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Phase III clinical trial cancer

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https://www.readbyqxmd.com/read/28931213/a-review-on-the-efficacy-and-toxicity-of-different-doxorubicin-nanoparticles-for-targeted-therapy-in-metastatic-breast-cancer
#1
REVIEW
Ayman Shafei, Wesam El-Bakly, Ahmed Sobhy, Omar Wagdy, Ahmed Reda, Omar Aboelenin, Amr Marzouk, Khalil El Habak, Randa Mostafa, Mahmoud A Ali, Mahmoud Ellithy
In metastatic breast cancer (MBC), the conventional doxorubicin (DOX) has various problems due to lack of selectivity with subsequent therapeutic failure and adverse effects. DOX- induced cardiotoxicity is a major problem that necessitates the presence of new forms to decrease the risk of associated morbidity. Nanoparticles (NPs) are considered an important approach to selectively increase drug accumulation inside tumor cells and thus decreasing the associated side effects. Tumor cells develop resistance to chemotherapeutic agents through multiple mechanisms, one of which is over expression of efflux transporters...
September 16, 2017: Biomedicine & Pharmacotherapy, Biomédecine & Pharmacothérapie
https://www.readbyqxmd.com/read/28929083/emerging-therapies-for-stage-iii-non-small-cell-lung-cancer-stereotactic-body-radiation-therapy-and-immunotherapy
#2
REVIEW
Sameera S Kumar, Kristin A Higgins, Ronald C McGarry
The current standard of care for locally advanced non-small cell lung cancer (NSCLC) includes radiation, chemotherapy, and surgery in certain individualized cases. In unresectable NSCLC, chemoradiation has been the standard of care for the past three decades. Local and distant failure remains high in this group of patients, so dose escalation has been studied in both single institution and national clinical trials. Though initial studies showed a benefit to dose escalation, phase III studies examining dose escalation using standard fractionation or hyperfractionation have failed to show a benefit...
2017: Frontiers in Oncology
https://www.readbyqxmd.com/read/28927084/thalidomide-and-lenalidomide-for-recurrent-ovarian-cancer-a-systematic-review-of-the-literature
#3
Clemens B Tempfer, Beate Schultheis, Ziad Hilal, Askin Dogan, Günther A Rezniczek
The present review aimed to assess the safety and efficacy of thalidomide and lenalidomide, two immunomodulatory drugs with anti-angiogenic properties, in women with recurrent ovarian, fallopian tube, and primary peritoneal cancer. A systematic review of the literature was conducted whereby Medline and the Cochrane Central Register of Controlled Trials were searched using terms associated with thalidomide, lenalidomide, and recurrent ovarian, fallopian tube and primary peritoneal cancer. Published English language case reports, trials and studies that described the safety and efficacy of thalidomide or lenalidomide alone, or in combination with other drugs were reviewed...
September 2017: Oncology Letters
https://www.readbyqxmd.com/read/28926956/carbonic-anhydrase-inhibition-and-the-management-of-hypoxic-tumors
#4
REVIEW
Claudiu T Supuran
Hypoxia and acidosis are salient features of many tumors, leading to a completely different metabolism compared to normal cells. Two of the simplest metabolic products, protons and bicarbonate, are generated by the catalytic activity of the metalloenzyme carbonic anhydrase (CA, EC 4.2.1.1), with at least two of its isoforms, CA IX and XII, mainly present in hypoxic tumors. Inhibition of tumor-associated CAs leads to an impaired growth of the primary tumors, metastases and reduces the population of cancer stem cells, leading thus to a complex and beneficial anticancer action for this class of enzyme inhibitors...
September 16, 2017: Metabolites
https://www.readbyqxmd.com/read/28926579/cervical-screening-with-primary-hpv-testing-or-cytology-in-a-population-of-women-in-which-those-aged-33-years-or-younger-had-previously-been-offered-hpv-vaccination-results-of-the-compass-pilot-randomised-trial
#5
Karen Canfell, Michael Caruana, Val Gebski, Jessica Darlington-Brown, Stella Heley, Julia Brotherton, Dorota Gertig, Chloe J Jennett, Annabelle Farnsworth, Jeffrey Tan, C David Wrede, Philip E Castle, Marion Saville
BACKGROUND: Using primary human papillomavirus (HPV) testing for cervical screening increases detection of high-grade cervical intraepithelial neoplastic lesions and invasive cancer (cervical intraepithelial neoplasia grade 2+ [CIN2+]) compared to cytology, but no evaluation has been conducted in a population previously offered HPV vaccination. We aimed to assess colposcopy referral and CIN2+ detection rates for HPV-screened versus cytology-screened women in Australia's HPV-vaccinated population (by 2014, resident women ≤33 years had been age-eligible for HPV vaccination, with 3-dose uptake across age cohorts being about 50%-77%)...
