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https://www.readbyqxmd.com/read/28854067/phase-iii-trial-of-ipilimumab-combined-with-paclitaxel-and-carboplatin-in-advanced-squamous-non-small-cell-lung-cancer
#1
Ramaswamy Govindan, Aleksandra Szczesna, Myung-Ju Ahn, Claus-Peter Schneider, Pablo Fernando Gonzalez Mella, Fabrice Barlesi, Baohui Han, Doina Elena Ganea, Joachim Von Pawel, Vladimir Vladimirov, Natalia Fadeeva, Ki Hyeong Lee, Takayasu Kurata, Li Zhang, Tomohide Tamura, Pieter E Postmus, Jacek Jassem, Kenneth O'Byrne, Justin Kopit, Mingshun Li, Marina Tschaika, Martin Reck
Purpose Patients with squamous non-small-cell lung cancer (NSCLC) have poor prognosis and limited treatment options. This randomized, double-blind, phase III study investigated the efficacy and safety of first-line ipilimumab or placebo plus paclitaxel and carboplatin in advanced squamous NSCLC. Patients and Methods Patients with stage IV or recurrent chemotherapy-naïve squamous NSCLC were randomly assigned (1:1) to receive paclitaxel and carboplatin plus blinded ipilimumab 10 mg/kg or placebo every 3 weeks on a phased induction schedule comprising six chemotherapy cycles, with ipilimumab or placebo from cycles 3 to 6 and then, after induction treatment, ipilimumab or placebo maintenance every 12 weeks for patients with stable disease or better...
October 20, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
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 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/28493811/pooled-analysis-of-individual-patient-data-on-concurrent-chemoradiotherapy-for-stage-iii-non-small-cell-lung-cancer-in-elderly-patients-compared-with-younger-patients-who-participated-in-us-national-cancer-institute-cooperative-group-studies
#3
Thomas E Stinchcombe, Ying Zhang, Everett E Vokes, Joan H Schiller, Jeffrey D Bradley, Karen Kelly, Walter J Curran, Steven E Schild, Benjamin Movsas, Gerald Clamon, Ramaswamy Govindan, George R Blumenschein, Mark A Socinski, Neal E Ready, Wallace L Akerley, Harvey J Cohen, Herbert H Pang, Xiaofei Wang
Purpose Concurrent chemoradiotherapy is standard treatment for patients with stage III non-small-cell lung cancer. Elderly patients may experience increased rates of adverse events (AEs) or less benefit from concurrent chemoradiotherapy. Patients and Methods Individual patient data were collected from 16 phase II or III trials conducted by US National Cancer Institute-supported cooperative groups of concurrent chemoradiotherapy alone or with consolidation or induction chemotherapy for stage III non-small-cell lung cancer from 1990 to 2012...
September 1, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28463960/phase-i-dose-escalation-studies-of-roniciclib-a-pan-cyclin-dependent-kinase-inhibitor-in-advanced-malignancies
#4
MULTICENTER STUDY
Rastislav Bahleda, Juneko E Grilley-Olson, Ramaswamy Govindan, Fabrice Barlesi, Laurent Greillier, Maurice Perol, Isabelle Ray-Coquard, Dirk Strumberg, Beate Schultheis, Grace K Dy, Gérard Zalcman, Glen J Weiss, Annette O Walter, Martin Kornacker, Prabhu Rajagopalan, David Henderson, Hendrik Nogai, Matthias Ocker, Jean-Charles Soria
BACKGROUND: To evaluate safety, pharmacokinetics, and maximum tolerated dose of roniciclib in patients with advanced malignancies, with dose expansion to evaluate clinical benefit at the recommended phase II dose (RP2D). METHODS: Two phase I dose-escalation studies evaluated two roniciclib dosing schedules: 3 days on/4 days off or 4 weeks on/2 weeks off. The expansion phase included patients with small-cell lung cancer (SCLC), ovarian cancer, or tumour mutations involving the CDK signalling pathway...
