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https://www.readbyqxmd.com/read/28213743/development-of-cer-001-preclinical-dose-selection-through-to-phase-i-clinical-findings
#1
Constance H Keyserling, Ronald Barbaras, Renee Benghozi, Jean-Louis Dasseux
BACKGROUND: CER-001 comprises recombinant human apolipoprotein A-I complexed with phospholipids that mimics natural, nascent, pre-β high-density lipoprotein (HDL). We present animal model data showing dose-dependent increases in cholesterol efflux with CER-001 and its subsequent elimination by reverse lipid transport, together with inhibition of atherosclerotic plaque progression. We report the first phase I study results with CER-001 in humans, starting at 0.25 mg/kg, which is 1/80th of the safe dose (20 mg/kg) established in 4-week multiple-dose animal studies dosed every second day...
February 17, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28210861/the-effects-of-alcoholism-and-smoking-on-advanced-cancer-patients-admitted-to-an-acute-supportive-palliative-care-unit
#2
Sebastiano Mercadante, Claudio Adile, Patrizia Ferrera, Alessandra Casuccio
AIM: The aim of this prospective study was to determine the characteristics and symptom burden of advanced cancer patients with alcoholism problems and smoking, who were referred to an acute palliative/supportive care unit (ASPCU) of a comprehensive cancer center. METHODS: Patients' characteristics, indications for admission, kind of admission, awareness of prognosis, and anticancer treatments were recorded. The Edmonton Symptom Assessment Scale (ESAS) was used to assess physical and psychological symptoms, and the CAGE questionnaire for the diagnosis of alcoholism...
February 16, 2017: Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer
https://www.readbyqxmd.com/read/28204981/phase-1b-trial-of-proteasome-inhibitor-carfilzomib-with-irinotecan-in-lung-cancer-and-other-irinotecan-sensitive-malignancies-that-have-progressed-on-prior-therapy-onyx-ist-reference-number-car-ist-553
#3
Susanne M Arnold, Kari Chansky, Markos Leggas, Michael A Thompson, John L Villano, John Hamm, Rachel E Sanborn, Glen J Weiss, Gurkamal Chatta, Maria Q Baggstrom
Introduction Proteasome inhibition is an established therapy for many malignancies. Carfilzomib, a novel proteasome inhibitor, was combined with irinotecan to provide a synergistic approach in relapsed, irinotecan-sensitive cancers. Materials and Methods Patients with relapsed irinotecan-sensitive cancers received carfilzomib (Day 1, 2, 8, 9, 15, and 16) at three dose levels (20/27 mg/m2, 20/36 mg/m2 and 20/45 mg/m2/day) in combination with irinotecan (Days 1, 8 and 15) at 125 mg/m2/day. Key eligibility criteria included measurable disease, a Zubrod PS of 0 or 1, and acceptable organ function...
February 16, 2017: Investigational New Drugs
https://www.readbyqxmd.com/read/28203581/long-term-response-and-possible-cure-of-patients-with-b-cell-malignancies-with-dose-escalated-rituximab
#4
Lauren M Jacobs, Peter H Wiernik, Janice P Dutcher, Pablo Muxi
Rituximab (R), a chimeric monoclonal antibody targeting CD20 antigen on B-cells, has become a standard of care in the treatment of B-cell malignancies, most often in conjunction with cytotoxic chemotherapy. Activity has been demonstrated in many subtypes of B-cell lymphoma, including diffuse large cell lymphoma, follicular lymphoma (FL), mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), lymphocyte-predominant Hodgkin lymphoma, and Waldenström macroglobulinemia (WM). Additionally, dose escalation of R as a single agent has demonstrated improved activity in previously treated/poor prognosis CLL...
January 2017: Journal of Investigative Medicine High Impact Case Reports
https://www.readbyqxmd.com/read/28203303/refractory-carcinoid-syndrome-a-review-of-treatment-options
#5
REVIEW
Rachel P Riechelmann, Allan A Pereira, Juliana F M Rego, Frederico P Costa
Carcinoid syndrome (CSy) is a constellation of symptoms that may commonly present in patients with well differentiated neuroendocrine tumors (NETs), with somatostatin analogs (SSAs) being the first-line option for symptom management. However, symptomatic progression eventually occurs and in this scenario of a refractory CSy; several treatment options have been studied such as dose escalation of SSA, interferon and liver-directed therapies. Nevertheless, recent phase III trials have contributed to the understanding and management of this condition...
