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Non small cell lung cancer phase iii

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https://www.readbyqxmd.com/read/29140138/cox-2-expression-and-effects-of-celecoxib-in-addition-to-standard-chemotherapy-in-advanced-non-small-cell-lung-cancer
#1
Miklos Gulyas, Johanna Sofia Margareta Mattsson, Andrea Lindgren, Lars Ek, Kristina Lamberg Lundström, Annelie Behndig, Erik Holmberg, Patrick Micke, Bengt Bergman
AIM: Inhibition of cyclooxygenase-2 (COX-2) is proposed as a treatment option in several cancer types. However, in non-small cell lung cancer (NSCLC), phase III trials have failed to demonstrate a benefit of adding COX-2 inhibitors to standard chemotherapy. The aim of this study was to analyze COX-2 expression in tumor and stromal cells as predictive biomarker for COX-2 inhibition. METHODS: In a multicenter phase III trial, 316 patients with advanced NSCLC were randomized to receive celecoxib (400 mg b...
November 15, 2017: Acta Oncologica
https://www.readbyqxmd.com/read/29134432/phase-iii-study-of-dulanermin-recombinant-human-tumor-necrosis-factor-related-apoptosis-inducing-ligand-apo2-ligand-combined-with-vinorelbine-and-cisplatin-in-patients-with-advanced-non-small-cell-lung-cancer
#2
Xuenong Ouyang, Meiqi Shi, Fangwei Jie, Yuxian Bai, Peng Shen, Zhuang Yu, Xiuwen Wang, Cheng Huang, Min Tao, Zhehai Wang, Conghua Xie, Qi Wu, Yongqian Shu, Baohui Han, Fengchun Zhang, Yiping Zhang, Chunhong Hu, Xitao Ma, Yongjie Liang, Anlan Wang, Bing Lu, Yi Shi, Jinfei Chen, Zhixiang Zhuang, Jiejun Wang, Jianjin Huang, Changhui Wang, Chunxue Bai, Xin Zhou, Qiang Li, Feng Chen, Hao Yu, Jifeng Feng
Background Dulanermin is a recombinant soluble human Apo2 ligand/tumor necrosis factor-related apoptosis-inducing ligand (TRAIL) that activates apoptotic pathways by binding to proapoptotic death receptor (DR) 4 and DR5. The purpose of this study was to evaluate the efficacy and safety of dulanermin combined with vinorelbine and cisplatin (NP) as the first-line treatment for patients with advanced non-small-cell lung cancer (NSCLC). Experimental design Patients were randomly assigned to receive NP chemotherapy (vinorelbine 25 mg/m(2) on days 1 and 8 and cisplatin 30 mg/m(2) on days 2 to 4) for up to six cycles plus dulanermin (75 μg/kg on days 1 to 14) or placebo every three weeks until disease progression, intolerable toxicity, or withdrawal of consent...
November 14, 2017: Investigational New Drugs
https://www.readbyqxmd.com/read/29133080/population-pharmacokinetics-of-nintedanib-in-patients-with-idiopathic-pulmonary-fibrosis
#3
Ulrike Schmid, Christiane Doege, Claudia Dallinger, Matthias Freiwald
BACKGROUND: Nintedanib is a potent intracellular inhibitor of tyrosine kinases, including the receptor kinases vascular endothelial growth factor, platelet-derived growth factor and fibroblast growth factor. A previous model assessed the population pharmacokinetics of nintedanib and its main metabolite BIBF 1202 in patients with non-small cell lung cancer and idiopathic pulmonary fibrosis (IPF). The objective of this analysis was to further characterise the population pharmacokinetics of nintedanib in patients with IPF by including data from the Phase III trials...
November 10, 2017: Pulmonary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/29129758/impact-of-nivolumab-versus-docetaxel-on-health-related-quality-of-life-and-symptoms-in-patients-with-advanced-squamous-non-small-cell-lung-cancer-results-from-the-checkmate-017-study
#4
Martin Reck, Fiona Taylor, John R Penrod, Michael DeRosa, Laura Morrissey, Homa Dastani, Lucinda Orsini, Richard J Gralla
INTRODUCTION: In the phase III CheckMate 017 study, nivolumab prolonged overall survival versus docetaxel in previously treated patients with advanced squamous non-small cell lung cancer (NSCLC). Study objectives included health-related quality of life (HRQoL) and symptom assessments. METHODS: Patients serially completed Lung Cancer Symptom Scale (LCSS) and European Quality of Life Five Dimensions (EQ-5D) questionnaires. The LCSS average symptom burden index (ASBI; mean score for six lung cancer-specific symptoms; range, 0-100), LCSS 3-item global index, EQ-5D utility index, and EQ-5D visual analog scale scores were analyzed...
