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https://www.readbyqxmd.com/read/28549783/irinotecan-temozolomide-with-temsirolimus-or-dinutuximab-in-children-with-refractory-or-relapsed-neuroblastoma-cog-anbl1221-an-open-label-randomised-phase-2-trial
#1
Rajen Mody, Arlene Naranjo, Collin Van Ryn, Alice L Yu, Wendy B London, Barry L Shulkin, Marguerite T Parisi, Sabah-E-Noor Servaes, Mitchell B Diccianni, Paul M Sondel, Julia G Bender, John M Maris, Julie R Park, Rochelle Bagatell
BACKGROUND: Outcomes for children with relapsed and refractory neuroblastoma are dismal. The combination of irinotecan and temozolomide has activity in these patients, and its acceptable toxicity profile makes it an excellent backbone for study of new agents. We aimed to test the addition of temsirolimus or dinutuximab to irinotecan-temozolomide in patients with relapsed or refractory neuroblastoma. METHODS: For this open-label, randomised, phase 2 selection design trial of the Children's Oncology Group (COG; ANBL1221), patients had to have histological verification of neuroblastoma or ganglioneuroblastoma at diagnosis or have tumour cells in bone marrow with increased urinary catecholamine concentrations at diagnosis...
May 23, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28549676/exposure-response-relationship-of-regorafenib-efficacy-in-patients-with-hepatocellular-carcinoma
#2
Alexander Solms, Isabel Reinecke, Sabine Fiala-Buskies, Anne Keunecke, Henk-Jan Drenth, Jordi Bruix, Gerold Meinhardt, Adriaan Cleton, Bart Ploeger
PURPOSE: To explore the relationship between regorafenib exposure and efficacy in patients with hepatocellular carcinoma (HCC) who had disease progression during sorafenib treatment (RESORCE). METHODS: Exposure-response (ER) analyses for regorafenib were performed using data from a phase 3, randomized, placebo-controlled trial (RESORCE). Patients received 160mg regorafenib or placebo once daily (3weeks on/1week off in a 4-week cycle) with best supportive care until disease progression, death, or unacceptable toxicity...
May 23, 2017: European Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28546227/keyboard-a-novel-bayesian-toxicity-probability-interval-design-for-phase-i-clinical-trials
#3
Fangrong Yan, Sumithra J Mandrekar, Ying Yuan
The primary objective of phase I oncology trials is to find the maximum tolerated dose (MTD). The 3+3 design is easy to implement but performs poorly in finding the MTD. A newer design, such as the modified toxicity probability interval (mTPI) design, provides better accuracy to identify the MTD but tends to overdose patients. We propose the keyboard design, an intuitive Bayesian design that conducts dose escalation and de-escalation based on whether the strongest key, defined as the dosing interval that most likely contains the current dose, is below or above the target dosing interval...
May 25, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28544128/a-pediatric-trial-of-radiation-cetuximab-followed-by-irinotecan-cetuximab-in-newly-diagnosed-diffuse-pontine-gliomas-and-high-grade-astrocytomas-a-pediatric-oncology-experimental-therapeutics-investigators-consortium-study
#4
Margaret E Macy, Mark W Kieran, Susan N Chi, Kenneth J Cohen, Tobey J MacDonald, Amy A Smith, Michael M Etzl, Michele C Kuei, Andrew M Donson, Lia Gore, Jennifer DiRenzo, Tanya M Trippett, Irina Ostrovnaya, Aru Narendran, Nicholas K Foreman, Ira J Dunkel
BACKGROUND: Diffuse intrinsic pontine gliomas (DIPGs) and high-grade astrocytomas (HGA) continue to have dismal prognoses. The combination of cetuximab and irinotecan was demonstrated to be safe and tolerable in a previous pediatric phase 1 combination study. We developed this phase 2 trial to investigate the safety and efficacy of cetuximab given with radiation therapy followed by adjuvant cetuximab and irinotecan. METHODS: Eligible patients of age 3-21 years had newly diagnosed DIPG or HGA...
