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Non small cell lung cancer phase iii

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https://www.readbyqxmd.com/read/28213005/is-clarithromycin-a-potential-treatment-for-cachexia-in-people-with-lung-cancer-a-feasibility-study
#1
Sarah Awan, Vincent Crosby, Vanessa Potter, Ivo Hennig, David Baldwin, Mehluli Ndlovu, Sharon Paradine, Andrew Wilcock
Clarithromycin may improve cachexia and survival in non-small cell lung cancer (NSCLC), but adequately controlled data are lacking. This study was undertaken primarily to inform the feasibility and scale of a phase III trial. Eligible consenting patients with stage IV NSCLC and cachexia were to be randomized to receive either clarithromycin 250mg twice daily or placebo for eight weeks. Aspects of trial feasibility recorded included numbers eligible, approached and recruited, together with adherence and completion of treatment and assessments...
February 2017: Lung Cancer: Journal of the International Association for the Study of Lung Cancer
https://www.readbyqxmd.com/read/28212999/meta-analysis-examining-impact-of-age-on-overall-survival-with-pemetrexed-for-the-treatment-of-advanced-non-squamous-non-small-cell-lung-cancer
#2
Luis G Paz-Ares, Annamaria Zimmermann, Tudor Ciuleanu, Paul A Bunn, Belen San Antonio, Jonathan Denne, Nancy Iturria, William John, Giorgio V Scagliotti
OBJECTIVE: In clinical practice, elderly patients are often undertreated relative to younger patients. This meta-analysis was designed to determine whether older patients with non-squamous non-small cell lung cancer (NSCLC) could derive an overall survival (OS) benefit from pemetrexed treatment comparable to that experienced by younger patients in the first-line, second-line, or maintenance settings. METHODS: Data from 2671 patients with non-squamous NSCLC participating in four pemetrexed phase III studies were included in a meta-analysis using a random-effects model...
February 2017: Lung Cancer: Journal of the International Association for the Study of Lung Cancer
https://www.readbyqxmd.com/read/28212993/efficacy-according-to-blind-independent-central-review-post-hoc-analyses-from-the-phase-iii-randomized-multicenter-ipass-study-of-first-line-gefitinib-versus-carboplatin-paclitaxel-in-asian-patients-with-egfr-mutation-positive-advanced-nsclc
#3
Yi-Long Wu, Nagahiro Saijo, Sumitra Thongprasert, J C-H Yang, Baohui Han, Benjamin Margono, Busayamas Chewaskulyong, Patrapim Sunpaweravong, Yuichiro Ohe, Yukito Ichinose, Jin-Ji Yang, Tony S K Mok, Helen Young, Vincent Haddad, Yuri Rukazenkov, Masahiro Fukuoka
OBJECTIVE: The Phase III, randomized, open-label IPASS study (NCT00322452) of first-line epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) gefitinib versus carboplatin/paclitaxel for Asian patients with advanced non-small-cell lung cancer (NSCLC) showed that investigator-assessed progression-free survival (PFS) and objective response rate (ORR) were significantly prolonged in patients with EGFR mutation-positive NSCLC who received gefitinib versus patients with EGFR mutation-negative NSCLC...
February 2017: Lung Cancer: Journal of the International Association for the Study of Lung Cancer
https://www.readbyqxmd.com/read/28193771/ceritinib-bests-chemo-for-untreated-alk-nsclc
#4
(no author information available yet)
Patients with ALK-positive non-small cell lung cancer may soon have a new first-line treatment option in ceritinib, which outperformed chemotherapy in a phase III study. However, toxicity issues remain a problem for ceritinib, and another next-generation ALK inhibitor, alectinib, is more likely to become the drug of choice for untreated patients.
