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Ettore D'Argento, Sabrina Rossi, Giovanni Schinzari, Antonia Strippoli, Michele Basso, Alessandra Cassano, Carlo Barone
New treatments-as immunotherapies and new antiangiogenic agents-are now available in second-line setting for patients affected by EGFR wild-type and ALK-negative non-small-cell lung cancer (NSCLC). Nintedanib, ramucirumab, nivolumab and pembrolizumab have to be included in the therapeutic sequences for patients affected by NSCLC, but no clear selection criteria are to date offered, except for patients with PD-L1 expression ≥50 %. Performance status, smoking habits and comorbidities should be considered as clinical criteria in order to select the appropriate treatment, but also tumour characteristics as histotype, platinum resistance and rapid progression after a first-line therapy should be taken into account...
December 2016: Current Treatment Options in Oncology
Jun Fukihara, Yasuhiro Kondoh
Nintedanib is a new anti-fibrosis agent that is an intracellular tyrosine kinase inhibitor targeting platelet derived growth factor receptor, fibroblast growth factor receptor and vascular endothelial growth factor receptor. Although nintedanib is attracting much attention as a new treatment option for patients with idiopathic pulmonary fibrosis (IPF), the clinical evidence is limited mainly to the results from the dose-deciding phase II TOMORROW trial and phase III INPULSIS trials, which evaluated efficacy and safety of nintedanib for patients with IPF, prespecified subgroup analyses, pooled analyses and meta-analyses derived from those trials...
October 17, 2016: Expert Review of Respiratory Medicine
Christian Manegold, Anne-Marie C Dingemans, Jhanelle E Gray, Kazuhiko Nakagawa, Marianne Nicolson, Solange Peters, Martin Reck, Yi-Long Wu, Odd Terje Brustugun, Lucio Crino, Enriqueta Felip, Dean Fennell, Pilar Garrido, Rudolf M Huber, Aurelien Marabelle, Marcin Moniuszko, Francoise Mornex, Silvia Novello, Mauro Papotti, Maurice Pérol, Egbert F Smit, Kostas Syrigos, Jan P van Meerbeeck, Nico van Zandwijk, James Chih-Hsin Yang, Caicun Zhou, Everett Vokes
Over the past few years, there have been considerable advances in the treatments available to patients with metastatic or locally advanced non-small cell lung cancer (NSCLC), particularly those who have progressed on or during first-line treatment. Some of the treatment options available to patients are discussed here, with a focus on checkpoint inhibitor immunotherapies (nivolumab and pembrolizumab) and antiangiogenic agents (bevacizumab, ramucirumab and nintedanib). It is hypothesised that combining immunotherapy with antiangiogenic treatment may have a synergistic effect and enhance the efficacy of both treatments...
October 8, 2016: Journal of Thoracic Oncology
Christoph Schliemann, Joachim Gerss, Stefanie Wiebe, Jan-Henrik Mikesch, Nicola Knoblauch, Tim Sauer, Linus Angenendt, Tobias Kewitz, Marc Urban, Trude Butterfass-Bahloul, Sabine Edemir, Kerstin Vehring, Carsten Müller-Tidow, Wolfgang E Berdel, Utz Krug
: Nintedanib (BIBF 1120), a potent multikinase inhibitor of VEGFR-1/-2/-3, FGFR-1/-2/-3 and PDGFR-α/-β, exerts growth inhibitory and pro-apoptotic effects in myeloid leukemic cells, especially when used in combination with cytarabine. This phase I study evaluated nintedanib in combination with low-dose cytarabine (LDAC) in elderly patients with untreated or relapsed/refractory acute myeloid leukemia (AML) ineligible for intensive chemotherapy in a 3+3 design. Nintedanib (dose levels 100, 150, and 200 mg orally twice daily) and LDAC (20 mg subcutaneous injection twice daily for 10 days) were administered in 28-day cycles...
2016: PloS One
Valérie Paulus, Virginie Avrillon, Maurice Pérol
Angiogenesis is critical for tumor growth, proliferation and metastasis with the crucial role of Vascular Endothelial Growth factor (VEGF) pathway. Ramucirumab is a monoclonal antibody that specifically targets the extracellular domain of Vascular Endothelial Growth Factor Receptor 2. Areas covered: We performed a search on Medline to browse the current literature on Ramucirumab and anti-angiogenic agents, for the treatment of NSCLC. The REVEL study demonstrated a significant improvement of response rate, progression-free survival and overall survival by adding ramucirumab to docetaxel compared to docetaxel plus a placebo in second-line treatment of advanced non-small cell lung cancer, irrespective of histology, with an acceptable safety profile...
October 8, 2016: Expert Review of Anticancer Therapy
Giorgio V Scagliotti, Rabab Gaafar, Anna Nowak, Nicholas J Vogelzang, Ute Von Wangenheim, Nassim Morsli, Derek Velema, Sanjay Popat
No abstract text is available yet for this article.
