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https://www.readbyqxmd.com/read/28437190/consuming-a-ketogenic-diet-while-receiving-radiation-and-chemotherapy-for-locally-advanced-lung-cancer-and-pancreatic-cancer-the-university-of-iowa-experience-of-two-phase-1-clinical-trials
#1
Amir Zahra, Melissa A Fath, Emyleigh Opat, Kranti A Mapuskar, Sudershan K Bhatia, Daniel C Ma, Samuel N Rodman Iii, Travis P Snyders, Catherine A Chenard, Julie M Eichenberger-Gilmore, Kellie L Bodeker, Logan Ahmann, Brian J Smith, Sandy A Vollstedt, Heather A Brown, Taher Abu Hejleh, Gerald H Clamon, Daniel J Berg, Luke I Szweda, Douglas R Spitz, John M Buatti, Bryan G Allen
Ketogenic diets are low in carbohydrates and high in fat, which forces cells to rely more heavily upon mitochondrial oxidation of fatty acids for energy. Relative to normal cells, cancer cells are believed to exist under a condition of chronic mitochondrial oxidative stress that is compensated for by increases in glucose metabolism to generate reducing equivalents. In this study we tested the hypothesis that a ketogenic diet concurrent with radiation and chemotherapy would be clinically tolerable in locally advanced non-small cell lung cancer (NSCLC) and pancreatic cancer and could potentially exploit cancer cell oxidative metabolism to improve therapeutic outcomes...
April 24, 2017: Radiation Research
https://www.readbyqxmd.com/read/28437161/randomized-phase-iii-trial-of-trastuzumab-plus-capecitabine-with-or-without-pertuzumab-in-patients-with-human-epidermal-growth-factor-receptor-2-positive-metastatic-breast-cancer-who-experienced-disease-progression-during-or-after-trastuzumab-based-therapy
#2
Ander Urruticoechea, Mohammed Rizwanullah, Seock-Ah Im, Antonio Carlos Sánchez Ruiz, István Láng, Gianluca Tomasello, Hannah Douthwaite, Tanja Badovinac Crnjevic, Sarah Heeson, Jennifer Eng-Wong, Montserrat Muñoz
Purpose To assess the efficacy and safety of trastuzumab plus capecitabine with or without pertuzumab in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer who experienced disease progression during or after trastuzumab-based therapy and received a prior taxane. Patients and Methods Patients were randomly assigned to arm A: trastuzumab 8 mg/kg → 6 mg/kg once every 3 weeks plus capecitabine 1,250 mg/m(2) twice a day (2 weeks on, 1 week off, every 3 weeks); or arm B: pertuzumab 840 mg → 420 mg once every 3 weeks plus trastuzumab at the same dose and schedule as arm A plus capecitabine 1,000 mg/m(2) on the same schedule as arm A...
April 24, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28434660/reduced-dose-radiotherapy-for-human-papillomavirus-associated-squamous-cell-carcinoma-of-the-oropharynx-a-single-arm-phase-2-study
#3
Allen M Chen, Carol Felix, Pin-Chieh Wang, Sophia Hsu, Vincent Basehart, Jordan Garst, Phillip Beron, Deborah Wong, Michael H Rosove, Shyam Rao, Heather Melanson, Edward Kim, Daphne Palmer, Lihong Qi, Karen Kelly, Michael L Steinberg, Patrick A Kupelian, Megan E Daly
BACKGROUND: Head and neck cancers positive for human papillomavirus (HPV) are exquisitely radiosensitive. We investigated whether chemoradiotherapy with reduced-dose radiation would maintain survival outcomes while improving tolerability for patients with HPV-positive oropharyngeal carcinoma. METHODS: We did a single-arm, phase 2 trial at two academic hospitals in the USA, enrolling patients with newly diagnosed, biopsy-proven stage III or IV squamous-cell carcinoma of the oropharynx, positive for HPV by p16 testing, and with Zubrod performance status scores of 0 or 1...
