Le Rhun E.,Breast Cancer Unit |
Le Rhun E.,University Hospital |
Le Rhun E.,French Institute of Health and Medical Research |
Delbeuck X.,French Institute of Health and Medical Research |
And 6 more authors.
Breast Cancer Research and Treatment | Year: 2015
Cognitive impairment, especially verbal episodic memory and executive function impairments, has been considered to be a possible adverse effect of aromatase inhibitors (AI). This phase III open-label study compared the impact of tamoxifen and AI on verbal episodic memory (Rey auditory verbal learning test—RAVLT) and other cognitive functions (visual memory, psychomotor speed, and executive functions) after 6 and 12 months of treatment in breast cancer patients undergoing adjuvant hormonotherapy. Menopausal chemo-naïve patients with resectable breast cancer were randomly assigned (1:1) at the end of the radiotherapy to receive tamoxifen or AI. Neuropsychological assessments, self-reported quality of life, and depression assessments were performed at baseline, before any hormonal treatment, and at 6 and 12 months. Mixed design analysis models of variance was used to compare the evolution of the scores between the groups during follow-up. A total of 74 evaluable patients were enrolled (Tamoxifen arm, n = 37; AI arm, n = 37; letrozole n = 18; anastrozole n = 16; exemestane n = 3). The median age at inclusion was 61 years (range, minimum 49–maximum 69). The patient and breast cancer characteristics were well balanced between arms. After 6 months, no significant differential effect of AI or tamoxifen was observed on the RAVLT. Moreover, considering the other cognitive measures and the quality of life questionnaires, there were also no differences between the groups during the 1-year follow-up. In this study, AI has not demonstrated worse adverse effects on cognitive functions than tamoxifen during a 1-year follow-up © 2015, Springer Science+Business Media New York.
Bompas E.,Center Rene Gauducheau |
Le Cesne A.,Institute Gustave Roussy |
Tresch-Bruneel E.,Methodology and Biostatistics Unit |
Lebellec L.,Center Oscar Lambret |
And 12 more authors.
Annals of Oncology | Year: 2015
Background: There is no consensual treatment of locally advanced or metastatic chordomas. Patients and methods: We conducted a multicenter, open-label, uncontrolled phase II trial of sorafenib (800 mg/day). The primary end point was the 9-month progression-free rate according to RECIST 1.1. All patients had documented progressive disease at the time of study entry. Results: Twenty-seven patients were enrolled between May 2011 and January 2014. The median age was 64 (range, 30-86) years. There were 17 men and 10 women. Twelve patients had been previously treated with chemotherapy and molecularly targeted agents. The maximum toxicity grade per patient was grade 3 in 21 cases (77.8%) and grade 4 in 4 cases (14.8%). Sorafenib provided an intent-to-treat best objective response of 1/27 [3.7%; 95% confidence interval (CI) 0.1% to 19.0%], a 9-month progression-free rate of 73.0% (95% CI 46.1-88.0) and a 12-month overall survival rate of 86.5% (95% CI 55.8-96.5). Survival curves were similar in pretreated and not pretreated patients. Discussion: Additional clinical trials further exploring sorafenib as a treatment of locally advanced or metastatic chordomas are warranted. © The Author 2015. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.
Chibaudel B.,Institute Hospitalier Franco Britannique |
Tournigand C.,Hopitaux de Paris |
Bonnetain F.,Methodology and Biostatistics Unit |
Richa H.,Institute Hospitalier Franco Britannique |
And 5 more authors.
Therapeutic Advances in Medical Oncology | Year: 2015
Systemic therapy is the standard care for patients with unresectable advanced colorectal cancer (CRC), but salvage surgery of metastatic disease should be considered in the case of adequate tumor shrinkage. Several drugs and combinations are now available for use in treating patients with advanced CRC, but the optimal sequence of therapy remains unknown. Moreover, the administration of antitumor therapy can be modulated by periods of maintenance or treatment breaks rather than delivered as full therapy until disease progression or unacceptable toxicity, followed by reintroduction of prior full therapy when required, before switching to other drugs. Consequently, randomized strategy trials are needed to define the optimal treatment sequences. Molecular testing for Kirsten rat sarcoma viral oncogene homolog (KRAS) and neuroblastoma RAS viral oncogene homolog (NRAS) is mandatory but not sufficient to select appropriate patients for epidermal growth factor receptor (EGFR) monoclonal antibody (MoAb) therapy. © The Author(s), 2015.
Bogart E.,Methodology and Biostatistics Unit |
Jouin A.,Methodology and Biostatistics Unit |
Behal H.,University of Lille Nord de France |
Duhamel A.,University of Lille Nord de France |
And 2 more authors.
Computer Methods and Programs in Biomedicine | Year: 2016
Objective: The analysis of treatment effects in clinical trials usually focus on efficacy and safety in separate descriptive statistical analyses. The Q-TWiST (Quality adjusted Time Without Symptoms and Toxicity) method has been proposed by Gelber in the 90s to enable a statistical comparison between two groups with a graphical representation by incorporating benefit and risk into a single analysis. Although the method has been programmed in SAS, it is rarely used. The availability of the method in the freely software environment system like R would greatly enhanced the accessibility by researchers. The objective of this paper is to present a program for Q-TWiST analyses within R software environment. Methods: The qtwist function was developed in order to estimate and compare Q-TWiST for two groups. Two individual patient data files are required used for input: one for visits and one for follow-up. Q-TWiST is obtained as a sum of time spent in three health states: period in toxicity (TOX), period without relapse and toxicity (TWiST) and period in relapse (REL), weighted by associated utility scores restricted to median overall survival for example. The bootstrap method is used for testing statistical significance. Threshold analysis and gain functions allow a group comparison for different utility values. Results: Input data is checked for consistency. Descriptive statistics and mean durations for each health state are provided, allowing statistical comparisons. Graphical results are presented in a PDF file. The use of the function is illustrated with data from a simulated data set and a randomized clinical trial. Conclusions: qtwist is an easy to use R function, allowing a quality adjusted survival analysis with the Q-TWiST method. © 2015 Elsevier Ireland Ltd.
Ray-Coquard I.,Center Leon Berard |
Ray-Coquard I.,University of Lyon |
Italiano A.,Institute Bergonie |
Bompas E.,Center Rene Gauducheau |
And 15 more authors.
Oncologist | Year: 2012
Background. Angiosarcomas account for <2% of all soft tissue sarcomas. This subtype is one of the most aggressive forms of soft tissue sarcoma. The prognosis for angiosarcoma patients in the advanced phase remains poor with current cytotoxic agents (progression-free survival [PFS] time of ~4 months and overall survival [OS] time of ~8 months). We investigated the antitumor activity of sorafenib in patients with metastatic or advanced angiosarcomas in a phase II trial. Methods. We conducted a stratified phase II trial. The primary endpoint was the progression-free rate (PFR) at 9 months according to the Response Evaluation Criteria in Solid Tumors.Atwo-stage design (optimal Simon design) was used. Patients received sorafenib (400 mg twice daily) for 9 months until unacceptable toxicity or tumor progression. Central pathological and radiological reviews were performed. Data on stratum A (superficial angiosarcoma) and stratum B (visceral angiosarcoma) are currently available. ©AlphaMed Press 1083- 7159/2012/$40.00/0.