Menée sur 36 patients atteints d'un mésothéliome pleural non résécable, cette étude évalue la faisabilité et la toxicité d'une approche thérapeutique utilisant la radiothérapie avec modulation d'intensité

Pleural Intensity-Modulated Radiotherapy for Malignant Pleural Mesothelioma

Rosenzweig, Kenneth E. ; Zauderer, Marjorie G. ; Laser, Benjamin ; Krug, Lee M. ; Yorke, Ellen ; Sima, Camelia S. ; Rimner, Andreas ; Flores, Raja ; Rusch, Valerie

In patients with malignant pleural mesothelioma who are unable to undergo pneumonectomy, it is difficult to deliver tumoricidal radiation doses to the pleura without significant toxicity. We have implemented a technique of using intensity-modulated radiotherapy (IMRT) to treat these patients, and we report the feasibility and toxicity of this approach. Between 2005 and 2010, 36 patients with malignant pleural mesothelioma and two intact lungs (i.e., no previous pneumonectomy) were treated with [...]

A partir de données administratives portant sur 1 124 patientes atteintes d'un cancer récidivant de l'ovaire, des trompes de Fallope ou du péritoine diagnostiqué entre 1990 et 2009, cette étude prospective monocentrique évalue l'intérêt d'une seconde cytoréduction chirurgicale pour améliorer la survie globale des patientes

The Role of Secondary Cytoreductive Surgery in Patients with Recurrent Epithelial Ovarian, Tubal, and Peritoneal Cancers: A Comparative Effectiveness Analysis

Chuang, Chi-Mu ; Chou, Yiing-Jeng ; Yen, Ming-Shyen ; Chao, Kuan-Chong ; Twu, Nae-Fang ; Wu, Hua-Hsi ; Wen, Kuo-Chang ; Chen, Yi-Jen ; Wang, Peng-Hui ; Lai, Chung-Ru ; Chou, Pesus

Abstract Background. All published reports concerning secondary cytoreductive surgery for relapsed ovarian cancer have essentially been observational studies. However, the validity of observational studies is usually threatened from confounding by indication. We sought to address this issue by using comparative effectiveness methods to adjust for confounding.Methods. Using a prospectively collected administrative health care database in a single institution, we identified 1,124 patients [...]

Menée sur 67 patients atteints d'un lymphome orbital ou oculaire non hodgkinien et traités par radiothérapie externe, cette étude rétrospective évalue le risque de développer une rétinopathie postraitement en fonction de la dose de rayonnements ionisants délivrés, puis identifie les facteurs de risque et la nature des complications associées

Risk of Radiation Retinopathy in Patients With Orbital and Ocular Lymphoma

Kaushik, Megha ; Pulido, Jose S. ; Schild, Steven E. ; Stafford, Scott

Radiation retinopathy is a potential long-term complication of radiation therapy to the orbit. The risk of developing this adverse effect is dose dependent; however, the threshold is unclear. The aim of this study was to identify the risk of developing radiation retinopathy at increasing radiation doses. A 40-year retrospective review was performed of patients who received external beam radiation therapy for ocular/orbital non-Hodgkin lymphoma (NHL). Sixty-seven patients who had at least one [...]

Menée sur 60 patients atteints d'un schwannome vestibulaire intracanaliculaire unilatéral sporadique, cette étude coréenne évalue la préservation de l'audition 1, 2 et 5 ans après une radiochirurgie stéréotaxique, et analyse la relation entre l'expansion transitoire du volume tumoral après le traitement et la perte des capacités auditives

Hearing Outcomes After Stereotactic Radiosurgery for Unilateral Intracanalicular Vestibular Schwannomas: Implication of Transient Volume Expansion

Kim, Young-Hoon ; Kim, Dong Gyu ; Ho Han, Jung ; Chung, Hyun-Tai ; Kim, In Kyung ; Song, Sang Woo ; Park, Jeong-Hoon ; Kim, Jin Wook ; Kim, Yong Hwy ; Park, Chul-Kee ; Kim, Chae-Yong ; Paek, Sun Ha ; Jung, Hee-Won

