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https://www.readbyqxmd.com/read/27908454/fulvestrant-500-mg-versus-anastrozole-1-mg-for-hormone-receptor-positive-advanced-breast-cancer-falcon-an-international-randomised-double-blind-phase-3-trial
#1
John F R Robertson, Igor M Bondarenko, Ekaterina Trishkina, Mikhail Dvorkin, Lawrence Panasci, Alexey Manikhas, Yaroslav Shparyk, Servando Cardona-Huerta, Kwok-Leung Cheung, Manuel Jesus Philco-Salas, Manuel Ruiz-Borrego, Zhimin Shao, Shinzaburo Noguchi, Jacqui Rowbottom, Mary Stuart, Lynda M Grinsted, Mehdi Fazal, Matthew J Ellis
BACKGROUND: Aromatase inhibitors are a standard of care for hormone receptor-positive locally advanced or metastatic breast cancer. We investigated whether the selective oestrogen receptor degrader fulvestrant could improve progression-free survival compared with anastrozole in postmenopausal patients who had not received previous endocrine therapy. METHODS: In this phase 3, randomised, double-blind trial, we recruited eligible patients with histologically confirmed oestrogen receptor-positive or progesterone receptor-positive, or both, locally advanced or metastatic breast cancer from 113 academic hospitals and community centres in 20 countries...
November 28, 2016: Lancet
https://www.readbyqxmd.com/read/27896268/challenges-for-relative-effectiveness-assessment-and-early-access-of-cancer-immunotherapies-in-europe
#2
Mira Pavlovic
Clinical endpoints relevant for relative effectiveness assessment (REA) reflect how patients feel, function, or survive. Outcome data requested by health technology assessment (HTA) bodies in Europe to support reimbursement of an anticancer drug are based on final endpoints coming from completed comparative phase 3 trials; overall survival improvement is the preferred criterion for the demonstration of the patient benefit in this field. Recent arrival of new treatments that target identified functional genetic mutations ("targeted therapies") or PD-1/PD-L1,2 axis ("immunotherapies") and their combinations have profoundly changed treatment strategies in cancers as they considerably improve patient survival, but also raise new challenges in REA and decision-making process in Europe as compared to the REA of "classical" chemotherapies...
2016: Frontiers in Medicine
https://www.readbyqxmd.com/read/27884614/robotic-major-hepatectomy-is%C3%A2-there-a-learning-curve
#3
Po-Da Chen, Chao-Yin Wu, Rey-Heng Hu, Chiung-Nien Chen, Ray-Hwang Yuan, Jin-Tung Liang, Hong-Shiee Lai, Yao-Ming Wu
BACKGROUND: Robotic hepatectomy has been suggested as a safe and effective management of liver disease. However, no large case series have documented the learning curve for robotic major hepatectomy. METHOD: We conducted a retrospective study for robotic major hepatectomy performed by the same operative team between January 2012 and October 2015 and evaluated the learning curve for operation time using the cumulative sum method, presented as cumulative sumoperation time...
November 21, 2016: Surgery
https://www.readbyqxmd.com/read/27882724/efficacy-and-safety-of-darbepoetin-alfa-initiated-at-hemoglobin-%C3%A2-10%C3%A2-g-dl-in-patients-with-stage-iv-cancer-and-chemotherapy-induced-anemia
#4
Ralph V Boccia, David H Henry, Laura Belton, Chet Bohac, Hassan H Ghazal
Data on efficacy and safety of darbepoetin alfa (DA) administered at hemoglobin (Hb) ≤10 g/dL are limited. In this analysis, we examined DA's efficacy and safety in patients with Stage IV cancers and chemotherapy-induced anemia (CIA) initiated on DA at Hb ≤10 g/dL. Data for patients with Stage IV cancers and CIA and who initiated DA at Hb ≤10 g/dL were extracted from three phase 3 trials identified in a central database of Amgen-sponsored DA studies in CIA. Efficacy outcomes were assessed by achievement of Hb increases of ≥1 g/dL and ≥2 g/dL and red blood cell (RBC) or whole blood transfusion requirements...
