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https://www.readbyqxmd.com/read/29168933/role-of-chemotherapy-and-targeted-therapy-in-early-stage-non-small-cell-lung-cancer
#1
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...
November 26, 2017: 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
#2
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...
November 16, 2017: 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
#3
Manish K Thakur, Julie J Ruterbusch, Ann G Schwartz, Shirish M Gadgeel, Jennifer L Beebe-Dimmer, Antoinette J Wozniak
BACKGROUND: The risk of developing a second primary lung cancer (SPLC) after the treatment of an initial primary lung cancer (IPLC) is around 1-2 % per patient per year. Present screening/surveillance guidelines do not adequately address this particular patient population. PATIENTS AND METHODS: We retrospectively reviewed patients in the Surveillance, Epidemiology, and End Results (SEER) data base from 1992 to 2007 to assess the frequency of occurrence of SPLC with regard to multiple patient demographics and calculated Standardized Incidence Ratios (SIRs)...
October 5, 2017: 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
#4
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...
August 31, 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
#5
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
#6
Misako Nagasaka, Shirish M Gadgeel
No abstract text is available yet for this article.
July 6, 2017: 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
#7
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
#8
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
#9
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
#10
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
#11
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
#12
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
#13
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
#14
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
#15
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
#16
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
#17
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
#18
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
#19
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
#20
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
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