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Non small cell lung cancer phase iii

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https://www.readbyqxmd.com/read/28934120/angiogenesis-inhibitors-in-nsclc
#1
REVIEW
Anna Manzo, Agnese Montanino, Guido Carillio, Raffaele Costanzo, Claudia Sandomenico, Nicola Normanno, Maria Carmela Piccirillo, Gennaro Daniele, Francesco Perrone, Gaetano Rocco, Alessandro Morabito
Angiogenesis is a complex biological process that plays a relevant role in sustaining the microenvironment, growth, and metastatic potential of several tumors, including non-small cell lung cancer (NSCLC). Bevacizumab was the first angiogenesis inhibitor approved for the treatment of patients with advanced NSCLC in combination with chemotherapy; however, it was limited to patients with non-squamous histology and first-line setting. Approval was based on the results of two phase III trials (ECOG4599 and AVAIL) that demonstrated an improvement of about two months in progression-free survival (PFS) in both trials, and in the ECOG4599 trial, an improvement in overall survival (OS) also...
September 21, 2017: International Journal of Molecular Sciences
https://www.readbyqxmd.com/read/28929083/emerging-therapies-for-stage-iii-non-small-cell-lung-cancer-stereotactic-body-radiation-therapy-and-immunotherapy
#2
REVIEW
Sameera S Kumar, Kristin A Higgins, Ronald C McGarry
The current standard of care for locally advanced non-small cell lung cancer (NSCLC) includes radiation, chemotherapy, and surgery in certain individualized cases. In unresectable NSCLC, chemoradiation has been the standard of care for the past three decades. Local and distant failure remains high in this group of patients, so dose escalation has been studied in both single institution and national clinical trials. Though initial studies showed a benefit to dose escalation, phase III studies examining dose escalation using standard fractionation or hyperfractionation have failed to show a benefit...
2017: Frontiers in Oncology
https://www.readbyqxmd.com/read/28919394/concomitant-chemotherapy-and-radiotherapy-with-sbrt-boost-for-unresectable-stage-iii-non-small-cell-lung-cancer-a-phase-i-study
#3
Kristin A Higgins, Rathi N Pillai, Zhengjia Chen, Sibo Tian, Chao Zhang, Pretesh Patel, Suchita Pakkala, Jay Shelton, Seth D Force, Felix G Fernandez, Conor E Steuer, Taofeek K Owonikoko, Suresh S Ramalingam, Jeffrey D Bradley, Walter J Curran
PURPOSE: Stereotactic Body Radiation Therapy (SBRT) is now the standard of care in medically inoperable stage I non-small cell lung cancer, yielding high rates of local control. It is unknown if SBRT can be safely utilized in the locally advanced NSCLC setting. This multi-institution phase I study evaluated the safety of 44 Gy conventionally fractionated thoracic radiation with concurrent chemotherapy plus a dose escalated SBRT boost to both the primary tumor and involved mediastinal lymph nodes...
September 12, 2017: Journal of Thoracic Oncology
https://www.readbyqxmd.com/read/28915900/a-randomized-phase-ii-study-to-assess-the-effect-of-adjuvant-immunotherapy-using-%C3%AE-galcer-pulsed-dendritic-cells-in-the-patients-with-completely-resected-stage-ii-iiia-non-small-cell-lung-cancer-study-protocol-for-a-randomized-controlled-trial
#4
Hideo Saka, Chiyoe Kitagawa, Yukito Ichinose, Mitsuhiro Takenoyama, Hidenori Ibata, Tatsuo Kato, Koji Takami, Motohiro Yamashita, Tadashi Maeda, Sadanori Takeo, Hitoshi Ueda, Kan Okabayashi, Seiji Nagashima, Tadayuki Oka, Hidenori Kouso, Seiichi Fukuyama, Kentaro Yoshimoto, Mototsugu Shimokawa, Akiko M Saito, Suminobu Ito
BACKGROUND: As the toxicity associated with the α-GalCer-pulsed dendritic cell (DC) therapy could be considered to be negligible, its addition to postoperative adjuvant chemotherapy would be expected to greatly improve the therapeutic effect, and could result in prolonged survival. The aim of the present study is to compare the therapeutic efficacy of alpha-galactosylceramide-pulsed DC therapy in patients who have undergone a complete resection of stage II-IIIA non-small-cell lung cancer (NSCLC) followed by postoperative adjuvant therapy with cisplatin plus vinorelbine, to that in patients who did not receive additional treatment (surgical resection plus postoperative adjuvant chemotherapy only)...
