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Non small cell lung cancer phase iii

Antonin Levy, Etienne Bardet, Benjamin Lacas, Jean-Pierre Pignon, Julien Adam, Ludovic Lacroix, Xavier Artignan, Pierre Verrelle, Cécile Le Péchoux
BACKGROUND: Gefitinib is an oral EGFR tyrosine kinase inhibitors which may act as a radiosensitizer. PATIENTS AND METHODS: This phase II study evaluated the efficacy of gefitinib 250 mg once daily in combination with thoracic radiotherapy (66 Gy in 6.5 weeks, 2 Gy/day, 5 fractions/week) followed by consolidation chemotherapy (IV cisplatin and vinorelbine) as first line treatment in a population of unselected stage IIIB NSCLC patients according to EGFR mutation status...
October 18, 2016: Oncotarget
Shouzheng Wang, Junling Li
In recent years, squamous non-small cell lung cancer (NSCLC) didn't progress much in chemotherapy or target therapy. However, immunotherapy has made breakthroughs in treating squamous NSCLC. Immunotherapy includes two main broad classes of immune checkpoint inhibitors and therapeutic vaccines. Immune checkpoint inhibitors, including anti cytotoxic T-lymphocyte associated antigen 4 (CTLA-4) and anti programmed death receptor 1 (PD-1) antibodies, have been tested in the phase II/III clinical trials and have demonstrated promising outcomes...
October 20, 2016: Zhongguo Fei Ai za Zhi, Chinese Journal of Lung Cancer
Cecilia Ferreira da Silva, Miriam Ventura da Silva, Claudia Garcia Serpa Osorio-de-Castro
Objective To analyze the pathway of clinical trials of monoclonal antibodies and biological medicines for cancer treatment involving Brazilian institutions from 2003 to 2012. Method This retrospective, descriptive study was based on review of two clinical trial registries, and the Brazilian registry ReBEC. Phase II or III studies with participation from Brazilian institutions listed in at least one of the registries were included. Following selection of the trials, the pathway of monoclonal antibodies and biological medicines was investigated from the research stage until licensing by the Brazilian Agency for Sanitary Surveillance (Anvisa), Food and Drug Administration (FDA), and European Medicines Agency (EMA)...
March 2016: Revista Panamericana de Salud Pública, Pan American Journal of Public Health
Jaroslaw T Hepel, Kara Lynne Leonard, Howard Safran, Thomas Ng, Angela Taber, Humera Khurshid, Ariel Birnbaum, David E Wazer, Thomas DiPetrillo
PURPOSE: Stereotactic body radiation therapy (SBRT) boost to primary and nodal disease after chemoradiation has potential to improve outcomes for advanced non-small cell lung cancer (NSCLC). A dose escalation study was initiated to evaluate the maximum tolerated dose (MTD). METHODS AND MATERIALS: Eligible patients received chemoradiation to a dose of 50.4 Gy in 28 fractions and had primary and nodal volumes appropriate for SBRT boost (<120 cc and <60 cc, respectively)...
August 31, 2016: International Journal of Radiation Oncology, Biology, Physics
Steven J Isakoff, Shannon Puhalla, Susan M Domchek, Michael Friedlander, Bella Kaufman, Mark Robson, Melinda L Telli, Véronique Diéras, Hyo Sook Han, Judy E Garber, Eric F Johnson, David Maag, Qin Qin, Vincent L Giranda, Stacie P Shepherd
Veliparib is an orally administered poly(ADP-ribose) polymerase inhibitor that is being studied in Phase I-III clinical trials, including Phase III studies in non-small-cell lung cancer, ovarian cancer and breast cancer. Tumor cells with deleterious BRCA1 or BRCA2 mutations are deficient in homologous recombination DNA repair and are intrinsically sensitive to platinum therapy and poly(ADP-ribose) polymerase inhibitors. We describe herein the design and rationale of a Phase II trial investigating whether the addition of veliparib to temozolomide or carboplatin/paclitaxel provides clinical benefit over carboplatin/paclitaxel with placebo in patients with locally recurrent or metastatic breast cancer harboring a deleterious BRCA1 or BRCA2 germline mutation (Trial registration: EudraCT 2011-002913-12, NCT01506609)...