June 6, 2017: British Journal of Cancer
https://www.readbyqxmd.com/read/28404761/non-small-cell-lung-cancer-version-5-2017-nccn-clinical-practice-guidelines-in-oncology
#5
David S Ettinger, Douglas E Wood, Dara L Aisner, Wallace Akerley, Jessica Bauman, Lucian R Chirieac, Thomas A D'Amico, Malcolm M DeCamp, Thomas J Dilling, Michael Dobelbower, Robert C Doebele, Ramaswamy Govindan, Matthew A Gubens, Mark Hennon, Leora Horn, Ritsuko Komaki, Rudy P Lackner, Michael Lanuti, Ticiana A Leal, Leah J Leisch, Rogerio Lilenbaum, Jules Lin, Billy W Loo, Renato Martins, Gregory A Otterson, Karen Reckamp, Gregory J Riely, Steven E Schild, Theresa A Shapiro, James Stevenson, Scott J Swanson, Kurt Tauer, Stephen C Yang, Kristina Gregory, Miranda Hughes
This selection from the NCCN Guidelines for Non-Small Cell Lung Cancer (NSCLC) focuses on targeted therapies and immunotherapies for metastatic NSCLC, because therapeutic recommendations are rapidly changing for metastatic disease. For example, new recommendations were added for atezolizumab, ceritinib, osimertinib, and pembrolizumab for the 2017 updates.
April 2017: Journal of the National Comprehensive Cancer Network: JNCCN
https://www.readbyqxmd.com/read/28212994/an-open-label-phase-ii-study-of-the-polo-like-kinase-1-plk-1-inhibitor-bi-2536-in-patients-with-relapsed-small-cell-lung-cancer-sclc
#6
Mark M Awad, Quincy S-C Chu, Leena Gandhi, Joe J Stephenson, Ramaswamy Govindan, Daniel S Bradford, Philip D Bonomi, David M Ellison, Keith D Eaton, Holger Fritsch, Gerd Munzert, Bruce E Johnson, Mark A Socinski
OBJECTIVES: This phase II, open-label study was designed to evaluate the response rate to the polo-like kinase 1 (Plk-1) inhibitor BI 2536 in patients with sensitive-relapsed small cell lung cancer (SCLC). Secondary endpoints included progression-free survival (PFS), overall survival (OS), duration of response, and safety. MATERIALS AND METHODS: Patients were treated with the recommended phase II dose of 200mg of BI 2536 intravenously every 21days. This was a two-stage design with an early stopping rule in place if responses were not seen in at least 2 of the first 18 enrolled patients...
February 2017: Lung Cancer: Journal of the International Association for the Study of Lung Cancer
https://www.readbyqxmd.com/read/27969525/ps01-58-a-phase-3-trial-of-nivolumab-nivolumab-plus-ipilimumab-or-placebo-maintenance-for-extensive-stage-sclc-after-first-line-chemotherapy-topic-medical-oncology
#7
Taofeek Owonikoko, Neal Ready, Pieter Postmus, Martin Reck, Solange Peters, Anne Pieters, Giovanni Selvaggi, Justin Fairchild, Ramaswamy Govindan
No abstract text is available yet for this article.
November 2016: Journal of Thoracic Oncology
https://www.readbyqxmd.com/read/27969444/oral02-01-safety-and-efficacy-of-single-agent-rovalpituzumab-tesirine-a-dll3-targeted-adc-in-recurrent-or%C3%A2-refractory-sclc-topic-medical-oncology
#8
Todd M Bauer, David Spigel, Neal Ready, Daniel Morgensztern, Bonnie S Glisson, Lauren A Byers, Howard Burris, Francisco Robert, Donald K Strickland, Maria C Pietanza, Ramaswamy Govindan, Scott J Dylla, Stanford Peng, Charles Rudin
No abstract text is available yet for this article.
