Azienda Ospedaliera Camillo Forlanini
Azienda Ospedaliera Camillo Forlanini
Rosell R.,Catalan Institute of Nanoscience and Nanotechnology |
Rosell R.,University of Barcelona |
Carcereny E.,Catalan Institute of Nanoscience and Nanotechnology |
Gervais R.,Center Francois Baclesse |
And 54 more authors.
The Lancet Oncology | Year: 2012
Background: Erlotinib has been shown to improve progression-free survival compared with chemotherapy when given as first-line treatment for Asian patients with non-small-cell lung cancer (NSCLC) with activating EGFR mutations. We aimed to assess the safety and efficacy of erlotinib compared with standard chemotherapy for first-line treatment of European patients with advanced EGFR-mutation positive NSCLC. Methods: We undertook the open-label, randomised phase 3 EURTAC trial at 42 hospitals in France, Italy, and Spain. Eligible participants were adults (>18 years) with NSCLC and EGFR mutations (exon 19 deletion or L858R mutation in exon 21) with no history of chemotherapy for metastatic disease (neoadjuvant or adjuvant chemotherapy ending ≥6 months before study entry was allowed). We randomly allocated participants (1:1) according to a computer-generated allocation schedule to receive oral erlotinib 150 mg per day or 3 week cycles of standard intravenous chemotherapy of cisplatin 75 mg/m 2 on day 1 plus docetaxel (75 mg/m 2 on day 1) or gemcitabine (1250 mg/m 2 on days 1 and 8). Carboplatin (AUC 6 with docetaxel 75 mg/m 2 or AUC 5 with gemcitabine 1000 mg/m 2) was allowed in patients unable to have cisplatin. Patients were stratified by EGFR mutation type and Eastern Cooperative Oncology Group performance status (0 vs 1 vs 2). The primary endpoint was progression-free survival (PFS) in the intention-to-treat population. We assessed safety in all patients who received study drug (≥1 dose). This study is registered with ClinicalTrials.gov, number NCT00446225. Findings: Between Feb 15, 2007, and Jan 4, 2011, 174 patients with EGFR mutations were enrolled. One patient received treatment before randomisation and was thus withdrawn from the study; of the remaining patients, 86 were randomly assigned to receive erlotinib and 87 to receive standard chemotherapy. The preplanned interim analysis showed that the study met its primary endpoint; enrolment was halted, and full evaluation of the results was recommended. At data cutoff (Jan 26, 2011), median PFS was 9·7 months (95% CI 8·4-12·3) in the erlotinib group, compared with 5·2 months (4·5-5·8) in the standard chemotherapy group (hazard ratio 0·37, 95% CI 0·25-0·54; p<0·0001). Main grade 3 or 4 toxicities were rash (11 [13%] of 84 patients given erlotinib vs none of 82 patients in the chemotherapy group), neutropenia (none vs 18 [22%]), anaemia (one [1%] vs three [4%]), and increased amino-transferase concentrations (two [2%] vs 0). Five (6%) patients on erlotinib had treatment-related severe adverse events compared with 16 patients (20%) on chemotherapy. One patient in the erlotinib group and two in the standard chemotherapy group died from treatment-related causes. Interpretation: Our findings strengthen the rationale for routine baseline tissue-based assessment of EGFR mutations in patients with NSCLC and for treatment of mutation-positive patients with EGFR tyrosine-kinase inhibitors. Funding: Spanish Lung Cancer Group, Roche Farma, Hoffmann-La Roche, and Red Temática de Investigacion Cooperativa en Cancer. © 2012 Elsevier Ltd.
Agency: European Commission | Branch: FP7 | Program: CP | Phase: ICT-2009.5.1 | Award Amount: 10.38M | Year: 2010
BRAVEHEALTH proposes a patient-centric vision to CVD management and treatment, providing people already diagnosed as subjects at risk with a sound solution for continuous and remote monitoring and real time prevention of malignant events. The solution proposed will be made up of the following sub-systems: 1)WEARABLE UNIT: it is an innovative concept of miniaturised multi-parameter sensor, able to continuously monitoring the most critical parameters needed to perform a thorough diagnosis by means of specific diagnostic and prognostic algorithms running on it. It will be possible both to perform scheduled analysis of critical parameters and to remotely trigger the screening of specific vital signs. 2)REMOTE MANAGEMENT UNIT: it represents the main interface between physicians and the system, providing both automated support, in the form of text messages with information or suggestions to the patient directly generated by the system, and doctor managed supervision, allowing direct communication with the patients with voice/text/chat messages. The most important added value of the this unit is the possibility to be interfaced with existing National Health Records and Physiological Data Banks in order to generating and verifying risk prediction models using advanced data mining approaches. 3)LIFE! GATEWAY: Data acquired by the wearable unit will be relayed to a gateway which represents the means by which the information flow from the user to the Central Supervision Unit. This unit will provide the user with the following functionalities: a)Real time communications: in case of anomalies, or simply to suggest specific drugs to be taken, or to advice some particular activity to be performed; 2)Location aware information, exploiting the positioning capabilities of GPS. 3)Mobile virtual community for education and support.