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https://www.readbyqxmd.com/read/28235882/fda-approval-summary-accelerated-approval-of-pembrolizumab-for-second-line-treatment-of-metastatic-melanoma
#1
Meredith K Chuk, Jennie T Chang, Marc R Theoret, Emmanuel Sampene, Kun He, Shawna L Weis, Whitney S Helms, Runyan Jin, Hongshan Li, Jingyu Yu, Hong Zhao, Liang Zhao, Mark Paciga, Deborah Schmiel, Rashmi Rawat, Patricia Keegan, Richard Pazdur
On September 4, 2014, FDA approved pembrolizumab (KEYTRUDA, Merck Sharp & Dohme Corp.) with a recommended dose of 2 mg/kg every 3 weeks by intravenous infusion for the treatment of patients with unresectable or metastatic melanoma who have progressed following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Approval was based on demonstration of objective tumor responses with prolonged response durations in 89 patients enrolled in a randomized, multicenter, open-label, dose-finding, and activity-estimating Phase 1 trial...
February 24, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28219023/phase-ii-trials-in-osteosarcoma-recurrences-a-systematic-review-of-past-experience
#2
REVIEW
Natacha Omer, Marie-Cécile Le Deley, Sophie Piperno-Neumann, Perrine Marec-Berard, Antoine Italiano, Nadège Corradini, Carine Bellera, Laurence Brugières, Nathalie Gaspar
BACKGROUND: The most appropriate design of Phase-II trials evaluating new therapies in osteosarcoma remains poorly defined. OBJECTIVE: To study consistency in phase-II clinical trials evaluating new therapies for osteosarcoma recurrences with respect to eligibility criteria, response assessment, end-points, statistical design and reported results. METHODS: Systematic review of clinical trials registered on clinicaltrials.gov, clinicaltrialsregister...
February 17, 2017: European Journal of Cancer
https://www.readbyqxmd.com/read/28216622/effects-of-gene-polymorphisms-in-the-endoplasmic-reticulum-stress-pathway-on-clinical-outcomes-of-chemoradiotherapy-in-chinese-patients-with-nasopharyngeal-carcinoma
#3
Xiao-Bin Guo, Wan-le Ma, Li-Juan Liu, Yu-Ling Huang, Jing Wang, Li-Hua Huang, Xiang-Dong Peng, Ji-Ye Yin, Jin-Gao Li, Shao-Jun Chen, Guo-Ping Yang, Hui Wang, Cheng-Xian Guo
There is considerable inter-individual variabil¬ity in chemoradiotherapy responses in nasopharyngeal carcinoma (NPC) patients receiv¬ing the same or similar treatment protocols. In this study we evaluated the association between the gene polymorphisms in endoplasmic reticulum (ER) stress pathway and chemoradiation responses in Chinese NPC patients. A total of 150 patients with histopathologically conformed NPC and treated with concurrent chemoradiotherapy were enrolled. Genotypes in ER stress pathway genes, including VCP (valosin-containing protein) rs2074549, HSP90B1 rs17034943, CANX (calnexin) rs7566, HSPA5 [heat shock protein family A (Hsp70) member 5] rs430397, CALCR (calcitonin receptor) rs2528521, and XBP1 (X-box binding protein 1) rs2269577 were analyzed by Sequenom MassARRAY system...
February 20, 2017: Acta Pharmacologica Sinica
https://www.readbyqxmd.com/read/28216422/systemic-chemotherapy-combined-with-resection-for-locally-advanced-gallbladder-carcinoma-surgical-and-survival-outcomes
#4
John M Creasy, Debra A Goldman, Vikas Dudeja, Maeve A Lowery, Andrea Cercek, Vinod P Balachandran, Peter J Allen, Ronald P DeMatteo, T Peter Kingham, Michael I D'Angelica, William R Jarnagin
BACKGROUND: Preoperative chemotherapy is a strategy for conversion to resection and/or assessing disease biology prior to operation. The utility of such an approach in gallbladder carcinoma (GBCA) is unknown. This study evaluates outcomes of GBCA patients treated with chemotherapy for locally advanced or lymph node involved tumors. STUDY DESIGN: Patients that received systemic chemotherapy for locally advanced or lymph node positive GBCA were identified from a departmental database...
