Phase III clinical trials of the cell differentiation agent-2 (CDA-2): Therapeutic efficacy on breast cancer, non-small cell lung cancer and primary hepatoma1

2005 ◽  
Vol 2 (4) ◽  
pp. 706-716 ◽  
Author(s):  
Fengyi Feng ◽  
Qing Li ◽  
Changquan Ling ◽  
Yang Zhang ◽  
Fengzhan Qin ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Lung Cancer ◽  
Clinical Trials ◽  
Cell Differentiation ◽  
Small Cell Lung Cancer ◽  
Therapeutic Efficacy ◽  
Small Cell ◽  
Phase Iii ◽  
Small Cell Lung ◽  
Phase Iii Clinical Trials

Review of end points of phase III clinical trials with combination chemotherapy regimens for non-small cell lung cancer evaluating importance of quality of life.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e19119-e19119
Author(s):  
Kumar Prabhash ◽  
Ganesh Divekar ◽  
Minish Mahendra Jain ◽  
Bharatsinha Baburao Bhosale
Keyword(s):  
Quality Of Life ◽  
Lung Cancer ◽  
Clinical Trials ◽  
Small Cell Lung Cancer ◽  
Combination Chemotherapy ◽  
Small Cell ◽  
Phase Iii ◽  
Small Cell Lung ◽  
End Points

e19119 Background: Systemic combination chemotherapy is accepted as a standard of care for patients with advanced non-small cell lung cancer (NSCLC). Substantial similarities in terms of treatment efficacy and survival have emerged over the years between the different systemic chemotherapy regimens used. Quality of life (QOL) analysis will help to customize chemotherapy to improve outcome in NSCLC patients. Methods: Using PUBMED database, a review of randomized controlled phase III trials of advanced NSCLC published in last 5 years reporting comparative safety and efficacy between chemotherapeutic regimens as end points was conducted. An evaluation of end points, difference in efficacy endpoints, QOL analysis, and final conclusion was conducted. Results: The search criteria identified 51 trials (33,481 patients). Out of these 51 clinical trials, 16 trials showed difference in efficacy (13 survival endpoint, 1 ORR (objective response rate), 2 survival without grade 3/4 toxicity) and 11 trials used validated QOL instruments and were included for review. Two trials; one comparing pemetrexed/cisplatin with gemcitabine/cisplatin, and other comparing cisplatin/weekly vinoralbine with cisplatin/vinoralbine on day 1 and 8; showed difference with QOL; though not statistically significant. The QOL reporting/analysis techniques were heterogeneous. Two trials used QOL as primary endpoint. Safety reporting included percentage adverse events with treatment arms. Conclusions: Based on our review, it seems critical to have QOL as an endpoint while evaluating newer combination chemotherapeutic regimens for NSCLC. Secondly, it is unlikely that a major difference exists in the global QOL associated with standard chemotherapy regimens for NSCLC. An effort to have uniform QOL assessment across trials evaluating newer combination regimens for NSCLC will help to customize treatment.

The combination of unique biomolecules and nanoparticles has shown successful gene therapy treatment approaches for non-small cell lung cancer treatment

2021 ◽  
Author(s):  
Moataz Dowaidar
Keyword(s):  
Lung Cancer ◽  
Gene Therapy ◽  
Clinical Trials ◽  
Gene Delivery ◽  
Cancer Treatment ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Therapeutic Efficacy ◽  
Small Cell ◽  
Small Cell Lung

