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https://www.readbyqxmd.com/read/29329598/treatment-outcome-of-anti-angiogenesis-through-vegf-pathway-in-the-management-of-gastric-cancer-a-systematic-review-of-phase-ii-and-iii-clinical-trials
#1
Brian Mawalla, Xianglin Yuan, Xiaoxiao Luo, Phillip L Chalya
OBJECTIVES: Advanced gastric cancer poses a therapeutic challenge worldwide. In randomised clinical trials, anti-VEGF has been reported as an essential agent for the treatment of advanced gastric cancer. This review aims at assessing the treatment outcome of anti-angiogenesis therapy through the VEGF pathway in the management of patients with advanced gastric cancer. RESULTS: During this review, 38 clinical trials were identified. Of these, 30 clinical trials were excluded, leaving eight trials of phase II and III...
January 12, 2018: BMC Research Notes
https://www.readbyqxmd.com/read/29328860/quality-of-life-from-canadian-cancer-trials-group-ma-17r-a-randomized-trial-of-extending-adjuvant-letrozole-to-10-years
#2
Julie Lemieux, Michael D Brundage, Wendy R Parulekar, Paul E Goss, James N Ingle, Kathleen I Pritchard, Paul Celano, Hyman Muss, Julie Gralow, Kathrin Strasser-Weippl, Kate Whelan, Dongsheng Tu, Timothy J Whelan
Purpose MA.17R was a Canadian Cancer Trials Group-led phase III randomized controlled trial comparing letrozole to placebo after 5 years of aromatase inhibitor as adjuvant therapy for hormone receptor-positive breast cancer. Quality of life (QOL) was a secondary outcome measure of the study, and here, we report the results of these analyses. Methods QOL was measured using the Short Form-36 (SF-36; two summary scores and eight domains) and menopause-specific QOL (MENQOL; four symptom domains) at baseline and every 12 months up to 60 months...
January 12, 2018: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/29326191/establishing-anchor-based-minimally-important-differences-mid-with-the-eortc-quality-of-life-measures-a-meta-analysis-protocol
#3
Zebedee Jammbe Musoro, Jean-Francois Hamel, Divine Ewane Ediebah, Kim Cocks, Madeleine T King, Mogens Groenvold, Mirjam A G Sprangers, Yvonne Brandberg, Galina Velikova, John Maringwa, Hans-Henning Flechtner, Andrew Bottomley, Corneel Coens
INTRODUCTION: As patient assessment of health-related quality of life (HRQOL) in cancer clinical trials has increased over the years, so has the need to attach meaningful interpretations to differences in HRQOL scores between groups and changes within groups. Determining what represents a minimally important difference (MID) in HRQOL scores is useful to clinicians, patients and researchers, and can be used as a benchmark for assessing the success of a healthcare intervention. Our objective is to provide an evidence-based protocol to determine MIDs for the European Organisation for Research and Treatment for Cancer Quality of life Questionnaire core 30 (EORTC QLQ-C30)...
January 10, 2018: BMJ Open
https://www.readbyqxmd.com/read/29318022/clinical-trial-experience-with-ca4p-anticancer-therapy-focus-on-efficacy-cardiovascular-adverse-events-and-hypertension-management
#4
REVIEW
Rachel Grisham, Bonnie Ky, Krishnansu S Tewari, David J Chaplin, Joan Walker
Combretastatin A4-phosphate (CA4P) is a vascular-disrupting agent (VDA) in clinical development for the treatment of ovarian and other cancers. In contrast to antiangiogenic agents, such as bevacizumab, which suppress the development of new tumor vasculature, VDAs target established tumor vasculature. These differing but complementary mechanisms of action are currently being explored in clinical trials combining CA4P and bevacizumab. Clinical experience to date has highlighted an important need to better understand the cardiovascular adverse events of CA4P, both alone and in combination with antiangiogenic agents, which can also be associated with cardiovascular adverse events...