April 20, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28431480/predictive-and-prognostic-factors-associated-with-soft-tissue-sarcoma-response-to-chemotherapy-a-subgroup-analysis-of-the-european-organisation-for-research-and-treatment-of-cancer-62012-study
#4
Robin J Young, Saskia Litière, Michela Lia, Pancras C W Hogendoorn, Cyril Fisher, Gunhild Mechtersheimer, Søren Daugaard, Raf Sciot, Françoise Collin, Christina Messiou, Viktor Grünwald, Alessandro Gronchi, Winette van der Graaf, Eva Wardelmann, Ian Judson
BACKGROUND: The European Organization for Research and Treatment of Cancer (EORTC) 62012 study was a Phase III trial of doxorubicin versus doxorubicin-ifosfamide chemotherapy in 455 patients with advanced soft tissue sarcoma (STS). Analysis of the main study showed that combination chemotherapy improved tumor response and progression-free survival, but differences in overall survival (OS) were not statistically significant. We analyzed factors prognostic for tumor response and OS, and assessed histological subgroup and tumor grade as predictive factors to identify patients more likely to benefit from combination chemotherapy...
April 21, 2017: Acta Oncologica
https://www.readbyqxmd.com/read/28430862/how-health-related-quality-of-life-assessment-should-be-used-in-advanced-colorectal-cancer-clinical-trials
#5
F Bonnetain, C Borg, R R Adams, J A Ajani, A Benson, H Bleiberg, B Chibaudel, E Diaz-Rubio, J Y Douillard, C S Fuchs, B J Giantonio, R Goldberg, V Heinemann, M Koopman, R Labianca, A K Larsen, T Maughan, E Mitchell, M Peeters, C J A Punt, H J Schmoll, C Tournigand, A de Gramont
Traditionally, the efficacy of cancer treatment in patients with advance or metastatic disease in clinical studies has been studied using overall survival (OS) and more recently tumor-based endpoints such as progression-free survival, measurements of response to treatment. However, these seem not to be the relevant clinical endpoints in current situation if such endpoints were no validated as surrogate of OS to demonstrate the clinical efficacy. Appropriate, meaningful, primary patient-oriented and patient-reported endpoints that adequately measure the effects of new therapeutic interventions are then crucial for the advancement of clinical research in metastatic colorectal cancer to complement the results of tumor-based endpoints...
April 18, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/28429147/docetaxel-related-fatigue-in-men-with-metastatic-prostate-cancer-a-descriptive-analysis
#6
A R T Bergin, E Hovey, A Lloyd, G Marx, P Parente, T Rapke, P de Souza
PURPOSE: Fatigue is a prevalent and debilitating side effect of docetaxel chemotherapy in metastatic prostate cancer. A better understanding of the kinetics and nature of docetaxel-related fatigue may provide a framework for intervention. METHODS: This secondary analysis was performed using the MOTIF database, from a phase III, randomised, double-blind, placebo-controlled study of modafinil (200 mg/day for 15 days) for docetaxel-related fatigue in men with metastatic prostate cancer [1]...
April 20, 2017: Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer
https://www.readbyqxmd.com/read/28427507/is-still-there-a-place-for-orteronel-in-management-of-prostate-cancer-data-from-a-literature-based-meta-analysis-of-randomized-trials
#7
REVIEW
Giandomenico Roviello, Chiara Pacifico, Giorgio Chiriacò, Daniele Generali
Orteronel (TAK-700) is an oral, non-steroidal 17,20-lyase inhibitor with higher specificity for 17,20 lyase over 17 hydroxylase. The first phase III studies showed an advantage with orteronel compared with placebo in terms of progression free survival and response of PSA. Unfortunately orteronel did not significantly prolong the overall survival. In order to assess the efficacy of orteronel in prostate cancer, we evaluated all available data on orteronel in the management of prostate cancer. A total of 2716 patients were evaluated from 3 randomized trials...
May 2017: Critical Reviews in Oncology/hematology
https://www.readbyqxmd.com/read/28427189/identifying-biomarkers-of-papillary-renal-cell-carcinoma-associated-with-pathological-stage-by-weighted-gene-co-expression-network-analysis
#8
Zhongshi He, Min Sun, Yuan Ke, Rongjie Lin, Youde Xiao, Shuliang Zhou, Hong Zhao, Yan Wang, Fuxiang Zhou, Yunfeng Zhou
Although papillary renal cell carcinoma (PRCC) accounts for 10%-15% of renal cell carcinoma (RCC), no predictive molecular biomarker is currently applicable to guiding disease stage of PRCC patients. The mRNASeq data of PRCC and adjacent normal tissue in The Cancer Genome Atlas was analyzed to identify 1148 differentially expressed genes, on which weighted gene co-expression network analysis was performed. Then 11 co-expressed gene modules were identified. The highest association was found between blue module and pathological stage (r = 0...
