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Phase III clinical trial cancer

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https://www.readbyqxmd.com/read/28645482/proton-pump-inhibitors-and-survival-outcomes-in-patients-with-metastatic-renal-cell-carcinoma
#1
Aly-Khan A Lalani, Rana R McKay, Xun Lin, Ronit Simantov, Marina D Kaymakcalan, Toni K Choueiri
INTRODUCTION: Proton pump inhibitors (PPIs) are potent inhibitors of gastric acid secretion and can affect the optimal absorption of concomitant oral medications, such as vascular endothelial growth factor (VEGF) tyrosine kinase inhibitors (TKIs). The purpose of this study was to investigate the effect of PPI use on survival in metastatic renal cell carcinoma (mRCC) patients treated in the targeted therapy era. MATERIALS AND METHODS: We conducted a pooled analysis of mRCC patients treated in phase II and III clinical trials...
May 31, 2017: Clinical Genitourinary Cancer
https://www.readbyqxmd.com/read/28644303/prostate-cancer-immunotherapy-the-path-forward
#2
Ravi A Madan, James L Gulley
PURPOSE OF REVIEW: To provide an overview of current strategies being investigated in the development of immunotherapy in prostate cancer. RECENT FINDINGS: Development of immunotherapy in prostate cancer actually began in 2010 with FDA approval of sipuleucel-T. Given that immune checkpoint inhibitor trials have either been negative at the phase III level or underwhelming in smaller studies, it is likely that combination strategies will be required to further maximize the impact immune-based therapies on the clinical course of the disease...
July 20, 2017: Current Opinion in Supportive and Palliative Care
https://www.readbyqxmd.com/read/28643244/durvalumab-first-global-approval
#3
Yahiya Y Syed
Intravenous durvalumab (Imfinzi™; AstraZeneca) is a fully human monoclonal antibody that blocks programmed cell death ligand-1 binding to its receptors (PD-1 and CD80), resulting in enhanced T-cell responses against cancer cells. The US FDA has granted durvalumab accelerated approval for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy...
June 22, 2017: Drugs
https://www.readbyqxmd.com/read/28637373/efficacy-pharmacokinetic-and-pharmacodynamic-evaluation-of-apaziquone-in-the-treatment-of-non-muscle-invasive-bladder-cancer
#4
R M Phillips, H R Hendriks, J B Sweeney, G Reddy, G J Peters
Apaziquone (also known as EO9 and Qapzola) is a prodrug that is activated to DNA damaging species by oxidoreductases (particularly NQO1) and has the ability to kill aerobic and/or hypoxic cancer cells. Areas covered: Whilst its poor pharmacokinetic properties contributed to its failure in phase II clinical trials when administered intravenously, these properties were ideal for loco-regional therapies. Apaziquone demonstrated good anti-cancer activity against non-muscle invasive bladder cancer (NMIBC) when administered intravesically to marker lesions and was well tolerated with no systemic side effects...
June 21, 2017: Expert Opinion on Drug Metabolism & Toxicology
https://www.readbyqxmd.com/read/28634748/exposure-response-relationship-of-ramucirumab-in-east-asian-patients-from-rainbow-a-randomized-clinical-trial-in-second-line-treatment-of-gastric-cancer
#5
Tae You Kim, Chia-Jui Yen, Salah-Eddin Al-Batran, David Ferry, Ling Gao, Yanzhi Hsu, Rebecca Cheng, Mauro Orlando, Atsushi Ohtsu
BACKGROUND: Ramucirumab is a recombinant human IgG1 neutralizing monoclonal antibody specific for vascular endothelial growth factor receptor-2. Second-line ramucirumab, in conjunction with paclitaxel (ramucirumab 8 mg/kg or placebo in combination with 80 mg/m(2) paclitaxel), has been shown to be effective and safe in patients with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma in RAINBOW, a global phase III randomized clinical trial. We conducted an exploratory exposure-response analysis of efficacy and safety of ramucirumab in East Asian patients from the RAINBOW trial...
