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https://www.readbyqxmd.com/read/29902295/association-of-erbb-mutations-with-clinical-outcomes-of-afatinib-or-erlotinib-treated-patients-with-lung-squamous-cell-carcinoma-secondary-analysis-of-the-lux-lung-8-randomized-clinical-trial
#1
Glenwood D Goss, Enriqueta Felip, Manuel Cobo, Shun Lu, Konstantinos Syrigos, Ki Hyeong Lee, Erdem Göker, Vassilis Georgoulias, Wei Li, Salih Guclu, Dolores Isla, Young Joo Min, Alessandro Morabito, Andrea Ardizzoni, Shirish M Gadgeel, Andrea Fülöp, Claudia Bühnemann, Neil Gibson, Nicole Krämer, Flavio Solca, Agnieszka Cseh, Eva Ehrnrooth, Jean-Charles Soria
Importance: Treatment choice for lung squamous cell carcinoma could be aided by identifying predictive biomarkers. Objective: To assess whether patient outcomes in the LUX-Lung 8 trial were associated with ERBB gene family member aberrations in tumor specimens. Design, Setting, and Participants: Ad hoc secondary analysis of the LUX-Lung 8 trial conducted at 183 centers in 23 countries from March 30, 2012, to January 30, 2014. Eligible patients had stage IIIB or IV lung squamous cell carcinoma with progressive disease after 4 or more cycles of platinum-based chemotherapy...
June 14, 2018: JAMA Oncology
https://www.readbyqxmd.com/read/29775808/phase-ii-study-of-maintenance-pembrolizumab-in-patients-with-extensive-stage-small-cell-lung-cancer-sclc
#2
Shirish M Gadgeel, Nathan A Pennell, Mary Jo Fidler, Balazs Halmos, Philip Bonomi, James Stevenson, Bryan Schneider, Ammar Sukari, Jaclyn Ventimiglia, Wei Chen, Cathy Galasso, Antoinette Wozniak, Julie Boerner, Gregory P Kalemkerian
PURPOSE: To assess the efficacy of maintenance pembrolizumab in extensive-stage small cell lung cancer (SCLC) patients, after treatment with platinum/etoposide. PATIENTS AND METHODS: Extensive-stage SCLC patients with a response or stable disease following induction chemotherapy were eligible. Pembrolizumab at a dose of 200 mg IV every 3 weeks was initiated within 8 weeks of the last cycle of chemotherapy. The primary endpoint of the study was progression-free survival (PFS) from study registration, with overall survival (OS) as a key secondary endpoint...
May 15, 2018: Journal of Thoracic Oncology
https://www.readbyqxmd.com/read/29674424/utilizing-radiolabeled-3-deoxy-3-18-f-fluorothymidine-with-positron-emission-tomography-to-monitor-the-effect-of-dexamethasone-on-non-small-cell-lung-cancer
#3
Christopher McHugh, Monica R Thipparthi, Jawana M Lawhorn-Crews, Lisa Polin, Shirish Gadgeel, Janice Akoury, Thomas J Mangner, Kirk A Douglas, Jing Li, Manohar Ratnam, Anthony F Shields
Non-small cell lung cancer (NSCLC) is a leading cause of cancer mortality in the United States and pemetrexed-based therapies are regularly used to treat non-squamous NSCLC. Despite widespread use, pemetrexed has a modest effect on progression-free survival, with varying efficacy between individuals. Recent work has indicated that dexamethasone, given to prevent pemetrexed toxicity, is able to protect a subset of NSCLC cells from pemetrexed cytotoxicity by temporarily suppressing of the S-phase of the cell cycle...
