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Non small cell lung cancer phase iii

Shirish M Gadgeel
Anaplastic lymphoma kinase (ALK) gene rearrangements as driver genetic alterations occur in approximately 2-4% of non-small-cell lung cancer (NSCLC) patients. Alectinib, a next generation ALK inhibitor, recently demonstrated, in two separate Phase III trials, superior efficacy to crizotinib, the first ALK inhibitor to demonstrate clinical efficacy in ALK-positive NSCLC patients. Alectinib also demonstrated superior efficacy in the CNS. The data from these two Phase III studies suggest that the efficacy of starting with alectinib is superior to the overall clinical efficacy of starting with crizotinib followed by switching to alectinib at the time of disease progression...
March 14, 2018: Future Oncology
Luca Mazzarella, Alessandro Guida, Giuseppe Curigliano
Epidermal Growth Factor Receptor (EGFR)-dependent signaling plays a crucial role in epithelial cancer biology, and dictated the development of several targeting agents. The mouse-human chimeric antibody Cetuximab was among the first to be developed. After about two decades of clinical research it has gained a significant place in the management of advanced colorectal and head and neck cancers, whereas its development in non small cell lung cancer (NSCLC) has not led to a place in routine clinical practice, because of marginal clinical benefit despite statistically significant Phase III trials...
March 14, 2018: Expert Opinion on Biological Therapy
T W Zhang, G B Rodrigues, A V Louie, D Palma, A R Dar, B Dingle, W Kocha, M Sanatani, B Yaremko, E Yu, J Younus, M D Vincent
Background: We designed a phase i study of concurrent chemoradiotherapy (ccrt) with docetaxel (D) and cisplatin (C), followed by consolidation dc, for unresectable stage iii non-small cell lung cancer (nsclc). Methods: Patients with histologically proven and unresectable stage iii nsclc were eligible. During ccrt, C was given every 3 weeks (75 mg/m2 ) and D given weekly. The starting dose of D was 20 mg/m2 , escalated in cohorts of 3 to define the maximum tolerated dose (mtd)...
February 2018: Current Oncology
Yoshihito Morimoto, Hidefumi Takei, Keisei Tachibana, Yoko Nakazato, Ryota Tanaka, Yasushi Nagashima, Kazuhiro Watanabe, Reisuke Seki, Takao Shinohara, Haruhiko Kondo
 Adjuvant cisplatin-vinorelbine chemotherapy has been shown to be effective in patients with completely resected non-small cell lung cancer (NSCLC) in several Phase III trials, but not yet in the Japanese population. Pharmacists are expected to assist patients with completion of adjuvant chemotherapy. The aim of this retrospective study was to evaluate the compliance with and safety of adjuvant cisplatin-vinorelbine chemotherapy in Japanese patients and to evaluate the contribution of pharmacists to completion of treatment...
2018: Yakugaku Zasshi: Journal of the Pharmaceutical Society of Japan
Makoto Sonobe, Masatsugu Hamaji, Hideki Motoyama, Toshi Menju, Akihiro Aoyama, Toyofumi F Chen-Yoshikawa, Toshihiko Sato, Hiroshi Date
PURPOSE: We reported previously a phase II study of adjuvant chemotherapy consisting of four cycles of vinorelbine (25 mg/m2 ) and cisplatin (40 mg/m2 ), given on days 1 and 8, every 4 weeks, to Japanese patients with completely resected stage II or III non-small cell lung cancer (NSCLC; UMIN 000005055). However, the follow-up was too short for us to evaluate a definitive 5-year overall survival rate and after-effects. METHODS: Between December 2006 and January 2011, 60 patients were enrolled in this study...
March 3, 2018: Surgery Today
Jean-Paul Sculier, Jean-Jacques Lafitte, Thierry Berghmans, Anne-Pascale Meert, Arnaud Scherpereel, Martine Roelandts, Olivier Van Cutsem, Benoit Colinet, Yves Bonduelle, Vicente Giner, Marianne Paesmans, Nathalie Leclercq, Paul Van Houtte
OBJECTIVES: To assess if induction radiochemotherapy followed by consolidation chemotherapy (arm A) will improve survival in comparison with the same chemotherapy given as induction followed by consolidation concurrent radiochemotherapy (arm B) in patients with unresectable non-metastatic non-small cell lung cancer (NSCLC). PATIENTS AND METHODS: Chemotherapy consisted in a combination of cisplatin with docetaxel, with one initial course for each patient, two courses in single modality therapy and weekly administration during chest irradiation (66 Gy)...
