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shirish gadgeel

Corey J Langer, Shirish M Gadgeel, Hossein Borghaei, Vassiliki A Papadimitrakopoulou, Amita Patnaik, Steven F Powell, Ryan D Gentzler, Renato G Martins, James P Stevenson, Shadia I Jalal, Amit Panwalkar, James Chih-Hsin Yang, Matthew Gubens, Lecia V Sequist, Mark M Awad, Joseph Fiore, Yang Ge, Harry Raftopoulos, Leena Gandhi
BACKGROUND: Limited evidence exists to show that adding a third agent to platinum-doublet chemotherapy improves efficacy in the first-line advanced non-small-cell lung cancer (NSCLC) setting. The anti-PD-1 antibody pembrolizumab has shown efficacy as monotherapy in patients with advanced NSCLC and has a non-overlapping toxicity profile with chemotherapy. We assessed whether the addition of pembrolizumab to platinum-doublet chemotherapy improves efficacy in patients with advanced non-squamous NSCLC...
October 10, 2016: Lancet Oncology
Manish K Thakur, Shirish M Gadgeel
Therapy of non-small cell lung cancer (NSCLC) patients has evolved over the past few years with the incorporation of targeted therapy and immune therapy. These changes have increased the importance of prognostic and predictive biomarkers to enable practicing physicians in making the most appropriate treatment decisions for NSCLC patients. A variety of prognostic factors based on clinical and pathologic features determine the overall outcome of the patient and these factors do influence decisions regarding initiation of therapy...
October 2016: Seminars in Respiratory and Critical Care Medicine
Natasha B Leighl, Naiyer A Rizvi, Lopes Gilberto de Lima, Wichit Arpornwirat, Charles M Rudin, Alberto A Chiappori, Myung-Ju Ahn, Laura Q M Chow, Lyudmila Bazhenova, Arunee Dechaphunkul, Patrapim Sunpaweravong, Keith Eaton, Jihong Chen, Sonja Medley, Srinivasu Poondru, Margaret Singh, Joyce Steinberg, Rosalyn A Juergens, Shirish M Gadgeel
INTRODUCTION: First-line epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor treatment of advanced non-small-cell lung cancer with EGFR-activating mutations improves outcomes compared with chemotherapy, but resistance develops in most patients. Compensatory signaling through type 1 insulin-like growth factor 1 receptor (IGF-1R) may contribute to resistance; dual blockade of IGF-1R and EGFR may improve outcomes. PATIENTS AND METHODS: We performed a randomized, double-blind, placebo-controlled phase II study of linsitinib, a dual IGF-1R and insulin receptor tyrosine kinase inhibitor, plus erlotinib versus placebo plus erlotinib in chemotherapy-naive patients with EGFR-mutation positive, advanced non-small-cell lung cancer...
August 8, 2016: Clinical Lung Cancer
Mark Zaki, Michael Dominello, Gregory Dyson, Shirish Gadgeel, Antoinette Wozniak, Steven Miller, Peter Paximadis
BACKGROUND: The objective of this study was to review our institution's experience among patients with locally advanced non-small-cell lung cancer (LA-NSCLC) treated with chemotherapy and radiation and to determine the prognostic significance of age. PATIENTS AND METHODS: Patients were included if they underwent sequential or concurrent chemoradiotherapy from 2006 to 2014 for LA-NSCLC. Patients were stratified according to age ≤70 and >70 years. Kaplan-Meier and Cox regression methods were performed to evaluate overall survival (OS) and progression-free survival (PFS)...
July 22, 2016: Clinical Lung Cancer
Karen L Reckamp, Vladislava O Melnikova, Chris Karlovich, Lecia V Sequist, D Ross Camidge, Heather Wakelee, Maurice Perol, Geoffrey R Oxnard, Karena Kosco, Peter Croucher, Errin Samuelsz, Cecile Rose Vibat, Shiloh Guerrero, Jennifer Geis, David Berz, Elaina Mann, Shannon Matheny, Lindsey Rolfe, Mitch Raponi, Mark G Erlander, Shirish Gadgeel
INTRODUCTION: In approximately 60% of patients with NSCLC who are receiving EGFR tyrosine kinase inhibitors, resistance develops through the acquisition of EGFR T790M mutation. We aimed to demonstrate that a highly sensitive and quantitative next-generation sequencing analysis of EGFR mutations from urine and plasma specimens is feasible. METHODS: Short footprint mutation enrichment next-generation sequencing assays were used to interrogate EGFR activating mutations and the T790M resistance mutation in urine or plasma specimens from patients enrolled in TIGER-X (NCT01526928), a phase 1/2 clinical study of rociletinib in previously treated patients with EGFR mutant-positive advanced NSCLC...
