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Phase 3 oncology

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https://www.readbyqxmd.com/read/28213002/a-phase-ii-trial-of-dovitinib-in-previously-treated-advanced-pleural-mesothelioma-the-ontario-clinical-oncology-group
#1
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/28205060/validation-of-the-jcog-prognostic-index-in-advanced-gastric-cancer-using-individual-patient-data-from-the-spirits-and-g-sox-trials
#2
Daisuke Takahari, Junki Mizusawa, Wasaburo Koizumi, Ichinosuke Hyodo, Narikazu Boku
BACKGROUND: In a phase III study for advanced gastric cancer (AGC), the Japan Clinical Oncology Group (JCOG) 9912 trial, we previously identified the following four prognostic factors-performance status ≥1, number of metastatic sites ≥2, no prior gastrectomy, and abnormal serum alkaline phosphatase levels-and proposed a prognostic index (good risk with 0 or 1 factor, moderate risk with 2 or 3 factors, and poor risk with all 4 factors). To assess the generalizability of this index, we attempted an external validation study using an independent data set...
February 16, 2017: Gastric Cancer
https://www.readbyqxmd.com/read/28204912/effect-of-food-on-the-bioavailability-of-palbociclib
#3
Ana Ruiz-Garcia, Anna Plotka, Melissa O'Gorman, Diane D Wang
PURPOSE: This phase I study estimated the effect of food on bioavailability of palbociclib (IBRANCE(®)), and a selective inhibitor of cyclin-dependent kinase 4/6 approved for oncology indications has pH-dependent solubility and high permeability. METHODS: In this randomized, four-sequence, four-period crossover study, 28 healthy volunteers received a single 125-mg dose of palbociclib (free-base capsule) following an overnight fast or (1) after a high-fat/-calorie meal, (2) after a low-fat/-calorie meal, and (3) between two moderate-fat/standard-calorie meals...
February 15, 2017: Cancer Chemotherapy and Pharmacology
https://www.readbyqxmd.com/read/28199818/cabozantinib-versus-sunitinib-as-initial-targeted-therapy-for-patients-with-metastatic-renal-cell-carcinoma-of-poor-or-intermediate-risk-the-alliance-a031203-cabosun-trial
#4
Toni K Choueiri, Susan Halabi, Ben L Sanford, Olwen Hahn, M Dror Michaelson, Meghara K Walsh, Darren R Feldman, Thomas Olencki, Joel Picus, Eric J Small, Shaker Dakhil, Daniel J George, Michael J Morris
Purpose Cabozantinib is an oral potent inhibitor of vascular endothelial growth factor receptor 2, MET, and AXL and is a standard second-line therapy for metastatic renal cell carcinoma (mRCC). This randomized phase II multicenter trial evaluated cabozantinib compared with sunitinib as first-line therapy in patients with mRCC. Patients and Methods Eligible patients had untreated clear cell mRCC and Eastern Cooperative Oncology Group performance status of 0 to 2 and were intermediate or poor risk per International Metastatic Renal Cell Carcinoma Database Consortium criteria...
February 20, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28190762/optimal-fractionation-of-preoperative-radiotherapy-and-timing-to-surgery-for-rectal-cancer-stockholm-iii-a-multicentre-randomised-non-blinded-phase-3-non-inferiority-trial
#5
Johan Erlandsson, Torbjörn Holm, David Pettersson, Åke Berglund, Björn Cedermark, Calin Radu, Hemming Johansson, Mikael Machado, Fredrik Hjern, Olof Hallböök, Ingvar Syk, Bengt Glimelius, Anna Martling
BACKGROUND: Radiotherapy reduces the risk of local recurrence in rectal cancer. However, the optimal radiotherapy fractionation and interval between radiotherapy and surgery is still under debate. We aimed to study recurrence in patients randomised between three different radiotherapy regimens with respect to fractionation and time to surgery. METHODS: In this multicentre, randomised, non-blinded, phase 3, non-inferiority trial (Stockholm III), all patients with a biopsy-proven adenocarcinoma of the rectum, without signs of non-resectability or distant metastases, without severe cardiovascular comorbidity, and planned for an abdominal resection from 18 Swedish hospitals were eligible...