February 2017: Therapeutic Advances in Medical Oncology
https://www.readbyqxmd.com/read/28202227/phase-i-trial-of-radiation-therapy-and-sorafenib-in-unresectable-liver-metastases
#6
Rebecca B Goody, Anthony M Brade, Lisa Wang, Tim Craig, James Brierley, Robert Dinniwell, Rebecca K S Wong, Charles Cho, John Kim, Zahra Kassam, Jolie Ringash, Jennifer J Knox, Laura A Dawson
BACKGROUND AND PURPOSE: To determine maximum tolerated dose (MTD) and toxicities of sorafenib combined with stereotactic radiotherapy (SBRT) or whole liver radiotherapy (WLRT) in patients with liver metastases. MATERIAL AND METHODS: Eligible patients had unresectable liver metastases. Sorafenib dose was escalated in 2 strata: I - SBRT: effective liver volume irradiated (Veff)<80% (30-60Gy in 6 fractions); II - WLRT: Veff>80% (21.6Gy in 6 fractions). Four weeks of sorafenib, with radiotherapy during weeks 2-3, was delivered at 3 escalating dose levels (200-400mg twice daily)...
February 12, 2017: Radiotherapy and Oncology: Journal of the European Society for Therapeutic Radiology and Oncology
https://www.readbyqxmd.com/read/28202048/chemotherapy-for-primary-mediastinal-yolk-sac-tumor-in-a-patient-undergoing-chronic-hemodialysis-a-case-report
#7
Haruki Hirakawa, Chiho Nakashima, Tomomi Nakamura, Masanori Masuda, Taro Funakoshi, Shunsaku Nakagawa, Takahiro Horimatsu, Kazuo Matsubara, Manabu Muto, Shinya Kimura, Naoko Sueoka-Aragane
BACKGROUND: The safety and efficacy of chemotherapy for patients undergoing concomitant hemodialysis have not been fully established and optimal doses of anti-cancer drugs and best timing of hemodialysis remains unclear. Although chemosensitive cancers, such as germ cell tumors, treated with chemotherapy should have sufficient dose intensity maintained to achieve the desired effect, many patients with cancer undergoing hemodialysis might be under-treated because the pharmacokinetics of anti-cancer drugs in such patients remains unknown...
February 16, 2017: Journal of Medical Case Reports
https://www.readbyqxmd.com/read/28199478/evaluation-of-o6-benzylguanine-potentiated-topical-carmustine-for-mycosis-fungoides-a-phase-1-2-clinical-trial
#8
Joselin D Tacastacas, Derek V Chan, Sean Carlson, Stanton L Gerson, Afshin Dowlati, Pingfu Fu, Kurt Lu, Sarah Groft, Julie Rosenjack, Kord Honda, Thomas McCormick, Kevin D Cooper
Importance: In a phase 1 trial, single-dose O6-benzylguanine with topical carmustine for patients with early stage (stage IA through stage IIA) cutaneous T-cell lymphoma, mycosis fungoides (MF) type, resulted in clinical responses proportional to inhibition of O6-alkylguanine DNA alkyltransferase activity, but a maximum tolerated dose (MTD) was not reached. Objective: To determine whether dose escalation of carmustine in combination with dual-dose O6-benzylguanine to prolong alkyltransferase inhibition could reach an MTD...
February 15, 2017: JAMA Dermatology
https://www.readbyqxmd.com/read/28198726/community-acquired-pneumonia-requiring-hospitalization-rational-decision-making-and-interpretation-of-guidelines
#9
Douwe F Postma, Cornelis H van Werkhoven, Jan Jelrik Oosterheert
PURPOSE OF REVIEW: This review focuses on the evidence base for guideline recommendations on the diagnosis, the optimal choice, timing and duration of empirical antibiotic therapy, and the use of microbiological tests for patients hospitalized with community-acquired pneumonia (CAP): issues for which guidelines are frequently used as a quick reference. Furthermore, we will discuss possibilities for future research in these topics. RECENT FINDINGS: Many national and international guideline recommendations, even on critical elements of CAP management, are based on low-to-moderate quality evidence...
February 13, 2017: Current Opinion in Pulmonary Medicine
https://www.readbyqxmd.com/read/28197653/does-selective-pleural-irradiation-of-malignant-pleural-mesothelioma-allow-radiation-dose-escalation-a-planning-study
#10
A Botticella, G Defraene, K Nackaerts, C Deroose, J Coolen, P Nafteux, B Vanstraelen, S Joosten, L A W Michiels, S Peeters, D De Ruysscher
BACKGROUND: After lung-sparing radiotherapy for malignant pleural mesothelioma (MPM), local failure at sites of previous gross disease represents the dominant form of failure. Our aim is to investigate if selective irradiation of the gross pleural disease only can allow dose escalation. MATERIALS AND METHODS: In all, 12 consecutive stage I-IV MPM patients (6 left-sided and 6 right-sided) were retrospectively identified and included. A magnetic resonance imaging-based pleural gross tumor volume (GTV) was contoured...