June 20, 2017: Gastric Cancer
https://www.readbyqxmd.com/read/28634730/phase-iii-trial-comparing-uft%C3%A2-%C3%A2-psk-to-uft%C3%A2-%C3%A2-lv-in-stage-iib-iii-colorectal-cancer-mcsgo-cctg
#6
Yasuhiro Miyake, Junichi Nishimura, Takeshi Kato, Masataka Ikeda, Masaki Tsujie, Taishi Hata, Ichiro Takemasa, Tsunekazu Mizushima, Hirofumi Yamamoto, Mitsugu Sekimoto, Riichiro Nezu, Yuichiro Doki, Masaki Mori
PURPOSE: Oral adjuvant uracil and tegafur plus leucovorin (UFT/LV) is not inferior to standard weekly fluorouracil and folinate for stage II/III colon cancer. However, protein-bound polysaccharide K (PSK) has been evaluated as postoperative adjuvant therapy for colorectal cancer. This report is the first of MCSGO-CCTG, which compared UFT/LV to UFT/PSK as adjuvant chemotherapy for stage IIB or III colorectal cancer in patients who had undergone Japanese D2/D3 lymph node dissection. METHODS: The primary endpoint was the 3-year disease-free survival (DFS)...
June 20, 2017: Surgery Today
https://www.readbyqxmd.com/read/28631216/safety-and-tolerability-of-empagliflozin-in-patients-with-type-2-diabetes-pooled-analysis-of-phase-i-iii-clinical-trials
#7
Sven Kohler, Cordula Zeller, Hristo Iliev, Stefan Kaspers
INTRODUCTION: We characterized the safety and tolerability of empagliflozin in patients with type 2 diabetes (T2DM) randomized 1:1:1 to placebo, empagliflozin 10 mg, or empagliflozin 25 mg in clinical trials. METHODS: Pooled data were analyzed from patients with T2DM treated with placebo (N = 4203), empagliflozin 10 mg (N = 4221), or empagliflozin 25 mg (N = 4196) in 15 randomized phase I-III trials plus four extension studies. Adverse events (AEs) were assessed descriptively in participants who took at least one dose of study drug...
June 19, 2017: Advances in Therapy
https://www.readbyqxmd.com/read/28625642/randomized-phase-ii-trial-of-weekly-dose-intensive-chemotherapy-or-amrubicin-plus-cisplatin-chemotherapy-following-induction-chemoradiotherapy-for-limited-disease-small-cell-lung-cancer-jcog1011
#8
Ikuo Sekine, Hideyuki Harada, Noboru Yamamoto, Masashi Wakabayashi, Haruyasu Murakami, Koichi Goto, Naoyuki Nogami, Takashi Seto, Fumihiro Oshita, Hiroaki Okamoto, Hiroshi Tanaka, Tomohide Tamura, Satoshi Ishikura, Yuichiro Ohe
OBJECTIVES: The objective of this study was to select, for a phase III trial, the more promising of weekly-dose intensive chemotherapy or amrubicin+cisplatin chemotherapy as subsequent therapy after induction chemoradiotherapy for previously untreated limited-disease small cell lung cancer (LD-SCLC). MATERIALS AND METHODS: Patients aged 20-70 years with untreated clinical stage II/III LD-SCLC were eligible. After one cycle of accelerated hyperfractionation thoracic radiotherapy with etoposide plus cisplatin, patients without progression were randomized to either 3 cycles of cisplatin 25mg/m2 (days 1, 8), doxorubicin 40mg/m2 (day 1), etoposide 80mg/m2 (days 1-3), and vincristine 1mg/m2 (day 8) every 2 weeks (CODE) or amrubicin 40mg/m2 (days 1-3) and cisplatin 60mg/m2 (day 1) every 3 weeks (AP)...