September 15, 2017: Trials
https://www.readbyqxmd.com/read/28915692/biomarker-analysis-of-the-phase-3-torch-trial-for-first-line-erlotinib-versus-chemotherapy-in-advanced-non-small-cell-lung-cancer-patients
#5
Lucia Kim, Mauro Saieg, Massimo Di Maio, Ciro Gallo, Charles Butts, Fortunato Ciardiello, Ronald Feld, Dengxiao Cheng, Vittorio Gebbia, Marco Angelo Burgio, Yasmin Alam, Simona Signoriello, Antonio Rossi, Natasha Leighl, Paolo Maione, Alessandro Morabito, Geoffrey Liu, Ming-Sound Tsao, Francesco Perrone, Cesare Gridelli
BACKGROUND: The TORCH phase III trial compared the efficacy of first-line erlotinib followed by chemotherapy at progression (experimental arm) with the reverse sequence (standard arm) in unselected advanced non-small cell lung cancer (NSCLC) patients. Here we report biomarker analyses. METHODS: EGFR and KRAS mutation, expression of EGFR family members and of cMET and PTEN and EGFR and ABCG2 germline polymorphisms were tested on tumor tissue or blood samples to either confirm previously proposed predictive role or describe it in an explorative setting...
August 22, 2017: Oncotarget
https://www.readbyqxmd.com/read/28912395/-cytotoxic-agents-and-immune-checkpoint-inhibitors
#6
Akihito Kawazoe, Kohei Shitara
It has been reported that favorable influences of cytotoxic agents to anti-tumor immune response included immunogenic cell death and suppression of regulatory T cell and myeloid-derived suppressor cell. Some clinical trials showed that the addition of immune checkpoint inhibitor to standard chemotherapy improved efficacy in patients with non-small-cell lung cancer or malignant melanoma in first-line settings. Phase III trials of the combination of immune checkpoint inhibitor and chemotherapy in several malignancies are ongoing...
September 2017: Gan to Kagaku Ryoho. Cancer & Chemotherapy
https://www.readbyqxmd.com/read/28902534/phase-iii-randomized-placebo-controlled-double-blind-trial-of-motesanib-amg-706-in-combination-with-paclitaxel-and-carboplatin-in-east-asian-patients-with-advanced-nonsquamous-non-small-cell-lung-cancer
#7
Kaoru Kubota, Hiroshige Yoshioka, Fumihiro Oshita, Toyoaki Hida, Kiyotaka Yoh, Hidetoshi Hayashi, Terufumi Kato, Hiroyasu Kaneda, Kazuhiko Yamada, Hiroshi Tanaka, Yukito Ichinose, Keunchil Park, Eun Kyung Cho, Kyung-Hee Lee, Chih-Bin Lin, James Chih-Hsin Yang, Kaori Hara, Takayuki Asato, Kazuhiko Nakagawa
Purpose This phase III, randomized, placebo-controlled, double-blind study determined whether motesanib improved progression-free survival (PFS) compared with placebo in combination with paclitaxel and carboplatin (P/C) in East Asian patients with stage IV/recurrent nonsquamous non-small-cell lung cancer. Patients and Methods Patients were randomly assigned (1:1) to receive oral motesanib 125 mg or placebo once daily plus paclitaxel 200 mg/m(2) IV and carboplatin area under the concentration-time curve 6 mg/mL ⋅ min IV for up to six 3-week cycles...
