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Response evaluation of solid tumors

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https://www.readbyqxmd.com/read/27920527/pharmacokinetics-and-safety-of-dts-108-a-human-oligopeptide-bound-to-sn-38-with-an-esterase-sensitive-cross-linker-in-patients-with-advanced-malignancies-a-phase-i-study
#1
Romain Coriat, Sandrine J Faivre, Olivier Mir, Chantal Dreyer, Stanislas Ropert, Mohammed Bouattour, Robert Desjardins, François Goldwasser, Eric Raymond
BACKGROUND: DTS-108 is a hydrosoluble prodrug, where the SN-38 moiety is covalently linked to a 20-amino acid vector peptide by a specific esterase-sensitive cross-linker, releasing 7-ethyl-10-hydroxycampthotecin (SN-38) by esterase bond cleavage. METHODS: The pharmacokinetics of DTS-108, adverse events graded according to NCI-CTCv3.1, dose-limiting toxicities at cycle 1, the maximum tolerated dose (MTD), and the recommended Phase II dose (RP2D) of intravenous DTS-108 (1-2 hours) every 2 weeks were evaluated in a first-in-human Phase I study in patients with advanced/metastatic carcinomas, according to an accelerated dose escalation design...
2016: International Journal of Nanomedicine
https://www.readbyqxmd.com/read/27916795/first-and-second-line-targeted-systemic-therapy-in-hepatocellular-carcinoma-an-update-on-patient-selection-and-response-evaluation
#2
REVIEW
Johann von Felden, Kornelius Schulze, Ines Gil-Ibanez, Tobias Werner, Henning Wege
Advanced hepatocellular carcinoma (HCC) with vascular invasion and/or extrahepatic spread and preserved liver function, according to stage C of the Barcelona Clinic Liver Cancer (BCLC) classification, has a dismal prognosis. The multi-targeted tyrosine-kinase receptor inhibitor (TKI) sorafenib is the only proven active substance in systemic HCC therapy for first-line treatment. In this review, we summarize current aspects in patient selection and management of side effects, and provide an update on response evaluation during first-line sorafenib therapy...
November 28, 2016: Diagnostics
https://www.readbyqxmd.com/read/27915408/a-phase-i-study-of-intravenous-pi3k-inhibitor-copanlisib-in-japanese-patients-with-advanced-or-refractory-solid-tumors
#3
Toshihiko Doi, Nozomu Fuse, Takayuki Yoshino, Takashi Kojima, Hideaki Bando, Hideaki Miyamoto, Masato Kaneko, Motonobu Osada, Atsushi Ohtsu
PURPOSE: To evaluate the safety, tolerability, pharmacokinetics, and efficacy of the intravenously administered pan-PI3K inhibitor copanlisib in Japanese patients with advanced or refractory solid tumors. METHODS: A Phase I open-label study in Japanese patients with advanced or refractory solid tumors was carried out. Patients received a single intravenous dose of either copanlisib 0.4 mg/kg or copanlisib 0.8 mg/kg, dosed intermittently on days 1, 8, and 15 of a 28-day cycle...
December 3, 2016: Cancer Chemotherapy and Pharmacology
https://www.readbyqxmd.com/read/27914917/the-role-of-dual-phase-cone-beam-ct-in-predicting-short-term-response-after-transarterial-chemoembolization-for-hepatocellular-carcinoma
#4
Kerstin Müller, Sanjit Datta, Sonja Gehrisch, Moiz Ahmad, Mohammed Ahmed Abdelrazek Mohammed, Jarrett Rosenberg, Gloria L Hwang, John D Louie, Daniel Y Sze, Nishita Kothary
PURPOSE: To identify computational and qualitative features derived from dual-phase cone-beam CT that predict short-term response in patients undergoing transarterial chemoembolization for hepatocellular carcinoma (HCC). MATERIALS AND METHODS: This retrospective study included 43 patients with 59 HCCs. Six features were extracted, including intensity of tumor enhancement on both phases and characteristics of the corona on the washout phase. Short-term response was evaluated by modified Response Evaluation Criteria in Solid Tumors on follow-up imaging, and extracted features were correlated to response using univariate and multivariate analyses...