May 24, 2017: Pediatric Blood & Cancer
https://www.readbyqxmd.com/read/28541775/cellular-response-to-exponentially-increasing-and-decreasing-dose-rates-implications-for-treatment-planning-in-targeted-radionuclide-therapy
#5
Jay H Solanki, Thomas Tritt, Jordan B Pasternack, Julia J Kim, Calvin N Leung, Jason D Domogauer, Nicholas W Colangelo, Venkat R Narra, Roger W Howell
The treatment of cancer using targeted radionuclide therapy is of interest to nuclear medicine and radiation oncology because of its potential for killing tumor cells while minimizing dose-limiting toxicities to normal tissue. The ionizing radiations emitted by radiopharmaceuticals deliver radiation absorbed doses over protracted periods of time with continuously varying dose rates. As targeted radionuclide therapy becomes a more prominent part of cancer therapy, accurate models for estimating the biologically effective dose (BED) or equieffective dose given in 2 fractions (EQD2α/β) will become essential for treatment planning...
May 25, 2017: Radiation Research
https://www.readbyqxmd.com/read/28536826/a-phase-ii-study-of-5-fluorouracil-l-leucovorin-oxaliplatin-mfolfox6-in-japanese-patients-with-metastatic-or-unresectable-small-bowel-adenocarcinoma
#6
Takahiro Horimatsu, Norisuke Nakayama, Toshikazu Moriwaki, Yoshinori Hirashima, Mikio Fujita, Masako Asayama, Ichiro Moriyama, Koji Nakashima, Eishi Baba, Hiroshi Kitamura, Takao Tamura, Ayumu Hosokawa, Kenichi Yoshimura, Manabu Muto
BACKGROUND: Several studies have suggested that chemotherapy prolonged survival in patients with metastatic or recurrent small bowel adenocarcinoma (SBA); however, there is still no standard chemotherapy regimen. Here, we evaluated the efficacy and safety of a 5-fluorouracil (5-FU)/L-leucovorin (l-LV)/oxaliplatin (mFOLFOX6) protocol as a first-line therapy for patients with SBA. PATIENTS AND METHODS: This was a multicenter, single-arm, open-label phase II study...
May 23, 2017: International Journal of Clinical Oncology
https://www.readbyqxmd.com/read/28535359/association-between-nutrition-status-and-survival-in-elderly-patients-with-colorectal-cancer
#7
Katia Barao, Mariana Abe Vicente Cavagnari, Patricia Silva Fucuta, Nora Manoukian Forones
BACKGROUND: Aging patients with cancer have a higher risk of mortality and treatment-associated morbidity than younger patients. Nutrition status may play an important role in cancer mortality. We aimed to evaluate the survival time of elderly patients with colorectal cancer and its association with body mass index (BMI), the patient-generated subjective global assessment (PG-SGA), and phase angle (PA). MATERIALS AND METHODS: BMI, PG-SGA, and PA were determined for all patients (n = 250) at first assessment...
May 1, 2017: Nutrition in Clinical Practice
https://www.readbyqxmd.com/read/28526538/trastuzumab-emtansine-versus-treatment-of-physician-s-choice-in-patients-with-previously-treated-her2-positive-metastatic-breast-cancer-th3resa-final-overall-survival-results-from-a-randomised-open-label-phase-3-trial
#8
Ian E Krop, Sung-Bae Kim, Antonio Gonzalez Martin, Patricia M LoRusso, Jean-Marc Ferrero, Tanja Badovinac-Crnjevic, Silke Hoersch, Melanie Smitt, Hans Wildiers
BACKGROUND: In the randomised, parallel assignment, open-label, phase 3 TH3RESA study, progression-free survival was significantly longer with trastuzumab emtansine versus treatment of physician's choice in previously treated patients with HER2-positive advanced breast cancer. We report results from the final overall survival analysis of the TH3RESA trial. METHODS: Eligible patients for the TH3RESA trial were men and women (aged ≥18 years) with centrally confirmed HER2-positive advanced breast cancer previously treated with both trastuzumab and lapatinib (advanced setting) and a taxane (any setting) and with progression on two or more HER2-directed regimens in the advanced setting...