September 13, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28895417/the-prognostic-value-of-pre-treatment-thrombocytosis-in-two-cohorts-of-patients-with-non-small-cell-lung-cancer-treated-with-curatively-intended-chemoradiotherapy
#8
G Holgersson, S BergstrOm, A Hallqvist, P Liv, J Nilsson, L WillEn, J Nyman, S Ekman, R Henriksson, M Bergqvist
Chemoradiotherapy is the standard of care for inoperable stage III non-small cell lung cancer (NSCLC). This treatment, however, offers only a small chance of cure and is associated with many side effects. Little research has been made concerning which patients benefit most/least from the treatment. The present study evaluates the prognostic value of anemia, leukocytosis and thrombocytosis at diagnosis in this treatment setting. In the present study, data were collected retrospectively for 222 patients from two different phase II studies conducted between 2002-2007 in Sweden with patients treated with chemoradiotherapy for stage IIIA-IIIB NSCLC...
September 12, 2017: Neoplasma
https://www.readbyqxmd.com/read/28887317/biomarker-stratified-phase-iii-clinical-trials-enhancement-with-a-subgroup-focused-sequential-design
#9
Shigeyuki Matsui, John Crowley
Among various design approaches to phase III clinical trials with a predictive biomarker, the marker-stratified all-comers design is advantageous because it allows for establishing the utility of both treatment and biomarker, but it is often criticized for requiring large sample sizes, since the design includes both marker-positive and marker-negative patients. In this paper, we propose a simple but flexible subgroup-focused design for marker-stratified trials that allows both sequential assessment across marker-defined subgroups and adaptive subgroup selection, while retaining an assessment using the entire patient cohort at the final analysis stage, possibly using established marker-based multiple testing procedures...
September 8, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28885881/durvalumab-after-chemoradiotherapy-in-stage-iii-non-small-cell-lung-cancer
#10
Scott J Antonia, Augusto Villegas, Davey Daniel, David Vicente, Shuji Murakami, Rina Hui, Takashi Yokoi, Alberto Chiappori, Ki H Lee, Maike de Wit, Byoung C Cho, Maryam Bourhaba, Xavier Quantin, Takaaki Tokito, Tarek Mekhail, David Planchard, Young-Chul Kim, Christos S Karapetis, Sandrine Hiret, Gyula Ostoros, Kaoru Kubota, Jhanelle E Gray, Luis Paz-Ares, Javier de Castro Carpeño, Catherine Wadsworth, Giovanni Melillo, Haiyi Jiang, Yifan Huang, Phillip A Dennis, Mustafa Özgüroğlu
Background Most patients with locally advanced, unresectable, non-small-cell lung cancer (NSCLC) have disease progression despite definitive chemoradiotherapy (chemotherapy plus concurrent radiation therapy). This phase 3 study compared the anti-programmed death ligand 1 antibody durvalumab as consolidation therapy with placebo in patients with stage III NSCLC who did not have disease progression after two or more cycles of platinum-based chemoradiotherapy. Methods We randomly assigned patients, in a 2:1 ratio, to receive durvalumab (at a dose of 10 mg per kilogram of body weight intravenously) or placebo every 2 weeks for up to 12 months...
September 8, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28883282/development-of-immune-checkpoint-inhibitors
#11
Shigehisa Kitano
Immune checkpoint inhibitors are the most striking innovation in the clinical development of immunotherapy. Monoclonal antibodies (mAbs) restore and augment the antitumor immune activities of cytotoxic T cells by mainly blocking immune checkpoint molecules on T cells or their ligands on antigen-presenting and tumor cells. Based on preclinical data, many clinical trials have demonstrated the acceptable safety profiles and efficacies of mAb in various cancers. The A first-in-class approved immune checkpoint inhibitor is ipilimumab, which is a fully humanized mAb that blocks the immunosuppressive signal by cytotoxic T-lymphocyte antigen 4...
2017: [Rinshō Ketsueki] the Japanese Journal of Clinical Hematology
https://www.readbyqxmd.com/read/28881694/individual-isotoxic-radiation-dose-escalation-based-on-v20-and-advanced-technologies-benefits-unresectable-stage-iii-non-small-cell-lung-cancer-patients-treated-with-concurrent-chemoradiotherapy-long-term-follow-up
#12
Ming Liu, Zhongtang Wang, Tao Zhou, Antang Zhou, Qian Zhao, Hongsheng Li, Hongfu Sun, Wei Huang, BaoSheng Li
Under the assumption that the highest therapeutic ratio could be achieved by increasing the total tumor dose (TTD) to the limits of normal tissues, the phase I trial was conducted in patients with unresectable stage III non-small cell lung cancer treated with concurrent chemoradiotherapy, to determine the feasibility and effects of individual isotoxic radiation dose escalation based on bilateral lung V20 and advanced technologies. Consecutive eligible patients were assigned to cohorts of eight. V20 of each cohort was increased from 27% to 30%, 33%, 35%, 37%, and so on...