September 2017: PLoS Medicine
https://www.readbyqxmd.com/read/28923358/targets-for-immunotherapy-of-liver-cancer
#6
REVIEW
Tim F Greten, Bruno Sangro
Drug development in HCC has been characterized in the past by many failures. Despite good rationales and promising phase II data, many phase III trials failed. Immunotherapy represents an alternate treatment approach and has been successful in many different types of cancer. Being an inflammation induced cancer HCC represents a very interesting target for immune based approaches and indeed early results from clinical trials testing immune checkpoint inhibitors are not only promising but have already led to evaluation of such in a phase III setting...
September 15, 2017: Journal of Hepatology
https://www.readbyqxmd.com/read/28922787/optimal-duration-of-extended-adjuvant-endocrine-therapy-for-early-breast-cancer-results-of-the-ideal-trial-boog-2006-05
#7
Erik J Blok, Judith R Kroep, Elma Meershoek-Klein Kranenbarg, Marjolijn Duijm-de Carpentier, Hein Putter, Joan van den Bosch, Eduard Maartense, A Elise van Leeuwen-Stok, Gerrit-Jan Liefers, Johan W R Nortier, Emiel J Th Rutgers, Cornelis J H van de Velde
Background: The optimal duration of extended endocrine therapy beyond five years after initial aromatase inhibitor-based adjuvant therapy for postmenopausal women with hormone receptor-positive breast cancer is still unknown. Therefore, we conducted a clinical trial to compare two different extended endocrine therapy durations. Methods: In the randomized phase III IDEAL trial, postmenopausal patients with hormone receptor-positive breast cancer were randomly allocated to either 2...
January 1, 2018: Journal of the National Cancer Institute
https://www.readbyqxmd.com/read/28920006/dosing-immunotherapy-combinations-analysis-of-3-526-patients-for-toxicity-and-response-patterns
#8
Mina Nikanjam, Harsh Patel, Razelle Kurzrock
Immunotherapy combinations are used to improve outcomes in metastatic cancer, but evidence-based knowledge of appropriate starting doses for novel combinations is lacking. Phase I-III adult combination clinical trials (≥ 1 drug was immunotherapy; anti-PD-1, PD-L1, or CTLA-4) were reviewed (PubMed Jan 1, 2010 to Sep 1, 2016; ASCO 2014-2016, ASH/ESMO 2014-2015 abstracts). The safe dose for each drug used in each combination was divided by the single-agent recommended dose to calculate dose percentage. Additive dose percentage was the sum of each dose percentage...
2017: Oncoimmunology
https://www.readbyqxmd.com/read/28919454/a-robust-immune-system-conditions-the-response-to-abagovomab-anti-idiotypic-monoclonal-antibody-mimicking-the-ca125-protein-vaccination-in-ovarian-cancer-patients
#9
Alessandra Battaglia, Marco Fossati, Alexia Buzzonetti, Giovanni Scambia, Andrea Fattorossi
INTRODUCTION: Despite encouraging phase I and II study results, vaccination of ovarian cancer patients with abagovomab - an anti-idiotypic mAb that mimics the ovarian cancer CA125 protein - failed to demonstrate efficacy in the phase III trial named MIMOSA (NCT00418574). We postulated that in this trial patients with a more robust immune system did respond to abagovomab but went undetected among a larger number of non-responders. We also postulated that assessment of the immune system status ahead of abagovomab administration might predict patients' propensity to respond to abagovomab...
September 14, 2017: Immunology Letters
https://www.readbyqxmd.com/read/28918048/mir-133a-promotes-trail-resistance-in-glioblastoma-via-suppressing-death-receptor-5-and-activating-nf-%C3%AE%C2%BAb-signaling
#10
Shan-Shan Wang, Lu Feng, Bao-Guang Hu, Ying-Fei Lu, Wei-Mao Wang, Wei Guo, Chun-Wai Suen, Bao-Hua Jiao, Jian-Xin Pang, Wei-Ming Fu, Jin-Fang Zhang
Recombinant tumor necrosis factor (TNF)-related apoptosis-inducing ligand (TRAIL), as a novel cancer therapeutic, is being tested in phase II and III clinical trials; however, TRAIL resistance remains a big obstacle preventing its clinical application. Considering that TRAIL-induced apoptosis through death receptors DR4 and DR5, their activation may be an alternative pathway to suppress TRAIL resistance. In this study, a negative correlation between DR5 expression and TRAIL resistance was observed, and miR-133a was predicted to be the most promising candidate to suppress DR5 expression...