We evaluated the prognostic factors for hearing outcomes after stereotactic radiosurgery (SRS) for unilateral sporadic intracanalicular vestibular schwannomas (IC-VSs) as a clinical homogeneous group of VSs. Sixty consecutive patients with unilateral sporadic IC-VSs, defined as tumors in the internal acoustic canal, and serviceable hearing (Gardner-Roberson grade 1 or 2) were treated with SRS as an initial treatment. The mean tumor volume was 0.34 ± 0.03 cm3 (range, 0.03-1.00 cm3), and the mean [...]

Menée sur une cohorte européenne de 890 patients atteints d'un cancer de la prostate de stade pT3N0 et traités par prostatectomie radicale, cette étude comparative multicentrique montre qu'une radiothérapie de sauvetage précoce ne compromet pas le contrôle de la maladie et réduit le surtraitement associé à une radiothérapie adjuvante

Early Salvage Radiation Therapy Does Not Compromise Cancer Control in Patients with pT3N0 Prostate Cancer After Radical Prostatectomy: Results of a Match-controlled Multi-institutional Analysis

Alberto, Briganti ; Thomas, Wiegel ; Steven, Joniau ; Cesare, Cozzarini ; Marco, Bianchi ; Maxine, Sun ; Bertrand, Tombal ; Karin, Haustermans ; Tom, Budiharto ; Wolfgang, Hinkelbein ; Nadia Di, Muzio ; Pierre, I. Karakiewicz ; Francesco, Montorsi ; Hein Van, Poppel

Background : Previous randomised trials demonstrated that adjuvant radiation therapy (aRT) improves cancer control in patients with pT3 prostate cancer (PCa). However, there is currently no evidence supporting early salvage radiation therapy (eSRT) as equivalent to aRT in improving freedom from biochemical recurrence (BCR) after radical prostatectomy (RP). Objective : To evaluate BCR-free survival for aRT versus observation followed by eSRT in cases of relapse in patients undergoing RP for [...]

Menée sur 116 patients atteints d'un carcinome sporadique isolé à cellules rénales traité entre 2003 et 2010 (durée médiane de suivi : 21 mois), cette étude rétrospective monocentrique évalue, du point de vue de la récidive locale et des complications associées au traitement, l'efficacité et la toxicité d'une cryoablation percutanée en fonction du stade de la tumeur au diagnostic

Percutaneous cryoablation of solitary sporadic renal cell carcinomas

Schmit, Grant D. ; Thompson, R. Houston ; Kurup, Anil N. ; Weisbrod, Adam J. ; Carter, Rickey E. ; Callstrom, Matthew R. ; Atwell, Thomas D.

Study Type – Therapy (case series)Level of Evidence 4What's known on the subject? and What does the study add?Percutaneous renal cryoablation is a safe and effective treatment for patients with small renal masses, who are poor surgical candidates.Oncological outcomes from previous percutaneous ablation studies are difficult to interpret because of the large number of patients treated with a history of RCC (38% in our experience) and the large number of treated renal masses without a [...]

Mené entre 2004 et 2007 sur 59 patientes atteintes d'un cancer du col de l'utérus (âge : 37 à 84 ans ; durée médiane de suivi : 24 mois), cet essai prospectif multicentrique japonais évalue l'incidence de fractures par insuffisance osseuse après une radiothérapie pelvienne, puis identifie les facteurs de risque associés

Insufficiency Fractures After Pelvic Radiation Therapy for Uterine Cervical Cancer: An Analysis of Subjects in a Prospective Multi-institutional Trial, and Cooperative Study of the Japan Radiation Oncology Group (JAROG) and Japanese Radiation Oncology Study Group (JROSG)

