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Phase 3 oncology

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https://www.readbyqxmd.com/read/28642008/concurrent-once-daily-versus-twice-daily-chemoradiotherapy-in-patients-with-limited-stage-small-cell-lung-cancer-convert-an-open-label-phase-3-randomised-superiority-trial
#1
Corinne Faivre-Finn, Michael Snee, Linda Ashcroft, Wiebke Appel, Fabrice Barlesi, Adityanarayan Bhatnagar, Andrea Bezjak, Felipe Cardenal, Pierre Fournel, Susan Harden, Cecile Le Pechoux, Rhona McMenemin, Nazia Mohammed, Mary O'Brien, Jason Pantarotto, Veerle Surmont, Jan P Van Meerbeeck, Penella J Woll, Paul Lorigan, Fiona Blackhall
BACKGROUND: Concurrent chemoradiotherapy is the standard of care in limited-stage small-cell lung cancer, but the optimal radiotherapy schedule and dose remains controversial. The aim of this study was to establish a standard chemoradiotherapy treatment regimen in limited-stage small-cell lung cancer. METHODS: The CONVERT trial was an open-label, phase 3, randomised superiority trial. We enrolled adult patients (aged ≥18 years) who had cytologically or histologically confirmed limited-stage small-cell lung cancer, Eastern Cooperative Oncology Group performance status of 0-2, and adequate pulmonary function...
June 19, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28641315/sequential-vs-concurrent-epirubicin-and-docetaxel-as-adjuvant-chemotherapy-for-high-risk-node-negative-early-breast-cancer-an-interim-analysis-of-a-randomised-phase-iii-study-from-the-hellenic-oncology-research-group
#2
Dimitrios Mavroudis, Emmanouil Saloustros, Ioannis Boukovinas, Pavlos Papakotoulas, Stylianos Kakolyris, Nikolaos Ziras, Charalampos Christophylakis, Nikolaos Kentepozidis, Georgios Fountzilas, Georgios Rigas, Ioannis Varthalitis, Konstantinos Kalbakis, Sofia Agelaki, Dora Hatzidaki, Vasilios Georgoulias
BACKGROUND: Sequential anthracyclines and taxanes are standard adjuvant chemotherapy for patients with high-risk axillary node-positive breast cancer. We compared a sequential to a concurrent regimen in high-risk node-negative early breast cancer. METHODS: Patients were eligible if they had tumours >2 cm or T1c with two of the following characteristics: no oestrogen receptor (ER) and progesterone receptor (PR) expression, histological grade III, Ki67 >40% and vascular, lymphovascular or perineural invasion...
June 22, 2017: British Journal of Cancer
https://www.readbyqxmd.com/read/28629896/randomized-phase-ii-study-of-preoperative-chemoradiotherapy-panitumumab-followed-by-consolidation-chemotherapy-in-potentially-operable-locally-advanced-stage-iiia-n2-non-small-cell-lung-cancer-nrg-oncology-rtog-0839
#3
Martin J Edelman, Chen Hu, Quynh-Thu Le, Jessica S Donington, Warren D D'Souza, Adam P Dicker, Billy W Loo, Elizabeth M Gore, Gregory M M Videtic, Nathaniel R Evans, Joseph W Leach, Maximilian Diehn, Steven J Feigenberg, Yuhchyau Chen, Rebecca Paulus, Jeffrey D Bradley
INTRODUCTION: Multimodality therapy has curative potential in locally advanced non-small cell lung cancer (LASCLC). Mediastinal nodal sterilization (MNS) after induction chemoradiotherapy (CRT) can serve as an intermediate marker for efficacy. NRG Oncology RTOG 0229 demonstrated the feasibility and efficacy of combining full dose radiation (61.2Gy) with chemotherapy followed by resection and chemotherapy. Based upon that experience and evidence that epidermal growth factor receptor (EGFR) antibodies are radiosensitizing, we explored adding panitumumab to CRT followed by resection and consolidation chemotherapy in LANSCLC with a primary endpoint of MNS...