October 2016: Journal of Thoracic Oncology
Justin F Gainor, Leila Dardaei, Satoshi Yoda, Luc Friboulet, Ignaty Leshchiner, Ryohei Katayama, Ibiayi Dagogo-Jack, Shirish Gadgeel, Katherine Schultz, Manrose Singh, Emily Chin, Melissa Parks, Dana Lee, Richard H DiCecca, Elizabeth Lockerman, Tiffany Huynh, Jennifer Logan, Lauren L Ritterhouse, Long P Le, Ashok Muniappan, Subba Digumarthy, Colleen Channick, Colleen Keyes, Gad Getz, Dora Dias-Santagata, Rebecca S Heist, Jochen Lennerz, Lecia V Sequist, Cyril H Benes, A John Iafrate, Mari Mino-Kenudson, Jeffrey A Engelman, Alice T Shaw
: Advanced, anaplastic lymphoma kinase (ALK)-positive lung cancer is currently treated with the first-generation ALK inhibitor crizotinib followed by more potent, second-generation ALK inhibitors (e.g., ceritinib and alectinib) upon progression. Second-generation inhibitors are generally effective even in the absence of crizotinib-resistant ALK mutations, likely reflecting incomplete inhibition of ALK by crizotinib in many cases. Herein, we analyzed 103 repeat biopsies from ALK-positive patients progressing on various ALK inhibitors...
October 2016: Cancer Discovery
Ann G Schwartz, Christine M Lusk, Angela S Wenzlaff, Donovan Watza, Stephanie Pandolfi, Laura Mantha, Michele L Cote, Ayman O Soubani, Garrett Walworth, Antoinette Wozniak, Christine Neslund-Dudas, Amy A Ardisana, Michael J Flynn, Thomas Song, David L Spizarny, Paul A Kvale, Robert A Chapman, Shirish M Gadgeel
BACKGROUND: Chronic obstructive pulmonary disease (COPD) is a risk factor for lung cancer. This study evaluates alternative measures of COPD based on spirometry and quantitative image analysis to better define a phenotype that predicts lung cancer risk. METHODS: A total of 341 lung cancer cases and 752 volunteer controls, ages 21 to 89 years, participated in a structured interview, standardized CT scan, and spirometry. Logistic regression, adjusted for age, race, gender, pack-years, and inspiratory and expiratory total lung volume, was used to estimate the odds of lung cancer associated with FEV1/FVC, percent voxels less than -950 Hounsfield units on the inspiratory scan (HUI) and percent voxels less than -856 HU on expiratory scan (HUE)...
September 2016: Cancer Epidemiology, Biomarkers & Prevention
Louis A Penner, John F Dovidio, Richard Gonzalez, Terrance L Albrecht, Robert Chapman, Tanina Foster, Felicity W K Harper, Nao Hagiwara, Lauren M Hamel, Anthony F Shields, Shirish Gadgeel, Michael S Simon, Jennifer J Griggs, Susan Eggly
PURPOSE: Health providers' implicit racial bias negatively affects communication and patient reactions to many medical interactions. However, its effects on racially discordant oncology interactions are largely unknown. Thus, we examined whether oncologist implicit racial bias has similar effects in oncology interactions. We further investigated whether oncologist implicit bias negatively affects patients' perceptions of recommended treatments (i.e., degree of confidence, expected difficulty)...
August 20, 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
Aamir Ahmad, Shirish M Gadgeel
No abstract text is available yet for this article.
2016: Advances in Experimental Medicine and Biology
Priscila H Goncalves, Stephanie L Peterson, Fawn D Vigneau, Ronald D Shore, William O Quarshie, Khairul Islam, Ann G Schwartz, Antoinette J Wozniak, Shirish M Gadgeel
BACKGROUND: Brain metastases (BM) remain an important cause of morbidity and mortality in patients with lung cancer. The current study evaluated population-based incidence and outcomes of BM in patients with nonmetastatic lung cancer. METHODS: Patients diagnosed with nonmetastatic first primary lung cancer between 1973 and 2011 in the Metropolitan Detroit Surveillance, Epidemiology, and End Results (SEER) registry were used for the current analysis. Age-adjusted odds ratios of developing BM based on various demographic characteristics and histology were calculated with 95% confidence intervals...