Tokumaru, Sunao ; Toita, Takafumi ; Oguchi, Masahiko ; Ohno, Tatsuya ; Kato, Shingo ; Niibe, Yuzuru ; Kazumoto, Tomoko ; Kodaira, Takeshi ; Kataoka, Masaaki ; Shikama, Naoto ; Kenjo, Masahiro ; Yamauchi, Chikako ; Suzuki, Osamu ; Sakurai, Hideyuki ; Teshima, Teruki ; Kagami, Yoshikazu ; Nakano, Takashi ; Hiraoka, Masahiro ; Mitsuhashi, Norio ; Kudo, Sho

To investigate pelvic insufficiency fractures (IF) after definitive pelvic radiation therapy for early-stage uterine cervical cancer, by analyzing subjects of a prospective, multi-institutional study. Between September 2004 and July 2007, 59 eligible patients were analyzed. The median age was 73 years (range, 37-84 years). The International Federation of Gynecologic Oncology and Obstetrics stages were Ib1 in 35, IIa in 12, and IIb in 12 patients. Patients were treated with the constant method, [...]

Mené sur des lignées cellulaires et un modèle murin, cette étude évalue l'activité antitumorale et la toxicité du vandetanib, un composé dont le mécanisme d'action consiste à supprimer la phosphorylation des récepteurs VEGFR-2 et EGFR

Vandetanib, an Inhibitor of VEGF Receptor-2 and EGF Receptor, Suppresses Tumor Development and Improves Prognosis of Liver Cancer in Mice

Inoue, Kinya ; Torimura, Takuji ; Nakamura, Toru ; Iwamoto, Hideki ; Masuda, Hiroshi ; Abe, Mitsuhiko ; Hashimoto, Osamu ; Koga, Hironori ; Ueno, Takato ; Yano, Hirohisa ; Sata, Michio

Purpose: Vascular endothelial growth factor (VEGF), epithelial growth factor (EGF) and transforming growth factor-alpha (TGF-alpha) are expressed in hepatocellular carcinoma (HCC) and play a role in its growth. Vandetanib, a multi-kinase inhibitor, suppresses the phosphorylation of VEGF receptor 2 (VEGFR-2) and EGF receptor (EGFR). The aim of this study was to clarify the anti-tumor effect of vandetanib in mouse HCC. Experimental Design:We evaluated the effects of vandetanib on proliferation of [...]

Cet article passe en revue les perspectives offertes par le ciblage de la voie de signalisation PAK1 pour le traitement des cancers

Molecular Pathways: Targeting P21-activated Kinase 1 Signaling in Cancer: Opportunities, Challenges and Limitations

Eswaran, Jeyanthy ; Li, Da-Qiang ; Shah, Anil ; Kumar, Rakesh

The evolution of cancer cells involves deregulation of highly regulated fundamental pathways that are central to normal cellular architecture and functions. The p21-activated kinase 1 (PAK1) was initially identified as a downstream effector of the GTPases Rac and Cdc42. Subsequent studies uncovered a plethora of its new functions in growth factor and steroid receptor signaling, cytoskeleton remodeling, cell survival, oncogenic transformation, and gene transcription, largely through systematic [...]

Menée in vitro, à l'aide de xénogreffes et sur des singes cynomolgus, cette étude évalue l'activité d'un anticorps monoclonal appelé CDX-1127 dans les leucémies et lymphomes CD27+

Development of a human monoclonal antibody for potential therapy of CD27-expressing lymphoma and leukemia

Vitale, Laura ; He, Li-Zhen ; Thomas, Lawrence J ; Widger, Jennifer ; Weidlick, Jeffrey ; Crocker, Andrea ; O'Neill, Thomas ; Storey, James ; Glennie, Martin J. ; Grote, Deanna M. ; Ansell, Stephen M. ; Marsh, Henry ; Keler, Tibor

Purpose: The TNF receptor superfamily member, CD27 is best known for its important role in T cell immunity, but is also recognized as a cell-surface marker on a number of B and T cell malignancies. In this report, we describe a novel human monoclonal antibody (mAb) specific for CD27 with properties that suggest a potential utility against malignancies that express CD27. Experimental Design: The fully human mAb 1F5 was generated using human Ig transgenic mice and characterized by analytical and [...]

