Menée à partir de données portant sur 1 249 patientes atteintes d'un carcinome épidermoïde de la vulve traité entre 1998 et 2008, cette étude multicentrique évalue, du point de vue du taux de survie sans progression et du taux de survie globale à 3 ans, l'intérêt d'un traitement adjuvant chez les patientes présentant une ou plusieurs métastases ganglionnaires

Adjuvant Therapy in Lymph Node–Positive Vulvar Cancer: The AGO-CaRE-1 Study

Mahner, Sven ; Jueckstock, Julia ; Hilpert, Felix ; Neuser, Petra ; Harter, Philipp ; de Gregorio, Nikolaus ; Hasenburg, Annette ; Sehouli, Jalid ; Habermann, Annika ; Hillemanns, Peter ; Fuerst, Sophie ; Strauss, Hans-Georg ; Baumann, Klaus ; Thiel, Falk ; Mustea, Alexander ; Meier, Werner ; du Bois, Andreas ; Griebel, Lis-Femke ; Woelber, Linn ; for the AGO-CaRE 1 investigators

Background : Women with node-positive vulvar cancer have a high risk for disease recurrence. Indication criteria for adjuvant radiotherapy are controversial. This study was designed to further understand the role of adjuvant therapy in node-positive disease. Methods : Patients with primary squamous-cell vulvar cancer treated at 29 gynecologic cancer centers in Germany from 1998 through 2008 were included in this retrospective exploratory multicenter cohort study. Of 1618 documented patients, [...]

Menée sur 277 patients atteints d'un cancer du poumon à petites cellules de stade limité, cette étude rétrospective évalue, du point de vue du taux de survie à 5 ans, l'intérêt d'une résection chirurgicale en fonction du stade de la maladie

Role of Surgical Resection for Patients with Limited Disease-Small Cell Lung Cancer

Takenaka, Tomoyoshi ; Takenoyama, Mitsuhiro ; Inamasu, Eiko ; Yoshida, Tsukihisa ; Toyokawa, Gouji ; Nosaki, Kaname ; Hirai, Fumihiko ; Yamaguchi, Masafumi ; Shimokawa, Mototsugu ; Seto, Takashi ; Ichinose, Yukito

Objectives : Although Chemotherapy and radiotherapy are recommended for patients with limited disease small cell lung cancer (LD-SCLC), several series have reported favorable survival outcomes even in patients with stage II and III disease who underwent surgical resection. The purpose of this study is to compare the outcomes of the use of surgical resection to the other conventional non-surgical treatments in patients with LD-SCLC with respect to each clinical stage. Materials and Methods : We [...]

Menée à partir de données portant sur 2 358 patients atteints d'un cancer de la prostate traité par radiothérapie externe entre 1988 et 2005 (durée médiane de suivi : 95 mois), cette étude met en évidence une association entre le tabagisme durant le traitement et une augmentation de la toxicité liée au traitement ou de la mortalité spécifique

Cigarette smoking during external beam radiation therapy for prostate cancer is associated with an increased risk of prostate cancer-specific mortality and treatment-related toxicity

Steinberger, Emily ; Kollmeier, Marisa ; McBride, Sean ; Novak, Caroline ; Pei, Xin ; Zelefsky, Michael J.

Objective : To evaluate whether a history of smoking or smoking during therapy after external beam radiotherapy (EBRT) for clinically localised prostate cancer is associated with increased treatment-related toxicity or disease progression. Patients and Methods : Of 2358 patients receiving EBRT for prostate cancer between 1988 and 2005, 2156 had chart-recorded smoking histories. Patients were classified as ‘never smokers’, ‘current smokers’, ‘former smokers’, and ‘current smoking unknown’. [...]