February 12, 2017: Journal of the American College of Surgeons
https://www.readbyqxmd.com/read/28214659/clinical-outcomes-and-prognostic-factors-of-patients-with-advanced-mesothelioma-treated-in-a-phase-i-clinical-trials-unit
#5
Dionysis Papadatos-Pastos, Desam Roda, Maria Jose De Miguel Luken, Ann Petruckevitch, Awais Jalil, Marta Capelan, Vasiliki Michalarea, Joao Lima, Nikolaos Diamantis, Jaishree Bhosle, L Rhoda Molife, Udai Banerji, Johann S de Bono, Sanjay Popat, Mary E R O'Brien, Timothy A Yap
BACKGROUND: We have previously reported a prognostic score for patients in phase I trials in the Drug Development Unit, treated at the Royal Marsden Hospital (RPS). The RPS is an objective tool used in patient selection for phase I trials based on albumin, number of disease sites and LDH. Patients with mesothelioma are often selected for phase I trials as the disease remains localised for long periods of time. We have now reviewed the clinical outcomes of patients with relapsed malignant mesothelioma (MM) and propose a specific mesothelioma prognostic score (m-RPS) that can help identify patients who are most likely to benefit from early referral...
February 16, 2017: European Journal of Cancer
https://www.readbyqxmd.com/read/28214655/identification-of-microrna-biomarkers-for-response-of-advanced-soft-tissue-sarcomas-to-eribulin-translational-results-of-the-eortc-62052-trial
#6
Erik A C Wiemer, Agnieszka Wozniak, Herman Burger, Marcel Smid, Giuseppe Floris, Axelle Nzokirantevye, Raf Sciot, Stefan Sleijfer, Patrick Schöffski
BACKGROUND: Recent phase II and III clinical trials demonstrated anti-tumour activity of eribulin, a tubulin-interacting cytotoxic agent, in patients with metastatic soft tissue sarcoma (STS). In this exploratory study, we aimed to identify putative microRNA biomarkers that associate with eribulin sensitivity or resistance in STS. MATERIALS AND METHODS: Archival tumour tissue from primary tumours or metastatic lesions was collected prior to eribulin treatment, from 65 consenting patients involved in the EORTC trial 62052...
February 16, 2017: European Journal of Cancer
https://www.readbyqxmd.com/read/28213002/a-phase-ii-trial-of-dovitinib-in-previously-treated-advanced-pleural-mesothelioma-the-ontario-clinical-oncology-group
#7
Scott A Laurie, Desiree Hao, Natasha B Leighl, John Goffin, Abderrahim Khomani, Ashish Gupta, Christina L Addison, Anita Bane, Jean Seely, Marc L Filion, Gregory R Pond, Mark N Levine
OBJECTIVES: Following failure of a platinum-antifolate combination regimen, there is no standard therapy for advanced malignant pleural mesothelioma (MPM). The fibroblast growth factor receptor (FGFR) signaling pathways may be a relevant target in MPM. Dovitinib inhibits multiple tyrosine receptor kinases, predominantly the vascular endothelial growth factor receptors (VEGFR), but also FGFRs, and could be active in MPM. METHODS: This open-label multicentre phase II trial [NCT01769547] enrolled fit, consenting adult patients with advanced MPM who had previously received platinum-antifolate combination chemotherapy and up to one additional line of systemic therapy...
February 2017: Lung Cancer: Journal of the International Association for the Study of Lung Cancer
https://www.readbyqxmd.com/read/28211941/upfront-window-vincristine-irinotecan-treatment-of-high-risk-hepatoblastoma-a-report-from-the-children-s-oncology-group-ahep0731-study-committee
#8
Howard M Katzenstein, Wayne L Furman, Marcio H Malogolowkin, Mark D Krailo, M Beth McCarville, Alexander J Towbin, Greg M Tiao, Milton J Finegold, Sarangarajan Ranganathan, Stephen P Dunn, Max R Langham, Eugene D McGahren, Carlos Rodriguez-Galindo, Rebecka L Meyers
BACKGROUND: The identification of new therapies for high-risk (HR) hepatoblastoma is challenging. Children's Oncology Group study AHEP0731 included a HR stratum to explore the efficacy of novel agents. Herein, the authors report the response rate to the combination of vincristine (V) and irinotecan (I) and the outcome of patients with high-risk hepatoblastoma. METHODS: Patients with newly diagnosed metastatic hepatoblastoma or those with a serum α-fetoprotein (AFP) level <100 ng/mL were eligible...
