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https://www.readbyqxmd.com/read/28819727/abiraterone-acetate-a-review-in-metastatic-castration-resistant-prostrate-cancer
#1
Lesley J Scott
Oral abiraterone acetate (Zytiga(®)) is a selective inhibitor of CYP17 and thereby inhibits androgen biosynthesis, with androgen signalling crucial in the progression from primary to metastatic prostate cancer (PC) and subsequently, in the development of metastatic castration-resistant PC (mCRPC). In large phase 3 trials and in the clinical practice setting, oral abiraterone acetate in combination with prednisone was an effective treatment and had an acceptable, manageable tolerability and safety profile in chemotherapy-naive and docetaxel-experienced men with mCRPC...
August 17, 2017: Drugs
https://www.readbyqxmd.com/read/28818493/progression-free-survival-and-time-to-progression-as-real-surrogate-end-points-for-overall-survival%C3%A2-in-advanced-breast-cancer-a-meta-analysis-of-37-trials
#2
Ling Li, Zhanyu Pan
BACKGROUND: Progression-free survival (PFS) and time to progression (TTP) have been reported to correlate with overall survival (OS) in several cancer types. To our knowledge, however, the correlation between them is unclear. METHODS: A literature-based meta-analysis was performed to assess whether PFS and TTP can be considered reliable surrogate end points for OS in a phase 3 clinical trial of advanced breast cancer (ABC). The median hazard ratios of PFS/TTP and OS were analyzed by determining their nonparametric Spearman rank correlation coefficients (Rs)...
July 25, 2017: Clinical Breast Cancer
https://www.readbyqxmd.com/read/28817175/drug-development-for-breast-colorectal-and-non-small-cell-lung-cancers-from-1979-to-2014
#3
Nancy A Nixon, Omar F Khan, Hasiba Imam, Patricia A Tang, Jose Monzon, Haocheng Li, Gavin Sun, Doreen Ezeife, Sunil Parimi, Scot Dowden, Vincent C Tam
BACKGROUND: Understanding the drug development pathway is critical for streamlining the development of effective cancer treatments. The objective of the current study was to delineate the drug development timeline and attrition rate of different drug classes for common cancer disease sites. METHODS: Drugs entering clinical trials for breast, colorectal, and non-small cell lung cancer were identified using a pharmaceutical business intelligence database. Data regarding drug characteristics, clinical trials, and approval dates were obtained from the database, clinical trial registries, PubMed, and regulatory Web sites...
August 17, 2017: Cancer
https://www.readbyqxmd.com/read/28805135/intermittent-dosing-of-dabrafenib-and-trametinib-in-metastatic-brafv600e-mutated-papillary-thyroid-cancer-two-case-reports
#4
Paul S White, Anita Pudusseri, Stephanie L Lee, Omar Eton
BACKGROUND: A multi-institutional randomized Phase II trial of continuous dosing of dabrafenib with or without trametinib is ongoing in metastatic thyroid cancer. Preclinical evidence and emerging clinical experience in other cancers support evaluating intermittent dosing of these two agents to achieve more durable response, while being better tolerated and more cost effective. PATIENTS: Two consecutive patients with symptomatic, metastatic radioactive iodine (RAI) resistant BRAF V600E mutated papillary thyroid cancer and poor performance status were treated initially with dabrafenib 150mg twice daily plus trametinib 2mg once daily, first in continuous daily dosing, then in a five-week-on and three-week-off schedule...
August 12, 2017: Thyroid: Official Journal of the American Thyroid Association
https://www.readbyqxmd.com/read/28791622/lenalidomide-a-review-in-newly-diagnosed-multiple-myeloma-as-maintenance-therapy-after-asct
#5
Yahiya Y Syed
Lenalidomide (Revlimid(®)) is an immunomodulatory drug with multiple mechanisms of action against multiple myeloma. It is a thalidomide analogue, with improved potency and reduced toxicity compared with thalidomide. In the EU and USA, lenalidomide monotherapy is indicated for the maintenance treatment of patients with newly diagnosed multiple myeloma who have undergone autologous stem-cell transplantation (ASCT). In the pivotal, phase 3 IFM 2005-02 and CALGB 100104 trials, lenalidomide maintenance therapy after ASCT administered until disease progression significantly prolonged progression-free survival (PFS; primary endpoint) relative to placebo in patients with newly diagnosed multiple myeloma...
