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https://www.readbyqxmd.com/read/28324920/an-open-label-randomized-parallel-phase-ii-trial-to-evaluate-the-efficacy-and-safety-of-a-cremophor-free-polymeric-micelle-formulation-of-paclitaxel-as-first-line-treatment-for-ovarian-cancer-a-korean-gynecologic-oncology-group-study-kgog-3021
#1
Shin-Wha Lee, Yong-Man Kim, Chi Heum Cho, Young Tae Kim, Seok Mo Kim, Soo Young Hur, Jae-Hoon Kim, Byoung-Gie Kim, Seung-Cheol Kim, Hee-Sug Ryu, Soon Beom Kang
Purpose: Genexol-PM is a biodegradable cremophor EL-free polymeric micelle formulation of paclitaxel. Here we compared efficacy and safety of Genexol-PM plus carboplatin vs. Genexol plus carboplatin for ovarian cancer treatment. Materials and Methods: In this multicenter, randomized, phase II study, patients with FIGO IC-IV epithelial ovarian cancer were randomly assigned (1:1) to receive Genexol-PM 260 mg/m2 or Genexol 175 mg/m2 with 5 AUC carboplatin every three weeks (6 cycles)...
March 21, 2017: Cancer Research and Treatment: Official Journal of Korean Cancer Association
https://www.readbyqxmd.com/read/28324751/the-rationale-of-indoleamine-2-3-dioxygenase-inhibition-for-cancer-therapy
#2
REVIEW
Lieve Brochez, Ines Chevolet, Vibeke Kruse
Indoleamine 2,3-dioxygenase (IDO, also referred to as IDO1) has been demonstrated to be a normal endogenous mechanism of acquired peripheral immune tolerance in vivo. In the field of oncology, IDO expression and/or activity has been observed in several cancer types and has usually been associated with negative prognostic factors and worse outcome measures. This manuscript reviews current available data on the role of IDO in cancer and the current results obtained with IDO inhibition, both in animal models and in phase 1 and 2 clinical trials in humans...
March 18, 2017: European Journal of Cancer
https://www.readbyqxmd.com/read/28317651/clinical-validity-of-presynaptic-dopaminergic-imaging-with%C3%A2-123-i-ioflupane%C3%A2-and-noradrenergic-imaging-with-123-i-mibg-in-the-differential-diagnosis-between-alzheimer-s-disease-and-dementia-with-lewy-bodies-in-the-context-of-a-structured-5-phase-development
#3
REVIEW
Ida Sonni, Osman Ratib, Marina Boccardi, Agnese Picco, Karl Herholz, Flavio Nobili, Andrea Varrone
The use of biomarkers (BMs) for accurate diagnosis of Alzheimer's disease (AD) has been proposed by recent diagnostic criteria; however, their maturity is not sufficient to grant implementation in the clinical routine. A proper diagnostic process requires not only confirmation of the disease but also the exclusion of similar disorders entering differential diagnosis, like dementia with Lewy bodies (DLB). This review is aimed at evaluating the clinical validity of (123)I-ioflupane brain single photon emission tomography and (123)I-MIBG cardiac scintigraphy as imaging BMs for DLB...
April 2017: Neurobiology of Aging
https://www.readbyqxmd.com/read/28317650/clinical-validity-of-increased-cortical-uptake-of-amyloid-ligands-on-pet-as-a-biomarker-for-alzheimer-s-disease-in-the-context-of-a-structured-5-phase-development-framework
#4
REVIEW
Konstantinos Chiotis, Laure Saint-Aubert, Marina Boccardi, Anton Gietl, Agnese Picco, Andrea Varrone, Valentina Garibotto, Karl Herholz, Flavio Nobili, Agneta Nordberg
The use of biomarkers has been proposed for diagnosing Alzheimer's disease in recent criteria, but some biomarkers have not been sufficiently investigated to justify their routine clinical use. Here, we evaluate in a literature review the clinical validity of amyloid positron emission tomography (PET) imaging using a structured framework developed for the assessment of oncological biomarkers. Homogenous criteria have been addressed in reviews of other Alzheimer's disease biomarkers. There is adequate evidence that the main aims of phases 1 (rationale for use) and 2 (discriminative ability) have been achieved...