February 17, 2017: Cancer
https://www.readbyqxmd.com/read/28202000/safety-and-efficacy-of-lobaplatin-combined-with-5-fluorouracil-as-first-line-induction-chemotherapy-followed-by-lobaplatin-radiotherapy-in-locally-advanced-nasopharyngeal-carcinoma-preliminary-results-of-a-prospective-phase-ii-trial
#9
Liang-Ru Ke, Wei-Xiong Xia, Wen-Ze Qiu, Xin-Jun Huang, Jing Yang, Ya-Hui Yu, Hu Liang, Guo-Ying Liu, Yan-Fang Ye, Yan-Qun Xiang, Xiang Guo, Xing Lv
BACKGROUND: Due to improvements in imaging and radiological techniques as well as the use of chemotherapy, distant metastasis has become the predominant mode of treatment failure in patients with locally advanced nasopharyngeal carcinoma (LA-NPC). Platinum-based systemic chemotherapy has shown survival benefits and is now the standard strategy for systemic therapy in patients with LA-NPC. Notably, the third-generation platinum reagent lobaplatin has shown anti-tumor effects in several solid tumors with lower incidences of gastrointestinal, hepatic and renal toxicity relative to other platinum drugs...
February 15, 2017: BMC Cancer
https://www.readbyqxmd.com/read/28188682/stereotactic-ablative-body-radiotherapy-for-inoperable-primary-kidney-cancer-a-prospective-clinical-trial
#10
Shankar Siva, Daniel Pham, Tomas Kron, Mathias Bressel, Jacqueline Lam, Tan Teng Han, Brent Chesson, Mark Shaw, Sarat Chander, Suki Gill, Nicholas R Brook, Nathan Lawrentschuck, Declan G Murphy, Farshad Foroudi
OBJECTIVE: To assess the feasibility and safety of stereotactic ablative body radiotherapy (SABR) for RCC in patients unsuitable for surgery. Secondary objectives were to assess oncologic and functional outcomes. MATERIALS AND METHODS: This was a prospective interventional clinical trial with institutional ethics board approval. Inoperable patients were enrolled after multidisciplinary consensus for intervention and informed consent. Tumor response was defined using RECIST 1...
February 10, 2017: BJU International
https://www.readbyqxmd.com/read/28186961/combination-epigenetic-therapy-in-metastatic-colorectal-cancer-mcrc-with-subcutaneous-5-azacitidine-and-entinostat-a-phase-2-consortium-stand-up-2-cancer-study
#11
Nilofer S Azad, Anthony El-Khoueiry, Jun Yin, Ann L Oberg, Patrick Flynn, Douglas Adkins, Anup Sharma, Daniel J Weisenberger, Thomas Brown, Prakriti Medvari, Peter A Jones, Hariharan Easwaran, Ihab Kamel, Nathan Bahary, George Kim, Joel Picus, Henry C Pitot, Charles Erlichman, Ross Donehower, Hui Shen, Peter W Laird, Richard Piekarz, Stephen Baylin, Nita Ahuja
PURPOSE: Therapy with demethylating agent 5-azacitidine and histone deacetylase inhibitor entinostat shows synergistic re-expression of tumor-suppressor genes and growth inhibition in colorectal (CRC) cell lines and in vivo studies. EXPERIMENTAL DESIGN: We conducted a phase II, multi-institutional study of the combination in metastatic CRC patients. Subcutaneous azacitidine was administered at 75 mg/m2 days 1-5 and 8-10 and entinostat was given 7 mg orally on days 3 and 10...