October 14, 2016: Future Oncology
Hidehito Horinouchi
A number of promising new approaches for both local and systemic control of locally advanced non-small cell lung cancer have been examined in clinical trials, aimed at improving the patient survival. Development of better systemic therapies by adopting newer agents (such as epidermal growth factor receptor-tyrosine kinase inhibitors and immune checkpoint inhibitors) from advanced non-small cell lung cancer is mandatory. As for radiotherapy, adaptive radiotherapy and proton therapy are under investigation after the RTOG 0617 trial unexpectedly failed to show the efficacy of high-dose radiotherapy for Stage III disease...
October 4, 2016: Japanese Journal of Clinical Oncology
Yongzhao Zhao, Huixian Wang, Yan Shi, Shangli Cai, Tongwei Wu, Guangyue Yan, Sijin Cheng, Kang Cui, Ying Xi, Xiaolong Qi, Jie Zhang, Wang Ma
BACKGROUND & AIMS: Combined therapy inhibiting EGFR and VEGF pathways is becoming a promising therapy in the treatment of advanced non-small-cell lung cancer (NSCLC), however, with controversy. The study aims to compare the efficacy of combined inhibition therapy versus control therapy (including placebo, single EGFR inhibition and single VEGF inhibition) in patients with advanced NSCLC. MATERIALS AND METHODS: An adequate literature search in EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), American Society of Clinical Oncology (ASCO) and European Society of Medical Oncology (ESMO) was conducted...
September 27, 2016: Oncotarget
J Liang
No abstract text is available yet for this article.
October 1, 2016: International Journal of Radiation Oncology, Biology, Physics
A Matikas, V Georgoulias, A Kotsakis
Non-small cell lung cancer lung cancer (NSCLC) is a devastating disease, with poor prognosis for patients with metastatic disease. The management of these patients has evolved during the past decade, challenging the role of cytotoxic chemotherapy as the only available treatment option. Nevertheless, chemotherapy still retains a dominant position for the majority of both treatment naïve and pretreated patients. Among the chemotherapeutic agents, docetaxel is one of the most commonly used in 1st and subsequent treatment lines, even in the current era of precision medicine...
October 3, 2016: Expert Review of Respiratory Medicine
Antonio Passaro, Alessia Pochesci, Spitaleri Gianluca, Chiara Catania, Cristina Noberasco, Ester Del Signore, Filippo de Marinis
INTRODUCTION: Epidermal growth factor receptor (EGFR) mutations are detected in about 10-15% of Caucasian and 30-40% of Asian patients with advanced or metastatic non-small-cell lung cancer (NSCLC). In patients harbouring EGFR mutations, the treatment with different available EGFR tyrosine kinase inhibitors (TKIs) showed to be more effective and safe than platinum-based chemotherapy regimens. AREAS COVERED: The current evidences about the role of afatinib for patients with EGFR-positive NSCLC are reviewed and discussed...
September 14, 2016: Expert Review of Clinical Pharmacology
Carlo Genova, Fred R Hirsch
Despite significant progress, new therapeutic approaches for advanced non-small cell lung cancer (NSCLC) are highly needed, particularly for the treatment of patients with squamous cell carcinoma. The epidermal growth factor receptor (EGFR) is often overexpressed in NSCLC and represents a relevant target for specific treatments. Although EGFR mutations are more frequent in non-squamous histology, the receptor itself is more often overexpressed in squamous NSCLC. Necitumumab is a human monoclonal antibody that is able to inhibit the EGFR pathway and cause antibody-dependent cell cytotoxicity...