April 2017: Neurobiology of Aging
https://www.readbyqxmd.com/read/28317648/clinical-validity-of-brain-fluorodeoxyglucose-positron-emission-tomography-as-a-biomarker-for-alzheimer-s-disease-in-the-context-of-a-structured-5-phase-development-framework
#5
REVIEW
Valentina Garibotto, Karl Herholz, Marina Boccardi, Agnese Picco, Andrea Varrone, Agneta Nordberg, Flavio Nobili, Osman Ratib
The use of Alzheimer's disease (AD) biomarkers is supported in diagnostic criteria, but their maturity for clinical routine is still debated. Here, we evaluate brain fluorodeoxyglucose positron emission tomography (FDG PET), a measure of cerebral glucose metabolism, as a biomarker to identify clinical and prodromal AD according to the framework suggested for biomarkers in oncology, using homogenous criteria with other biomarkers addressed in parallel reviews. FDG PET has fully achieved phase 1 (rational for use) and most of phase 2 (ability to discriminate AD subjects from healthy controls or other forms of dementia) aims...
April 2017: Neurobiology of Aging
https://www.readbyqxmd.com/read/28317647/clinical-validity-of-medial-temporal-atrophy-as-a-biomarker-for-alzheimer-s-disease-in-the-context-of-a-structured-5-phase-development-framework
#6
REVIEW
Mara Ten Kate, Frederik Barkhof, Marina Boccardi, Pieter Jelle Visser, Clifford R Jack, Karl-Olof Lovblad, Giovanni B Frisoni, Philip Scheltens
Research criteria for Alzheimer's disease recommend the use of biomarkers for diagnosis, but whether biomarkers improve the diagnosis in clinical routine has not been systematically assessed. The aim is to evaluate the evidence for use of medial temporal lobe atrophy (MTA) as a biomarker for Alzheimer's disease at the mild cognitive impairment stage in routine clinical practice, with an adapted version of the 5-phase oncology framework for biomarker development. A literature review on visual assessment of MTA and hippocampal volumetry was conducted with other biomarkers addressed in parallel reviews...
April 2017: Neurobiology of Aging
https://www.readbyqxmd.com/read/28317646/clinical-validity-of-delayed-recall-tests-as-a-gateway-biomarker-for-alzheimer-s-disease-in-the-context-of-a-structured-5-phase-development-framework
#7
REVIEW
Chiara Cerami, Bruno Dubois, Marina Boccardi, Andreas U Monsch, Jean Francois Demonet, Stefano F Cappa
Although Alzheimer's disease criteria promote the use of biomarkers, their maturity in clinical routine still needs to be assessed. In the light of the oncology framework, we conducted a literature review on measures used to assess delayed recall impairment due to medial temporal lobe dysfunction (i.e., free and cued word list recall tests). Ample evidence is available for phases 1 (rationale for use), 2 (discriminative ability), and 3 (early detection ability) for many of the tests in routine use. Evidence about phase 4 (performance in real world) and phase 5 (quantify impact and costs) is yet to come...
April 2017: Neurobiology of Aging
https://www.readbyqxmd.com/read/28317582/robotic-right-hemicolectomy-analysis-of-108-consecutive-procedures-and-multidimensional-assessment-of-the-learning-curve
#8
Amilcare Parisi, Luca Scrucca, Jacopo Desiderio, Alessandro Gemini, Salvatore Guarino, Francesco Ricci, Roberto Cirocchi, Giorgio Palazzini, Vito D'Andrea, Liliana Minelli, Stefano Trastulli
PURPOSE: Surgeons tend to view the robotic right colectomy (RRC) as an ideal beginning procedure to gain proficiency in robotic general and colorectal surgery. Nevertheless, oncological RRC, especially if performed with intracorporeal ileocolic anastomosis confectioning, cannot be considered a technically easier procedure. The aim of this study was to assess the learning curve of the RRC performed for oncological purposes and to evaluate its safety and efficacy investigating the perioperative and pathology outcomes in the different learning phases...