June 16, 2017: Journal of Thoracic Oncology
https://www.readbyqxmd.com/read/28629338/a-phase-2-randomized-trial-to-evaluate-the-impact-of-a-supervised-exercise-program-on-cardiotoxicity-at-3%C3%A2-months-in-patients-with-her2-overexpressing-breast-cancer-undergoing-adjuvant-treatment-by-trastuzumab-design-of-the-cardapac-study
#4
Quentin Jacquinot, Nathalie Meneveau, Marion Chatot, Franck Bonnetain, Bruno Degano, Malika Bouhaddi, Gilles Dumoulin, Dewi Vernerey, Xavier Pivot, Fabienne Mougin
BACKGROUND: The overexpression of human epidermal growth factor receptor-2 (HER2) in breast cancer is a poor prognosis. Trastuzumab improves overall survival but is associated with cardiotoxicity, especially a decline in left ventricular ejection fraction (LVEF). In addition, chemotherapy and radiotherapy increase fatigue and pain, decrease physical capacity and health-related quality of life. To date, no study has evaluated the benefits of physical activity on the side effects of treatment in patients with HER2 positive breast cancer...
June 19, 2017: BMC Cancer
https://www.readbyqxmd.com/read/28625637/a-randomized-phase-2-evaluation-of-the-chk1-inhibitor-ly2603618-administered-in-combination-with-pemetrexed-and-cisplatin-in-patients-with-advanced-nonsquamous-non-small-cell-lung-cancer
#5
Thomas Wehler, Michael Thomas, Christian Schumann, Joaquim Bosch-Barrera, Nuria Viñolas Segarra, Nicolas J Dickgreber, Klaus Dalhoff, Martin Sebastian, Jesus Corral Jaime, Miriam Alonso, Scott M Hynes, Ji Lin, Karla Hurt, Aimee Bence Lin, Emiliano Calvo, Luis Paz-Ares
This phase 2 portion of a phase 1/2 study examined the efficacy and safety of LY2603618, a selective checkpoint kinase 1 inhibitor, combined with pemetrexed and cisplatin (LY+Pem+Cis) in patients with advanced nonsquamous non-small cell lung cancer (NSCLC). This multicenter, randomized, controlled, open-label study (NCT01139775) enrolled patients with stage IV nonsquamous NSCLC and an Eastern Cooperative Oncology Group performance status ≤1. Patients were randomized (2:1) to LY+Pem+Cis or pemetrexed and cisplatin (Pem+Cis)...
June 2017: Lung Cancer: Journal of the International Association for the Study of Lung Cancer
https://www.readbyqxmd.com/read/28623524/does-a-laparoscopic-approach-attenuate-the-body-weight-loss-and-lean-body-mass-loss-observed-in-open-distal-gastrectomy-for-gastric-cancer-a-single-institution-exploratory-analysis-of-the-jcog-0912-phase-iii-trial
#6
Toru Aoyama, Tsutomu Sato, Tsutomu Hayashi, Takanobu Yamada, Haruhiko Cho, Takashi Ogata, Koji Oba, Takaki Yoshikawa
BACKGROUND: Laparoscopy-assisted distal gastrectomy (LADG) for gastric cancer may prevent the loss of body weight and lean body mass resulting from reduced surgical stress in comparison to open distal gastrectomy (ODG). A multicenter phase III trial conducted by the Japan Clinical Oncology Group (JCOG0912 trial) was performed to confirm the non-inferiority of LADG to ODG for stage I gastric cancer in terms of relapse-free survival. METHODS: This study was performed as a single-institution exploratory analysis using the data of the patients from our hospital who were enrolled in the JCOG0912 phase III trial...