Menée sur 75 patients atteints d'un cancer de la prostate de stade T3, cette étude évalue, du point de vue de la survie sans progression biochimique, de la survie spécifique et de la survie globale à 5 ans, l'efficacité d'un traitement par cryochirurgie, puis identifie les facteurs pronostiques associés

Oncological outcomes of cryosurgery as primary treatment in T3 prostate cancer: experience of a single centre

Guo, Zhi ; Si, Tongguo ; Yang, Xueling ; Xu, Yan

Objective : To assess the oncological outcomes and determine prognostic factors for overall survival (OS), cancer-specific survival (CSS), and biochemical progression-free survival (BPFS) after cryosurgery for clinical stage T3 prostate cancer. Patients and Methods : Between 2002 and 2007, 75 patients with clinical stage T3 prostate cancer received cryosurgery as primary treatment in our institution. No adjuvant treatment was provided until biochemical failure. After biochemical failure, [...]

Menée sur 998 patientes atteintes d'un cancer invasif du sein de stade I ou II entre 1998 et 2007 (durée médiane de suivi : 119 mois), cette étude évalue, du point de vue du taux de récidive à 10 ans et en fonction du type histologique de la tumeur au diagnostic (carcinome lobulaire infiltrant et/ou carcinome canalaire in situ), l'intérêt d'un traitement conservateur comportant une intervention chirurgicale et une radiothérapie du sein entier

Invasive lobular carcinoma of the breast: local recurrence after breast-conserving therapy by subtype approximation and surgical margin

Braunstein, LiorZ ; Brock, JaneE ; Chen, Yu-Hui ; Truong, Linh ; Russo, AndreaL ; Arvold, NilsD ; Harris, JayR

Invasive lobular carcinoma (ILC) typically presents at a later stage than invasive ductal carcinoma (IDC) and poses unique radiographic and surgical challenges. However, current principles of breast-conserving therapy (BCT) do not distinguish between histologic subtypes, raising uncertainty about the optimal approach for patients with ILC. We studied 998 BCT patients from 1998–2007, comprised 74 % IDC, 8 % ILC, and 18 % with mixed ILC/IDC. In light of recent guidelines addressing surgical [...]

Cet article passe en revue les perspectives offertes par les travaux récents sur les mécanismes de mort cellulaire par autophagie pour le développement de nouveaux traitements anticancéreux

Cell death by autophagy: emerging molecular mechanisms and implications for cancer therapy

Fulda, S. ; Kogel, D.

Autophagy is a tightly-regulated catabolic process of cellular self-digestion by which cellular components are targeted to lysosomes for their degradation. Key functions of autophagy are to provide energy and metabolic precursors under conditions of starvation and to alleviate stress by removal of damaged proteins and organelles, which are deleterious for cell survival. Therefore, autophagy appears to serve as a pro-survival stress response in most settings. However, the role of autophagy in [...]

Menée sur des lignées cellulaires et à l'aide de modèles murins, cette étude met en évidence des mécanismes de nature immunitaire permettant de rendre compte de l'activité antitumorale de la metformine

Immune-mediated antitumor effect by type 2 diabetes drug, metformin

Eikawa, Shingo ; Nishida, Mikako ; Mizukami, Shusaku ; Yamazaki, Chihiro ; Nakayama, Eiichi ; Udono, Heiichiro

Metformin, a prescribed drug for type 2 diabetes, has been reported to have anti-cancer effects; however, the underlying mechanism is poorly understood. Here we show that this mechanism may be immune-mediated. Metformin enabled normal but not T-cell–deficient SCID mice to reject solid tumors. In addition, it increased the number of CD8+ tumor-infiltrating lymphocytes (TILs) and protected them from apoptosis and exhaustion characterized by decreased production of IL-2, TNFα, and IFNγ. CD8+ TILs [...]

