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Phase III clinical trial cancer

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https://www.readbyqxmd.com/read/29792572/galnac-sirna-conjugates-leading-the-way-for-delivery-of-rnai-therapeutics
#1
Aaron D Springer, Steven F Dowdy
Short-interfering RNA (siRNA)-induced RNAi responses have great potential to treat a wide variety of human diseases from cancer to pandemic viral outbreaks to Parkinson's Disease. However, before siRNAs can become drugs, they must overcome a billion years of evolutionary defenses designed to keep invading RNAs on the outside cells from getting to the inside of cells. Not surprisingly, significant effort has been placed in developing a wide array of delivery technologies. Foremost of these has been the development of N-acetylgalactosamine (GalNAc) siRNA conjugates for delivery to liver...
May 24, 2018: Nucleic Acid Therapeutics
https://www.readbyqxmd.com/read/29792122/drug-cost-avoidance-in-clinical-trials-of-breast-cancer
#2
M Mañes-Sevilla, R Romero-Jiménez, A Herranz-Alonso, M Sánchez-Fresneda, E Gonzalez-Haba, R Collado-Borrel, J Benedi-González, M Sanjurjo-Sáez
Background The objectives of this study were to determine if clinical trials in breast cancer, with an investigational drug, created direct drug cost savings for the healthcare system related to cost avoidance of the best standard of care treatments used in these studies. The aim was to quantify this potential drug cost avoidance. Methods We conducted a retrospective observational study of the drug cost avoidance during the study period (2014-2016). We included clinical trials with investigational drug, managed by pharmacy department and provided by the sponsor...
January 1, 2018: Journal of Oncology Pharmacy Practice
https://www.readbyqxmd.com/read/29790694/advances-in-antibody-therapeutics-targeting-small-cell-lung-cancer
#3
REVIEW
Hongyang Lu, Zhiming Jiang
The proportion of small-cell lung cancer (SCLC) among all lung cancers decreased from 17.26% in 1986 to 12.95% in 2002. Chemotherapy is the key mode of treatment. However, novel therapeutic strategies and drugs are imperative, as the prognosis remains poor. In recent years, antibody therapies have shown promising prospects against malignancy. This review focuses on the advances in antibody therapies in SCLC. Although the results of pembrolizumab, nivolumab, ipilimumab, and rovalpituzumab tesirine are inspiring, all of the clinical trials on these drugs are phase I/II and have been verified for further phase III clinical trials...
May 16, 2018: Advances in Clinical and Experimental Medicine: Official Organ Wroclaw Medical University
https://www.readbyqxmd.com/read/29787356/selection-of-optimal-adjuvant-chemotherapy-and-targeted-therapy-for-early-breast-cancer-asco-clinical-practice-guideline-focused-update
#4
Neelima Denduluri, Mariana Chavez-MacGregor, Melinda L Telli, Andrea Eisen, Stephanie L Graff, Michael J Hassett, Jamie N Holloway, Arti Hurria, Tari A King, Gary H Lyman, Ann H Partridge, Mark R Somerfield, Maureen E Trudeau, Antonio C Wolff, Sharon H Giordano
Purpose To update key recommendations of the ASCO guideline adaptation of the Cancer Care Ontario guideline on the selection of optimal adjuvant chemotherapy regimens for early breast cancer and adjuvant targeted therapy for breast cancer. Methods An Expert Panel conducted targeted systematic literature reviews guided by a signals approach to identify new, potentially practice-changing data that might translate to revised practice recommendations. Results The Expert Panel reviewed phase III trials that evaluated adjuvant capecitabine after completion of standard preoperative anthracycline- and taxane-based combination chemotherapy by patients with early-stage breast cancer HER2-negative breast cancer with residual invasive disease at surgery; the addition of 1 year of adjuvant pertuzumab to combination chemotherapy and trastuzumab for patients with early-stage, HER2-positive breast cancer; and the use of neratinib as extended adjuvant therapy for patients after combination chemotherapy and trastuzumab-based adjuvant therapy with early-stage, HER2-positive breast cancer...