2016: OncoTargets and Therapy
Qing Zhou, Jin-Ji Yang, Zhi-Hong Chen, Xu-Chao Zhang, Hong-Hong Yan, Chong-Rui Xu, Jian Su, Hua-Jun Chen, Hai-Yan Tu, Wen-Zhao Zhong, Xue-Ning Yang, Yi-Long Wu
BACKGROUND: Detecting epidermal growth factor receptor (EGFR) activating mutations in plasma could guide EGFR-tyrosine kinase inhibitor (EGFR-TKI) treatment for advanced non-small cell lung cancer (NSCLC). However, dynamic quantitative changes of plasma EGFR mutations during the whole course of EGFR-TKI treatment and its correlation with clinical outcomes were not determined. The aim of this study was to measure changes of plasma EGFR L858R mutation during EGFR-TKI treatment and to determine its correlation with the response and resistance to EGFR-TKI...
September 13, 2016: Journal of Hematology & Oncology
J C-H Yang, L V Sequist, C Zhou, M Schuler, S L Geater, T Mok, C-P Hu, N Yamamoto, J Feng, K O'Byrne, S Lu, V Hirsh, Y Huang, M Sebastian, I Okamoto, N Dickgreber, R Shah, A Märten, D Massey, S Wind, Y-L Wu
BACKGROUND: Afatinib 40 mg/day is approved for first-line treatment of EGFR mutation-positive non-small-cell lung cancer (NSCLC). In the case of drug-related grade ≥3 or selected prolonged grade 2 adverse events (AEs), the dose can be reduced by 10 mg decrements to a minimum of 20 mg. Here, we evaluate the influence of afatinib dose reduction on AEs, pharmacokinetics and progression-free survival (PFS) in the phase III LUX-Lung 3 and 6 (LL3/6) trials. PATIENTS AND METHODS: Treatment-naïve patients with advanced EGFR mutation-positive NSCLC in LL3 (global) and LL6 (China, Thailand, South Korea) were randomized to afatinib or chemotherapy...
September 6, 2016: Annals of Oncology: Official Journal of the European Society for Medical Oncology
F Blackhall, F Cappuzzo
Non-small-cell lung cancer (NSCLC) is associated with a poor prognosis and low survival rates, providing a strong rationale for the development of new treatment options. The discovery of ALK gene rearrangements in a subset of NSCLC specimens and the identification and development of the first-in-class ALK inhibitor crizotinib provided a personalised treatment option for patients with advanced ALK-positive NSCLC. Crizotinib demonstrated rapid and durable responses in advanced ALK-positive NSCLC patients in phase I and II studies, leading to accelerated FDA approval...
September 2016: Annals of Oncology: Official Journal of the European Society for Medical Oncology
Joshua K Sabari, Jamie E Chaft
Despite broad advances in molecularly targeted therapies, lung cancer remains the leading cause of cancer related mortality in the United States. Epidermal growth factor receptor (EGFR) mutations occur in approximately 17% of advanced non-small cell lung cancer (NSCLC) in the US population. The remarkable efficacy of small-molecule EGFR tyrosine kinase inhibitors (TKIs) in this unique subset of patients has revolutionized the therapeutic approach to lung cancer. The success of these agents in the metastatic setting leads to the logical question of what role these drugs may have in the adjuvant setting for patients with earlier stage disease...
August 2016: Annals of Translational Medicine
Egbert F Smit, Yi-Long Wu, Radj Gervais, Caicun Zhou, Enriqueta Felip, Jifeng Feng, Salih Zeki Guclu, Mathias Hoiczyk, Elena Dorokhova, Ulrich Freudensprung, Susan Grange, Pablo Diego Perez-Moreno, Lada Mitchell, Martin Reck
OBJECTIVES: Active smokers with non-small-cell lung cancer (NSCLC) have increased erlotinib metabolism versus non-smoking patients, which reduces exposure. Therefore, an increased erlotinib dose may be beneficial. The CurrentS study (NCT01183858) assessed efficacy and safety of 300mg erlotinib (E300) as second-line therapy in current smokers with locally advanced or metastatic NSCLC versus the standard 150mg dose (E150). MATERIALS AND METHODS: Patients with stage IIIB/IV NSCLC (current smokers who failed first-line platinum-based chemotherapy) were randomized to receive E150 or E300 until progression/death/unacceptable toxicity...