November 9, 2017: Journal of Thoracic Oncology
https://www.readbyqxmd.com/read/29121501/does-c-met-remain-a-rational-target-for-therapy-in-patients-with-egfr-tki-resistant-non-small-cell-lung-cancer
#5
REVIEW
Yi-Long Wu, Ross Andrew Soo, Giuseppe Locatelli, Uz Stammberger, Giorgio Scagliotti, Keunchil Park
Non-small cell lung cancer (NSCLC) inevitably develops resistance to epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) treatment. In 5-20% of cases, this can be attributed to aberrant c-Met activity, providing a clear rationale for the use of c-Met inhibitors in these patients. EGFR TKI-resistant tumors often remain sensitive to EGFR signaling, such that c-Met inhibitors are likely to be most effective when combined with continued EGFR TKI therapy. The phase III trials of the c-Met inhibitors onartuzumab and tivantinib, which failed to demonstrate significant benefit in patients with NSCLC but excluded patients with EGFR TKI-resistant disease, do not allow c-Met to be dismissed as a rational target in EGFR TKI-resistant NSCLC...
October 25, 2017: Cancer Treatment Reviews
https://www.readbyqxmd.com/read/29119292/population-pharmacokinetics-of-nintedanib-an-inhibitor-of-tyrosine-kinases-in-patients-with-non-small-cell-lung-cancer-or-idiopathic-pulmonary-fibrosis
#6
Ulrike Schmid, Karl-Heinz Liesenfeld, Angele Fleury, Claudia Dallinger, Matthias Freiwald
PURPOSE: A population pharmacokinetic model was developed for nintedanib in patients with non-small cell lung cancer (NSCLC) or idiopathic pulmonary fibrosis (IPF). The effects of intrinsic and extrinsic patient factors on exposure of nintedanib and its main metabolite BIBF 1202 were studied. METHODS: Data from 1191 patients with NSCLC (n = 849) or IPF (n = 342) treated with oral nintedanib (once- or twice-daily, dose range 50-250 mg) in 4 Phase II or III studies were combined...
November 8, 2017: Cancer Chemotherapy and Pharmacology
https://www.readbyqxmd.com/read/29116379/phase-ii-study-of-nedaplatin-and-irinotecan-as-adjuvant-chemotherapy-for-completely-resected-non-small-cell-lung-cancer
#7
Shuji Murakami, Haruhiro Saito, Tetsuro Kondo, Hiroyuki Ito, Fumihiro Oshita, Kouzo Yamada
INTRODUCTION: Cisplatin-based chemotherapy is the standard adjuvant therapy for patients with completely resected stage II or III non-small cell lung cancer (NSCLC). However, the completion rate of four cycles of cisplatin-based chemotherapy is about 50%. This phase II study was conducted to evaluate the tolerability and efficacy of nedaplatin and irinotecan as adjuvant chemotherapy. METHODS: Patients with pathological stage II or III NSCLC who underwent complete resection were enrolled...
November 7, 2017: Cancer Chemotherapy and Pharmacology
https://www.readbyqxmd.com/read/29098034/asa404-a-vascular-disrupting-agent-as-an-experimental-treatment-approach-for-brain-tumors
#8
Oliver Bähr, Stefanie Gross, Patrick N Harter, Elmar Kirches, Christian Mawrin, Joachim P Steinbach, Michel Mittelbronn
Malignant brain tumors, including gliomas, brain metastases and anaplastic meningiomas, are associated with poor prognosis, and represent an unmet medical need. ASA404 (DMXAA), a vascular disrupting agent, has demonstrated promising results in several preclinical tumor models and early phase clinical trials. However, two phase III trials in non-small cell lung cancer reported insufficient results. The aim of the present study was to determine the effects of ASA404 on brain tumors. The effects of ASA404 were evaluated in vitro and in vivo using subcutaneous, and orthotopical models for malignant glioma (U-87, LN-229, U-251, LN-308 and Tu-2449), brain metastasis (HT-29) and malignant meningioma (IOMM-Lee)...