August 8, 2017: Drugs
https://www.readbyqxmd.com/read/28782266/population-exposure-response-modeling-supported-selection-of-naloxegol-doses-in-phase-3-studies-in-patients-with-opioid-induced-constipation
#6
Nidal Al-Huniti, Hongmei Xu, Diansong Zhou, Sergey Aksenov, Robert Fox, Khanh H Bui
Naloxegol is approved for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain. Population exposure-response models were developed using data from a Phase 2 study comprising 185 adults with OIC. The weekly probability of response defined as having ≥3/week spontaneous bowel movements (SBMs) and ≥1 SBM/week increase over baseline was characterized by a longitudinal mixed-effects logistic regression dose-response model, and the probability of time to discontinuation was modeled with a Weibull distribution function...
August 7, 2017: CPT: Pharmacometrics & Systems Pharmacology
https://www.readbyqxmd.com/read/28781171/first-line-selective-internal-radiotherapy-plus-chemotherapy-versus-chemotherapy-alone-in-patients-with-liver-metastases-from-colorectal-cancer-foxfire-sirflox-and-foxfire-global-a-combined-analysis-of-three-multicentre-randomised-phase-3-trials
#7
Harpreet S Wasan, Peter Gibbs, Navesh K Sharma, Julien Taieb, Volker Heinemann, Jens Ricke, Marc Peeters, Michael Findlay, Andrew Weaver, Jamie Mills, Charles Wilson, Richard Adams, Anne Francis, Joanna Moschandreas, Pradeep S Virdee, Peter Dutton, Sharon Love, Val Gebski, Alastair Gray, Guy van Hazel, Ricky A Sharma
BACKGROUND: Data suggest selective internal radiotherapy (SIRT) in third-line or subsequent therapy for metastatic colorectal cancer has clinical benefit in patients with colorectal liver metastases with liver-dominant disease after chemotherapy. The FOXFIRE, SIRFLOX, and FOXFIRE-Global randomised studies evaluated the efficacy of combining first-line chemotherapy with SIRT using yttrium-90 resin microspheres in patients with metastatic colorectal cancer with liver metastases. The studies were designed for combined analysis of overall survival...
August 3, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28779963/partial-breast-radiotherapy-after-breast-conservation-surgery-for-patients-with-early-breast-cancer-uk-import-low-trial-5-year-results-from-a-multicentre-randomised-controlled-phase-3-non-inferiority-trial
#8
Charlotte E Coles, Clare L Griffin, Anna M Kirby, Jenny Titley, Rajiv K Agrawal, Abdulla Alhasso, Indrani S Bhattacharya, Adrian M Brunt, Laura Ciurlionis, Charlie Chan, Ellen M Donovan, Marie A Emson, Adrian N Harnett, Joanne S Haviland, Penelope Hopwood, Monica L Jefford, Ronald Kaggwa, Elinor J Sawyer, Isabel Syndikus, Yat M Tsang, Duncan A Wheatley, Maggie Wilcox, John R Yarnold, Judith M Bliss
BACKGROUND: Local cancer relapse risk after breast conservation surgery followed by radiotherapy has fallen sharply in many countries, and is influenced by patient age and clinicopathological factors. We hypothesise that partial-breast radiotherapy restricted to the vicinity of the original tumour in women at lower than average risk of local relapse will improve the balance of beneficial versus adverse effects compared with whole-breast radiotherapy. METHODS: IMPORT LOW is a multicentre, randomised, controlled, phase 3, non-inferiority trial done in 30 radiotherapy centres in the UK...
August 2, 2017: Lancet
https://www.readbyqxmd.com/read/28774879/outcomes-in-refractory-diffuse-large-b-cell-lymphoma-results-from-the-international-scholar-1-study
#9
Michael Crump, Sattva S Neelapu, Umar Farooq, Eric Van Den Neste, John Kuruvilla, Jason Westin, Brian K Link, Annette Hay, James R Cerhan, Liting Zhu, Sami Boussetta, Lei Feng, Matthew J Maurer, Lynn Navale, Jeff Wiezorek, William Y Go, Christian Gisselbrecht
Diffuse large B-cell lymphoma (DLBCL) is the most common subtype of non-Hodgkin lymphoma. Although 5-year survival rates in the first-line setting range from 60% to 70%, up to 50% of patients become refractory to or relapse after treatment. Published analyses of large-scale outcome data from patients with refractory DLBCL are limited. The international, multicohort retrospective non-Hodgkin lymphomaresearch (SCHOLAR-1) study retrospectively evaluated outcomes in patients with refractory DLBCL, which, for this study, was defined as progressive disease or stable disease as best response at any point during chemotherapy (>4 cycles of first-line or 2 cycles of later-line therapy) or relapsed ≤12 months of autologous stem cell transplantation...
