason Y Park, Yang Xie, David E Gerber,

BACKGROUND:Historically, tumor burden has been considered an impediment to efficacy of immunotherapeutic agents, including vaccines, stem cell transplant, cytokine therapy, and intravesical bacillus Calmette-Guérin. This effect has been attributed to hypoxic zones in the tumor core contributing to poor T-cell infiltration, formation of immunosuppressive stromal cells, and development of therapy-resistant ... Read more >>

Oncologist (The oncologist)
[2020, :]

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Increased reporting but decreased mortality associated with adverse events in patients undergoing lung cancer surgery: Competing forces in an era of heightened focus on care quality?

Mitchell S von Itzstein, Arjun Gupta, Kemp H Kernstine, Kristin C Mara, Sahil Khanna, David E Gerber,

INTRODUCTION:Advances in surgical techniques have improved clinical outcomes and decreased complications. At the same time, heightened attention to care quality has resulted in increased identification of hospital-acquired adverse events. We evaluated these divergent effects on the reported safety of lung cancer resection. METHODS AND MATERIALS:We analyzed hospital-acquired adverse events in ... Read more >>

PLoS ONE (PloS one)
[2020, 15(4):e0231258]

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Rates of appropriate laxative prophylaxis for opioid-induced constipation in veterans with lung cancer: a retrospective cohort study.

Timothy J Brown, Neil Keshvani, Arjun Gupta, Hui Yang, Deepak Agrawal, Tri C Le, David E Gerber, Carlos A Alvarez,

PURPOSE:Opioid-induced constipation (OIC) is the most common side effect in patient-prescribed opioids for cancer pain treatment. Current guidelines recommend routine prescription of a laxative for preventing OIC in all patients prescribed an opioid unless a contraindication exists. We determined patterns of prescription of laxative agents in patients with lung cancer ... Read more >>

Support Care Cancer (Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer)
[2020, :]

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Tracking the Nonenrolled: Lung Cancer Screening Patterns Among Individuals not Accrued to a Clinical Trial.

David E Gerber, Heidi A Hamann, Claudia Chavez, Olivia Dorsey, Noel O Santini, Travis Browning, Cristhiaan D Ochoa, Joyce Adesina, Vijaya Subbu Natchimuthu, Eric Steen, Hong Zhu, Simon J Craddock Lee,

INTRODUCTION:For lung cancer screening, the available data are often derived from patients enrolled prospectively in clinical trials. We, therefore, investigated lung cancer screening patterns among individuals eligible for, but not enrolled in, a screening trial. PATIENTS AND METHODS:From February 2017 through February 2019, we enrolled subjects in a trial examining ... Read more >>

Clin Lung Cancer (Clinical lung cancer)
[2020, :]

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Late-Onset Immunotherapy Toxicity and Delayed Autoantibody Changes: Checkpoint Inhibitor-Induced Raynaud's-Like Phenomenon.

Shaheen Khan, Mitchell S von Itzstein, Rong Lu, Bonnie L Bermas, David R Karp, Saad A Khan, Farjana J Fattah, Jason Y Park, Jessica M Saltarski, Yvonne Gloria-McCutchen, Yang Xie, Quan-Zhen Li, Edward K Wakeland, David E Gerber,

Immune checkpoint inhibitor (ICI)-induced immune-related adverse events (irAEs) may affect almost any organ system and occur at any point during therapy. Autoantibody analysis may provide insight into the mechanism, nature, and timing of these events. We report a case of ICI-induced late-onset Raynaud's-like phenomenon in a patient receiving combination immunotherapy. ... Read more >>

Oncologist (The oncologist)
[2020, 25(5):e753-e757]

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Patient familiarity with, understanding of, and preferences for clinical trial endpoints and terminology.

Mitchell S von Itzstein, Elda Railey, Mary L Smith, Carol B White, George W Sledge, John R Howell, Wendy Lawton, Donna M Marinucci, Nisha Unni, David E Gerber,

BACKGROUND:Although there is increased attention to designing and explaining clinical trials in ways that are clinically meaningful for patients, there is limited information on patient preferences, understanding, and perceptions of this content. METHODS:Maximum difference scaling (MaxDiff) methodology was used to develop a survey for assessing patients' understanding of 19 clinical ... Read more >>

Cancer (Cancer)
[2020, 126(8):1605-1613]

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Unique Patterns of Distant Metastases in HPV-Positive Head and Neck Cancer.

Ruth Sacks, Jennie Y Law, Hong Zhu, Muhammad S Beg, David E Gerber, Baran D Sumer, Larry L Myers, John M Truelson, Lucien Nedzi, David Sher, Randall S Hughes, Saad A Khan,

BACKGROUND:HPV-positive head and neck squamous cell carcinoma (HPV+ HNSCC) demonstrates favorable outcomes compared to HPV-negative SCC, but distant metastases (DM) still occur. The pattern of DM in HPV+ HNSCC is unclear. METHODS:1,494 HNSCC patients were treated from 2006 to 2012. Recurrence time and metastatic sites in HPV+ HNSCC (Group 1) ... Read more >>

Oncology (Oncology)
[2020, 98(3):179-185]

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DC-HIL/Gpnmb Is a Negative Regulator of Tumor Response to Immune Checkpoint Inhibitors.

