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https://www.readbyqxmd.com/read/28430862/how-health-related-quality-of-life-assessment-should-be-used-in-advanced-colorectal-cancer-clinical-trials
#1
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/28427507/is-still-there-a-place-for-orteronel-in-management-of-prostate-cancer-data-from-a-literature-based-meta-analysis-of-randomized-trials
#2
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/28424775/second-line-treatment-of-non-small-cell-lung-cancer-focus-on-the-clinical-development-of-dacomitinib
#3
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
#4
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/28421161/incidence-of-immune-related-adverse-events-with-program-death-receptor-1-and-program-death-receptor-1-ligand-directed-therapies-in-genitourinary-cancers
#5
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/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
#6
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
https://www.readbyqxmd.com/read/28413680/seven-day-capecitabine-plus-docetaxel-and-oxaliplatin-regimen-for-the-treatment-of-advanced-gastric-cancer-a-phase-i-clinical-trial
#7
Rong Liang, Yan Lin, Yongqiang Li, Qian Li, Chunling Yuan, Xiaoli Liao, Sina Liao, Jinyan Zhang, Zhihui Liu
Docetaxel, cisplatin and 5-fluorouracil (DCF regimen) are currently applied as an effective combination treatment for various human malignancies; however, the efficacy of this regimen is impaired by severe adverse events associated with it. Therefore, better-tolerated regimens with comparable efficiency are required for patients with gastric cancer. To explore such possibilities, a phase-I clinical trial was performed to evaluate the safety and tolerability of a modified regimen replacing cisplatin and 5-fluorouracil with oxaliplatin and capecitabine, respectively (DOX program)...
April 2017: Molecular and Clinical Oncology
https://www.readbyqxmd.com/read/28411115/sponging-off-nature-for-new-drug-leads
#8
REVIEW
Raymond Andersen
Marine sponges have consistently been the richest source of new marine natural products with unprecedented chemical scaffolds and potent biological activities that have been reported in the chemical literature since the early 1970s. During the last 40 years, chemists in the Andersen laboratory at UBC, in collaboration with biologists, have discovered many novel bioactive sponge natural products. Four experimental drug candidates for treatment of inflammation and cancer, that were inspired by members of this sponge natural product collection, have progressed to phase I/II/III clinical trials...
April 11, 2017: Biochemical Pharmacology
https://www.readbyqxmd.com/read/28409561/the-most-prevalent-side-effects-of-pegylated-liposomal-doxorubicin-monotherapy-in-women-with-metastatic-breast-cancer-a-systematic-review-of-clinical-trials
#9
REVIEW
L Ansari, F Shiehzadeh, Z Taherzadeh, S Nikoofal-Sahlabadi, A A Momtazi-Borojeni, A Sahebkar, S Eslami
Despite benefits of systemic chemotherapy in breast cancer treatment, several patients with early-stage breast cancer will develop metastatic breast cancer (MBC). Doxorubicin is among the most active agents against MBC. However, the use of doxorubicin is related to some life-threatening side effects including cardiotoxicity. Many efforts were made to lessen the side effects of doxorubicin and improve its efficacy. Pegylated liposomal doxorubicin (PLD) is a product claimed to achieve these two objectives because of its different pharmacokinetic profile...
April 14, 2017: Cancer Gene Therapy
https://www.readbyqxmd.com/read/28404155/survival-outcomes-following-laparoscopic-versus-open-d3-dissection-for-stage-ii-or-iii-colon-cancer-jcog0404-a-phase-3-randomised-controlled-trial
#10
Seigo Kitano, Masafumi Inomata, Junki Mizusawa, Hiroshi Katayama, Masahiko Watanabe, Seiichiro Yamamoto, Masaaki Ito, Shuji Saito, Shoichi Fujii, Fumio Konishi, Yoshihisa Saida, Hirotoshi Hasegawa, Tomonori Akagi, Kenichi Sugihara, Takashi Yamaguchi, Tadahiko Masaki, Yosuke Fukunaga, Kohei Murata, Masazumi Okajima, Yoshihiro Moriya, Yasuhiro Shimada
BACKGROUND: Although benefits of laparoscopic surgery compared with open surgery have been suggested, the long-term survival of patients undergoing laparoscopic surgery for colon cancer requiring Japanese D3 dissection remains unclear. We did a randomised controlled trial to establish non-inferiority of laparoscopic surgery to open surgery. METHODS: We did an open-label, multi-institutional, randomised, two-arm phase 3 trial in 30 hospitals in Japan. Patients aged 20-75 years who had histologically proven colon cancer; tumours located in the caecum or ascending, sigmoid, or rectosigmoid colon; T3 or deeper lesions without involvement of other organs, node stages N0-2, and metastasis stage M0; and tumour size of 8 cm or smaller were included...