Menée in vitro, cette étude identifie divers mécanismes associés à l'émergence d'une résistance au vémurafenib dans le traitement des patients atteints d'un mélanome

Vemurafenib resistance signature by proteome analysis offers new strategies and rational therapeutic concepts

Paulitschke, Verena ; Berger, Walter ; Paulitschke, Philipp ; Hofstaetter, Elisabeth ; Knapp, Bernhard ; Dingelmaier-Hovorka, Ruth ; Födinger, Dagmar ; Jäger, Walter ; Szekeres, Thomas ; Meshcheryakova, Anastasia ; Bileck, Andrea ; Pirker, Christine ; Pehamberger, Hubert ; Gerner, Christopher ; Kunstfeld, Rainer

The FDA-approved BRAF inhibitor vemurafenib achieves outstanding clinical response rates in patients with melanoma, but early resistance is common. Understanding the pathologic mechanisms of drug resistance and identification of effective therapeutic alternatives are key scientific challenges in the melanoma setting. Using proteomic techniques including shotgun analysis and 2D-gel electrophoresis, we identified a comprehensive signature of the vemurafenib-resistant M24met in comparison to the [...]

Menée in vitro et à l'aide de modèles murins de mélanome, cette étude met en évidence le rôle joué par des macrophages dans l'émergence d'une résistance aux inhibiteurs de BRAF

BRAF Inhibition Stimulates Melanoma-Associated Macrophages to Drive Tumor Growth

Wang, Tao ; Xiao, Min ; Ge, Yingbin ; Krepler, Clemens ; Belser, Eric ; Lopez-Coral, Alfonso ; Xu, Xaiowei ; Zhang, Gao ; Azuma, Rikka ; Liu, Qin ; Liu, Rui ; Li, Ling ; Amaravadi, Ravi K ; Xu, Wei ; Karakousis, Giorgos C ; Gangadhar, Tara C ; Schuchter, Lynn M. ; Lieu, Melissa ; Khare, Sanika ; Halloran, Molly B ; Herlyn, Meenhard ; Kaufman, Russel E.

Purpose: To investigate the roles of melanoma-associated macrophages in melanoma resistance to BRAF inhibitors (BRAFi). Experimental Design: An in vitro macrophage and melanoma cell co-culture system was used to investigate whether macrophages play a role in melanoma resistance to BRAFi. The effects of macrophages in tumor resistance were examined by proliferation assay, cell death assay and western blot analyses. Furthermore, two mouse preclinical models were used to validate whether targeting [...]

Menée à l'aide d'un modèle murin, cette étude met en évidence le rôle joué par la voie de signalisation AKT/BAD dans la résistance aux inhibiteurs de BRAF pour le traitement d'un mélanome

BRAF inhibitor resistance mediated by the AKT pathway in an oncogenic BRAF mouse melanoma model

Perna, Daniele ; Karreth, Florian A. ; Rust, Alistair G. ; Perez-Mancera, Pedro A. ; Rashid, Mamunur ; Iorio, Francesco ; Alifrangis, Constantine ; Arends, Mark J. ; Bosenberg, Marcus W. ; Bollag, Gideon ; Tuveson, David A. ; Adams, David J.

BRAF (v-raf murine sarcoma viral oncogene homolog B) inhibitors elicit a transient anti-tumor response in ∼80% of BRAFV600-mutant melanoma patients that almost uniformly precedes the emergence of resistance. Here we used a mouse model of melanoma in which melanocyte-specific expression of BrafV618E (analogous to the human BRAFV600E mutation) led to the development of skin hyperpigmentation and nevi, as well as melanoma formation with incomplete penetrance. Sleeping Beauty insertional [...]

Menée sur des lignées cellulaires de sarcome d'Ewing et à l'aide de xénogreffes, cette étude met en évidence des mécanismes suggérant l'intérêt d'un traitement combinant la trabectédine avec des agents anti-IGF-1R

Trabectedin efficacy in Ewing sarcoma is greatly increased by combination with anti-IGF signaling agents

Monterio Amaral, Ana Teresa ; Garofalo, Cecilia ; Frapolli, Roberta ; Manara, Maria Cristina ; Mancarella, Caterina ; Uboldi, Sarah ; Di Giandomenico, Silvana ; Ordóñez, José Luis ; Sevillano, Victoria ; Malaguarnera, Roberta ; Picci, Piero ; Hassan, Andrew Bassim ; De Alava, Enrique ; D'Incalci, Maurizio ; Scotlandi, Katia

