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falcon trial

Chiara Cremolini, Massimo Milione, Federica Marmorino, Federica Morano, Gemma Zucchelli, Alessia Mennitto, Michele Prisciandaro, Sara Lonardi, Alessio Pellegrinelli, Daniele Rossini, Francesca Bergamo, Giuseppe Aprile, Lucio Urbani, Luca Morelli, Marta Schirripa, Giovanni Gerardo Cardellino, Matteo Fassan, Gabriella Fontanini, Filippo de Braud, Vincenzo Mazzaferro, Alfredo Falcone, Filippo Pietrantonio
BACKGROUND: Many factors, including histopathologic parameters, seem to influence the prognosis of patients undergoing resection of colorectal cancer liver metastases (CRCLM), although their relative weight is unclear. Histopathologic growth patterns (HGPs) of CRCLM may affect sensitivity to antiangiogenics. We aimed at evaluating differences in histopathologic parameters of response according to the use of bevacizumab or cetuximab as first-line targeted agents, and at exploring the prognostic and predictive role of HGPs...
March 13, 2018: British Journal of Cancer
Chiara Cremolini, Marzia Del Re, Carlotta Antoniotti, Sara Lonardi, Francesca Bergamo, Fotios Loupakis, Beatrice Borelli, Federica Marmorino, Valentina Citi, Enrico Cortesi, Roberto Moretto, Monica Ronzoni, Gianluca Tomasello, Alberto Zaniboni, Patrizia Racca, Angela Buonadonna, Giacomo Allegrini, Vincenzo Ricci, Samantha Di Donato, Vittorina Zagonel, Luca Boni, Alfredo Falcone, Romano Danesi
Our study addresses the issue of the clinical reliability of three candidate DPYD and one UGT single nucleotide polymorphisms in predicting 5-fluorouracil- and irinotecan-related adverse events. To this purpose, we took advantage of a large cohort of metastatic colorectal cancer patients treated with first-line 5-fluorouracil- and irinotecan-based chemotherapy regimens (i.e., FOLFIRI or FOLFOXIRI) plus bevacizumab in the randomized clinical trial TRIBE by GONO ( NCT00719797), in which adverse events were carefully and prospectively collected at each treatment cycle...
January 30, 2018: Oncotarget
Lisa C Hickman, Natalia C Llarena, Lindsey N Valentine, Xiaobo Liu, Tommaso Falcone
PURPOSE: To evaluate the available randomized controlled trials (RCTs) in the literature investigating the use of gonadotropin-releasing hormone agonist (GnRHa) co-treatment for ovarian preservation in women receiving chemotherapy. METHODS: A systematic review of the literature was performed from 1960 through 2017 to identify relevant RCTs. Included patients had lymphoma, ovarian cancer, or breast cancer. The primary outcome was the proportion of women who retained ovarian function after chemotherapy...
February 22, 2018: Journal of Assisted Reproduction and Genetics
Wilfredo Falcón, Rich P Baxter, Samuel Furrer, Martin Bauert, Jean-Michel Hatt, Gabriela Schaepman-Strub, Arpat Ozgul, Nancy Bunbury, Marcus Clauss, Dennis M Hansen
We studied the temperature relations of wild and zoo Aldabra giant tortoises ( Aldabrachelys gigantea ) focusing on (1) the relationship between environmental temperature and tortoise activity patterns ( n  = 8 wild individuals) and (2) on tortoise body temperature fluctuations, including how their core and external body temperatures vary in relation to different environmental temperature ranges (seasons; n  = 4 wild and n  = 5 zoo individuals). In addition, we surveyed the literature to review the effect of body mass on core body temperature range in relation to environmental temperature in the Testudinidae...
February 2018: Ecology and Evolution
Shinzaburo Noguchi, Matthew J Ellis, John F R Robertson, Jackie Thirlwell, Mehdi Fazal, Zhimin Shao
BACKGROUND: The international, phase III FALCON study (NCT01602380) in postmenopausal patients with hormone receptor-positive, locally advanced/metastatic breast cancer (LA/MBC) who had not received prior endocrine therapy, demonstrated statistically significant improvement in progression-free survival (PFS) for patients who received fulvestrant 500 mg vs anastrozole 1 mg. This subgroup analysis evaluated PFS in Asian (randomized in China, Japan, or Taiwan) and non-Asian patients from the FALCON study...
