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Non small cell lung cancer phase iii

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https://www.readbyqxmd.com/read/29336009/gefitinib-for-advanced-non-small-cell-lung-cancer
#1
REVIEW
Esther Ha Sim, Ian A Yang, Richard Wood-Baker, Rayleen V Bowman, Kwun M Fong
BACKGROUND: The role of gefitinib for the treatment of advanced non-small cell lung cancer (NSCLC) is evolving. We undertook a systematic review to evaluate the available evidence from all randomised trials. OBJECTIVES: To determine the effectiveness and safety of gefitinib as first-line, second-line or maintenance treatment for advanced NSCLC. SEARCH METHODS: We performed searches in CENTRAL, MEDLINE and Embase from inception to 17 February 2017...
January 16, 2018: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/29317191/randomized-double-blind-phase-ib-iii-study-of-erlotinib-with-ramucirumab-or-placebo-in-previously-untreated-egfr-mutant-metastatic-non-small-cell-lung-cancer-relay-phase-ib-results
#2
Martin Reck, Edward B Garon, Luis Paz-Ares, Santiago Ponce, Jesus Corral Jaime, Oscar Juan, Ernest Nadal, Katsuyuki Kiura, Ryan C Widau, Shuang He, Rita Dalal, Pablo Lee, Kazuhiko Nakagawa
BACKGROUND: Despite the likelihood of an initial response to an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), EGFR-mutant non-small-cell lung cancer (NSCLC) patients develop disease progression. Antiangiogenic agents in combination with an EGFR TKI might provide additional benefit in patients with EGFR-mutant NSCLC. In this article we report safety, exposure, and progression-free survival (PFS) results for part A (phase Ib) of RELAY, a randomized, double-blind, phase Ib/III study investigating safety and efficacy of erlotinib (EGFR TKI) with ramucirumab (anti-vascular endothelial growth factor receptor-2 antibody) or placebo in first-line EGFR-mutant stage IV NSCLC...
November 21, 2017: Clinical Lung Cancer
https://www.readbyqxmd.com/read/29290261/does-nivolumab-for-progressed-metastatic-lung-cancer-fulfill-its-promises-an-efficacy-and-safety-analysis-in-20-general-hospitals
#3
Kurt G Tournoy, Michiel Thomeer, Paul Germonpré, Sofie Derijcke, Rebecca De Pauw, Daniëlla Galdermans, Karl Govaert, Elke Govaerts, Rob Schildermans, Isabelle Declercq, Nele De Brucker, Karin Pat, Rika Van Herreweghe, Luc Van Zandweghe, Luc Vanmaele, Valerie Van Damme, Heidi Marien, Sofie De Craene, Isabelle Fabry, Patrick Alexander, Piet Vercauter, Ingel Demedts
OBJECTIVES: In patients with refractory or recurrent non-small-cell lung cancer (NSCLC) after first line chemotherapy, phase III trials showed superiority of nivolumab, an IgG4 programmed death-1 immune-checkpoint-inhibitor antibody, over docetaxel. We evaluated case mix, effectiveness and safety of nivolumab upon implementation in general practice. MATERIALS AND METHODS: In 20 general hospitals, all consecutive NSCLC patients treated with nivolumab within the medical need program (inclusion period 12 months) in Flanders - Belgium were evaluated...
January 2018: Lung Cancer: Journal of the International Association for the Study of Lung Cancer
https://www.readbyqxmd.com/read/29273262/long-term-quality-of-life-in-inoperable-non-small-cell-lung-cancer-patients-treated-with-conventionally-fractionated-compared-to-hyperfractionated-accelerated-radiotherapy-results-of-the-randomized-chartwel-trial
#4
Marlene Hechtner, Mechthild Krause, Jochem König, Steffen Appold, Beate Hornemann, Susanne Singer, Michael Baumann
BACKGROUND AND PURPOSE: To evaluate the quality of life (QoL) of patients with inoperable non-small cell lung cancer treated with conventionally fractionated radiotherapy (CF) vs. continuous hyperfractionated accelerated radiotherapy weekend-less (CHARTWEL). MATERIAL AND METHODS: The largest monocentric subgroup of the phase III CHARTWEL trial was analyzed up to three years after randomization. QoL was assessed with the European Organization for Research and Treatment of Cancer QoL Core Questionnaire (QLQ-C30) and lung cancer module (QLQ-LC13) and compared using linear mixed models...