Purpose: Goal of this study was to identify mechanisms that limit efficacy of trabectedin (ET-743, YondelisTM) in Ewing sarcoma (EWS), so as to develop a clinical applicable combination therapy. Experimental Design: By chromatin immunoprecipitation, we analyzed EWS-FLI1 binding to the promoters of several target genes such as TGFβR2, CD99, insulin-like growth factor receptor 1 (IGF-1R), and IGF-1 both in vitro and in xenografts treated with trabectedin or doxorubicin. Combined therapy with [...]

A partir d'échantillons tumoraux prélevés sur 37 patients atteints d'un cancer colorectal ayant développé une résistance au cetuximab, cette étude identifie des mutations du gène EGFR associées à l'émergence de la résistance thérapeutique

Emergence of multiple EGFR extracellular mutations during cetuximab treatment in colorectal cancer

Arena, Sabrina ; Bellosillo, Beatriz ; Siravegna, Giulia ; Martinez, Alejandro ; Canadas, Israel ; Lazzari, Luca ; Ferruz, Noelia ; Russo, Mariangela ; Misale, Sandra ; Gonzalez, Iria ; Iglesias, Mar ; Gavilan, Elena ; Corti, Giorgio ; Hobor, Sebastijan ; Crisafulli, Giovanni ; Salido, Marta ; Sanchez, Juan ; Dalmases, Alba ; Bellmunt, Joaquim ; De Fabritiis, Gianni ; Rovira, Ana ; Di Nicolantonio, Federica ; Albanell, Joan ; Bardelli, Alberto ; Montagut, Clara

Purpose:Colorectal cancer (CRC) patients who respond to the anti-EGFR antibody cetuximab often develop resistance within several months of initiating therapy. To design new lines of treatment the molecular landscape of resistant tumors must be ascertained. We investigated the role of mutations in the EGFR signalling axis on the acquisition of resistance to cetuximab in patients and cellular models. Experimental Design:Tissue samples were obtained from 37 CRC patients who became refractory to [...]

Menée à l'aide de modèles murins, cette étude suggère l'intérêt de la ribavarine, un inhibiteur du facteur elF4E, pour le traitement d'un cancer métastatique du sein

Genetic and pharmacologic inhibition of eIF4E reduces breast cancer cell migration, invasion and metastasis

Pettersson, Filippa ; del Rincon, Sonia V ; Emond, Audrey ; Huor, Bonnie ; Ngan, Elaine ; Ng, Jonathan ; Dobocan, Monica C. ; Siegel, Peter M. ; Miller, Wilson H.

Translation initiation factor eIF4E is an oncogene that is commonly overexpressed in primary breast cancers and metastases. In this report, we report that a pharmacologic inhibitor of eIF4E function, ribavirin, safely and potently suppresses breast tumor formation. Ribavirin administration blocked the growth of primary breast tumors in several murine models and reduced the development of lung metastases in an invasive model. Mechanistically, eIF4E silencing or blockade reduced the invasiveness [...]

Menée in vitro et in vivo sur des modèles de cancer HER2+, cette étude évalue, par rapport au trastuzumab et au pertuzumab, l'activité antitumorale d'un anticorps tripartite ciblant trois sous-domaines du récepteur HER2

Targeting Three Distinct HER2 Domains with a Recombinant Antibody Mixture Overcomes Trastuzumab Resistance

Pedersen, Mikkel W ; Jacobsen, Helle J. ; Koefoed, Klaus ; Dahlman, Anna ; Kjaer, Ida ; Poulsen, Thomas T ; Meijer, Per-Johan ; Nielsen, Lars S ; Horak, Ivan D. ; Lantto, Johan ; Kragh, Michael

Human epidermal growth factor receptor 2 (HER2) plays an important role in the development and maintenance of the malignant phenotype of several human cancers. As such, it is a frequently pursued therapeutic target and two antibodies targeting HER2 have been clinically approved trastuzumab and, pertuzumab. It has been suggested that optimal inhibition of HER2 is achieved when utilizing two or more antibodies targeting non-overlapping epitopes. Superior clinical activity of trastuzumab plus [...]