August 3, 2017: Blood
https://www.readbyqxmd.com/read/28760403/health-related-quality-of-life-for-immediate-versus-delayed-androgen-deprivation-therapy-in-patients-with-asymptomatic-non-curable-prostate-cancer-trog-03-06-and-vcog-pr-01-03-toad-a-randomised-multicentre-non-blinded-phase-3-trial
#10
Gillian M Duchesne, Henry H Woo, Madeleine King, Steven J Bowe, Martin R Stockler, Alice Ames, Catherine D'Este, Mark Frydenberg, Andrew Loblaw, Shawn Malone, Jeremy Millar, Keen Hun Tai, Sandra Turner
BACKGROUND: Androgen-deprivation therapy in patients with prostate cancer who have relapsed with rising prostate-specific antigen concentration only (PSA-only relapse), or with non-curable but asymptomatic disease at diagnosis, could adversely affect quality of life at a time when the disease itself does not. We aimed to compare the effect of immediate versus delayed androgen-deprivation therapy on health-related quality of life over 5 years in men enrolled in the TOAD (Timing of Androgen Deprivation) trial...
July 28, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28758319/treatment-options-for-unresectable-hcc-with-a-focus-on-sirt-with-yttrium-90-resin-microspheres
#11
REVIEW
Eric A Wang, Jeff P Stein, Ross J Bellavia, Scott R Broadwell
Hepatocellular carcinoma (HCC), the predominant form of primary liver cancer, is the second leading cause of cancer-related deaths across the globe. Only a small percentage of HCC patients (~20%-30%) are diagnosed at an early stage when first-line treatment options may be effective. The majority of HCC patients (>70%) are diagnosed with unresectable disease and given a poor overall prognosis. Current treatment guidelines recommend locoregional therapy with transarterial chemoembolisation (TACE) and systemic therapy with sorafenib as first-line treatment for patients with intermediate and advanced stage HCC...
July 30, 2017: International Journal of Clinical Practice
https://www.readbyqxmd.com/read/28756902/bevacizumab-for-advanced-cervical-cancer-final-overall-survival-and-adverse-event-analysis-of-a-randomised-controlled-open-label-phase-3-trial-gynecologic-oncology-group-240
#12
Krishnansu S Tewari, Michael W Sill, Richard T Penson, Helen Huang, Lois M Ramondetta, Lisa M Landrum, Ana Oaknin, Thomas J Reid, Mario M Leitao, Helen E Michael, Philip J DiSaia, Larry J Copeland, William T Creasman, Frederick B Stehman, Mark F Brady, Robert A Burger, J Tate Thigpen, Michael J Birrer, Steven E Waggoner, David H Moore, Katherine Y Look, Wui-Jin Koh, Bradley J Monk
BACKGROUND: On Aug 14, 2014, the US Food and Drug Administration approved the antiangiogenesis drug bevacizumab for women with advanced cervical cancer on the basis of improved overall survival (OS) after the second interim analysis (in 2012) of 271 deaths in the Gynecologic Oncology Group (GOG) 240 trial. In this study, we report the prespecified final analysis of the primary objectives, OS and adverse events. METHODS: In this randomised, controlled, open-label, phase 3 trial, we recruited patients with metastatic, persistent, or recurrent cervical carcinoma from 81 centres in the USA, Canada, and Spain...