March 2017: Surgical Oncology
https://www.readbyqxmd.com/read/28314699/safety-and-tolerability-of-idelalisib-lenalidomide-and-rituximab-in-relapsed-and-refractory-lymphoma-the-alliance-for-clinical-trials-in-oncology-a051201-and-a051202-phase-1-trials
#9
Sonali M Smith, Brandelyn N Pitcher, Sin-Ho Jung, Nancy L Bartlett, Nina Wagner-Johnston, Steven I Park, Kristy L Richards, Amanda F Cashen, Anthony Jaslowski, Scott E Smith, Bruce D Cheson, Eric Hsi, John P Leonard
BACKGROUND: A new generation of biological and targeted agents might potentially replace traditional cytotoxic agents in lymphoma. Lenalidomide plus rituximab was felt to be a safe and promising backbone based on available data. Idelalisib is an oral phosphatidylinositol 3-kinase delta (PI3Kδ) inhibitor that has promising activity as a monotherapy in refractory indolent lymphomas. The primary objective of these two trials was to determine the maximum tolerated dose of lenalidomide in combination with rituximab and idelalisib in relapsed follicular and mantle cell lymphoma...
March 14, 2017: Lancet Haematology
https://www.readbyqxmd.com/read/28295182/a-phase-1-trial-of-temsirolimus-and-intensive-re-induction-chemotherapy-for-2nd-or-greater-relapse-of-acute-lymphoblastic-leukaemia-a-children-s-oncology-group-study-advl1114
#10
Susan R Rheingold, Sarah J Tasian, James A Whitlock, David T Teachey, Michael J Borowitz, Xiaowei Liu, Charles G Minard, Elizabeth Fox, Brenda J Weigel, Susan M Blaney
The phosphatidylinositol 3-kinase (PI3K)/mammalian (or mechanistic) target of rapamycin (mTOR) signalling pathway is commonly dysregulated in acute lymphoblastic leukaemia (ALL). A phase 1 trial of the mTOR inhibitor temsirolimus in combination with UKALL R3 re-induction chemotherapy was conducted in children and adolescents with second or greater relapse of ALL. The initial temsirolimus dose level (DL1) was 10 mg/m(2) weekly × 3 doses. Subsequent patient cohorts received temsirolimus 7·5 mg/m(2) weekly × 3 doses (DL0) or, secondary to toxicity, 7·5 mg/m(2) weekly × 2 doses (DL-1)...
March 14, 2017: British Journal of Haematology
https://www.readbyqxmd.com/read/28294391/a-population-pharmacokinetic-meta-analysis-of-custirsen-an-antisense-oligonucleotide-in-oncology-patients-and-healthy-subjects
#11
Alena Y Edwards, Anna Elgart, Colm Farrell, Ofra Barnett-Griness, Laura Rabinovich-Guilatt, Ofer Spiegelstein
AIMS: Custirsen (OGX-011/TV-1011), a second-generation antisense oligonucleotide that reduces clusterin production, is under investigation with chemotherapy in prostate and lung cancer. This meta-analysis evaluated the population pharmacokinetics (PK) of custirsen in cancer patients and healthy subjects. METHODS: The population PK analysis used custirsen plasma concentrations from five phase 1 studies, one phase 1/2 study, and one phase 3 study in two stages. Cancer patients received multiple doses of custirsen (40-640 mg intravenously over 120 minutes) with chemotherapy; healthy subjects received single or multiple doses (320-640 mg)...
March 11, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28293794/do-all-patients-in-the-phase-i-oncology-trials-need-to-be-hospitalized-domestic-but-outstanding-issues-for-globalization-of-drug-development-in-japan
#12
Akihiko Shimomura, Shunsuke Kondo, Noriko Kobayashi, Satoru Iwasa, Shigehisa Kitano, Kenji Tamura, Yutaka Fujiwara, Noboru Yamamoto
INTRODUCTION: Most trials investigating new drugs around the world, including phase I trials, are conducted in outpatient clinics. However, in Japan, regulatory authority requirements and traditional domestic guidelines often require hospitalization of phase I study participants. PATIENTS AND METHODS: Patients participating in single-agent phase I clinical trials at National Cancer Center Hospital between December 1996 and August 2014 were monitored. Toxicity requiring hospitalization is defined as toxicity that needs intensive treatment...
