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Phase III clinical trial cancer

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https://www.readbyqxmd.com/read/28542577/leptin-signals-via-tgfb1-to-promote-metastatic-potential-and-stemness-in-breast-cancer
#1
Ameet K Mishra, Christopher R Parish, Ma-Li Wong, Julio Licinio, Anneke C Blackburn
Epidemiological studies have shown obesity to be linked with poorer outcomes in breast cancer patients. The molecular mechanisms responsible for the increased risk of invasive/metastatic disease with obesity are complex, but may include elevated levels of adipokines such as leptin. Using physiological levels of leptin found in obesity in a novel chronic in vitro treatment model (≤200 ng/ml for 14 days), we confirmed the occurrence of leptin-mediated changes in growth, apoptosis and metastatic behavior, and gene expression changes representing epithelial-to-mesenchymal transition (EMT) and a cancer stem cell (CSC) like phenotype in breast epithelial and cancer cell lines (MCF10A, MCF10AT1, MCF7 and MDA-MB-231)...
2017: PloS One
https://www.readbyqxmd.com/read/28539888/safety-and-immunogenicity-of-a-human-epidermal-growth-factor-receptor-1-her1-based-vaccine-in-prostate-castration-resistant-carcinoma-patients-a-dose-escalation-phase-i-study-trial
#2
Iraida Caballero, Lazaro E Aira, Anabel Lavastida, Xitlally Popa, Javier Rivero, Joaquín González, Mónica Mesa, Narjara González, Kelly Coba, Patricia Lorenzo-Luaces, Barbara Wilkinson, Yuliannis Santiesteban, Yanela Santiesteban, Mayelin Troche, Eduardo Suarez, Tania Crombet, Belinda Sánchez, Angel Casacó, Amparo Macías, Zaima Mazorra
Metastatic castration-resistant prostate cancer (CRPC) remains incurable due to the lack of effective therapies. Activation of the human epidermal growth factor receptor 1 (HER1) in prostate cancer contributes to metastatic progression as well as to disease relapse. Here, we determined the toxicity and immunogenicity of a HER1-based cancer vaccine in CRPC patients included in a phase I clinical trial. CRPC patients (n = 24) were intramuscularly vaccinated with HER1 vaccine consisting of the extracellular domain of HER1 molecule (ECD) and very small size proteoliposome from Neisseria meningitidis (VSSP) and Montanide ISA-51 VG as adjuvants...
2017: Frontiers in Pharmacology
https://www.readbyqxmd.com/read/28536494/adjuvant-chemotherapy-with-paclitaxel-and-cisplatin-in-lymph-node-positive-thoracic-esophageal-squamous-cell-carcinoma
#3
Liangze Zhang, Weiwei Li, Xiao Lyu, Yan Song, Yousheng Mao, Shaoming Wang, Jing Huang
OBJECTIVE: No standard postoperative adjuvant chemotherapy has ever been established in node-positive esophageal squamous cell carcinoma (ESCC). This is a study to explore the effect of postoperative paclitaxel (PTX) and cisplatin (DDP) in lymph node-positive, completely resected thoracic ESCC patients. METHODS: We conducted a prospective phase II trial. Patients had pathologically node-positive thoracic ESCC with negative margins. Outcomes of disease-free survival (DFS) and overall survival (OS) were compared with a matched historical control cohort...
April 2017: Chinese Journal of Cancer Research, Chung-kuo Yen Cheng Yen Chiu
https://www.readbyqxmd.com/read/28536487/current-status-and-challenges-in-sentinel-node-navigation-surgery-for-early-gastric-cancer
#4
Bang Wool Eom, Young-Il Kim, Hong Man Yoon, Soo-Jeong Cho, Jong Yeul Lee, Chan Gyoo Kim, Soo Jin Kim, Ji Yoon Rho, Seok Ki Kim, Myeong-Cherl Kook, Young-Woo Kim, Keun Won Ryu
Although a number of feasibility studies for sentinel node (SN) concepts in gastric cancer have been conducted since 2000, there remains a debate regarding detailed detection techniques and oncological safety. Two important multicenter phase II clinical trials were performed in Japan that used different methods and reached different conclusions; one confirmed acceptable results with a false-negative rate of 7%, and the other showed an unacceptably high false-negative rate of 46.4%. The Sentinel Node Oriented Tailored Approach (SENORITA) trial is a multicenter randomized controlled phase III trial being performed in Korea...
