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https://www.readbyqxmd.com/read/28936569/treatment-related-serious-adverse-events-and-fatal-adverse-events-with-regorafenib-in-cancer-patients-a-meta-analysis-of-phase-3-randomized-controlled-trials
#1
REVIEW
Meihui Cao, Feifei Li, Yue Wang, Jingdong Zhang
Regorafenib (Stivarga) is an oral small-molecule multikinase inhibitor commonly used against a variety of cancers. We performed a meta-analysis of all phase 3 randomized controlled trials (RCTs) of regorafenib to quantify the increased risk of SAEs and FAEs. We carried out a systematic search of electronic databases for studies published from inception to February 2017 without any restrictions. Eligibility criteria included phase 3 RCTs of tumors comparing regorafenib, alone or in combination with non-targeted chemotherapy (regorafenib arm) versus placebo or non-targeted chemotherapy (control arm)...
September 22, 2017: Investigational New Drugs
https://www.readbyqxmd.com/read/28923526/results-of-a-double-blind-randomized-placebo-controlled-study-of-nabiximols-oromucosal-spray-as-adjunctive-therapy-in-advanced-cancer-patients-with-chronic-uncontrolled-pain
#2
Aron H Lichtman, Eberhard Albert Lux, Robert McQuade, Sandro Rossetti, Raymond Sanchez, Wei Sun, Stephen Wright, Elena Kornyeyeva, Marie T Fallon
CONTEXT: Prior phase 2/3 studies found that cannabinoids might provide adjunctive analgesia in advanced cancer patients with uncontrolled pain. OBJECTIVE: To assess adjunctive nabiximols (Sativex(®)), an extract of Cannabis sativa containing two potentially therapeutic cannabinoids (Δ9-tetrahydrocannabinol [27 mg/mL] and cannabidiol [25mg/mL]), in advanced cancer patients with chronic pain unalleviated by optimized opioid therapy. METHODS: Phase 3, double-blind, randomized, placebo-controlled trial in patients with advanced cancer and average pain NRS scores ≥ 4 and ≤ 8 despite optimized opioid therapy...
September 15, 2017: Journal of Pain and Symptom Management
https://www.readbyqxmd.com/read/28923101/durable-response-rate-as-an-endpoint-in-cancer-immunotherapy-insights-from-oncolytic-virus-clinical-trials
#3
Howard L Kaufman, Robert H I Andtbacka, Frances A Collichio, Michael Wolf, Zhongyun Zhao, Mark Shilkrut, Igor Puzanov, Merrick Ross
BACKGROUND: Traditional response criteria may be insufficient to characterize full clinical benefits of anticancer immunotherapies. Consequently, endpoints such as durable response rate (DRR; a continuous response [complete or partial objective response] beginning within 12 months of treatment and lasting ≥6 months) have been employed. There has not, however, been validation that DRR correlates with other more traditional endpoints of clinical benefit such as overall survival. METHODS: We evaluated whether DRR was associated with clinically meaningful measures of benefit (eg, overall survival [OS], quality of life [QoL], or treatment-free interval [TFI]) in a phase 3 clinical trial of an oncolytic virus for melanoma treatment...
September 19, 2017: Journal for Immunotherapy of Cancer
https://www.readbyqxmd.com/read/28919712/recent-developments-in-the-clinical-pharmacology-of-rolapitant-subanalyses-in-specific-populations
#4
REVIEW
Bernardo Leon Rapoport, Matti Aapro, Martin R Chasen, Karin Jordan, Rudolph M Navari, Ian Schnadig, Lee Schwartzberg
Knowledge of the involvement of the neurokinin substance P in emesis has led to the development of the neurokinin-1 receptor antagonists (NK-1 RAs) for control of chemotherapy-induced nausea and vomiting (CINV), in combination with serotonin type 3 receptor antagonists and corticosteroids. The NK-1 RA rolapitant, recently approved in oral formulation, has nanomolar affinity for the NK-1 receptor, as do the other commercially available NK-1 RAs, aprepitant and netupitant. Rolapitant is rapidly absorbed and has a long half-life in comparison to aprepitant and netupitant...