March 14, 2017: International Journal of Clinical Oncology
https://www.readbyqxmd.com/read/28291584/clinical-safety-and-activity-of-pembrolizumab-in-patients-with-malignant-pleural-mesothelioma-keynote-028-preliminary-results-from-a-non-randomised-open-label-phase-1b-trial
#13
Evan W Alley, Juanita Lopez, Armando Santoro, Anne Morosky, Sanatan Saraf, Bilal Piperdi, Emilie van Brummelen
BACKGROUND: Malignant pleural mesothelioma is a highly aggressive cancer with poor prognosis and few treatment options following progression on platinum-containing chemotherapy. We assessed the safety and efficacy of pembrolizumab (an anti-programmed cell death receptor 1 [PD-1] antibody) in advanced solid tumours expressing programmed cell death ligand 1 (PD-L1) and report here on the interim analysis of the malignant pleural mesothelioma cohort. METHODS: Previously treated patients with PD-L1-positive malignant pleural mesothelioma were enrolled from 13 centres in six countries...
March 10, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28285845/a-stratified-randomized-double-blind-phase-ii-trial-of-celecoxib-for-treating-patients-with-cervical-intraepithelial-neoplasia-the-potential-predictive-value-of-vegf-serum-levels-an-nrg-oncology-gynecologic-oncology-group-study
#14
Janet S Rader, Michael W Sill, Jan H Beumer, Heather A Lankes, Doris Mangiaracina Benbrook, Francisco Garcia, Connie Trimble, J Tate Thigpen, Richard Lieberman, Rosemary E Zuna, Charles A Leath, Nick M Spirtos, John Byron, Premal H Thaker, Shashikant Lele, David Alberts
PURPOSE: To examine the effect of celecoxib on cervical intraepithelial neoplasia 3 (CIN 3). This is a NRG Oncology/Gynecologic Oncology Group study with translational biomarkers. PATIENTS AND METHODS: Patients with CIN 3 were randomized to celecoxib 400mg once daily (67 patients) or placebo (63 patients) for 14-18weeks. The primary outcome measure was histologic regression. A test of equal probabilities of success between two therapies was conducted, using Fisher's Exact Test at alpha=10% and 90% power when the treatment arm boosted the probability of success by 30%...
March 9, 2017: Gynecologic Oncology
https://www.readbyqxmd.com/read/28282612/imatinib-induces-sustained-progression-arrest-in-recist-progressive-desmoid-tumours-final-results-of-a-phase-ii-study-of-the-german-interdisciplinary-sarcoma-group-gisg
#15
Bernd Kasper, Viktor Gruenwald, Peter Reichardt, Sebastian Bauer, Geraldine Rauch, Ronald Limprecht, Michaela Sommer, Antonia Dimitrakopoulou-Strauss, Lothar Pilz, Florian Haller, Peter Hohenberger
BACKGROUND: Desmoid tumours describe a rare monoclonal, fibroblastic proliferation characterised by an often unpredictable clinical course. Surgery is one therapeutic option for progressing patients, except if mutilating and associated with considerable function loss. Different systemic treatment approaches have been investigated and promising results could be demonstrated using imatinib. PATIENTS AND METHODS: We initiated a phase II trial within the German Interdisciplinary Sarcoma Group (GISG) evaluating imatinib to induce progression arrest in desmoid tumour patients being Response Evaluation Criteria in Solid Tumours (RECIST) progressive, not amenable to surgical resection with R0 intent or accompanied by unacceptable function loss (NCT01137916)...
March 7, 2017: European Journal of Cancer
https://www.readbyqxmd.com/read/28282611/phase-ib-dose-finding-study-of-abiraterone-acetate-plus-buparlisib-bkm120-or-dactolisib-bez235-in-patients-with-castration-resistant-prostate-cancer
#16
Christophe Massard, Kim Nguyen Chi, Daniel Castellano, Johann de Bono, Gwenaelle Gravis, Luc Dirix, Jean-Pascal Machiels, Alain Mita, Begona Mellado Gonzalez, Sabine Turri, Joan Maier, Denes Csonka, Arunava Chakravartty, Karim Fizazi
BACKGROUND: The phosphatidylinositol-3-kinase (PI3K)/protein kinase B (Akt) signalling axis and androgen receptor (AR) pathways exhibit reciprocal feedback regulation in phosphatase and tensin homologue (PTEN)-deficient metastatic castration-resistant prostate cancer (CRPC) in preclinical models. This phase Ib study evaluated the pan-PI3K inhibitor buparlisib (BKM120) and the dual pan-PI3K/ mammalian target of rapamycin (mTOR) inhibitor dactolisib (BEZ235) in combination with abiraterone acetate (AA) in patients with CRPC...
