0000000000309071
AUTHOR
X. Pivot
Bon usage des anticancéreux dans les tumeurs solides : impact des référentiels de bon usage
Resume Introduction Le bon usage des medicaments anticancereux est un enjeu majeur de pilotage des etablissements de sante. L’elaboration de referentiels de bon usage (RBU) est un dispositif specifique de notre systeme de sante. Objectif L’objectif principal de notre travail est de confronter les pratiques therapeutiques aux RBU. L’objectif secondaire est d’evaluer l’impact des RBU sur les recours « hors referentiel » en comparaison d’une etude similaire realisee en 2004. Patients et methode L’etude est realisee entre le 01/07/2008 et le 31/03/2009 sur deux centres de reference en cancerologie. Elle inclut 2289 patients representant 3187 recours a une molecule anticancereuse financee en sus…
TH-302 + Gemcitabine (G + T) vs Gemcitabine (G) in Patients with Previously Untreated advanced Pancreatic Cancer (PAC)
ABSTRACT Background TH-302 is a hypoxia targeted prodrug with a hypoxia-triggered 2-nitroimidazole component designed to release the DNA alkylator, bromo-isophosphoramide mustard (Br-IPM), when reduced in severe hypoxia. A randomized Phase 2B study (NCT01144455) was conducted to assess the benefit of G + T to standard dose G as first-line therapy of PAC. Materials and methods An open-label multi-center study of two dose levels of TH-302 (240 mg/m2 or 340 mg/m2) in combination with G versus G alone (randomized 1:1:1). G (1000 mg/m2) and T were administered IV over 30-60 minutes on Days 1, 8 and 15 of a 28-day cycle. Patients on the G could crossover after progression and be randomized to a G…
Association Between Tumor Egfr and Kras Mutation Status and Clinical Outcomes in Nsclc Patients Randomized to Sorafenib Plus Best Supportive Care (BSC) or Bsc Alone: Subanalysis of the Phase III Mission Trial
ABSTRACT Background Tumor EGFR and KRas mutations are both predictive and prognostic biomarkers in patients with advanced NSCLC. We analyzed the correlation between these biomarkers and treatment outcomes in a phase III trial of 3rd/4th line sorafenib in patients with NSCLC. Methods The global, randomized, placebo-controlled MISSION trial enrolled 703 patients with advanced relapsed/refractory NSCLC of predominantly non-squamous histology. The primary study endpoint was overall survival (OS). EGFR and KRas mutations were analyzed in archival tumor samples and in circulating tumor DNA isolated from plasma. Results Tumor and/or plasma mutation data were available from 347 patients (49%). EGFR…
Appropriate cytotoxic drugs usages in solid tumors: Impact of appropriate use referentials
Summary Background The appropriate use of anticancer drugs is at major stake of steering health facilities. French health authorities have specifically elaborated evidence-based principles and guidelines on good practice for the management of anticancer drugs called “referentiels de bon usage” (RBU in French). Objectives The primary aim of the survey is to confront therapeutic practices and PGU. The secondary objective is to evaluate the impact of PGU on “outside the prescribing guidelines” therapeutic use, as compared with a similar study conducted in 2004. Patients and methods The survey was conducted from 1st July 2008 to 31st March 2009 at two reference centers in cancer research, and i…