February 15, 2018: Breast Cancer: the Journal of the Japanese Breast Cancer Society
Chiara Cremolini, Carlotta Antoniotti, Sara Lonardi, Giuseppe Aprile, Francesca Bergamo, Gianluca Masi, Roberta Grande, Giuseppe Tonini, Claudia Mescoli, Giovanni Gerardo Cardellino, Luigi Coltelli, Lisa Salvatore, Domenico Cristiano Corsi, Cristiana Lupi, Donatello Gemma, Monica Ronzoni, Emanuela Dell'Aquila, Federica Marmorino, Francesca Di Fabio, Maria Laura Mancini, Lorenzo Marcucci, Gabriella Fontanini, Vittorina Zagonel, Luca Boni, Alfredo Falcone
Importance: The combination of a triple-drug chemotherapy regimen with an anti-epidermal growth factor receptor (EGFR) agent as a first-line treatment of metastatic colorectal cancer (mCRC) showed promising activity along with safety concerns in single-arm phase 2 trials. The role of maintenance following chemotherapy and anti-EGFR and the optimal regimen to be adopted are not established. Objectives: To evaluate the activity and safety of cetuximab plus modified FOLFOXIRI (mFOLFOXIRI) and explore the role of maintenance with cetuximab or bevacizumab in RAS and BRAF wild-type mCRC...
February 15, 2018: JAMA Oncology
Ignacio J Amat-Santos, Pablo Catalá, Felipe Diez Del Hoyo, Jose A Fernandez-Diaz, Juan H Alonso-Briales, María Del Trigo, Ander Regueiro, Pablo Juan-Salvadores, Vicenç Serra, Enrique Gutierrez-Ibanes, Antonio J Muñoz-García, Luis Nombela-Franco, Manel Sabate, Victor A Jimenez-Diaz, Bruno García Del Blanco, Javier López, Luis H Varela-Falcón, Teresa Sevilla, Roman Arnold, Ana Revilla, J Alberto San Roman
INTRODUCTION: Transcatheter aortic valve implantation (TAVI) as a treatment in severe aortic stenosis (AS) is an excellent alternative to conventional surgical replacement. However, long-term outcomes are not benign. Renin-angiotensin system (RAS) blockade has shown benefit in terms of adverse remodelling in severe AS and after surgical replacement. METHODS AND ANALYSIS: The RAS blockade after TAVI (RASTAVI) trial aims to detect if there is a benefit in clinical outcomes and ventricular remodelling with this therapeutic strategy following the TAVI procedure...
February 13, 2018: BMJ Open
K L van Rooijen, Q Shi, K K H Goey, J Meyers, V Heinemann, E Diaz-Rubio, E Aranda, A Falcone, E Green, A de Gramont, D J Sargent, C J A Punt, M Koopman
Indication for primary tumour resection (PTR) in asymptomatic metastatic colorectal cancer (mCRC) patients is unclear. Previous retrospective analyses suggest a survival benefit for patients who underwent PTR. The aim was to evaluate the prognostic value of PTR in patients with synchronous mCRC by analysis of recent large RCTs including systemic therapy with modern targeted agents. Individual patient data (IPD) of 3423 patients enrolled into 8 randomised controlled trials (RCTs) with first-line systemic therapy in the ARCAD (Aide et Recherche en Cancérologie Digestive) database were analysed...
January 17, 2018: European Journal of Cancer
Giselle Pentón-Rol, Javier Marín-Prida, Viviana Falcón-Cama
Myelin loss has a crucial impact on behavior disabilities associated to Multiple Sclerosis (MS) and Ischemic Stroke (IS). Although several MS therapies are approved, none of them promote remyelination in patients, limiting their ability for chronic recovery. With no available therapeutic options, enhanced demyelination in stroke survivors is correlated with a poorer behavioral recovery. Here, we show the experimental findings of our group and others supporting the remyelinating effects of C-Phycocyanin (C-PC), the main biliprotein of Spirulina platensis and its linked tetrapyrrole Phycocyanobilin (PCB), in models of these illnesses...
January 18, 2018: Behavioral Sciences
E Dell'Aquila, C Cremolini, T Zeppola, S Lonardi, F Bergamo, G Masi, M Stellato, F Marmorino, M Schirripa, F Urbano, M Ronzoni, G Tomasello, A Zaniboni, P Racca, A Buonadonna, G Allegrini, E Fea, S Di Donato, S Chiara, G Tonini, D Tomcikova, L Boni, A Falcone, D Santini
Background: Neutrophil/Lymphocyte ratio (NLR), defined as absolute neutrophils count divided by absolute lymphocytes count, has been reported as poor prognostic factor in several neoplastic diseases but only a few data are available about unresectable metastatic colorectal cancer (mCRC) patients (pts). The aim of our study was to evaluate the prognostic and predictive role of NLR in the TRIBE trial. Patients and Methods: Pts enrolled in TRIBE trial were included...