May 16, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28523098/incb24360-epacadostat-a-highly-potent-and-selective-indoleamine-2-3-dioxygenase-1-ido1-inhibitor-for-immuno-oncology
#9
Eddy W Yue, Richard Sparks, Padmaja Polam, Dilip Modi, Brent Douty, Brian Wayland, Brian Glass, Amy Takvorian, Joseph Glenn, Wenyu Zhu, Michael Bower, Xiangdong Liu, Lynn Leffet, Qian Wang, Kevin J Bowman, Michael J Hansbury, Min Wei, Yanlong Li, Richard Wynn, Timothy C Burn, Holly K Koblish, Jordan S Fridman, Tom Emm, Peggy A Scherle, Brian Metcalf, Andrew P Combs
A data-centric medicinal chemistry approach led to the invention of a potent and selective IDO1 inhibitor 4f, INCB24360 (epacadostat). The molecular structure of INCB24360 contains several previously unknown or underutilized functional groups in drug substances, including a hydroxyamidine, furazan, bromide, and sulfamide. These moieties taken together in a single structure afford a compound that falls outside of "drug-like" space. Nevertheless, the in vitro ADME data is consistent with the good cell permeability and oral bioavailability observed in all species (rat, dog, monkey) tested...
May 11, 2017: ACS Medicinal Chemistry Letters
https://www.readbyqxmd.com/read/28510571/second-line-pazopanib-in-patients-with-relapsed-and-refractory-small-cell-lung-cancer-a-multicentre-phase-ii-study-of-the-hellenic-oncology-research-group
#10
F Koinis, S Agelaki, V Karavassilis, N Kentepozidis, E Samantas, S Peroukidis, P Katsaounis, E Hartabilas, I I Varthalitis, I Messaritakis, G Fountzilas, V Georgoulias, A Kotsakis
BACKGROUND: Pazopanib is a tyrosine kinase inhibitor with antiangiogenic activity. Vascular endothelial growth factor expression is increased in SCLC and is correlated with poor prognosis. The efficacy and tolerance of second-line pazopanib in SCLC was evaluated. PATIENTS AND METHODS: Patients with platinum-sensitive (cohort A; n=39) and -resistant/refractory (cohort B; n=19) SCLC were enrolled in a multicentre phase II study. The primary end point was the progression-free survival rate (PFS-R) at week 8 in each cohort...
May 16, 2017: British Journal of Cancer
https://www.readbyqxmd.com/read/28505697/-the-development-of-palliative-care-hospital-support-teams-hpcts-in-bavaria-from-2011-2015-tasks-acceptance-structure-and-funding
#11
Johanna Anneser, Tamara Thurn, Gian Domenico Borasio
Introduction Palliative care hospital support teams (HPCTs) provide inpatients from all departments palliative medical support. Seriously ill as well as dying patients, who are being treated in facilities that do not have their own palliative care unit, can benefit from these multi-professional teams just as much as patients who do not (yet) need to be admitted to a palliative care unit. At the end of 2015, 53 HPCTs, which were in accordance with the requirements established in the "Program for HPCTs" by the Bavarian Ministry of Health in 2009, had been approved in Bavaria...
May 15, 2017: Das Gesundheitswesen
https://www.readbyqxmd.com/read/28505195/dose-escalation-study-to-evaluate-safety-tolerability-and-efficacy-of-intravenous-etoposide-phosphate-administration-in-27-dogs-with-multicentric-lymphoma
#12
Pierre Boyé, François Serres, Laurent Marescaux, Juliette Hordeaux, Emmanuel Bouchaert, Bruno Gomes, Dominique Tierny
Comparative oncology has shown that naturally occurring canine cancers are of valuable and translatable interest for the understanding of human cancer biology and the characterization of new therapies. This work was part of a comparative oncology project assessing a new, clinical-stage topoisomerase II inhibitor and comparing it with etoposide in dogs with spontaneous lymphoma with the objective to translate findings from dogs to humans. Etoposide is a topoisomerase II inhibitor widely used in various humans' solid and hematopoietic cancer, but little data is available concerning its potential antitumor efficacy in dogs...
2017: PloS One
https://www.readbyqxmd.com/read/28501140/alectinib-versus-crizotinib-in-patients-with-alk-positive-non-small-cell-lung-cancer-j-alex-an-open-label-randomised-phase-3-trial
#13
Toyoaki Hida, Hiroshi Nokihara, Masashi Kondo, Young Hak Kim, Koichi Azuma, Takashi Seto, Yuichi Takiguchi, Makoto Nishio, Hiroshige Yoshioka, Fumio Imamura, Katsuyuki Hotta, Satoshi Watanabe, Koichi Goto, Miyako Satouchi, Toshiyuki Kozuki, Takehito Shukuya, Kazuhiko Nakagawa, Tetsuya Mitsudomi, Nobuyuki Yamamoto, Takashi Asakawa, Ryoichi Asabe, Tomohiro Tanaka, Tomohide Tamura
BACKGROUND: Alectinib, a potent, highly selective, CNS-active inhibitor of anaplastic lymphoma kinase (ALK), showed promising efficacy and tolerability in the single-arm phase 1/2 AF-001JP trial in Japanese patients with ALK-positive non-small-cell lung cancer. Given those promising results, we did a phase 3 trial to directly compare the efficacy and safety of alectinib and crizotinib. METHODS: J-ALEX was a randomised, open-label, phase 3 trial that recruited ALK inhibitor-naive Japanese patients with ALK-positive non-small-cell lung cancer, who were chemotherapy-naive or had received one previous chemotherapy regimen, from 41 study sites in Japan...