October 2016: Journal of Thoracic Oncology
Martin Kolb, Luca Richeldi, Jürgen Behr, Toby M Maher, Wenbo Tang, Susanne Stowasser, Christoph Hallmann, Roland M du Bois
RATIONALE: There is no consensus as to when treatment for idiopathic pulmonary fibrosis (IPF) should be initiated. Some physicians prefer not to treat patients with preserved lung volume. OBJECTIVE: To investigate whether patients with IPF and preserved lung volume receive the same benefit from nintedanib as patients with more impaired lung volume. METHODS: Post hoc subgroup analyses of pooled data from the two replicate phase III INPULSIS trials by baseline FVC % predicted (≤90%, >90%)...
September 26, 2016: Thorax
Vasileios S Skouras, Charis Maragkos, Dimitra Grapsa, Konstantinos N Syrigos
Chemotherapy has reached a plateau in the efforts for survival improvement in non-small cell lung cancer (NSCLC). The growing knowledge of NSCLC molecular pathobiology has led to the development of new treatments that target specific tumor functions. Angiogenesis is a tumor function leading to the formation of new tumor vessels that are crucial for its survival. Although vascular endothelial growth factor (VEGF) plays a primary role in angiogenesis, the inhibition of the VEGF pathway with VEGF-receptor (VEGFR) tyrosine kinase inhibitors (TKIs) is associated with a modest survival benefit due to the development of resistance by the tumor that has been mainly attributed to the up-regulation of other stimulators of angiogenesis...
October 2016: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
Daniel C Chambers
No abstract text is available yet for this article.
November 2016: Respirology: Official Journal of the Asian Pacific Society of Respirology
Takuji Okusaka, Taiga Otsuka, Hideki Ueno, Shuichi Mitsunaga, Rie Sugimoto, Kei Muro, Isao Saito, Yusuke Tadayasu, Kohei Inoue, Arsene-Bienvenu Loembé, Masafumi Ikeda
This phase I, dose-escalation study evaluated the safety, preliminary efficacy and pharmacokinetics of nintedanib, a triple angiokinase inhibitor, in Japanese patients with advanced hepatocellular carcinoma and mild/moderate liver impairment. Thirty patients with unresectable hepatocellular carcinoma were enrolled to groups, depending on whether liver impairment was mild (Group I: AST and ALT ≤2x ULN and Child-Pugh score 5 [n=14] or 6 [n=2]) or moderate (Group II: Child-Pugh score 5-6 and AST or ALT >2x to ≤5x ULN [n=7] or Child-Pugh score 7 [n=7]); 22 patients had prior sorafenib treatment...
September 14, 2016: Cancer Science
Deborah L Clarke, Lynne A Murray, Bruno Crestani, Matthew A Sleeman
Idiopathic pulmonary fibrosis (IPF) is a chronic fibrosing interstitial pneumonia of unknown cause, characterised by progressive worsening in lung function and dyspnoea with an associated prognosis similar to or worse than many cancers. As a better understanding emerges around the pathogenesis and mechanisms driving disease pathology, a host of novel agents are being tested both pre-clinically and clinically. However even with this deeper understanding and positive pre-clinical supportive data, negative trial outcomes are frequently reported, highlighting the problems faced in treating such a heterogeneous disease with a varied clinical course...
September 13, 2016: Pharmacology & Therapeutics
Gareth Hughes, Hannah Toellner, Helen Morris, Colm Leonard, Nazia Chaudhuri
Idiopathic Pulmonary Fibrosis (IPF) now has two licensed treatments available. Pirfenidone was the first drug to be licensed and approved for use, followed by nintedanib. We set out our real world experience with these agents in terms of their adverse events profile outside the restrictions of a clinical trial. We have demonstrated in the real world setting, that side effects are common and predominantly gastrointestinal with both therapies. Our study shows that the side effects can be effectively managed in the majority of patients with an acceptable discontinuation rate similar to that seen in the clinical trials...
September 2, 2016: Journal of Clinical Medicine
Bishal Gyawali, Vinay Prasad
Recently, two clinical trials of novel agents in metastatic ovarian cancer were published: a phase 3 study of nintedanib and a phase 2 study of volasertib. There seemed to be discordance between the results and conclusions in the publication of both these trials. Despite not very optimistic results, the studies concluded optimistically in favor of the new agents under study. Using these examples, we point out the discrepancies and the risks of concluding optimistically based on statistical significance when the actual benefit is minimal...
