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https://www.readbyqxmd.com/read/29352713/clinical-variables-associated-with-overall-survival-in-metastatic-castration-resistant-prostate-cancer-patients-treated-with-sipuleucel-t-immunotherapy
#1
Xiao X Wei, Jaselle Perry, Emily Chang, Li Zhang, Robert A Hiatt, Charles J Ryan, Eric J Small, Lawrence Fong
BACKGROUND: Sipuleucel-T is an autologous cell-based cancer immunotherapy for men with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC). Its approval by the Food and Drug Administration was based on demonstration of an overall survival (OS) benefit in randomized placebo-controlled phase III trials. However, treatment was associated with a prostate-specific antigen (PSA) decline in only a small minority of patients. Understanding the clinical factors that are associated with OS could help guide treatment decisions, including patient selection and the timing of sipuleucel-T relative to other therapies...
December 27, 2017: Clinical Genitourinary Cancer
https://www.readbyqxmd.com/read/29351570/joint-adolescent-adult-early-phase-clinical-trials-to-improve-access-to-new-drugs-for-adolescents-with-cancer-proposals-from-the-multi-stakeholder-platform-accelerate
#2
N Gaspar, L V Marshall, D Binner, R Herold, R Rousseau, P Blanc, R Capdeville, J Carleer, C Copland, Y Kerloeguen, K Norga, L Pacaud, M-A Sevaux, C Spadoni, J Sterba, F Ligas, T Taube, M Uttenreuther-Fischer, S Chioato, M A O'Connell, B Geoerger, J-Y Blay, J C Soria, S Kaye, B Wulff, L Brugières, G Vassal, A D J Pearson
The impressive progress recently observed in adult cancers through the introduction of new drugs has not yet been translated to adolescents between 12 and 17 years of age. Currently adolescents are grouped with children, so their access to new, effective drugs already available for adults is delayed because paediatric drug development starts late relative to adult programmes. Moreover, specific early phase trials designed exclusively for adolescents in rare diseases recruit poorly, even if conducted internationally...
January 16, 2018: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/29350568/abp-980-promising-trastuzumab-biosimilar-for-her2-positive-breast-cancer
#3
Elisavet Paplomata, Rita Nahta
Approval of the HER2-targeted antibody trastuzumab dramatically improved outcomes for patients with HER2-positive breast cancer. Multiple trastuzumab biosimilars, including ABP 980, are in clinical development. Biosimilars are not identical to the reference biologic, but exhibit equivalence and safety in analytical and clinical studies. Areas covered: A brief introduction to trastuzumab, overview of trastuzumab biosimilars, and detailed review of ABP 980 preclinical and clinical studies are included. We searched PubMed and 2016-2017 ASCO and ESMO conference proceedings for "ABP 980" or "trastuzumab biosimilar"...
January 19, 2018: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/29346040/bevacizumab-maintenance-versus-no-maintenance-during-chemotherapy-free-intervals-in-metastatic-colorectal-cancer-a-randomized-phase-iii-trial-prodige-9
#4
Thomas Aparicio, Francois Ghiringhelli, Valérie Boige, Karine Le Malicot, Julien Taieb, Olivier Bouché, Jean-Marc Phelip, Eric François, Christian Borel, Roger Faroux, Laetitia Dahan, Stéphane Jacquot, Dominique Genet, Faiza Khemissa, Etienne Suc, Françoise Desseigne, Patrick Texereau, Come Lepage, Jaafar Bennouna
Purpose Conflicting results are reported for maintenance treatment with bevacizumab during chemotherapy-free intervals (CFI) in metastatic colorectal cancer after induction chemotherapy. Patients and Methods In this open-label, phase III, randomized controlled trial, we compared the tumor control duration (TCD) observed with bevacizumab maintenance and with no treatment (observation) during CFI subsequent to induction chemotherapy with 12 cycles of fluorouracil, leucovorin, and irinotecan plus bevacizumab. After disease progression, the induction regimen was repeated for eight cycles, followed by a new CFI...