April 19, 2018: Journal of Nuclear Medicine: Official Publication, Society of Nuclear Medicine
https://www.readbyqxmd.com/read/29658856/pembrolizumab-plus-chemotherapy-in-metastatic-non-small-cell-lung-cancer
#4
RANDOMIZED CONTROLLED TRIAL
Leena Gandhi, Delvys Rodríguez-Abreu, Shirish Gadgeel, Emilio Esteban, Enriqueta Felip, Flávia De Angelis, Manuel Domine, Philip Clingan, Maximilian J Hochmair, Steven F Powell, Susanna Y-S Cheng, Helge G Bischoff, Nir Peled, Francesco Grossi, Ross R Jennens, Martin Reck, Rina Hui, Edward B Garon, Michael Boyer, Belén Rubio-Viqueira, Silvia Novello, Takayasu Kurata, Jhanelle E Gray, John Vida, Ziwen Wei, Jing Yang, Harry Raftopoulos, M Catherine Pietanza, Marina C Garassino
BACKGROUND: First-line therapy for advanced non-small-cell lung cancer (NSCLC) that lacks targetable mutations is platinum-based chemotherapy. Among patients with a tumor proportion score for programmed death ligand 1 (PD-L1) of 50% or greater, pembrolizumab has replaced cytotoxic chemotherapy as the first-line treatment of choice. The addition of pembrolizumab to chemotherapy resulted in significantly higher rates of response and longer progression-free survival than chemotherapy alone in a phase 2 trial...
May 31, 2018: New England Journal of Medicine
https://www.readbyqxmd.com/read/29656869/comparing-treatment-strategies-for-stage-i-small-cell-lung-cancer
#5
Peter Paximadis, Jennifer L Beebe-Dimmer, Julie George, Anne G Schwartz, Antoinette Wozniak, Shirish Gadgeel
INTRODUCTION: The diagnosis of stage I small-cell lung cancer (SCLC) is increasing in incidence with the advent of low-dose screening computed tomography. Surgery is considered the standard of care but there are very few data to guide clinical decision-making. The purpose of this study was to compare outcomes for patients receiving definitive surgery, stereotactic body radiation therapy (SBRT), or external beam radiation therapy (EBRT) for stage I SCLC. PATIENTS AND METHODS: Patients with a primary diagnosis of stage I SCLC were identified in the National Cancer Database...
March 23, 2018: Clinical Lung Cancer
https://www.readbyqxmd.com/read/29536761/the-use-of-alectinib-in-the-first-line-treatment-of-anaplastic-lymphoma-kinase-positive-non-small-cell-lung-cancer
#6
Shirish M Gadgeel
Anaplastic lymphoma kinase (ALK) gene rearrangements as driver genetic alterations occur in approximately 2-4% of non-small-cell lung cancer (NSCLC) patients. Alectinib, a next generation ALK inhibitor, recently demonstrated, in two separate Phase III trials, superior efficacy to crizotinib, the first ALK inhibitor to demonstrate clinical efficacy in ALK-positive NSCLC patients. Alectinib also demonstrated superior efficacy in the CNS. The data from these two Phase III studies suggest that the efficacy of starting with alectinib is superior to the overall clinical efficacy of starting with crizotinib followed by switching to alectinib at the time of disease progression...
March 14, 2018: Future Oncology
https://www.readbyqxmd.com/read/29396237/second-line-treatment-options-in-non-small-cell-lung-cancer-report-from-an-international-experts-panel-meeting-of-the-italian-association-of-thoracic-oncology
#7
REVIEW
Cesare Gridelli, Paul Baas, Fabrice Barlesi, Fortunato Ciardiello, Lucio Crinò, Enriqueta Felip, Shirish Gadgeel, Vali Papadimitrakopoulou, Luis Paz-Ares, David Planchard, Maurice Perol, Nasser Hanna, Assunta Sgambato, Francesca Casaluce, Filippo de Marinis
Non-small-cell lung cancer (NSCLC) patients inevitably progress to first-line therapy and further active treatments are warranted. In the past few years, new second-line therapies, beyond chemotherapy agents, have become available in clinical practice. To date, several options for the second-line treatment of non-oncogene-addicted NSCLC patients ranging from chemotherapy in combination with antivascular endothelial growth factor receptor to immunotherapeutics are available. In oncogene-driven tumors, the better knowledge of mechanisms of acquired resistance to earlier tyrosine kinase inhibitors is leading to novel active inhibitors now available/in development...
December 22, 2017: Clinical Lung Cancer
https://www.readbyqxmd.com/read/29168933/role-of-chemotherapy-and-targeted-therapy-in-early-stage-non-small-cell-lung-cancer
#8
REVIEW
Misako Nagasaka, Shirish M Gadgeel
Adjuvant platinum based chemotherapy is accepted as standard of care in stage II and III non-small cell lung cancer (NSCLC) patients and is often considered in patients with stage IB disease who have tumors ≥ 4 cm. The survival advantage is modest with approximately 5% at 5 years. Areas covered: This review article presents relevant data regarding chemotherapy use in the perioperative setting for early stage NSCLC. A literature search was performed utilizing PubMed as well as clinical trial.gov. Randomized phase III studies in this setting including adjuvant and neoadjuvant use of chemotherapy as well as ongoing trials on targeted therapy and immunotherapy are also discussed...