2018: Gynecologic Oncology Research and Practice
https://www.readbyqxmd.com/read/29317553/safety-profile-of-biosimilar-filgrastim-zarzio-zarxio-a-combined-analysis-of-phase-iii-studies
#5
Nadia Harbeck, Pere Gascón, Andriy Krendyukov, Nadja Hoebel, Sreekanth Gattu, Kimberly Blackwell
BACKGROUND: Evaluation of adverse events (AEs) in pivotal registration trials and ongoing postmarketing surveillance is important for all biologics, including biosimilars. A combined analysis of two pivotal registration studies was performed to strengthen evidence on safety for biosimilar filgrastim EP2006 in patients with breast cancer receiving myelosuppressive chemotherapy, a sensitive clinical setting to confirm biosimilarity of filgrastim. MATERIALS AND METHODS: Data were combined from two phase III studies of biosimilar filgrastim EP2006...
January 9, 2018: Oncologist
https://www.readbyqxmd.com/read/29317395/the-role-of-elotuzumab-in-the-treatment-of-relapsed-or-refractory-multiple-myeloma
#6
REVIEW
Jill M Comeau, Katherine Kelly, Gary W Jean
PURPOSE: The pharmacology, pharmacokinetics, clinical efficacy and safety, cost, and place in therapy of elotuzumab for treatment of relapsed or refractory multiple myeloma (MM) are reviewed. SUMMARY: Elotuzumab is a humanized monoclonal antibody that targets the signaling lymphocytic activation molecule (SLAM) protein SLAMF7 and facilitates an antibody-dependent cellular cytotoxicity interaction between myeloma cells and natural killer cells. Elotuzumab has U.S...
January 15, 2018: American Journal of Health-system Pharmacy: AJHP
https://www.readbyqxmd.com/read/29304537/clinical-impact-and-course-of-anticoagulant-related-major-bleeding-in-cancer-patients
#7
Noémie Kraaijpoel, Nick van Es, Suzanne M Bleker, Marjolein P A Brekelmans, Elise S Eerenberg, Saskia Middeldorp, Alexander T Cohen, Gary E Raskob, Harry R Büller
Cancer patients with venous thromboembolism (VTE) have a two- to six-fold increased risk of anticoagulant-related major bleeding events compared with VTE patients without cancer. It is unknown whether major bleeding events are more severe in cancer patients than in those without cancer. Individual patient data from four randomized phase III trials that compared factor Xa inhibitors and vitamin K antagonists for the treatment of VTE were used to compare the severity of major bleeding events in patients with and without cancer...
January 2018: Thrombosis and Haemostasis
https://www.readbyqxmd.com/read/29300345/folfirinox-chemotherapy-in-metastatic-pancreatic-cancer-a-systematic-review-and-meta-analysis-of-retrospective-and-phase-ii-studies
#8
Stephane Thibodeau, Ioannis A Voutsadakis
The introduction of the FOLFIRINOX regimen within the last decade marked the first progress in the clinical field of metastatic pancreatic cancer which had not seen any improvements in treatment availability for several years. In a phase III randomized clinical trial, FOLFIRINOX showed superior efficacy compared to the previous standard treatment of gemcitabine monotherapy. Nevertheless, it is unknown whether the superior results observed in this single phase III clinical trial can be translated more broadly to clinical practice...
January 4, 2018: Journal of Clinical Medicine
https://www.readbyqxmd.com/read/29297698/a-clinical-trial-protocol-paper-discussing-the-brighter-study
#9
Mohamad Bassam Sonbol, Tanios Bekaii-Saab
Napabucasin is a novel oral first-in-class cancer stemness inhibitor. Preclinical and early phase clinical trials showed promising antitumor efficacy signals for napabucasin in a variety of malignancies. In this article, we describe the design and rationale for the now completed BRIGHTER trial, a multicenter, randomized, placebo-controlled, Phase III study designed to determine the efficacy and safety of combining napabucasin with paclitaxel in previously treated patients with advanced gastric and gastroesophageal junction adenocarcinoma (NCT02178956)...