November 23, 2016: Cancer Medicine
https://www.readbyqxmd.com/read/27871271/assessing-the-acceptability-and-feasibility-of-encounter-decision-aids-for-early-stage-breast-cancer-targeted-at-underserved-patients
#5
Shama Alam, Glyn Elwyn, Sanja Percac-Lima, Stuart Grande, Marie-Anne Durand
BACKGROUND: Women of low socioeconomic status (SES) diagnosed with early stage breast cancer are less likely to be involved in treatment decisions. They tend to report higher decisional regret and poorer communication. Evidence suggests that well-designed encounter decision aids (DAs) could improve outcomes and potentially reduce healthcare disparities. Our goal was to evaluate the acceptability and feasibility of encounter decision aids (Option Grid, Comic Option Grid, and Picture Option Grid) adapted for a low-SES and low-literacy population...
November 21, 2016: BMC Medical Informatics and Decision Making
https://www.readbyqxmd.com/read/27869081/long-term-update-of-nrg-oncology-rtog-0319-a-phase-1-and-2%C3%A2-trial-to-evaluate-3-dimensional-conformal-radiation-therapy-confined-to-the-region-of%C3%A2-the%C3%A2-lumpectomy-cavity-for-stage-i-and-ii-breast%C3%A2-carcinoma
#6
Rachel Rabinovitch, Jennifer Moughan, Frank Vicini, Helen Pass, John Wong, Susan Chafe, Ivy Petersen, Douglas W Arthur, Julia White
PURPOSE: NRG Oncology RTOG 0319 was the first cooperative group trial in the United States to evaluate 3-dimensional conformal radiation therapy (3D-CRT) accelerated partial breast irradiation (APBI). This report updates secondary endpoints of toxicity and efficacy. METHODS AND MATERIALS: Patients with stage I or II invasive breast cancer (tumor size ≤3 cm, ≤3 positive lymph nodes, negative margins) were eligible for 3D-CRT APBI: 38.5 Gy in 10 twice-daily fractions...
December 1, 2016: International Journal of Radiation Oncology, Biology, Physics
https://www.readbyqxmd.com/read/27866835/over-using-chemotherapy-in-the-adjuvant-setting
#7
Giuseppe Curigliano, Carmen Criscitiello, Angela Esposito, Giancarlo Pruneri
Avoidance of unnecessary or ineffective treatment should be one of the main goals in adjuvant breast oncology today. Unfortunately, both patients and doctors hunt for tiny statistical differences in survival curves. This search could not only lead to an oncological approach of unlimited addition that we will not be able to afford, but would also end inevitably in indeterminate overtreatment with substantial risks of unexpected toxic effects eating away whatever progress we might make. "Do not harm" remains the main principle in medicine...
November 17, 2016: Breast: Official Journal of the European Society of Mastology
https://www.readbyqxmd.com/read/27865821/the-effects-of-tumor-treating-fields-and-temozolomide-in-mgmt-expressing-and-non-expressing-patient-derived-glioblastoma-cells
#8
Paul A Clark, Jordan T Gaal, Joslyn K Strebe, Cheri A Pasch, Dustin A Deming, John S Kuo, H Ian Robins
A recent Phase 3 study of newly diagnosed glioblastoma (GBM) demonstrated the addition of tumor treating fields (TTFields) to temozolomide (TMZ) after combined radiation/TMZ significantly increased survival and progression free survival. Preliminary data suggested benefit with both methylated and unmethylated O-6-methylguanine-DNA methyl-transferase (MGMT) promoter status. To date, however, there have been no studies to address the potential interactions of TTFields and TMZ. Thus, the effects of TTFields and TMZ were studied in vitro using patient-derived GBM stem-like cells (GSCs) including MGMT expressing (TMZ resistant: 12...
November 16, 2016: Journal of Clinical Neuroscience: Official Journal of the Neurosurgical Society of Australasia
https://www.readbyqxmd.com/read/27864015/prediction-of-overall-survival-for-patients-with-metastatic-castration-resistant-prostate-cancer-development-of-a-prognostic-model-through-a-crowdsourced-challenge-with-open-clinical-trial-data
#9
Justin Guinney, Tao Wang, Teemu D Laajala, Kimberly Kanigel Winner, J Christopher Bare, Elias Chaibub Neto, Suleiman A Khan, Gopal Peddinti, Antti Airola, Tapio Pahikkala, Tuomas Mirtti, Thomas Yu, Brian M Bot, Liji Shen, Kald Abdallah, Thea Norman, Stephen Friend, Gustavo Stolovitzky, Howard Soule, Christopher J Sweeney, Charles J Ryan, Howard I Scher, Oliver Sartor, Yang Xie, Tero Aittokallio, Fang Liz Zhou, James C Costello
BACKGROUND: Improvements to prognostic models in metastatic castration-resistant prostate cancer have the potential to augment clinical trial design and guide treatment strategies. In partnership with Project Data Sphere, a not-for-profit initiative allowing data from cancer clinical trials to be shared broadly with researchers, we designed an open-data, crowdsourced, DREAM (Dialogue for Reverse Engineering Assessments and Methods) challenge to not only identify a better prognostic model for prediction of survival in patients with metastatic castration-resistant prostate cancer but also engage a community of international data scientists to study this disease...