June 2017: Lung Cancer: Journal of the International Association for the Study of Lung Cancer
https://www.readbyqxmd.com/read/28624922/targeting-the-pd-1-pd-l1-immune-checkpoint-in-egfr-mutated-or-alk-translocated-non-small-cell-lung-cancer
#9
Olivier Bylicki, Nicolas Paleiron, Jacques Margery, Florian Guisier, Alain Vergnenegre, Gilles Robinet, Jean-Bernard Auliac, Radj Gervais, Christos Chouaid
Immune checkpoint inhibitors, notably antibodies targeting programmed death-1 (PD-1) and programmed death ligand-1 (PD-L1), have modified the management of patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC). Several PD-1/PD-L1 inhibitors have been approved by health authorities for this indication and others are in clinical development. However, only a subset of patients truly benefits from these agents. For patients with mutated EGFR or translocated ALK NSCLC, for whom an immune checkpoint inhibitor can be prescribed after progression on tyrosine kinase inhibitors and chemotherapy, information is scarce and sometimes contradictory...
June 18, 2017: Targeted Oncology
https://www.readbyqxmd.com/read/28624696/superimposable-outcomes-for-sequential-and-concomitant-administration-of-adjuvant-trastuzumab-in%C3%A2-her2-positive-breast-cancer-results-from-the-signal-phare-prospective-cohort
#10
Xavier Pivot, Pierre Fumoleau, Jean-Yves Pierga, Suzette Delaloge, Hervé Bonnefoi, Thomas Bachelot, Christelle Jouannaud, Hugues Bourgeois, Maria Rios, Patrick Soulié, Jean-Philippe Jacquin, Sandrine Lavau-Denes, Pierre Kerbrat, David Cox, Céline Faure-Mercier, Iris Pauporte, Joseph Gligorov, Elsa Curtit, Julie Henriques, Sophie Paget-Bailly, Gilles Romieu
AIM: Adjuvant clinical trials in early human epidermal growth factor receptor 2 (HER2)-positive breast cancer have assessed either sequential or concomitant incorporation of trastuzumab with chemotherapy; only the North Central Cancer Treatment Group (NCCTG)-N9831 trial prospectively compared both modalities. In routine trastuzumab has been incorporated into a concurrent regimen with taxane chemotherapy instead of sequential modality on the basis of a positive risk-benefit ratio. This present study assessed sequential versus concomitant administration of adjuvant trastuzumab...
June 15, 2017: European Journal of Cancer
https://www.readbyqxmd.com/read/28623524/does-a-laparoscopic-approach-attenuate-the-body-weight-loss-and-lean-body-mass-loss-observed-in-open-distal-gastrectomy-for-gastric-cancer-a-single-institution-exploratory-analysis-of-the-jcog-0912-phase-iii-trial
#11
Toru Aoyama, Tsutomu Sato, Tsutomu Hayashi, Takanobu Yamada, Haruhiko Cho, Takashi Ogata, Koji Oba, Takaki Yoshikawa
BACKGROUND: Laparoscopy-assisted distal gastrectomy (LADG) for gastric cancer may prevent the loss of body weight and lean body mass resulting from reduced surgical stress in comparison to open distal gastrectomy (ODG). A multicenter phase III trial conducted by the Japan Clinical Oncology Group (JCOG0912 trial) was performed to confirm the non-inferiority of LADG to ODG for stage I gastric cancer in terms of relapse-free survival. METHODS: This study was performed as a single-institution exploratory analysis using the data of the patients from our hospital who were enrolled in the JCOG0912 phase III trial...