March 2018: Lung Cancer: Journal of the International Association for the Study of Lung Cancer
Yingcheng Wu, Qianqian Ju, Bei Qian, Feng Zhang, Hui Shi
Background: Immunosenescence, the age-related decline of immunity, affects the immune responses of non-small cell lung cancer (NSCLC) patients. Through immune responses, programmed death-1 (PD-1) inhibitors exert their antitumor robustness. In different ages of NSCLC patients, especially the older patients, the effectiveness of PD-1 inhibitors remains unclear. It is still controversial whether pembrolizumab or nivolumab should be used in treating NSCLC patients. Results: 2,192 NSCLC patients from four phase III RCTs were included...
January 30, 2018: Oncotarget
James J Urbanic, Xiaofei Wang, Jeffrey A Bogart, Thomas E Stinchcombe, Lydia Hodgson, Steven E Schild, Lyudmila Bazhenova, Olwen Hahn, Ravi Salgia, Everett E Vokes
PURPOSE: To investigate the safety of accelerated hypofractionated radiation therapy (AHRT) with concurrent chemotherapy (CT) for inoperable stage III non-small cell lung cancer (NSCLC). PATIENTS AND METHODS: The primary objectives were to define the maximally tolerable course of accelerated radiation therapy and to describe toxicities of therapy. Total radiation therapy remained at 60 Gy. The number of once-daily fractions in each successive cohort was reduced as follows: cohort 1, 60 Gy in 27 fractions; cohort 2, 60 Gy in 24 fractions; cohort 3, 60 Gy in 22 fractions; and cohort 4, 60 Gy in 20 fractions...
January 31, 2018: International Journal of Radiation Oncology, Biology, Physics
Chiara Tomasello, Cinzia Baldessari, Martina Napolitano, Giulia Orsi, Giulia Grizzi, Federica Bertolini, Fausto Barbieri, Stefano Cascinu
In the last few years, the development of targeted therapies for non-small cell lung cancer (NSCLC) expressing oncogenic driver mutations (e.g. EGFR) has changed the clinical management and the survival outcomes of this specific minority of patients. Several phase III trials demonstrated the superiority of epidermal growth factor receptor tyrosine kinase inhibitors (EGFR TKIs) over chemotherapy in EGFR-mutant NSCLC patients. However, in the vast majority of cases EGFR TKIs lose their clinical activity within 8-12 months...
March 2018: Critical Reviews in Oncology/hematology
Idoroenyi Amanam, Rohan Gupta, Isa Mambetsariev, Ravi Salgia
Lung cancer remains the leading cause of cancer deaths in the world with 1.69 million deaths in 2015. A total of 85% of lung cancer cases are non-small-cell lung cancers (NSCLCs). Driver mutations associated with anaplastic lymphoma kinase (ALK) have been identified in a variety of malignancies, including NSCLC. An ALK inhibitor (crizotinib, ceritinib and alectinib) is the preferred therapeutic approach to those advanced ALK fusion variant-positive NSCLC patients. Brigatinib, a next-generation ALK inhibitor, shows promising activity in ALK-rearranged NSCLC that have previously received crizotinib with response rates in ALTA ranging from 42-50%, intracranial response 42-67% and median progression-free survival 9...
February 16, 2018: Future Oncology
Monica Khunger, Prantesh Jain, Sagar Rakshit, Vinay Pasupuleti, Adrian V Hernandez, James Stevenson, Nathan A Pennell, Vamsidhar Velcheti
INTRODUCTION: Programmed death 1 (PD-1)/programmed death ligand 1 (PD-L1) inhibitors show significant clinical activity in non-small-cell lung carcinoma (NSCLC). However, there is a relative lack of data on comparative efficacy of these drugs in the first-line setting versus chemotherapy-treated patients. We compared the efficacy and toxicity of these drugs in these 2 distinct groups of patients. MATERIALS AND METHODS: Electronic databases (PubMed-Medline, EMBASE, Scopus) and major conference proceedings were systematically searched for all phase I to III clinical trials in NSCLC using PD-1/PD-L1 inhibitors...