May 22, 2018: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/29785577/atezolizumab-a-review-in-previously-treated-advanced-non-small-cell-lung-cancer
#5
REVIEW
Hannah A Blair
Atezolizumab (TECENTRIQ™), an immune checkpoint inhibitor, is an immunoglobulin G1 monoclonal antibody that binds to programmed death ligand 1 (PD-L1) and blocks its interactions with programmed death 1 and B7.1 receptors. Atezolizumab is approved as monotherapy in several countries worldwide for the treatment of patients with advanced non-small cell lung cancer (NSCLC) who have previously received chemotherapy. Approval was based on its clinical benefit in this setting in the phase II POPLAR and phase III OAK trials...
May 21, 2018: Targeted Oncology
https://www.readbyqxmd.com/read/29775807/fir-efficacy-safety-and-biomarker-analysis-of-a-phase-ii-open-label-study-of-atezolizumab-in-pd-l1-selected-patients-with-non-small-cell-lung-cancer
#6
David R Spigel, Jamie E Chaft, Scott Gettinger, Bo H Chao, Luc Dirix, Peter Schmid, Laura Q M Chow, Rodney J Hicks, Larry Leon, Jill Fredrickson, Marcin Kowanetz, Alan Sandler, Roel Funke, Naiyer A Rizvi
INTRODUCTION: The FIR phase II study (NCT01846416) evaluated the efficacy and safety of anti-programmed death-ligand 1 (PD-L1) atezolizumab in advanced non-small-cell lung cancer (NSCLC) selected by tumor cell (TC) or tumor-infiltrating immune cell (IC) PD-L1 expression. METHODS: Patients with PD-L1 TC2/3 (PD-L1 staining on ≥5% of TC) or IC2/3 tumors (PD-L1 staining on ≥5% of IC; determined by SP142 PD-L1 immunohistochemistry assay) with paired fresh and archival histology samples were recruited into Cohort 1 (chemotherapy-naïve/>6 months between adjuvant chemotherapy and recurrence), Cohort 2 (≥ second-line without brain metastases), or Cohort 3 (≥ second-line with treated brain metastases)...
May 15, 2018: Journal of Thoracic Oncology
https://www.readbyqxmd.com/read/29774061/immunotherapy-in-non-metastatic-non-small-cell-lung-cancer-can-the-benefits-of-stage-iv-therapy-be-translated-into-earlier-stages
#7
REVIEW
Griet Deslypere, Dorothée Gullentops, Els Wauters, Johan Vansteenkiste
Over the last decade, several steps forward in the treatment of patients with stage IV non-small cell lung cancer (NCSLC) were made. Examples are the use of pemetrexed, pemetrexed maintenance therapy, or bevacizumab for patients with nonsquamous NSCLC. A big leap forward was the use of tyrosine kinase inhibitors in patients selected on the basis of an activating oncogene, such as epidermal growth factor receptor ( EGFR ) activating mutations or anaplastic lymphoma kinase ( ALK ) translocations. However, all of these achievements could not be translated into survival benefits when studied in randomized controlled trials in patients with nonmetastatic NSCLC...
2018: Therapeutic Advances in Medical Oncology
https://www.readbyqxmd.com/read/29773991/first-biologic-drug-in-the-treatment-of-ras-wild-type-metastatic-colorectal-cancer-anti-egfr-or-bevacizumab-results-from-a-meta-analysis
#8
REVIEW
Alessandro Ottaiano, Alfonso De Stefano, Monica Capozzi, Anna Nappi, Chiara De Divitiis, Carmela Romano, Lucrezia Silvestro, Antonino Cassata, Rossana Casaretti, Salvatore Tafuto, Michele Caraglia, Massimiliano Berretta, Guglielmo Nasti, Antonio Avallone
Introduction: We performed a meta-analysis in order to analyze and quantify the effect on survival of starting therapy in RAS wild-type (wt) metastatic colorectal cancer (mCRC) patients with anti-EGFR agents or bevacizumab. Patients and Methods: Randomized, phase II or III, clinical trials reporting overall survival (OS) in RAS wt mCRC patients treated with first-line chemotherapy (CT) associated with bevacizumab or anti-EGFR agents were selected. The primary end-point of this meta-analysis was OS; findings were depicted in classical Forest plots...
