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Nsclc clinical trials

Denghai Mi, Weiwei Ren, Kehu Yang
BACKGROUND & OBJECTIVES: The effectiveness of interleukin-2 (IL-2) and induced killer cells for non-small cell lung cancer (NSCLC) is controversial. This study evaluates the efficacy and safety of interleukin-2 and induced killer cells on NSCLC, so as to provide references for further clinical practice and research. METHODS: Relevant randomized controlled trials (RCTs) were searched in Cochrane library (Issue 2, 2013), Web of Science (1980-March 2013), PubMed (1966-March 2013), China Knowledge Resource Integrated database (CNKI) (1994-March 2013), China Biology Medicine database (CBM) (1978-March 2013), VIP (1989-March 2013), and Wan Fang databases (1997-March 2013)...
May 2016: Indian Journal of Medical Research
Orsolya E Lunacsek, Arliene Ravelo, Anna D Coutinho, Sebastien J Hazard, Mark R Green, Joanne Willey, Michael Eaddy, Hans-Peter Goertz
BACKGROUND: Real-world evidence is lacking on the impact of bevacizumab added to carboplatin/paclitaxel (Bev + CP) therapy versus CP alone for patients with non-squamous non-small cell lung cancer (NS-NSCLC), particularly in those excluded from clinical trials. METHODS: This is a retrospective electronic medical record analysis of patients who received first-line therapy with Bev + CP or CP between 1 October 2006 and 30 June 2013. We identified four subsets: elderly patients (≥65 years), patients with brain/central nervous system (CNS) metastases, patients with Eastern Cooperative Oncology Group performance status (ECOG PS) ≥2, and patients receiving anticoagulation...
September 2016: Drugs—Real World Outcomes
Christina K Speirs, Todd A DeWees, Sana Rehman, Alerson Molotievschi, Maria A Velez, Daniel Mullen, Sandra Fergus, Marco Trovo, Jeffrey D Bradley, Cliff G Robinson
INTRODUCTION: In the randomized trial of standard vs high dose chemoradiotherapy (CRT) for locally advanced non-small cell lung cancer (LA-NSCLC) (RTOG 0617), overall survival (OS) was worse in the high dose arm. While heart dose was suggested as a contributing factor, actionable parameters have not been established. We present an analysis of clinical and dosimetric parameters impacting OS in this patient population, focusing on heart dose. METHODS: Clinical data was collected on 416 patients with LA-NSLC treated at a single institution, with a subset of 333 available treatment plans re-contoured using RTOG normal tissue guidelines...
October 12, 2016: Journal of Thoracic Oncology
J C Del Paggio, B Azariah, R Sullivan, W M Hopman, F V James, S Roshni, I F Tannock, C M Booth
BACKGROUND: The European Society for Medical Oncology (ESMO) recently released a magnitude of clinical benefit scale (ESMO-MCBS) for systemic therapies for solid cancers. Here, we evaluate contemporary randomized controlled trials (RCTs) against the proposed ESMO thresholds for meaningful clinical benefit. METHODS: RCTs evaluating systemic therapy for breast cancer, non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and pancreatic cancer published 2011-2015 were reviewed...
October 13, 2016: Annals of Oncology: Official Journal of the European Society for Medical Oncology
Emily Han-Chung Hsiue, Jih-Hsiang Lee, Chia-Chi Lin, James Chih-Hsin Yang
Gefitinib is recently approved by the US Food and Drug Administration as a first-line treatment for non-small cell lung cancer (NSCLC) patients harboring EGFR mutations. The therascreen® EGFR RGQ PCR Kit is approved as a companion diagnostic to select patients with EGFR exon 19 deletions and L858R mutation for treatment with gefitinib. Areas covered: This article reviews the methods for detecting EGFR mutations, the technology and indication of the therascreen® kit, and the clinical utility of the assay in phase 3 and phase 4 clinical trials...
October 13, 2016: Expert Review of Molecular Diagnostics
Roz G Brant, Alan Sharpe, Tom Liptrot, Jonathan Dry, Elizabeth A Harrington, J Carl Barrett, Nicky Whalley, Chris Womack, Paul D Smith, Darren Hodgson
PURPOSE: To develop a clinically viable gene expression assay to measure RAS/RAF/MEK/ERK (RAS-ERK) pathway output suitable for hypothesis testing in non-small cell lung cancer (NSCLC) clinical studies. EXPERIMENTAL DESIGN: A published MEK-functional-activation signature (MEK signature) that measures RAS-ERK functional output was optimized for NSCLC in silico. NanoString assays were developed for the NSCLC optimized MEK signature and the 147-gene RAS signature. First, platform transfer from Affymetrix to NanoString, and signature modulation following treatment with KRAS siRNA and MEK inhibitor, were investigated in cell lines...