January 18, 2018: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/29344270/lenvatinib-in-advanced-radioiodine-refractory-thyroid-cancer-a-retrospective-analysis-of-the-swiss-lenvatinib-named-patient-program
#5
Catharina Balmelli, Nikola Railic, Marco Siano, Kristin Feuerlein, Richard Cathomas, Valerie Cristina, Christiane Güthner, Stefan Zimmermann, Sabine Weidner, Miklos Pless, Frank Stenner, Sacha I Rothschild
Purpose: Differentiated thyroid cancer (DTC) accounts for approximately 95% of thyroid carcinomas. In the metastatic RAI-refractory disease, chemotherapy has very limited efficacy and is associated with substantial toxicity. With increasing knowledge of the molecular pathogenesis of DTC, novel targeted therapies have been developed. Lenvatinib is a tyrosine kinase inhibitor (TKI) with promising clinical activity based on the randomized phase III SELECT trial. In Switzerland, a Named Patient Program (NPP) was installed to bridge the time gap to Swissmedic approval...
2018: Journal of Cancer
https://www.readbyqxmd.com/read/29344106/overall-survival-and-progression-free-survival-with-endocrine-therapy-for-hormone-receptor-positive-her2-negative-advanced-breast-cancer-review
#6
REVIEW
Tomás Reinert, Carlos H Barrios
We reviewed randomized phase II/III trials comparing first- or second-line endocrine therapy as monotherapy or in combination with targeted therapies for treatment of postmenopausal patients with hormone receptor-positive advanced breast cancer. First-line was defined as treatment for endocrine therapy-naïve advanced breast cancer or advanced disease treated with endocrine therapy in the adjuvant/neoadjuvant setting. Second-line was defined as endocrine therapy for advanced breast cancer following disease progression on endocrine therapy for advanced disease...
November 2017: Therapeutic Advances in Medical Oncology
https://www.readbyqxmd.com/read/29342393/hyperthermic-intraperitoneal-chemotherapy-in-ovarian-cancer
#7
Willemien J van Driel, Simone N Koole, Karolina Sikorska, Jules H Schagen van Leeuwen, Henk W R Schreuder, Ralph H M Hermans, Ignace H J T de Hingh, Jacobus van der Velden, Henriëtte J Arts, Leon F A G Massuger, Arend G J Aalbers, Victor J Verwaal, Jacobien M Kieffer, Koen K Van de Vijver, Harm van Tinteren, Neil K Aaronson, Gabe S Sonke
BACKGROUND: Treatment of newly diagnosed advanced-stage ovarian cancer typically involves cytoreductive surgery and systemic chemotherapy. We conducted a trial to investigate whether the addition of hyperthermic intraperitoneal chemotherapy (HIPEC) to interval cytoreductive surgery would improve outcomes among patients who were receiving neoadjuvant chemotherapy for stage III epithelial ovarian cancer. METHODS: In a multicenter, open-label, phase 3 trial, we randomly assigned 245 patients who had at least stable disease after three cycles of carboplatin (area under the curve of 5 to 6 mg per milliliter per minute) and paclitaxel (175 mg per square meter of body-surface area) to undergo interval cytoreductive surgery either with or without administration of HIPEC with cisplatin (100 mg per square meter)...
January 18, 2018: New England Journal of Medicine
https://www.readbyqxmd.com/read/29340601/how-to-treat-borderline-resectable-pancreatic-cancer-current-challenges-and-future-directions
#8
Shinichiro Takahashi
Borderline resectable pancreatic cancer (BRPC) is an advanced tumor in contact with the surrounding major vessels, making R0 resection difficult to achieve. Neoadjuvant treatment is expected to provide substantial local control and prolong survival. However, there is no standard treatment. I therefore conducted a strategic literature search from January 2013 to September 2017 and identified 37 clinical studies of pancreatic cancer, including BRPC, to evaluate treatment interventions. Twenty (54%) studies were prospective...