Mené sur 64 patients atteints d'une tumeur solide de stade avancé, cet essai de phase I évalue la dose maximale tolérée et divers paramètres d'activité clinique d'un inhibiteur de la protéine de choc thermique HSP90

A first-in-human phase I, dose-escalation, multicentre study of HSP990 administered orally in adult patients with advanced solid malignancies

Spreafico, A. ; Delord, J. P. ; De Mattos-Arruda, L. ; Berge, Y. ; Rodon, J. ; Cottura, E. ; Bedard, P. L. ; Akimov, M. ; Lu, H. ; Pain, S. ; Kaag, A. ; Siu, L. L. ; Cortés, J.

Background: Heat-shock protein 990 (HSP990) is a potent and selective synthetic small-molecule HSP90 inhibitor. The primary objectives of this phase I first-in-human study were to determine dose-limiting toxicities (DLTs), maximum-tolerated dose (MTD) and recommended phase II dose (RP2D). Secondary objectives included characterisation of the safety profile, pharmacokinetics (PKs) and pharmacodynamics (PDs). Methods: Heat-shock protein 990 was administered orally once or two times weekly on a [...]

A partir de données portant sur 275 patients atteints d'un cancer du poumon non à petites cellules avec réarrangements ALK et présentant des métastases cérébrales asymptomatiques, cette étude rétrospective évalue, du point de vue du taux de contrôle de la maladie systémique et intracrânienne, l'efficacité du crizotinib

Clinical Experience With Crizotinib in Patients With Advanced ALK-Rearranged Non–Small-Cell Lung Cancer and Brain Metastases

Costa, Daniel B. ; Shaw, Alice T. ; Ou, Sai-Hong I. ; Solomon, Benjamin J. ; Riely, Gregory J. ; Ahn, Myung-Ju ; Zhou, Caicun ; Shreeve, S. Martin ; Selaru, Paulina ; Polli, Anna ; Schnell, Patrick ; Wilner, Keith D. ; Wiltshire, Robin ; Camidge, D. Ross ; Crino, Lucio

Purpose : Crizotinib is an oral kinase inhibitor approved for the treatment of ALK-rearranged non–small-cell lung cancer (NSCLC). The clinical benefits of crizotinib in patients with brain metastases have not been previously studied. Patients and Methods : Patients with advanced ALK-rearranged NSCLC enrolled onto clinical trial PROFILE 1005 or 1007 (randomly assigned to crizotinib) were included in this retrospective analysis. Patients with asymptomatic brain metastases (nontarget or target [...]

Mené en France sur des patients atteints d'un cancer du poumon non à petites cellules présentant des métastases cérébrales asymptomatiques, cet essai de phase II évalue l'efficacité, du point de vue de la survie sans progression à 6 mois, et la toxicité d'un traitement de première ligne combinant bevacizumab, carboplatine et paclitaxel (67 patients) et d'un traitement de deuxième ligne combinant bevacizumab et erlotinib (24 patients)

Bevacizumab in Patients with Non-Squamous Non-Small-Cell Lung Cancer and Asymptomatic, Untreated Brain Metastases (BRAIN): a Non-Randomised, Phase II Study

Besse, Benjamin ; Le Moulec, Sylvestre ; Maazieres, Julien ; Senellart, Helene ; Barlesi, Fabrice ; Chouaid, Christos ; Dansin, Eric ; Berard, Henri ; Falchero, Lionel ; Gervais, Radj ; Robinet, Gilles ; Ruppert, Anne-Marie ; Schott, Roland ; Léna, Hervé ; Clement-Duchene, Christelle ; Quantin, Xavier ; Souquet, Pierre Jean ; Tredaniel, Jean ; Moro-Sibilot, Denis ; Pérol, Maurice ; Madroszyk, Anne-Catherine ; Soria, Jean-Charles

Purpose: The phase II prospective, non-comparative BRAIN study (NCT00800202) investigated efficacy and safety of bevacizumab in chemotherapy-naive or pretreated patients with non-small-cell lung cancer (NSCLC) and asymptomatic untreated brain metastases, to provide data in this previously unexplored subgroup. Experimental Design: Patients with stage IV non-squamous NSCLC, Eastern Cooperative Oncology Group performance status 0-1, and untreated, asymptomatic brain metastases received first-line [...]