November 2016: Journal of Thoracic Oncology
https://www.readbyqxmd.com/read/27932068/rovalpituzumab-tesirine-a-dll3-targeted-antibody-drug-conjugate-in-recurrent-small-cell-lung-cancer-a-first-in-human-first-in-class-open-label-phase-1-study
#9
MULTICENTER STUDY
Charles M Rudin, M Catherine Pietanza, Todd M Bauer, Neal Ready, Daniel Morgensztern, Bonnie S Glisson, Lauren A Byers, Melissa L Johnson, Howard A Burris, Francisco Robert, Tae H Han, Sheila Bheddah, Noah Theiss, Sky Watson, Deepan Mathur, Bharathi Vennapusa, Hany Zayed, Satwant Lally, Donald K Strickland, Ramaswamy Govindan, Scott J Dylla, Stanford L Peng, David R Spigel
BACKGROUND: Rovalpituzumab tesirine is a first-in-class antibody-drug conjugate directed against delta-like protein 3 (DLL3), a novel target identified in tumour-initiating cells and expressed in more than 80% of patients with small-cell lung cancer. We aimed to assess the safety and activity of rovalpituzumab tesirine in patients who progressed after one or more previous regimen. METHODS: We conducted a phase 1 open-label study at ten cancer centres in the USA...
January 2017: Lancet Oncology
https://www.readbyqxmd.com/read/27912831/systemic-treatment-of-brain-metastases
#10
REVIEW
Saiama N Waqar, Daniel Morgensztern, Ramaswamy Govindan
Lung cancer continues to be the leading cause of cancer-related mortality in the United States. Brain metastases are a significant problem in patients with lung cancer and have conventionally been treated with whole-brain radiation. This article reviews the data for systemic chemotherapy to treat brain metastasis from lung cancer and examines the activity of small molecule tyrosine kinase inhibitors for the targeted therapy for brain metastases from EGFR-mutant and ALK-rearranged non-small cell lung cancer...
February 2017: Hematology/oncology Clinics of North America
https://www.readbyqxmd.com/read/27912825/next-generation-sequencing-of-lung-cancers-lessons-learned-and-future-directions
#11
REVIEW
Siddhartha Devarakonda, Ashiq Masood, Ramaswamy Govindan
Targeted therapies and immune checkpoint inhibitors have significantly improved outcomes in a sizable fraction of patients with metastatic non-small cell lung cancer. Nevertheless, a majority of patients with lung cancer continue to have poor outcomes. The ability to comprehensively characterize the genomic alterations in various subtypes of lung cancer has the potential to transform cancer care by facilitating the identification of novel treatment strategies. The objective of this review is to summarize key findings from recent studies that have sequenced a large number of lung cancer samples and discuss the diagnostic, prognostic, and therapeutic relevance of these findings...
February 2017: Hematology/oncology Clinics of North America
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
#12
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/27697581/phase-i-results-from-a-study-of-crizotinib-in-combination-with-erlotinib-in-patients-with-advanced-nonsquamous-non-small-cell-lung-cancer
#13
Sai-Hong Ignatius Ou, Ramaswamy Govindan, Keith D Eaton, Gregory A Otterson, Martin E Gutierrez, Alain C Mita, Athanassios Argiris, Nicoletta M Brega, Tiziana Usari, Weiwei Tan, Steffan N Ho, Francisco Robert
INTRODUCTION: This phase I trial was conducted to determine the safety, maximum tolerated dose (MTD)/recommended phase II dose, and efficacy of crizotinib plus erlotinib in patients with advanced NSCLC. METHODS: Patients with NSCLC and an Eastern Cooperative Oncology Group performance status of 0 to 2 after failure of one or two prior chemotherapy regimens were eligible. Erlotinib, 100 mg, was given continuously once daily starting between day -14 and -7; crizotinib, 200 mg twice daily (dose level 1) or 150 mg twice daily (dose level -1), was added continuously beginning on day 1 of treatment cycle 1...