January 11, 2018: Japanese Journal of Clinical Oncology
https://www.readbyqxmd.com/read/29340160/stereotactic-body-radiation-therapy-for-the-treatment-of-oligoprogression-on-androgen-receptor-targeted-therapy-in-castration-resistant-prostate-cancer
#9
Thu-Cuc Nguyen, Ravneet Bajwa, Shahla Bari, Azka Ali, William Paul Skelton, Roland-Austin Federico, Rohit Bishnoi, Justin W Wray, Robert A Zlotecki, Long H Dang, Jameel Muzaffar
Castration-resistant prostate cancer is an incurable disease. To date, six agents-abiraterone, enzalutamide, docetaxel, cabazitaxel, radium-223 and sipuleucel-T- have shown clinical efficacy in phase III clinical trials, leading to their FDA approval. Patients are typically sequenced through most or all of these agents, and then eventually succumb to their disease. Development of new treatments remains an unmet need. We report a case of a patient who progressed on enzalutamide with a single enlarging metastatic lesion, was treated with ablative stereotactic body radiation therapy while maintaining the same systemic treatment, who then had durable complete remission...
January 2018: Oxford Medical Case Reports
https://www.readbyqxmd.com/read/29339046/stereotactic-body-radiation-therapy-sbrt-for-high-risk-prostate-cancer-where-are-we-now
#10
REVIEW
Alejandro Gonzalez-Motta, Mack Roach
PURPOSE: Stereotactic body radiation therapy (SBRT) is increasingly being used for the management of localized prostate cancer. This trend combined with declining use of brachytherapy (BT) has pushed issues and questions regarding the use of SBRT to the forefront. A systematic literature review was conducted to review the current evidence of biochemical disease-free survival (bDFS) and toxicity of SBRT in high-risk (HR) prostate cancer. METHODS AND MATERIALS: A search was carried out on the PubMed and Embase databases...
December 2, 2017: Practical Radiation Oncology
https://www.readbyqxmd.com/read/29336009/gefitinib-for-advanced-non-small-cell-lung-cancer
#11
REVIEW
Esther Ha Sim, Ian A Yang, Richard Wood-Baker, Rayleen V Bowman, Kwun M Fong
BACKGROUND: The role of gefitinib for the treatment of advanced non-small cell lung cancer (NSCLC) is evolving. We undertook a systematic review to evaluate the available evidence from all randomised trials. OBJECTIVES: To determine the effectiveness and safety of gefitinib as first-line, second-line or maintenance treatment for advanced NSCLC. SEARCH METHODS: We performed searches in CENTRAL, MEDLINE and Embase from inception to 17 February 2017...
January 16, 2018: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/29334758/anticancer-thiosemicarbazones-chemical-properties-interaction-with-iron-metabolism-and-resistance-development
#12
Petra Heffeter, Veronika F S Pape, Eva A Enyedy, Bernhard K Keppler, Gergely Szakas, Christian R Kowol
SIGNIFICANCE: During the last decades, thiosemicarbazones have been clinically developed for a variety of diseases including tuberculosis, viral infections, malaria and cancer. With regard to malignant diseases, the class of α-N-heterocyclic thiosemicarbazones, and here especially Triapine, was intensively developed in multiple clinical phase I/II trials. Recent Advances: Very recently two new derivatives, namely COTI-2 and DpC have entered phase I evaluation. Based on the strong metal-chelating/metal-interacting properties of thiosemicarbazones, interference with the cellular iron (and copper) homeostasis is assumed to play an important role in their biological activity...
January 15, 2018: Antioxidants & Redox Signaling
https://www.readbyqxmd.com/read/29330636/a-randomised-trial-comparing-the-pharmacokinetics-and-safety-of-the-biosimilar-ct-p6-with-reference-trastuzumab
#13
Francisco J Esteva, Justin Stebbing, Rebecca N Wood-Horrall, Peter J Winkle, Sung Young Lee, Sang Joon Lee
PURPOSE: Access to trastuzumab, a valuable anti-cancer treatment, can be limited by cost. The primary aim of this study was to evaluate and compare the PK profiles of CT-P6, a biosimilar of trastuzumab, and US-licensed reference trastuzumab (Herceptin®) in healthy subjects. Secondary study aims included comparison of the safety and immunogenicity of CT-P6 and reference trastuzumab in these subjects. METHODS: We performed a single-dose, randomised, double-blind, parallel group study (NCT02665637) comparing CT-P6 with reference trastuzumab (6 mg/kg, 90 min intravenous infusion) in 70 healthy adult males...
