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https://www.readbyqxmd.com/read/29453232/a-randomized-multicenter-phase-ii-study-of-docosahexaenoic-acid-in-patients-with-a-history-of-breast-cancer-premalignant-lesions-or-benign-breast-disease
#1
Ayca Gucalp, Xi K Zhou, Elise D Cook, Judy E Garber, Katherine D Crew, Julie R Nangia, Priya Bhardwaj, Dilip D Giri, Olivier Elemento, Akanksha Verma, Hanhan Wang, J Jack Lee, Lana A Vornik, Carrie Mays, Diane Weber, Valerie Sepeda, Holly O'Kane, Margaret Krasne, Samantha Williams, Patrick G Morris, Brandy M Heckman-Stoddard, Barbara K Dunn, Clifford A Hudis, Powel H Brown, Andrew J Dannenberg
Obesity, a cause of subclinical inflammation, is a risk factor for the development of postmenopausal breast cancer (BC) and is associated with poorer cancer outcomes. Docosahexaenoic acid (DHA), an omega-3 fatty acid, possesses anti-inflammatory properties. We hypothesized that treatment with DHA would reduce the expression of proinflammatory genes and aromatase, the rate-limiting enzyme for estrogen biosynthesis, in benign breast tissue of overweight/obese women. A randomized, placebo-controlled, double-blind phase II study of DHA given for 12 weeks to overweight/obese women with a history of stage I-III BC, DCIS/LCIS, Paget's disease, or proliferative benign breast disease was carried out...
February 16, 2018: Cancer Prevention Research
https://www.readbyqxmd.com/read/29451701/phase-1b-study-of-pasireotide-everolimus-and-selective-internal-radioembolization-therapy-for-unresectable-neuroendocrine-tumors-with-hepatic-metastases
#2
Hyun S Kim, Walid L Shaib, Chao Zhang, Ganji Purnachandra Nagaraju, Christina Wu, Olatunji B Alese, Zhengjia Chen, Edith Brutcher, Meredith Renfroe, Bassel F El-Rayes
BACKGROUND: Neuroendocrine tumors (NETs) metastasize to the liver. Everolimus and selective internal radioembolization (SIRT) are approved treatments. Pasireotide is a somatostatin analogue with an affinity for somatostatin receptors 1, 2, 3, and 5. Everolimus and pasireotide may potentiate SIRT radiosensitization and inhibit rebound angiogenesis. This study evaluated the safety of pasireotide, everolimus, and SIRT. METHODS: This 3 + 3 phase 1 trial evaluated 3 dose levels of everolimus (2...
February 16, 2018: Cancer
https://www.readbyqxmd.com/read/29451696/randomized-phase-2-trial-of-pemetrexed-pemetrexed-bevacizumab-and-pemetrexed-carboplatin-bevacizumab-in-patients-with-stage-iiib-iv-non-small-cell-lung-cancer-and-an-eastern-cooperative-oncology-group-performance-status-of-2
#3
David R Spigel, John D Hainsworth, Mathew J Joseph, Dianna L Shipley, M Kelly Hagan, Dana S Thompson, Howard A Burris, F Anthony Greco
BACKGROUND: The best treatment for patients with advanced non-small cell lung cancer (NSCLC) and a poor performance status is not well defined. In this phase 2 trial, patients were randomized to receive treatment with either single-agent pemetrexed or 1 of 2 combination regimens. METHODS: Patients with newly diagnosed, histologically confirmed nonsquamous NSCLC and an Eastern Cooperative Oncology Group (ECOG) performance status of 2 were stratified by age and serum albumin level and were randomized (1:1:1) to 1 of 3 regimens: pemetrexed (arm 1), pemetrexed and bevacizumab (arm 2), or pemetrexed, carboplatin, and bevacizumab (arm 3)...