September 2016: Lung Cancer: Journal of the International Association for the Study of Lung Cancer
Shinya Sakata, Sho Saeki, Isamu Okamoto, Kohei Otsubo, Kazutoshi Komiya, Ryotaro Morinaga, Yasuto Yoneshima, Yuichiro Koga, Aimi Enokizu, Hiroto Kishi, Susumu Hirosako, Emi Yamaguchi, Naoko Aragane, Shinji Fujii, Taishi Harada, Eiji Iwama, Hiroshi Semba, Yoichi Nakanishi, Hirotsugu Kohrogi
OBJECTIVES: We performed an open-label, multicenter, single-arm phase II study (UMIN ID 000010532) to prospectively evaluate the efficacy and safety of nab-paclitaxel for previously treated patients with advanced non-small cell lung cancer (NSCLC). METHODS: Patients with advanced NSCLC who experienced failure of prior platinum-doublet chemotherapy received weekly nab-paclitaxel (100mg/m(2)) on days 1, 8, and 15 of a 21-day cycle until disease progression or the development of unacceptable toxicity...
September 2016: Lung Cancer: Journal of the International Association for the Study of Lung Cancer
Federico Cappuzzo, Alessandro Morabito, Nicola Normanno, Paolo Bidoli, Alessandro Del Conte, Laura Giannetta, Agnese Montanino, Francesca Mazzoni, Roberta Buosi, Marco Angelo Burgio, Giulio Cerea, Rita Chiari, Diego Cortinovis, Giovanna Finocchiaro, Luisa Foltran, Maria Rita Migliorino, Marcello Tiseo, Silvia Ferrari, Filippo De Marinis
OBJECTIVES: Although patients with advanced non-small cell lung cancer (NSCLC) and an activating epidermal growth factor receptor (EGFR) mutation benefit from the use of EGFR-tyrosine kinase inhibitors (TKI), most of them progress within 12 months from treatment start due to acquired resistance. In clinical practice, many physicians frequently offer these patients retreatment with EGFR-TKIs after a chemotherapy break, based on small or retrospective studies. MATERIALS AND METHODS: A phase II trial was conducted in patients with stage III/IV NSCLC, to assess the efficacy, safety and impact on quality of life (QoL) and disease-related symptoms of gefitinib rechallenge...
September 2016: Lung Cancer: Journal of the International Association for the Study of Lung Cancer
Liang Zhou, Xi-Ling Wang, Qing-Long Deng, Yan-Qiu Du, Nai-Qing Zhao
Immunotherapy is a novel treatment for advanced non-small cell lung cancer (NSCLC) patients. Immunotherapy includes two main broad classes of therapeutic vaccines and immune checkpoint inhibitors, as well as cytokines, biological response modifiers and cellular therapy. The present systematic review and meta-analysis aims to evaluate the efficacy and safety of different classes of immunotherapy in patients with advanced NSCLC. Literature search was done on Medline, Embase and Cochrane Library. The primary endpoints were overall survival (OS) and grade ≥3 adverse events...
2016: Scientific Reports
Giulia Zago, Mirte Muller, Michel van den Heuvel, Paul Baas
Non-small-cell lung cancer (NSCLC) is often diagnosed at an advanced stage of disease, where it is no longer amenable to curative treatment. During the last decades, the survival has only improved significantly for lung cancer patients who have tumors harboring a driver mutation. Therefore, there is a clear unmet need for effective therapies for patients with no mutation. Immunotherapy has emerged as an effective treatment for different cancer types. Nivolumab, a monoclonal inhibitory antibody against PD-1 receptor, can prolong survival of NSCLC patients, with a manageable toxicity profile...
2016: Biologics: Targets & Therapy
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