March 2, 2017: Oncotarget
https://www.readbyqxmd.com/read/28427160/biomarker-analysis-of-the-phase-3-torch-trial-for-first-line-erlotinib-versus-chemotherapy-in-advanced-non-small-cell-lung-cancer-patients
#9
Lucia Kim, Mauro Saieg, Massimo Di Maio, Ciro Gallo, Charles Butts, Fortunato Ciardiello, Ronald Feld, Dengxiao Cheng, Vittorio Gebbia, Marco Angelo Burgio, Yasmin Alam, Simona Signoriello, Antonio Rossi, Natasha Leighl, Paolo Maione, Alessandro Morabito, Geoffrey Liu, Ming-Sound Tsao, Francesco Perrone, Cesare Gridelli
BACKGROUND: The TORCH phase III trial compared the efficacy of first-line erlotinib followed by chemotherapy at progression (experimental arm) with the reverse sequence (standard arm) in unselected advanced non-small cell lung cancer (NSCLC) patients. Here we report biomarker analyses. METHODS: EGFR and KRAS mutation, expression of EGFR family members and of cMET and PTEN and EGFR and ABCG2 germline polymorphisms were tested on tumor tissue or blood samples to either confirm previously proposed predictive role or describe it in an explorative setting...
February 25, 2017: Oncotarget
https://www.readbyqxmd.com/read/28426104/a-randomized-open-label-phase-iii-trial-comparing-amrubicin-versus-docetaxel-in-patients-with-previously-treated-non-small-cell-lung-cancer
#10
H Yoshioka, N Katakami, H Okamoto, Y Iwamoto, T Seto, T Takahashi, N Sunaga, S Kudoh, K Chikamori, M Harada, H Tanaka, H Saito, H Saka, K Takeda, N Nogami, N Masuda, T Harada, H Kitagawa, H Horio, T Yamanaka, M Fukuoka, N Yamamoto, K Nakagawa
Background: Amrubicin is approved for treating non-small-cell lung cancer (NSCLC) and small-cell lung cancer. However, no direct comparisons between amrubicin and docetaxel, a standard treatment for NSCLC, have been reported. Patients and methods: We conducted a randomized phase III trial of Japanese NSCLC patients after one or two chemotherapy regimens. Patients were randomized to amrubicin (35 mg/m2 on days 1-3 every 3 weeks) or docetaxel (60 mg/m2 on day 1 every 3 weeks)...
February 1, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/28424775/second-line-treatment-of-non-small-cell-lung-cancer-focus-on-the-clinical-development-of-dacomitinib
#11
REVIEW
Jon Zugazagoitia, Asunción Díaz, Elisabeth Jimenez, Juan Antonio Nuñez, Lara Iglesias, Santiago Ponce-Aix, Luis Paz-Ares
Dacomitinib is a second-generation, irreversible, covalent pan-HER tyrosine-kinase inhibitor (TKI). It showed potent EGFR signaling inhibition in experimental models, including first-generation TKI-resistant non-small cell lung cancer (NSCLC) cell lines. This preclinical efficacy did not translate into clinically meaningful treatment benefits for advanced, pretreated, molecularly unselected NSCLC patients enrolled in two parallel phase III trials. Dacomitinib and erlotinib showed overlapping efficacy data in chemotherapy-pretreated EGFR wild-type (WT) patients in the ARCHER 1009 trial...
2017: Frontiers in Medicine
https://www.readbyqxmd.com/read/28424323/dosing-three-drug-combinations-that-include-targeted-anti-cancer-agents-analysis-of-37-763-patients
#12
Mina Nikanjam, Sariah Liu, Jincheng Yang, Razelle Kurzrock
BACKGROUND: Combining targeted and cytotoxic agents has the potential to improve efficacy and attenuate resistance for metastatic cancer. Information regarding safe starting doses for clinical trials of novel three-drug combinations is lacking. MATERIALS AND METHODS: Published phase I-III adult oncology clinical trials of three-drug combinations involving a targeted agent were identified by PubMed search (January 1, 2010 to December 31, 2013). A dose percentage was calculated to compare the dose used in combination to the single agent recommended dose: (U...