April 2017: Lancet. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28399112/cetuximab-in-treatment-of-metastatic-colorectal-cancer-final-survival-analyses-and-extended-ras-data-from-the-nordic-vii-study
#11
Tormod Kyrre Guren, Maria Thomsen, Elin H Kure, Halfdan Sorbye, Bengt Glimelius, Per Pfeiffer, Pia Österlund, Fridbjörn Sigurdsson, Inger Marie Bowitz Lothe, Astrid Marie Dalsgaard, Eva Skovlund, Thoralf Christoffersen, Kjell Magne Tveit
BACKGROUND: The NORDIC-VII study is a randomised phase III trial of cetuximab plus continuous or intermittent fluorouracil, folinic acid, and oxaliplatin (Nordic FLOX) vs FLOX alone in first-line treatment of metastatic colorectal cancer. The present report presents an updated and final survival analysis with BRAF and extended RAS mutational status, 5 years after the primary analysis. METHODS: A total of 566 patients were included in the intention-to-treat (ITT) population of the NORDIC-VII study...
April 11, 2017: British Journal of Cancer
https://www.readbyqxmd.com/read/28398845/potentially-curable-pancreatic-cancer-american-society-of-clinical-oncology-clinical-practice-guideline-update
#12
Alok A Khorana, Pamela B Mangu, Jordan Berlin, Anitra Engebretson, Theodore S Hong, Anirban Maitra, Supriya G Mohile, Matthew Mumber, Richard Schulick, Marc Shapiro, Susan Urba, Herbert J Zeh, Matthew H G Katz
Purpose To update the Potentially Curable Pancreatic Cancer: American Society of Clinical Oncology Clinical Practice Guideline published on May 31, 2016. The October 2016 update focuses solely on new evidence that pertains to clinical question 4 of the guideline: What is the appropriate adjuvant regimen for patients with pancreatic cancer who have undergone an R0 or R1 resection of their primary tumor? Methods The recently published results of a randomized phase III study prompted an update of this guideline...
April 11, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28395543/pharmacokinetic-drug-evaluation-of-ribociclib-for-the-treatment-of-metastatic-hormone-positive-breast-cancer
#13
Giuseppe Curigliano, Carmen Criscitiello, Angela Esposito, Mattia Intra, Saverio Minucci
Cyclin D-cyclin-dependent kinase (CDK) 4/6-inhibitor of CDK4/6-retinoblastoma (Rb) pathway hyperactivation is associated with hormone receptor-positive (HR+) breast cancer (BC). Ribociclib is an orally bioavailable, highly selective small molecule inhibitor of CDK4/6 that induces G1 arrest at sub-micromolar concentrations in a variety of pRb-positive cancer cells in vitro. Ribociclib is a new standard of care for metastatic HR+/HER2 negative metastatic breast cancer. Area covered: In this article, we review the preclinical and clinical development of ribociclib as well as discussing the role for novel applications of these agents outside the arena of HR-positive, HER2-negative advanced breast cancer...
April 11, 2017: Expert Opinion on Drug Metabolism & Toxicology
https://www.readbyqxmd.com/read/28395540/olaparib-for-the-treatment-of-breast-cancer
#14
Marie Robert, Jean-Sébastien Frenel, Carole Gourmelon, Anne Patsouris, Paule Augereau, Mario Campone
Basal-like breast cancer is characterized by being triple negative and aggressive. Defects in DNA repair is a promising therapeutic target as BRCA alterations are found in 11 to 42% of these tumors, with a frequency varying according to family history and ethnicity. The oral PARP inhibitors exploit this deficiency through a synthetic lethality and are considered as promising anticancer therapies, especially in patients harboring BRCA1 or BRCA 2 mutations. Areas covered: Olaparib is one of the most widely investigated PARP inhibitors...
April 11, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28395526/ramucirumab-in-the-treatment-of-non-small-cell-lung-cancer
#15
Arrieta Oscar, Zatarain-Barron Zyanya Lucia, Felipe Cardona Andres, Carmona Amir, Lopez Mejia Mariana
Therapeutic options for treating Non-Small Cell Lung Cancer (NSCLC) have recently increased. Ramucirumab (Cyramza), an anti-angionenic agent was approved in 2014 for treatment of several malignancies, including second-line treatment of patients with NSCLC with disease progression on or after platinum-based chemotherapy. Areas covered: We performed a comprehensive search of the literature focused on clinical trials with use of ramucirumab, targeting its evolution in the treatment of NSCLC. This review summarizes the results regarding its safety and efficacy...