September 15, 2017: Molecular Therapy. Nucleic Acids
https://www.readbyqxmd.com/read/28917648/challenges-of-conducting-a-prospective-clinical-trial-for-older-patients-lessons-learned-from-ncctg-n0949-alliance
#11
Nadine J McCleary, Joleen Hubbard, Michelle R Mahoney, Jeffrey A Meyerhardt, Daniel Sargent, Alan Venook, Axel Grothey
OBJECTIVES: While the risk of developing colorectal cancer increases with age, there are limited prospective data regarding best treatment in the older adult population. We launched a phase III trial to evaluate difference in treatment outcome for older adults (aged ≥70years) with advanced colorectal cancer. Here we review the challenges faced and reasons for poor accrual to N0949. MATERIALS AND METHODS: We describe the conceptualization, development and limited results of N0949, a randomized phase III study of fluoropyrimidine/bevacizumab with or without oxaliplatin (mFOLFOX7 or XELOX) as first line chemotherapy for metastatic colorectal cancer...
September 13, 2017: Journal of Geriatric Oncology
https://www.readbyqxmd.com/read/28915702/targeted-therapies-for-gastric-cancer-failures-and-hopes-from-clinical-trials
#12
REVIEW
Maria Apicella, Simona Corso, Silvia Giordano
Gastric cancer is the third leading cause of cancer mortality worldwide. As surgery is the only curative treatment strategy and conventional chemotherapy has shown limited efficacy -with a median overall survival of 10 months- new treatments are urgently needed. Trastuzumab and Ramucirumab (targeting HER2 and VEGFR2, respectively) are the only targeted therapies approved so far. Indeed, most Phase III clinical trials evaluating molecular drugs in gastric cancer failed. This review will retrace the relevant clinical trials with molecular therapies performed in gastric cancer patients, discussing the possible reasons for their failure and indicating new perspective for a real improvement of the treatment of this disease...
August 22, 2017: Oncotarget
https://www.readbyqxmd.com/read/28914440/olaratumab-in-combination-with-doxorubicin-for-the-treatment-of-advanced-soft-tissue-sarcoma-an-evidence-review-group-perspective-of-a-national-institute-for-health-and-care-excellence-single-technology-appraisal
#13
REVIEW
Irina A Tikhonova, Tracey Jones-Hughes, James Dunham, Fiona C Warren, Sophie Robinson, Peter Stephens, Martin Hoyle
The manufacturer of olaratumab (Lartruvo(®)), Eli Lilly & Company Limited, submitted evidence for the clinical and cost effectiveness of this drug, in combination with doxorubicin, for untreated advanced soft tissue sarcoma (STS) not amenable to surgery or radiotherapy, as part of the National Institute for Health and Care Excellence (NICE) Single Technology Appraisal process. The Peninsula Technology Assessment Group, commissioned to act as the Evidence Review Group (ERG), critically reviewed the company's submission...
September 15, 2017: PharmacoEconomics
https://www.readbyqxmd.com/read/28912395/-cytotoxic-agents-and-immune-checkpoint-inhibitors
#14
Akihito Kawazoe, Kohei Shitara
It has been reported that favorable influences of cytotoxic agents to anti-tumor immune response included immunogenic cell death and suppression of regulatory T cell and myeloid-derived suppressor cell. Some clinical trials showed that the addition of immune checkpoint inhibitor to standard chemotherapy improved efficacy in patients with non-small-cell lung cancer or malignant melanoma in first-line settings. Phase III trials of the combination of immune checkpoint inhibitor and chemotherapy in several malignancies are ongoing...
September 2017: Gan to Kagaku Ryoho. Cancer & Chemotherapy
https://www.readbyqxmd.com/read/28911728/protein-kinase-inhibitors-for-the-treatment-of-advanced-and-progressive-radiorefractory-thyroid-tumors-from-the-clinical-trials-to-the-real-life
#15
REVIEW
Antonio Matrone, Laura Valerio, Letizia Pieruzzi, Carlotta Giani, Virginia Cappagli, Loredana Lorusso, Laura Agate, Luciana Puleo, David Viola, Valeria Bottici, Marzia Del Re, Eleonora Molinaro, Romano Danesi, Rossella Elisei
The last ten years have been characterized by the introduction in the clinical practice of new drugs named tyrosine kinase inhibitors for the treatment of several human tumors. After the positive conclusion of two international multicentric, randomized phase III clinical trials, two of these drugs, sorafenib and lenvatinib, have been recently approved and they are now available for the treatment of advanced and progressive radioiodine refractory thyroid tumors. We have been involved in most clinical trials performed with different tyrosine kinase inhibitors in different histotypes of thyroid cancer thus acquiring a lot of experience in the management of both drugs and their adverse events...