November 30, 2016: Journal of Vascular and Interventional Radiology: JVIR
https://www.readbyqxmd.com/read/27908454/fulvestrant-500-mg-versus-anastrozole-1-mg-for-hormone-receptor-positive-advanced-breast-cancer-falcon-an-international-randomised-double-blind-phase-3-trial
#5
John F R Robertson, Igor M Bondarenko, Ekaterina Trishkina, Mikhail Dvorkin, Lawrence Panasci, Alexey Manikhas, Yaroslav Shparyk, Servando Cardona-Huerta, Kwok-Leung Cheung, Manuel Jesus Philco-Salas, Manuel Ruiz-Borrego, Zhimin Shao, Shinzaburo Noguchi, Jacqui Rowbottom, Mary Stuart, Lynda M Grinsted, Mehdi Fazal, Matthew J Ellis
BACKGROUND: Aromatase inhibitors are a standard of care for hormone receptor-positive locally advanced or metastatic breast cancer. We investigated whether the selective oestrogen receptor degrader fulvestrant could improve progression-free survival compared with anastrozole in postmenopausal patients who had not received previous endocrine therapy. METHODS: In this phase 3, randomised, double-blind trial, we recruited eligible patients with histologically confirmed oestrogen receptor-positive or progesterone receptor-positive, or both, locally advanced or metastatic breast cancer from 113 academic hospitals and community centres in 20 countries...
November 28, 2016: Lancet
https://www.readbyqxmd.com/read/27906677/the-implication-of-flt3-amplification-for-flt-targeted-therapeutics-in-solid-tumors
#6
Sung Hee Lim, Sun-Young Kim, Kyung Kim, Hyojin Jang, Soomin Ahn, Kyoung-Mee Kim, Nayoung K D Kim, Woongyang Park, Su Jin Lee, Seung Tae Kim, Se Hoon Park, Joon Oh Park, Young Suk Park, Se-Hoon Lee, Ho Yeong Lim, Keunchil Park, Won Ki Kang, Jeeyun Lee
We investigated the patients with solid cancers harboring Fms-like tyrosine kinase 3 (FLT3) amplification using targeted sequencing of tumor tissue specimen and FISH assay. Simultaneously, FLT3-amplified patient-derived cells (PDCs) were generated to evaluate the sensitivity to FLT3 inhibition. A patient with metastatic colon cancer who was previously treated with more than 3rd line cytotoxic chemotherapy was found to have FLT3 amplification and then received regorafenib showing partial response. In two PDC cell lines with FLT3 amplification, FLT3 mRNA expression was increased, however, the growth of tumor cells was not significantly inhibited by either regorafenib or sorafenib which is known to block the activity FLT3...
November 29, 2016: Oncotarget
https://www.readbyqxmd.com/read/27895495/predictive-values-of-diffusion-weighted-imaging-and-perfusion-weighted-imaging-in-evaluating-the-efficacy-of-transcatheter-arterial-chemoembolization-for-hepatocellular-carcinoma
#7
Min Lin, Man-Man Tian, Wei-Ping Zhang, Li Xu, Ping Jin
This study explored the predictive values of diffusion-weighted imaging (DWI) and perfusion-weighted imaging (PWI) in evaluating the efficacy of transcatheter arterial chemoembolization (TACE) for patients with hepatocellular carcinoma (HCC). A total of 118 HCC patients treated with TACE were selected from April 2013 to November 2015. T1-weighted imaging (T1WI)/T2-weighted imaging (T2WI), DWI, and PWI were performed on all patients before and after TACE. Efficacy was evaluated according to modified Response Evaluation Criteria in Solid Tumors 1...
2016: OncoTargets and Therapy
https://www.readbyqxmd.com/read/27884140/phase-ii-clinical-study-of-valproic-acid-plus-cisplatin-and-cetuximab-in-recurrent-and-or-metastatic-squamous-cell-carcinoma-of-head-and-neck-v-chance-trial
#8
Francesco Caponigro, Elena Di Gennaro, Franco Ionna, Francesco Longo, Corrado Aversa, Ettore Pavone, Maria Grazia Maglione, Massimiliano Di Marzo, Paolo Muto, Ernesta Cavalcanti, Antonella Petrillo, Fabio Sandomenico, Piera Maiolino, Roberta D'Aniello, Gerardo Botti, Rossella De Cecio, Nunzia Simona Losito, Stefania Scala, Annamaria Trotta, Andrea Ilaria Zotti, Francesca Bruzzese, Antonio Daponte, Ester Calogero, Massimo Montano, Monica Pontone, Gianfranco De Feo, Francesco Perri, Alfredo Budillon
BACKGROUND: Recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN) has a poor prognosis and the combination of cisplatin and cetuximab, with or without 5-fluorouracil, is the gold standard treatment in this stage. Thus, the concomitant use of novel compounds represents a critical strategy to improve treatment results. Histone deacetylase inhibitors (HDACi) enhance the activity of several anticancer drugs including cisplatin and anti-Epidermal Growth Factor Receptor (anti-EGFR) compounds...