Menée sur un modèle murin de lymphome diffus à grandes cellules B, cette étude évalue l'activité antitumorale d'un composé appelé MLN0905, une petite molécule inhibitrice de PLK1, seul et en combinaison avec du rituximab

MLN0905, A Small Molecule PLK1 Inhibitor, Induces Anti-Tumor Responses in Human Models of Diffuse Large B-cell Lymphoma

Shi, Judy ; Lasky, Kerri ; Shinde, Vaishali ; Stringer, Bradley ; Qian, Mark G ; Liao, Debra ; Liu, Ray ; Driscoll, Denise L ; Nestor, Michelle T ; Amidon, Benjamin S. ; Rao, Youlan ; Duffey, Matt O ; Manfredi, Mark G. ; Vos, Tricia J ; D'Amore, Natalie R ; Hyer, Marc L

Diffuse large B-cell lymphoma (DLBCL) is the most common of the non-Hodgkin lymphomas, accounting for up to 30 percent of all newly diagnosed lymphoma cases. Current treatment options for this disease are effective, but not always curative; therefore experimental therapies continue to be investigated. We have discovered an experimental, potent and selective small molecule inhibitor of PLK1, MLN0905, which inhibits cell proliferation in a broad range of human tumor cells including DLBCL cell [...]

Menée sur 36 lignées cellulaires de cancer ovarien, cette étude identifie des voies de signalisation associées à la réponse au carboplatine, au cisplatine et au paclitaxel

In vitro analysis of ovarian cancer response to cisplatin, carboplatin, and paclitaxel identifies common pathways that are also associated with overall patient survival

Bicaku, E. ; Xiong, Y. ; Marchion, D. C. ; Chon, H. S. ; Stickles, X. B. ; Chen, N. ; Judson, P. L. ; Hakam, A. ; Gonzalez-Bosquet, J. ; Wenham, R. M. ; Apte, S. M. ; Fulp, W. ; Cubitt, C. L. ; Chen, D. T. ; Lancaster, J. M.

Background: Carboplatin and cisplatin, alone or in combination with paclitaxel, have similar efficacies against ovarian cancer (OVCA) yet exhibit different toxicity profiles. We characterised the common and unique cellular pathways that underlie OVCA response to these drugs and analyse whether they have a role in OVCA survival. Methods: Ovarian cancer cell lines (n=36) were treated with carboplatin, cisplatin, paclitaxel, or carboplatin–paclitaxel (CPTX). For each cell line, IC50 levels were [...]

Menée à l'aide de xénogreffes, cette étude met en évidence un mécanisme impliquant les voies de signalisation de la bêta-caténine et FOXO3a dans l'apparition d'une résistance aux inhibiteurs de PI3K et AKT et dans le processus métastatique d'un cancer du côlon

[beta]-catenin confers resistance to PI3K and AKT inhibitors and subverts FOXO3a to promote metastasis in colon cancer

Tenbaum, Stephan P. ; Ordonez-Moran, Paloma ; Puig, Isabel ; Chicote, Irene ; Arques, Oriol ; Landolfi, Stefania ; Fernandez, Yolanda ; Herance, Jose Raul ; Gispert, Juan D. ; Mendizabal, Leire ; Aguilar, Susana ; Cajal, Santiago Ramon y ; Schwartz, Simo ; Vivancos, Ana ; Espin, Eloy ; Rojas, Santiago ; Baselga, Jose ; Tabernero, Josep ; Munoz, Alberto ; Palmer, Hector G.

The Wnt–

Menée in vitro et sur des patients atteints d'un cancer métastatique du sein, cette étude évalue l’ajout d’un vaccin thérapeutique au daclizumab, un anticorps monoclonal anti CD25

CD25 Blockade Depletes and Selectively Reprograms Regulatory T Cells in Concert with Immunotherapy in Cancer Patients

Rech, Andrew J. ; Mick, Rosemarie ; Martin, Sunil ; Recio, Adri ; Aqui, Nicole A. ; Powell, Daniel J. ; Colligon, Theresa A. ; Trosko, Jennifer A. ; Leinbach, Leah I. ; Pletcher, Charles H. ; Tweed, Carol K. ; DeMichele, Angela ; Fox, Kevin R. ; Domchek, Susan M. ; Riley, James L. ; Vonderheide, Robert H.