February 16, 2018: Cancer
https://www.readbyqxmd.com/read/29450468/activity-and-safety-of-cetuximab-plus-modified-folfoxiri-followed-by-maintenance-with-cetuximab-or-bevacizumab-for-ras-and-braf-wild-type-metastatic-colorectal-cancer-a-randomized-phase-2-clinical-trial
#4
Chiara Cremolini, Carlotta Antoniotti, Sara Lonardi, Giuseppe Aprile, Francesca Bergamo, Gianluca Masi, Roberta Grande, Giuseppe Tonini, Claudia Mescoli, Giovanni Gerardo Cardellino, Luigi Coltelli, Lisa Salvatore, Domenico Cristiano Corsi, Cristiana Lupi, Donatello Gemma, Monica Ronzoni, Emanuela Dell'Aquila, Federica Marmorino, Francesca Di Fabio, Maria Laura Mancini, Lorenzo Marcucci, Gabriella Fontanini, Vittorina Zagonel, Luca Boni, Alfredo Falcone
Importance: The combination of a triple-drug chemotherapy regimen with an anti-epidermal growth factor receptor (EGFR) agent as a first-line treatment of metastatic colorectal cancer (mCRC) showed promising activity along with safety concerns in single-arm phase 2 trials. The role of maintenance following chemotherapy and anti-EGFR and the optimal regimen to be adopted are not established. Objectives: To evaluate the activity and safety of cetuximab plus modified FOLFOXIRI (mFOLFOXIRI) and explore the role of maintenance with cetuximab or bevacizumab in RAS and BRAF wild-type mCRC...
February 15, 2018: JAMA Oncology
https://www.readbyqxmd.com/read/29450452/effect-of-neoadjuvant-chemotherapy-plus-regional-hyperthermia-on-long-term-outcomes-among-patients-with-localized-high-risk-soft-tissue-sarcoma-the-eortc-62961-esho-95-randomized-clinical-trial
#5
Rolf D Issels, Lars H Lindner, Jaap Verweij, Rüdiger Wessalowski, Peter Reichardt, Peter Wust, Pirus Ghadjar, Peter Hohenberger, Martin Angele, Christoph Salat, Zeljko Vujaskovic, Soeren Daugaard, Olav Mella, Ulrich Mansmann, Hans Roland Dürr, Thomas Knösel, Sultan Abdel-Rahman, Michael Schmidt, Wolfgang Hiddemann, Karl-Walter Jauch, Claus Belka, Alessandro Gronchi
Importance: Patients with soft tissue sarcoma are at risk for local recurrence and distant metastases despite optimal local treatment. Preoperative anthracycline plus ifosfamide chemotherapy improves outcome in common histological subtypes. Objective: To analyze whether the previously reported improvement in local progression-free survival by adding regional hyperthermia to neoadjuvant chemotherapy translates into improved survival. Design, Setting, and Participants: Open-label, phase 3 randomized clinical trial to evaluate the efficacy and toxic effects of neoadjuvant chemotherapy plus regional hyperthermia...
February 15, 2018: JAMA Oncology
https://www.readbyqxmd.com/read/29450203/real-life-experience-of-ceritinib-in-crizotinib-pretreated-alk-advanced-non-small-cell-lung-cancer-patients
#6
Jacques Cadranel, Alexis B Cortot, Hervé Lena, Bertrand Mennecier, Pascal Do, Eric Dansin, Julien Mazieres, Christos Chouaid, Maurice Perol, Fabrice Barlesi, Gilles Robinet, Sylvie Friard, Luc Thiberville, Clarisse Audigier-Valette, Alain Vergnenegre, Virginie Westeel, Khemaies Slimane, Alexandru Buturuga, Denis Moro-Sibilot, Benjamin Besse
Here we report our experience of ceritinib in crizotinib-pretreated patients with anaplastic lymphoma kinase ( ALK ) positive ( ALK + ) non-small cell lung cancer (NSCLC) in a French temporary authorisation for use (TAU) study. The French TAU study included crizotinib-pretreated patients with advanced ALK + or ROS proto-oncogene 1 positive ( ROS1 + ) tumours. Patients received oral ceritinib (750 mg·day -1 as a starting dose) and best tumour response (as evaluated by the investigator) and safety were reported every 3 months...