November 25, 2016: BMC Cancer
https://www.readbyqxmd.com/read/27878356/phase-i-trial-of-daily-triapine-in-combination-with-cisplatin-chemotherapy-for-advanced-stage-malignancies
#9
Charles A Kunos, Edward Chu, Jan H Beumer, Mario Sznol, S Percy Ivy
PURPOSE: Advanced-stage malignancies have increased deoxyribonucleotide demands in DNA replication and repair, making deoxyribonucleotide supply a potential exploitable target for therapy based on ribonucleotide reductase (RNR) inhibition. METHODS: A dose-finding phase I trial was conducted of intravenous (i.v.) triapine, a small-molecule RNR inhibitor, and cisplatin chemotherapy in patients with advanced-stage solid tumor malignancies. Patients received dose-finding levels of i...
November 22, 2016: Cancer Chemotherapy and Pharmacology
https://www.readbyqxmd.com/read/27875761/prognostic-value-of-post-yttrium-90-radioembolization-therapy-18f-fluorodeoxyglucose-positron-emission-tomography-in-patients-with-liver-tumors
#10
Sebastian Obrzut, Kevin McCammack, Karam W Badran, Anthony Balistreri, Evan Ou, Brian J Nguyen, Carl K Hoh, Steven C Rose
OBJECTIVE: This study assessed the benefit of post-therapy (18)F-FDG PET/CT versus CT alone in identifying malignant liver tumor progression following radioembolization with Y-90 microspheres. METHODS: 24 patients with 44 liver tumors underwent CT imaging pre-radioembolization and PET/CT post-radioembolization. Predictive value of Response Evaluation Criteria in Solid Tumors (RECIST 1.1), The World Health Organization (WHO), mRECIST and European Association for the Study of the Liver (EASL) with PET/CT versus CT alone was assessed...
November 16, 2016: Clinical Imaging
https://www.readbyqxmd.com/read/27873130/phase-i-clinical-and-pharmacokinetic-study-of-pm01183-a-tetrahydroisoquinoline-lurbinectedin-in-combination-with-gemcitabine-in-patients-with-advanced-solid-tumors
#11
Luis Paz-Ares, Martin Forster, Valentina Boni, Sergio Szyldergemajn, Jesús Corral, Samantha Turnbull, Antonio Cubillo, Carlos Fernandez Teruel, Iker López Calderero, Mariano Siguero, Patrick Bohan, Emiliano Calvo
Background To determine the recommended dose (RD) of a combination of PM01183 and gemcitabine in patients with advanced solid tumors. Methods Forty-five patients received escalating doses of PM01183/gemcitabine on Days 1 and 8 every 3 weeks (d1,8 q3wk) following a standard 3 + 3 design. Results PM01183 3.5 mg flat dose (FD)/gemcitabine 1000 mg/m(2) was the highest dose level tested. Dose-limiting toxicities (DLTs) were mostly hematological and resulted in the expansion of a lower dose level (PM01183 3...
November 21, 2016: Investigational New Drugs
https://www.readbyqxmd.com/read/27872953/a-phase-i-study-of-afatinib-combined-with-paclitaxel-and-bevacizumab-in-patients-with-advanced-solid-tumors
#12
James Spicer, Sheeba Irshad, Joo Ern Ang, Deborah Enting, Rebecca Kristeleit, Martina Uttenreuther-Fischer, Karine Pemberton, Katy Pelling, David Schnell, Johann de Bono
PURPOSE: The combination of afatinib, an irreversible ErbB family blocker, with paclitaxel and bevacizumab was assessed in patients with advanced solid tumors. METHODS: This phase I study used a 3 + 3 design to determine the maximum tolerated dose (MTD) of afatinib combined with paclitaxel and bevacizumab. Safety, pharmacokinetics, and anti-tumor activity were also assessed. The starting dose was oral afatinib 40 mg once daily plus intravenous paclitaxel (fixed dose 80 mg/m(2), Days 1, 8, and 15 of a 4-week cycle) and intravenous bevacizumab 5 mg/kg every 2 weeks...