January 2018: Expert Review of Anticancer Therapy
https://www.readbyqxmd.com/read/29149104/cumulative-incidence-rates-for-cns-and-non-cns-progression-in-two-phase-ii-studies-of-alectinib-in-alk-positive-nsclc
#9
Shirish Gadgeel, Alice T Shaw, Fabrice Barlesi, Lucio Crinò, James Chih-Hsin Yang, Anne-Marie C Dingemans, Dong-Wan Kim, Filippo de Marinis, Mathias Schulz, Shiyao Liu, Ravindra Gupta, Ahmed Kotb, Sai-Hong Ignatius Ou
BACKGROUND: We evaluated the cumulative incidence rate (CIR) of central nervous system (CNS) and non-CNS progression in alectinib-treated patients with anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) to determine the extent to which alectinib may treat or control CNS disease. METHODS: Patients with crizotinib-pretreated locally advanced or metastatic disease received alectinib 600 mg orally twice daily in two phase II trials. All patients underwent baseline imaging and regular centrally reviewed scans...
January 2018: British Journal of Cancer
https://www.readbyqxmd.com/read/28989038/risk-of-second-lung-cancer-in-patients-with-previously-treated-lung-cancer-analysis-of-surveillance-epidemiology-and-end-results-seer-data
#10
Manish K Thakur, Julie J Ruterbusch, Ann G Schwartz, Shirish M Gadgeel, Jennifer L Beebe-Dimmer, Antoinette J Wozniak
INTRODUCTION: The risk for development of a second primary lung cancer (SPLC) after treatment of an initial primary lung cancer (IPLC) is around 1% to 2% per patient per year. The present screening and surveillance guidelines do not adequately address this particular patient population. METHODS: We retrospectively reviewed patients in the Surveillance, Epidemiology, and End Results database from 1992 to 2007 to assess the frequency of occurrence of SPLC with regard to multiple patient demographics and calculated standardized incidence ratios (SIRs)...
January 2018: Journal of Thoracic Oncology
https://www.readbyqxmd.com/read/28856564/the-current-landscape-of-anaplastic-lymphoma-kinase-alk-in-non-small-cell-lung-cancer-emerging-treatment-paradigms-and-future-directions
#11
Angel Qin, Shirish Gadgeel
Tumorigenic rearrangements in anaplastic lymphoma kinase (ALK) account for 3-7% of all non-small cell lung cancers (NSCLC). Treatment with targeted tyrosine kinase inhibitors (TKIs) has shown impressive clinical responses. Crizotinib was the first agent approved for front-line therapy of ALK-rearranged NSCLC after it demonstrated superiority to chemotherapy in response rate, duration of response, and progression-free survival. However, eventually all patients progress on crizotinib therapy, with the central nervous system (CNS) being the most common site, which served as the impetus for the development of more potent next-generation ALK inhibitors...
December 2017: Targeted Oncology
https://www.readbyqxmd.com/read/28838400/emergence-of-fgfr3-tacc3-fusions-as-a-potential-by-pass-resistance-mechanism-to-egfr-tyrosine-kinase-inhibitors-in-egfr-mutated-nsclc-patients
#12
Sai-Hong Ignatius Ou, Leora Horn, Marcelo Cruz, Davood Vafai, Christine M Lovly, Allison Spradlin, Michael J Williamson, Ibiayi Dagogo-Jack, Adrienne Johnson, Vincent A Miller, Shirish Gadgeel, Siraj M Ali, Alexa B Schrock
Resistance to EGFR tyrosine kinase inhibitors (TKIs) in non-small cell lung cancers (NSCLCs) with activating EGFR mutations generally involve development of acquired secondary or tertiary EGFR mutations, such as T790M or C797S. However, case reports have demonstrated that actionable receptor tyrosine kinase fusions such as EML4-ALK, CCDC6-RET, and FGFR3-TACC3 can potentially confer resistance to EGFR TKIs. We seeked to identify the prevalence of FGFR3-TACC3 fusion transcripts as resistance mechanism to EGFR TKIs...