January 2018: ERJ Open Research
https://www.readbyqxmd.com/read/29449189/adjuvant-chemoradiotherapy-versus-radiotherapy-alone-for-women-with-high-risk-endometrial-cancer-portec-3-final-results-of-an-international-open-label-multicentre-randomised-phase-3-trial
#7
Stephanie M de Boer, Melanie E Powell, Linda Mileshkin, Dionyssios Katsaros, Paul Bessette, Christine Haie-Meder, Petronella B Ottevanger, Jonathan A Ledermann, Pearly Khaw, Alessandro Colombo, Anthony Fyles, Marie-Helene Baron, Ina M Jürgenliemk-Schulz, Henry C Kitchener, Hans W Nijman, Godfrey Wilson, Susan Brooks, Silvestro Carinelli, Diane Provencher, Chantal Hanzen, Ludy C H W Lutgens, Vincent T H B M Smit, Naveena Singh, Viet Do, Romerai D'Amico, Remi A Nout, Amanda Feeney, Karen W Verhoeven-Adema, Hein Putter, Carien L Creutzberg
BACKGROUND: Although women with endometrial cancer generally have a favourable prognosis, those with high-risk disease features are at increased risk of recurrence. The PORTEC-3 trial was initiated to investigate the benefit of adjuvant chemotherapy during and after radiotherapy (chemoradiotherapy) versus pelvic radiotherapy alone for women with high-risk endometrial cancer. METHODS: PORTEC-3 was an open-label, international, randomised, phase 3 trial involving 103 centres in six clinical trials collaborating in the Gynaecological Cancer Intergroup...
February 12, 2018: Lancet Oncology
https://www.readbyqxmd.com/read/29448309/the-value-of-additional-bevacizumab-in-patients-with-high-risk-stroma-high-colon-cancer-a-study-within-the-quasar2-trial-an-open-label-randomized-phase-3-trial
#8
Anouck Huijbers, Gabi W van Pelt, Rachel S Kerr, Elaine C Johnstone, Rob A E M Tollenaar, David J Kerr, Wilma E Mesker
INTRODUCTION: Patients with a high stroma percentage within the primary tumor have a poor prognosis. In this study, we investigate whether anti-angiogenic therapy might improve survival of patients with a stroma-high profile with potentially increased angiogenesis. MATERIALS AND METHODS: Tissue samples of the primary tumor of 965 colon cancer patients participating in the QUASAR2 trial were analyzed for tumor-stroma ratio (TSR). Stroma-high (>50%) and stroma-low (≤50%) groups were evaluated with respect to survival...
February 15, 2018: Journal of Surgical Oncology
https://www.readbyqxmd.com/read/29448138/dual-targeting-antitumor-hybrids-derived-from-pt-iv-species-and-millepachine-analogues
#9
Xiaochao Huang, Shixian Hua, Rizhen Huang, Zhikun Liu, Shaohua Gou, Zhimei Wang, Zhixin Liao, Hengshan Wang
Many strategies have been developed to circumvent the shortcomings of Pt(II)-based chemotherapy, but the inherent problems still have not been effectively resolved. Here we report a new series of dual-targeting Pt(IV) prodrugs, conjugates of millepachine analogues with the related Pt(IV) complexes derived from cisplatin or oxaliplatin, respectively, which can inhibit tubulin polymerization and induce DNA damage. Among them, compound 19 possessed excellent antitumor activities against the tested human cancer cell lines, and arrested the cell cycle at the G2/M phases and ultimately induced cell apoptosis...