November 21, 2016: Cancer Chemotherapy and Pharmacology
https://www.readbyqxmd.com/read/27872340/evaluating-the-needs-of-patients-living-with-solid-tumor-cancer-a-survey-design
#13
April L Schmidt, Rebecca A Lorenz, Paula M Buchanan, Laura McLaughlin
PURPOSE: To describe the unmet needs of adult patients living with solid tumor cancer. DESIGN: Survey design. METHOD: Adult patients living with solid tumor cancer from two outpatient clinics were mailed the Sheffield Profile for Assessment and Referral to Care, a holistic screening questionnaire for assessing palliative care needs, and a demographics questionnaire. One hundred fifteen patients returned the instruments, corresponding to a 62% response rate...
November 20, 2016: Journal of Holistic Nursing: Official Journal of the American Holistic Nurses' Association
https://www.readbyqxmd.com/read/27870704/clinical-outcomes-for-stereotactic-ablative-radiotherapy-in-oligometastatic-and-oligoprogressive-gynecological-malignancies
#14
Shane Mesko, Kiri Sandler, Joshua Cohen, Gottfried Konecny, Michael Steinberg, Mitchell Kamrava
OBJECTIVES: We report single-institution clinical outcomes of women treated with stereotactic ablative radiotherapy (SABR) for oligometastatic or progressive gynecological malignancies. MATERIALS AND METHODS: From 2009 to 2015, 47 lesions from 28 patients were treated with SABR and retrospectively analyzed. All patients had oligometastatic (93%) or oligoprogressive (7%) disease. Primary cancer diagnoses were 15 ovarian, 8 endometrial, 2 cervical, 2 vaginal, and 1 uterine carcinosarcoma...
November 17, 2016: International Journal of Gynecological Cancer
https://www.readbyqxmd.com/read/27870574/evaluation-of-bgj398-a-fibroblast-growth-factor-receptor-1-3-kinase-inhibitor-in-patients-with-advanced-solid-tumors-harboring-genetic-alterations-in-fibroblast-growth-factor-receptors-results-of-a-global-phase-i-dose-escalation-and-dose-expansion-study
#15
Lucia Nogova, Lecia V Sequist, Jose Manuel Perez Garcia, Fabrice Andre, Jean-Pierre Delord, Manuel Hidalgo, Jan H M Schellens, Philippe A Cassier, D Ross Camidge, Martin Schuler, Ulka Vaishampayan, Howard Burris, G Gary Tian, Mario Campone, Zev A Wainberg, Wan-Teck Lim, Patricia LoRusso, Geoffrey I Shapiro, Katie Parker, Xueying Chen, Somesh Choudhury, Francois Ringeisen, Diana Graus-Porta, Dale Porter, Randi Isaacs, Reinhard Buettner, Jürgen Wolf
Purpose This two-part, first-in-human study was initiated in patients with advanced solid tumors harboring genetic alterations in fibroblast growth factor receptors (FGFRs) to determine the maximum tolerated dose (MTD), the recommended phase II dose (RP2D), and the schedule, safety, pharmacokinetics, pharmacodynamics, and antitumor activity of oral BGJ398, a selective FGFR1-3 tyrosine kinase inhibitor. Patients and Methods Adult patients were treated with escalating dosages of BGJ398 5 to 150 mg once daily or 50 mg twice daily continuously in 28-day cycles...
November 21, 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/27869446/-oncopathological-aspects-of-brca1-and-brca2-genes-inactivation-in-tumors-of-ovary-fallopian-tube-and-pelvic-peritoneum
#16
Petr Škapa, Pavel Dundr
Ovarian carcinoma represents a heterogeneous group of malignant epithelial tumors which could be divided into two fundamental groups: Type I (endometrioid carcinoma, clear cell carcinoma, low grade serous carcinoma, mucinous carcinoma and more rare seromucinous carcinoma and malignant Brenner tumor) and type II (high grade serous carcinoma - HGSC). HGSC is the most frequent ovarian carcinoma which may be etiologically linked to inactivation of tumor suppressor genes BRCA1/2 and TP53 and differs from type I carcinomas by higher aggressiveness, tendency to peritoneal spread and worse prognosis...