February 14, 2017: Strahlentherapie und Onkologie: Organ der Deutschen Röntgengesellschaft ... [et Al]
https://www.readbyqxmd.com/read/28196905/a-phase-i-iia-study-of-dhp107-a-novel-oral-paclitaxel-formulation-in-patients-with-advanced-solid-tumors-or-gastric-cancer
#11
Min-Hee Ryu, Baek-Yeol Ryoo, Tae Won Kim, Sung Bae Kim, Hyeong-Seok Lim, Kyun-Seop Bae, Sook Ryun Park, Yeong-Woo Jo, Hyun Ju Cho, Yoon-Koo Kang
LESSONS LEARNED: Ideally, patients should have access to an oral formulation of paclitaxel, as well as an intravenous formulation, to allow development of regimens exploring alternate schedules and to avoid reactions to Cremophor EL (BASF Corp., Ludwigshafen, Germany, https://www.basf.com).DHP107 is a novel oral paclitaxel formulation that is a tolerable and feasible regimen for patients with gastric cancer, with data suggesting efficacy similar to that of intravenous paclitaxel. BACKGROUND: We evaluated the maximum tolerated dose (MTD) of DHP107, a novel oral paclitaxel formulation, and the efficacy and safety of the agent in patients with advanced solid tumors...
February 14, 2017: Oncologist
https://www.readbyqxmd.com/read/28194539/phase-i-trial-of-mek-1-2-inhibitor-pimasertib-combined-with-mtor-inhibitor-temsirolimus-in-patients-with-advanced-solid-tumors
#12
Monica Mita, Siqing Fu, Sarina Anne Piha-Paul, Filip Janku, Alain Mita, Ronald Natale, Wei Guo, Charles Zhao, Razelle Kurzrock, Aung Naing
Background Dual inhibition of activated MAPK and mTOR signaling pathways may enhance the antitumor efficacy of the MEK 1/2 inhibitor pimasertib and the mTOR inhibitor temsirolimus given in combination. Methods In this phase I study, patients with refractory advanced solid tumors (NCT01378377) received once-weekly temsirolimus plus once-daily oral pimasertib in 21-day cycles in a modified 3 + 3 dose-escalation design. The maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of pimasertib in combination with temsirolimus, safety and pharmacokinetics (PK) were investigated...
February 13, 2017: Investigational New Drugs
https://www.readbyqxmd.com/read/28192114/sirolimus-and-autophagy-inhibition-in-lam-results-of-a-phase-i-clinical-trial
#13
Souheil El-Chemaly, Angelo Taveira-Dasilva, Hilary J Goldberg, Elizabeth Peters, Mary Haughey, Don Bienfang, Amanda M Jones, Patricia Julien-Williams, Ye Cui, Julian A Villalba, Shefali Bagwe, Rie Maurer, Ivan O Rosas, Joel Moss, Elizabeth P Henske
BACKGROUND: Animal and cellular studies support the importance of autophagy inhibition in lymphangioleiomyomatosis (LAM). In a cohort of subjects with LAM, we tested the hypothesis that treatment with sirolimus and hydroxycholoroquine (an autophagy inhibitor) at 2 different dose levels is safe and well tolerated. Secondary endpoints included changes in lung function. METHODS: This 48-week, two-center Phase I trial evaluated the safety of escalating oral hydroxychloroquine doses (100-200 mg) given twice a day in combination with sirolimus to eligible patients ≥18 years old with LAM...
February 10, 2017: Chest
https://www.readbyqxmd.com/read/28188773/maternal-buprenorphine-treatment-and-fetal-neurobehavioral-development
#14
Lauren M Jansson, Martha Velez, Krystle McConnell, Nancy Spencer, Michelle Tuten, Hendree E Jones, Van L King, Neeraj Gandotra, Lorraine A Milio, Kristin Voegtline, Janet A DiPietro
BACKGROUND: Gestational opioid use/misuse is escalating in the United States, however, little is understood about the fetal effects of medications used to treat maternal opioid use disorders. OBJECTIVE: The purpose of this study was to determine the effect of maternal buprenorphine administration on longitudinal fetal neurobehavioral development. STUDY DESIGN: Forty-nine buprenorphine-maintained women attending a substance use disorder treatment facility with generally uncomplicated pregnancies underwent fetal monitoring for 60 minutes at times of trough and peak maternal buprenorphine levels...
February 7, 2017: American Journal of Obstetrics and Gynecology
https://www.readbyqxmd.com/read/28188055/the-emergency-medicine-management-of-severe-alcohol-withdrawal
#15
Drew Long, Brit Long, Alex Koyfman
INTRODUCTION: Alcohol use is widespread, and withdrawal symptoms are common after decreased alcohol intake. Severe alcohol withdrawal may manifest with delirium tremens, and new therapies may assist in management of this life-threatening condition. OBJECTIVE: To provide an evidence-based review of the emergency medicine management of alcohol withdrawal and delirium tremens. DISCUSSION: The underlying pathophysiology of alcohol withdrawal syndrome (AWS) is central nervous system hyperexcitation...