2017: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/28916367/rucaparib-maintenance-treatment-for-recurrent-ovarian-carcinoma-after-response-to-platinum-therapy-ariel3-a-randomised-double-blind-placebo-controlled-phase-3-trial
#5
Robert L Coleman, Amit M Oza, Domenica Lorusso, Carol Aghajanian, Ana Oaknin, Andrew Dean, Nicoletta Colombo, Johanne I Weberpals, Andrew Clamp, Giovanni Scambia, Alexandra Leary, Robert W Holloway, Margarita Amenedo Gancedo, Peter C Fong, Jeffrey C Goh, David M O'Malley, Deborah K Armstrong, Jesus Garcia-Donas, Elizabeth M Swisher, Anne Floquet, Gottfried E Konecny, Iain A McNeish, Clare L Scott, Terri Cameron, Lara Maloney, Jeff Isaacson, Sandra Goble, Caroline Grace, Thomas C Harding, Mitch Raponi, James Sun, Kevin K Lin, Heidi Giordano, Jonathan A Ledermann
BACKGROUND: Rucaparib, a poly(ADP-ribose) polymerase inhibitor, has anticancer activity in recurrent ovarian carcinoma harbouring a BRCA mutation or high percentage of genome-wide loss of heterozygosity. In this trial we assessed rucaparib versus placebo after response to second-line or later platinum-based chemotherapy in patients with high-grade, recurrent, platinum-sensitive ovarian carcinoma. METHODS: In this randomised, double-blind, placebo-controlled, phase 3 trial, we recruited patients from 87 hospitals and cancer centres across 11 countries...
September 12, 2017: Lancet
https://www.readbyqxmd.com/read/28915692/biomarker-analysis-of-the-phase-3-torch-trial-for-first-line-erlotinib-versus-chemotherapy-in-advanced-non-small-cell-lung-cancer-patients
#6
Lucia Kim, Mauro Saieg, Massimo Di Maio, Ciro Gallo, Charles Butts, Fortunato Ciardiello, Ronald Feld, Dengxiao Cheng, Vittorio Gebbia, Marco Angelo Burgio, Yasmin Alam, Simona Signoriello, Antonio Rossi, Natasha Leighl, Paolo Maione, Alessandro Morabito, Geoffrey Liu, Ming-Sound Tsao, Francesco Perrone, Cesare Gridelli
BACKGROUND: The TORCH phase III trial compared the efficacy of first-line erlotinib followed by chemotherapy at progression (experimental arm) with the reverse sequence (standard arm) in unselected advanced non-small cell lung cancer (NSCLC) patients. Here we report biomarker analyses. METHODS: EGFR and KRAS mutation, expression of EGFR family members and of cMET and PTEN and EGFR and ABCG2 germline polymorphisms were tested on tumor tissue or blood samples to either confirm previously proposed predictive role or describe it in an explorative setting...
August 22, 2017: Oncotarget
https://www.readbyqxmd.com/read/28911726/novel-concepts-for-initiating-multitargeted-kinase-inhibitors-in-radioactive-iodine-refractory-differentiated-thyroid-cancer
#7
REVIEW
R Michael Tuttle, Marcia S Brose, Enrique Grande, Sun Wook Kim, Makoto Tahara, Mona M Sabra
Multitargeted kinase inhibitors have been shown to improve progression-free survival in patients with structurally progressive, radioactive iodine refractory differentiated thyroid cancer. While the inclusion criteria for phase 3 clinical trials and clinical practice guidelines provide guidance with regard to the minimal requirements that need to be met prior to initiation of a multitargeted kinase inhibitor, a better way to integrate the rate of structural disease progression with the size of the metastatic foci to more precisely define the optimal time to recommend initiation of therapy for individual patients is needed...