August 1, 2017: Oncotarget
https://www.readbyqxmd.com/read/28860885/osimertinib-in-the-treatment-of-non-small-cell-lung-cancer-design-development-and-place-in-therapy
#13
REVIEW
Mariacarmela Santarpia, Alessia Liguori, Niki Karachaliou, Maria Gonzalez-Cao, Maria Grazia Daffinà, Alessandro D'Aveni, Grazia Marabello, Giuseppe Altavilla, Rafael Rosell
The discovery of epidermal growth factor receptor (EGFR) mutations and subsequent demonstration of the efficacy of genotype-directed therapies with EGFR tyrosine kinase inhibitors (TKIs) marked the advent of the era of precision medicine for non-small-cell lung cancer (NSCLC). First- and second-generation EGFR TKIs, including erlotinib, gefitinib and afatinib, have consistently shown superior efficacy and better toxicity compared with first-line platinum-based chemotherapy and currently represent the standard of care for EGFR-mutated advanced NSCLC patients...
2017: Lung Cancer: Targets and Therapy
https://www.readbyqxmd.com/read/28854067/phase-iii-trial-of-ipilimumab-combined-with-paclitaxel-and-carboplatin-in-advanced-squamous-non-small-cell-lung-cancer
#14
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...
August 30, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28841858/skeletal-muscle-depletion-during-chemotherapy-has-a-large-impact-on-physical-function-in-elderly-japanese-patients-with-advanced-non-small-cell-lung-cancer
#15
Tateaki Naito, Taro Okayama, Takashi Aoyama, Takuya Ohashi, Yoshiyuki Masuda, Madoka Kimura, Hitomi Shiozaki, Haruyasu Murakami, Hirotsugu Kenmotsu, Tetsuhiko Taira, Akira Ono, Kazushige Wakuda, Hisao Imai, Takuya Oyakawa, Takeshi Ishii, Shota Omori, Kazuhisa Nakashima, Masahiro Endo, Katsuhiro Omae, Keita Mori, Nobuyuki Yamamoto, Akira Tanuma, Toshiaki Takahashi
BACKGROUND: Elderly patient with advanced cancer is one of the most vulnerable populations. Skeletal muscle depletion during chemotherapy may have substantial impact on their physical function. However, there is little information about a direct relationship between quantity of muscle and physical function. We sought to explore the quantitative association between skeletal muscle depletion, and muscle strength and walking capacity in elderly patients with advanced non-small cell lung cancer (NSCLC)...
August 25, 2017: BMC Cancer
https://www.readbyqxmd.com/read/28829490/effect-of-alk-inhibitors-in-the-treatment-of-non-small-cell-lung-cancer-a-systematic-review-and-meta-analysis
#16
G Li, W-R Dai, F-C Shao
OBJECTIVE: Lung cancer is the leading cause of cancer-related mortality. Over 80% of all lung cancer cases are non-small-cell lung cancer (NSCLC) and approximately 5% of NSCLC patients are positive for anaplastic lymphoma kinase (ALK) gene rearrangement or fusion with echinoderm microtubule-associated protein-like 4 (EML4). NSCLC patients with positive ALK-EML4 gene fusion are highly sensitive to ALK-inhibitors. While the efficacy of the ALK-inhibitors in the treatment of NSCLC has been consistently reported, a limited number of randomized, large-scale clinical trials have been reported...