April 19, 2017: Oncologist
https://www.readbyqxmd.com/read/28423407/randomized-trial-comparing-a-web-mediated-follow-up-with-routine-surveillance-in-lung-cancer-patients
#13
Fabrice Denis, Claire Lethrosne, Nicolas Pourel, Olivier Molinier, Yoann Pointreau, Julien Domont, Hugues Bourgeois, Hélène Senellart, Pierre Trémolières, Thibaut Lizée, Jaafar Bennouna, Thierry Urban, Claude El Khouri, Alexandre Charron, Anne-Lise Septans, Magali Balavoine, Sébastien Landry, Philippe Solal-Céligny, Christophe Letellier
Background: The use of web-based monitoring for lung cancer patients is growing in interest because of promising recent results suggesting improvement in cancer and resource utilization outcomes. It remains an open question whether the overall survival (OS) in these patients could be improved by using a web-mediated follow-up rather than classical scheduled follow-up and imaging. Methods: Advanced-stage lung cancer patients without evidence of disease progression after or during initial treatment were randomly assigned in a multicenter phase III trial to compare a web-mediated follow-up algorithm (experimental arm), based on weekly self-scored patient symptoms, with routine follow-up with CT scans scheduled every three to six months according to the disease stage (control arm)...
September 1, 2017: Journal of the National Cancer Institute
https://www.readbyqxmd.com/read/28422774/squamous-cellular-carcinoma-antigen-serum-determination-as-a-biomarker-of-barrett-esophagus-and-esophageal-cancer-a-phase-iii-study
#14
Gemma Maddalo, Matteo Fassan, Romilda Cardin, Marika Piciocchi, Filippo Marafatto, Massimo Rugge, Giovanni Zaninotto, Caterina Pozzan, Carlo Castoro, Alberto Ruol, Alessandra Biasiolo, Fabio Farinati
GOAL: To evaluate the potential role of the determination of the immunocomplexed form of squamous cell carcinoma antigen [SCCA-immunoglobulin (Ig)M] for the screening of Barrett esophagus (BE) and esophageal adenocarcinoma (EAC). BACKGROUND: The cost-effectiveness of surveillance in BE is still debated and the use of biomarkers in screening and surveillance still not recommended. No information is available regarding SCCA-IgM determination in BE. STUDY: SCCA-IgM levels were determined (enzyme-linked immunosorbent assay) in 231 patients prospectively recruited, 71 with BE, 53 with EAC, and 107 controls, including 42 blood donors and 65 patients with gastroesophageal reflux...
April 18, 2017: Journal of Clinical Gastroenterology
https://www.readbyqxmd.com/read/28421161/incidence-of-immune-related-adverse-events-with-program-death-receptor-1-and-program-death-receptor-1-ligand-directed-therapies-in-genitourinary-cancers
#15
REVIEW
Benjamin L Maughan, Erin Bailey, David M Gill, Neeraj Agarwal
Program death receptor-1 (PD-1) and program death receptor-1 ligand (PD-L1) inhibitors are increasingly being used in the clinic to treat a growing number of malignancies, including many genitourinary (GU) malignancies. These immune-based therapies have demonstrated a distinct toxicity profile compared to traditional chemotherapy and the targeted therapies directed at the vascular endothelial growth factor pathway or the mammalian target of rapamycin pathway. Autoimmune toxicity targeting the skin, gastrointestinal tract, or the endocrine organs are some of the more common adverse events (AEs) noted with these therapies...
2017: Frontiers in Oncology
https://www.readbyqxmd.com/read/28419193/a-randomized-phase-ii-iii-study-of-cabazitaxel-versus-vinflunine-in-metastatic-or-locally-advanced-transitional-cell-carcinoma-of-the-urothelium-secavin
#16
J Bellmunt, J M Kerst, F Vázquez, R Morales-Barrera, E Grande, A Medina, Mªb González Graguera, G Rubio, U Anido, O Fernández Calvo, E González-Billalabeitia, Ajm Van den Eertwegh, E Pujol, J L Perez-Gracia, J L González Larriba, R Collado, M Los, S Maciá, R De Wit
BACKGROUND: Despite the advent of immunotherapy in urothelial cancer, there is still a need to find effective cytotoxic agents beyond first and second line. Vinflunine is the only treatment approved in this setting by the European Medicines Agency (EMA) and taxanes are also widely used in second line. Cabazitaxel is a taxane with activity in docetaxel-refractory cancers. A randomized study was conducted to compare its efficacy vs vinflunine. PATIENTS AND METHODS: This is a multicenter, randomized, open-label, phase II/III study, following a Simon's optimal method with stopping rules based on an interim futility analysis and a formal efficacy analysis at the end of the phase II...