February 5, 2017: Oncotarget
https://www.readbyqxmd.com/read/28179454/fda-approval-summary-pembrolizumab-for-the-treatment-of-patients-with-unresectable-or-metastatic-melanoma
#12
Amy Barone, Maitreyee Hazarika, Marc R Theoret, Pallavi Mishra-Kalyani, Huanyu Chen, Kun He, Rajeshwari Sridhara, Sriram Subramaniam, Elimika Pfuma, Yaning Wang, Hongshan Li, Hong Zhao, Jeanne Fourie Zirkelbach, Patricia Keegan, Richard Pazdur
On December 18, 2015, the U.S. Food and Drug Administration (FDA) granted regular approval to pembrolizumab (KEYTRUDA®; Merck Sharp & Dohme Corp.) for treatment of patients with unresectable or metastatic melanoma, based on results of two randomized, open-label, active-controlled clinical trials. In Trial PN006, 834 patients with ipilimumab-naïve metastatic melanoma were randomized (1:1:1) to pembrolizumab 10 mg/kg intravenously (IV) every 2 (q2w) or 3 (q3w) weeks until disease progression or ipilimumab 3 mg/kg q3w for up to four doses...
February 8, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28179351/a-multicenter-phase-ii-study-of-gemcitabine-plus-s-1-chemotherapy-for-advanced-biliary-tract-cancer
#13
Shiho Arima, Kyoko Shimizu, Tomoyoshi Okamoto, Masao Toki, Yutaka Suzuki, Naohiro Okano, Daisuke Naruge, Kirio Kawai, Takaaki Kobayashi, Akiyoshi Kasuga, Hiroshi Kitamura, Atuko Takasu, Fumio Nagashima, Masanori Sugiyama, Junji Furuse
BACKGROUND: Gemcitabine (GEM) plus cisplatin (CDDP) chemotherapy has been used worldwide as the standard first-line treatment for advanced biliary tract cancer (BTC). A phase II trial has also suggested promising activity of GEM plus S-1 chemotherapy against advanced BTC. The aim of this study was to evaluate the efficacy and safety of GEM plus S-1 chemotherapy in patients with advanced BTC. PATIENTS AND METHODS: The eligibility criteria were as follows: histologically-proven BTC, unresectable or recurrent disease, ECOG performance status (PS) 0-1 regardless of previous treatment...
2017: Anticancer Research
https://www.readbyqxmd.com/read/28179176/peri-srs-administration-of-immune-checkpoint-therapy-for-melanoma-metastatic-to-the-brain-investigating-efficacy-and-the-effects-of-relative-treatment-timing-on-lesion-response
#14
Mehran B Yusuf, Mark J Amsbaugh, Eric Burton, Jason Chesney, Shiao Woo
OBJECTIVE(S): To investigate the efficacy of immune checkpoint therapy (ICT) administered with stereotactic radiosurgery (SRS) and determine the effects of relative treatment timing on lesion response. METHODS: A prospective institutional database of all patients with intact brain metastases treated with SRS from 2007 to 2015 was reviewed for patients diagnosed with malignant melanoma. Lesion response was determined using a modified RECIST v1.1 criteria. Patients were grouped according to if they received ICT and the timing of ICT relative to SRS...
February 4, 2017: World Neurosurgery
https://www.readbyqxmd.com/read/28178685/overwhelming-rapid-metabolic-and-structural-response-to-apatinib-in-radioiodine-refractory-differentiated-thyroid-cancer
#15
Yansong Lin, Chen Wang, Wen Gao, Ruixue Cui, Jun Liang
Currently, patients with radioiodine refractory differentiated thyroid cancer (RAIR-DTC) have limited treatment options. In this study, we aimed to assess the short-term efficacy and safety of apatinib in RAIR-DTC. Ten adult patients were prospectively enrolled to receive oral apatinib (750 mg q.d). The primary endpoints were change in serum thyroglobulin (Tg) concentration, disease control rate (DCR) and objective response rate (ORR) based on RECIST 1.1 criteria. The secondary endpoints included change in glucose metabolism, evaluated by maximum standard uptake value (SUVmax), and safety...
February 2, 2017: Oncotarget
https://www.readbyqxmd.com/read/28174141/checkpoint-inhibition-for-advanced-mucosal-melanoma
#16
Julia Thierauf, Johannes A Veit, Jochen Hess, Nicolai Treiber, Catharina Lisson, Stephanie E Weissinger, Martin Bommer, Thomas K Hoffmann
BACKGROUND: Whereas anti-PD-1 therapy has demonstrated a significant and durable response against advanced cutaneous melanoma, conventional chemotherapies have shown only minor benefit against advanced mucosal melanoma. OBJECTIVES: To investigate the efficacy of anti-PD-1 therapy in a small cohort of patients with mucosal melanoma of the head and neck. MATERIAL & METHODS: We analysed five patients with mucosal melanoma of the head and neck who received nivolumab or pembrolizumab, at an advanced stage...