April 2017: Chinese Journal of Cancer Research, Chung-kuo Yen Cheng Yen Chiu
https://www.readbyqxmd.com/read/28534381/evaluation-of-complementary-and-alternative-medicine-trials-registered-in-clinicaltrials-gov-database
#5
Omer Dizdar, Emre Bilgin, Serkan Akin, Saadettin Kilickap, Mutlu Hayran
PURPOSE: Complementary and alternative medicine (CAM) products are increasingly used because they are perceived as natural, relatively low-cost and probably effective therapies for various diseases including cancer. We aimed to determine the quantity and major characteristics of recent herbal/alternative medicine trials registered in clinicaltrials. gov in patients with cancer. METHODS: "Cancer AND (herbal OR complementary OR alternative)" key words were used to query clinicaltrials...
March 2017: Journal of B.U.ON.: Official Journal of the Balkan Union of Oncology
https://www.readbyqxmd.com/read/28533474/weekly-low-dose-versus-three-weekly-high-dose-cisplatin-for-concurrent-chemoradiation-in-locoregionally-advanced-non-nasopharyngeal-head-and-neck-cancer-a-systematic-review-and-meta-analysis-of-aggregate-data
#6
Petr Szturz, Kristien Wouters, Naomi Kiyota, Makoto Tahara, Kumar Prabhash, Vanita Noronha, Ana Castro, Lisa Licitra, David Adelstein, Jan B Vermorken
BACKGROUND: Three-weekly high-dose cisplatin (100 mg/m(2)) is considered the standard systemic regimen given concurrently with postoperative or definitive radiotherapy in locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN). However, due to unsatisfactory patient tolerance, various weekly low-dose schedules have been increasingly used in clinical practice. The aim of this meta-analysis was to compare the efficacy, safety, and compliance between these two approaches...
May 22, 2017: Oncologist
https://www.readbyqxmd.com/read/28532387/robust-estimation-of-the-expected-survival-probabilities-from-high-dimensional-cox-models-with-biomarker-by-treatment-interactions-in-randomized-clinical-trials
#7
Nils Ternès, Federico Rotolo, Stefan Michiels
BACKGROUND: Thanks to the advances in genomics and targeted treatments, more and more prediction models based on biomarkers are being developed to predict potential benefit from treatments in a randomized clinical trial. Despite the methodological framework for the development and validation of prediction models in a high-dimensional setting is getting more and more established, no clear guidance exists yet on how to estimate expected survival probabilities in a penalized model with biomarker-by-treatment interactions...
May 22, 2017: BMC Medical Research Methodology
https://www.readbyqxmd.com/read/28529549/abiraterone-acetate-and-prednisone-in-chemotherapy-na%C3%A3-ve-prostate-cancer-patients-rationale-evidence-and-clinical-utility
#8
REVIEW
E David Crawford, Neal D Shore, Daniel P Petrylak, Celestia S Higano, Charles J Ryan
Abiraterone acetate 1000 mg/day, combined with prednisone 5 mg PO twice daily, is indicated for the treatment of metastatic castration-resistant prostate cancer (mCRPC). Abiraterone acetate is the oral prodrug of abiraterone, a specific CYP17 inhibitor that blocks androgen biosynthesis within the adrenal glands, testes and tumor microenvironment. In a phase III trial of men with asymptomatic or minimally symptomatic, chemotherapy-naïve mCRPC, treatment with oral abiraterone acetate plus prednisone led to a statistically significant improvement in the co-primary endpoints of overall survival and radiographic progression-free survival when compared with placebo plus prednisone...