February 9, 2018: European Journal of Medicinal Chemistry
https://www.readbyqxmd.com/read/29448072/a-phase-iii-study-comparing-sb3-a-proposed-trastuzumab-biosimilar-and-trastuzumab-reference-product-in-her2-positive-early-breast-cancer-treated-with-neoadjuvant-adjuvant-treatment-final-safety-immunogenicity-and-survival-results
#10
X Pivot, I Bondarenko, Z Nowecki, M Dvorkin, E Trishkina, J-H Ahn, S-A Im, T Sarosiek, S Chatterjee, M Z Wojtukiewicz, Y Shparyk, V Moiseyenko, M Bello, V Semiglazov, Y Lee, J Lim
BACKGROUND: The equivalent efficacy between SB3, a proposed trastuzumab biosimilar, and the trastuzumab reference product (TRZ) in terms of the breast pathologic complete response rate after neoadjuvant therapy in patients with early or locally advanced human epidermal growth factor receptor 2-positive breast cancer was demonstrated in the previous report. Here, we report the final safety, immunogenicity and survival results after neoadjuvant-adjuvant treatment. PATIENTS AND METHODS: Patients were randomised 1:1 to receive neoadjuvant SB3 or TRZ for 8 cycles concurrently with chemotherapy (4 cycles of docetaxel followed by 4 cycles of 5-fluorouracil/epirubicin/cyclophosphamide)...
February 12, 2018: European Journal of Cancer
https://www.readbyqxmd.com/read/29447329/randomised-phase-iii-trial-of-vinflunine-plus-capecitabine-versus-capecitabine-alone-in-patients-with-advanced-breast-cancer-previously-treated-with-an-anthracycline-and-resistant-to-taxane
#11
M Martin, M Campone, I Bondarenko, D Sakaeva, S Krishnamurthy, L Roman, L Lebedeva, J-C Vedovato, M Aapro
Background: Capecitabine is an approved standard therapy for anthracycline- and taxane-pretreated locally advanced or metastatic breast cancer (BC). Vinflunine has demonstrated single-agent activity in phase II studies in this setting, and activity and tolerability when combined with capecitabine. We compared the combination of vinflunine plus capecitabine (VC) with single-agent capecitabine. Patients and methods: Patients with locally recurrent/metastatic BC previously treated or resistant to an anthracycline and resistant to taxane therapy were randomly assigned to either vinflunine (280 mg/m2, day 1) plus oral capecitabine (825 mg/m2 twice daily [bid], days 1-14) every 3 weeks (q3w) or single-agent oral capecitabine (1250 mg/m2 bid, days 1-14) q3w...
February 10, 2018: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/29446317/credentialing-of-radiotherapy-centres-in-australasia-for-trog-09-02-chisel-a-phase-iii-clinical-trial-on-stereotactic-ablative-body-radiotherapy-of-early-stage-lung-cancer
#12
Tomas Kron, Brent Chesson, Nicholas Hardcastle, Melissa Crain, Natalie Clements, Mark Burns, David Ball
OBJECTIVE: A randomised clinical trial comparing Stereotactic Ablative Body Radiotherapy (SABR) with conventional radiotherapy for early stage lung cancer has been conducted in Australia and New Zealand under the auspices of the TransTasman Radiation Oncology Group (NCT01014130). We report on the technical credentialing program as prerequisite for centres joining the trial. METHODS: Participating centres were asked to develop treatment plans for two test cases to assess their ability to create plans according to protocol...
February 15, 2018: British Journal of Radiology
https://www.readbyqxmd.com/read/29445224/lup-20-29-en-3%C3%AE-28-di-yl-nitrooxy-acetate-affects-mcf-7-proliferation-through-the-crosstalk-between-apoptosis-and-autophagy-in-mitochondria
#13
Xiaoning Yan, Lei Yang, Gaili Feng, Zhuli Yu, Minjie Xiao, Weibin Cai, Yanmei Xing, Shasha Bai, Junqia Guo, Zhiyu Wang, Tao Wang, Rong Zhang
Betulin (BT), a pentacyclic lupine-type triterpenoid natural product, possesses antitumor activity in various types of cancers. However, its clinical development was discouraged due to its low biological activities and poor solubility. We prepared lup-20(29)-en-3β,28-di-yl-nitrooxy acetate (NBT), a derivative of BT, that was chemically modified at position 3 of ring A and C-28 by introducing a NO-releasing moiety. This study mainly explored the mechanism of NBT in treating breast cancer through the crosstalk between apoptosis and autophagy in mitochondria...