June 16, 2017: Gastric Cancer
https://www.readbyqxmd.com/read/28622691/prospective-randomized-phase-ii-study-of-folfiri-versus-folfox7-in-advanced-gastric-adenocarcinoma-a-chinese-western-cooperative-gastrointestinal-oncology-group-study
#7
Qiu Li, Feng Wen, Chengya Zhou, Meng Qiu, Jiyan Liu, Jing Chen, Cheng Yi, Zhiping Li, Deyun Luo, Feng Xu, Xiaohong Cai, Feng Bi
Until now, no standard chemotherapy has been widely accepted for advanced gastric cancer (GC). The current research aimed to compare folinic acid, fluorouracil with irinotecan (mFOLFIRI) or with oxaliplatin (mFOLFOX7) as first-line treatments in patients with locally advanced GC in an open, randomized, phase II study. Previously untreated metastatic or recurrent GC patients with measurable disease received mFOLFIRI (arm A) or mFOLFOX7 (arm B) every 2 weeks. The defined second-line treatment was mFOLFOX7 for arm A and mFOLFIRI for arm B...
June 9, 2017: Oncotarget
https://www.readbyqxmd.com/read/28622249/dynamic-liver-magnetic-resonance-imaging-in-free-breathing-feasibility-of-a-cartesian-t1-weighted-acquisition-technique-with-compressed-sensing-and-additional-self-navigation-signal-for-hard-gated-and-motion-resolved-reconstruction
#8
Benjamin Kaltenbach, Andreas M Bucher, Julian L Wichmann, Dominik Nickel, Christoph Polkowski, Renate Hammerstingl, Thomas J Vogl, Boris Bodelle
OBJECTIVES: The aim of this study was to assess the feasibility of a free-breathing dynamic liver imaging technique using a prototype Cartesian T1-weighted volumetric interpolated breathhold examination (VIBE) sequence with compressed sensing and simultaneous acquisition of a navigation signal for hard-gated and motion state-resolved reconstruction. MATERIALS AND METHODS: A total of 43 consecutive oncologic patients (mean age, 66 ± 11 years; 44% female) underwent free-breathing dynamic liver imaging for the evaluation of liver metastases from colorectal cancer using a prototype Cartesian VIBE sequence (field of view, 380 × 345 mm; image matrix, 320 × 218; echo time/repetition time, 1...
June 16, 2017: Investigative Radiology
https://www.readbyqxmd.com/read/28619538/synthesis-and-biological-evaluation-of-2-3-4-dimethoxyphenyl-6-2-18-f-fluoroethoxy-benzothiazole-18-f-fedbt-for-pet-imaging-of-breast-cancer
#9
Geng-Ying Li, Daria D Vaulina, Jia-Je Li, Olga S Fedorova, Hsin-Ell Wang, Ren-Shyan Liu, Raisa N Krasikova, Chuan-Lin Chen
Given the ever-present demand for improved PET radiotracer in oncology imaging, we have synthesized 2-(3,4-dimethoxyphenyl)-6-(2-[(18)F]fluoroethoxy)benzothiazole ([(18)F]FEDBT), a fluorine-18-containing fluoroethylated benzothiazole to explore its utility as a PET imaging tracer. [(18)F]FEDBT was prepared via kryptofix-mediated nucleophilic substitution of the tosyl group precursor. Fractionated ethanol-based solid-phase (SPE cartridge-based) purification afforded [(18)F]FEDBT in 60% radiochemical yield (EOB), with radiochemical purity in excess of 98% and the specific activity was 35GBq/μmol...
May 26, 2017: Bioorganic & Medicinal Chemistry Letters
https://www.readbyqxmd.com/read/28605730/gemcitabine-and-vinorelbine-combination-chemotherapy-in-taxane-pretreated-patients-with-metastatic-breast-cancer-a-phase-ii-study-of-the-kinki-multidisciplinary-breast-oncology-group-kmbog-1015
#10
Jun Yamamura, Norikazu Masuda, Daigo Yamamoto, Shigeru Tsuyuki, Masahide Yamaguchi, Satoru Tanaka, Junji Tsurutani, Shinya Tokunaga, Katsuhide Yoshidome, Makiko Mizutani, Toyokazu Aono, Asako Ooe, Hirokazu Tanino, Nobuki Matsunami, Hiroyuki Yasojima, Takahiro Nakayama, Yukihiro Nishida
BACKGROUND: This phase II study was conducted to evaluate the efficacy and safety of the chemotherapy combination of gemcitabine and vinorelbine in taxane-pretreated Japanese metastatic breast cancer patients. METHODS: In this multicenter, phase II, single-arm study, patients with recurrent or metastatic HER2-negative breast cancer were administered gemcitabine (1,200 mg/m2) and vinorelbine (25 mg/m2) intravenously on days 1 and 8 every 3 weeks. The primary endpoint was the objective response rate, and other endpoints included progression-free survival, overall survival, and safety...