January 2017: Journal of Thoracic Oncology
https://www.readbyqxmd.com/read/27461773/efficacy-and-safety-results-from-a-phase-ii-placebo-controlled-study-of-onartuzumab-plus-first-line-platinum-doublet-chemotherapy-for-advanced-squamous-cell-non-small-cell-lung-cancer
#14
RANDOMIZED CONTROLLED TRIAL
Fred R Hirsch, Ramaswamy Govindan, Zanete Zvirbule, Fadi Braiteh, Achim Rittmeyer, Cristóbal Belda-Iniesta, Dolores Isla, Thomas Cosgriff, Michelle Boyer, Masamichi Ueda, See Phan, David R Gandara
INTRODUCTION: The treatment options for squamous cell non-small-cell lung cancer (NSCLC) are limited. We assessed the efficacy and safety of onartuzumab plus platinum-doublet chemotherapy in previously untreated advanced squamous cell NSCLC. PATIENTS AND METHODS: The patients were randomized to receive onartuzumab plus paclitaxel plus carboplatin/cisplatin (n = 55) or placebo plus paclitaxel plus carboplatin/cisplatin (n = 54). Randomization was stratified by MET diagnostic status: MET immunohistochemistry (IHC)-positive (MET IHC 3+/2+) or MET IHC-negative (MET IHC 1+/0)...
January 2017: Clinical Lung Cancer
https://www.readbyqxmd.com/read/27407123/nccn-guidelines-insights-malignant-pleural-mesothelioma-version-3-2016
#15
David S Ettinger, Douglas E Wood, Wallace Akerley, Lyudmila A Bazhenova, Hossein Borghaei, David Ross Camidge, Richard T Cheney, Lucian R Chirieac, Thomas A D'Amico, Thomas Dilling, Michael Dobelbower, Ramaswamy Govindan, Mark Hennon, Leora Horn, Thierry M Jahan, Ritsuko Komaki, Rudy P Lackner, Michael Lanuti, Rogerio Lilenbaum, Jules Lin, Billy W Loo, Renato Martins, Gregory A Otterson, Jyoti D Patel, Katherine M Pisters, Karen Reckamp, Gregory J Riely, Steven E Schild, Theresa A Shapiro, Neelesh Sharma, Scott J Swanson, James Stevenson, Kurt Tauer, Stephen C Yang, Kristina Gregory, Miranda Hughes
These NCCN Guidelines Insights focus on recent updates to the NCCN Guidelines for Malignant Pleural Mesothelioma (MPM). These NCCN Guidelines Insights discuss systemic therapy regimens and surgical controversies for MPM. The NCCN panel recommends cisplatin/pemetrexed (category 1) for patients with MPM. The NCCN panel also now recommends bevacizumab/cisplatin/pemetrexed as a first-line therapy option for patients with unresectable MPM who are candidates for bevacizumab. The complete version of the NCCN Guidelines for MPM, available at NCCN...
July 2016: Journal of the National Comprehensive Cancer Network: JNCCN
https://www.readbyqxmd.com/read/27401214/clinician-perspectives-on-current-issues-in-lung-cancer-drug-development
#16
REVIEW
Saiama N Waqar, Philip D Bonomi, Ramaswamy Govindan, Fred R Hirsch, Gregory J Riely, Vassiliki Papadimitrakopoulou, Dickran Kazandjian, Sean Khozin, Erin Larkins, Dane J Dickson, Shakun Malik, Leora Horn, Andrea Ferris, Alice T Shaw, Pasi A Jänne, Tony S K Mok, Roy Herbst, Patricia Keegan, Richard Pazdur, Gideon M Blumenthal
Recent advances in molecularly targeted therapy and immunotherapy offer a glimmer of hope for potentially realizing the dream of personalized therapy for lung cancer. This article highlights current questions in clinical trial design, enrollment strategies and patient focused drug development, with particular emphasis on unique issues in trials of targeted therapy and immunotherapy.