April 11, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28393710/rolapitant-a-nk-1-receptor-antagonist-for-the-prevention-of-chemotherapy-induced-nausea-and-vomiting
#16
Bernardo Leon Rapaport
BACKGROUND: Nausea and vomiting are among the most feared side effects of chemotherapy and can prevent cancer patients from completing their treatment regimens. Rolapitant is a highly selective neurokinin-1 (NK-1) receptor antagonist with very good oral activity, central nervous system penetration and a long (180-hour) plasma half-life. Unlike other available NK-1 receptor antagonists, rolapitant does not inhibit or induce cytochrome P450 (CYP) 3A4. METHODS: Findings from recent phase II and III clinical trials of rolapitant in patients receiving highly or moderately emetogenic chemotherapy are reviewed and discussed...
April 6, 2017: Reviews on Recent Clinical Trials
https://www.readbyqxmd.com/read/28393614/current-and-future-perspectives-on-the-treatment-of-cerebral-ischemia
#17
REVIEW
Brandon R Christophe, Shyle H Mehta, Andrew L A Garton, Jonathan Sisti, E Sander Connolly
After heart disease and combined forms of cancer, stroke is the leading cause of death in the United States. Currently, tissue-plasminogen activator (tPA) thrombolysis is the only thrombolytic therapy that has been shown to improve patient outcome. Presently, the only antithrombotic drug treatment that has proven effective at improving acute ischemic stroke patient outcome is aspirin administration. Despite these studies, no clinical trials have yet demonstrated a reliably effective pharmacological treatment...
April 2017: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/28392837/denosumab-treatment-in-the-management-of-patients-with-advanced-prostate-cancer-clinical-evidence-and-experience
#18
REVIEW
Miriam Hegemann, Jens Bedke, Arnulf Stenzl, Tilman Todenhöfer
Osteoprotective therapies have become an essential component in the management of advanced prostate cancer (PC) patients as bone metastases (BMs) have a major impact on morbidity and mortality. Denosumab is a fully humanized antibody targeting the receptor activator of nuclear factor κB ligand (RANKL), which has been approved by the European Medicines Agency (EMA) in Europe and the United States (US) Food and Drug Administration (FDA) in the US for prevention of skeletal-related events (SREs) in patients with solid tumors and BMs, including PC...
March 2017: Therapeutic Advances in Urology
https://www.readbyqxmd.com/read/28389707/the-race-of-10-synthetic-rnai-based-drugs-to-the-pharmaceutical-market
#19
REVIEW
Ricardo Titze-de-Almeida, Catherine David, Simoneide Souza Titze-de-Almeida
Ten years after Fire and Melo's Nobel Prize for discovery of gene silencing by double-stranded RNA, a remarkable progress was achieved in RNA interference (RNAi). Changes in the chemical structure of synthetic oligonucleotides make them more stable and specific, and new delivery strategies became progressively available. The attention of pharmaceutical industry rapidly turned to RNAi, as an opportunity to explore new drug targets. This review addresses nine small-interfering RNAs (siRNAs) and one unique microRNA (miRNA) inhibitor, which entered the phase 2-3 clinical trials...
April 7, 2017: Pharmaceutical Research
https://www.readbyqxmd.com/read/28382802/major-clinical-research-advances-in-gynecologic-cancer-in-2016-10-year-special-edition
#20
REVIEW
Dong Hoon Suh, Miseon Kim, Kidong Kim, Hak Jae Kim, Kyung Hun Lee, Jae Weon Kim
In 2016, 13 topics were selected as major research advances in gynecologic oncology. For ovarian cancer, study results supporting previous ones regarding surgical preventive strategies were reported. There were several targeted agents that showed comparable responses in phase III trials, including niraparib, cediranib, and nintedanib. On the contrary to our expectations, dose-dense weekly chemotherapy regimen failed to prove superior survival outcomes compared with conventional triweekly regimen. Single-agent non-platinum treatment to prolong platinum-free-interval in patients with recurrent, partially platinum-sensitive ovarian cancer did not improve and even worsened overall survival (OS)...
May 2017: Journal of Gynecologic Oncology
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