June 2017: Best Practice & Research. Clinical Endocrinology & Metabolism
https://www.readbyqxmd.com/read/28911725/which-patient-with-thyroid-cancer-deserves-systemic-therapy-and-when
#16
REVIEW
Furio Pacini
Distant metastases from differentiated thyroid cancer (DTC) are a rare event, occurring in less than 10% of patients with persistent or recurrent clinical disease. About 50% of these patients do respond to radioiodine (RAI) therapy, either with complete remission or stabilization of the disease on a long term period. Unfortunately, another 50% of these patients are refractory to the treatment with RAI, either from the first appearance of distant metastases or during follow-up. Overall, these patients represent 4-5 new cases/year/million...
June 2017: Best Practice & Research. Clinical Endocrinology & Metabolism
https://www.readbyqxmd.com/read/28911091/a-phase-iii-trial-comparing-oral-s-1-cisplatin-and-intravenous-5-fluorouracil-cisplatin-in-patients-with-untreated-diffuse-gastric-cancer
#17
J A Ajani, M Abramov, I Bondarenko, Y Shparyk, V Gorbunova, A Hontsa, N Otchenash, M Alsina, S Lazarev, J Feliu, A Elme, V Esko, K Abdalla, U Verma, F Benedetti, T Aoyama, H Mizuguchi, L Makris, G Rosati
Background: The effect of histology-based treatment regimen on diffuse gastric adenocarcinoma has not been evaluated in clinical trials. This international phase III trial evaluated the efficacy and safety of S-1 (a contemporary oral fluoropyrimidine)/cisplatin versus 5-fluorouracil (5-FU)/cisplatin in chemotherapy-naïve patients with diffuse-type adenocarcinoma involving the gastroesophageal junction or stomach. Patients and methods: Eligibility criteria included untreated, measurable, advanced diffuse adenocarcinoma confirmed by central pathology and performance status of 0-1...
September 1, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/28911070/induction-tpf-followed-by-concomitant-treatment-versus-concomitant-treatment-alone-in-locally-advanced-head-and-neck-cancer-a-phase-ii-iii-trial
#18
M G Ghi, A Paccagnella, D Ferrari, P Foa, D Alterio, C Codecà, F Nolè, E Verri, R Orecchia, F Morelli, S Parisi, C Mastromauro, C A Mione, C Rossetto, M Polsinelli, H Koussis, L Loreggian, A Bonetti, F Campostrini, G Azzarello, C D'Ambrosio, F Bertoni, C Casanova, E Emiliani, M Guaraldi, F Bunkheila, P Bidoli, R M Niespolo, A Gava, E Massa, A Frattegiani, F Valduga, G Pieri, T Cipani, D Da Corte, F Chiappa, E Rulli
Background: Platinum-based chemoradiation (CCRT) is the standard treatment for Locally Advanced Head and Neck Squamous-Cell Carcinoma (LAHNSCC). Cetuximab/RT (CET/RT) is an alternative treatment option to CCRT. The efficacy of induction chemotherapy (IC) followed by chemoradiation compared to chemoradiation alone has not been demonstrated in randomized clinical trials. The goals of this phase II-III trial were to assess: (i) the overall survival (OS) of IC versus no-induction (no-IC) and (ii) the Grade 3-4 in-field mucosal toxicity of CCRT versus CET/RT...
September 1, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/28895304/a-hindsight-reflection-on-the-clinical-studies-of-poly-l-glutamic-acid-paclitaxel
#19
REVIEW
Jun Zhao, Eugene J Koay, Tingting Li, Xiaoxia Wen, Chun Li
Chemotherapy for cancer treatment is limited by the excessive toxicity to normal tissues. The design of chemodrug-loaded nanoformulations provides a unique approach to improve the treatment efficacy while minimizing toxicity. Despite the numerous publications of nanomedicine for the last several decades, however, only a small fraction of the developed nanoformulations have entered clinical trials, with even fewer being approved for clinical application. Poly(l-glutamic acid)-paclitaxel (PG-TXL) belongs to the few formulations that reached phase III clinical trials...
September 11, 2017: Wiley Interdisciplinary Reviews. Nanomedicine and Nanobiotechnology
https://www.readbyqxmd.com/read/28894827/the-genetic-landscape-of-programmed-death-ligand-1-pd-l1-alterations-in-head-and-neck-cancer
#20
Thomas E Heineman, Adam Widman, Edward C Kuan, Maie St John
OBJECTIVES: Nivolumab has recently been shown in the phase III clinical trial CheckMate-141 to have superior survival rates compared to the current standard of care chemotherapy for recurrent or metastatic platinum-resistant head and neck squamous cell carcinoma (HNSCC). Nivolumab targets the immune inhibitory receptor programmed cell death 1 (PD-1). Programmed cell death ligand 1 (PD-L1) genomics have been poorly characterized in the context of HNSCC, including expression levels of PD-L1 in individual tumors as well as related up or down-regulated genes that might function as co-targets...
June 2017: Laryngoscope Investigative Otolaryngology
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