Regulatory T cells (Tregs) are key mediators of immune tolerance and feature prominently in cancer. Depletion of CD25+ FoxP3+ Tregs in vivo may promote T cell cancer immunosurveillance, but no strategy to do so in humans while preserving immunity and preventing autoimmunity has been validated. We evaluated the Food and Drug Administration–approved CD25-blocking monoclonal antibody daclizumab with regard to human Treg survival and function. In vitro, daclizumab did not mediate antibody-dependent [...]

Menée in vitro et sur un modèle murin, cette étude suggère d'utiliser un composé appelé PLX4720 pour traiter un astrocytome pédiatrique présentant la mutation BRAFV600E et des délétions du gène CDNK2A

Cooperative interactions of BRAFV600E kinase and CDKN2A locus deficiency in pediatric malignant astrocytoma as a basis for rational therapy

Huillard, Emmanuelle ; Hashizume, Rintaro ; Phillips, Joanna J. ; Griveau, Amélie ; Ihrie, Rebecca A. ; Aoki, Yasuyuki ; Nicolaides, Theodore ; Perry, Arie ; Waldman, Todd ; McMahon, Martin ; Weiss, William A. ; Petritsch, Claudia ; James, C. David ; Rowitch, David H.

Although malignant astrocytomas are a leading cause of cancer-related death in children, rational therapeutic strategies are lacking. We previously identified activating mutations of v-raf murine sarcoma viral oncogene homolog B1 (BRAF) (BRAFT1799A encoding BRAFV600E) in association with homozygous cyclin-dependent kinase inhibitor 2A (CDKN2A, encoding p14ARF and p16Ink4a) deletions in pediatric infiltrative astrocytomas. Here we report that BRAFV600E expression in neural progenitors (NPs) is [...]

Cet article passe en revue les perspectives offertes par les inhibiteurs d'ALK pour le traitement des neuroblastomes

Targeting ALK in neuroblastoma-preclinical and clinical advancements

Carpenter, Erica L. ; Mosse, Yael P.

Despite improvements in cancer therapies in the past 50 years, neuroblastoma remains a devastating clinical problem and a leading cause of childhood cancer deaths. Advances in treatments for children with high-risk neuroblastoma have, until recently, involved addition of cytotoxic therapy to dose-intensive regimens. In this era of targeted therapies, substantial efforts have been made to identify optimal targets for different types of cancer. The discovery of hereditary and somatic activating [...]

Cet article présente les résultats, après 8 ans de suivi, de l'essai PACS01 (Programme Action Concertée Sein 01) ayant évalué un traitement comprenant l'administration de docétaxel après une chimiothérapie FEC100 chez les patientes atteintes d'un cancer du sein opérable avec envahissement ganglionnaire

Extended Benefit from Sequential Administration of Docetaxel after Standard Fluorouracil, Epirubicin, and Cyclophosphamide Regimen for Node-Positive Breast Cancer: The 8-Year Follow-Up Results of the UNICANCER-PACS01 Trial

Coudert, Bruno ; Asselain, Bernard ; Campone, Mario ; Spielmann, Marc ; Machiels, Jean-Pascal ; Pénault-Llorca, Frédérique ; Serin, Daniel ; Levy, Christelle ; Romieu, Gilles ; Canon, Jean-Luc ; Orfeuvre, Hubert ; Piot, Gilles ; Petit, Thierry ; Jerusalem, Guy ; Audhuy, Bruno ; Veyret, Corinne ; Beauduin, Marc ; Eymard, Jean-Christophe ; Martin, Anne-Laure ; Roché, Henri

Abstract Purpose. The initial report from the Programme Action Concertée Sein (PACS) PACS01 trial demonstrated a benefit at 5 years for disease-free survival (DFS) and overall survival (OS) rates with the sequential administration of docetaxel after FEC100 (fluorouracil 500 mg/m2, epirubicin 100 mg/m2, and cyclophosphamide 500 mg/m2) for patients with node-positive, operable breast cancer. We evaluate here the impact of this regimen at 8 years.Patients and Methods. Between June 1997 and March [...]