December 19, 2017: Radiotherapy and Oncology: Journal of the European Society for Therapeutic Radiology and Oncology
https://www.readbyqxmd.com/read/29248169/simultaneous-integrated-boost-for-radiation-dose-escalation-to-the-gross-tumor-volume-with-intensity-modulated-photon-radiation-therapy-or-intensity-modulated-proton-therapy-and-concurrent-chemotherapy-for-stage-ii-to-iii-non-small-cell-lung-cancer-a-phase
#5
Melenda D Jeter, Daniel Gomez, Quynh-Nhu Nguyen, Ritsuko Komaki, Xiaodong Zhang, Xiaorong Zhu, Michael O'Reilly, Frank V Fossella, Ting Xu, Xiong Wei, Hui Wang, Wenjuan Yang, Anne Tsao, Radhe Mohan, Zhongxing Liao
PURPOSE: To establish, in the phase 1 portion of a prospective phase 1/2 study, the maximum tolerated dose of image guided intensity modulated radiation therapy (IMRT) or proton therapy (IMPT), both with a simultaneous integrated boost (SIB), for patients with stage II to IIIB non-small cell lung cancer receiving concurrent chemoradiation therapy. METHODS AND MATERIALS: Patients had pathologically proven non-small cell lung cancer, either unresectable stage II to IIIB disease or recurrent disease after surgical resection, and could tolerate concurrent chemoradiation...
November 3, 2017: International Journal of Radiation Oncology, Biology, Physics
https://www.readbyqxmd.com/read/29247502/immunotherapy-excluding-checkpoint-inhibitors-for-stage-i-to-iii-non-small-cell-lung-cancer-treated-with-surgery-or-radiotherapy-with-curative-intent
#6
REVIEW
Jianwei Zhu, Rui Li, Eva Tiselius, Raheleh Roudi, Olivia Teghararian, Chen Suo, Huan Song
BACKGROUND: Non-small cell lung cancer (NSCLC) is the most common lung cancer, accounting for approximately 80% to 85% of all cases. For patients with localised NSCLC (stages I to III), it has been speculated that immunotherapy may be helpful for reducing postoperative recurrence rates, or improving the clinical outcomes of current treatment for unresectable tumours. While several new agents have now entered phase III clinical trials, we felt a systematic review was needed to address the question of the effectiveness and safety of immunotherapy in patients with stages I to III NSCLC...
December 16, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/29221762/continuous-infusion-of-cilengitide-plus-chemoradiotherapy-for-patients-with-stage-iii-non-small-cell-lung-cancer-a-phase-i-study
#7
Carole Massabeau, Jonathan Khalifa, Thomas Filleron, Anouchka Modesto, Laurence Bigay-Gamé, Gavin Plat, Lawrence Dierickx, Richard Aziza, Isabelle Rouquette, Carlos Gomez-Roca, Muriel Mounier, Jean-Pierre Delord, Christine Toulas, Pascale Olivier, Etienne Chatelut, Julien Mazières, Elizabeth Cohen-Jonathan Moyal
INTRODUCTION: Because of our previous preclinical results, we conducted a phase I study associating the specific αvβ3/αvβ5 integrin inhibitor cilengitide, given as a continuous infusion, with exclusive chemoradiotherapy for patients with stage III non-small-cell lung cancer. PATIENTS AND METHODS: A standard 3+3 dose escalation design was used. Cilengitide was given as a continuous infusion (dose levels of 12, 18, 27, and 40 mg/h), starting 2 weeks before and continuing for the whole course of chemoradiotherapy (66 Gy combined with platinum/vinorelbine), and then at a dose of 2000 mg twice weekly in association with chemotherapy...
November 21, 2017: Clinical Lung Cancer
https://www.readbyqxmd.com/read/29217691/first-line-osimertinib-beneficial-in-advanced-nsclc
#8
(no author information available yet)
Osimertinib is more effective as first-line therapy than other EGFR inhibitors for patients with advanced EGFR-mutated non-small cell lung cancer-notably Asians, who have a higher incidence of the disease compared with Western populations. The conclusion is based on data from a subgroup analysis of the phase III FLAURA trial.