June 2017: Best Practice & Research. Clinical Endocrinology & Metabolism
https://www.readbyqxmd.com/read/28911085/a-randomized-open-label-multicenter-phase-3-study-to-compare-the-efficacy-and-safety-of-eribulin-to-treatment-of-physician-s-choice-in-patients-with-advanced-non-small-cell-lung-cancer
#8
N Katakami, E Felip, D R Spigel, J-H Kim, M Olivo, M Guo, H Nokihara, J C-H Yang, N Iannotti, M Satouchi, F Barlesi
Background: Eribulin is a microtubule dynamics inhibitor with a novel mechanism of action. This phase 3 study aimed to compare overall survival (OS) in patients with heavily pretreated non-small cell lung cancer (NSCLC) receiving eribulin to treatment of physician's choice (TPC). Patients and methods: Patients with advanced NSCLC who had received ≥2 prior therapies, including platinum-based doublet and epidermal growth factor receptor tyrosine kinase inhibitor, were randomly assigned to receive eribulin or TPC (gemcitabine, pemetrexed, vinorelbine, docetaxel)...
September 1, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/28911067/maintenance-treatment-with-capecitabine-and-bevacizumab-versus-observation-in-metastatic-colorectal-cancer-updated-results-and-molecular-subgroup-analyses-of-the-phase-3-cairo3-study
#9
K K H Goey, S G Elias, H van Tinteren, M M Laclé, S M Willems, G J A Offerhaus, W W J de Leng, E Strengman, A J Ten Tije, G-J M Creemers, A van der Velden, F E de Jongh, F L G Erdkamp, B C Tanis, C J A Punt, M Koopman
Background: The phase 3 CAIRO3 study showed that capecitabine plus bevacizumab (CAP-B) maintenance treatment after six cycles capecitabine, oxaliplatin, and bevacizumab (CAPOX-B) in metastatic colorectal cancer (mCRC) patients is effective, without compromising quality of life. In this post hoc analysis with updated follow-up and data regarding sidedness, we defined subgroups according to RAS/BRAF mutation status and mismatch repair (MMR) status, and investigated their influence on treatment efficacy...
September 1, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/28899813/re-inventing-drug-development-a-case-study-of-the-i-spy-2-breast-cancer-clinical-trials-program
#10
Sonya Das, Andrew W Lo
BACKGROUND: In this case study, we profile the I-SPY 2 TRIAL (Investigation of Serial studies to Predict Your Therapeutic Response with Imaging And molecular anaLysis 2), a unique breast cancer clinical trial led by researchers at 20 leading cancer centers across the US, and examine its potential to serve as a model of drug development for other disease areas. This multicenter collaboration launched in 2010 to reengineer the drug development process to be more efficient and patient-centered...
September 9, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28898379/effect-of-axillary-dissection-vs-no-axillary-dissection-on-10-year-overall-survival-among-women-with-invasive-breast-cancer-and-sentinel-node-metastasis-the-acosog-z0011-alliance-randomized-clinical-trial
#11
RANDOMIZED CONTROLLED TRIAL
Armando E Giuliano, Karla V Ballman, Linda McCall, Peter D Beitsch, Meghan B Brennan, Pond R Kelemen, David W Ollila, Nora M Hansen, Pat W Whitworth, Peter W Blumencranz, A Marilyn Leitch, Sukamal Saha, Kelly K Hunt, Monica Morrow
Importance: The results of the American College of Surgeons Oncology Group Z0011 (ACOSOG Z0011) trial were first reported in 2005 with a median follow-up of 6.3 years. Longer follow-up was necessary because the majority of the patients had estrogen receptor-positive tumors that may recur later in the disease course (the ACOSOG is now part of the Alliance for Clinical Trials in Oncology). Objective: To determine whether the 10-year overall survival of patients with sentinel lymph node metastases treated with breast-conserving therapy and sentinel lymph node dissection (SLND) alone without axillary lymph node dissection (ALND) is noninferior to that of women treated with axillary dissection...
September 12, 2017: JAMA: the Journal of the American Medical Association
https://www.readbyqxmd.com/read/28887756/development-of-the-pediatric-neuro-oncology-rating-of-treatment-intensity-pnorti
#12
Matthew C Hocking, Wendy Hobbie, Michael J Fisher
Measures of treatment intensity for childhood cancer are needed in research in order to control for variability in treatments. Existing measures of treatment intensity for childhood cancers do not reflect the complexities of treatment protocols for central nervous system (CNS) tumors. This paper describes the development of the Pediatric Neuro-Oncology Rating of Treatment Intensity (PNORTI). PNORTI development occurred in three phases. Phase 1: five experts in pediatric neuro-oncology created a 5-point scale of treatment intensity and 42 pediatric neuro-oncology providers completed a three-part online questionnaire to evaluate the classification system and apply the rating system to 16 sample patients...