2016: Ceskoslovenská Patologie
https://www.readbyqxmd.com/read/27863558/development-of-an-autologous-canine-cancer-vaccine-system-for-resectable-malignant-tumors-in-dogs
#17
J R Yannelli, R Wouda, T J Masterson, M G Avdiushko, D A Cohen
While conventional therapies exist for canine cancer, immunotherapies need to be further explored and applied to the canine setting. We have developed an autologous cancer vaccine (K9-ACV), which is available for all dogs with resectable disease. K9-ACV was evaluated for safety and immunogenicity for a variety of cancer types in a cohort of companion dogs under veterinary care. The autologous vaccine was prepared by enzymatic digestion of solid tumor biopsies. The resultant single cell suspensions were then UV-irradiated resulting in immunogenic cell death of the tumor cells...
December 2016: Veterinary Immunology and Immunopathology
https://www.readbyqxmd.com/read/27863201/pooled-analysis-of-cns-response-to-alectinib-in-two-studies-of-pretreated-patients-with-alk-positive-non-small-cell-lung-cancer
#18
Shirish M Gadgeel, Alice T Shaw, Ramaswamy Govindan, Leena Gandhi, Mark A Socinski, D Ross Camidge, Luigi De Petris, Dong-Wan Kim, Alberto Chiappori, Denis L Moro-Sibilot, Michael Duruisseaux, Lucio Crino, Tommaso De Pas, Eric Dansin, Antje Tessmer, James Chih-Hsin Yang, Ji-Youn Han, Walter Bordogna, Sophie Golding, Ali Zeaiter, Sai-Hong Ignatius Ou
Purpose Alectinib has shown activity in the CNS in phase I and II studies. To further evaluate this activity, we pooled efficacy and safety data from two single-arm phase II studies (NP28761 and NP28673; ClinicalTrials.gov identifiers: NCT01871805 and NCT01801111, respectively) in patients with ALK-positive non-small-cell lung cancer (NSCLC). Patients and Methods Both studies included patients with ALK-positive NSCLC who had previously received crizotinib; all patients received alectinib 600 mg twice per day...
December 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/27863197/programmed-death-ligand-1-expression-and-response-to-the-anti-programmed-death-1-antibody-pembrolizumab-in-melanoma
#19
Adil I Daud, Jedd D Wolchok, Caroline Robert, Wen-Jen Hwu, Jeffrey S Weber, Antoni Ribas, F Stephen Hodi, Anthony M Joshua, Richard Kefford, Peter Hersey, Richard Joseph, Tara C Gangadhar, Roxana Dronca, Amita Patnaik, Hassane Zarour, Charlotte Roach, Grant Toland, Jared K Lunceford, Xiaoyun Nicole Li, Kenneth Emancipator, Marisa Dolled-Filhart, S Peter Kang, Scot Ebbinghaus, Omid Hamid
Purpose Expression of programmed death-ligand 1 (PD-L1) is a potential predictive marker for response and outcome after treatment with anti-programmed death 1 (PD-1). This study explored the relationship between anti-PD-1 activity and PD-L1 expression in patients with advanced melanoma who were treated with pembrolizumab in the phase Ib KEYNOTE-001 study (clinical trial information: NCT01295827). Patients and Methods Six hundred fifty-five patients received pembrolizumab10 mg/kg once every 2 weeks or once every 3 weeks, or 2 mg/kg once every 3 weeks...
December 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/27856136/korean-multicenter-registry-of-transcatheter-arterial-chemoembolization-with-drug-eluting-embolic-agents-for-nodular-hepatocellular-carcinomas-six-month-outcome-analysis
#20
Myungsu Lee, Jin Wook Chung, Kwang-Hun Lee, Jong Yun Won, Ho Jong Chun, Han Chu Lee, Jin Hyoung Kim, In Joon Lee, Saebeom Hur, Hyo-Cheol Kim, Yoon Jun Kim, Gyoung Min Kim, Seung-Moon Joo, Jung Suk Oh
PURPOSE: To assess the efficacy and safety of transcatheter arterial chemoembolization with drug-eluting embolic (DEE) agents for nodular hepatocellular carcinoma (HCC). MATERIALS AND METHODS: The study design was a prospective multicenter registry-based, single-arm clinical trial that included 152 patients. One hundred three (67.8%) had a Child-Pugh class/score of A5, 114 (75.0%) had a performance status of 0, and 77 (50.7%) had Barcelona Clinic Liver Cancer (BCLC) stage A disease...
November 14, 2016: Journal of Vascular and Interventional Radiology: JVIR
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