December 7, 2017: Cancer Discovery
https://www.readbyqxmd.com/read/29217088/induction-cisplatin-docetaxel-followed-by-surgery-and-erlotinib-in-non-small-cell-lung-cancer
#9
Tina Cascone, Kathryn A Gold, Stephen G Swisher, Diane D Liu, Frank V Fossella, Boris Sepesi, Apar Pataer, Annikka Weissferdt, Neda Kalhor, Ara A Vaporciyan, Wayne L Hofstetter, Ignacio I Wistuba, John V Heymach, Edward S Kim, William N William
BACKGROUND: Data from meta-analyses support the use of induction or adjuvant platinum-based chemotherapy for locally advanced non-small cell lung cancers (NSCLCs). This phase 2 study assessed the role of induction cisplatin and docetaxel followed by surgery in patients with resectable stage I to III NSCLCs, followed by 12 months of adjuvant erlotinib. METHODS: Patients with resectable stage I to III NSCLCs received cisplatin 80 mg/m2, docetaxel 75 mg/m2 every 21 days for 3 cycles, followed by surgery, followed by adjuvant erlotinib for 12 months...
December 4, 2017: Annals of Thoracic Surgery
https://www.readbyqxmd.com/read/29216787/mek-inhibitors-under-development-for-treatment-of-non-small-cell-lung-cancer
#10
Chul Kim, Giuseppe Giaccone
The mitogen-activated protein kinase (MAPK) pathway is intimately implicated in the molecular pathogenesis of non-small-cell lung cancer (NSCLC). Aberrant MAPK signaling resulting from the upstream activating mutations converges on mitogen-activated protein kinase kinase 1/2 (MEK1/2), making MEK inhibition an attractive strategy for the treatment of NSCLC. Several MEK inhibitors have demonstrated anticancer activity in patients with NSCLC. Areas covered: In this article, we discuss the biological rationale for the use of MEK inhibitors and summarize the clinical experience with MEK1/2 inhibitors for the treatment of NSCLC, from initial phase I studies to phase II/III studies, both as monotherapy or in combination with other anticancer agents...
December 7, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/29201573/on-the-relationship-between-tumour-growth-rate-and-survival-in-non-small-cell-lung-cancer
#11
Hitesh B Mistry
A recurrent question within oncology drug development is predicting phase III outcome for a new treatment using early clinical data. One approach to tackle this problem has been to derive metrics from mathematical models that describe tumour size dynamics termed re-growth rate and time to tumour re-growth. They have shown to be strong predictors of overall survival in numerous studies but there is debate about how these metrics are derived and if they are more predictive than empirical end-points. This work explores the issues raised in using model-derived metric as predictors for survival analyses...
2017: PeerJ
https://www.readbyqxmd.com/read/29191593/outcomes-in-patients-with-aggressive-or-refractory-disease-from-revel-a-randomized-phase-iii-study-of-docetaxel-with-ramucirumab-or-placebo-for-second-line-treatment-of-stage-iv-non-small-cell-lung-cancer
#12
Martin Reck, Luis Paz-Ares, Paolo Bidoli, Federico Cappuzzo, Shaker Dakhil, Denis Moro-Sibilot, Hossein Borghaei, Melissa Johnson, Robert Jotte, Nathan A Pennell, Frances A Shepherd, Anne Tsao, Michael Thomas, Gebra Cuyun Carter, Faye Chan-Diehl, Ekaterine Alexandris, Pablo Lee, Annamaria Zimmermann, Andreas Sashegyi, Maurice Pérol
OBJECTIVES: The REVEL study demonstrated improved efficacy for patients with advanced non-small cell lung cancer treated with ramucirumab plus docetaxel, independent of histology. This exploratory analysis characterized the treatment effect in REVEL patients who were refractory to prior first-line treatment. MATERIALS AND METHODS: Refractory patients had a best response of progressive disease to first-line treatment. Endpoints included overall survival (OS), progression-free survival (PFS), objective response rate (ORR), quality of life (QoL), and safety...