A partir de deux essais de phase I incluant au total 32 patients atteints d'une leucémie myéloïde aiguë de stade avancé ou d'une leucémie lymphoblastique aiguë et bénéficiant d'une greffe allogénique de cellules hématopoïétiques (âges médians : 33 ans et 41 ans), cette étude évalue l'efficacité et la toxicité de deux protocoles d'irradiation totale de la moelle osseuse par escalade de doses en combinaison avec une chimiothérapie concomitante

Dose Escalation of Total Marrow Irradiation With Concurrent Chemotherapy in Patients With Advanced Acute Leukemia Undergoing Allogeneic Hematopoietic Cell Transplantation

Wong, Jeffrey Y. C. ; Forman, Stephen ; Somlo, George ; Rosenthal, Joseph ; Liu, An ; Schultheiss, Timothy ; Radany, Eric ; Palmer, Joycelynne ; Stein, Anthony

We have demonstrated that toxicities are acceptable with total marrow irradiation (TMI) at 16 Gy without chemotherapy or TMI at 12 Gy and the reduced intensity regimen of fludarabine/melphalan in patients undergoing hematopoietic cell transplantation (HCT). This article reports results of a study of TMI combined with higher intensity chemotherapy regimens in 2 phase I trials in patients with advanced acute myelogenous leukemia or acute lymphoblastic leukemia (AML/ALL) who would do poorly on [...]

Mené sur 248 patients atteints d'un cancer rectal localement avancé, cet essai randomisé de phase III compare, du point de vue de la rémission complète, l'efficacité et la toxicité de 2 doses de rayonnements ionisants pré-opératoires en combinaison avec une chimiothérapie concomitante

Dose-Effect Relationship in Chemoradiotherapy for Locally Advanced Rectal Cancer: A Randomized Trial Comparing Two Radiation Doses

Jakobsen, Anders ; Ploen, John ; Vuong, Té ; Appelt, Ane ; Lindebjerg, Jan ; Rafaelsen, Soren R.

Locally advanced rectal cancer represents a major therapeutic challenge. Preoperative chemoradiation therapy is considered standard, but little is known about the dose-effect relationship. The present study represents a dose-escalation phase III trial comparing 2 doses of radiation. The inclusion criteria were resectable T3 and T4 tumors with a circumferential margin of ≤5 mm on magnetic resonance imaging. The patients were randomized to receive 50.4 Gy in 28 fractions to the tumor and pelvic [...]

Mené sur 75 patientes atteintes d'un cancer du sein de stade précoce et traitées de décembre 2003 à novembre 2005 (âge : 31 à 81 ans ; durée médiane de suivi : 69 mois), cet essai de phase II évalue, du point de vue du contrôle local à 5 ans, l'efficacité d'un traitement combinant une radiothérapie hypofractionnée avec modulation d'intensité et une dose de rayonnement additionnel du lit tumoral

Five-year Local Control in a Phase II Study of Hypofractionated Intensity Modulated Radiation Therapy With an Incorporated Boost for Early Stage Breast Cancer

Freedman, Gary M. ; Anderson, Penny R. ; Bleicher, Richard J. ; Litwin, Samuel ; Li, Tianyu ; Swaby, Ramona F. ; Ma, Chang-Ming Charlie ; Li, Jinsheng ; Sigurdson, Elin R. ; Watkins-Bruner, Deborah ; Morrow, Monica ; Goldstein, Lori J.