March 3, 2017: European Journal of Cancer
https://www.readbyqxmd.com/read/28281911/comparing-oncology-clinical-programs-by-use-of-innovative-designs-and-expected-net-present-value-optimization-which-adaptive-approach-leads-to-the-best-result
#17
Tom Parke, Olga Marchenko, Vladimir Anisimov, Anastasia Ivanova, Christopher Jennison, Inna Perevozskaya, Guochen Song
Designing an oncology clinical program is more challenging than designing a single study. The standard approaches have been proven to be not very successful during the last decade; the failure rate of Phase 2 and Phase 3 trials in oncology remains high. Improving a development strategy by applying innovative statistical methods is one of the major objectives of a drug development process. The oncology sub-team on Adaptive Program under the Drug Information Association Adaptive Design Scientific Working Group (DIA ADSWG) evaluated hypothetical oncology programs with two competing treatments and published the work in the Therapeutic Innovation and Regulatory Science journal in January 2014...
February 7, 2017: Journal of Biopharmaceutical Statistics
https://www.readbyqxmd.com/read/28271997/a-retrospective-study-of-clinical-profile-and-long-term-outcome-to-imatinib-mesylate-alone-in-childhood-chronic-myeloid-leukemia-in-chronic-phase
#18
(no author information available yet)
OBJECTIVE: Chronic myeloid leukemia (CML) is relatively rare malignancy in childhood. There are limited studies of use of Imatinib Mesylate (IM) alone in management of CML in this age group. METHOD: We retrospectively analyzed the outcome of 30 consecutive children with CML chronic phase treated with IM alone. RESULTS: The median age at the time of diagnosis was 11 years with male preponderance. Asthenia and abdominal discomfort due to splenomegaly were the most common presenting features and splenomegaly a dominant sign...
January 2017: Gulf Journal of Oncology
https://www.readbyqxmd.com/read/28270162/a-phase-ii-study-of-concurrent-chemoradiotherapy-combined-with-a-weekly-paclitaxel-and-5-fluorouracil-regimen-to-treat-patients-with-advanced-oesophageal-carcinoma
#19
Yi Xia, Yun-Hai Li, Yun Chen, Jun-Hua Zhang, Qi Liu, Jia-Ying Deng, Ta-Shan Ai, Han-Ting Zhu, Jian-Hong Fan, Harun Badakhshi, Kuai-le Zhao
BACKGROUND: A phase II study was performed to investigate the safety and efficacy of weekly doses of combined paclitaxel and 5-fluorouracil (5-FU) with concurrent radiation therapy, followed by 2 cycles of consolidation chemotherapy to treat patients with advanced oesophageal carcinoma. METHODS: The eligibility criteria included local, advanced, newly diagnosed and postoperative local regional lymph node metastasis; an Eastern Cooperative Oncology Group (ECOG) score of ≤ 2; and adequate organ function...
March 7, 2017: Radiation Oncology
https://www.readbyqxmd.com/read/28267243/overall-survival-of-1st-line-axitinib-in-metastatic-renal-cell-carcinoma-japanese-subgroup-analysis-from-phase-ii-study
#20
Mototsugu Oya, Yoshihiko Tomita, Satoshi Fukasawa, Nobuo Shinohara, Tomonori Habuchi, Brian I Rini, Yosuke Fujii, Yoichi Kamei, Yoshiko Umeyama, Angel H Bair, Hirotsugu Uemura
Subgroup analyses of a randomized global phase II study of axitinib showed objective response rate of 66% and median progression-free survival of 27.6 months in treatment-naïve Japanese patients with metastatic renal cell carcinoma (RCC). This analysis evaluated overall survival (OS) and updated safety in 44 Japanese patients and compared with 169 non-Japanese patients. In addition, baseline characteristics for predictive factors that may influence OS in first-line metastatic RCC were explored using a Cox proportional hazard model in all patients...
March 7, 2017: Cancer Science
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