May 2017: Therapeutic Advances in Medical Oncology
https://www.readbyqxmd.com/read/28525403/genetic-diseases-associated-with-an-increased-risk-of-skin-cancer-development-in-childhood
#9
Alexander L Fogel, Kavita Y Sarin, Joyce M C Teng
PURPOSE OF REVIEW: Childhood skin cancers are relatively rare and may indicate an underlying genetic disorder. The increasing elucidation of genetic pathways is changing the diagnosis and management of genetic skin cancer susceptibility syndromes. In this review, we provide an overview of genetic conditions that predispose to skin cancer development in childhood and signs that providers should assess when evaluating affected individuals. RECENT FINDINGS: In basal cell nevus syndrome (BCNS), the patched2 (PTCH2) and suppressor of fused (SUFU) genes have been implicated in disease pathogenesis...
May 18, 2017: Current Opinion in Pediatrics
https://www.readbyqxmd.com/read/28521614/overcoming-platinum-resistance-in-ovarian-cancer-treatment-from-clinical-practice-to-emerging-chemical-therapies
#10
Federica Tomao, Claudia Marchetti, Alessia Romito, Anna Di Pinto, Violante Di Donato, Innocenza Palaia, Marco Monti, Ludovico Muzii, Pierluigi Benedetti Panici
The objective of this review is to summarize results from clinical trials that tested cytotoxic drugs and target strategies for the treatment of platinum resistant (PR) recurrent ovarian cancer (ROC) with particular attention to Phase III and ongoing trials. Areas covered: Since platinum free interval (PFI) represents the most important predictive factor for response to platinum re-treatment in ROC, non-platinum regimens are conventionally considered the most appropriate approaches. Impressive progress has been made in recent decades, resulting in the identification of most effective cytotoxic agents and in the development of new target strategies...
May 18, 2017: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/28520849/beta-blockers-and-improved-progression-free-survival-in-patients-with-advanced-her2-negative-breast-cancer-a-retrospective-analysis-of-the-rose-trio-012-study
#11
G Spera, R Fresco, H Fung, J R B Dyck, E Pituskin, I Paterson, J R Mackey
Background: Recent retrospective studies suggest that beta-adrenergic blocking drugs (BB) are associated with improved outcomes in people with a range of cancers. Although limited and discordant data suggest that BB may increase overall survival (OS) of patients with localized breast cancer (BC), there is no information on the effects of BB in women with advanced BC. Patients and Methods: To explore the association between BB use and BC outcomes, we retrospectively reviewed the ROSE/TRIO-012, a double-blinded, multinational phase III trial that randomized 1,144 patients with HER2-negative advanced BC to first-line docetaxel in combination with ramucirumab or placebo...
May 18, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/28516155/phase-i-clinical-trial-of-everolimus-combined-with-trimodality-therapy-in-patients-with-muscle-invasive-bladder-cancer
#12
Bassel G Bachir, Luis Souhami, Jose João Mansure, Fabio Cury, Marie Vanhuyse, Fadi Brimo, Armen G Aprikian, Simon Tanguay, Jeremy Sturgeon, Wassim Kassouf
Background: Local control following trimodality therapy (TMT) for muscle-invasive bladder cancer (MIBC) requires further optimization. Objective: Evaluating the biologic endpoint, feasibility, and toxicity of integrating everolimus to TMT in patients with MIBC. Methods: This was a phase I trial in patients with MIBC who were not surgical candidates or who refused cystectomy. Following maximal transurethral tumor resection, patients were treated by radiotherapy (50 Gy/20 fractions), gemcitabine (100 mg/m2/weekly) and escalating doses of everolimus (2...