November 2017: Oncology Letters
https://www.readbyqxmd.com/read/29097074/a-phase-ii-toxicity-end-point-trial-icorg-99-09-of-accelerated-dose-escalated-hypofractionated-radiation-in-non-small-cell-lung-cancer
#9
D N Cagney, P G Thirion, M T Dunne, C Fleming, D Fitzpatrick, C M O'Shea, M A Finn, S O'Sullivan, C Booth, C D Collins, S J Buckney, A Shannon, J G Armstrong
AIMS: The objective of this phase II clinical trial was to prospectively evaluate the safety and efficacy of accelerated hypofractionated three-dimensional conformal radiation therapy (3DCRT) in localised non-resectable/non-operable non-small cell lung cancer (NSCLC). MATERIALS AND METHODS: Sixty patients with stage I-III NSCLC were enrolled in a prospective single-arm All Ireland Co-operative Oncology Research Group (ICORG 99-09) toxicity end point phase II trial...
October 30, 2017: Clinical Oncology: a Journal of the Royal College of Radiologists
https://www.readbyqxmd.com/read/29069867/erlotinib-based-doublet-targeted-therapy-versus-erlotinib-alone-in-previously-treated-advanced-non-small-cell-lung-cancer-a-meta-analysis-from-24-randomized-controlled-trials
#10
REVIEW
Jian-Wei Gao, Ping Zhan, Xiang-Yu Qiu, Jia-Jia Jin, Tang-Feng Lv, Yong Song
BACKGROUND: To assess the efficacy profile of erlotinib-based doublet targeted therapy compared with erlotinib monotherapy for previously treated patients with advanced NSCLC, a meta-analysis was performed. PATIENTS AND METHODS: We rigorously searched PubMed, Embase, Cochrane and meeting proceedings. Phase II/III randomized trials reporting on the efficacy of erlotinib-doublet therapy versus single-agent therapy were selected. We estimated the HR for OS, PFS and the RR for ORR, DCR, 1-year SR...
September 22, 2017: Oncotarget
https://www.readbyqxmd.com/read/29067878/brain-penetration-of-the-ros1-alk-inhibitor-lorlatinib-confirmed-by-pet
#11
T Lee Collier, Kevin P Maresca, Marc D Normandin, Paul Richardson, Timothy J McCarthy, Steven H Liang, Rikki N Waterhouse, Neil Vasdev
The Massachusetts General Hospital Radiochemistry Program, in collaboration with Pfizer, has developed unique (11)C and (18)F-labeling strategies to synthesize isotopologs of lorlatinib (PF-06463922) which is undergoing phase III clinical trial investigations for treatment of non-small-cell lung cancers with specific molecular alterations. A major goal in cancer therapeutics is to measure the concentrations of this drug in the brain metastases of patients with lung cancer, and penetration of the blood-brain barrier is important for optimal therapeutic outcomes...
January 2017: Molecular Imaging
https://www.readbyqxmd.com/read/29066671/-landscape-of-lung-cancer-with-oligometastasis
#12
Yasushi Goto, Jun Sato
Lung cancer with a few to several metastases is so-called oligometastatic disease. Patient with recurrence only to limited site is also known as oligo-recurrence, and may be included as oligometastatic disease. From biological aspect, any existence of metastases is a sign of systemic disease. Due to the reports of long survival with only local treatment and without systemic disease in oligometastatic lung cancer, word of oligometastasis is used with fascinating expectation of cure to advanced lung cancer. Most of the previous reports are retrospective and no comprehensive data exists for selecting patient for local treatment to oligometastasis...