November 15, 2016: Lancet Oncology
https://www.readbyqxmd.com/read/27853999/quantifying-the-exposure-of-tapentadol-extended-release-in-japanese-patients-with-cancer-pain-and-bridging-tapentadol-pharmacokinetics-across-populations-using-a-modeling-approach
#10
Liping Zhang, Xiaoyu Yan, Sayori Nobe, Peter Zannikos, Mila Etropolski, Partha Nandy
BACKGROUND AND OBJECTIVES: Tapentadol extended release (ER) is approved for the management of chronic and acute pain in adults. There has been no report of tapentadol ER pharmacokinetics in subjects with cancer pain. This analysis investigated tapentadol ER pharmacokinetics in Japanese patients with cancer pain and bridged it with the pharmacokinetics in Japanese healthy subjects and Caucasian patients with cancer pain. METHODS: Nonlinear mixed-effect pharmacokinetic modeling was conducted based on pooled tapentadol ER concentration data collected in five Phase 1 studies from 138 Japanese and Korean healthy subjects and in two Phase 3 studies from 215 Japanese and Korean subjects with cancer pain...
November 17, 2016: Clinical Drug Investigation
https://www.readbyqxmd.com/read/27843627/twenty-years-of-anti-her2-therapy-associated-cardiotoxicity
#11
REVIEW
Noam F Pondé, Matteo Lambertini, Evandro de Azambuja
Over the past 20 years, the prognosis of HER2-positive breast cancer has been transformed by the development of anti-HER2 targeted therapies. In early clinical trials of trastuzumab (ie, the first anti-HER2 agent to be developed) cardiotoxicity became a major concern. In the first published phase 3 trial of trastuzumab, 27% of patients receiving anthracyclines and trastuzumab experienced cardiac events and 16% suffered from severe congestive heart failure. In subsequent trials conducted in advanced and early settings, the incidence of cardiac events was reduced through changes in chemotherapy regimens, more strict patient selection and close cardiac assessment...
2016: ESMO Open
https://www.readbyqxmd.com/read/27843597/quality-of-life-during-first-line-folfox4%C3%A2-panitumumab-in-ras-wild-type-metastatic-colorectal-carcinoma-results-from-a-randomised-controlled-trial
#12
Salvatore Siena, Josep Tabernero, Gyorgy Bodoky, David Cunningham, Fernando Rivera, Paul Ruff, Jean Luc Canon, Reija Koukakis, Gaston Demonty, Guy Hechmati, Jean-Yves Douillard
INTRODUCTION: Metastatic colorectal cancer is rarely curable. Improving quality of life is therefore a key treatment goal. We report quality of life for patients with RAS wild-type metastatic colorectal cancer in the PRIME study. METHODS: A randomised phase 3 open-label study of first-line panitumumab+FOLFOX4 vs FOLFOX4 enrolled adults with untreated metastatic colorectal cancer and an Eastern Cooperative Oncology Group performance status of 0-2. This analysis includes patients with wild-type RAS tumours (n=505)...
2016: ESMO Open
https://www.readbyqxmd.com/read/27830957/health-related-quality-of-life-and-patient-reported-outcomes-of-ofatumumab-plus-fludarabine-and-cyclophosphamide-versus-fludarabine-and-cyclophosphamide-in-the-complement-2-trial-of-patients-with-relapsed-cll
#13
Tadeusz Robak, Krzysztof Warzocha, K Govind Babu, Yaroslav Kulyaba, Kazimierz Kuliczkowski, Kudrat Abdulkadyrov, Javier Loscertales, Iryna Kryachok, Janusz Kłoczko, Grygoriy Rekhtman, Wojciech Homenda, Jerzy Z Błoński, Astrid McKeown, Chai-Ni Chang, Vasudha Bal, Steen Lisby, Ira V Gupta, Sebastian Grosicki
Chronic lymphocytic leukemia (CLL) is an incurable disease. Quality of life during treatment and periods of subsequent remission is therefore vital. Health-related quality of life (HRQoL) was compared in relapsed CLL during and after treatment with ofatumumab combined with fludarabine and cyclophosphamide versus fludarabine and cyclophosphamide alone. The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 v3 and QLQ-CLL16 were used to assess HRQoL in this open-label, phase 3 study. Improvements in prespecified domains of patient-reported outcomes (Global Health Status [GHS]/HRQoL and B symptom scores) were recorded in both treatment arms after three cycles and were sustained after 18 months of follow-up...