September 2017: Lung Cancer: Journal of the International Association for the Study of Lung Cancer
https://www.readbyqxmd.com/read/28736180/retreatment-with-osimertinib-following-pneumonitis
#13
Misako Nagasaka, Shirish M Gadgeel
No abstract text is available yet for this article.
January 2018: Clinical Lung Cancer
https://www.readbyqxmd.com/read/28729180/symptom-and-quality-of-life-improvement-in-lux-lung-8-an-open-label-phase-iii-study-of-second-line-afatinib-versus-erlotinib-in-patients-with-advanced-squamous-cell-carcinoma-of-the-lung-after-first-line-platinum-based-chemotherapy
#14
Enriqueta Felip, Vera Hirsh, Sanjay Popat, Manuel Cobo, Andrea Fülöp, Charles Dayen, José M Trigo, Richard Gregg, Cornelius F Waller, Jean-Charles Soria, Glenwood D Goss, James Gordon, Bushi Wang, Michael Palmer, Eva Ehrnrooth, Shirish M Gadgeel
INTRODUCTION: In the phase III LUX-Lung 8 trial, afatinib significantly improved progression-free survival (PFS) and overall survival (OS) versus erlotinib in patients with squamous cell carcinoma (SCC) of the lung progressing during or after platinum-based chemotherapy. Patient-reported outcomes (PROs) and health-related quality of life (QoL) in these patients are presented. PATIENTS AND METHODS: Patients (n = 795) were randomized 1:1 to oral afatinib (40 mg/d) or erlotinib (150 mg/d)...
January 2018: Clinical Lung Cancer
https://www.readbyqxmd.com/read/28689043/pooled-systemic-efficacy-and-safety-data-from-the-pivotal-phase-ii-studies-np28673-and-np28761-of-alectinib-in-alk-positive-non-small-cell-lung-cancer
#15
James Chih-Hsin Yang, Sai-Hong Ignatius Ou, Luigi De Petris, Shirish Gadgeel, Leena Gandhi, Dong-Wan Kim, Fabrice Barlesi, Ramaswamy Govindan, Anne-Marie C Dingemans, Lucio Crino, Herve Lena, Sanjay Popat, Jin Seok Ahn, Eric Dansin, Sophie Golding, Walter Bordogna, Bogdana Balas, Peter N Morcos, Ali Zeaiter, Alice T Shaw
INTRODUCTION: Alectinib demonstrated clinical efficacy and an acceptable safety profile in two phase II studies (NP28761 and NP28673). Here we report the pooled efficacy and safety data after 15 and 18 months more follow-up than in the respective primary analyses. METHODS: Enrolled patients had ALK receptor tyrosine kinase gene (ALK)-positive NSCLC and had progressed while taking, or could not tolerate, crizotinib. Patients received oral alectinib, 600 mg twice daily...
July 6, 2017: Journal of Thoracic Oncology
https://www.readbyqxmd.com/read/28646771/efficacy-of-alectinib-in-central-nervous-system-metastases-in-crizotinib-resistant-alk-positive-non-small-cell-lung-cancer-comparison-of-recist-1-1-and-rano-hgg-criteria
#16
Leena Gandhi, Sai-Hong Ignatius Ou, Alice T Shaw, Fabrice Barlesi, Anne-Marie C Dingemans, Dong-Wan Kim, D Ross Camidge, Brett G M Hughes, James C-H Yang, Javier de Castro, Lucio Crino, Hervé Léna, Pascal Do, Sophie Golding, Walter Bordogna, Ali Zeaiter, Ahmed Kotb, Shirish Gadgeel
BACKGROUND: Central nervous system (CNS) progression is common in patients with anaplastic lymphoma kinase-positive (ALK+) non-small-cell lung cancer (NSCLC) receiving crizotinib. Next-generation ALK inhibitors have shown activity against CNS metastases, but accurate assessment of response and progression is vital. Data from two phase II studies in crizotinib-refractory ALK+ NSCLC were pooled to examine the CNS efficacy of alectinib, a CNS-active ALK inhibitor, using Response Evaluation Criteria in Solid Tumours (RECIST version 1...