October 2017: Gan to Kagaku Ryoho. Cancer & Chemotherapy
https://www.readbyqxmd.com/read/29063069/targeting-met-in-cancer-therapy
#13
REVIEW
Hong-Nan Mo, Peng Liu
MET encodes a receptor tyrosine kinase c-MET for hepatocyte growth factor (HGF). The specific combination of c-MET and HGF activates downstream signaling pathways to trigger cell migration, proliferation, and angiogenesis. MET exon 14 alterations and MET gene amplification play a critical role in the origin of cancer. Several monoclonal antibodies and small-molecule inhibitors of c-MET have been evaluated in clinical trials. In patients with advanced non-small cell lung cancer, cabozantinib and crizotinib showed clear efficacy with a generally tolerable adverse events profile...
September 2017: Chronic Dis Transl Med
https://www.readbyqxmd.com/read/29059635/phase-ii-randomised-discontinuation-trial-of-cabozantinib-in-patients-with-advanced-solid-tumours
#14
Patrick Schöffski, Michael Gordon, David C Smith, Razelle Kurzrock, Adil Daud, Nicholas J Vogelzang, Yihua Lee, Christian Scheffold, Geoffrey I Shapiro
BACKGROUND: Cabozantinib is an inhibitor of tyrosine kinases, including MET, vascular endothelial growth factor receptor, AXL and RET. This multi-cohort phase II randomised discontinuation trial explored anticancer activity of cabozantinib in nine tumour types. PATIENTS AND METHODS: Cabozantinib was administered (100 mg, once daily) to patients with advanced, recurrent or metastatic cancers. Those with stable disease at week 12 were randomised 1:1 to cabozantinib or placebo...
October 20, 2017: European Journal of Cancer
https://www.readbyqxmd.com/read/29057232/expanded-molecular-interrogation-for-potential-actionable-targets-in-non-squamous-non-small-cell-lung-cancer
#15
REVIEW
Kah Weng Lau, Claudia Seng, Tony K H Lim, Daniel S W Tan
The advent of targeted therapies has established new standards of care for defined molecular subsets of non-small cell lung cancer (NSCLC). Not only has this led to significant changes in the routine clinical management of lung cancer e.g., multiplexed genomic testing, but it has provided important principles and benchmarks for determining "actionability". At present, the clinical paradigms are most evolved for EGFR mutations and ALK rearrangements, where multiple randomized phase III trials have determined optimal treatment strategies in both treatment naïve and resistant settings...
September 2017: Annals of Translational Medicine
https://www.readbyqxmd.com/read/29045265/dose-escalation-study-of-concurrent-chemoradiotherapy-with-the-use-of-involved-field-conformal-radiotherapy-and-accelerated-hyperfractionation-in-combination-with-cisplatin-and-vinorelbine-chemotherapy-for-stage-iii-non-small-cell-lung-cancer-the-final-report
#16
Naruo Yoshimura, Takuhito Tada, Yoshiya Matsumoto, Kenji Sawa, Naoki Yoshimoto, Tomohiro Suzumura, Hidenori Tanaka, Shigeki Mitsuoka, Tatsuo Kimura, Tomohiro Tamiya, Tomonori Hirashima, Tomoya Kawaguchi, Shinzoh Kudoh, Masako Hosono, Kazuto Hirata
OBJECTIVES: A phase I study to determine a recommended dose of thoracic radiotherapy using accelerated hyperfractionation for unresectable non-small cell lung cancer was conducted. MATERIALS AND METHODS: We used chemotherapy of a cisplatin doublet and 2 dose levels of radiation with accelerated hyperfractionation. The radiation dose levels were: a total dose of 60 Gy in 40 fractions at level 1, and 66 Gy in 44 fractions at level 2. Eligible patients with unresectable stage III non-small cell lung cancer received cisplatin and vinorelbine...
October 17, 2017: American Journal of Clinical Oncology
https://www.readbyqxmd.com/read/29024815/identification-of-a-novel-autophagic-inhibitor-cepharanthine-to-enhance-the-anti-cancer-property-of-dacomitinib-in-non-small-cell%C3%A2-lung-cancer
#17
Zheng-Hai Tang, Wen-Xiang Cao, Xia Guo, Xiao-Yang Dai, Jia-Hong Lu, Xiuping Chen, Hong Zhu, Jin-Jian Lu
Inhibition of autophagy is a promising strategy for non-small cell lung cancer (NSCLC) treatment, which is in the clinical trials. However, only chloroquine is used in clinic as an autophagic inhibitor and the inhibitory effect of chloroquine on autophagy is finite. Therefore, the development of an alternative autophagic inhibitor for NSCLC therapy becomes necessary. In the present study, cepharanthine (CEP), an alkaloid extracted from Stephania cepharantha Hayata, was identified as a novel autophagic inhibitor in NSCLC cells...