Jin-Sung Chung, Vijay Ramani, Masato Kobayashi, Farjana Fattah, Vinita Popat, Song Zhang, Ponciano D Cruz, David E Gerber, Kiyoshi Ariizumi,

PURPOSE:Immune checkpoint inhibitors (ICI) benefit only a minority of treated patients with cancer. Identification of biomarkers distinguishing responders and nonresponders will improve management of patients with cancer. Because the DC-HIL checkpoint differs from the PD1 pathway in expression and inhibitory mechanisms, we examined whether DC-HIL expression regulates ICI responsiveness. EXPERIMENTAL ... Read more >>

Clin. Cancer Res. (Clinical cancer research : an official journal of the American Association for Cancer Research)
[2020, 26(6):1449-1459]

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Timing, Sites, and Correlates of Lung Cancer Recurrence.

Chelsea M Karacz, Jingsheng Yan, Hong Zhu, David E Gerber,

INTRODUCTION:Understanding temporal and anatomic patterns of lung cancer recurrence could guide disease management and monitoring. However, these data are not available in population-based datasets and are not routinely recorded in clinical trials. MATERIALS AND METHODS:We identified cases of stage 1 to 3 lung cancer diagnosed January 1, 2000, to December ... Read more >>

Clin Lung Cancer (Clinical lung cancer)
[2020, 21(2):127-135.e3]

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Efficacy of EGFR plus TNF inhibition in a preclinical model of temozolomide-resistant glioblastoma.

Gao Guo, Ke Gong, Vineshkumar Thidil Puliyappadamba, Nishah Panchani, Edward Pan, Bipasha Mukherjee, Ziba Damanwalla, Sabrina Bharia, Kimmo J Hatanpaa, David E Gerber, Bruce E Mickey, Toral R Patel, Jann N Sarkaria, Dawen Zhao, Sandeep Burma, Amyn A Habib,

BACKGROUND:Glioblastoma (GBM) is the most common primary malignant adult brain tumor. Temozolomide (TMZ) is the standard of care and is most effective in GBMs that lack the DNA repair protein O6-methylguanine-DNA methyltransferase (MGMT). Moreover, even initially responsive tumors develop a secondary resistance to TMZ and become untreatable. Since aberrant epidermal ... Read more >>

Neuro-oncology (Neuro-oncology)
[2019, 21(12):1529-1539]

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QTc Interval-Prolonging Medications Among Patients With Lung Cancer: Implications for Clinical Trial Eligibility and Clinical Care.

Tri Le, Hui Yang, Sawsan Rashdan, Mark S Link, Vlad G Zaha, Carlos Alvarez, David E Gerber,

BACKGROUND:Concomitant medication use, including agents that prolong the corrected QT (QTc) interval, can result in the exclusion of patients with cancer from clinical trials. To estimate the potential effects on accrual, we determined the prevalence of QTc-prolonging medication prescriptions in a national patient cohort. PATIENTS AND METHODS:We identified adult patients ... Read more >>

Clin Lung Cancer (Clinical lung cancer)
[2020, 21(1):21-27.e5]

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Phase 2 study of the focal adhesion kinase inhibitor defactinib (VS-6063) in previously treated advanced KRAS mutant non-small cell lung cancer.

David E Gerber, D Ross Camidge, Daniel Morgensztern, Jeremey Cetnar, Ronan J Kelly, Suresh S Ramalingam, David R Spigel, Woondong Jeong, Pier P Scaglioni, Song Zhang, Marilyn Li, David T Weaver, Louis Vaikus, Mitchell Keegan, Joanna C Horobin, Timothy F Burns,

OBJECTIVES:KRAS mutations, which occur in approximately 25% of lung adenocarcinoma cases, represent a major unmet clinical need in thoracic oncology. Preclinical studies have demonstrated that KRAS mutant NSCLC cell lines and xenografts with additional alterations in either TP53 or CDKN2A (INK4A/ARF) loci are sensitive to focal adhesion kinase (FAK) inhibition. ... Read more >>

Lung Cancer (Lung cancer (Amsterdam, Netherlands))
[2020, 139:60-67]

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Definition and Coordination of Roles and Responsibilities Among Cancer Center Clinic and Research Personnel.