February 13, 2017: Cancer Discovery
https://www.readbyqxmd.com/read/28188101/antiangiogenic-therapy-in-advanced-non-small-cell-lung-cancer-a-meta-analysis-of-phase-iii-randomized-trials
#5
REVIEW
Jacques Raphael, Kelvin Chan, Safiya Karim, Robert Kerbel, Henry Lam, Keemo Delos Santos, Ronak Saluja, Sunil Verma
We conducted a meta-analysis to evaluate the efficacy of adding any antiangiogenic therapy (AT) to the standard of care in advanced non-small-cell lung cancer (NSCLC). The electronic databases Ovid PubMed, Cochrane Central Register of Controlled Trials, and Embase were searched to identify eligible trials. We included all phase III randomized trials with any line and type of treatment, histology. and AT dose. Pooled hazard ratios (HRs) for overall survival (OS) and progression-free survival (PFS), and pooled odds ratio (OR) for overall response rates (RR) were calculated...
January 12, 2017: Clinical Lung Cancer
https://www.readbyqxmd.com/read/28185792/randomized-phase-iii-study-of-docetaxel-plus-cisplatin-versus-pemetrexed-plus-cisplatin-as-first-line-treatment-of-nonsquamous-non-small-cell-lung-cancer-a-trail-trial
#6
Cheol-Kyu Park, In-Jae Oh, Kyu-Sik Kim, Yoo-Duk Choi, Tae-Won Jang, Youn-Seup Kim, Kwan-Ho Lee, Kyeong-Cheol Shin, Chi Young Jung, Sei-Hoon Yang, Jeong-Seon Ryu, Seung-Hun Jang, Seung-Soo Yoo, Suk-Joong Yong, Kye Young Lee, Kwang-Ho In, Min-Ki Lee, Young-Chul Kim
INTRODUCTION: To date, no prospective phase III trials have directly compared the efficacy of pemetrexed plus cisplatin (Pem-Cis) with docetaxel plus cisplatin (Doc-Cis) in patients with nonsquamous non-small-cell lung cancer. MATERIALS AND METHODS: A total of 148 chemotherapy-naive patients lacking driver mutations were randomized into 21-day regimens of cisplatin 70 mg/m(2) with either docetaxel 60 mg/m(2) (n = 71) or pemetrexed 500 mg/m(2) (n = 77) for ≤ 4 cycles...
January 11, 2017: Clinical Lung Cancer
https://www.readbyqxmd.com/read/28181415/a-phase-ii-trial-of-concurrent-chemotherapy-with-intravenous-cisplatin-and-vinorelbine-and-radiotherapy-followed-by-consolidation-chemotherapy-with-oral-vinorelbine-in-locally-advanced-non-small-cell-lung-cancer-nsclc-the-concave-study
#7
Brett Gm Hughes, Elizabeth Ahern, Margot Lehman, Gary Pratt, Margaret Dauth, Wendy Pritchard, Leesa Wockner, Keith Horwood
AIM: Despite recent advances, outcomes for patients with stage III non-small cell lung cancer (NSCLC) with concurrent chemoradiotherapy (CRT) remain poor. We evaluated the combination of ciplatin/vinorelbine and concurrent thoracic radiotherapy followed by consolidation oral vinorelbine in this phase II study. METHODS: Eligible patients with unresectable stage III NSCLC received cisplatin intravenous (IV) 40 mg/m(2) and vinorelbine IV 20 mg/m(2) on days 1, 8, 22 and 29 concurrent with thoracic radiotherapy of 60 Gy in 30 fractions...
February 9, 2017: Asia-Pacific Journal of Clinical Oncology
https://www.readbyqxmd.com/read/28162945/postoperative-adjuvant-systemic-therapy-in-completely-resected-non-small-cell-lung-cancer-a-systematic-review
#8
REVIEW
Penelope Bradbury, Duvaraga Sivajohanathan, Adrien Chan, Swati Kulkarni, Yee Ung, Peter M Ellis
The purpose of the present review was to determine whether the use of postoperative adjuvant systemic therapy in patients with completely resected non-small-cell lung cancer (NSCLC) improves survival. Cancer Care Ontario's Program in Evidence-Based Care reviewed the evidence to update previously published recommendations for patients with completely resected NSCLC. Relevant studies were identified from a systematic MEDLINE, EMBASE, and Cochrane Database of Systematic Reviews search of studies published from 2010 to 2016...