October 2017: Lung Cancer: Journal of the International Association for the Study of Lung Cancer
https://www.readbyqxmd.com/read/29191585/treatment-outcomes-by-histology-in-revel-a-randomized-phase-iii-trial-of-ramucirumab-plus-docetaxel-for-advanced-non-small-cell-lung-cancer
#13
Luis G Paz-Ares, Maurice Pérol, Tudor-Eliade Ciuleanu, Ruben Dario Kowalyszyn, Martin Reck, Conrad R Lewanski, Konstantinos Syrigos, Oscar Arrieta, Kumar Prabhash, Keunchil Park, Joanna Pikiel, Tuncay Göksel, Pablo Lee, Anna Zimmermann, Gebra Cuyun Carter, Ekaterine Alexandris, Edward B Garon
OBJECTIVES: Ramucirumab, a recombinant human immunoglobulin G1 monoclonal antibody inhibiting vascular endothelial growth factor receptor-2, increased overall survival (OS) combined with docetaxel versus docetaxel alone in non-small cell lung cancer (NSCLC) in the REVEL trial. Pre-specified exploratory analysis examined efficacy and safety by histology. MATERIALS AND METHODS: 1253 patients with NSCLC were randomized to receive ramucirumab (10mg/kg; n=628) plus docetaxel (75mg/m2) or placebo plus docetaxel (n=625) after disease progression on or after platinum-based therapy, with or without bevacizumab or maintenance therapy...
October 2017: Lung Cancer: Journal of the International Association for the Study of Lung Cancer
https://www.readbyqxmd.com/read/29187901/mutational-landscape-of-cfdna-identifies-distinct-molecular-features-associated-with-therapeutic-response-to-first-line-platinum-based-doublet-chemotherapy-in-patients-with-advanced-nsclc
#14
Tao Jiang, Xuefei Li, Jianfei Wang, Chunxia Su, Wenbo Han, Chao Zhao, Fengying Wu, Guanghui Gao, Wei Li, Xiaoxia Chen, Jiayu Li, Fei Zhou, Jing Zhao, Weijing Cai, Henghui Zhang, Bo Du, Jun Zhang, Shengxiang Ren, Caicun Zhou, Hui Yu, Fred R Hirsch
Rationale To investigate whether the mutational landscape of circulating cell-free DNA (cfDNA) could predict and dynamically monitor the response to first-line platinum-based chemotherapy in patients with advanced non-small-cell lung cancer (NSCLC). Methods Eligible patients were included and blood samples were collected from a phase III trial. Both cfDNA fragments and fragmented genomic DNA were extracted for enrichment in a 1.15M size panel covering exon regions of 1,086 genes. Molecular mutational burden (MMB) was calculated to investigate the relationship between molecular features of cfDNA and response to chemotherapy...
2017: Theranostics
https://www.readbyqxmd.com/read/29181191/anti-pd-1-anti-pd-l1-immunotherapy-versus-docetaxel-for-previously-treated-advanced-non-small-cell-lung-cancer-a-systematic-review-and-meta-analysis-of-randomised-clinical-trials
#15
Allan Ramos-Esquivel, Alicia van der Laat, Raquel Rojas-Vigott, Melissa Juárez, Luis Corrales-Rodríguez
Background: To compare the efficacy and toxicity of anti-programmed cell death receptor 1 (PD-1) and anti-programmed cell death ligand 1 (PD-L1) versus docetaxel in previously treated patients with advanced non-small cell lung cancer (NSCLC). Materials and methods: Phase III randomised clinical trials (RCTs) were identified after systematic review of databases and conference proceedings. A random-effect model was used to determine the pooled HR for overall survival (OS), progression-free survival (PFS) and duration of response...