January 8, 2018: Annals of Oncology: Official Journal of the European Society for Medical Oncology
Eric Van Cutsem, Alfredo Falcone, Rocio Garcia-Carbonero, Yoshito Komatsu, Alessandro Pastorino, Marc Peeters, Yasuhiro Shimada, Kentaro Yamazaki, Takayuki Yoshino, Alberto Zaniboni, Nadia Amellal, Akira Kanehisa, Robert Winkler, Lukas Makris, Robert J Mayer, Atsushi Ohtsu, Josep Tabernero
Background: In the pivotal phase III, randomised, double-blind, placebo-controlled RECOURSE study, treatment with trifluridine/tipiracil was well tolerated and associated with prolonged progression-free and overall survival in patients with metastatic colorectal cancer (mCRC). There was no formal analysis of quality of life (QoL) in RECOURSE. The aim of the present analysis was to assess proxies of QoL during the RECOURSE treatment period, in terms of adverse events (AEs) likely to affect QoL and Eastern Cooperative Oncology Group performance status (ECOG PS)...
2017: ESMO Open
Chiara Cremolini, Filippo Pietrantonio, Gianluca Tomasello, Vincenzo Dadduzio, Roberto Moretto, Federica Morano, Marta Schirripa, Carlotta Antoniotti, Giovanni Fucà, Francesca Bergamo, Daniele Rossini, Federico Nichetti, Stamatia Ziampiri, Michele Ghidini, Federica Marmorino, Michele Prisciandaro, Alfredo Falcone, Filippo De Braud, Fotios Loupakis, Sara Lonardi
Background: BRAF V600E mutation defines a specific colorectal cancer (CRC) subgroup with poor prognosis. Promising preclinical data showed synthetically lethal activity of mitotic spindle poisons on BRAF- mutated and BRAF -like CRC models. We designed a phase II trial to test the activity of vinorelbine in patients with BRAF V600E mutated metastatic CRC (mCRC). Patients and methods: Patients progressed to or not deemed eligible for standard treatments received oral (60 mg/sqm) or intravenous (25 mg/sqm) vinorelbine, on days 1 and 8 every 21 days...
2017: ESMO Open
Martin D Berger, Sebastian Stintzing, Volker Heinemann, Shu Cao, Dongyun Yang, Yu Sunakawa, Satoshi Matsusaka, Yan Ning, Satoshi Okazaki, Yuji Miyamoto, Mitsukuni Suenaga, Marta Schirripa, Diana L Hanna, Shivani Soni, Alberto Puccini, Wu Zhang, Chiara Cremolini, Alfredo Falcone, Fotios Loupakis, Heinz-Josef Lenz
Purpose: Vitamin D exerts its inhibitory influence on colon cancer growth by inhibiting Wnt signaling and angiogenesis. We hypothesized that SNPs in genes involved in vitamin D transport, metabolism, and signaling are associated with outcome in metastatic colorectal cancer (mCRC) patients treated with first-line FOLFIRI and bevacizumab. Experimental Design: 522 mCRC patients enrolled in the FIRE-3 (discovery cohort) and TRIBE (validation set) trials treated with FOLFIRI/bevacizumab were included in this study...
February 15, 2018: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
Debbie Falconer, Nikolaos Papageorgiou, Emmanuel Androulakis, Yasmin Alfallouji, Wei Yao Lim, Rui Providencia, Dimitris Tousoulis
Arrhythmias can cause symptoms ranging from simple dizziness to life-threatening circulatory collapse. Current management includes medical therapy and procedures such as catheter ablation or device implantation. However, these strategies still pose a risk of serious side effects, and some patients remain symptomatic. Advancement in our understanding of how arrhythmias develop on the cellular level has made more targeted approaches possible. In addition, contemporary studies have found that several genes are involved in the pathogenesis of arrhythmias...
March 2018: Expert Opinion on Biological Therapy
Alfredo Falcone, Atsushi Ohtsu, Eric Van Cutsem, Robert J Mayer, Michele Buscaglia, Johanna C Bendell, Scott Kopetz, Paul Bebeau, Takayuki Yoshino
Trifluridine/tipiracil, an oral treatment combining trifluridine (an antineoplastic thymidine-based nucleoside analog) and tipiracil hydrochloride (a thymidine phosphorylase inhibitor), led to significant improvement in overall survival in metastatic colorectal cancer (mCRC) patients refractory to standard therapy in the phase III RECOURSE trial. Here, we report an integrated summary of the safety of trifluridine/tipiracil. The main safety analysis includes integrated data from the RECOURSE and J003 studies (safety data group 2) of patients with refractory mCRC receiving trifluridine/tipiracil at the recommended starting dose: 35 mg/m twice daily for 5 days with 2 days' rest for 2 weeks, followed by a 14-day rest (one cycle)...