July 12, 2016: Clinical Lung Cancer
https://www.readbyqxmd.com/read/28161993/eribulin-in-non-small-cell-lung-cancer-challenges-and-potential-strategies
#9
Umang Swami, Umang Shah, Sanjay Goel
Eribulin is a non-taxane, macrocyclic, synthetic, ketone analog of Halichondrin B with a microtubule inhibitory action specific towards plus ends. It is approved by United States Food and Drug Administration (USFDA) for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen. It is also approved as a third line therapy for patients with metastatic breast cancer who have received a prior treatment with anthracycline and taxane in either adjuvant or metastatic setting...
February 6, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28161554/maintenance-sunitinib-following-initial-platinum-based-combination-chemotherapy-in-advanced-stage-iiib-iv-non-small-cell-lung-cancer-a-randomized-double-blind-placebo-controlled-phase-iii-study-calgb-30607-alliance
#10
Maria Q Baggstrom, Mark A Socinski, Xiaofei F Wang, Lin Gu, Thomas E Stinchcombe, Martin J Edelman, Sherman Baker, Josephine Feliciano, Paul Novotny, Olwen Hahn, Jeffrey A Crawford, Everett E Vokes
INTRODUCTION: To evaluate efficacy of maintenance sunitinib after first-line chemotherapy for stage IIIB/IV non-small cell lung cancer (NSCLC). METHODS: Cancer and Leukemia Group B (CALGB) 30607 trial was a randomized, double-blind, placebo-controlled, phase III study that enrolled patients without progression after four cycles of first-line platinum-based doublet chemotherapy with or without bevacizumab. Bevacizumab was only allowed during the four cycles of chemotherapy...
February 1, 2017: Journal of Thoracic Oncology
https://www.readbyqxmd.com/read/28156604/efficacy-of-anamorelin-in-cachectic-patients-with-non-small-cell-lung-cancer-nsclc-and-low-bmi-20-kg-m-2-post-hoc-analysis-of-two-phase-iii-studies
#11
Jennifer S Temel, Amy Pickar Abernethy, Ruben Giorgino, John Friend, Kenneth Fearon
: 203 Background: Patients with advanced cancer frequently experience anorexia/cachexia, which can be characterized by weight loss or low BMI, and is associated with reduced function and quality of life. The randomized, phase III, double-blind ROMANA 1 [NCT01387269; N = 484] and ROMANA 2 [NCT01387282; N = 495]) trials in cachectic NSCLC patients demonstrated that the ghrelin receptor agonist anamorelin improved LBM, body weight, fat mass (FM), and symptom burden compared with placebo, and was well tolerated...
October 9, 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28138934/novel-egfr-inhibitors-in-non-small-cell-lung-cancer-current-status-of-afatinib
#12
REVIEW
Bin-Chi Liao, Chia-Chi Lin, James Chih-Hsin Yang
Afatinib, a second-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, has been approved worldwide as a first-line treatment for advanced non-small cell lung cancer (NSCLC) that harbors activating EGFR mutations. Here, we have reviewed the recent clinical developments in the treatment of lung cancer using afatinib. Emerging data have revealed the overall survival benefit of first-line afatinib therapy in patients with advanced EGFR (del19)-positive NSCLC. Phase III studies of afatinib have shown the effectiveness of afatinib as a second-line treatment for advanced lung squamous cell carcinoma, as well as the benefit of continuing afatinib therapy in combination with cytotoxic chemotherapy for advanced NSCLC after the occurrence of disease progression in patients who are receiving afatinib monotherapy...