June 13, 2017: Chemotherapy
https://www.readbyqxmd.com/read/28602585/janus-kinase-2-inhibitor-fedratinib-in-patients-with-myelofibrosis-previously-treated-with-ruxolitinib-jakarta-2-a-single-arm-open-label-non-randomised-phase-2-multicentre-study
#11
Claire N Harrison, Nicolaas Schaap, Alessandro M Vannucchi, Jean-Jacques Kiladjian, Ramon V Tiu, Pierre Zachee, Eric Jourdan, Elliott Winton, Richard T Silver, Harry C Schouten, Francesco Passamonti, Sonja Zweegman, Moshe Talpaz, Joanne Lager, Zhenming Shun, Ruben A Mesa
BACKGROUND: Myelofibrosis is a chronic myeloproliferative neoplasm characterised by splenomegaly, cytopenias, bone marrow fibrosis, and debilitating symptoms including fatigue, weight loss, and bone pain. Mutations in Janus kinase-2 (JAK2) occur in approximately 50% of patients. The only approved JAK2 inhibitor for myelofibrosis is the dual JAK1 and JAK2 inhibitor, ruxolitinib. 58-71% of patients treated with ruxolitinib in clinical trials so far have not achieved the primary endpoint of 35% or more reduction in spleen volume from baseline assessed by MRI or CT...
June 8, 2017: Lancet Haematology
https://www.readbyqxmd.com/read/28592624/prolonged-pemetrexed-infusion-plus-gemcitabine-in-refractory-metastatic-colorectal-cancer-preclinical-rationale-and-phase-ii-study-results
#12
Alessandro Passardi, Francesca Fanini, Livia Turci, Flavia Foca, Paola Rosetti, Silvia Ruscelli, Andrea Casadei Gardini, Martina Valgiusti, Claudio Dazzi, Maurizio Marangolo
LESSONS LEARNED: Difficulties in translating in vitro results into clinical practice are inevitable.Further efforts to verify the efficacy of alternative schedules of pemetrexed in solid tumors are encouraged. BACKGROUND: We investigated the cytotoxic activity of pemetrexed in combination with several drugs (gemcitabine, carboplatin, vinorelbine, and mitomycin C) using different exposure schedules in three colon cancer cell lines. The best results were obtained with the following schedule: a prolonged pemetrexed exposure followed by a 48-hour wash-out and then gemcitabine...
June 7, 2017: Oncologist
https://www.readbyqxmd.com/read/28592620/phase-ii-study-of-first-line-trebananib-plus-sorafenib-in-patients-with-advanced-hepatocellular-carcinoma
#13
Ghassan K Abou-Alfa, Jean-Frederic Blanc, Steven Miles, Tom Ganten, Jörg Trojan, Jonathan Cebon, Andre K Liem, Lara Lipton, Charu Gupta, Benjamin Wu, Michael Bass, Ellen Hollywood, Jennifer Ma, Margaret Bradley, Jason Litten, Leonard B Saltz
LESSONS LEARNED: Trebananib leveraging anti-angiogenic mechanism that is distinct from the classic sorafenib anti-vascular endothelial growth factor inhibition did not demonstrate improved progression-free survival at 4 months in patients with advanced hepatocellular carcinoma (HCC).In support of previously reported high Ang-2 levels' association with poor outcome in HCC for patients, trebananib treatment with lower baseline Ang-2 at study entry was associated with improved overall survival to 22 months and may suggest future studies to be performed within the context of low baseline Ang-2...