July 27, 2017: Lancet
https://www.readbyqxmd.com/read/28754483/olaparib-tablets-as-maintenance-therapy-in-patients-with-platinum-sensitive-relapsed-ovarian-cancer-and-a-brca1-2-mutation-solo2-engot-ov21-a-double-blind-randomised-placebo-controlled-phase-3-trial
#13
Eric Pujade-Lauraine, Jonathan A Ledermann, Frédéric Selle, Val Gebski, Richard T Penson, Amit M Oza, Jacob Korach, Tomasz Huzarski, Andrés Poveda, Sandro Pignata, Michael Friedlander, Nicoletta Colombo, Philipp Harter, Keiichi Fujiwara, Isabelle Ray-Coquard, Susana Banerjee, Joyce Liu, Elizabeth S Lowe, Ralph Bloomfield, Patricia Pautier
BACKGROUND: Olaparib, a poly(ADP-ribose) polymerase (PARP) inhibitor, has previously shown efficacy in a phase 2 study when given in capsule formulation to all-comer patients with platinum-sensitive, relapsed high-grade serous ovarian cancer. We aimed to confirm these findings in patients with a BRCA1 or BRCA2 (BRCA1/2) mutation using a tablet formulation of olaparib. METHODS: This international, multicentre, double-blind, randomised, placebo-controlled, phase 3 trial evaluated olaparib tablet maintenance treatment in platinum-sensitive, relapsed ovarian cancer patients with a BRCA1/2 mutation who had received at least two lines of previous chemotherapy...
July 25, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28753863/exploratory-subgroup-analyses-of-renal-function-and-overall-survival-in-european-organization-for-research-and-treatment-of-cancer-randomized-trial-of-nephron-sparing-surgery-versus-radical-nephrectomy
#14
Emil Scosyrev, Edward M Messing, Richard Sylvester, Hendrik Van Poppel
BACKGROUND: In the European Organization for Research and Treatment of Cancer (EORTC) randomized trial 30904, nephron-sparing surgery (NSS) reduced the risk of renal dysfunction compared with radical nephrectomy (RN); however, overall survival was better in the RN arm. OBJECTIVE: To determine whether treatment effect on the risk of renal dysfunction and all-cause mortality differed in magnitude across levels of baseline variables. DESIGN, SETTING, AND PARTICIPANTS: This was an exploratory subgroup analysis of EORTC 30904, a phase 3 randomized trial conducted in patients with a small (≤5cm) renal mass and normal contralateral kidney...
April 4, 2017: European Urology Focus
https://www.readbyqxmd.com/read/28750133/role-of-cytotoxic-tumor-infiltrating-lymphocytes-in-predicting-outcomes-in-metastatic-her2-positive-breast-cancer-a-secondary-analysis-of-a-randomized-clinical-trial
#15
Shuzhen Liu, Bingshu Chen, Samantha Burugu, Samuel Leung, Dongxia Gao, Shakeel Virk, Zuzana Kos, Wendy R Parulekar, Lois Shepherd, Karen A Gelmon, Torsten O Nielsen
Importance: Accumulating evidence indicates that tumor-infiltrating lymphocytes (TILs) are associated with clinical outcomes and may predict the efficacy of chemotherapy and human epidermal growth factor receptor 2 (HER2, encoded by the gene ERBB2)-targeted therapy in patients with HER2-positive breast cancer. Objective: To investigate the role of TILs, particularly cytotoxic CD8+ T cells, in the prediction of outcomes in patients with HER2-positive metastatic breast cancer randomized to an antibody-based (trastuzumab) vs a small molecule-based (lapatinib) anti-HER2 therapy...
July 27, 2017: JAMA Oncology
https://www.readbyqxmd.com/read/28748331/eligibility-for-phase-3-clinical-trials-of-systemic-therapy-in-real-world-patients-with-metastatic-renal-cell-cancer-managed-in-a-rural-region
#16
Carsten Nieder, Mohsan A Syed, Astrid Dalhaug, Adam Pawinski, Jan Norum
Previous research has identified disparities between urban and rural cancer care, including clinical trial access. Therefore, we addressed three different questions in patients with metastatic renal cell cancer managed according to national guidelines in a rural Norwegian standard practice setting. (1) How many patients would have been eligible for three recent landmark randomized clinical trials? (2) Is survival different between eligible and non-eligible patients receiving first-line systemic therapy? (3) Is survival different between eligible patients and published trial results? We performed a retrospective analysis of 101 consecutive patients (2006-2016)...