June 16, 2017: Gastric Cancer
https://www.readbyqxmd.com/read/28622892/a-phase-ii-trial-of-induction-nab-paclitaxel-and-cisplatin-followed-by-concurrent-chemoradiotherapy-in-patients-with-locally-advanced-nasopharyngeal-carcinoma
#12
Liang-Ru Ke, Wei-Xiong Xia, Wen-Ze Qiu, Xin-Jun Huang, Ya-Hui Yu, Hu Liang, Guo-Ying Liu, Yan-Qun Xiang, Xiang Guo, Xing Lv
OBJECTIVES: Nanoparticle albumin-bound paclitaxel (NAB-paclitaxel) was designed to avoid solvent-related toxicities, and improve anti-tumor efficacy via increasing paclitaxel's intratumoral concentration and its uptake by tumor cells. This trial aimed to determine the safety and efficacy of induction NAB-paclitaxel combined with cisplatin followed by concurrent chemoradiotherapy (CCRT) in patients with locally advanced nasopharyngeal carcinoma (LA-NPC). PATIENTS AND METHODS: Patients with stage III-IVb NPC received NAB-paclitaxel (260mg/m(2)) combined with cisplatin (80mg/m(2)) intravenously on days 1 and 22, followed by cisplatin (80mg/m(2)) on days 43 and 64, concomitant with intensity-modulated radiation therapy...
July 2017: Oral Oncology
https://www.readbyqxmd.com/read/28616599/current-status-and-future-perspectives-of-laparoscopic-radical-surgery-for-advanced-gastric-cancer
#13
REVIEW
Takahiro Kinoshita, Akio Kaito
Laparoscopic radical gastrectomy with lymph node dissection has widely penetrated to East Asian countries, where incidence of gastric cancer occurrence is higher than the rest of the world. Laparoscopic distal gastrectomy for cStageI disease is regarded as one of the option in daily practice in the latest Japanese guidelines; however its applicability to more advanced disease (Stage II/III) is still under debate. Actually, operative techniques of laparoscopic D2 dissection is being matured, but still, necessity of total omentectomy, splenic hilar dissection, management of bulky nodes or large primary tumor, high-level anastomosis in esophageal invasion cases, and extensive peritoneal lavage can be raised as technical limitations...
2017: Translational Gastroenterology and Hepatology
https://www.readbyqxmd.com/read/28611199/u-s-food-and-drug-administration-approval-summary-atezolizumab-for-metastatic-non-small-cell-lung-cancer
#14
Chana Weinstock, Sean Khozin, Daniel Suzman, Lijun Zhang, Shenghui Tang, Sakar Wahby, Kirsten B Goldberg, Geoffrey Kim, Richard Pazdur
On October 18 2016, the U.S. Food and Drug Administration approved atezolizumab (TECENTRIQ®, Genentech Inc.) for treatment of patients with metastatic non-small cell lung cancer (mNSCLC) whose disease progressed during or following platinum-containing chemotherapy. Approval was based on demonstration of clinically meaningful improvements in overall survival (OS) and an acceptable safety profile in two randomized clinical trials (OAK and POPLAR). Median OS in OAK, a phase III trial, was 13.8 months (95% confidence interval [CI] 11...
June 13, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28605319/medicinal-mushrooms-in-human-clinical-studies-part-i-anticancer-oncoimmunological-and-immunomodulatory-activities-a-review
#15
Solomon P Wasser
More than 130 medicinal functions are thought to be produced by medicinal mushrooms (MMs) and fungi, including antitumor, immunomodulating, antioxidant, radical scavenging, cardiovascular, antihypercholesterolemic, antiviral, antibacterial, antiparasitic, antifungal, detoxification, hepatoprotective, antidiabetic, and other effects. Many, if not all, higher Basidiomycetes mushrooms contain biologically active compounds in fruit bodies, cultured mycelia, and cultured broth. Special attention has been paid to mushroom polysaccharides...
2017: International Journal of Medicinal Mushrooms
https://www.readbyqxmd.com/read/28604556/immunologic-response-elicited-in-breast-cancer-patients-receiving-a-neugcgm3-based-vaccine-as-adjuvant-therapy
#16
Anet Valdes-Zayas, Zuyen Gonzalez, Vladimir Mulens, Aliz M Vega, Kirenia Perez, Patricia Lorenzo-Luaces, Maria C Rubio, Anabely Estevez, Idelmis Curbelo, Luis E Fernandez, Tania Crombet, Zaima Mazorra
This study aimed to investigate the immunogenicity of a cancer vaccine consisting of the NeuGcGM3 ganglioside combined with the outer membrane protein complex of Neisseria meningitides to form very small size particles. The vaccine is administered together with Montanide ISA51, as adjuvant treatment for breast cancer patients. After surgical resection and standard first-line chemo/radiotherapy, breast cancer patients in stage II-III were enrolled in a phase III clinical trial and allocated into 2 strata, according to the number of positive lymph nodes [stratum I (0-3); stratum II (≥4)]...
