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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
#1
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)...
June 23, 2017: 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
#2
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 pooled efficacy and safety data after 15 and 18 months' longer follow-up than the respective primary analyses. MATERIALS AND METHODS: Enrolled patients had ALK-positive NSCLC and had progressed on, or were intolerant to, crizotinib. Patients received oral alectinib 600 mg twice daily. The primary endpoint in both studies was objective response rate (ORR) assessed by an independent review committee (IRC) using Response Evaluation Criteria in Solid Tumors (RECIST v1...
July 5, 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
#3
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...
July 10, 2017: European Journal of Cancer
https://www.readbyqxmd.com/read/28586279/alectinib-versus-crizotinib-in-untreated-alk-positive-non-small-cell-lung-cancer
#4
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)...
June 6, 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
#5
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
#6
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
#7
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
https://www.readbyqxmd.com/read/28502723/histologic-transformation-in-nsclc-with-pd-1-therapy
#8
Misako Nagasaka, Rahul S Pansare, Eman Abdulfatah, Hui Guan, Paul Tranchida, Shirish M Gadgeel
No abstract text is available yet for this article.
May 10, 2017: Journal of Thoracic Oncology
https://www.readbyqxmd.com/read/28365051/optimal-front-line-alk-anaplastic-lymphoma-kinase-directed-therapy
#9
EDITORIAL
Shirish M Gadgeel
No abstract text is available yet for this article.
July 2017: Lung Cancer: Journal of the International Association for the Study of Lung Cancer
https://www.readbyqxmd.com/read/28164089/met-hgf-pathway-activation-as-a-paradigm-of-resistance-to-targeted-therapies
#10
REVIEW
Brian Ko, Tianfang He, Shirish Gadgeel, Balazs Halmos
Resistance to targeted therapeutics is a key issue limiting the long-term utility of these medications in the management of molecularly selected subsets of cancer patients, including patients with non-small cell lung cancer harboring oncogenic alterations affecting EGFR, ALK and other genes. Bypass resistance mediated by activation of MET kinase has emerged as a frequent, validated and pivotal resistance mechanism in multiple types of cancers. Biochemical understanding is accumulating to explain the unique role of MET in such bypass pathways, providing alternate downstream activation opportunities and intricate interactions during epithelial-mesenchymal transitions...
January 2017: Annals of Translational Medicine
https://www.readbyqxmd.com/read/28073615/randomized-trial-of-a-question-prompt-list-to-increase-patient-active-participation-during-interactions-with-black-patients-and-their-oncologists
#11
Susan Eggly, Lauren M Hamel, Tanina S Foster, Terrance L Albrecht, Robert Chapman, Felicity W K Harper, Hayley Thompson, Jennifer J Griggs, Richard Gonzalez, Lisa Berry-Bobovski, Rifky Tkatch, Michael Simon, Anthony Shields, Shirish Gadgeel, Randa Loutfi, Haythem Ali, Ira Wollner, Louis A Penner
OBJECTIVE: Communication during racially-discordant interactions is often of poor quality and may contribute to racial treatment disparities. We evaluated an intervention designed to increase patient active participation and other communication-related outcomes during interactions between Black patients and non-Black oncologists. METHODS: Participants were 18 non-Black medical oncologists and 114 Black patients at two cancer hospitals in Detroit, Michigan, USA. Before a clinic visit to discuss treatment, patients were randomly assigned to usual care or to one of two question prompt list (QPL) formats: booklet (QPL-Only), or booklet and communication coach (QPL-plus-Coach)...
May 2017: Patient Education and Counseling
https://www.readbyqxmd.com/read/28063799/phase-ii-trial-of-dose-dense-pemetrexed-gemcitabine-and-bevacizumab-in-patients-with-advanced-non-small-cell-lung-cancer
#12
Bryan J Schneider, Gregory P Kalemkerian, Shirish M Gadgeel, Manuel Valdivieso, Deborah M Hackstock, Wei Chen, Lance K Heilbrun, John C Ruckdeschel, Antoinette J Wozniak
INTRODUCTION: Platinum-based chemotherapy is standard for untreated, advanced non-small-cell lung cancer (NSCLC). We investigated the activity and tolerability of the novel combination of dose-dense pemetrexed, gemcitabine, and bevacizumab in patients with advanced NSCLC. METHODS: This multicenter phase II trial evaluated the safety and efficacy of the combination of pemetrexed (400 mg/m(2)), gemcitabine (1200 mg/m(2)), and bevacizumab (10 mg/kg), given every 14 days in patients with untreated, advanced NSCLC...
December 2, 2016: Clinical Lung Cancer
https://www.readbyqxmd.com/read/27979383/atezolizumab-versus-docetaxel-in-patients-with-previously-treated-non-small-cell-lung-cancer-oak-a-phase-3-open-label-multicentre-randomised-controlled-trial
#13
Achim Rittmeyer, Fabrice Barlesi, Daniel Waterkamp, Keunchil Park, Fortunato Ciardiello, Joachim von Pawel, Shirish M Gadgeel, Toyoaki Hida, Dariusz M Kowalski, Manuel Cobo Dols, Diego L Cortinovis, Joseph Leach, Jonathan Polikoff, Carlos Barrios, Fairooz Kabbinavar, Osvaldo Arén Frontera, Filippo De Marinis, Hande Turna, Jong-Seok Lee, Marcus Ballinger, Marcin Kowanetz, Pei He, Daniel S Chen, Alan Sandler, David R Gandara
BACKGROUND: Atezolizumab is a humanised antiprogrammed death-ligand 1 (PD-L1) monoclonal antibody that inhibits PD-L1 and programmed death-1 (PD-1) and PD-L1 and B7-1 interactions, reinvigorating anticancer immunity. We assessed its efficacy and safety versus docetaxel in previously treated patients with non-small-cell lung cancer. METHODS: We did a randomised, open-label, phase 3 trial (OAK) in 194 academic or community oncology centres in 31 countries. We enrolled patients who had squamous or non-squamous non-small-cell lung cancer, were 18 years or older, had measurable disease per Response Evaluation Criteria in Solid Tumors, and had an Eastern Cooperative Oncology Group performance status of 0 or 1...