September 2016: Journal of Thoracic Oncology
https://www.readbyqxmd.com/read/27287414/adjuvant-chemotherapy-for-patients-with-t2n0m0-nsclc
#17
Daniel Morgensztern, Lingling Du, Saiama N Waqar, Aalok Patel, Pamela Samson, Siddhartha Devarakonda, Feng Gao, Cliff G Robinson, Jeffrey Bradley, Maria Baggstrom, Ashiq Masood, Ramaswamy Govindan, Varun Puri
BACKGROUND: Adjuvant chemotherapy improves survival in patients with completely resected stage II and III NSCLC. However, its role in patients with stage IB NSCLC disease remains unclear. We evaluated the role of adjuvant chemotherapy in a large data set of patients with completely resected T2N0M0 NSCLC. METHODS: Patients with pathologic stage T2N0M0 NSCLC who underwent complete (R0) resection between 2004 and 2011 were identified from the National Cancer Data Base and classified into four groups based on tumor size: 3...
October 2016: Journal of Thoracic Oncology
https://www.readbyqxmd.com/read/27194218/nutritional-properties-of-the-largest-bamboo-fruit-melocanna-baccifera-and-its-ecological-significance
#18
Balaji Govindan, Anil John Johnson, Sadasivan Nair Ajikumaran Nair, Bhaskaran Gopakumar, Karuna Sri Lakshmi Mallampalli, Ramaswamy Venkataraman, Konnath Chacko Koshy, Sabulal Baby
Melocanna baccifera is a unique bamboo which produces the largest fruits in the grass family. Its gregarious flowering once in 45-50 years in north east India and adjacent regions is a botanical enigma, resulting in a glut of fruits. Proper utilization of M. baccifera fruits is not extant, and huge quantities of fruits are left underexploited due to lack of scientific information on their chemical composition and nutritional potential. Here we report the nutritional properties of M. baccifera fruits, and the ecological significance of its fruiting...
2016: Scientific Reports
https://www.readbyqxmd.com/read/27168435/clinical-implications-of-genomic-discoveries-in-lung-cancer
#19
REVIEW
Charles Swanton, Ramaswamy Govindan
No abstract text is available yet for this article.
May 12, 2016: New England Journal of Medicine
https://www.readbyqxmd.com/read/27158780/distinct-patterns-of-somatic-genome-alterations-in-lung-adenocarcinomas-and-squamous-cell-carcinomas
#20
Joshua D Campbell, Anton Alexandrov, Jaegil Kim, Jeremiah Wala, Alice H Berger, Chandra Sekhar Pedamallu, Sachet A Shukla, Guangwu Guo, Angela N Brooks, Bradley A Murray, Marcin Imielinski, Xin Hu, Shiyun Ling, Rehan Akbani, Mara Rosenberg, Carrie Cibulskis, Aruna Ramachandran, Eric A Collisson, David J Kwiatkowski, Michael S Lawrence, John N Weinstein, Roel G W Verhaak, Catherine J Wu, Peter S Hammerman, Andrew D Cherniack, Gad Getz, Maxim N Artyomov, Robert Schreiber, Ramaswamy Govindan, Matthew Meyerson
To compare lung adenocarcinoma (ADC) and lung squamous cell carcinoma (SqCC) and to identify new drivers of lung carcinogenesis, we examined the exome sequences and copy number profiles of 660 lung ADC and 484 lung SqCC tumor-normal pairs. Recurrent alterations in lung SqCCs were more similar to those of other squamous carcinomas than to alterations in lung ADCs. New significantly mutated genes included PPP3CA, DOT1L, and FTSJD1 in lung ADC, RASA1 in lung SqCC, and KLF5, EP300, and CREBBP in both tumor types...
June 2016: Nature Genetics
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