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randomized controlled trial toxicity

Mei Jiang, Feifeng Ren, Yaning Zheng, Ruyu Yan, Wenhan Huang, Ning Xia, Lei Luo, Jun Zhou, Lin Tang
OBJECTIVES: To evaluate the efficacy and safety of down-titration (dose reduction/tapering) strategies compared with continuation of biological disease-modifying anti-rheumatic drugs (DMARDs) in patients with rheumatoid arthritis (RA) who achieved and maintained low disease activity or remission. METHODS: We searched the following electronic database up to March 2016: MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), and conference proceedings of the American College of Rheumatology (ACR) and European League against Rheumatism (EULAR)...
September 7, 2016: Clinical and Experimental Rheumatology
Mahesh Kudrimoti, Amarintha Curtis, Samar Azawi, Francis Worden, Sanford Katz, Douglas Adkins, Marcelo Bonomi, Jenna Elder, Stephen T Sonis, Richard Straube, Oreola Donini
Dusquetide, a novel Innate Defense Regulator, modulates the innate immune system at a key convergence point in intracellular signaling pathways and has demonstrated activity in both reducing inflammation and increasing clearance of bacterial infection. Innate immunity has also been implicated in the pathogenesis of oral mucositis (OM), a universal toxicity of chemoradiation therapy (CRT). Testing the hypothesis that dusquetide can mitigate the development and duration of OM, preclinical studies have been completed and correlated with interim results from a Phase 2 clinical study in patients undergoing CRT for head and neck cancer...
October 13, 2016: Journal of Biotechnology
Ze-Chun Zhang, Qi-Ni Xu, Sui-Ling Lin, Xu-Yuan Li
Capecitabine has been investigated in early breast cancer in several studies, but it was undefined that whether it could improve survival. To investigate whether the addition of capecitabine affected survival in patients with early breast cancer, a meta-analysis was conducted and overall survival (OS), disease-free survival (DFS), and toxicity were assessed. The PubMed, Embase databases and the Cochrane Central Register of Controlled Trials were searched for studies between January 2006 and April 2016. Hazard ratios (HRs) with their 95% confidence intervals (CIs), or data for calculating HRs with 95% CI were derived...
2016: PloS One
Michael P Chu, J Randolph Hecht, Dennis Slamon, Zev A Wainberg, Yung-Jue Bang, Paulo M Hoff, Alberto Sobrero, Shukui Qin, Karen Afenjar, Vincent Houe, Karen King, Sheryl Koski, Karen Mulder, Julie Price Hiller, Andrew Scarfe, Jennifer Spratlin, Yingjie J Huang, Saba Khan-Wasti, Neil Chua, Michael B Sawyer
Importance: Capecitabine is an oral cytotoxic chemotherapeutic commonly used across cancer subtypes. As with other oral medications though, it may suffer from drug interactions that could impair its absorption. Objective: To determine if gastric acid suppressants such as proton pump inhibitors (PPIs) may impair capecitabine efficacy. Design, Setting, and Participants: This secondary analysis of TRIO-013, a phase III randomized trial, compares capecitabine and oxaliplatin (CapeOx) with or without lapatinib in 545 patients with ERBB2/HER2-positive metastatic gastroesophageal cancer (GEC); patients were randomized 1:1 between CapeOx with or without lapatinib...
October 13, 2016: JAMA Oncology
Nicola Lindson-Hawley, Jamie Hartmann-Boyce, Thomas R Fanshawe, Rachna Begh, Amanda Farley, Tim Lancaster
BACKGROUND: Although smoking cessation is currently the only guaranteed way to reduce the harm caused by tobacco smoking, a reasonable secondary tobacco control approach may be to try and reduce the harm from continued tobacco use amongst smokers unable or unwilling to quit. Possible approaches to reduce the exposure to toxins from smoking include reducing the amount of tobacco used, and using less toxic products, such as pharmaceutical, nicotine and potential reduced-exposure tobacco products (PREPs), as an alternative to cigarettes...