June 7, 2017: Oncologist
https://www.readbyqxmd.com/read/28592387/dabrafenib-plus-trametinib-in-patients-with-braf-v600-mutant-melanoma-brain-metastases-combi-mb-a-multicentre-multicohort-open-label-phase-2-trial
#14
Michael A Davies, Philippe Saiag, Caroline Robert, Jean-Jacques Grob, Keith T Flaherty, Ana Arance, Vanna Chiarion-Sileni, Luc Thomas, Thierry Lesimple, Laurent Mortier, Stergios J Moschos, David Hogg, Iván Márquez-Rodas, Michele Del Vecchio, Céleste Lebbé, Nicolas Meyer, Ying Zhang, Yingjie Huang, Bijoyesh Mookerjee, Georgina V Long
BACKGROUND: Dabrafenib plus trametinib improves clinical outcomes in BRAF(V600)-mutant metastatic melanoma without brain metastases; however, the activity of dabrafenib plus trametinib has not been studied in active melanoma brain metastases. Here, we report results from the phase 2 COMBI-MB trial. Our aim was to build on the current body of evidence of targeted therapy in melanoma brain metastases through an evaluation of dabrafenib plus trametinib in patients with BRAF(V600)-mutant melanoma brain metastases...
June 2, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28592386/ct-p6-compared-with-reference-trastuzumab-for-her2-positive-breast-cancer-a-randomised-double-blind-active-controlled-phase-3-equivalence-trial
#15
Justin Stebbing, Yauheni Baranau, Valeriy Baryash, Alexey Manikhas, Vladimir Moiseyenko, Giorgi Dzagnidze, Edvard Zhavrid, Dmytro Boliukh, Daniil Stroyakovskii, Joanna Pikiel, Alexandru Eniu, Dmitry Komov, Gabriela Morar-Bolba, Rubi K Li, Andriy Rusyn, Sang Joon Lee, Sung Young Lee, Francisco J Esteva
BACKGROUND: CT-P6 is a proposed biosimilar to reference trastuzumab. In this study, we aimed to establish equivalence of CT-P6 to reference trastuzumab in neoadjuvant treatment of HER2-positive early-stage breast cancer. METHODS: In this randomised, double-blind, active-controlled, phase 3 equivalence trial, we recruited women aged 18 years or older with stage I-IIIa operable HER2-positive breast cancer from 112 centres in 23 countries. Inclusion criteria were an Eastern Cooperative Oncology Group performance status score of 0 or 1; a normal left ventricular ejection fraction of at least 55%; adequate bone marrow, hepatic, and renal function; at least one measureable lesion; and known oestrogen and progesterone receptor status...
June 2, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28589510/singlicate-ligand-binding-assay-using-an-automated-microfluidic-system-a-clinical-case-study
#16
Hao Jiang, Alex Kozhich, Jennifer Cummings, Janice Gambardella, Frank Zambito, Craig Titsch, Jonathan Haulenbeek, Kelli Phillips, Ross Fergus, Heather Myler
The bioanalytical strategy for monoclonal antibody therapeutics, intended for multiple oncology indications, includes multiple integrated measurements of pharmacologically relevant therapeutics from discovery through development. Three ligand binding assays were cohesively developed and validated, as applicable, using the Gyrolab microfluidic system for the measurement of a free monoclonal antibody BMS-986207. Accuracy and precision demonstrate %bias from -6.3 to 4.4%, percent coefficient of variation (%CV) from 2...
June 6, 2017: AAPS Journal
https://www.readbyqxmd.com/read/28586948/clinical-outcomes-of-image-guided-adaptive-hypofractionated-weekly-radiation-therapy-for-bladder-cancer-in-patients-unsuitable-for-radical-treatment
#17
Shaista Hafeez, Fiona McDonald, Susan Lalondrelle, Helen McNair, Karole Warren-Oseni, Kelly Jones, Victoria Harris, Helen Taylor, Vincent Khoo, Karen Thomas, Vibeke Hansen, David Dearnaley, Alan Horwich, Robert Huddart
PURPOSE AND OBJECTIVES: We report on the clinical outcomes of a phase 2 study assessing image guided hypofractionated weekly radiation therapy in bladder cancer patients unsuitable for radical treatment. METHODS AND MATERIALS: Fifty-five patients with T2-T4aNx-2M0-1 bladder cancer not suitable for cystectomy or daily radiation therapy treatment were recruited. A "plan of the day" radiation therapy approach was used, treating the whole (empty) bladder to 36 Gy in 6 weekly fractions...