April 27, 2017: Bladder Cancer
https://www.readbyqxmd.com/read/28511146/real-world-prospective-experience-of-axitinib-in-metastatic-renal-cell-carcinoma%C3%A2-in-a-large-comprehensive-cancer-centre
#13
Margarida Matias, Gwénaël Le Teuff, Laurence Albiges, Annalisa Guida, Caroline Brard, Giulia Bacciarelo, Yohann Loriot, Christophe Massard, Nathalie Lassau, Karim Fizazi, Bernard Escudier
BACKGROUND: Axitinib has shown activity in metastatic renal cell carcinoma (mRCC) in a large phase III clinical trial and was approved in patients who failed first-line therapy. This drug has been available in France since November 2012. The objective is to report efficacy and safety of axitinib in mRCC outside of clinical trials. METHODS: A prospective evaluation of mRCC patients treated by axitinib in second or further next-line therapy at Gustave Roussy was conducted from 2012 to 2015...
May 13, 2017: European Journal of Cancer
https://www.readbyqxmd.com/read/28508185/titan-phase-iii-study-of-doxorubicin-cyclophosphamide-followed-by-ixabepilone-or-paclitaxel-in-early-stage-triple-negative-breast-cancer
#14
Denise A Yardley, Edward R Arrowsmith, Brooke R Daniel, Janice Eakle, Adam Brufsky, David R Drosick, Fred Kudrik, Linda D Bosserman, Mark R Keaton, Sharon A Goble, Jeffrey A Bubis, Victor M Priego, Kelly Pendergrass, Yvonne Manalo, Martin Bury, Donald S Gravenor, Gladys I Rodriguez, Roger C Inhorn, Robyn R Young, William N Harwin, Caryn Silver, John D Hainsworth, Howard A Burris
PURPOSE: Ixabepilone is a microtubule stabilizer with activity in taxane-refractory metastatic breast cancer and low susceptibility to taxane-resistance mechanisms including multidrug-resistant phenotypes and high β-III tubulin expression. Since these resistance mechanisms are common in triple-negative breast cancer (TNBC), ixabepilone may have particular advantages in this patient population. This study evaluated the substitution of ixabepilone for paclitaxel following doxorubicin/cyclophosphamide (AC) in the adjuvant treatment of early-stage TNBC...
May 15, 2017: Breast Cancer Research and Treatment
https://www.readbyqxmd.com/read/28506408/genetics-of-medullary-thyroid-cancer-an-overview
#15
REVIEW
Giacomo Accardo, Giovanni Conzo, Daniela Esposito, Claudio Gambardella, Marco Mazzella, Filomena Castaldo, Carlo Di Donna, Andrea Polistena, Nicola Avenia, Vittorio Colantuoni, Dario Giugliano, Daniela Pasquali
Medullary thyroid carcinoma (MTC) represents 3-5% of thyroid cancers. 75% is sporadic and 25% is the dominant component of the hereditary multiple endocrine neoplasia (MEN) type 2 syndromes. Three different subtypes of MEN2, such as MEN2A, MEN2B, and Familial MTC (FMTC) have been defined, based on presence or absence of hyperparathyroidism, pheocromocytoma and characteristic clinical features. Mutations of the RET proto-oncogene are implicated in the pathogenesis of MTC, but there are many other mutational patterns involved...
May 2017: International Journal of Surgery
https://www.readbyqxmd.com/read/28502694/phase-ii-trial-of-the-pi3-kinase-inhibitor-buparlisib-bkm-120-with-or-without-enzalutamide-in-men-with-metastatic-castration-resistant-prostate-cancer
#16
Andrew J Armstrong, Susan Halabi, Patrick Healy, Joshi J Alumkal, Carolyn Winters, Julie Kephart, Rhonda L Bitting, Carey Hobbs, Colleen F Soleau, Tomasz M Beer, Rachel Slottke, Kelly Mundy, Evan Y Yu, Daniel J George
BACKGROUND: Phosphatidylinositol-3-kinase (PI3K) and androgen receptor pathway activation is common in metastatic castration resistant prostate cancer (mCRPC). Buparlisib is an oral, pan-class I PI3 kinase inhibitor. METHODS: This was a multisite single arm phase II trial of buparlisib 100 mg ± enzalutamide daily in men with mCRPC whose disease progressed on or who were not candidates for docetaxel. The primary end-point was the rate of radiographic/clinical progression-free survival (PFS) at 6 months...