October 13, 2016: Cochrane Database of Systematic Reviews
Bryan P Schneider, Dongbing Lai, Fei Shen, Guanglong Jiang, Milan Radovich, Lang Li, Laura Gardner, Kathy D Miller, Anne O'Neill, Joseph A Sparano, Gloria Xue, Tatiana Foroud, George W Sledge
PURPOSE: Taxane-induced peripheral neuropathy (TIPN) is one of the most important survivorship issues for cancer patients. African Americans (AA) have previously been shown to have an increased risk for this toxicity. Germline predictive biomarkers were evaluated to help identify a priori which patients might be at extraordinarily high risk for this toxicity. EXPERIMENTAL DESIGN: Whole exome sequencing was performed using germline DNA from 213 AA patients who received a standard dose and schedule of paclitaxel in the adjuvant, randomized phase III breast cancer trial, E5103...
October 9, 2016: Oncotarget
Xi Zhang, Yuge Ran, Kunjie Wang, Yuanxue Zhu, Jinghua Li
PURPOSE: Anti-programmed cell death receptor-1 (PD-1) antibodies have demonstrated antitumor activity in many cancer entities. Hepatic adverse events (AEs) are one of its major side effects, but the overall risks have not been systematically evaluated. Thus, we conducted this meta-analysis to investigate the overall incidence and risk of developing hepatic AEs in cancer patients treated with PD-1 inhibitors. METHODS: PubMed, Embase, and oncology conference proceedings were searched for relevant studies...
2016: Drug Design, Development and Therapy
Chunyuan Tang, Fang Wu, Rensheng Wang, Heming Lu, Guisheng Li, Meilian Liu, Haisheng Zhu, Jinxian Zhu, Yong Zhang, Kai Hu
Nasopharyngeal carcinoma (NPC) is highly incident in southern China. Metastasis is the major cause of death in NPC patients. Concurrent chemoradiotherapy (CCRT) has been accepted as standard in the treatment of patients with locoregionally advanced nasopharyngeal carcinoma (NPC). However, induction chemotherapy (IC) also has benefits in this disease, especially in the patients with certain high-risk factors such as bulky and/or extensive nodal disease. It has been presented that adding IC to CCRT might be a reasonable approach and need more work to confirm...
2016: American Journal of Cancer Research
Christoph Rochlitz, Martin Bigler, Roger von Moos, Jürg Bernhard, Klazien Matter-Walstra, Andreas Wicki, Khalil Zaman, Sandro Anchisi, Marc Küng, Kyung-Jae Na, Daniela Bärtschi, Markus Borner, Tamara Rordorf, Daniel Rauch, Andreas Müller, Thomas Ruhstaller, Marcus Vetter, Andreas Trojan, Ursula Hasler-Strub, Richard Cathomas, Ralph Winterhalder
BACKGROUND: Adding bevacizumab to chemotherapy improves response rates and progression-free survival (PFS) in metastatic breast cancer (mBC). We aimed to demonstrate decreased toxicity with metronomic chemotherapy/bevacizumab compared with paclitaxel/bevacizumab. METHODS: This multicenter, randomized phase III trial compared bevacizumab with either paclitaxel (arm A) or daily oral capecitabine-cyclophosphamide (arm B) as first-line treatment in patients with HER2-negative advanced breast cancer...
October 10, 2016: BMC Cancer
Diyu Huang, Jie Fang, Gaojian Luo
PURPOSE: The aim of this study is to assess the efficacy and safety of combination chemotherapy with gemcitabine (GEM) and cisplatin (CIS) compared with GEM alone in patients with pancreatic cancer. METHODS: A computerized search through electronic databases, including PubMed (until February 2016), was performed to obtain eligible randomized controlled trials that compared effectiveness of GEM and CIS combination chemotherapy with GEM alone in patients with pancreatic cancer...