May 1, 2017: International Journal of Radiation Oncology, Biology, Physics
https://www.readbyqxmd.com/read/28581400/first-results-of-a-phase-2-trial-of-once-weekly-hypofractionated-breast-irradiation-whbi-for-early-stage-breast-cancer
#18
Anthony E Dragun, Nicholas J Ajkay, Elizabeth C Riley, Teresa L Roberts, Jianmin Pan, Shesh N Rai, Dharamvir Jain, Amy R Quillo, Charles R Scoggins, Kelly M McMasters, Shiao Y Woo
PURPOSE: To report early outcome analysis of a prospective institutional phase 2 trial of weekly hypofractionated breast irradiation (WHBI) for patients undergoing breast-conserving surgery (BCS). METHODS AND MATERIALS: Patients who underwent BCS for American Joint Committee on Cancer stage 0, I, or II breast cancer with negative surgical margins received whole-breast radiation therapy to 30 or 28.5 Gy in 5 weekly fractions with or without an additional boost. The eligibility criteria were the same as for NSABP (National Surgical Adjuvant Breast and Bowel Project) B39/RTOG (Radiation Therapy Oncology Group) 0413, and there were no restrictions on age, breast size, tumor grade, receptor status, or the use of cytotoxic chemotherapy for otherwise eligible patients...
July 1, 2017: International Journal of Radiation Oncology, Biology, Physics
https://www.readbyqxmd.com/read/28581126/systemic-therapy-for-head-and-neck-squamous-cell-carcinoma-historical-perspectives-and-recent-breakthroughs
#19
REVIEW
Michael A Blasco, Peter F Svider, S Naweed Raza, John R Jacobs, Adam J Folbe, Pankhoori Saraf, Jean Anderson Eloy, Soly Baredes, Andrew M Fribley
OBJECTIVES: Despite dramatic developments in drugs established for other malignancies, historically there have been few novel systemic agents available for the management of head and neck squamous cell carcinoma (HNSCC). However, the last decade has observed increased interest in targeted therapies for HNSCC. In 2006, cetuximab became the first major drug for HNSCC to gain Food and Drug Administration (FDA) approval in 3 decades. Recently, both pembrolizumab and nivolumab gained FDA approval for treatment of recurrent or metastatic HNSCC, and trials for other indications in HNSCC are actively underway...
June 5, 2017: Laryngoscope
https://www.readbyqxmd.com/read/28579151/validation-of-the-association-of-recist-changes-with-survival-in-men-with-metastatic-castration-resistant-prostate-cancer-treated-on-swog-study-s0421
#20
Guru Sonpavde, Gregory R Pond, Melissa Plets, Catherine M Tangen, Maha H A Hussain, Primo N Lara, Amir Goldkorn, Mark G Garzotto, Philip C Mack, Celestia S Higano, Nicholas J Vogelzang, Ian M Thompson, Przemyslaw W Twardowski, Peter J Van Veldhuizen, Neeraj Agarwal, Michael A Carducci, J Paul Monk, David I Quinn
BACKGROUND: Phase 2 trials evaluating new agents for metastatic castration-resistant prostate cancer (mCRPC) have relied on bone scan and prostate-specific antigen changes to assess activity. Given the increasing detection of measurable disease, Response Evaluation Criteria in Solid Tumors (RECIST) changes warrant consideration to evaluate activity. We validated the association of RECIST 1.0 changes with survival in men with mCRPC receiving docetaxel. PATIENTS AND METHODS: Data for men with measurable disease from the Southwest Oncology Group (SWOG) S0421, a phase 3 trial in men with mCRPC receiving docetaxel and prednisone plus placebo or atrasentan, were used...
May 10, 2017: Clinical Genitourinary Cancer
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