0000000000224942
AUTHOR
F. Bonnetain
Impact of sentinel node biopsy on long-term quality of life in breast cancer patients
Background: The aim of this study was to assess long-term quality of life (QoL) over a period of 6 years in women with breast cancer (BC) who underwent sentinel lymph node biopsy (SLNB), axillary lymph node dissection (ALND), or SLNB followed by ALND. Methods: The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ)-C30 and the EORTC-QLQ-BR-23 questionnaires were used to assess QoL before surgery, just after surgery, 6, 12 and 72 months later. The longitudinal effect of surgical modalities on QoL was assessed with a mixed model analysis of variance for repeated measurements. Results: Five hundred and eighteen BC patients were initially include…
Surrogate end points for overall survival and local control in neoadjuvant rectal cancer trials: statistical evaluation based on the FFCD 9203 trial.
Abstract Background In resectable rectal cancer trials, pathological parameters are early preoperative treatment efficacy measures. Their validation as surrogate end points for long-term clinical outcomes would allow to reduce trial duration. The aim was to evaluate potential surrogates for overall survival (OS) and local control (LC) in preoperative T3/T4 rectal cancer trials. Candidate variables included ypT and ypN stages, T downstaging, tumor regression grade (TRG), and circumferential resection margin (CRM) status. Patients and methods In the Federation Francophone de Cancerologie Digestive (FFCD) 9203 trial, 742 eligible patients were randomly assigned to receive preoperative radiothe…
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…
Guidelines for time-to-event end point definitions in sarcomas and gastrointestinal stromal tumors (GIST) trials: results of the DATECAN initiative (Definition for the Assessment of Time-to-event Endpoints in CANcer trials)
ABSTRACT The DATECAN initiative (Definition for the Assessment of Time-to-event Endpoints in CANcer trials) aims to provide recommendations for definitions of time-to-event end points in cancer randomized controlled trials. We relied on a consensus method based on a multidisciplinary panel of experts to develop these guidelines for trials on sarcomas and gastrointestinal stromal tumors. Background The use of potential surrogate end points for overall survival, such as disease-free survival (DFS) or time-to-treatment failure (TTF) is increasingly common in randomized controlled trials (RCTs) in cancer. However, the definition of time-to-event (TTE) end points is rarely precise and lacks unif…
Impact of pharmaceutical intervention on quality of life and coping strategies in patients with haematological malignancies
Summary Objectives We conducted a prospective study approved by the local ethics committee to determine the impact of a pharmaceutical intervention (PI) on pain, fatigue, quality of life (QoL) and coping strategies in patients with HMs starting chemotherapy sessions. Material and methods Patients received either usual care (UC) + PI (PI group) or UC alone (UC group). They had to complete 2 questionnaires, QLQ-C30 and MAC 21, at 3 different time points: before starting the 1st chemotherapy session (T1), during the intercure (T2) and the day before starting the 2nd chemotherapy session (T3). To determine predictive factors of pain, fatigue, QoL and coping scores at T3, a multivariate ANOVA wa…
Cancer du pancréas localement évolué non resécable : chimioradiothérapie d’induction suivie de chimiothérapie par gemcitabine contre chimiothérapie exclusive par gemcitabine : résultats définitifs de l’étude de phase III 2000–2001de la FFCD et de la SFRO
Resume Objectif de l’etude Etudier l’apport de la chimioradiotherapie concomitante suivie de chimiotherapie dans le cancer pancreatique localement evolue, par rapport a la chimiotherapie seule. Patients et methodes Cent dix-neuf patients atteints d’un cancer pancreatique localement evolue, avec indice de performance de 0 a 2 selon l’Organisation mondiale de la sante, ont ete randomises entre une chimioradiotherapie concomitante d’induction (60 Gy, 2 Gy/fraction ; perfusion concomitante de 5-fluoro-uracile de 300 mg/m2 par jour, de j1 a j5 pendant six semaines ; cisplatine, 20 mg/m2 par jour, de j1 a j5 pendant la premiere et la cinquieme semaines) et une chimiotherapie d’induction par gemci…
Évaluation de l’impact de l’intervention d’un travailleur social auprès d’aidants informels de personnes âgées atteintes d’une pathologie chronique. Protocole de l’étude ICE : cohorte prospective multicentrique d’aidants informels en BFC
Introduction L’amelioration des conditions de vie et les progres medicaux ont permis un allongement de la duree de vie a des âges tres eleves, lequel a genere l’apparition et le developpement de maladies chroniques associees a des comorbidites. Dans ce contexte, la problematique de la dependance est devenue un enjeu majeur pour les politiques publiques. Depuis de nombreuses annees, elles traduisent leur volonte de faciliter le maintien au domicile le plus longtemps possible a des personnes âgees en perte d’autonomie. Ainsi, cette volonte de continuer a vivre a domicile, directement exprimee par les aines, repose en grande partie sur un reseau d’aides informelles (famille, amis, voisins). Le…
Impact of neoadjuvant chemotherapy on survival in breast cancer patients in daily practice: a population-based study
This population-based study aimed to describe the effects of neoadjuvant chemotherapy (NC) on survival in breast cancer (BC) patients in daily practice. BC patients treated with NC followed by surgery and radiotherapy, were retrospectively selected from 1982 to 2005 using the Cote d’Or BC registry. These patients were matched for the baseline AJCC (American Joint Committee on Cancer) stage, age at diagnosis, date of diagnosis and oestrogens receptors status to those who had undergone surgery followed by adjuvant chemotherapy and radiotherapy. The prognostic effect of NC on survival in BC patients was assessed with relative survival (RS) analyses. From 1982 to 2005, 210 patients with BC diag…