October 2016: Journal of Cancer Research and Therapeutics
Xiaoli Wang, Weimei Jin, Bingmu Fang, Jinhong Jiang, Min Liu, Yifen Lan, Zhigang Qu, Guangli Ma, Yu Jiang, Yonghua Liu, Yuxiao Zeng, Xiaoqiu Wang
OBJECTIVE: The aim of this study was to evaluate the clinical efficacy of Aidi injection combined with CHOP chemotherapy regimen in the treatment of malignant lymphoma. METHODS: We made an electronic search in the database of Wanfang, CNKI, and PubMed. All the clinical studies related to Aidi injection combined with CHOP chemotherapy regimen in the treatment of malignant lymphoma were screened and reviewed. The combined objective response rate (ORR), life quality improvement, and hematological toxicity were pooled by random- or fixed-effect model according to the heterogeneity across the included study...
October 2016: Journal of Cancer Research and Therapeutics
Amit Roy, Pawinee Mahasittiwat, Ashley A Weiner, Steven R Hunt, Matthew G Mutch, Elisa H Birnbaum, Ira J Kodner, Thomas E Read, James W Fleshman, Jeffrey R Olsen, Robert J Myerson, Parag J Parikh
PURPOSE: Preoperative short-course radiation therapy (SCRT) has rarely been used for rectal cancer in the United States, although 2 randomized phase 3 trials demonstrate equivalence to conventional chemoradiation (CRT), and recent updates to national guidelines include this regimen as a treatment option. We sought to evaluate the efficacy and safety of preoperative SCRT followed by immediate surgery within 1 week to treat rectal cancer in the US setting. METHODS AND MATERIALS: All patients treated with preoperative SCRT (4 Gy × 5 fractions for total 20 Gy) followed by planned surgery within 1 week at our institution were retrospectively evaluated...
August 31, 2016: Practical Radiation Oncology
Christoph Schliemann, Joachim Gerss, Stefanie Wiebe, Jan-Henrik Mikesch, Nicola Knoblauch, Tim Sauer, Linus Angenendt, Tobias Kewitz, Marc Urban, Trude Butterfass-Bahloul, Sabine Edemir, Kerstin Vehring, Carsten Müller-Tidow, Wolfgang E Berdel, Utz Krug
: Nintedanib (BIBF 1120), a potent multikinase inhibitor of VEGFR-1/-2/-3, FGFR-1/-2/-3 and PDGFR-α/-β, exerts growth inhibitory and pro-apoptotic effects in myeloid leukemic cells, especially when used in combination with cytarabine. This phase I study evaluated nintedanib in combination with low-dose cytarabine (LDAC) in elderly patients with untreated or relapsed/refractory acute myeloid leukemia (AML) ineligible for intensive chemotherapy in a 3+3 design. Nintedanib (dose levels 100, 150, and 200 mg orally twice daily) and LDAC (20 mg subcutaneous injection twice daily for 10 days) were administered in 28-day cycles...
2016: PloS One
Oliver Oehlke, Michael Mix, Erika Graf, Tanja Schimek-Jasch, Ursula Nestle, Irina Götz, Sabine Schneider-Fuchs, Astrid Weyerbrock, Irina Mader, Brigitta G Baumert, Susan C Short, Philipp T Meyer, Wolfgang A Weber, Anca-Ligia Grosu
BACKGROUND: The higher specificity of amino-acid positron emission tomography (AA-PET) in the diagnosis of gliomas, as well as in the differentiation between recurrence and treatment-related alterations, in comparison to contrast enhancement in T1-weighted MRI was demonstrated in many studies and is the rationale for their implementation into radiation oncology treatment planning. Several clinical trials have demonstrated the significant differences between AA-PET and standard MRI concerning the definition of the gross tumor volume (GTV)...