April 13, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/28417244/ribociclib-first-global-approval
#17
Yahiya Y Syed
Ribociclib is an oral, small-molecule inhibitor of cyclin-dependent kinase (CDK) 4 and 6 that is under development by Novartis for the treatment of cancer. CDKs play an important role in cell cycle progression and cellular proliferation, and inhibition of these kinases with ribociclib results in G1 phase cell-cycle arrest. Ribociclib, in combination with an aromatase inhibitor, was recently approved in the USA for the first-line treatment of advanced breast cancer and has been submitted for approval in the EU for this indication...
May 2017: Drugs
https://www.readbyqxmd.com/read/28415803/individual-isotoxic-radiation-dose-escalation-based-on-v20-and-advanced-technologies-benefits-unresectable-stage-iii-non-small-cell-lung-cancer-patients-treated-with-concurrent-chemoradiotherapy-long-term-follow-up
#18
Ming Liu, Zhongtang Wang, Tao Zhou, Antang Zhou, Qian Zhao, Hongsheng Li, Hongfu Sun, Wei Huang, BaoSheng Li
Under the assumption that the highest therapeutic ratio could be achieved by increasing the total tumor dose (TTD) to the limits of normal tissues, the phase I trial was conducted in patients with unresectable stage III non-small cell lung cancer treated with concurrent chemoradiotherapy, to determine the feasibility and effects of individual isotoxic radiation dose escalation based on bilateral lung V20 and advanced technologies. Consecutive eligible patients were assigned to cohorts of eight. V20 of each cohort was increased from 27% to 30%, 33%, 35%, 37%, and so on...
March 16, 2017: Oncotarget
https://www.readbyqxmd.com/read/28415706/the-role-of-targeted-agents-in-the-adjuvant-treatment-of-colon-cancer-a-meta-analysis-of-randomized-phase-iii-studies-and-review
#19
Bum Jun Kim, Jae Ho Jeong, Jung Han Kim, Hyeong Su Kim, Hyun Joo Jang
There has been debate as to whether targeted agents have beneficial effect when added to adjuvant chemotherapy for patient with colon cancer. We conducted this meta-analysis to investigate the role of targeted agents in the adjuvant treatment of colon cancer. We searched PubMed, MEDLINE, EMBASE, and the Cochrane Library databases. We included phase III trials with the data of disease-free survival (DFS) and adverse events (AEs) of adjuvant treatment with targeted agents. From 5 eligible studies, a total of 9,991 patients with resected colon cancer were included in the meta-analysis of hazard ratio (HR) for 3-year DFS and odds ratio (OR) for grade 3 or higher AEs...
March 10, 2017: Oncotarget
https://www.readbyqxmd.com/read/28414610/clinical-calculator-for-early-mortality-in-metastatic-colorectal-cancer-an-analysis-of-patients-from-28-clinical-trials-in-the-aide-et-recherche-en-canc%C3%A3-rologie-digestive-database
#20
Lindsay A Renfro, Richard M Goldberg, Axel Grothey, Alberto Sobrero, Richard Adams, Matthew T Seymour, Volker Heinemann, Hans-Joachim Schmoll, Jean-Yves Douillard, Herbert Hurwitz, Charles S Fuchs, Eduardo Diaz-Rubio, Rainer Porschen, Christophe Tournigand, Benoist Chibaudel, Paulo M Hoff, Fairooz F Kabbinavar, Alfredo Falcone, Niall C Tebbutt, Cornelis J A Punt, J Randolph Hecht, John Souglakos, Carsten Bokemeyer, Eric Van Cutsem, Leonard Saltz, Aimery de Gramont, Daniel J Sargent
Purpose Factors contributing to early mortality after initiation of treatment of metastatic colorectal cancer are poorly understood. Materials and Methods Data from 22,654 patients enrolled in 28 randomized phase III trials contained in the ARCAD (Aide et Recherche en Cancérologie Digestive) database were pooled. Multivariable logistic regression models for 30-, 60-, and 90-day mortality were constructed, including clinically and statistically significant patient and disease factors and interaction terms. A calculator (nomogram) for 90-day mortality was developed and validated internally using bootstrapping methods and externally using a 10% random holdout sample from each trial...
April 17, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
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