February 14, 2018: Cell Death & Disease
https://www.readbyqxmd.com/read/29444544/uridine-5-diphospho-glucuronosyltransferase-1a-expression-as-an-independent-prognosticator-in-urothelial-carcinoma-of-the-upper-urinary-tract
#14
Koji Izumi, Satoshi Inoue, Hiroki Ide, Kazutoshi Fujita, Taichi Mizushima, Guiyang Jiang, Seiji Yamaguchi, Hiroaki Fushimi, Norio Nonomura, Hiroshi Miyamoto
OBJECTIVE: To determine the expression status of uridine 5'diphospho-glucuronosyltransferase 1A, a major phase II drug metabolism enzyme, in upper urinary tract urothelial carcinoma, as well as to assess its prognostic significance. METHODS: We immunohistochemically stained for uridine 5'diphospho-glucuronosyltransferase 1A in tissue microarray consisting of 99 upper urinary tract urothelial carcinoma samples and paired non-neoplastic urothelial tissues. We also assessed the effect of uridine 5'diphospho-glucuronosyltransferase 1A knockdown on urothelial cancer cell growth...
February 14, 2018: International Journal of Urology: Official Journal of the Japanese Urological Association
https://www.readbyqxmd.com/read/29444512/a-phase-ii-study-of-irinotecan-for-patients-with-previously-treated-small-cell-lung-cancer
#15
Rie Kondo, Satoshi Watanabe, Satoshi Shoji, Kosuke Ichikawa, Tetsuya Abe, Junko Baba, Junta Tanaka, Hiroki Tsukada, Masaki Terada, Kazuhiro Sato, Yoshie Maruyama, Masato Makino, Akira Hirata, Hiroshi Tanaka, Toshiyuki Koya, Hirohisa Yoshizawa, Toshiaki Kikuchi
OBJECTIVE: Chemotherapy with irinotecan plus cisplatin has shown promise in chemo-naïve small-cell lung cancer (SCLC) patients. However, irinotecan treatment for relapsed or refractory SCLC has not been adequately evaluated. This phase II study evaluated the appropriate treatment schedule of irinotecan as a single agent. This study was designed to determine the antitumor activity, toxicity, and survival in previously treated SCLC patients. METHODS: Previously treated SCLC patients with at least one platinum-based regimen received irinotecan (100 mg/m2) on days 1 and 8, every 3 weeks, until disease progression...
February 14, 2018: Oncology
https://www.readbyqxmd.com/read/29444073/projected-future-impact-of-hpv-vaccination-and-primary-hpv-screening-on-cervical-cancer-rates-from-2017-2035-example-from-australia
#16
Michaela T Hall, Kate T Simms, Jie-Bin Lew, Megan A Smith, Marion Saville, Karen Canfell
BACKGROUND: Many countries are transitioning from cytology-based to longer-interval HPV screening. Trials comparing HPV-based screening to cytology report an increase in CIN2/3 detection at the first screen, and longer-term reductions in CIN3+; however, population level year-to-year transitional impacts are poorly understood. We undertook a comprehensive evaluation of switching to longer-interval primary HPV screening in the context of HPV vaccination. We used Australia as an example setting, since Australia will make this transition in December 2017...
2018: PloS One
https://www.readbyqxmd.com/read/29442401/single-arm-phase-ii-study-of-oral-vitamin-b12-for-the-treatment-of-musculoskeletal-symptoms-associated-with-aromatase-inhibitors-in-women-with-early-stage-breast-cancer
#17
Aleli Campbell, Rosalinda Heydarian, Cecilia Ochoa, Alok Kumar Dwivedi, Zeina A Nahleh
Breast cancer patients receiving endocrine therapy with aromatase Inhibitors (AIs) often experience musculoskeletal and joint-related side effects. The purpose of this study was to evaluate the effect of Vitamin B12 supplements on musculoskeletal symptoms such as pain and arthralgias induced by AIs and to correlate response with serum and inflammatory biomarkers. Upon receiving approval by the Institutional Review Board (IRB), the majority of the patients consented into the study were treated at the Texas Tech Breast Care Center...