November 10, 2016: Leukemia & Lymphoma
https://www.readbyqxmd.com/read/27826132/increasing-complexity-in-rule-based-clinical-decision-support-the-symptom-assessment-and-management-intervention
#14
David F Lobach, Ellis B Johns, Barbara Halpenny, Toni-Ann Saunders, Jane Brzozowski, Guilherme Del Fiol, Donna L Berry, Ilana M Braun, Kathleen Finn, Joanne Wolfe, Janet L Abrahm, Mary E Cooley
BACKGROUND: Management of uncontrolled symptoms is an important component of quality cancer care. Clinical guidelines are available for optimal symptom management, but are not often integrated into the front lines of care. The use of clinical decision support (CDS) at the point-of-care is an innovative way to incorporate guideline-based symptom management into routine cancer care. OBJECTIVE: The objective of this study was to develop and evaluate a rule-based CDS system to enable management of multiple symptoms in lung cancer patients at the point-of-care...
November 8, 2016: JMIR Medical Informatics
https://www.readbyqxmd.com/read/27825007/effect-of-tailored-dose-dense-chemotherapy-vs-standard-3-weekly-adjuvant-chemotherapy-on-recurrence-free-survival-among-women-with-high-risk-early-breast-cancer-a-randomized-clinical-trial
#15
Theodoros Foukakis, Gunter von Minckwitz, Nils-Olof Bengtsson, Yvonne Brandberg, Birgitta Wallberg, Tommy Fornander, Brigitte Mlineritsch, Sabine Schmatloch, Christian F Singer, Günther Steger, Daniel Egle, Eva Karlsson, Lena Carlsson, Sibylle Loibl, Michael Untch, Mats Hellström, Hemming Johansson, Harald Anderson, Per Malmström, Michael Gnant, Richard Greil, Volker Möbus, Jonas Bergh
Importance: Standard dosing of chemotherapy based on body surface area results in marked interpatient variation in pharmacokinetics, toxic effects, and efficacy. Whether tailored dosing can improve outcomes is unknown, as is the role of dose-dense adjuvant chemotherapy. Objective: To determine whether tailored dose-dense adjuvant chemotherapy improves the outcomes of early breast cancer compared with a standard 3-weekly chemotherapy schedule. Design, Setting, and Participants: A randomized, open-label, phase 3 trial of women aged 65 years and younger who had surgery for nonmetastatic node-positive or high-risk node-negative breast cancer at 86 sites in Sweden, Germany, and Austria between February 20, 2007, and September 14, 2011...
November 8, 2016: JAMA: the Journal of the American Medical Association
https://www.readbyqxmd.com/read/27821320/significant-increase-of-synchronous-disease-in-first-line-metastatic-colorectal-cancer-trials-results-of-a-systematic-review
#16
REVIEW
Kaitlyn K H Goey, Jorine 't Lam-Boer, Johannes H W de Wilt, Cornelis J A Punt, Martijn G H van Oijen, Miriam Koopman
BACKGROUND: Although synchronous and metachronous metastases are considered as separate entities of metastatic colorectal cancer (mCRC) with different outcomes, its proportion is reported infrequently. We compared inclusion rates and survival of synchronous versus metachronous mCRC in different types of studies investigating initial systemic therapy or surgical treatment of mCRC. METHODS: We searched PubMed and EMBASE (January 2004 - February 2016) for mCRC studies investigating first-line systemic therapy or surgical treatment of mCRC including information on synchronous versus metachronous metastases...