January 3, 2018: Future Oncology
https://www.readbyqxmd.com/read/29295696/antibody-based-epcam-targeted-therapy-of-cancer-review-and-update
#10
Shirin Eyvazi, Safar Farajnia, Siavoush Dastmalchi, Farzad Kanipour, Habib Zarredar, Mojgan Bandehpour
Todays, after four decades of the discovery of monoclonal antibodies by Kohler and Milstein in 1975, a dozen of antibodies are used in cancer targeted therapy with different strategies. The success of these antibodies depends on the specificity of antigens expressed on the cancer cells. Epithelial cell adhesion molecule (EpCAM), a homophilic cell-cell adhesion glycoprotein is a well- known tumor antigen, which expresses on epithelial tumors and circulating tumor cells as well as cancer stem cells. The EpCAM signaling pathway is associated with proliferation, differentiation and adhesion of epithelial cancer cells...
January 1, 2018: Current Cancer Drug Targets
https://www.readbyqxmd.com/read/29290251/prevalence-of-delta-like-protein-3-expression-in-patients-with-small-cell-lung-cancer
#11
Kentaro Tanaka, Kumiko Isse, Tomomichi Fujihira, Mitsuhiro Takenoyama, Laura Saunders, Sheila Bheddah, Yoichi Nakanishi, Isamu Okamoto
OBJECTIVES: Rovalpituzumab tesirine (Rova-T), an antibody-drug conjugate directed against Delta-like protein 3 (DLL3), is under development for patients with small cell lung cancer (SCLC) positive for this protein. However, the prevalence of DLL3 expression and its association with patient ethnicity and other characteristics have remained unclear. MATERIAIS AND METHODS: Tumor samples from 63 patients with SCLC were subjected to immunohistochemical staining for DLL3...
January 2018: Lung Cancer: Journal of the International Association for the Study of Lung Cancer
https://www.readbyqxmd.com/read/29288534/an-overview-on-vadimezan-dmxaa-the-vascular-disrupting-agent
#12
REVIEW
Amir Daei Farshchi Adli, Rana Jahanban-Esfahlan, Khaled Seidi, Sonia Samandari-Rad, Nosratollah Zarghami
Vascular disrupting agents (VDAs), a group of cancer remedies, can cause a specific and irreversible destruction of established tumor vessels, and the complete halt of blood flow in the tumor. DMXAA(ASA404) or Vadimezan, a flavone-acetic acid-based drug is the most promising VDAs that induces a rapid shutdown of blood flow in tumors but not in normal tissue. The exact mechanism of vascular disruption is unknown; however proposed direct and indirect mechanisms of action for DMXAA comprises: i) inducing apoptosis in endothelial cells; ii) hemorrhagic necrosis and ischemia in tumor; iii) release of serotonin (5-HT); vi) stimulation of innate immune system; v) production of inflammatory cytokines e...
December 30, 2017: Chemical Biology & Drug Design
https://www.readbyqxmd.com/read/29288190/can-we-save-the-rectum-by-watchful-waiting-or-transanal-microsurgery-following-chemo-radiotherapy-versus-total-mesorectal-excision-for-early-rectal-cancer-star-trec-study-protocol-for-a-multicentre-randomised-feasibility-study
#13
Anouk J M Rombouts, Issam Al-Najami, Natalie L Abbott, Ane Appelt, Gunnar Baatrup, Simon Bach, Aneel Bhangu, Karen-Lise Garm Spindler, Richard Gray, Kelly Handley, Manjinder Kaur, Ellen Kerkhof, Camilla Jensenius Kronborg, Laura Magill, Corrie A M Marijnen, Iris D Nagtegaal, Lars Nyvang, Femke P Peters, Per Pfeiffer, Cornelis Punt, Philip Quirke, David Sebag-Montefiore, Mark Teo, Nick West, Johannes H W de Wilt
INTRODUCTION: Total mesorectal excision (TME) is the highly effective standard treatment for rectal cancer but is associated with significant morbidity and may be overtreatment for low-risk cancers. This study is designed to determine the feasibility of international recruitment in a study comparing organ-saving approaches versus standard TME surgery. METHODS AND ANALYSIS: STAR-TREC trial is a multicentre international randomised, three-arm parallel, phase II feasibility study in patients with biopsy-proven adenocarcinoma of the rectum...