2018: Frontiers in Pharmacology
https://www.readbyqxmd.com/read/29773080/adjuvant-ny-eso-1-vaccine-immunotherapy-in-high-risk-resected-melanoma-a-retrospective-cohort-analysis
#9
Michael Lattanzi, Joseph Han, Una Moran, Kierstin Utter, Jeremy Tchack, Rachel Lubong Sabado, Russell Berman, Richard Shapiro, Hsin-Hui Huang, Iman Osman, Nina Bhardwaj, Anna C Pavlick
BACKGROUND: Cancer-testis antigen NY-ESO-1 is a highly immunogenic melanoma antigen which has been incorporated into adjuvant vaccine clinical trials. Three such early-phase trials were conducted at our center among patients with high-risk resected melanoma. We herein report on the pooled long-term survival outcomes of these patients in comparison to historical controls. METHODS: All melanoma patients treated at NYU Langone Health under any of three prospective adjuvant NY-ESO-1 vaccine trials were retrospectively pooled into a single cohort...
May 18, 2018: Journal for Immunotherapy of Cancer
https://www.readbyqxmd.com/read/29765474/on-the-design-principles-of-peptide-drug-conjugates-for-targeted-drug-delivery-to-the-malignant-tumor-site
#10
REVIEW
Eirinaios I Vrettos, Gábor Mező, Andreas G Tzakos
Cancer is the second leading cause of death affecting nearly one in two people, and the appearance of new cases is projected to rise by >70% by 2030. To effectively combat the menace of cancer, a variety of strategies have been exploited. Among them, the development of peptide-drug conjugates (PDCs) is considered as an inextricable part of this armamentarium and is continuously explored as a viable approach to target malignant tumors. The general architecture of PDCs consists of three building blocks: the tumor-homing peptide, the cytotoxic agent and the biodegradable connecting linker...
2018: Beilstein Journal of Organic Chemistry
https://www.readbyqxmd.com/read/29765249/is-progression-free-survival-a-more-relevant-endpoint-than-overall-survival-in-first-line-hr-her2-metastatic-breast-cancer
#11
Anna Forsythe, David Chandiwana, Janina Barth, Marroon Thabane, Johan Baeck, Anastasiya Shor, Gabriel Tremblay
Background: Hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), metastatic breast cancer (MBC) accounts for 73% of all MBCs. Endocrine therapy (ET) is the basis of first-line (1L) therapy for patients with HR+/HER2- MBC. Novel therapies have demonstrated improvements in progression-free survival (PFS) compared to ET. The clinical relevance of PFS is being debated, as there is no proven direct correlation with overall survival (OS) benefit to date...
2018: Cancer Management and Research
https://www.readbyqxmd.com/read/29764892/intense-exercise-for-survival-among-men-with-metastatic-castrate-resistant-prostate-cancer-interval-gap4-a-multicentre-randomised-controlled-phase-iii-study-protocol
#12
Robert U Newton, Stacey A Kenfield, Nicolas H Hart, June M Chan, Kerry S Courneya, James Catto, Stephen P Finn, Rosemary Greenwood, Daniel C Hughes, Lorelei Mucci, Stephen R Plymate, Stephan F E Praet, Emer M Guinan, Erin L Van Blarigan, Orla Casey, Mark Buzza, Sam Gledhill, Li Zhang, Daniel A Galvão, Charles J Ryan, Fred Saad
INTRODUCTION: Preliminary evidence supports the beneficial role of physical activity on prostate cancer outcomes. This phase III randomised controlled trial (RCT) is designed to determine if supervised high-intensity aerobic and resistance exercise increases overall survival (OS) in patients with metastatic castrate-resistant prostate cancer (mCRPC). METHODS AND ANALYSIS: Participants (n=866) must have histologically documented metastatic prostate cancer with evidence of progressive disease on androgen deprivation therapy (defined as mCRPC)...