Conventional radiation fractionation of 1.8-2 Gy per day for early stage breast cancer requires daily treatment for 6-7 weeks. We report the 5-year results of a phase II study of intensity modulated radiation therapy (IMRT), hypofractionation, and incorporated boost that shortened treatment time to 4 weeks. The study design was phase II with a planned accrual of 75 patients. Eligibility included patients aged ≥18 years, Tis-T2, stage 0-II, and breast conservation. Photon IMRT and an [...]

Cet article passe en revue les avancées récentes concernant les différentes modalités d'une radiothérapie ou d'une chimioradiothérapie pour traiter un carcinome épidermoïde de la tête et du cou, associé au tabagisme ou au papillomavirus humain et de stade localement avancé, puis analyse le rôle des thérapies ciblées et personnalisées dans la prise en charge des patients

Current issues in combined modality therapy in locally advanced head and neck cancer

Cmelak, Anthony J.

Curative treatment for patients with locally advanced squamous cell carcinomas of the head and neck (SCCHN) is complex and multidisciplinary. Our understanding of the optimal management of this disease has improved over the years, incorporating refined surgical approaches, better radiotherapy delivery methods, and greater use of systemic therapies. Investigation into shifting epidemiology patterns has uncovered two biologically and clinically distinct diseases: the smoking-related entity and [...]

Cet article passe en revue les différents modèles murins utilisés pour l'étude des mécanismes de résistance aux traitements anticancéreux

Using mice to unveil the genetics of cancer resistance

van der Weyden, Louise ; Adams, David J.

In the UK, four in ten people will develop some form of cancer during their lifetime, with an individual's relative risk depending on many factors, including age, lifestyle and genetic make-up. Much research has gone into identifying the genes that are mutated in tumorigenesis with the over-whelming majority of genetically-modified (GM) mice in cancer research showing accelerated tumorigenesis or recapitulating key aspects of the tumorigenic process. Yet if six out of ten people will not [...]

A partir de données portant sur la période 2001-2010, cette étude compare les délais d'autorisation de mise sur le marché de nouveaux médicaments au sein des agences de réglementation américaine, européenne et canadienne

Regulatory Review of Novel Therapeutics — Comparison of Three Regulatory Agencies

Downing, Nicholas S. ; Aminawung, Jenerius A. ; Shah, Nilay D. ; Braunstein, Joel B. ; Krumholz, Harlan M. ; Ross, Joseph S.

Background: The upcoming reauthorization of the Prescription Drug User Fee Act focuses on improving the review process for new drug applications at the Food and Drug Administration (FDA). Methods: Using publicly available information from the FDA, the European Medicines Agency (EMA), and Health Canada, we compared the time for completion of the first review and the total review time for all applications involving novel therapeutic agents approved by the three regulatory agencies from 2001 [...]

A partir d'une revue systématique de la littérature en matière d'essais cliniques randomisés publiés entre 2005 et 2007 dans les cinq principaux journaux médicaux (235 articles), cette étude évalue l'impact du nombre de patients perdus de vue sur l'interprétation des résultats

Potential impact on estimated treatment effects of information lost to follow-up in randomised controlled trials (LOST-IT): systematic review

Elie A Akl ; Matthias Briel ; John J You ; Xin Sun ; Bradley C Johnston ; Jason W Busse ; Sohail Mulla ; Francois Lamontagne ; Dirk Bassler ; Claudio Vera ; Mohamad Alshurafa ; Christina M Katsios ; Qi Zhou ; Tali Cukierman-Yaffe ; Azim Gangji ; Edward J Mills ; Stephen D Walter ; Deborah J Cook ; Holger J Schünemann ; Douglas G Altman ; Gordon H Guyatt

Objective: To assess the reporting, extent, and handling of loss to follow-up and its potential impact on the estimates of the effect of treatment in randomised controlled trials. Design: Systematic review. We calculated the percentage of trials for which the relative risk would no longer be significant under a number of assumptions about the outcomes of participants lost to follow-up. Data sources : Medline search of five top general medical journals, 2005-07. Eligibility criteria : Randomised [...]