February 9, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28187089/clinical-outcome-of-neoadjuvant-radiochemotherapy-in-locally-advanced-cervical-cancer-results-of-an-open-prospective-multicenter-phase-2-study-of-the-north-eastern-german-society-of-gynecological-oncology
#6
Dominique Koensgen, Jalid Sehouli, Antje Belau, Martin Weiss, Matthias B Stope, Vivien Grokopf, Michael Eichbaum, Peter Ledwon, Werner Lichtenegger, Marek Zygmunt, Günter Köhler, Alexander Mustea
OBJECTIVE: The aim of this study was to determine the response rate, toxicity, operability, and surgical complication rate of neoadjuvant concomitant radiochemotherapy (cRCH) (ifosfamide + carboplatin) followed by radical hysterectomy plus external-beam radiotherapy with curative intention in locally advanced primary inoperable stages IIB and IIIB squamous cell cervical cancer. METHODS: Patients with cervical cancer from 8 departments were enrolled. Patients received 3 cycles of ifosfamide 1...
March 2017: International Journal of Gynecological Cancer
https://www.readbyqxmd.com/read/28166468/dose-finding-designs-for-trials-of-molecularly-targeted-agents-and-immunotherapies
#7
Cody Chiuzan, Jonathan Shtaynberger, Gulam A Manji, Jimmy K Duong, Gary K Schwartz, Anastasia Ivanova, Shing M Lee
Recently, there has been a surge of early phase trials of molecularly targeted agents (MTAs) and immunotherapies. These new therapies have different toxicity profiles compared to cytotoxic therapies. MTAs can benefit from new trial designs that allow inclusion of low-grade toxicities, late-onset toxicities, addition of an efficacy endpoint, and flexibility in the specification of a target toxicity probability. To study the degree of adoption of these methods, we conducted a Web of Science search of articles published between 2008 and 2014 that describe phase 1 oncology trials...
February 6, 2017: Journal of Biopharmaceutical Statistics
https://www.readbyqxmd.com/read/28156496/influence-of-early-phase-clinical-trial-enrollment-on-patterns-of-end-of-life-care-for-children-with-advanced-cancer
#8
Chalinee Monsereenusorn, Clement Ma, Hasan Al-Sayegh, Joanne Wolfe, Carlos Rodriguez-Galindo
: 151 Background: Early phase clinical trials are critical to enhancing therapies for children with advanced cancer. However, trial enrollment may intensify end-of-life (EOL) care. We evaluated patterns of EOL care for patients at a large cancer center. METHODS: Single-center, retrospective cohort study of pediatric oncology patients, ages 6 months-21 years, who died in 2010-2014. We queried electronic medical records to assess frequencies of medical procedures (e...
October 9, 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28155175/incidence-and-timing-of-common-adverse-events-in-lenvatinib-treated-patients-from-the-select-trial-and-their-association-with-survival-outcomes
#9
Robert I Haddad, Martin Schlumberger, Lori J Wirth, Eric J Sherman, Manisha H Shah, Bruce Robinson, Corina E Dutcus, Angela Teng, Andrew G Gianoukakis, Steven I Sherman
PURPOSE: In the study of (E7080) lenvatinib in differentiated cancer of the thyroid, most patients experienced an adverse event. In this report, we examine common lenvatinib-emergent adverse events in this phase three, randomized, double-blind study. METHODS: Adverse events were graded per Common Terminology Criteria for Adverse Events v4.0. 392 patients were enrolled (lenvatinib: 261, placebo: 131) and received lenvatinib 24 mg/day or placebo. The main outcome measures were: associations with progression-free survival and overall survival in exploratory univariate and multivariate analyses along with additional variables...
February 3, 2017: Endocrine
https://www.readbyqxmd.com/read/28152932/national-comprehensive-cancer-network-petitions-submissions-and-outcomes
#10
Dinah Faith Huff, William J Hrushesky, Charles Lee Bennett, Kevin Knopf, Michael Baum
: 248 Background: The National Comprehensive Cancer Network (NCCN) invites petitions to its scientific panels. Most ( > 95%) are from the pharmaceutical industry lobbying to include their products in the NCCN Guidelines. Rarely, physicians request scientific scrutiny of the guidelines. We report the experience of Oncology Analytics (OA) with petition submissions and the possible impact on guidelines. METHODS: From 2011-2015, OA made 7 petitions to NCCN. The content of each was tracked into subsequent NCCN Guidelines to ascertain whether any changes resulted...
March 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28152807/outcomes-by-schedule-and-line-of-therapy-in-patients-pts-with-metastatic-breast-cancer-mbc-treated-with-nab-paclitaxel-nab-p-a-u-s-retrospective-community-based-real-world-cohort-analysis
#11
Sotirios G Stergiopoulos, Rick Hippert, Robyn K Harrell, Janet L Espirito, Peg Squier, Amy Ko
: 86 Background: In a phase III study in MBC, nab-P showed activity across lines of therapy. nab-P is approved for MBC at 260 mg/m(2) every 3 weeks (q3w). This analysis evaluated outcomes with use of nab-P in MBC by schedule and line of therapy in a U.S. community setting. METHODS: A multicenter, retrospective cohort analysis was conducted using iKnowMed electronic health record data and electronic medical chart review of women with ≥ 5 visits to a site in the US Oncology Network...