February 14, 2018: Breast Journal
https://www.readbyqxmd.com/read/29442139/safety-profile-of-nivolumab-administered-as-30-min-infusion-analysis-of-data-from-checkmate-153
#18
David Waterhouse, Leora Horn, Craig Reynolds, David Spigel, Jason Chandler, Tarek Mekhail, Mohamed Mohamed, Ben Creelan, Kenneth B Blankstein, Petros Nikolinakos, Michael J McCleod, Ang Li, Abderrahim Oukessou, Shruti Agrawal, Nivedita Aanur
PURPOSE: Nivolumab has been administered using a 60-min infusion time. Reducing this time to 30 min would benefit both patients and infusion facilities. This analysis compared the safety of 30- and 60-min infusions of nivolumab in patients with previously treated advanced non-small cell lung cancer. METHODS: CheckMate 153 is an open-label, phase 3b/4, predominantly community-based study ongoing in the United States and Canada. Patients with stage IIIB/IV disease with progression/recurrence after at least one prior systemic therapy received nivolumab 3 mg/kg every 2 weeks over 30 or 60 min for 1 year or until disease progression...
February 13, 2018: Cancer Chemotherapy and Pharmacology
https://www.readbyqxmd.com/read/29440181/a-first-in-human-study-of-the-new-oral-selective-estrogen-receptor-degrader-azd9496-for-hr-her2-advanced-breast-cancer
#19
Erika P Hamilton, Manish R Patel, Anne C Armstrong, Richard D Baird, Komal Jhaveri, Matthias Hoch, Teresa Klinowska, Justin P O Lindemann, Shethah Morgan, Gaia Schiavon, Hazel M Weir, Seock-Ah Im
PURPOSE: AZD9496 is an oral non-steroidal, small-molecule inhibitor of estrogen receptor alpha (ERα), and a potent and selective antagonist and degrader of ERα. This first in human Phase 1 study determined the safety and tolerability of ascending doses of oral AZD9496 in women with estrogen receptor (ER)+/HER2- advanced breast cancer, characterized its pharmacokinetic (PK) profile, and made preliminary assessment of antitumor activity. EXPERIMENTAL DESIGN: Forty-five patients received AZD9496 (20 mg once daily to 600 mg twice daily) in a dose-escalation, dose- expansion 'rolling 6' design...
February 13, 2018: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/29439857/axitinib-in-combination-with-pembrolizumab-in-patients-with-advanced-renal-cell-cancer-a-non-randomised-open-label-dose-finding-and-dose-expansion-phase-1b-trial
#20
Michael B Atkins, Elizabeth R Plimack, Igor Puzanov, Mayer N Fishman, David F McDermott, Daniel C Cho, Ulka Vaishampayan, Saby George, Thomas E Olencki, Jamal C Tarazi, Brad Rosbrook, Kathrine C Fernandez, Mariajose Lechuga, Toni K Choueiri
BACKGROUND: Previous studies combining PD-1 checkpoint inhibitors with tyrosine kinase inhibitors of the VEGF pathway have been characterised by excess toxicity, precluding further development. We hypothesised that axitinib, a more selective VEGF inhibitor than others previously tested, could be combined safely with pembrolizumab (anti-PD-1) and yield antitumour activity in patients with treatment-naive advanced renal cell carcinoma. METHODS: In this ongoing, open-label, phase 1b study, which was done at ten centres in the USA, we enrolled patients aged 18 years or older who had advanced renal cell carcinoma (predominantly clear cell subtype) with their primary tumour resected, and at least one measureable lesion, Eastern Cooperative Oncology Group performance status 0-1, controlled hypertension, and no previous systemic therapy for renal cell carcinoma...
February 9, 2018: Lancet Oncology
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