October 9, 2017: Cancer Letters
https://www.readbyqxmd.com/read/29023213/nivolumab-versus-docetaxel-in-previously-treated-patients-with-advanced-non-small-cell-lung-cancer-two-year-outcomes-from-two-randomized-open-label-phase-iii-trials-checkmate-017-and-checkmate-057
#18
Leora Horn, David R Spigel, Everett E Vokes, Esther Holgado, Neal Ready, Martin Steins, Elena Poddubskaya, Hossein Borghaei, Enriqueta Felip, Luis Paz-Ares, Adam Pluzanski, Karen L Reckamp, Marco A Burgio, Martin Kohlhäeufl, David Waterhouse, Fabrice Barlesi, Scott Antonia, Oscar Arrieta, Jérôme Fayette, Lucio Crinò, Naiyer Rizvi, Martin Reck, Matthew D Hellmann, William J Geese, Ang Li, Anne Blackwood-Chirchir, Diane Healey, Julie Brahmer, Wilfried E E Eberhardt
Purpose Nivolumab, a programmed death-1 inhibitor, prolonged overall survival compared with docetaxel in two independent phase III studies in previously treated patients with advanced squamous (CheckMate 017; ClinicalTrials.gov identifier: NCT01642004) or nonsquamous (CheckMate 057; ClinicalTrials.gov identifier: NCT01673867) non-small-cell lung cancer (NSCLC). We report updated results, including a pooled analysis of the two studies. Methods Patients with stage IIIB/IV squamous (N = 272) or nonsquamous (N = 582) NSCLC and disease progression during or after prior platinum-based chemotherapy were randomly assigned 1:1 to nivolumab (3 mg/kg every 2 weeks) or docetaxel (75 mg/m(2) every 3 weeks)...
October 12, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28992562/a-phase-ib-dose-escalation-study-of-the-safety-and-pharmacokinetics-of-pictilisib-in-combination-with-either-paclitaxel-and-carboplatin-with-or-without-bevacizumab-or-pemetrexed-and-cisplatin-with-or-without-bevacizumab-in-patients-with-advanced-non-small-cell
#19
Jean-Charles Soria, Alex A Adjei, Rastilav Bahleda, Benjamin Besse, Charles Ferte, David Planchard, Jing Zhou, Joseph Ware, Kari Morrissey, Geetha Shankar, Wei Lin, Jennifer L Schutzman, Grace K Dy, Harry J M Groen
AIM: The phosphatidylinositol 3-kinase (PI3K) pathway is a potential therapeutic target in non-small cell lung cancer (NSCLC). This study aimed to evaluate the pan-PI3K inhibitor pictilisib in combination with first-line treatment regimens that were the standard of care at the time of study, in patients with NSCLC. PATIENTS AND METHODS: A 3 + 3 dose-escalation study was performed using a starting daily dose of 60 mg pictilisib on days 1-14 of a 21-day cycle...
October 6, 2017: European Journal of Cancer
https://www.readbyqxmd.com/read/28975084/a-phase-iii-randomized-study-comparing-a-chemotherapy-with-cisplatin-and-etoposide-to-a-etoposide-regimen-without-cisplatin-for-patients-with-extensive-small-cell-lung-cancer
#20
Thierry Berghmans, Arnaud Scherpereel, Anne-Pascale Meert, Vicente Giner, Jacques Lecomte, Jean-Jacques Lafitte, Nathalie Leclercq, Marianne Paesmans, Jean-Paul Sculier
INTRODUCTION: In a literature meta-analysis, we showed survival benefits for regimens including cisplatin [hazard ratio (HR) 0.61; 95% confidence interval (CI), 0.57-0.66] and for those including etoposide (HR 0.65; 0.61-0.69). That benefit was mainly observed when etoposide alone or in combination with cisplatin was included in the chemotherapy regimens. Our objective was to determine if chemotherapy with both drugs improves survival in comparison to a non-platinum regimen with etoposide...
2017: Frontiers in Oncology
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