January 10, 2018: Clinical Lung Cancer
Gary Middleton, Cesare Gridelli, Filippo De Marinis, Jean-Louis Pujol, Martin Reck, Rodryg Ramlau, Barbara Parente, Thierry Pieters, Carla M Visseren-Grul, Bélen San Antonio, William J John, Annamaria Hayden Zimmermann, Nadia Chouaki, Luis Paz-Ares
OBJECTIVES: To assess the long-term pemetrexed maintenance therapy on patients' renal function. METHODS: In the PARAMOUNT Phase III trial (NCT 00789373), pemetrexed was compared with placebo as maintenance treatment in advanced nonsquamous non-small-cell lung cancer patients who completed 4 cycles of pemetrexed plus cisplatin induction therapy. To evaluate changes in renal function during pemetrexed continuation maintenance treatment, we retrospectively analyzed changes in serum creatinine (sCr), treatment-emergent adverse events, dose delays, and treatment discontinuations associated with impaired renal function...
February 9, 2018: Current Medical Research and Opinion
Jennifer Lewis, Erin A Gillaspie, Evan C Osmundson, Leora Horn
The treatment of patients with stage IIIA ( N 2) non-small cell lung cancer (NSCLC) is one of the most challenging and controversial areas of thoracic oncology. This heterogeneous group is characterized by varying tumor size and location, the potential for involvement of surrounding structures, and ipsilateral mediastinal lymph node spread. Neoadjuvant chemotherapy, administered prior to definitive local therapy, has been found to improve survival in patients with stage IIIA ( N 2) NSCLC. Concurrent chemoradiation has also been evaluated in phase III studies in efforts to improve control of locoregional disease...
2018: Frontiers in Oncology
E E Vokes, N Ready, E Felip, L Horn, M A Burgio, S J Antonia, O Arén Frontera, S Gettinger, E Holgado, D Spigel, D Waterhouse, M Domine, M Garassino, L Q M Chow, G Blumenschein, F Barlesi, B Coudert, J Gainor, O Arrieta, J Brahmer, C Butts, M Steins, W J Geese, A Li, D Healey, L Crinò
Background: Long-term data with immune checkpoint inhibitors in non-small cell lung cancer (NSCLC) are limited. Two phase III trials demonstrated improved overall survival (OS) and a favorable safety profile with the anti-programmed death-1 antibody nivolumab versus docetaxel in patients with previously treated advanced squamous (CheckMate 017) and non-squamous (CheckMate 057) NSCLC. We report results from ≥3 years' follow-up, including subgroup analyses of patients with liver metastases, who historically have poorer prognosis among patients with NSCLC...
February 2, 2018: Annals of Oncology: Official Journal of the European Society for Medical Oncology
Keigo Kobayashi, Ichiro Nakachi, Katsuhiko Naoki, Ryosuke Satomi, Morio Nakamura, Takashi Inoue, Hiroki Tateno, Fumio Sakamaki, Koichi Sayama, Takeshi Terashima, Hidefumi Koh, Takayuki Abe, Makoto Nishino, Daisuke Arai, Hiroyuki Yasuda, Ichiro Kawada, Kenzo Soejima, Tomoko Betsuyaku
BACKGROUND: Nivolumab, an immune checkpoint inhibitor, is now a standard treatment for previously treated advanced non-small-cell lung cancer based on the results from phase III clinical trials. We evaluated the real-world efficacy and safety of nivolumab in a nonselected population and identified the clinical characteristics that influence efficacy. MATERIALS AND METHODS: A total of 142 patients with advanced non-small-cell lung cancer who were administered nivolumab at Keio University and affiliated hospitals in Japan from January to July 2016 were enrolled...