Mené sur 1 099 patients atteints d'un cancer métastatique de la prostate résistant à la castration et ayant progressé après un traitement au docétaxel, cet essai international de phase III évalue l'efficacité, du point de vue de la survie globale, et la toxicité de l'ajout d'orteronel à la prednisone

Phase III, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel (TAK-700) Plus Prednisone With Placebo Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer That Has Progressed During or After Docetaxel-Based Therapy: ELM-PC 5

Fizazi, Karim ; Jones, Robert ; Oudard, Stéphane ; Efstathiou, Eleni ; Saad, Fred ; de Wit, Ronald ; de Bono, Johann ; Cruz, Felipe Melo ; Fountzilas, George ; Ulys, Albertas ; Carcano, Flavio ; Agarwal, Neeraj ; Agus, David ; Bellmunt, Joaquim ; Petrylak, Daniel P. ; Lee, Shih-Yuan ; Webb, Iain J. ; Tejura, Bindu ; Borgstein, Niels ; Dreicer, Robert

Purpose : Orteronel (TAK-700) is an investigational, nonsteroidal, reversible, selective 17,20-lyase inhibitor. This study examined orteronel in patients with metastatic castration-resistant prostate cancer that progressed after docetaxel therapy. Patients and Methods : In our study, 1,099 men were randomly assigned in a 2:1 schedule to receive orteronel 400 mg plus prednisone 5 mg twice daily or placebo plus prednisone 5 mg twice daily, stratified by region (Europe, North America [NA], and [...]

A partir de données portant sur 452 patientes atteintes d'un cancer du col de l'utérus de stade avancé et incluses dans un essai de phase III évaluant l'ajout de bevacizumab à une chimiothérapie, cette étude analyse des indicateurs de qualité de vie rapportés par les patientes au cours du traitement

Bevacizumab for advanced cervical cancer: patient-reported outcomes of a randomised, phase 3 trial (NRG Oncology–Gynecologic Oncology Group protocol 240)

Penson, Richard T. ; Huang, Helen Q. ; Wenzel, Lari B. ; Monk, Bradley J. ; Stockman, Sharon ; Long, Harry J., III ; Ramondetta, Lois M. ; Landrum, Lisa M. ; Oaknin, Ana ; Reid, Thomas J. A. ; Leitao, Mario M. ; Method, Michael ; Michael, Helen ; Tewari, Krishnansu S.

Background : GOG 240 was a practice-changing randomised phase 3 trial that concluded that chemotherapy plus bevacizumab for advanced cervical cancer significantly improves overall and progression-free survival, and the proportion of patients achieving an overall objective response, compared with chemotherapy alone. In this study, we aimed to analyse patient-reported outcomes in GOG 240. Methods : Eligible adult participants (aged ≥18 years) had primary stage IVB or recurrent or persistent [...]

Mené sur 38 patientes atteintes d'un cancer récidivant de l'endomètre, cet essai de phase II évalue l'efficacité, du point de vue du taux de bénéfice clinique, d'un traitement combinant évérolimus et létrozole

Phase II Study of Everolimus and Letrozole in Patients With Recurrent Endometrial Carcinoma

Slomovitz, Brian M. ; Jiang, Yunyun ; Yates, Melinda S. ; Soliman, Pamela T. ; Johnston, Taren ; Nowakowski, Maureen ; Levenback, Charles ; Zhang, Qian ; Ring, Kari ; Munsell, Mark F. ; Gershenson, David M. ; Lu, Karen H. ; Coleman, Robert L.