September 2017: European Journal of Cancer
https://www.readbyqxmd.com/read/28586279/alectinib-versus-crizotinib-in-untreated-alk-positive-non-small-cell-lung-cancer
#17
RANDOMIZED CONTROLLED TRIAL
Solange Peters, D Ross Camidge, Alice T Shaw, Shirish Gadgeel, Jin S Ahn, Dong-Wan Kim, Sai-Hong I Ou, Maurice Pérol, Rafal Dziadziuszko, Rafael Rosell, Ali Zeaiter, Emmanuel Mitry, Sophie Golding, Bogdana Balas, Johannes Noe, Peter N Morcos, Tony Mok
BACKGROUND: Alectinib, a highly selective inhibitor of anaplastic lymphoma kinase (ALK), has shown systemic and central nervous system (CNS) efficacy in the treatment of ALK-positive non-small-cell lung cancer (NSCLC). We investigated alectinib as compared with crizotinib in patients with previously untreated, advanced ALK-positive NSCLC, including those with asymptomatic CNS disease. METHODS: In a randomized, open-label, phase 3 trial, we randomly assigned 303 patients with previously untreated, advanced ALK-positive NSCLC to receive either alectinib (600 mg twice daily) or crizotinib (250 mg twice daily)...
August 31, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28577938/evaluation-of-the-veristrat-%C3%A2-serum-protein-test-in-patients-with-advanced-squamous-cell-carcinoma-of-the-lung-treated-with-second-line-afatinib-or-erlotinib-in-the-phase-iii-lux-lung-8-study
#18
RANDOMIZED CONTROLLED TRIAL
Shirish Gadgeel, Glenwood Goss, Jean-Charles Soria, Enriqueta Felip, Vassilis Georgoulias, Shun Lu, Manuel Cobo, Konstantinos Syrigos, Ki Hyeong Lee, Erdem Göker, Salih Z Guclu, Dolores Isla, Alessandro Morabito, Nicholas Dupuis, Claudia Bühnemann, Nicole Krämer, Flavio Solca, Eva Ehrnrooth, Andrea Ardizzoni
OBJECTIVES: Identification of biomarkers associated with clinical benefit may be crucial in establishing optimal treatment choice for patients with squamous cell carcinoma (SCC) of the lung after first-line chemotherapy. In this study, the ability of the VeriStrat serum protein test to predict differential clinical benefit with afatinib versus erlotinib, and the association of VeriStrat status with clinical outcomes irrespective of EGFR-TKI used, was assessed in a retrospective analysis of the phase III LUX-Lung 8 trial...
July 2017: Lung Cancer: Journal of the International Association for the Study of Lung Cancer
https://www.readbyqxmd.com/read/28561669/role-of-chemotherapy-and-targeted-therapy-in-early-stage-non-small-cell-lung-cancer
#19
REVIEW
Shirish M Gadgeel
On the basis of several randomized trials and meta-analyses, adjuvant chemotherapy is the accepted standard of care for certain patients with early-stage non-small cell lung cancer (NSCLC). Patients with stage II, IIIA, or large (≥ 4 cm) IB tumors are candidates for adjuvant chemotherapy. The survival improvement with adjuvant chemotherapy is approximately 5% at 5 years, though certain trials have suggested that it can be 8% to 10%. Neoadjuvant chemotherapy also has shown a survival advantage, though the volume of data with this approach is far less than that of adjuvant chemotherapy...
2017: American Society of Clinical Oncology Educational Book
https://www.readbyqxmd.com/read/28534251/sequencing-of-alk-inhibitors-in-alk-non-small-cell-lung-cancer
#20
REVIEW
Shirish M Gadgeel
Major therapeutic advances have occurred over the last several years in the management of advanced ALK+ NSCLC patients. Crizotinib was the first agent approved for the management of ALK+ NSCLC patients after it demonstrated significantly greater clinical benefit compared to chemotherapy. Several next generation ALK inhibitors have demonstrated clinical benefit in patients with crizotinib refractory NSCLC patients including in the CNS. Based on available data, therapy with a next generation ALK inhibitor can be initiated following therapy with crizotinib without any assessment of the molecular mechanisms of resistance...
June 2017: Current Treatment Options in Oncology
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