June 15, 2016: Cancer
Harvey I Pass, Chandra Goparaju, Osvaldo Espin-Garcia, Jessica Donington, Michele Carbone, Devalben Patel, Zhuo Chen, Ronald Feld, John Cho, Shirish Gadgeel, Antoinette Wozniak, Abraham Chachoua, Natasha Leighl, Ming-Sound Tsao, Marc de Perrot, Wei Xu, Geoffrey Liu
OBJECTIVES: Prognostic models for malignant pleural mesothelioma (MPM) are needed to prevent potentially futile outcomes. We combined MPM plasma biomarkers with validated clinical prognostic indices to determine whether stratification of risk for death in 194 patients with MPM improved. METHODS: Individuals were recruited from three different centers: a discovery cohort (83 patients with MPM) created by combining patients from two U.S. centers and a separate, independent cohort from Canada (111 patients with MPM)...
June 2016: Journal of Thoracic Oncology
Valentine M Macaulay, Mark R Middleton, S Gail Eckhardt, Charles M Rudin, Rosalyn A Juergens, Richard Gedrich, Sven Gogov, Sean McCarthy, Srinivasu Poondru, Andrew W Stephens, Shirish M Gadgeel
PURPOSE: Cross-talk between type I IGF receptor (IGF1R), insulin receptor (INSR), and epidermal growth factor receptor (EGFR) mediates resistance to individual receptor blockade. This study aimed to determine the MTD, safety, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of linsitinib, a potent oral IGF1R/INSR inhibitor, with EGFR inhibitor erlotinib. EXPERIMENTAL DESIGN: This open-label, dose-escalation study investigated linsitinib schedules S1: once daily intermittent (days 1-3 weekly); S2, once daily continuous; S3, twice-daily continuous; each with erlotinib 100-150 mg once daily; and a non-small cell lung cancer (NSCLC) expansion cohort...
June 15, 2016: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
Chris Karlovich, Jonathan W Goldman, Jong-Mu Sun, Elaina Mann, Lecia V Sequist, Krzysztof Konopa, Wei Wen, Philipp Angenendt, Leora Horn, David Spigel, Jean-Charles Soria, Benjamin Solomon, D Ross Camidge, Shirish Gadgeel, Cloud Paweletz, Lin Wu, Sean Chien, Patrick O'Donnell, Shannon Matheny, Darrin Despain, Lindsey Rolfe, Mitch Raponi, Andrew R Allen, Keunchil Park, Heather Wakelee
PURPOSE: The evaluation of plasma testing for the EGFR resistance mutation T790M in NSCLC patients has not been broadly explored. We investigated the detection of EGFR activating and T790M mutations in matched tumor tissue and plasma, mostly from patients with acquired resistance to first-generation EGFR inhibitors. EXPERIMENTAL DESIGN: Samples were obtained from two studies, an observational study and a phase I trial of rociletinib, a mutant-selective inhibitor of EGFR that targets both activating mutations and T790M...
May 15, 2016: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
Christine M Lusk, Angela S Wenzlaff, Greg Dyson, Kristen S Purrington, Donovan Watza, Susan Land, Ayman O Soubani, Shirish M Gadgeel, Ann G Schwartz
Lung cancer continues to be a major public health challenge in the United States despite efforts to decrease the prevalence of smoking; outcomes are especially poor for African-American patients compared to other races/ethnicities. Chronic obstructive pulmonary disease (COPD) co-occurs with lung cancer frequently, but not always, suggesting both shared and distinct risk factors for these two diseases. To identify germline genetic variation that distinguishes between lung cancer in the presence and absence of emphysema, we performed whole-exome sequencing on 46 African-American lung cancer cases (23 with and 23 without emphysema frequency matched on age, sex, histology and pack years)...
February 2016: Carcinogenesis
Alice T Shaw, Leena Gandhi, Shirish Gadgeel, Gregory J Riely, Jeremy Cetnar, Howard West, D Ross Camidge, Mark A Socinski, Alberto Chiappori, Tarek Mekhail, Bo H Chao, Hossein Borghaei, Kathryn A Gold, Ali Zeaiter, Walter Bordogna, Bogdana Balas, Oscar Puig, Volkmar Henschel, Sai-Hong Ignatius Ou
BACKGROUND: Alectinib--a highly selective, CNS-active, ALK inhibitor-showed promising clinical activity in crizotinib-naive and crizotinib-resistant patients with ALK-rearranged (ALK-positive) non-small-cell lung cancer (NSCLC). We aimed to assess the safety and efficacy of alectinib in patients with ALK-positive NSCLC who progressed on previous crizotinib. METHODS: We did a phase 2 study at 27 centres in the USA and Canada. We enrolled patients aged 18 years or older with stage IIIB-IV, ALK-positive NSCLC who had progressed after crizotinib...