March 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28152750/impact-of-a-best-practice-alert-on-transfusion-practices-for-solid-tumor-oncology-patients
#12
Kelley Wachsberg, Charlotta Weaver, Lyndsey Dombrowski, Madeleine Ma, Jungwha Lee, Kevin O'Leary
: 57 Background: Recent evidence supports a restrictive transfusion strategy in the majority of hospitalized patients, though transfusion practices for oncology patients remain highly variable. We evaluated whether use of a best practice alert for solid tumor oncology inpatients would result in more restrictive transfusion practices and impact patient outcomes. METHODS: We conducted a retrospective, historical control analysis at a large academic hospital in Chicago, IL...
March 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28145036/living-and-dying-with-metastatic-bowel-cancer-serial-in-depth-interviews-with-patients
#13
E Carduff, M Kendall, S A Murray
Colorectal cancer is the second highest cause of cancer deaths. There are significant physical and psycho-social effects on quality of life with advanced disease. Despite this, there are few accounts of the patient experience from advanced illness through to dying. We elicited the longitudinal experiences of living and dying with incurable metastatic colorectal cancer by conducting serial interviews with patients for 12 months or until they died. The interviews were analysed, using a narrative approach, longitudinally as case studies and then together...
February 1, 2017: European Journal of Cancer Care
https://www.readbyqxmd.com/read/28140689/the-efficacy-of-trabectedin-in-treating-ovarian-cancer
#14
Eleonora Teplinsky, Thomas J Herzog
The majority of women with epithelial ovarian cancer present with advanced stage disease and there is a critical need for novel drugs and treatment strategies to improve outcomes. Trabectedin is a unique cytotoxic agent with a complex mechanism of action. It binds to guanines in the N2 position in the minor groove of DNA and its cytotoxicity involves DNA repair pathways and transcription regulation. Trabectedin's activity is also related to the drug-induced changes of the tumor microenvironment. It has been shown to improve progression-free survival in combination with pegylated liposomal doxorubicin in patients with platinum-sensitive relapsed ovarian cancer...
February 2017: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/28139362/eight-year-follow-up-result-of-the-otoasor-trial-the-optimal-treatment-of-the-axilla-surgery-or-radiotherapy-after-positive-sentinel-lymph-node-biopsy-in-early-stage-breast-cancer-a-randomized-single-centre-phase-iii-non-inferiority-trial
#15
Á Sávolt, G Péley, C Polgár, N Udvarhelyi, G Rubovszky, E Kovács, B Győrffy, M Kásler, Z Mátrai
INTRODUCTION: The National Institute of Oncology, Budapest conducted a single centre randomized clinical study. The OTOASOR (Optimal Treatment Of the Axilla - Surgery Or Radiotherapy) trial compares completion of axillary lymph node dissection (cALND) to regional nodal irradiation (RNI) in patients with sentinel lymph node metastasis (pN1sn) in stage I-II breast cancer. PATIENTS AND METHODS: Patients with primary invasive breast cancer (cN0 and cT ≤ 3 cm) were randomized before surgery for cALND (standard treatment) or RNI (investigational treatment)...
January 16, 2017: European Journal of Surgical Oncology
https://www.readbyqxmd.com/read/28135150/phase-iii-randomized-study-of-4-weeks-of-high-dose-interferon-%C3%AE-2b-in-stage-t2bno-t3a-bno-t4a-bno-and-t1-4n1a-2a-microscopic-melanoma-a-trial-of-the-eastern-cooperative-oncology-group-american-college-of-radiology-imaging-network-cancer-research-group-e1697
#16
Sanjiv S Agarwala, Sandra J Lee, Waiki Yip, Uma N Rao, Ahmad A Tarhini, Gary I Cohen, Douglas S Reintgen, Terry L Evans, Joanna M Brell, Mark R Albertini, Michael B Atkins, Shaker R Dakhil, Robert M Conry, Jeffrey A Sosman, Lawrence E Flaherty, Vernon K Sondak, William E Carson, Michael G Smylie, Alberto S Pappo, Richard F Kefford, John M Kirkwood
Purpose To test the efficacy of 4 weeks of intravenous (IV) induction with high-dose interferon (IFN) as part of the Eastern Cooperative Oncology Group regimen compared with observation (OBS) in patients with surgically resected intermediate-risk melanoma. Patients and Methods In this intergroup international trial, eligible patients had surgically resected cutaneous melanoma in the following categories: (1) T2bN0, (2) T3a-bN0, (3) T4a-bN0, and (4) T1-4N1a-2a (microscopic). Patients were randomly assigned to receive IFN α-2b at 20 MU/m(2)/d IV for 5 days (Monday to Friday) every week for 4 weeks (IFN) or OBS...