February 3, 2017: European Journal of Dermatology: EJD
https://www.readbyqxmd.com/read/28160267/third-line-treatment-of-colorectal-liver-metastases-using-debiri-chemoembolization
#17
Germano Scevola, Giorgio Loreni, Marco Rastelli, Stefano Sposato, Sara Ramponi, Vittorio Miele
To evaluate safety, efficacy of drug-eluting beads with irinotecan (DEBIRI) on local response and survival of patients affected by colorectal liver metastases (CRLM) progressing during or after second line was evaluated. Sixty-two patients, with colorectal liver metastases, not suitable for surgery or thermal ablation treatments, progressing during or within 6 month from the end of second-line chemotherapy, were treated with DEBIRI chemoembolization between February 2009 and July 2014. CRLM were histologically confirmed...
March 2017: Medical Oncology
https://www.readbyqxmd.com/read/28159937/unidimensional-measurement-may-be-superior-to-assess-primary-tumor-response-after-neoadjuvant-chemotherapy-for-nasopharyngeal-carcinoma
#18
Chuanben Chen, Xiurong Lin, Yuanji Xu, Penggang Bai, Youping Xiao, Yuhui Pan, Chao Li, Zhizhong Lin, Mingwei Zhang, Yunbin Chen
Application of current response evaluation criteria in solid tumors (RECIST 1.1) for assessment of irregularly shaped nasopharyngeal carcinoma (NPC) is a gray area with much ambiguity. Our aim was to compare unidimensional measurements (UDM) and bidimensional measurements (BDM) on magnetic resonance images in alternative planes for measurement of tumor response after neoadjuvant chemotherapy (NACT) in patients with locally advanced NPC. 59 patients with untreated non-metastatic NPC were prospectively enrolled...
February 1, 2017: Oncotarget
https://www.readbyqxmd.com/read/28159813/correlation-between-ferumoxytol-uptake-in-tumor-lesions-by-mri-and-response-to-nanoliposomal-irinotecan-in-patients-with-advanced-solid-tumors-a-pilot-study
#19
Ramesh K Ramanathan, Ronald Korn, Natarajan Raghunand, Jasgit C Sachdev, Ronald G Newbold, Gayle Jameson, Gerald J Fetterly, Joshua Prey, Stephan G Klinz, Jaeyeon Kim, Jason Cain, Bart S Hendriks, Daryl C Drummond, Eliel Bayever, Jonathan B Fitzgerald
PURPOSE: Determine if deposition characteristics of ferumoxytol (FMX) iron nanoparticles in tumors, identified by quantitative MRI, may predict tumor lesion response to nanoliposomal irinotecan (nal-IRI). EXPERIMENTAL DESIGN: Eligible patients with previously treated solid tumors had FMX-MRI scans before and following (1, 24, and 72 hours) FMX injection. After MRI acquisition, R2* signal was used to calculate FMX levels in plasma, reference tissue and tumor lesions by comparison with a phantom-based standard curve...
February 3, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28152775/quality-of-life-qol-by-response-an-interim-analysis-of-patients-pts-with-squamous-scc-nsclc-treated-with-nab-paclitaxel-carboplatin-nab-p-c-induction-therapy-in-the-phase-iii-abound-sqm-study
#20
Vera Hirsh, Katayoun Amiri, Amy Ko, Jeanna L Knoble, Melissa Lynne Johnson, Robert M Jotte, Michael McCleod, Teng Jin Ong, Ray D Page, David R Spigel, Howard Jack West
: 63 Background: The correlation of radiological response and pt-reported outcomes (PROs) in advanced NSCLC remains underreported. This interim analysis evaluated QoL by response (RECIST v1.1) in SCC NSCLC pts treated with nab-P/C during the induction part of the ABOUND.sqm study. METHODS: In the ongoing phase III ABOUND.sqm study, pts with advanced SCC NSCLC are treated with first-line nab-P 100 mg/m(2) d 1, 8, 15 and C AUC 6 mg•min/mL d 1 (21-d cycles) for 4 cycles (induction)...
March 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
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