January 2017: Current Oncology Reports
https://www.readbyqxmd.com/read/28137739/etoposide-and-cisplatin-vs-paclitaxel-and-carboplatin-with-concurrent-thoracic-radiotherapy-in-unresectable-stage-iii-non-small-cell-lung-cancer-a-multicenter-randomized-phase-iii-trial
#13
J Liang, N Bi, S Wu, M Chen, C Lv, L Zhao, A Shi, W Jiang, Y Xu, Z Zhou, W Wang, D Chen, Z Hui, J Lv, H Zhang, Q Feng, Z Xiao, X Wang, L Liu, T Zhang, L Du, W Chen, Y Shyr, W Yin, J Li, J He, L Wang
BACKGROUND: The optimal chemotherapy regimen administered currently with radiation in patients with stage III non-small cell lung cancer (NSCLC) remains unclear. A multi-center phase III trial was conducted to compare the efficacy of concurrent thoracic radiation therapy (TRT) with either etoposide/cisplatin (EP) or carboplatin/paclitaxel (PC) in patients with stage III non-small cell lung cancer (NSCLC). PATIENTS AND METHODS: Patients were randomly received 60 to 66 Gy of TRT concurrent with either etoposide 50 mg/m(2) on days 1 to 5 and cisplatin 50 mg/m(2) on days 1 and 8 every 4 weeks for two cycles (EP arm), or paclitaxel 45 mg/m(2) and carboplatin (AUC 2) on day 1 weekly (PC arm)...
January 30, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/28129007/a-new-frontier-for-targeted-therapy-in-nsclc-clinical-efficacy-of-pembrolizumab-in-the-inhibition-of-programmed-cell-death-1-pd-1
#14
Raffaele Addeo
Non-small-cell lung cancer (NSCLC) is the main pathological type among lung cancers, and it is often diagnosed at an advanced stage of the disease when it is no longer amenable to curative treatments. During recent decades, the survival rate for lung cancer patients has improved significantly in only those whose tumours harbour a driver mutation. Immune checkpoint inhibition is a promising therapeutic strategy for lung cancer. The Keynote 024 is randomized, open-label, international, phase III study to evaluate the efficacy of pembrolizumab, an antibody directed to programmed death 1 (PD-1),an immune checkpoint inhibitor, compared with platinum-based chemotherapy in patients with previously untreated advanced NSCLC and PD-L1 expression in at least 50% of the tumour cells...
January 27, 2017: Expert Review of Anticancer Therapy
https://www.readbyqxmd.com/read/28123729/randomized-phase-ii-study-of-sequential-carboplatin-plus-paclitaxel-and-gefitinib-in-chemotherapy-na%C3%A3-ve-patients-with-advanced-or-metastatic-non-small-cell-lung-cancer-long-term-follow-up-results
#15
Emi Kubo, Noboru Yamamoto, Hiroshi Nokihara, Yutaka Fujiwara, Hidehito Horinouchi, Shintaro Kanda, Yasushi Goto, Yuichiro Ohe
The epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor gefitinib was initially approved in Japan in 2002 for the treatment of advanced or metastatic non-small-cell lung cancer (NSCLC); however, the optimal order of conventional cytotoxic chemotherapy (carboplatin and paclitaxel) and gefitinib administration has not been determined. We conducted a randomized phase II study of carboplatin and paclitaxel followed by gefitinib vs. gefitinib followed by carboplatin and paclitaxel to select a candidate for further development in a phase III study of chemotherapy-naïve patients with advanced or metastatic NSCLC, regardless of their EGFR mutation status...
January 2017: Molecular and Clinical Oncology
https://www.readbyqxmd.com/read/28123721/toxicity-profile-of-epidermal-growth-factor-receptor-tyrosine-kinase-inhibitors-in-patients-with-epidermal-growth-factor-receptor-gene-mutation-positive-lung-cancer
#16
Masayuki Takeda, Kazuhiko Nakagawa
Recent progress in the research on the molecular biology of lung cancer revealed that the clinical response to epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) is associated with the presence of activating EGFR mutations. Three EGFR-TKIs, namely afatinib, erlotinib and gefitinib, are currently available for the treatment of patients with EGFR mutation-positive non-small-cell lung cancer (NSCLC). Due to the dearth of published phase III trials prospectively evaluating the effects of one EGFR-TKI in comparison with another in such patients, the decision-making regarding which agent to recommend to any given patient lies with the treating physician...