January 30, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28133095/-nab-paclitaxel-plus-gemcitabine-hydrochloride-in-patients-with-metastatic-or-recurrent-pancreatic-cancer-a-single-institution-experience
#17
Yutaka Takeda, Yoshiteru Katsura, Yoshiaki Ohmura, Takuya Sakamoto, Yasuki Akiyama, Ryuichi Kuwahara, Yoshihiro Morimoto, Tomo Ishida, Yasuo Oneda, Kouhei Murakami, Atsushi Naito, Yoshinori Kagawa, Atsushi Takeno, Takeshi Kato, Shigeyuki Tamura
BACKGROUND: Pancreatic adenocarcinoma is one of the leading causes of cancer deaths in Japan.Albumin -bound paclitaxel (nab-paclitaxel)plus gemcitabine hydrochloride(GEM)combination chemotherapy provided significant improvements in the overall and progression-free survival in a phase III trial in Europe and America and a phase II trial in Japan.As a result, this combination therapy was approved for use in Japan. METHODS: We evaluated the efficacy of nab-paclitaxel plus GEM with metastatic or recurrent pancreatic cancer...
November 2016: Gan to Kagaku Ryoho. Cancer & Chemotherapy
https://www.readbyqxmd.com/read/28131785/nivolumab-in-metastatic-urothelial-carcinoma-after-platinum-therapy-checkmate-275-a-multicentre-single-arm-phase-2-trial
#18
Padmanee Sharma, Margitta Retz, Arlene Siefker-Radtke, Ari Baron, Andrea Necchi, Jens Bedke, Elizabeth R Plimack, Daniel Vaena, Marc-Oliver Grimm, Sergio Bracarda, José Ángel Arranz, Sumanta Pal, Chikara Ohyama, Abdel Saci, Xiaotao Qu, Alexandre Lambert, Suba Krishnan, Alex Azrilevich, Matthew D Galsky
BACKGROUND: Patients with metastatic urothelial carcinoma have a dismal prognosis and few treatment options after first-line chemotherapy. Responses to second-line treatment are uncommon. We assessed nivolumab, a fully human IgG4 PD-1 immune checkpoint inhibitor antibody, for safety and activity in patients with metastatic or surgically unresectable urothelial carcinoma whose disease progressed or recurred despite previous treatment with at least one platinum-based chemotherapy regimen...
January 25, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28129789/short-report-interim-safety-results-for-a-phase-ii-trial-measuring-the-integration-of-stereotactic-ablative-radiotherapy-sabr-plus-surgery-for-early-stage-non-small-cell-lung-cancer-missile-nsclc
#19
David A Palma, Timothy K Nguyen, Keith Kwan, Stewart Gaede, Mark Landis, Richard Malthaner, Dalilah Fortin, Alexander V Louie, Eric Frechette, George B Rodrigues, Brian Yaremko, Edward Yu, A Rashid Dar, Ting-Yim Lee, Al Gratton, Andrew Warner, Aaron Ward, Richard Inculet
: A phase II trial was launched to evaluate if neoadjuvant stereotactic ablative radiotherapy (SABR) before surgery improves oncologic outcomes in patients with stage I non-small cell lung cancer (NSCLC). We report a mandated interim safety analysis for the first 10 patients who completed protocol treatment. Operable patients with biopsy-proven T1-2 N0 NSCLC were eligible. SABR was delivered using a risk-adapted fractionation (54Gy/3 fractions, 55/5 or 60/8). Surgical resection was planned 10 weeks later at a high-volume center (>200 lung cancer resections annually)...
January 27, 2017: Radiation Oncology
https://www.readbyqxmd.com/read/28125369/payer-perspectives-on-patient-reported-outcomes-in-health-care-decision-making-oncology-examples
#20
Andrew P Brogan, Carla DeMuro, Amy M Barrett, Denise D'Alessio, Vasudha Bal, Susan L Hogue
BACKGROUND: Health authorities and payers increasingly recognize the importance of patient perspectives and patient-reported outcomes (PROs) in health care decision making. However, given the broad variety of PRO endpoints included in clinical programs and variations in the timing of PRO data collection and country-specific needs, the role of PRO data in reimbursement decisions requires characterization. OBJECTIVES: To (a) determine the effect of PRO data on market access and reimbursement decisions for oncology products in multiple markets and (b) assess the effect of PRO data collected after clinical progression on payer decision making...
February 2017: Journal of Managed Care & Specialty Pharmacy
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