September 2017: Medical Oncology
https://www.readbyqxmd.com/read/28741453/no-effect-of-levothyroxine-and-levothyroxine-induced-subclinical-thyrotoxicosis-on-the-pharmacokinetics-of-sorafenib-in-healthy-male-subjects
#17
Funan Huang, Antoinette Ajavon-Hartmann, Erya Huang, John Lettieri, Rong Liu, Carol Pena, Matthias Berse
<b>Background</b>: Patients receiving the multikinase inhibitor sorafenib for locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) refractory to radioactive iodine often receive concomitant levothyroxine for thyroid-stimulating hormone (TSH) suppression. In the phase 3 DTC trial (DECISION), sorafenib exposure was ~2-fold higher than that observed in other cancers. We assessed sorafenib pharmacokinetics without and with concomitant levothyroxine to examine whether a levothyroxine interaction or levothyroxine-induced subclinical thyrotoxicosis results in increased sorafenib exposure in DTC patients...
July 25, 2017: Thyroid: Official Journal of the American Thyroid Association
https://www.readbyqxmd.com/read/28734822/icotinib-versus-whole-brain-irradiation-in-patients-with-egfr-mutant-non-small-cell-lung-cancer-and-multiple-brain-metastases-brain-a-multicentre-phase-3-open-label-parallel-randomised-controlled-trial
#18
Jin-Ji Yang, Caicun Zhou, Yisheng Huang, Jifeng Feng, Sun Lu, Yong Song, Cheng Huang, Gang Wu, Li Zhang, Ying Cheng, Chengping Hu, Gongyan Chen, Li Zhang, Xiaoqing Liu, Hong Hong Yan, Fen Lai Tan, Wenzhao Zhong, Yi-Long Wu
BACKGROUND: For patients with non-small-cell lung cancer (NSCLC) and multiple brain metastases, whole-brain irradiation (WBI) is a standard-of-care treatment, but its effects on neurocognition are complex and concerning. We compared the efficacy of an epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI), icotinib, versus WBI with or without chemotherapy in a phase 3 trial of patients with EGFR-mutant NSCLC and multiple brain metastases. METHODS: We did a multicentre, open-label, parallel randomised controlled trial (BRAIN) at 17 hospitals in China...
July 19, 2017: Lancet Respiratory Medicine
https://www.readbyqxmd.com/read/28732650/adjuvant-tamoxifen-and-exemestane-in-women-with-postmenopausal-early-breast-cancer-team-10-year-follow-up-of-a-multicentre-open-label-randomised-phase-3-trial
#19
Marloes G M Derks, Erik J Blok, Caroline Seynaeve, Johan W R Nortier, Elma Meershoek-Klein Kranenbarg, Gerrit-Jan Liefers, Hein Putter, Judith R Kroep, Daniel Rea, Annette Hasenburg, Christos Markopoulos, Robert Paridaens, Jan B E Smeets, Luc Y Dirix, Cornelis J H van de Velde
BACKGROUND: After 5 years of median follow-up, the Tamoxifen Exemestane Adjuvant Multinational (TEAM) trial reported no difference in disease-free survival between exemestane monotherapy and a sequential scheme of tamoxifen followed by exemestane in postmenopausal patients with early-stage, hormone receptor-positive breast cancer. As recurrence risk in hormone receptor-positive breast cancer remains linear beyond 5 years after diagnosis, we analysed long-term follow-up outcomes of this trial...
July 18, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28723675/tumor-antigen-ca125-suppresses-antibody-dependent-cellular-cytotoxicity-adcc-via-direct-antibody-binding-and-suppressed-fc-%C3%AE-receptor-engagement
#20
James Bradford Kline, Rina P Kennedy, Earl Albone, Qimin Chao, Shawn Fernando, Jennifer M McDonough, Katherine Rybinski, Wenquan Wang, Elizabeth B Somers, Charles Schweizer, Luigi Grasso, Nicholas C Nicolaides
Cancers employ a number of mechanisms to evade host immune responses. Here we report the effects of tumor-shed antigen CA125/MUC16 on suppressing IgG1-mediated antibody-dependent cellular cytotoxicity (ADCC). This evidence stems from prespecified subgroup analysis of a Phase 3 clinical trial testing farletuzumab, a monoclonal antibody to folate receptor alpha, plus standard-of-care carboplatin-taxane chemotherapy in patients with recurrent platinum-sensitive ovarian cancer. Patients with low serum CA125 levels treated with farletuzumab demonstrated improvements in progression free survival (HR 0...
July 7, 2017: Oncotarget
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