October 12, 2016: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
Kristen A Marrone, Jarushka Naidoo, Julie R Brahmer
The treatment paradigm for lung cancer has been transformed in recent years by the use of immunotherapy, specifically, immune checkpoint antibodies (mAb), which are agents designed to reinvigorate an immune-mediated anticancer response by releasing the effects of tumor-mediated immunosuppression. Late-phase clinical trials of these agents in patients with advanced lung cancers have translated into improved clinical outcomes compared with standard-of-care chemotherapy for the treatment of metastatic non-small cell lung cancer, and have resulted in FDA approvals for two immune checkpoint mAbs in the second-line setting...
October 2016: Seminars in Respiratory and Critical Care Medicine
E-E Ke, Yi-Long Wu
Targeting the epidermal growth factor receptor (EGFR) using tyrosine kinase inhibitors (TKIs) is highly effective in terms of tumor response rate, survival, and quality of life. However, acquired resistance to EGFR-TKIs is inevitable. Ongoing clinical trials will provide evidence for optimal strategies for patients with EGFR mutant non-small-cell lung cancer (NSCLC) in the near future. Numerous new agents are specifically addressing resistance mechanisms; mature data are related to the T790M mutation and MET pathway activation...
October 4, 2016: Trends in Pharmacological Sciences
Marlon C Rebelatto, Anita Midha, Amita Mistry, Constantine Sabalos, Nicole Schechter, Xia Li, Xiaoping Jin, Keith E Steele, Paul B Robbins, John A Blake-Haskins, Jill Walker
BACKGROUND: A high-quality programmed cell-death ligand 1 (PD-L1) diagnostic assay may help predict which patients are more likely to respond to anti-programmed cell death-1 (PD-1)/PD-L1 antibody-based cancer therapy. Here we describe a PD-L1 immunohistochemical (IHC) staining protocol developed by Ventana Medical Systems Inc. and key analytical parameters of its use in formalin-fixed, paraffin-embedded (FFPE) samples of non-small cell lung cancer (NSCLC) and head and neck squamous cell carcinoma (HNSCC)...
October 8, 2016: Diagnostic Pathology
Koichi Goto, Masahiro Endo, Masahiko Kusumoto, Nobuyuki Yamamoto, Yuichiro Ohe, Ayaka Shimizu, Masahiro Fukuoka
Potentially life-threatening, serious hemoptysis is an adverse event associated with bevacizumab in non-squamous non-small-cell lung cancer (NSCLC) trials. Suggested risk factors include central tumor location and cavitation; however, the profile of hemoptysis occurrence in clinical practice is still unclear. A nested case-control study was conducted to assess the onset profile and risk factors for hemoptysis in bevacizumab-treated patients in a real-world setting in Japan. After bevacizumab was approved for NSCLC, Physicians registered all NSCLC patients scheduled for bevacizumab therapy, from November 2009 to August 2011...
October 6, 2016: Cancer Science
Jiaxing Huang, Yaxiong Zhang, Jin Sheng, Hongyu Zhang, Wenfeng Fang, Jianhua Zhan, Ting Zhou, Ying Chen, Lin Liu, Li Zhang
BACKGROUND: Nivolumab (BMS-936558/ONO-4538) was the first monoclonal antibody targeting programmed death (PD)-1. So far, a number of clinical trials on nivolumab have showed satisfactory efficacy in treating non-small-cell lung cancer (NSCLC). Herein, we present a meta-analysis evaluating the efficacy and safety of nivolumab for previously treated advanced NSCLC patients. METHODS: Electronic databases were searched for eligible literature. Data of objective response rate (ORR), disease control rate, overall survival, progression-free survival, and adverse effects (AEs) were extracted and pooled...
2016: OncoTargets and Therapy
Pankit Vachhani, Hongbin Chen
Immunotherapy with immune checkpoint inhibitors has opened a new arena in cancer therapeutics. Pembrolizumab is a highly selective anti-programmed cell death protein 1 (PD-1) antibody that has shown efficacy, leading to survival benefit and durable responses, in some patients with non-small cell lung cancer (NSCLC). It has been approved by the US Food and Drug Administration for the treatment of patients with metastatic NSCLC, whose tumors express PD-1 ligand 1 (PD-L1), with disease progression on or after platinum-containing chemotherapy...
2016: OncoTargets and Therapy
Emma D Deeks
Ceritinib (Zykadia™) is an oral, selective inhibitor of the anaplastic lymphoma kinase (ALK), a receptor tyrosine kinase which, after genetic rearrangement, acts as an oncogenic driver in a proportion of non-small cell lung cancers (NSCLCs). The drug is approved in several countries worldwide for the treatment of patients with ALK-positive, advanced NSCLC who have previously received the first-generation ALK inhibitor crizotinib (indication details may vary by country). Approval was based on its clinical benefit in this setting in the phase I and II trials known as ASCEND-1 and -2...