January 2018: Anti-cancer Drugs
Andrea Cocci, Marco Capece, Gianmartin Cito, Giorgio Ivan Russo, Marco Falcone, Massimiliano Timpano, Michele Rizzo, Pier Andrea Della Camera, Simone Morselli, Riccardo Campi, Francesco Sessa, Giovanni Cacciamani, Andrea Minervini, Mauro Gacci, Vincenzo Mirone, Girolamo Morelli, Nicola Mondaini, Gaia Polloni, Sergio Serni, Alessandro Natali
BACKGROUND: A new oro-dispersible film (ODF) formulation of sildenafil has been developed for the treatment of erectile dysfunction (ED) to overcome the drawbacks that some patients experience when taking the conventional film-coated tablet (FCT). AIM: To assess the effectiveness and safety of sildenafil ODF formulation in patients with ED who were using the conventional FCT. METHODS: From May 2017 through July 2017, 139 patients with ED were enrolled...
December 2017: Journal of Sexual Medicine
Weiming Tang, Wen Chen, Ali Amini, Debi Boeras, Jane Falconer, Helen Kelly, Rosanna Peeling, Olivia Varsaneux, Joseph D Tucker, Philippa Easterbrook
BACKGROUND: Although direct-acting antivirals can achieve sustained virological response rates greater than 90% in Hepatitis C Virus (HCV) infected persons, at present the majority of HCV-infected individuals remain undiagnosed and therefore untreated. While there are a wide range of HCV serological tests available, there is a lack of formal assessment of their diagnostic performance. We undertook a systematic review and meta-analysis to evaluate he diagnostic accuracy of available rapid diagnostic tests (RDT) and laboratory based EIA assays in detecting antibodies to HCV...
November 1, 2017: BMC Infectious Diseases
I Ray-Coquard, AnnaLisa Trama, M J Seckl, C Fotopoulou, P Pautier, S Pignata, G Kristensen, G Mangili, H Falconer, L Massuger, J Sehouli, E Pujade-Lauraine, D Lorusso, F Amant, E Rokkones, I Vergote, J A Ledermann
PURPOSE OF THE REVIEW: More than 50% of all gynaecological cancers can be classified as rare tumours (defined as an annual incidence of <6 per 100,000) and such tumours represent an important challenge for clinicians. RECENT FINDINGS: Rare cancers account for more than one fifth of all new cancer diagnoses, more than any of the single common cancers alone. Reviewing the RARECAREnet database, some of the tumours occur infrequently, whilst others because of their natural history have a high prevalence, and therefore appear to be more common, although their incidence is also rare...
November 3, 2017: European Journal of Surgical Oncology
Majed A Refaai, Truptesh H Kothari, Shana Straub, Jacob Falcon, Ravi Sarode, Joshua N Goldstein, Andres Brainsky, Laurel Omert, Martin L Lee, Truman J Milling
INTRODUCTION: To investigate the impact of a 4-factor prothrombin complex concentrate (4F-PCC [Beriplex®/Kcentra®]) versus plasma on "time to procedure" in patients with acute/severe gastrointestinal bleeding requiring rapid vitamin K antagonist (VKA) reversal prior to invasive procedure. METHODS: A post hoc analysis of two phase III trials of 4F-PCC versus plasma in patients with acute/severe gastrointestinal bleeding. The treatment arms were compared for study treatment volume, infusion times, and time from start of study treatment to procedure...
2017: Emergency Medicine International
Caroline J Falconer, Penny Cutting, E Bethan Davies, Chris Hollis, Paul Stallard, Paul Moran
BACKGROUND: Borderline personality disorder (BPD) is characterised by severe instability in emotions, identity, relationships and impulsive behaviour. One contributing factor to BPD is deficient mentalizing-our ability to understand the mental states of others and ourselves. Psychotherapies can be effective at reducing symptoms of BPD but effects are small. Innovative ways of enhancing existing therapies are therefore essential. OBJECTIVE: In a mixed-methods, feasibility and acceptability study, we adjuncted conventional mentalization-based treatment (MBT) for BPD with avatar software (avatar-MBT)...
November 2017: Evidence-based Mental Health
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