October 5, 2016: BMC Cancer
Saro H Armenian, Melissa M Hudson, Ming Hui Chen, Steven D Colan, Lanie Lindenfeld, George Mills, Aida Siyahian, Sarah Gelehrter, Ha Dang, Wendy Hein, Daniel M Green, Leslie L Robison, F Lennie Wong, Pamela S Douglas, Smita Bhatia
BACKGROUND: Anthracyclines are widely used in the treatment of childhood cancer. One of the well-recognized side-effects of anthracycline therapy is dose-dependent cardiomyopathy that may progress to heart failure (HF) years after completion of cancer-directed therapy. This study will evaluate the efficacy of low-dose beta-blocker (carvedilol) for HF risk reduction in childhood cancer survivors at highest risk for HF. The proposed intervention has the potential to significantly reduce chronic cardiac injury via interruption of neurohormonal systems responsible for left ventricular (LV) remodeling, resulting in improved cardiac function and decreased risk of HF...
October 4, 2016: BMC Cardiovascular Disorders
Amanda R Townsend, Li Chia Chong, Christos Karapetis, Timothy J Price
Liver metastases are often the dominant site of metastatic disease in colorectal cancer. Selective internal radiation therapy (SIRT) involves embolising radiolabeled spheres (SIR-Spheres) into the arterial supply of the liver. This review assesses the effectiveness and toxicity of SIRT in the treatment of metastatic colorectal cancer liver metastasis when given alone or with systemic or regional hepatic artery chemotherapy. We reviewed only randomised controlled trials comparing SIRT and chemotherapy (systemic and/or regional) with chemotherapy alone, or comparing SIRT alone with best supportive care...
September 10, 2016: Cancer Treatment Reviews
B S Abdulkarim, K Joseph, L Vos, H K Warkentin, Z Gabos, N Pervez, K Tankel, S Ghosh, S M J Chafe, M B Parliament
No abstract text is available yet for this article.
October 1, 2016: International Journal of Radiation Oncology, Biology, Physics
G Sonpavde, G R Pond, A J Templeton, E D Kwon, J S De Bono
BACKGROUND: Despite palliative benefits and PSA responses, the objective clinical impact of daily oral prednisone (P) for metastatic castration-resistant prostate cancer (mCRPC) is unknown. We performed a pooled analysis of control arms of randomized trials that either did or did not administer single-agent P to evaluate its impact on overall survival (OS) and toxicities. METHODS: Individual patient data from control arms of randomized trials of men with mCRPC who received placebo or P+placebo post docetaxel were eligible for analysis...
September 27, 2016: Prostate Cancer and Prostatic Diseases
Stephen Lutz, Tracy Balboni, Joshua Jones, Simon Lo, Joshua Petit, Shayna E Rich, Rebecca Wong, Carol Hahn
PURPOSE: The purpose is to provide an update the Bone Metastases Guideline published in 2011 based on evidence complemented by expert opinion. The update will discuss new high-quality literature for the 8 key questions from the original guideline and implications for practice. METHODS AND MATERIALS: A systematic PubMed search from the last date included in the original Guideline yielded 414 relevant articles. Ultimately, 20 randomized controlled trials, 32 prospective nonrandomized studies, and 4 meta-analyses/pooled analyses were selected and abstracted into evidence tables...
August 5, 2016: Practical Radiation Oncology
Oliver Rick, Ulrike von Hehn, Eberhard Mikus, Hermann Dertinger, Georg Geiger
No causal treatment for chemotherapy-induced peripheral neuropathy (CIPN) is known. Therefore, there is an urgent need to develop a therapy for CIPN. Only scarce clinical data are available concerning magnetic field therapy (MFT) in this context. We conducted a unicentric, randomized, double-blind, placebo-controlled phase-III trial of an MFT device versus placebo. In this study, we randomized 44 patients with CIPN to two treatment groups, where 21 patients were treated with MFT (Group 1) and 23 patients received placebo (Group 2)...
September 22, 2016: Bioelectromagnetics
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