January 2017: Molecular and Clinical Oncology
https://www.readbyqxmd.com/read/28117221/comparative-effectiveness-and-resource-usage-in-patients-receiving-first-line-taxane-based-chemotherapy-for-stage-iv-non-small-cell-lung-cancer-in-a-us-community-oncology-setting
#17
Jared Weiss, Rex W Force, Brook A Pugmire, Teri Peterson, Claudio Faria, Sandra Margunato-Debay, Manish B Patel
BACKGROUND: Weekly (qw) nanoparticle albumin-bound (nab)-paclitaxel was approved for advanced non-small-cell lung cancer based on the results from a phase III trial in which nab-paclitaxel/carboplatin demonstrated a significantly greater response rate compared with paclitaxel/carboplatin every 3 weeks (q3w). Little information exists on relative real-world results. MATERIALS AND METHODS: The present retrospective study used data from a national electronic medical record database...
December 22, 2016: Clinical Lung Cancer
https://www.readbyqxmd.com/read/28111430/incorporating-erlotinib-or-irinotecan-plus-cisplatin-into-chemoradiotherapy-for-stage-iii-non-small-cell-lung-cancer-according-to-egfr-mutation-status
#18
Youngjoo Lee, Ji-Youn Han, Sung Ho Moon, Byung-Ho Nam, Kun Young Lim, Geon Kook Lee, Heung Tae Kim, Tak Yun, Hye Jin An, Jin Soo Lee
Purpose: Concurrent chemoradiotherapy (CCRT) is the standard care for stage III non-small cell lung cancer (NSCLC) patients; however, a more effective regimen is needed to improve the outcome by better controlling occult metastases. We conducted two parallel randomized phase II studies to incorporate erlotinib or irinotecan-cisplatin (IP) into CCRT for stage III NSCLC depending on EGFR mutation status. Materials and Methods: Patients with EGFR-mutant tumors were randomized to receive three cycles of erlotinib first and then either CCRT with erlotinib followed by erlotinib (arm A) or CCRT with IP only (arm B)...
January 6, 2017: Cancer Research and Treatment: Official Journal of Korean Cancer Association
https://www.readbyqxmd.com/read/28104361/igfbp-a-novel-target-of-lung-cancer
#19
REVIEW
Qiongge Hu, Yong Zhou, Kejing Ying, Wenjing Ruan
The insulin-like growth factor-1 receptor (IGF-1R) is a central component of lung cancer signal transduction pathways. A phase III study failed for carboplatin, paclitaxel, with or without figitumumab in first-line treating metastatic non-small cell lung cancer (NSCLC). There is an urgent need for a better understanding of signaling in IGF system. Insulin-like growth factor-binding proteins (IGFBPs) function as modulators for IGF signaling through sequestration of IGFs in serum and the extracellular fluid. IGFBPs can also act as transporters or modulators for IGF action and insulin action...
January 17, 2017: Clinica Chimica Acta; International Journal of Clinical Chemistry
https://www.readbyqxmd.com/read/28103612/a-phase-iii-randomised-controlled-trial-of-erlotinib-vs-gefitinib-in-advanced-non-small-cell-lung-cancer-with-egfr-mutations
#20
J J Yang, Q Zhou, H H Yan, X C Zhang, H J Chen, H Y Tu, Z Wang, C R Xu, J Su, B C Wang, B Y Jiang, X Y Bai, W Z Zhong, X N Yang, Y L Wu
BACKGROUND: A phase III trial was conducted to compare the safety and efficacy of erlotinib with that of gefitinib in advanced non-small cell lung cancer harbouring epidermal growth factor receptor mutations in exon 19 or 21. METHODS: Eligible patients were randomised to receive erlotinib (150 mg per day) or gefitinib (250 mg per day) orally until disease progression or unacceptable toxicity. We aimed to determine whether erlotinib is superior to gefitinib in efficacy...
January 19, 2017: British Journal of Cancer
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