February 2016: Lancet Oncology
Shirish M Gadgeel
Lung cancer remains the most common cause of cancer related deaths in both men and women in the United States and non-small cell lung cancer (NSCLC) accounts for over 85 % of all lung cancers. Survival of these patients has not significantly altered in over 30 years. This chapter initially discusses the clinical presentation of lung cancer patients. Most patients diagnosed with lung cancer due to symptoms have advanced stage cancer. Once diagnosed, lung cancer patients need imaging studies to assess the stage of the disease before decisions regarding therapy are finalized...
2016: Advances in Experimental Medicine and Biology
Matthew D Fountain, Lisa M Abernathy, Fulvio Lonardo, Shoshana E Rothstein, Michael M Dominello, Christopher K Yunker, Wei Chen, Shirish Gadgeel, Michael C Joiner, Gilda G Hillman
INTRODUCTION: Lung cancer patients receiving radiotherapy present with acute esophagitis and chronic fibrosis, as a result of radiation injury to esophageal tissues. We have shown that soy isoflavones alleviate pneumonitis and fibrosis caused by radiation toxicity to normal lung. The effect of soy isoflavones on esophagitis histopathological changes induced by radiation was investigated. METHODS: C57BL/6 mice were treated with 10 Gy or 25 Gy single thoracic irradiation and soy isoflavones for up to 16 weeks...
2015: Frontiers in Oncology
Lakshmi Nayak, Lisa M DeAngelis, H Ian Robins, Ramaswamy Govindan, Shirish Gadgeel, Karen Kelly, James R Rigas, David M Peereboom, Steven S Rosenfeld, Alona Muzikansky, Ming Zheng, Patrick Urban, Lauren E Abrey, Antonio Omuro, Patrick Y Wen
BACKGROUND: Treatment options for patients with non-small cell lung cancer (NSCLC) with brain metastases are limited. Patupilone (EPO906), a blood-brain barrier-penetrating, microtubule-targeting, cytotoxic agent, has shown clinical activity in phase 1/2 studies in patients with NSCLC. This study evaluates the efficacy, pharmacokinetics, and safety of patupilone in NSCLC brain metastases. METHODS: Adult patients with NSCLC and confirmed progressive brain metastases received patupilone intravenously at 10 mg/m(2) every 3 weeks...
December 1, 2015: Cancer
Balazs Halmos, Nathan A Pennell, Pingfu Fu, Shumaila Saad, Shirish Gadgeel, Gregory A Otterson, Tarek Mekhail, Michael Snell, J Philip Kuebler, Neelesh Sharma, Afshin Dowlati
BACKGROUND: Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) therapy is clearly beneficial in patients with advanced EGFR-mutated non-small cell lung cancer (NSCLC). However, acquired resistance develops uniformly and the benefit of continuation of EGFR TKI therapy beyond progression remains unclear. MATERIALS AND METHODS: This was a randomized phase II study of chemotherapy (arm A: pemetrexed or docetaxel) versus chemotherapy plus erlotinib (ERL) (arm B) in patients with progressive NSCLC following clinical benefit from erlotinib...
November 2015: Oncologist
Jean-Charles Soria, Enriqueta Felip, Manuel Cobo, Shun Lu, Konstantinos Syrigos, Ki Hyeong Lee, Erdem Göker, Vassilis Georgoulias, Wei Li, Dolores Isla, Salih Z Guclu, Alessandro Morabito, Young J Min, Andrea Ardizzoni, Shirish M Gadgeel, Bushi Wang, Vikram K Chand, Glenwood D Goss
BACKGROUND: There is a major unmet need for effective treatments in patients with squamous cell carcinoma of the lung. LUX-Lung 8 compared afatinib (an irreversible ErbB family blocker) with erlotinib (a reversible EGFR tyrosine kinase inhibitor), as second-line treatment for patients with advanced squamous cell carcinoma of the lung. METHODS: We did this open-label, phase 3 randomised controlled trial at 183 cancer centres in 23 countries worldwide. We enrolled adults with stage IIIB or IV squamous cell carcinoma of the lung who had progressed after at least four cycles of platinum-based-chemotherapy...
August 2015: Lancet Oncology
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