May 14, 2018: BMJ Open
https://www.readbyqxmd.com/read/29762545/marine-microalgae-with-anti-cancer-properties
#13
REVIEW
Kevin A Martínez Andrade, Chiara Lauritano, Giovanna Romano, Adrianna Ianora
Cancer is the leading cause of death globally and finding new therapeutic agents for cancer treatment remains a major challenge in the pursuit for a cure. This paper presents an overview on microalgae with anti-cancer activities. Microalgae are eukaryotic unicellular plants that contribute up to 40% of global primary productivity. They are excellent sources of pigments, lipids, carotenoids, omega-3 fatty acids, polysaccharides, vitamins and other fine chemicals, and there is an increasing demand for their use as nutraceuticals and food supplements...
May 15, 2018: Marine Drugs
https://www.readbyqxmd.com/read/29756633/immunotherapy-in-head-and-neck-cancer-scientific-rationale-current-treatment-options-and-future-directions
#14
Uta Rothschild, Laurent Muller, Axel Lechner, Hans A Schlösser, Dirk Beutner, Heinz Läubli, Alfred Zippelius, Sacha I Rothschild
Head and neck squamous cell carcinoma (HNSCC) is a frequent tumour arising from multiple anatomical subsites in the head and neck region. The treatment for early-stage disease is generally single modality, either surgery or radiotherapy. The treatment for locally advanced tumours is multimodal. For recurrent/metastatic HNSCC palliative chemotherapy is standard of care. The prognosis is limited and novel treatment approaches are urgently needed. HNSCC evades immune responses through multiple resistance mechanisms...
May 14, 2018: Swiss Medical Weekly
https://www.readbyqxmd.com/read/29753042/application-of-e75-peptide-vaccine-in-breast-cancer-patients-a-systematic-review-and-meta-analysis
#15
REVIEW
Reyhane Chamani, Peyman Ranji, Maryam Hadji, Azin Nahvijou, Ebrahim Esmati, Ali Mohammad Alizadeh
The E75 peptide vaccine, derived from tumor-associated antigen HER2, is the most frequently studied anti-HER2 vaccination strategy for the treatment of breast cancer patients. It has been investigated in the several phases Ι/Π of the clinical trials and is currently being evaluated in a randomized multicenter phase III clinical trial. We conducted a systematic review and meta-analysis to clarify the outcomes of the E75 peptide vaccine including the therapeutic efficacy, the disease recurrence, the survival rate, and the side effects...
May 9, 2018: European Journal of Pharmacology
https://www.readbyqxmd.com/read/29752687/a-phase-ii-study-evaluating-the-efficacy-of-zoledronic-acid-in-prevention-of-aromatase-inhibitor-associated-musculoskeletal-symptoms-the-zap-trial
#16
Cesar A Santa-Maria, Aditya Bardia, Amanda L Blackford, Claire Snyder, Roisin M Connolly, John H Fetting, Daniel F Hayes, Stacie C Jeter, Robert S Miller, Anne Nguyen, Katie Quinlan, Gary L Rosner, Shannon Slater, Anna Maria Storniolo, Antonio C Wolff, Jane Zorzi, Nora Lynn Henry, Vered Stearns
PURPOSE: Aromatase inhibitor-associated musculoskeletal symptoms (AIMSS) are common adverse events of AIs often leading to drug discontinuation. We initiated a prospective clinical trial to evaluate whether bisphosphonates are associated with reduced incidence of AIMSS. METHODS: In the single-arm trial, the Zoledronic Acid Prophylaxis (ZAP) trial, we compared the incidence of AIMSS against historical controls from the Exemestane and Letrozole Pharmacogenomics (ELPh) trial...