January 12, 2018: Cancer Chemotherapy and Pharmacology
https://www.readbyqxmd.com/read/29329598/treatment-outcome-of-anti-angiogenesis-through-vegf-pathway-in-the-management-of-gastric-cancer-a-systematic-review-of-phase-ii-and-iii-clinical-trials
#14
Brian Mawalla, Xianglin Yuan, Xiaoxiao Luo, Phillip L Chalya
OBJECTIVES: Advanced gastric cancer poses a therapeutic challenge worldwide. In randomised clinical trials, anti-VEGF has been reported as an essential agent for the treatment of advanced gastric cancer. This review aims at assessing the treatment outcome of anti-angiogenesis therapy through the VEGF pathway in the management of patients with advanced gastric cancer. RESULTS: During this review, 38 clinical trials were identified. Of these, 30 clinical trials were excluded, leaving eight trials of phase II and III...
January 12, 2018: BMC Research Notes
https://www.readbyqxmd.com/read/29328860/quality-of-life-from-canadian-cancer-trials-group-ma-17r-a-randomized-trial-of-extending-adjuvant-letrozole-to-10-years
#15
Julie Lemieux, Michael D Brundage, Wendy R Parulekar, Paul E Goss, James N Ingle, Kathleen I Pritchard, Paul Celano, Hyman Muss, Julie Gralow, Kathrin Strasser-Weippl, Kate Whelan, Dongsheng Tu, Timothy J Whelan
Purpose MA.17R was a Canadian Cancer Trials Group-led phase III randomized controlled trial comparing letrozole to placebo after 5 years of aromatase inhibitor as adjuvant therapy for hormone receptor-positive breast cancer. Quality of life (QOL) was a secondary outcome measure of the study, and here, we report the results of these analyses. Methods QOL was measured using the Short Form-36 (SF-36; two summary scores and eight domains) and menopause-specific QOL (MENQOL; four symptom domains) at baseline and every 12 months up to 60 months...
January 12, 2018: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/29326191/establishing-anchor-based-minimally-important-differences-mid-with-the-eortc-quality-of-life-measures-a-meta-analysis-protocol
#16
Zebedee Jammbe Musoro, Jean-Francois Hamel, Divine Ewane Ediebah, Kim Cocks, Madeleine T King, Mogens Groenvold, Mirjam A G Sprangers, Yvonne Brandberg, Galina Velikova, John Maringwa, Hans-Henning Flechtner, Andrew Bottomley, Corneel Coens
INTRODUCTION: As patient assessment of health-related quality of life (HRQOL) in cancer clinical trials has increased over the years, so has the need to attach meaningful interpretations to differences in HRQOL scores between groups and changes within groups. Determining what represents a minimally important difference (MID) in HRQOL scores is useful to clinicians, patients and researchers, and can be used as a benchmark for assessing the success of a healthcare intervention. Our objective is to provide an evidence-based protocol to determine MIDs for the European Organisation for Research and Treatment for Cancer Quality of life Questionnaire core 30 (EORTC QLQ-C30)...
January 10, 2018: BMJ Open
https://www.readbyqxmd.com/read/29324972/prognostic-and-predictive-role-of-neutrophil-lymphocytes-ratio-in-metastatic-colorectal-cancer-a-retrospective-analysis-of-the-tribe-study-by-gono
#17
E Dell'Aquila, C Cremolini, T Zeppola, S Lonardi, F Bergamo, G Masi, M Stellato, F Marmorino, M Schirripa, F Urbano, M Ronzoni, G Tomasello, A Zaniboni, P Racca, A Buonadonna, G Allegrini, E Fea, S Di Donato, S Chiara, G Tonini, D Tomcikova, L Boni, A Falcone, D Santini
Background: Neutrophil/Lymphocyte ratio (NLR), defined as absolute neutrophils count divided by absolute lymphocytes count, has been reported as poor prognostic factor in several neoplastic diseases but only a few data are available about unresectable metastatic colorectal cancer (mCRC) patients (pts). The aim of our study was to evaluate the prognostic and predictive role of NLR in the TRIBE trial. Patients and Methods: Pts enrolled in TRIBE trial were included...