Using nanotechnology-based drug delivery systems can solve some of the drawbacks of conventional cancer treatment, such as non-specific targeting, solubility difficulties, and poor entry of chemotherapeutic drugs into cancer cells. Over the last two decades, a combination of unique biomolecules and nanoparticles has shown successful treatment approaches for Non-small cell lung cancer (NSCLC) treatment. Targeted gene delivery employing lipid, polymer or metal-based nanoparticles showed positive in vivo and in vitro experimental findings with therapeutic efficacy. Gene therapy has shown enhanced transfection efficiency and targeting potential for various NSCLC cell lines when delivered locally or systemically. Despite this, there are a number of barriers to nanoparticle-mediated gene therapy, including ensuring the stability of biomolecules and nanoparticles during delivery, managing their biodistribution, and reducing the possible adverse effects of nanoparticles. These difficulties must be handled before clinical trials begin. Evaluation of therapeutic efficacy as well as inspection criteria for nanoparticles in gene therapy must be devised to widen the use of nano-gene therapy in cancer treatment. Advanced models, algorithms, and simulations to anticipate nanoparticles' biodistribution, design, and kinetics will be needed in the future to decrease the barrier to nanoparticles in clinical trials. Using new technologies and software, nanoparticles with increased selectivity, increased loading capacity, long circulation periods and effective influx into the vascular endothelium and the blood brain barrier may be generated. Nanoparticles having advanced qualities such as biodegradability, non-toxicity, and non-immunogenicity will facilitate the application of nanotechnology in gene therapy, leading to breakthroughs for cancer patients and in biomedical research. Formulation of unique techniques, notably using a combination of anticancer drugs, must be further researched for effective gene delivery-based therapies.

Atezolizumab for use in PD-L1-positive unresectable, locally advanced or metastatic triple-negative breast cancer

2020 ◽  
Vol 16 (3) ◽  
pp. 4439-4453 ◽  
Author(s):  
Athanasios Mavratzas ◽  
Julia Seitz ◽  
Katharina Smetanay ◽  
Andreas Schneeweiss ◽  
Dirk Jäger ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Lung Cancer ◽  
Monoclonal Antibody ◽  
Small Cell Lung Cancer ◽  
Triple Negative Breast Cancer ◽  
Triple Negative ◽  
Small Cell ◽  
Phase Iii ◽  
Small Cell Lung ◽  
Fda Approval

Since the US FDA-approval of the first immune checkpoint inhibitor, anticytotoxic T-lymphocyte antigen-4 monoclonal antibody ipilimumab, for metastatic melanoma on 28 March 2011, another six agents have been granted use among a multitude of tumors, including renal cell cancer, Hodgkin lymphoma, urothelial carcinoma and non-small-cell lung cancer. The first anti-programmed cell death ligand-1 monoclonal antibody to receive the FDA approval, atezolizumab (Tecentriq®), has yielded promising results among international Phase III trials in triple-negative breast cancer and small-cell lung cancer, expanding the field of cancer immunotherapies. Herein, we review the pharmacodynamic and pharmacokinetic properties of atezolizumab, its safety and efficacy data from early clinical trials and summarize data from Phase III IMpassion130 trial, prompting FDA and EMA approval of atezolizumab in metastatic triple-negative breast cancer. Finally, implications for clinical use and ongoing research will be briefly discussed.

scholarly journals Review of the Management of Relapsed Small-Cell Lung Cancer with Amrubicin Hydrochloride

2011 ◽  
Vol 5 ◽  
pp. CMO.S5072 ◽  
Author(s):  
Tatsuo Kimura ◽  
Shinzoh Kudoh ◽  
Kazuto Hirata
Keyword(s):  
Lung Cancer ◽  
Clinical Trials ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Tumor Regression ◽  
Small Cell ◽  
Phase Iii ◽  
In Vivo Studies ◽  
Small Cell Lung

Lung cancer is the leading cause of cancer death, and approximately 15% of all lung cancer patients have small-cell lung cancer (SCLC). Although second-line chemotherapy can produce tumor regression, the prognosis is poor. Amrubicin hydrochloride (AMR) is a synthetic anthracycline anticancer agent and a potent topoisomerase II inhibitor. Here, we discuss the features of SCLC, the chemistry, pharmacokinetics, and pharmacodynamics of AMR, the results of in vitro and in vivo studies, and the efficacy and safety of AMR monotherapy and combination therapy in clinical trials. With its predictable and manageable toxicities, AMR is one of the most attractive agents for the treatment of chemotherapy-sensitive and -refractory relapsed SCLC. Numerous studies are ongoing to define the applicability of AMR therapy for patients with SCLC. These clinical trials, including phase III studies, will clarify the status of AMR in the treatment of SCLC.

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