August 2017: European Review for Medical and Pharmacological Sciences
https://www.readbyqxmd.com/read/28794650/treating-egfr-mutation-resistance-in-non-small-cell-lung-cancer-role-of-osimertinib
#17
REVIEW
Valentina Mazza, Federico Cappuzzo
The discovery of mutations in EGFR significantly changed the treatment paradigm of patients with EGFR-mutant non-small cell lung cancer (NSCLC), a particular group of patients with different clinical characteristics and outcome to EGFR-wild-type patients. In these patients, the treatment of choice as first-line therapy is first- or second-generation EGFR-tyrosine kinase inhibitors (EGFR-TKIs), such as gefitinib, erlotinib, or afatinib. Inevitably, after the initial response, all patients become refractory to these drugs...
2017: Application of Clinical Genetics
https://www.readbyqxmd.com/read/28794648/cost-analysis-of-adverse-events-associated-with-non-small-cell-lung-cancer-management-in-france
#18
Christos Chouaid, Delphine Loirat, Emilie Clay, Aurélie Millier, Chloé Godard, Amira Fannan, Laurie Lévy-Bachelot, Eric Angevin
BACKGROUND: Adverse events (AEs) related to medical treatments in non-small cell lung cancer (NSCLC) are frequent and need an appropriate costing in health economic models. Nevertheless, data on costs associated with AEs in NSCLC are scarce, particularly since the development of immunotherapy with specific immune-related AEs. OBJECTIVE: To estimate the costs of grades 3 and 4 AEs related to NSCLC treatments including immunotherapy in France. METHODS: Grades 3 and 4 AEs related to treatment and reported in at least 1% of patients in Phase III clinical trials for erlotinib, ramucirumab plus docetaxel, docetaxel, pemetrexed plus carboplatin plus bevacizumab, platinum-based chemotherapies, nivolumab and pembrolizumab were identified...
2017: ClinicoEconomics and Outcomes Research: CEOR
https://www.readbyqxmd.com/read/28780466/carboplatin-versus-two-doses-of-cisplatin-in-combination-with-gemcitabine-in-the-treatment-of-advanced-non-small-cell-lung-cancer-results-from-a-british-thoracic-oncology-group-randomised-phase-iii-trial
#19
RANDOMIZED CONTROLLED TRIAL
David Ferry, Lucinda Billingham, Hugh Jarrett, David Dunlop, Penella J Woll, Marianne Nicolson, Riyaz Shah, Joyce Thompson, James Spicer, D Muthukumar, Geraldine Skailes, Pauline Leonard, A D Chetiyawardana, Paula Wells, Conrad Lewanski, Barbara Crosse, Michelle Hill, Piers Gaunt, Kenneth O'Byrne
BACKGROUND: Platinum-based combination chemotherapy is standard treatment for the majority of patients with advanced non-small-cell lung cancer (NSCLC). The trial investigates the importance of the choice of platinum agent and dose of cisplatin in relation to patient outcomes. METHODS: The three-arm randomised phase III trial assigned patients with chemo-naïve stage IIIB/IV NSCLC in a 1:1:1 ratio to receive gemcitabine 1250 mg/m(2) on days 1 and 8 of a 3-week cycle with cisplatin 80 mg/m(2) (GC80) or cisplatin 50 mg/m(2) (GC50) or carboplatin AUC6 (GCb6) for a maximum of four cycles...
September 2017: European Journal of Cancer
https://www.readbyqxmd.com/read/28761724/time-since-start-of-first-line-therapy-as-a-predictive-clinical-marker-for-nintedanib-in-patients-with-previously-treated-non-small-cell-lung-cancer
#20
Birgit Gaschler-Markefski, Patricia Sikken, John V Heymach, Maya Gottfried, Anders Mellemgaard, Silvia Novello, Claudia-Nanette Gann, José Barrueco, Martin Reck, Nasser H Hanna, Rolf Kaiser
INTRODUCTION: No predictive clinical or genetic markers have been identified or validated for antiangiogenic agents in lung cancer. We aimed to identify a predictive clinical marker of benefit for nintedanib, an angiokinase inhibitor, using data from two large second-line non-small cell lung cancer Phase III trials (LUME-Lung 1 ([LL1] and LUME-Lung 2). METHODS: Predictive marker identification was conducted in a multi-step process using data from both trials; a hypothesis was generated, confirmed and validated...
2017: ESMO Open
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