January 5, 2018: Clinical Lung Cancer
T Berghmans, B Grigoriu, J P Sculier, A P Meert
INTRODUCTION: Classical therapeutic strategy for advanced and metastatic non-small cell lung cancer, without activable oncogenic driver mutation, has been based mainly on cytotoxic chemotherapy with modest benefits in terms of increased survival. BACKGROUND: A better understanding of the mechanisms involved in the regulation of the immune system led to the development of antibodies directed against immune checkpoints such as PD-L1. The first encouraging clinical data from phase I studies assessing anti-PD1 and anti-PD-L1 antibodies have been confirmed in randomised phase III trials...
January 27, 2018: Revue des Maladies Respiratoires
Francesco Grossi, Carlo Genova, Erika Rijavec, Giulia Barletta, Federica Biello, Maria Giovanna Dal Bello, Krista Meyer, Joanna Roder, Heinrich Roder, Julia Grigorieva
OBJECTIVES: VeriStrat® is a blood-based test that utilizes matrix-assisted laser desorption/ionization time-of-flight (MALDI ToF) mass spectrometry to assign a binary classification of VeriStrat Good or VeriStrat Poor that is associated with treatment outcomes in cancer patients. A number of other studies have shown an association between VeriStrat status and clinical outcomes in second and subsequent lines of therapy. The prognostic properties of VeriStrat were demonstrated in the placebo arms of two randomized studies in non-small cell lung cancer (NSCLC): TOPICAL and BR...
December 13, 2017: Lung Cancer: Journal of the International Association for the Study of Lung Cancer
Edurne Arriola, Ramón García Gómez, Pilar Diz, Margarita Majem, Maite Martínez Aguillo, Javier Valdivia, Alfredo Paredes, José Miguel Sánchez-Torres, Sergio Peralta Muñoz, Isidoro Barneto, Vanesa Gutierrez, Jesús Manuel Andrade Santiago, Francisco Aparisi, Dolores Isla, Santiago Ponce, David Vicente Baz, Angel Artal, Mariluz Amador, Mariano Provencio
BACKGROUND: Although the benefit of first-line epidermal growth factor receptor (EGFR) tyrosine-kinase inhibitors (TKIs) over chemotherapy has been demonstrated in several clinical trials, data from clinical practice is lacking and the optimal EGFR TKI to be used remains unclear. This study aims to assess the real-life diagnostic and clinical management and outcome of patients with advanced non-small-cell lung cancer (NSCLC) carrying EGFR mutations in Spain. METHODS: All consecutive patients recently diagnosed with advanced or metastatic NSCLC from April 2010 to December 2011 in 18 Spanish hospitals and carrying EGFR mutations were retrospectively evaluated...
January 30, 2018: BMC Cancer
Jun-Ichi Saitoh, Katsuyuki Shirai, Takanori Abe, Nobuteru Kubo, Takeshi Ebara, Tatsuya Ohno, Koichi Minato, Ryusei Saito, Masanobu Yamada, Takashi Nakano
BACKGROUND/AIM: The aim of this study was to assess the feasibility and safety of hypofractionated carbon-ion radiotherapy (C-ion RT) in patients with stage III non-small cell lung cancer (NSCLC). PATIENTS AND METHODS: Patients with untreated, histologically proven, unresectable stage III NSCLC and not candidates for chemotherapy were included in this study. C-ion RT was planned and administered with 4 Gy (relative biological effectiveness (RBE)) in daily fractions for a total dose of 64 Gy (RBE) without combined chemotherapy...
February 2018: Anticancer Research
May N Tsao, Wei Xu, Rebecca Ks Wong, Nancy Lloyd, Normand Laperriere, Arjun Sahgal, Eileen Rakovitch, Edward Chow
BACKGROUND: This is an update to the review published in the Cochrane Library (2012, Issue 4).It is estimated that 20% to 40% of people with cancer will develop brain metastases during the course of their illness. The burden of brain metastases impacts quality and length of survival. OBJECTIVES: To assess the effectiveness and adverse effects of whole brain radiotherapy (WBRT) given alone or in combination with other therapies to adults with newly diagnosed multiple brain metastases...
January 25, 2018: Cochrane Database of Systematic Reviews
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