September 8, 2017: Journal of Neuro-oncology
https://www.readbyqxmd.com/read/28886305/sample-size-determination-for-the-current-strategy-in-oncology-phase-3-trials-that-tests-progression-free-survival-and-overall-survival-in-a-two-stage-design-framework
#13
Shogo Nomura, Akihiro Hirakawa, Chikuma Hamada
The selection of progression-free survival (PFS) or overall survival (OS) as the most suitable primary endpoint in oncology phase 3 trials is currently under intense debate. Because of substantial limitations in the single use of PFS (or OS) as the primary endpoint, trial designs that include PFS and OS as co-primary endpoints are attracting increasing interest. In this paper, we report on the formulation of determining the sample size for a trial that sequentially tests PFS and OS by treating them as co-primary endpoints...
September 8, 2017: Journal of Biopharmaceutical Statistics
https://www.readbyqxmd.com/read/28885881/durvalumab-after-chemoradiotherapy-in-stage-iii-non-small-cell-lung-cancer
#14
Scott J Antonia, Augusto Villegas, Davey Daniel, David Vicente, Shuji Murakami, Rina Hui, Takashi Yokoi, Alberto Chiappori, Ki H Lee, Maike de Wit, Byoung C Cho, Maryam Bourhaba, Xavier Quantin, Takaaki Tokito, Tarek Mekhail, David Planchard, Young-Chul Kim, Christos S Karapetis, Sandrine Hiret, Gyula Ostoros, Kaoru Kubota, Jhanelle E Gray, Luis Paz-Ares, Javier de Castro Carpeño, Catherine Wadsworth, Giovanni Melillo, Haiyi Jiang, Yifan Huang, Phillip A Dennis, Mustafa Özgüroğlu
Background Most patients with locally advanced, unresectable, non-small-cell lung cancer (NSCLC) have disease progression despite definitive chemoradiotherapy (chemotherapy plus concurrent radiation therapy). This phase 3 study compared the anti-programmed death ligand 1 antibody durvalumab as consolidation therapy with placebo in patients with stage III NSCLC who did not have disease progression after two or more cycles of platinum-based chemoradiotherapy. Methods We randomly assigned patients, in a 2:1 ratio, to receive durvalumab (at a dose of 10 mg per kilogram of body weight intravenously) or placebo every 2 weeks for up to 12 months...
September 8, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28884417/neratinib-first-global-approval
#15
Emma D Deeks
Neratinib (Nerlynx™) is an oral, irreversible inhibitor of the human epidermal growth factor receptors HER1 (EGFR), HER2 and HER4. The drug originally arose from research by Wyeth (now Pfizer) and is now being developed by Puma Biotechnology primarily for the treatment of HER2-positive (HER+) breast cancer. Neratinib is approved in the USA for the extended adjuvant treatment of patients with HER2+ early-stage breast cancer who have been previously treated with a trastuzumab-based adjuvant regimen, and is in the preregistration phase for this indication in the EU...
September 7, 2017: Drugs
https://www.readbyqxmd.com/read/28882536/gemcitabine-and-docetaxel-versus-doxorubicin-as-first-line-treatment-in-previously-untreated-advanced-unresectable-or-metastatic-soft-tissue-sarcomas-geddis-a-randomised-controlled-phase-3-trial
#16
Beatrice Seddon, Sandra J Strauss, Jeremy Whelan, Michael Leahy, Penella J Woll, Fiona Cowie, Christian Rothermundt, Zoe Wood, Charlotte Benson, Nasim Ali, Maria Marples, Gareth J Veal, David Jamieson, Katja Küver, Roberto Tirabosco, Sharon Forsyth, Stephen Nash, Hakim-Moulay Dehbi, Sandy Beare
BACKGROUND: For many years, first-line treatment for locally advanced or metastatic soft-tissue sarcoma has been doxorubicin. This study compared gemcitabine and docetaxel versus doxorubicin as first-line treatment for advanced or metastatic soft-tissue sarcoma. METHODS: The GeDDiS trial was a randomised controlled phase 3 trial done in 24 UK hospitals and one Swiss Group for Clinical Cancer Research (SAKK) hospital. Eligible patients had histologically confirmed locally advanced or metastatic soft-tissue sarcoma of Trojani grade 2 or 3, disease progression before enrolment, and no previous chemotherapy for sarcoma or previous doxorubicin for any cancer...