January 21, 2017: Lancet
https://www.readbyqxmd.com/read/27969533/ps01-66-biomarker-stratification-of-outcomes-of%C3%A2-third-generation-egfr-tki-therapy-in-patients-with-previously-treated-advanced-nsclc-topic-medical-oncology
#14
Heather Wakelee, Jonathan W Goldman, Shirish Gadgeel, David R Camidge, Karen L Reckamp, Sai-Hong I Ou, Helena A Yu, Benjamin Solomon, Stephen V Liu, Maurice Pérol, Nicholas F Dupuis, Alex Nickel, Chris Karlovich, Mitch Raponi, Sergey Yurasov, Jason Litten, Darrin Despain, Jean-Charles Soria, Lecia Sequist, David Carbone
No abstract text is available yet for this article.
November 2016: Journal of Thoracic Oncology
https://www.readbyqxmd.com/read/27913735/preoperative-pulmonary-rehabilitation-for-marginal-function-lung-cancer-patients
#15
Asra Hashmi, Frank A Baciewicz, Ayman O Soubani, Shirish M Gadgeel
Background This study aimed to evaluate the impact of preoperative pulmonary rehabilitation in lung cancer patients undergoing pulmonary resection surgery with marginal lung function. Methods Short-term outcomes of 42 patients with forced expiratory volume in 1 s < 1.6 L who underwent lung resection between 01/2006 and 12/2010 were reviewed retrospectively. They were divided into group A (no preoperative pulmonary rehabilitation) and group B (receiving pulmonary rehabilitation). In group B, a second set of pulmonary function tests was obtained...
January 2017: Asian Cardiovascular & Thoracic Annals
https://www.readbyqxmd.com/read/27863201/pooled-analysis-of-cns-response-to-alectinib-in-two-studies-of-pretreated-patients-with-alk-positive-non-small-cell-lung-cancer
#16
MULTICENTER STUDY
Shirish M Gadgeel, Alice T Shaw, Ramaswamy Govindan, Leena Gandhi, Mark A Socinski, D Ross Camidge, Luigi De Petris, Dong-Wan Kim, Alberto Chiappori, Denis L Moro-Sibilot, Michael Duruisseaux, Lucio Crino, Tommaso De Pas, Eric Dansin, Antje Tessmer, James Chih-Hsin Yang, Ji-Youn Han, Walter Bordogna, Sophie Golding, Ali Zeaiter, Sai-Hong Ignatius Ou
Purpose Alectinib has shown activity in the CNS in phase I and II studies. To further evaluate this activity, we pooled efficacy and safety data from two single-arm phase II studies (NP28761 and NP28673; ClinicalTrials.gov identifiers: NCT01871805 and NCT01801111, respectively) in patients with ALK-positive non-small-cell lung cancer (NSCLC). Patients and Methods Both studies included patients with ALK-positive NSCLC who had previously received crizotinib; all patients received alectinib 600 mg twice per day...
December 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/27822122/mesothelioma-in-the-united-states-a-surveillance-epidemiology-and-end-results-seer-medicare-investigation-of-treatment-patterns-and-overall-survival
#17
Jennifer L Beebe-Dimmer, Jon P Fryzek, Cecilia L Yee, Tapashi B Dalvi, David H Garabrant, Ann G Schwartz, Shirish Gadgeel
INTRODUCTION: Mesothelioma is a rare malignancy typically associated with exposure to asbestos and poor survival. The purpose of this investigation was to describe mesothelioma patient characteristics, treatment patterns, and overall survival (OS) utilizing the National Cancer Institute's Surveillance, Epidemiology, and End Results-Medicare database. MATERIALS AND METHODS: Patients in this study were diagnosed with malignant mesothelioma of the pleura or peritoneum between January 1, 2005 and December 31, 2009 with follow-up for survival through December 31, 2010...
2016: Clinical Epidemiology
https://www.readbyqxmd.com/read/27745820/carboplatin-and-pemetrexed-with-or-without-pembrolizumab-for-advanced-non-squamous-non-small-cell-lung-cancer-a-randomised-phase-2-cohort-of-the-open-label-keynote-021-study
#18
RANDOMIZED CONTROLLED TRIAL
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...
November 2016: Lancet Oncology
https://www.readbyqxmd.com/read/27732997/predictive-and-prognostic-biomarkers-in-non-small-cell-lung-cancer
#19
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
https://www.readbyqxmd.com/read/27686971/phase-2-study-of-erlotinib-in-combination-with%C3%A2-linsitinib-osi-906-or-placebo-in-chemotherapy-naive-patients-with-non-small-cell-lung-cancer-and-activating-epidermal-growth-factor-receptor-mutations
#20
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...
January 2017: Clinical Lung Cancer
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