December 28, 2017: BMJ Open
https://www.readbyqxmd.com/read/29285731/therapeutic-cancer-vaccines-how-much-closer-are-we
#14
Douglas G McNeel
The promise of immune-based therapies to treat cancer has been realized over the last several years with several breakthrough therapies, including T-cell checkpoint inhibitors and chimeric antigen receptor (CAR)-T cell therapies. While cancer vaccines have been investigated for many decades, to date only one has been approved in the USA as a treatment for existing cancer. The failure of several anti-tumor vaccines in large phase III trials has led many to question their future role in cancer treatment. Trials to date have demonstrated that many cancer vaccines can elicit tumor-specific T cells, but these T cells may be insufficient to mediate substantial anti-tumor effects without concurrent blockade of tumor-resistance mechanisms...
December 28, 2017: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/29285038/a-multicenter-phase-ii-trial-of-neoadjuvant-chemotherapy-with-docetaxel-and-gemcitabine-in-locally-advanced-breast-cancer
#15
Ye Won Jeon, Tae Hyun Kim, Hyun Jo Youn, Sehwan Han, Yongsik Jung, Geumhee Gwak, Young Sam Park, Jeong Soo Kim, Young Jin Suh
Purpose: The current multicenter phase II study was conducted to evaluate the efficacy and safety of the combination of docetaxel and gemcitabine as neoadjuvant chemotherapy (NAC) for locally advanced breast cancer. Methods: A total of 98 patients with stage II-III breast cancer were enrolled. The primary endpoint was pathological complete response (pCR) rate of invasive cancer after the completion of the fourth cycle of NAC. The secondary endpoints included response rate (RR), rate of breast-conserving surgery, toxicity, and disease-free survival (DFS)...
December 2017: Journal of Breast Cancer
https://www.readbyqxmd.com/read/29282689/brca-gene-mutations-and-poly-adp-ribose-polymerase-inhibitors-in-triple-negative-breast-cancer
#16
Hitomi Sumiyoshi Okuma, Kan Yonemori
Breast cancer is the most common cancer in women worldwide. Treatment is chosen according to its hormone receptor status and human epidermal growth factor receptor 2 (HER2) status. Among the four main clinically set subtypes, hormone receptor-negative/HER2-negative subtype, also called triple-negative subtype (TNBC), is the most aggressive type with limited choices of therapy. However, recent research has provided important new insights into effective treatments for this subtype. One molecular target that has gained attention is the BRCA gene...
2017: Advances in Experimental Medicine and Biology
https://www.readbyqxmd.com/read/29282088/the-renaissance-aio-flot5-trial-effect-of-chemotherapy-alone-vs-chemotherapy-followed-by-surgical-resection-on-survival-and-quality-of-life-in-patients-with-limited-metastatic-adenocarcinoma-of-the-stomach-or-esophagogastric-junction-a-phase-iii-trial-of-the
#17
Salah-Eddin Al-Batran, Thorsten O Goetze, Daniel W Mueller, Arndt Vogel, Michael Winkler, Sylvie Lorenzen, Alexander Novotny, Claudia Pauligk, Nils Homann, Thomas Jungbluth, Christoph Reissfelder, Karel Caca, Steffen Retter, Eva Horndasch, Julia Gumpp, Claus Bolling, Karl-Hermann Fuchs, Wolfgang Blau, Winfried Padberg, Michael Pohl, Andreas Wunsch, Patrick Michl, Frank Mannes, Matthias Schwarzbach, Harald Schmalenberg, Michael Hohaus, Christian Scholz, Christoph Benckert, Jorge Riera Knorrenschild, Veit Kanngießer, Thomas Zander, Hakan Alakus, Ralf-Dieter Hofheinz, Claus Roedel, Manish A Shah, Mitsuru Sasako, Dietmar Lorenz, Jakob Izbicki, Wolf O Bechstein, Hauke Lang, Stefan P Moenig
BACKGROUND: Historical data indicate that surgical resection may benefit select patients with metastatic gastric and gastroesophageal junction cancer. However, randomized clinical trials are lacking. The current RENAISSANCE trial addresses the potential benefits of surgical intervention in gastric and gastroesophageal junction cancer with limited metastases. METHODS: This is a prospective, multicenter, randomized, investigator-initiated phase III trial. Previously untreated patients with limited metastatic stage (retroperitoneal lymph node metastases only or a maximum of one incurable organ site that is potentially resectable or locally controllable with or without retroperitoneal lymph nodes) receive 4 cycles of FLOT chemotherapy alone or with trastuzumab if Her2+...