September 4, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28881712/tumor-antigen-ca125-suppresses-antibody-dependent-cellular-cytotoxicity-adcc-via-direct-antibody-binding-and-suppressed-fc-%C3%AE-receptor-engagement
#17
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...
August 8, 2017: Oncotarget
https://www.readbyqxmd.com/read/28862111/how-can-we-improve-education-of-breast-surgeons-across-europe
#18
Agnieszka Kolacinska
The proposed global curriculum developed by the American Society of Surgical Oncology (SSO) and the European Society of Surgical Oncology (ESSO) and the textbook: provides a state-of- the- art of breast cancer surgery, complements the syllabus and curriculum of the Union Europeenne des Medecins Specialistes (UEMS) examination in breast surgery/ European Board of Surgery Qualification in Breast Surgery (EBSQinBS) administered by ESSO (1) Knowledge and understanding of the principles of breast cancer incidence, aetiology, risk factors, genetics, premalignant and high-risk lesions, pathology, prognostic and predictive factors, risk prediction models, screening, diagnosis and imaging, breast cancer, oncoplastic, reconstructive breast surgery, axillary surgery and future perspective for this, radiation therapy, neoadjuvant and adjuvant systemic treatment- endocrine-, immuno- and chemotherapy, side effects and toxicities of treatment, locoregional recurrence, follow-up, locally advanced breast cancer, metastatic breast cancer, breast cancer in young and elderly patients, survivor issues, lymphedema, palliative care, chroni pain, body image and sexuality, fertility issues, cognitive functions, etc...
July 2017: Chirurgia
https://www.readbyqxmd.com/read/28859290/racial-differences-in-pam50-subtypes-in-the-carolina-breast-cancer-study
#19
Melissa A Troester, Xuezheng Sun, Emma H Allott, Joseph Geradts, Stephanie M Cohen, Chiu-Kit Tse, Erin L Kirk, Leigh B Thorne, Michelle Mathews, Yan Li, Zhiyuan Hu, Whitney R Robinson, Katherine A Hoadley, Olufunmilayo I Olopade, Katherine E Reeder-Hayes, H Shelton Earp, Andrew F Olshan, Lisa A Carey, Charles M Perou
Background: African American breast cancer patients have lower frequency of hormone receptor-positive (HR+)/human epidermal growth factor receptor 2 (HER2)-negative disease and higher subtype-specific mortality. Racial differences in molecular subtype within clinically defined subgroups are not well understood. Methods: Using data and biospecimens from the population-based Carolina Breast Cancer Study (CBCS) Phase 3 (2008-2013), we classified 980 invasive breast cancers using RNA expression-based PAM50 subtype and recurrence (ROR) score that reflects proliferation and tumor size...
February 1, 2018: Journal of the National Cancer Institute
https://www.readbyqxmd.com/read/28855797/oncology-update-anamorelin
#20
REVIEW
Eric Prommer
BACKGROUND: Cancer cachexia is a catabolic syndrome associated with uncontrolled muscle breakdown. There may be associated fat loss. Occurring in high frequency in advanced cancer, it is an indicator of poor prognosis. Besides weight loss, patients experience a cluster of symptoms including anorexia, early satiety, and weakness. The 3 stages of cachexia include stages of precachexia, cachexia, and refractory cachexia. Refractory cachexia is associated with active catabolism or the presence of factors that make active management of weight loss no longer possible...
2017: Palliative Care
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