February 4, 2017: American Journal of Emergency Medicine
https://www.readbyqxmd.com/read/28186838/biological-dose-escalated-definitive-radiation-therapy-in-head-and-neck-cancer
#16
Brigida da Costa Ferreira, Pedro Sá-Couto, Leila Khouri, Maria do Carmo Lopes
OBJECTIVE: To compare treatment outcome of patients with head and neck (HN) tumours treated with definitive Radiation Therapy (RT) that, mainly due to differences in the fractionation scheme used with simultaneous integrated boost techniques, resulted in a different biological dose. METHODS: 181 HN cancer patients, prescribed to about 70.2 Gy in the primary tumour, were included in this study. Population cohort was divided into Group <70 and Group ≥70 when the mean dose converted to a 2 Gy fractionation in the primary tumour was less or higher than 70...
February 10, 2017: British Journal of Radiology
https://www.readbyqxmd.com/read/28185761/image-guided-adaptive-brachytherapy-dose-escalation-for-cervix-cancer-via-fractionation-compensation
#17
William Shaw, William I D Rae, Markus L Alber
PURPOSE: In image-guided adaptive brachytherapy (IGABT), dose distributions are optimized for each fraction. Optimum fractional dose can be constant or adapted to previous fractions and a conjecture about the future ones. We evaluate the efficacy of different fraction size schemes, derived from total IGABT dose constraints, against constant per-fraction constraints. METHODS AND MATERIALS: This retrospective planning study included 20 IGABT patients where four different fractionation schedules were compared based on modern planning recommendations...
February 6, 2017: Brachytherapy
https://www.readbyqxmd.com/read/28183319/cytotoxic-effect-of-different-treatment-parameters-in-pressurized-intraperitoneal-aerosol-chemotherapy-pipac-on-the-in-vitro-proliferation-of-human-colonic-cancer-cells
#18
Veria Khosrawipour, David Diaz-Carballo, Acikelli Ali-Haydar, Tanja Khosrawipour, Thomas Albert Falkenstein, Dan Wu, Jürgen Zieren, Urs Giger-Pabst
BACKGROUND: Pressurized intraperitoneal aerosol chemotherapy (PIPAC) has been recently reported as a new approach for intraperitoneal chemotherapy (IPC). By means of a patented micropump, the liquid chemotherapy is delivered into the peritoneal cavity as an aerosol which is supposed to achieve "gas-like" distribution. However, recent data report that the fraction of the submicron aerosol (gas-like) is less than 3 vol% of the total amount of aerosolized chemotherapy. Until today, possible modifications of treatment parameters during PIPAC with the aim of improving therapeutic outcomes have not been studied yet...
February 10, 2017: World Journal of Surgical Oncology
https://www.readbyqxmd.com/read/28182127/impact-of-metoprolol-treatment-on-mental-status-of-chronic-heart-failure-patients-with-neuropsychiatric-disorders
#19
Xuelu Liu, Xueming Lou, Xianliang Cheng, Yong Meng
BACKGROUND: Metoprolol treatment is well established for chronic heart failure (CHF) patients, but the central nervous system side effects are often a potential drawback. OBJECTIVE: To investigate the impact of metoprolol treatment on change in mental status of CHF patients with clinical psychological disorders (such as depression, anxiety, and burnout syndrome). METHODS: From February 2013 to April 2016, CHF patients with clinical mental disorders received metoprolol (23...
2017: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/28181819/dose-escalation-study-with-respiratory-gated-carbon-ion-scanning-radiotherapy-using-a-simultaneous-integrated-boost-for-pancreatic-cancer-simulation-with-four-dimensional-computed-tomography
#20
Shohei Kawashiro, Shinichiro Mori, Shigeru Yamada, Kentaro Miki, Kenji Nemoto, Hiroshi Tsuji, Tadashi Kamada
OBJECTIVES: Pancreatic cancer is a difficult-to-treat disease with a persistently high mortality rate. We evaluated dose distribution simulation with respiratory-gated carbon-ion pencil beam scanning (C-PBS) with a simultaneous integrated boost (SIB) to increase tumor dose, sparing organs at risk (OARs). METHODS: Using four-dimensional computed tomography (4DCT) data of 12 patients, we delineated gross tumor volume (GTV) and two clinical target volumes (CTVs). To consider beam range intrafractional uncertainty, we calculated field-specific target volumes (FTVs), from which two planning target volumes (PTVs) were generated...
February 9, 2017: British Journal of Radiology
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