December 28, 2017: BMC Cancer
https://www.readbyqxmd.com/read/29280452/conventional-versus-hypofractionated-radiation-therapy-for-localized-or-locally-advanced-prostate-cancer-a-systematic-review-and-meta-analysis-along-with-therapeutic-implications
#18
REVIEW
Niloy R Datta, Emanuel Stutz, Susanne Rogers, Stephan Bodis
PURPOSE: A systematic review and meta-analysis were conducted to evaluate the therapeutic outcomes of conventional radiation therapy (CRT) and hypofractionated radiation therapy (HRT) for localized or locally advanced prostate cancer (LLPCa). METHODS AND MATERIALS: A total of 599 abstracts were extracted from 5 databases and screened in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Only phase III trials randomized between CRT and HRT in LLPCa with a minimum of 5 years of follow-up data were considered...
November 1, 2017: International Journal of Radiation Oncology, Biology, Physics
https://www.readbyqxmd.com/read/29275145/taxane-based-combination-therapies-for-metastatic-prostate-cancer
#19
REVIEW
Paul G Corn, Neeraj Agarwal, John Charles Araujo, Guru Sonpavde
CONTEXT: Multiple single-agent therapies improving survival are approved for the treatment of metastatic castration-resistant prostate cancer (mCRPC), including two chemotherapies, two androgen-signaling axis-targeting agents, an immunotherapeutic vaccine, and a radiopharmaceutical. Combination therapy can target multiple oncogenic pathways simultaneously, while potentially curbing the development of treatment resistance. OBJECTIVE: To provide a succinct overview of taxane-based combination therapies currently being evaluated for the treatment of metastatic prostate cancer...
December 20, 2017: European Urology Focus
https://www.readbyqxmd.com/read/29274618/the-subgroups-of-the-phase-iii-recourse-trial-of-trifluridine-tipiracil-tas-102-versus-placebo-with-best-supportive-care-in-patients-with-metastatic-colorectal-cancer
#20
Eric Van Cutsem, Robert J Mayer, Stéphanie Laurent, Robert Winkler, Cristina Grávalos, Manuel Benavides, Federico Longo-Munoz, Fabienne Portales, Fortunato Ciardiello, Salvatore Siena, Kensei Yamaguchi, Kei Muro, Tadamichi Denda, Yasushi Tsuji, Lukas Makris, Patrick Loehrer, Heinz-Josef Lenz, Atsushi Ohtsu
BACKGROUND: In the phase III RECOURSE trial, trifluridine/tipiracil (TAS-102) extended overall survival (OS) and progression-free survival (PFS) with an acceptable toxicity profile in patients with metastatic colorectal cancer refractory or intolerant to standard therapies. The present analysis investigated the efficacy and safety of trifluridine/tipiracil in RECOURSE subgroups. METHODS: Primary and key secondary end-points were evaluated using a Cox proportional hazards model in prespecified subgroups, including geographical subregion (United States of America [USA], European Union [EU], Japan), age (<65 years, ≥65 years) and v-Ki-ras2 Kirsten rat sarcoma 2 viral oncogene homologue (KRAS) status (wild type, mutant)...
December 20, 2017: European Journal of Cancer
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