May 10, 2017: Lancet
https://www.readbyqxmd.com/read/28500750/nausea-and-vomiting-in-children-and-adolescents-receiving-intrathecal-methotrexate-a-prospective-observational-study
#14
Jacqueline Flank, Komail Nadeem, Sheliza Moledina, Mila Khanna, Christina Schindera, Angela Punnett, L Lee Dupuis
BACKGROUND: The prevalence of nausea and vomiting after receipt of intrathecal methotrexate (IT-MTX) in pediatric oncology patients is unknown. METHODS: Patients (4-18 years) about to receive IT-MTX were eligible to participate in this prospective, observational study. Patients received antiemetics as prescribed by their clinical team. Nausea severity (patient-assessed), timing of emetic episodes, and administration of antiemetics were recorded beginning immediately prior to IT-MTX administration, for the next 24 hr (acute phase), and for a maximum of 7 additional days (delayed phase)...
May 13, 2017: Pediatric Blood & Cancer
https://www.readbyqxmd.com/read/28498880/a-two-arm-multicenter-phase-ii-trial-of-one-cycle-chemoselection-split-dose-docetaxel-cisplatin-and-5-fluorouracil-tpf-induction-chemotherapy-before-two-cycles-of-split-tpf-followed-by-curative-surgery-combined-with-postoperative-radiotherapy-in-patients-with
#15
J Inhestern, H Schmalenberg, A Dietz, N Rotter, G Maschmeyer, M Jungehülsing, C Grosse-Thie, T Kuhnt, M Görner, H Sudhoff, C Wittekindt, O Guntinas-Lichius
Background: : Induction chemotherapy (ICT) with docetaxel, cisplatin and fluorouracil (TPF) followed by radiotherapy is an effective treatment option for locally advanced head and neck cancer. This phase II study investigated the effectivity of a split-dose TPF ICT prior to surgery for locally advanced resectable (stage III/IVA) oral and oropharyngeal cancer. Patients and methods: : Patients received TPF split on two dosages on day 1 and 8 per cycle (30 mg/m 2 docetaxel, 40 mg/m 2 cisplatin, 2000 mg/m 2 fluorouracil per week)...
May 11, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/28495639/safety-and-tolerability-of-the-first-in-class-agent-cpi-613-in-combination-with-modified-folfirinox-in-patients-with-metastatic-pancreatic-cancer-a-single-centre-open-label-dose-escalation-phase-1-trial
#16
Angela Alistar, Bonny B Morris, Rodwige Desnoyer, Heidi D Klepin, Keyanoosh Hosseinzadeh, Clancy Clark, Amy Cameron, John Leyendecker, Ralph D'Agostino, Umit Topaloglu, Lakmal W Boteju, Asela R Boteju, Rob Shorr, Zuzana Zachar, Paul M Bingham, Tamjeed Ahmed, Sandrine Crane, Riddhishkumar Shah, John J Migliano, Timothy S Pardee, Lance Miller, Gregory Hawkins, Guangxu Jin, Wei Zhang, Boris Pasche
BACKGROUND: Pancreatic cancer statistics are dismal, with a 5-year survival of less than 10%, and more than 50% of patients presenting with metastatic disease. Metabolic reprogramming is an emerging hallmark of pancreatic adenocarcinoma. CPI-613 is a novel anticancer agent that selectively targets the altered form of mitochondrial energy metabolism in tumour cells, causing changes in mitochondrial enzyme activities and redox status that lead to apoptosis, necrosis, and autophagy of tumour cells...