October 2016: Targeted Oncology
Yongzhao Zhao, Huixian Wang, Yan Shi, Shangli Cai, Tongwei Wu, Guangyue Yan, Sijin Cheng, Kang Cui, Ying Xi, Xiaolong Qi, Jie Zhang, Wang Ma
BACKGROUND & AIMS: Combined therapy inhibiting EGFR and VEGF pathways is becoming a promising therapy in the treatment of advanced non-small-cell lung cancer (NSCLC), however, with controversy. The study aims to compare the efficacy of combined inhibition therapy versus control therapy (including placebo, single EGFR inhibition and single VEGF inhibition) in patients with advanced NSCLC. MATERIALS AND METHODS: An adequate literature search in EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), American Society of Clinical Oncology (ASCO) and European Society of Medical Oncology (ESMO) was conducted...
September 27, 2016: Oncotarget
Andrea Camerini, Antonio Chella, Francesca Mazzoni, Cheti Puccetti, Sara Donati, Alice Lunghi, Paolo Petreni, Gianna Tartarelli, Massimiliano Serradori, Francesco Di Costanzo, Domenico Amoroso
BACKGROUND: We aimed to explore the use of platinum plus bevacizumab in a real world NSCLC population. PATIENTS AND METHODS: We retrospectively collected data from patients affected by NS-NSCLC treated with platinum plus bevacizumab across Tuscany. RESULTS: We evaluated 62 (median age: 63.5 [30-77] years) pts. All but one presented with adenocarcinoma and the majority had ECOG PS of 0/1. 17.7% presented with central lesion, 11.3% with brain metastasis, 38...
August 16, 2016: Journal of Chemotherapy
Tengfei Zhang, Jing Xie, Seiji Arai, Liping Wang, Xuezhong Shi, Ni Shi, Fen Ma, Sen Chen, Lan Huang, Li Yang, Wang Ma, Bin Zhang, Weidong Han, Jianchuan Xia, Hu Chen, Yi Zhang
PURPOSE: To systematically evaluate the overall efficacy and safety of current anti-PD-1/PD-L1 antibodies for treatment of patients with advanced or refractory cancer. RESULTS: Fifty-one trials including 6,800 patients were included. The overall response rates for melanoma, non-small cell lung cancer (NSCLC), and renal cell carcinoma (RCC) were 29% (95% CI: 1.53-2.41), 21% (95% CI: 17%-25%) and 21% (95% CI: 16%-27%) respectively. While the overall adverse effects rate for melanoma, NSCLC, RCC were 16% (95% CI: 6%-28%), 11% (95% CI: 8%-14%) and 20% (95% CI: 11%-32%) respectively...
September 24, 2016: Oncotarget
Stephanie Hobbins, Doug West, Michael Peake, Paul Beckett, Ian Woolhouse
OBJECTIVES: Pulmonary carcinoid (PC) is a rare tumour with good prognosis following surgical resection. However, little is known regarding patient characteristics and use of other treatments modalities. Our objective was to review patient characteristics, treatment and survival for patients with PC and contrast these results with other forms of non-small cell lung cancer (NSCLC). SETTING: Audit data from UK National Lung Cancer Audit (NLCA) 2008-2013. PARTICIPANTS: 184 906 lung cancer cases were submitted to the NLCA...
2016: BMJ Open
Shan Xian Guo, Yan Jian, Ying Lan Chen, Yun Cai, Qing Yuan Zhang, Fang Fang Tou
Neoadjuvant Chemotherapy has been used for the stage III of non-small cell lung cancer (NSCLC) and has shown good clinical effects. However, the survival benefits of radiation therapy added in induction regimens remains controversial. We therefore conducted a meta-analysis of the published clinical trials to quantitatively evaluate the benefit of preoperative chemoradiotherapy. After searching the database of Pubmed, CNKI, EMBASE, ESMO, The Cochrane Library databases, The American Society of Clinical Oncology and Clinical Trials...
September 28, 2016: Scientific Reports
S N Badiyan, W F Hartsell, O Cahlon, H Giap, K Prabhu, S J Feigenberg, M D Chuong, P Mohindra, M P Mehta, C Vargas, B S Hoppe, C B Simone
No abstract text is available yet for this article.
October 1, 2016: International Journal of Radiation Oncology, Biology, Physics
A Matikas, V Georgoulias, A Kotsakis
Non-small cell lung cancer lung cancer (NSCLC) is a devastating disease, with poor prognosis for patients with metastatic disease. The management of these patients has evolved during the past decade, challenging the role of cytotoxic chemotherapy as the only available treatment option. Nevertheless, chemotherapy still retains a dominant position for the majority of both treatment naïve and pretreated patients. Among the chemotherapeutic agents, docetaxel is one of the most commonly used in 1st and subsequent treatment lines, even in the current era of precision medicine...
October 3, 2016: Expert Review of Respiratory Medicine
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