Quels sont les patients atteints d'un cancer du sein dont la décision de prise en charge thérapeutique bénéficie de l'utilisation d'un système d'aide à la décision ? Un exemple utilisant la fouille de données et OncoDoc2

Session 2 : Utilisateurs et usagesNational audienceOncoDoc2 est un système d'aide à la décision (SAD) s'appuyant sur des recommandations de pratique clinique (RPC) pour la prise en charge des cancers du sein. Il a été utilisé comme intervention dans un essai randomisé contrôlé dont l'objectif principal était d'évaluer son impact sur la conformité des décisions des réunions de concertation pluridisciplinaire aux RPC. Nous avons utilisé un algorithme de fouille de données pour découvrir les régularités des profils patients, ou " motifs émergents " (ME), associées à la conformité et à la non-conformité des décisions selon que le système OncoDoc2 était ou non utilisé, afin d'évaluer quels profils patients pouvaient bénéficier de l'utilisation du système. Les ME associés à la non conformité des décisions prises sans le système sont associées à la conformité quand le système est utilisé sauf dans certaines situations cliniques pour lesquelles la force de la recommandation est faible

Which patients may benefit from the use of a decision support system to improve compliance of physician decisions with clinical practice guidelines: a case study with breast cancer involving data mining.

International audienceOncoDoc2 is a guideline-based clinical decision support system (CDSS) for breast cancer management. It has been used as an intervention in a randomized controlled trial carried out to evaluate the impact of using a CDSS upon the compliance with clinical practice guidelines (CPGs) of multidisciplinary staff meeting decisions. Data mining was used to discover multi-criteria regularities as "emerging patterns" (EPs) associated with compliance and non-compliance with CPGs when using and not using OncoDoc2 and to assess which patients may benefit from the use of the CDSS. Decision data was collected from all participating centers. The number of EPs associated with non-compliance is smaller in the intervention arm, which suggests a practice harmonization effect of OncoDoc2. EPs associated with compliant decisions in both arms of the trial correspond to situations well identified in CPGs. EPs associated with non-compliant decisions when the system is not used are associated with compliance when the system is used except in clinical situations where evidence is lacking

Androgen deprivation therapy plus docetaxel and estramustine versus androgen deprivation therapy alone for high-risk localised prostate cancer (GETUG 12): a phase 3 randomised controlled trial

International audienceBACKGROUND:Early risk-stratified chemotherapy is a standard treatment for breast, colorectal, and lung cancers, but not for high-risk localised prostate cancer. Combined docetaxel and estramustine improves survival in patients with castration-resistant prostate cancer. We assessed the effects of combined docetaxel and estramustine on relapse in patients with high-risk localised prostate cancer.METHODS:We did this randomised phase 3 trial at 26 hospitals in France. We enrolled patients with treatment-naive prostate cancer and at least one risk factor (ie, stage T3-T4 disease, Gleason score of ≥8, prostate-specific antigen concentration >20 ng/mL, or pathological node-positive). All patients underwent a staging pelvic lymph node dissection. Patients were randomly assigned (1:1) to either androgen deprivation therapy (ADT; goserelin 10·8 mg every 3 months for 3 years) plus four cycles of docetaxel on day 2 at a dose of 70 mg/m(2) and estramustine 10 mg/kg per day on days 1-5, every 3 weeks, or ADT only. The randomisation was done centrally by computer, stratified by risk factor. Local treatment was administered at 3 months. Neither patients nor investigators were masked to treatment allocation. The primary endpoint was relapse-free survival in the intention-to-treat population. Follow-up for other endpoints is ongoing. This study is registered with ClinicalTrials.gov, number NCT00055731.FINDINGS:We randomly assigned 207 patients to the ADT plus docetaxel and estramustine group and 206 to the ADT only group. Median follow-up was 8·8 years (IQR 8·1-9·7). 88 (43%) of 207 patients in the ADT plus docetaxel and estramustine group had an event (relapse or death) versus 111 (54%) of 206 in the ADT only group. 8-year relapse-free survival was 62% (95% CI 55-69) in the ADT plus docetaxel and estramustine group versus 50% (44-57) in the ADT only group (adjusted hazard ratio [HR] 0·71, 95% CI 0·54-0·94, p=0·017). Of patients who were treated with radiotherapy and had data available, 31 (21%) of 151 in the ADT plus docetaxel and estramustine group versus 26 (18%) of 143 in the ADT only group reported a grade 2 or higher long-term side-effect (p=0·61). We recorded no excess second cancers (26 [13%] of 207 vs 22 [11%] of 206; p=0·57), and there were no treatment-related deaths.INTERPRETATION:Docetaxel-based chemotherapy improves relapse-free survival in patients with high-risk localised prostate cancer. Longer follow-up is needed to assess whether this benefit translates into improved metastasis-free survival and overall survival.FUNDING:Ligue Contre le Cancer, Sanofi-Aventis, AstraZeneca, Institut National du Cancer

Very Long‐Term Complete Remission Can Be Achieved in Men With High‐Risk Localized Prostate Cancer and a Very High PSA Value: An Analysis of the GETUG 12 Phase 3 Trial

International audienceIntroduction: Serum prostate specific antigen (PSA) is a well-known prognostic parameter in men with prostate cancer. The treatment of men with very high PSA values and apparently no detectable metastases is not fully established. Patients and Methods: Ancillary analysis from the GETUG 12 phase 3 trial. Patients with non-metastatic high-risk prostate cancer by bone and computerized tomography (CT) scan were randomly assigned to receive androgen deprivation therapy (ADT) and docetaxel plus estramustine or ADT alone. Relapse-free survival (RFS), clinical RFS, metastases-free survival (MFS), overall survival (OS), and prostate cancer-specific survival (PCSS) were estimated using the Kaplan–Meier method for different levels of PSA (50 ng/mL, 75 ng/mL, and 100 ng/mL). The relationship between PSA and outcomes was studied using residual-based approaches and spline functions. Results: The median follow-up was 12 years (range: 0-15.3). Baseline PSA (<50 ng/mL, n = 328; ≥50ng/mL, n = 85) was associated with improved RFS (P = .0005), cRFS (P = .0024), and MFS (P = .0068). The 12-year RFS rate was 46.33% (CI 40.59-51.86), 33.59% (CI 22.55-44.97), and 11.76% (1.96-31.20) in men with PSA values <50 ng/mL (n = 328), 50-100 ng/mL (n = 68), and ≥100 ng/mL (n = 17), respectively. Exploratory analyses revealed no deviation from the linear relationship assumption between PSA and the log hazard of events. Conclusions: Men with apparently localized prostate cancer and a high baseline PSA value have a reasonable chance of being long-term disease-free when treated with curative intent combining systemic and local therapy

Investigations of low-frequency noise of GaN based heterostructure field-effect transistors

NRC publication: Ye