Simon J Craddock Lee, Torsten Reimer, Sandra Garcia, Erin L Williams, Mary West, Tobi Stuart, David E Gerber,

PURPOSE:Effective enrollment and treatment of patients in cancer clinical trials require definition and coordination of roles and responsibilities among clinic and research personnel. MATERIALS AND METHODS:We developed a survey that incorporated modified components of the Survey of Physician Attitudes Regarding the Care of Cancer Survivors. Surveys were administered to clinic ... Read more >>

JCO Oncol Pract (JCO oncology practice)
[2020, 16(1):e64-e74]

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Variation in the Assessment of Immune-Related Adverse Event Occurrence, Grade, and Timing in Patients Receiving Immune Checkpoint Inhibitors.

David Hsiehchen, Mary K Watters, Rong Lu, Yang Xie, David E Gerber,

Importance:Toxic effects of conventional chemotherapy and molecularly targeted cancer therapies are generally well defined and occur at predictable points. By contrast, owing to their heterogeneous manifestations, unpredictable timing, and clinical overlap with other conditions, immune-related adverse events (irAE) may be more difficult to diagnose and characterize. Objective:To determine concordance of ... Read more >>

JAMA Netw Open (JAMA network open)
[2019, 2(9):e1911519]

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Phase Ia Study of Anti-NaPi2b Antibody-Drug Conjugate Lifastuzumab Vedotin DNIB0600A in Patients with Non-Small Cell Lung Cancer and Platinum-Resistant Ovarian Cancer.

David E Gerber, Jeffrey R Infante, Michael S Gordon, Sarah B Goldberg, Miguel Martín, Enriqueta Felip, Maria Martinez Garcia, Joan H Schiller, David R Spigel, Julie Cordova, Valerie Westcott, Yulei Wang, David S Shames, YounJeong Choi, Robert Kahn, Randall C Dere, Divya Samineni, Jian Xu, Kedan Lin, Katie Wood, Stephanie Royer-Joo, Vanessa Lemahieu, Eva Schuth, Anjali Vaze, Daniel Maslyar, Eric W Humke, Howard A Burris,

PURPOSE:This phase I trial assessed the safety, tolerability, and preliminary antitumor activity of lifastuzumab vedotin (LIFA), an antibody-drug conjugate of anti-NaPi2b mAb (MNIB2126A) and a potent antimitotic agent (monomethyl auristatin E). PATIENTS AND METHODS:LIFA was administered to patients with non-small cell lung cancer (NSCLC) and platinum-resistant ovarian cancer (PROC), once ... Read more >>

Clin. Cancer Res. (Clinical cancer research : an official journal of the American Association for Cancer Research)
[2020, 26(2):364-372]

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

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

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 ... Read more >>

Lung (Lung)
[2019, 197(5):593-599]

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Type and case volume of health care facility influences survival and surgery selection in cases with early-stage non-small cell lung cancer.

Shidan Wang, Sunny Lai, Mitchell S von Itzstein, Lin Yang, Donghan M Yang, Xiaowei Zhan, Guanghua Xiao, Ethan A Halm, David E Gerber, Yang Xie,

BACKGROUND:With the expansion of non-small cell lung cancer (NSCLC) screening methods, the percentage of cases with early-stage NSCLC is anticipated to increase. Yet it remains unclear how the type and case volume of the health care facility at which treatment occurs may affect surgery selection and overall survival for cases ... Read more >>

Cancer (Cancer)
[2019, 125(23):4252-4259]

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Stakeholder engagement to initiate lung cancer screening in an urban safety-net health system.

Simon J Craddock Lee, Heidi A Hamann, Travis Browning, Noel O Santini, Suhny Abbara, David S Balis, Hsienchang Chiu, Brett A Moran, Molly McGuire, David E Gerber,

Healthc (Amst) (Healthcare (Amsterdam, Netherlands))
[2020, 8(1):100370]

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Autoimmunity, checkpoint inhibitor therapy and immune-related adverse events: A review.

Shaheen Khan, David E Gerber,

Immune checkpoint inhibitors have emerged as a remarkable treatment option for diverse cancer types. However, a significant number of patients on checkpoint inhibitors develop immune-related adverse events (irAEs) affecting a wide variety of organs. These events, which may reflect enhanced T cell activation, are unpredictable, heterogeneous, and in some instances ... Read more >>

Semin. Cancer Biol. (Seminars in cancer biology)
[2019, :]

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Patient and provider perspectives on delivery of oral cancer therapies.

Caitlin C Murphy, Simon J Craddock Lee, David E Gerber, John V Cox, Hannah M Fullington, Robin T Higashi,

OBJECTIVE:The introduction of oral cancer therapies presents new challenges to delivery of quality cancer care. Little is known about how patients and providers address and overcome these challenges. We conducted a qualitative study exploring the range of patient and provider perspectives on oral cancer therapies. METHODS:We conducted semi-structured interviews with ... Read more >>

Patient Educ Couns (Patient education and counseling)
[2019, 102(11):2102-2109]

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Immunotherapy for non-small cell lung cancer: from clinical trials to real-world practice.

Sawsan Rashdan, David E Gerber,

Transl Lung Cancer Res (Translational lung cancer research)
[2019, 8(3):202-207]

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