June 9, 2017: Journal of Immunotherapy
https://www.readbyqxmd.com/read/28602103/advances-in-small-molecule-therapy-for-treating-metastatic-thyroid-cancer
#17
Jolanta Krajewska, Tomasz Gawlik, Barbara Jarzab
Multi kinase inhibitors (MKIs) are new drugs, which show activity against receptors of different growth factors leading to the inhibition of tumor cells growth and proliferation. This review summarizes a 10-year experience with the use of MKIs in thyroid cancer (TC). It focuses not only on sorafenib, lenvatinib, vandetanib and cabozantinib, already approved in TC, but also presents an overview of the results of different trials with distinct MKIs so far carried out in TC. Areas covered: published results of phase I, II and III studies and other reports evaluated the efficacy of different targeted drugs in TC...
June 12, 2017: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/28601256/aurora-a-kinase-is-a-priority-pharmaceutical-target-for-the-treatment-of-cancers
#18
REVIEW
Arun Prasath Damodaran, Lucie Vaufrey, Olivia Gavard, Claude Prigent
Aurora kinases control multiple events during cell cycle progression and are essential for mitotic and meiotic bipolar spindle assembly and function. There are three Aurora kinases in mammals, some of which have oncogenic properties and all of which are overexpressed in multiple cancers. Pharmaceutical companies quickly made these kinases priority targets for the development of inhibitors to be used as cancer treatments. In this review, we focus on Aurora A, against which several inhibiting compounds have been discovered and made available; however, even though some of these compounds underwent clinical trials, none have yet gone beyond Phase III trials...
June 7, 2017: Trends in Pharmacological Sciences
https://www.readbyqxmd.com/read/28600777/psychoneuroimmunology-developments-in-stress-research
#19
REVIEW
Rainer H Straub, Maurizio Cutolo
Links between the central nervous stress system and peripheral immune cells in lymphoid organs have been detailed through 50 years of intensive research. The brain can interfere with the immune system, where chronic psychological stress inhibits many functions of the immune system. On the other hand, chronic peripheral inflammation-whether mild (during aging and psychological stress) or severe (chronic inflammatory diseases)-clearly interferes with brain function, leading to disease sequelae like fatigue but also to overt psychiatric illness...
June 9, 2017: Wiener Medizinische Wochenschrift
https://www.readbyqxmd.com/read/28599628/tribe-2-a-phase-iii-randomized-open-label-strategy-trial-in-unresectable-metastatic-colorectal-cancer-patients-by-the-gono-group
#20
Chiara Cremolini, Federica Marmorino, Fotios Loupakis, Gianluca Masi, Carlotta Antoniotti, Lisa Salvatore, Marta Schirripa, Luca Boni, Vittorina Zagonel, Sara Lonardi, Giuseppe Aprile, Emiliano Tamburini, Vincenzo Ricci, Monica Ronzoni, Filippo Pietrantonio, Chiara Valsuani, Gianluca Tomasello, Alessandro Passardi, Giacomo Allegrini, Samantha Di Donato, Daniele Santini, Alfredo Falcone
BACKGROUND: Chemotherapy plus bevacizumab is a standard first-line treatment for unresectable metastatic colorectal cancer patients. Different chemotherapy backbones may be chosen, including one to three drugs, based on patients' general conditions and comorbidities, treatments' objectives, and disease characteristics. TRIBE trial demonstrated a significant advantage in terms of progression-free survival and overall survival for FOLFOXIRI plus bevacizumab as compared with FOLFIRI plus bevacizumab...
June 9, 2017: BMC Cancer
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