2016: Ecancermedicalscience
Miguel Quintela-Fandino, Ana Lluch, Luis M Manso, Isabel Calvo, Javier Cortes, Jose A García-Saenz, Juan M Gil, Noelia Martinez-Jañez, Antonio González-Martín, Encarna Adrover, Raquel De Andres, Gemma Viñas, Antonio Llombart Cussac, Emilio Alba, Juan Guerra, Begoña Bermejo, Esther Zamora, Fernando Moreno-Anton, Sonia Pernas-Simon, Alfredo Carrato, Antonio Lopez, María J Escudero, Ruth Campo, Eva M Carrasco, Jose Palacios, Francisca Mulero, Ramon Colomer
PURPOSE: We previously detected promising efficacy of neoadjuvant nintedanib (a multi-tyrosine kinase inhibitor, TKI) in early HER2-negative breast cancer. In a preclinical study we monitored stromal hypoxia with 18F-fluoromisonidazole-positron emission tomography (18F-FMISO-PET); we found that re-oxygenation of tumors (or lack of it) during a window-of-opportunity (WoO) treatment with TKIs correlated with the benefit (or lack of it) from TKI-plus-chemotherapy combinations. We studied the predictive role of 18F-FMISO-PET for the TKI nintedanib in the neoadjuvant setting in a phase II WoO randomized trial...
September 1, 2016: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
Masaaki Hibi, Hiroyasu Kaneda, Junko Tanizaki, Kazuko Sakai, Yosuke Togashi, Masato Terashima, Marco Antonio De Velasco, Yoshihiko Fujita, Eri Banno, Yu Nakamura, Masayuki Takeda, Akihiko Ito, Tetsuya Mitsudomi, Kazuhiko Nakagawa, Isamu Okamoto, Kazuto Nishio
Fibroblast growth factor receptor (FGFR) gene alterations are relatively frequent in lung squamous cell carcinoma (LSCC) and are a potential targets for therapy with FGFR inhibitors. However, little is known regarding the clinicopathologic features associated with FGFR alterations. The angiokinase inhibitor nintedanib has shown promising activity in clinical trials for non-small cell lung cancer. We have now applied next-generation sequencing (NGS) to characterize FGFR alterations in LSCC patients as well as examined the antitumor activity of nintedanib in LSCC cell lines positive for FGFR1 copy number gain (CNG)...
September 1, 2016: Cancer Science
H Coleman Robinson
Restrictive lung diseases are a heterogeneous group of conditions characterized by a restrictive pattern on spirometry and confirmed by a reduction in total lung volume. Patients with more severe symptoms may have a reduced diffusing capacity of the lung for carbon monoxide. Etiologies can be intrinsic with lung parenchymal involvement, as in interstitial lung diseases, or extrinsic to the lung, as in obesity and neuromuscular disorders. Idiopathic pulmonary fibrosis is a chronic progressive interstitial pneumonia with fibrosis for which treatment is primarily supportive with oxygen therapy, pulmonary rehabilitation, and management of comorbid conditions...
September 2016: FP Essentials
Jacqueline L Olin, J Andrew Woods, Stuart J Garner
No abstract text is available yet for this article.
August 17, 2016: American Journal of Therapeutics
María Espinosa Bosch, Rocío Asensi Diez, Sara García Agudo, Ana Clopes Estela
Nintedanib is a triple angiokinase inhibitor that has been approved by the European Agency Medicines (EMA) in combination with docetaxel for the treatment of adult patients with locally advanced, metastatic or locally recurrent non small cell lung cancer (NSCLC) of adenocarcinoma tumour histology, after first-line chemotherapy. In LUME-Lung 1 clinical trial, the combination of nintedanib plus docetaxel vs. placebo plus docetaxel improved progression free survival (PFS) in NSCLC patients, and improved overall survival in the population of adenocarcinoma patients, particularly in those with progression within 9 months after first line treatment initiation, median 10...
July 2016: Farmacia Hospitalaria
Elizabeth R Volkmann, Donald P Tashkin
Although interstitial lung disease accounts for the majority of deaths in patients with systemic sclerosis, treatment options for this manifestation of systemic sclerosis are limited. Few high quality, randomized controlled trials exist for systemic sclerosis-related interstitial lung disease, and historically, studies have favored the use of cyclophosphamide. However, the benefit of cyclophosphamide for systemic sclerosis-related interstitial lung disease is tempered by its complex adverse event profile. More recent studies have demonstrated the effectiveness of mycophenolate for systemic sclerosis-related interstitial lung disease, including the recently published Scleroderma Lung Study II...
August 25, 2016: Annals of the American Thoracic Society
Francesco Bonella, Michael Kreuter, Lars Hagmeyer, Claus Neurohr, Claus Keller, Martin J Kohlhaeufl, Joachim Müller-Quernheim, Katrin Milger, Antje Prasse
BACKGROUND: Nintedanib is approved for the treatment of idiopathic pulmonary fibrosis (IPF) and has been shown to slow disease progression by reducing annual lung function decline. OBJECTIVE: To evaluate the results of a large cohort of IPF patients treated with nintedanib within a compassionate use program (CUP) in Germany (9 centers). METHODS: Patients (≥40 years) were required to have a confirmed diagnosis of IPF, a forced vital capacity (FVC) ≥50% predicted (pred...
2016: Respiration; International Review of Thoracic Diseases
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