November 4, 2016: European Journal of Cancer
https://www.readbyqxmd.com/read/27812689/association-of-polymorphisms-in-fcgr2a-and-fcgr3a-with-degree-of-trastuzumab-benefit-in-the-adjuvant-treatment-of-erbb2-her2-positive-breast-cancer-analysis-of-the-nsabp-b-31-trial
#17
Patrick G Gavin, Nan Song, S Rim Kim, Corey Lipchik, Nicole L Johnson, Hanna Bandos, Melanie Finnigan, Priya Rastogi, Louis Fehrenbacher, Eleftherios P Mamounas, Sandra M Swain, D Lawrence Wickerham, Charles E Geyer, Jong-Hyeon Jeong, Joseph P Costantino, Norman Wolmark, Soonmyung Paik, Kay L Pogue-Geile
Importance: Preclinical models and studies in the metastatic and neoadjuvant settings suggest that single nucleotide polymorphisms in FCGR3A and FCGR2A may be associated with differential response to trastuzumab in the treatment of ERBB2/HER2-positive breast cancer, by modulating antibody-dependent cell-mediated cytotoxic effects. Objective: To evaluate the effect of FCGR2A and FCGR3A polymorphisms on trastuzumab efficacy in the adjuvant treatment of ERBB2/HER2-positive breast cancer...
November 3, 2016: JAMA Oncology
https://www.readbyqxmd.com/read/27810567/development-of-the-eortc-qlq-cax24-a-questionnaire-for-cancer-patients-with-cachexia
#18
S J Wheelwright, J B Hopkinson, A-S Darlington, D F Fitzsimmons, P Fayers, T R Balstad, A Bredart, E Hammerlid, S Kaasa, O Nicolatou-Galitis, M Pinto, H Schmidt, T S Solheim, F Strasser, I M Tomaszewska, C D Johnson
CONTEXT: Cachexia is commonly found in cancer patients and has profound consequences yet there is only one questionnaire that examines the patient's perspective. OBJECTIVE: To report a rigorously developed module for patient self-reported impact of cancer cachexia. METHODS: Module development followed published guidelines. Patients from across the cancer cachexia trajectory were included. In Phase 1, HRQOL issues were generated from a literature review and interviews with patients in four countries...
October 31, 2016: Journal of Pain and Symptom Management
https://www.readbyqxmd.com/read/27806307/rivaroxaban-versus-standard-anticoagulation-for-symptomatic-venous-thromboembolism-remotev-observational-study-analysis-of-6-month-outcomes
#19
Sébastien Gaertner, Elena-Mihaela Cordeanu, Salah Nouri, Alix-Marie Faller, Anne-Sophie Frantz, Corina Mirea, Pascal Bilbault, Patrick Ohlmann, Isabelle Le Ray, Dominique Stephan
BACKGROUND: This study aimed to provide safety and efficacy data of rivaroxaban in routine patient care in a non-selected symptomatic venous thromboembolism (VTE) population. METHODS AND RESULTS: REMOTEV is a prospective, non-interventional study of patients with acute symptomatic VTE, treated with oral rivaroxaban, VKA or parenteral heparin/fondaparinux alone for at least 3months and who are followed up for 6months. From Nov. 2013 to July 2015, 499 consecutive patients were retained for baseline analysis and 445 for safety analysis...
October 19, 2016: International Journal of Cardiology
https://www.readbyqxmd.com/read/27789196/local-consolidative-therapy-versus-maintenance-therapy-or-observation-for-patients-with-oligometastatic-non-small-cell-lung-cancer-without-progression-after-first-line-systemic-therapy-a-multicentre-randomised-controlled-phase-2-study
#20
Daniel R Gomez, George R Blumenschein, J Jack Lee, Mike Hernandez, Rong Ye, D Ross Camidge, Robert C Doebele, Ferdinandos Skoulidis, Laurie E Gaspar, Don L Gibbons, Jose A Karam, Brian D Kavanagh, Chad Tang, Ritsuko Komaki, Alexander V Louie, David A Palma, Anne S Tsao, Boris Sepesi, William N William, Jianjun Zhang, Qiuling Shi, Xin Shelley Wang, Stephen G Swisher, John V Heymach
BACKGROUND: Evidence from retrospective studies suggests that disease progression after first-line chemotherapy for metastatic non-small-cell lung cancer (NSCLC) occurs most often at sites of disease known to exist at baseline. However, the potential effect of aggressive local consolidative therapy for patients with oligometastatic NSCLC is unknown. We aimed to assess the effect of local consolidative therapy on progression-free survival. METHODS: In this multicentre, randomised, controlled, phase 2 study, eligible patients from three hospitals had histological confirmation of stage IV NSCLC, three or fewer metastatic disease lesions after first-line systemic therapy, an Eastern Cooperative Oncology Group performance status score of 2 or less, had received standard first-line systemic therapy, and had no disease progression before randomisation...
October 24, 2016: Lancet Oncology
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