May 11, 2017: European Journal of Cancer
https://www.readbyqxmd.com/read/28501991/innovations-in-clinical-trial-design-in-the-era-of-molecular-profiling
#17
Julia D Wulfkuhle, Alexander Spira, Kirsten H Edmiston, Emanuel F Petricoin
Historically, cancer has been studied, and therapeutic agents have been evaluated based on organ site, clinical staging, and histology. The science of molecular profiling has expanded our knowledge of cancer at the cellular and molecular level such that numerous subtypes are being described based on biomarker expression and genetic mutations rather than traditional classifications of the disease. Drug development has experienced a concomitant revolution in response to this knowledge with many new targeted therapeutic agents becoming available, and this has necessitated an evolution in clinical trial design...
2017: Methods in Molecular Biology
https://www.readbyqxmd.com/read/28501439/paclitaxel-what-has-been-done-and-the-challenges-remain-ahead
#18
REVIEW
Ezequiel Bernabeu, Maximiliano Cagel, Eduardo Lagomarsino, Marcela Moretton, Diego A Chiappetta
In recent years, the nanotechnology has offered researchers the opportunity to solve the problems caused by the vehicle of the standard and first formulation of paclitaxel (Taxol(®)), while maximizing the proven antineoplastic activity of the drug against many solid tumors. Hence, different types of nanocarriers have been employed to improve the efficacy, safety, physicochemical properties and pharmacokinetic/pharmacodynamic profile of this drug. To date, paclitaxel is the unique drug that is marketed in three different nanoplatforms for its parenteral delivery: polymeric nanoparticles (Abraxane(®)), liposomes (Lipusu(®)), and polymeric micelles (Genexol(®), Nanoxel(®) and Paclical(®))...
May 10, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28497804/vaccine-based-immunotherapeutic-approaches-to-gliomas-and-beyond
#19
REVIEW
Michael Weller, Patrick Roth, Matthias Preusser, Wolfgang Wick, David A Reardon, Michael Platten, John H Sampson
Astrocytic and oligodendroglial gliomas are intrinsic brain tumours characterized by infiltrative growth and resistance to classic cancer therapies, which renders them inevitably lethal. Glioblastoma, the most common type of glioma, also exhibits neoangiogenesis and profound immunosuppressive properties. Accordingly, strategies to revert glioma-associated immunosuppression and promote tumour-directed immune responses have been extensively explored in rodent models and in large clinical trials of tumour immunotherapy...
May 12, 2017: Nature Reviews. Neurology
https://www.readbyqxmd.com/read/28496333/immune-checkpoint-blockade-the-role-of-pd-1-pd-l-axis-in-lymphoid-malignancies
#20
REVIEW
Cristina Ilcus, Cristina Bagacean, Adrian Tempescul, Cristian Popescu, Andrada Parvu, Mihai Cenariu, Corina Bocsan, Mihnea Zdrenghea
The co-inhibitory receptor programmed cell death (PD)-1, expressed by immune effector cells, is credited with a protective role for normal tissue during immune responses, by limiting the extent of effector activation. Its presently known ligands, programmed death ligands (PD-Ls) 1 and 2, are expressed by a variety of cells including cancer cells, suggesting a role for these molecules as an immune evasion mechanism. Blocking of the PD-1-PD-L signaling axis has recently been shown to be effective and was clinically approved in relapsed/refractory tumors such as malignant melanoma and lung cancer, but also classical Hodgkin's lymphoma...
2017: OncoTargets and Therapy
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