2017: ESMO Open
https://www.readbyqxmd.com/read/29178024/does-egfr-mutation-type-influence-patient-reported-outcomes-in-patients-with-advanced-egfr-mutation-positive-non-small-cell-lung-cancer-analysis-of-two-large-phase-iii-studies-comparing-afatinib-with-chemotherapy-lux-lung-3-and-lux-lung-6
#16
Yi-Long Wu, Vera Hirsh, Lecia V Sequist, Cheng-Ping Hu, Jifeng Feng, Shun Lu, Yunchao Huang, Martin Schuler, Tony Mok, Nobuyuki Yamamoto, Kenneth O'Byrne, Sarayut L Geater, Caicun Zhou, Dan Massey, Angela Märten, Juliane Lungershausen, James Chih-Hsin Yang
INTRODUCTION: In LUX-Lung 3 and LUX-Lung 6, afatinib significantly improved progression-free survival (PFS) versus chemotherapy in patients with tumors harboring common epidermal growth factor receptor (EGFR) mutations (Del19/L858R) and significantly improved overall survival (OS) in patients with tumors harboring Del19 mutations. Patient-reported outcomes stratified by EGFR mutation type are reported. PATIENTS AND METHODS: Lung cancer symptoms and health-related quality of life (QoL) were assessed every 21 days until progression using the EORTC Quality of Life Core Questionnaire C30 and its lung cancer-specific module, LC13...
November 24, 2017: Patient
https://www.readbyqxmd.com/read/29177507/a-randomized-phase-iii-trial-of-lobe-specific-vs-systematic-nodal-dissection-for-clinical-stage-i-ii-non-small-cell-lung-cancer-jcog1413
#17
Tomoyuki Hishida, Hisashi Saji, Shun-Ichi Watanabe, Hisao Asamura, Keiju Aokage, Tomonori Mizutani, Masashi Wakabayashi, Taro Shibata, Morihito Okada
In January 2017, the Lung Cancer Surgical Study Group of the Japan Clinical Oncology Group commenced a randomized Phase III trial to confirm the clinical benefit of lobe-specific nodal dissection for clinical Stage I-II non-small cell lung cancer. The primary endpoint is overall survival, and the main objective is to confirm the non-inferiority of lobe-specific in comparison to systematic nodal dissection with regard to lobectomy. The secondary endpoints are relapse-free survival, %local recurrence, %regional lymph node recurrence, operation time, blood loss, length of hospitalization, duration of chest tube placement and adverse events...
November 21, 2017: Japanese Journal of Clinical Oncology
https://www.readbyqxmd.com/read/29173770/circulating-metabolite-profiles-to-predict-overall-survival-in-advanced-non-small-cell-lung-cancer-patients-receiving-first-line-chemotherapy
#18
Jie Shen, Yuanqing Ye, David W Chang, Maosheng Huang, John V Heymach, Jack A Roth, Xifeng Wu, Hua Zhao
OBJECTIVES: The prognosis for advanced-stage non-small cell lung cancer (NSCLC) is usually poor. However, survival may be variable and difficult to predict. In the current study, we aimed to identify circulating metabolites as potential predictive biomarkers for overall survival of advanced-stage (III/IV) NSCLC patients treated with first-line platinum-based chemotherapy. MATERIALS AND METHODS: Using two-stage study design, we performed global metabolomic profiling in blood of 220 advanced-stage NSCLC patients, including 110 with poor survival and 110 with good survival...
December 2017: Lung Cancer: Journal of the International Association for the Study of Lung Cancer
https://www.readbyqxmd.com/read/29168933/role-of-chemotherapy-and-targeted-therapy-in-early-stage-non-small-cell-lung-cancer
#19
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/29158696/65plus-open-label-study-of-bevacizumab-in-combination-with-pemetrexed-or-pemetrexed-carboplatin-as-first-line-treatment-of-patients-with-advanced-or-recurrent-nonsquamous-non-small-cell-lung-cancer
#20
Wolfgang Schuette, Claus-Peter Schneider, Walburga Engel-Riedel, Christian Schumann, Martin Kohlhaeufl, Monika Heidi Ursel Serke, Gert Hoeffken, Cornelius Kortsik, Martin Reck
Background: The aim of the study was to investigate in terms of noninferiority the efficacy and safety of a monochemotherapy regimen of pemetrexed plus bevacizumab (BevPem) versus carboplatin/pemetrexed plus bevacizumab (BevCPem) in elderly patients as first-line treatment for advanced metastatic or recurrent nonsquamous non-small-cell lung cancer (NSCLC). Materials and methods: 65Plus was a Phase III, randomized, open-label study. In total, 253 patients received BevPem (n=119) or BevCPem (n=134)...
2017: Lung Cancer: Targets and Therapy
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