January 8, 2018: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/29324303/first-line-vs-second-line-fulvestrant-for-hormone-receptor-positive-advanced-breast-cancer-a-post-hoc-analysis-of-the-confirm-study
#18
Angelo Di Leo, Guy Jerusalem, Roberto Torres, Didier Verhoeven, Kelly Pendergrass, Luca Malorni, Jasmine Lichfield, Miguel Martin
OBJECTIVES: The double-blind, phase III CONFIRM study (NCT00099437) evaluated fulvestrant 500 mg vs fulvestrant 250 mg in postmenopausal women with hormone receptor-positive locally advanced/metastatic breast cancer (LA/MBC). This post-hoc analysis investigated the efficacy and safety of fulvestrant given either first-line or second-line for advanced disease. MATERIALS & METHODS: Progression-free survival (PFS) and overall survival (OS) with fulvestrant 500 mg vs fulvestrant 250 mg was evaluated using unadjusted log-rank tests in patients treated in the first- (progression during or within 12 months after completing adjuvant endocrine therapy; n = 387) and second-line (following endocrine therapy for LA/MBC; n = 343) settings...
January 8, 2018: Breast: Official Journal of the European Society of Mastology
https://www.readbyqxmd.com/read/29321003/a-prototypical-non-malignant-epithelial-model-to-study-genome-dynamics-and-concurrently-monitor-micro-rnas-and-proteins-in-situ-during-oncogene-induced-senescence
#19
Eirini-Stavroula Komseli, Ioannis S Pateras, Thorbjørn Krejsgaard, Konrad Stawiski, Sophia V Rizou, Alexander Polyzos, Fani-Marlen Roumelioti, Maria Chiourea, Ioanna Mourkioti, Eleni Paparouna, Christos P Zampetidis, Sentiljana Gumeni, Ioannis P Trougakos, Dafni-Eleftheria Pefani, Eric O'Neill, Sarantis Gagos, Aristides G Eliopoulos, Wojciech Fendler, Dipanjan Chowdhury, Jiri Bartek, Vassilis G Gorgoulis
BACKGROUND: Senescence is a fundamental biological process implicated in various pathologies, including cancer. Regarding carcinogenesis, senescence signifies, at least in its initial phases, an anti-tumor response that needs to be circumvented for cancer to progress. Micro-RNAs, a subclass of regulatory, non-coding RNAs, participate in senescence regulation. At the subcellular level micro-RNAs, similar to proteins, have been shown to traffic between organelles influencing cellular behavior...
January 10, 2018: BMC Genomics
https://www.readbyqxmd.com/read/29318751/subgroup-analysis-of-east-asian-patients-in-regard-a-phase-iii-trial-of-ramucirumab-and-best-supportive-care-for-advanced-gastric-cancer
#20
Hyun Cheol Chung, Victor C Kok, Rebecca Cheng, Yanzhi Hsu, Mauro Orlando, Charles Fuchs, Jae Yong Cho
AIM: We describe a subgroup analysis assessing the efficacy and safety of ramucirumab monotherapy in East Asian (EA) patients from the REGARD trial. METHODS: Patients with advanced gastric or gastroesophageal junction adenocarcinoma with progressive disease were randomized 2:1 to receive ramucirumab (8 mg/kg) plus best supportive care (BSC) or placebo plus BSC every 2 weeks. Post hoc subset analyses were performed on the EA and non-EA intention-to-treat populations...
January 10, 2018: Asia-Pacific Journal of Clinical Oncology
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