May 11, 2018: Breast Cancer Research and Treatment
https://www.readbyqxmd.com/read/29750420/latest-clinical-evidence-and-further-development-of-parp-inhibitors-in-ovarian-cancer
#17
M R Mirza, S Pignata, J A Ledermann
Background: For several decades, the systemic treatment of ovarian cancer has involved chemotherapy, with the relatively recent addition of anti-angiogenic strategies given with chemotherapy and in the maintenance setting. In the past decade, numerous poly(ADP-ribose) polymerase (PARP)-inhibiting agents have been assessed. Design: We review key trials that have led to the approval of three PARP inhibitors - olaparib, niraparib and rucaparib - as maintenance therapy for platinum-sensitive recurrent ovarian cancer...
May 10, 2018: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/29750261/validation-of-previously-reported-predictors-for-radiation-induced-hypothyroidism-in-nasopharyngeal-cancer-patients-treated-with-intensity-modulated-radiation-therapy-a-post-hoc-analysis-from-a-phase-iii-randomized-trial
#18
Chawalit Lertbutsayanukul, Sarin Kitpanit, Anussara Prayongrat, Danita Kannarunimit, Buntipa Netsawang, Chakkapong Chakkabat
This study aimed to validate previously reported dosimetric parameters, including thyroid volume, mean dose, and percentage thyroid volume, receiving at least 40, 45 and 50 Gy (V40, V45 and V50), absolute thyroid volume spared (VS) from 45, 50 and 60 Gy (VS45, VS50 and VS60), and clinical factors affecting the development of radiation-induced hypothyroidism (RHT). A post hoc analysis was performed in 178 euthyroid nasopharyngeal cancer (NPC) patients from a Phase III study comparing sequential versus simultaneous-integrated boost intensity-modulated radiation therapy...
May 10, 2018: Journal of Radiation Research
https://www.readbyqxmd.com/read/29749272/fulvestrant-for-the-treatment-of-advanced-breast-cancer
#19
Sophie A Blackburn, Ruth M Parks, Kwokleung Cheung
The current issues with endocrine therapy for treatment of advanced breast cancer include balance of efficacy of therapy versus tolerability as well as hormone resistance. The efficacy of fulvestrant, a selective oestrogen receptor degrader (SERD), has been demonstrated in hormone receptor positive patients previously untreated or treated with hormonal therapy. Areas covered: This article discusses the journey of fulvestrant licensing, its efficacy in combination with other endocrine therapies and the future role it may have within breast cancer treatment...
May 11, 2018: Expert Review of Anticancer Therapy
https://www.readbyqxmd.com/read/29746229/phase-iii-trial-comparing-intraperitoneal-and-intravenous-paclitaxel-plus-s-1-versus-cisplatin-plus-s-1-in-patients-with-gastric-cancer-with-peritoneal-metastasis-phoenix-gc-trial
#20
Hironori Ishigami, Yoshiyuki Fujiwara, Ryoji Fukushima, Atsushi Nashimoto, Hiroshi Yabusaki, Motohiro Imano, Haruhiko Imamoto, Yasuhiro Kodera, Yoshikazu Uenosono, Kenji Amagai, Shigenori Kadowaki, Hiroto Miwa, Hironori Yamaguchi, Takuhiro Yamaguchi, Tempei Miyaji, Joji Kitayama
Purpose Intraperitoneal paclitaxel plus systemic chemotherapy demonstrated promising clinical effects in patients with gastric cancer with peritoneal metastasis. We aimed to verify its superiority over standard systemic chemotherapy in overall survival. Patients and Methods This randomized phase III trial enrolled patients with gastric cancer with peritoneal metastasis who had received no or short-term (< 2 months) chemotherapy. Patients were randomly assigned at a two-to-one ratio to receive intraperitoneal and intravenous paclitaxel plus S-1 (IP; intraperitoneal paclitaxel 20 mg/m2 and intravenous paclitaxel 50 mg/m2 on days 1 and 8 plus S-1 80 mg/m2 per day on days 1 to 14 for a 3-week cycle) or S-1 plus cisplatin (SP; S-1 80 mg/m2 per day on days 1 to 21 plus cisplatin 60 mg/m2 on day 8 for a 5-week cycle), stratified by center, previous chemotherapy, and extent of peritoneal metastasis...
May 10, 2018: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
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