May 8, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28490932/contextualizing-the-use-of-oncologic-imaging-within-treatment-phases-imaging-trends-and-modality-preferences-2000-2014
#17
T P Copeland, J M Creasman, D J Seidenwurm, B L Franc
BACKGROUND: In the present study, we retrospectively evaluated the use of tomographic imaging in adult cancer patients to clarify how recent growth plateaus in the use of tomographic imaging in the United States might have affected oncologic imaging during the same period. METHODS: At a U.S. academic cancer centre, 12,059 patients with dates of death from January 2000 through December 2014 were identified. Imaging was restricted to brain and body computed tomography (ct), brain and body magnetic resonance (mr), and body positron-emission tomography (pet) with and without superimposed ct...
April 2017: Current Oncology
https://www.readbyqxmd.com/read/28488143/methodology-of-phase-ii-clinical-trials-in-metastatic-elderly-breast-cancer-a-literature-review
#18
REVIEW
B Cabarrou, L Mourey, F Dalenc, L Balardy, D Kanoun, H Roché, J M Boher, M E Rougé-Bugat, Thomas Filleron
PURPOSE: As the incidence of invasive breast cancer will increase with age, the number of elderly patients with a diagnosis metastatic breast cancer will also rise. But the use of cytotoxic drugs in elderly metastatic breast cancer patients is not systematic and is dreaded by medical oncologists. The need for prospective oncologic data from this population seems increasingly obvious. The main objective of this review is to investigate design and characteristics of phase II trials that assess activity and feasibility of chemotherapies in elderly advanced/metastatic breast cancer patients...
May 9, 2017: Breast Cancer Research and Treatment
https://www.readbyqxmd.com/read/28483269/multiplex-profiling-identifies-distinct-local-and-systemic-alterations-during-intraperitoneal-chemotherapy-for-ovarian-cancer-an-nrg-oncology-gynecologic-oncology-group-study
#19
Shannon Grabosch, George Tseng, Robert P Edwards, Heather A Lankes, Kathleen Moore, Kunle Odunsi, Anda Vlad, Tianzhou Ma, Mary Strange, Joan Brozick, Amit Lugade, Angela Omilian, Wiam Bshara, Ashley R Stuckey, Joan L Walker, Michael Birrer
OBJECTIVES: Ovarian cancer leads to abdominal carcinomatosis and late stage (III/IV) diagnosis in 75% of patients. Three randomized phase III trials have demonstrated that intraperitoneal (IP) chemotherapy improves outcomes in epithelial ovarian cancer. While IP treatment is validated by clinical trials, there is a poor understanding of the mechanism(s) leading to the survival advantage other than the increased concentration of cytotoxic drugs within the tumor microenvironment. A better understanding of this process through analysis of dynamic biomarkers should promote novel approaches that may enhance tumor clearance...
May 5, 2017: Gynecologic Oncology
https://www.readbyqxmd.com/read/28479233/addition-of-gemcitabine-to-paclitaxel-epirubicin-and-cyclophosphamide-adjuvant-chemotherapy-for-women-with-early-stage-breast-cancer-tango-final-10-year-follow-up-of-an-open-label-randomised-phase-3-trial
#20
Helena M Earl, Louise Hiller, Helen C Howard, Janet A Dunn, Jennie Young, Sarah J Bowden, Michelle McDermaid, Anna K Waterhouse, Gregory Wilson, Rajiv Agrawal, Susan O'Reilly, Angela Bowman, Diana M Ritchie, Andrew Goodman, Tamas Hickish, Karen McAdam, David Cameron, David Dodwell, Daniel W Rea, Carlos Caldas, Elena Provenzano, Jean E Abraham, Peter Canney, John P Crown, M John Kennedy, Robert Coleman, Robert C Leonard, James A Carmichael, Andrew M Wardley, Christopher J Poole
BACKGROUND: The tAnGo trial was designed to investigate the potential role of gemcitabine when added to anthracycline and taxane-containing adjuvant chemotherapy for early breast cancer. When this study was developed, gemcitabine had shown significant activity in metastatic breast cancer, and there was evidence of a favourable interaction with paclitaxel. METHODS: tAnGo was an international, open-label, randomised, phase 3 superiority trial that enrolled women aged 18 years or older with newly diagnosed, early-stage breast cancer who had a definite indication for chemotherapy, any nodal status, any hormone receptor status, Eastern Cooperative Oncology Group performance status of 0-1, and adequate bone marrow, hepatic, and renal function...
May 4, 2017: Lancet Oncology
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