Purpose : The phosphoinositol-3 kinase (PI3K) pathway is frequently dysregulated in endometrial cancer (EC). Hormonal manipulation leads to response in some patients with EC, but resistance derived from PI3K pathway activation has been documented. Targeting mammalian target of rapamycin (mTOR) may overcome endocrine resistance. We conducted a two-institution phase II trial of everolimus and letrozole in women with recurrent EC. Patients and Methods : Patients were considered incurable, had [...]

Cet article présente la mise à jour 2014 des recommandations de l'"European Association of Urology" sur la prise en charge d'un carcinome à cellules rénales

EAU Guidelines on Renal Cell Carcinoma: 2014 Update

Ljungberg, Börje ; Bensalah, Karim ; Canfield, Steven ; Dabestani, Saeed ; Hofmann, Fabian ; Hora, Milan ; Kuczyk, Markus A. ; Lam, Thomas ; Marconi, Lorenzo ; Merseburger, Axel S. ; Mulders, Peter ; Powles, Thomas ; Staehler, Michael ; Volpe, Alessandro ; Bex, Axel

Context : The European Association of Urology Guideline Panel for Renal Cell Carcinoma (RCC) has prepared evidence-based guidelines and recommendations for RCC management. Objectives : To provide an update of the 2010 RCC guideline based on a standardised methodology that is robust, transparent, reproducible, and reliable. Evidence acquisition : For the 2014 update, the panel prioritised the following topics: percutaneous biopsy of renal masses, treatment of localised RCC (including surgical [...]

Menée à l'aide d'entretiens auprès d'auteurs ayant publié des résultats d'essais cliniques entre août 2007 et juillet 2008, cette étude analyse les défis rencontrés par les chercheurs dans la conduite des essais et leurs publications

The natural history of conducting and reporting clinical trials: interviews with trialists

Smyth, Rebecca ; Jacoby, Ann ; Altman, Douglas ; Gamble, Carrol ; Williamson, Paula

Background : To investigate the nature of the research process as a whole, factors that might influence the way in which research is carried out, and how researchers ultimately report their findings. Methods : Semi-structured qualitative telephone interviews with authors of trials, identified from two sources: trials published since 2002 included in Cochrane systematic reviews selected for the ORBIT project; and trial reports randomly sampled from 14,758 indexed on PubMed over the 12-month [...]

Cet article présente les recommandations d'un groupe d'experts internationaux sur la définition de critères de jugement de la réponse thérapeutique dans les essais cliniques de nouveaux traitements des patients atteints d'un syndrome myélodysplasique ou d'une néoplasie myéloproliférative

An international consortium proposal of uniform response criteria for myelodysplastic/myeloproliferative neoplasms (MDS/MPN) in adults

Savona, Michael R. ; Malcovati, Luca ; Komrokji, Rami ; Tiu, Ramon V. ; Mughal, Tariq I. ; Orazi, Attilio ; Kiladjian, Jean-Jacques ; Padron, Eric ; Solary, Eric ; Tibes, Raoul ; Itzykson, Raphaël ; Cazzola, Mario ; Mesa, Ruben ; Maciejewski, Jaroslaw ; Fenaux, Pierre ; Garcia-Manero, Guillermo ; Gerds, Aaron ; Sanz, Guillermo ; Niemeyer, Charlotte M. ; Cervantes, Francisco ; Germing, Ulrich ; Cross, Nicholas C. P. ; List, Alan F.

MDS/MPN are hematologically diverse stem cell malignancies sharing phenotypic features of both myelodysplastic syndromes (MDS) and myeloproliferative neoplasms (MPN). Currently there are no standard treatment recommendations for most adult patients with MDS/MPN. In order to optimize efforts to improve the management and disease outcomes it is essential to identify meaningful clinical and biologic endpoints, and standardized response criteria for clinical trials. The dual dysplastic and [...]