Roboz G.J.,New York Medical College |
Rosenblat T.,Columbia University |
Arellano M.,Emory University |
Gobbi M.,University of Genoa |
And 12 more authors.
Journal of Clinical Oncology | Year: 2014
Purpose: Most patients with acute myeloid leukemia (AML) eventually experience relapse. Relapsed/refractory AML has a dismal prognosis and currently available treatment options are generally ineffective. The objective of this large, international, randomized clinical trial was to investigate the efficacy of elacytarabine, a novel elaidic acid ester of cytarabine, versus the investigator's choice of one of seven commonly used AML salvage regimens, including high-dose cytarabine, multiagent chemotherapy, hypomethylating agents, hydroxyurea, and supportive care. Patients and Methods: A total of 381 patients with relapsed/refractory AML were treated in North America, Europe, and Australia. Investigators selected a control treatment for individual patients before random assignment. The primary end point was overall survival (OS). Results: There were no significant differences in OS (3.5 v 3.3 months), response rate (23% v 21%), or relapse-free survival (5.1 v 3.7 months) between the elacytarabine and control arms, respectively. There was no significant difference in OS among any of the investigator's choice regimens. Prolonged survival was only achieved in a few patients in both study arms whose disease responded and who underwent allogeneic stem-cell transplantation. Conclusion: Neither elacytarabine nor any of the seven alternative treatment regimens provided clinically meaningful benefit to these patients. OS in both study arms and for all treatments was extremely poor. Novel agents, novel clinical trial designs, and novel strategies of drug development are all desperately needed for this patient population. © 2014 by American Society of Clinical Oncology.
Tabouret E.,Timone Hospital |
Tabouret E.,LInstitut Paoli Calmettes |
Metellus P.,Timone Hospital |
Metellus P.,Aix - Marseille University |
And 6 more authors.
Neuro-Oncology | Year: 2014
BackgroundBreast cancer (BC) is the second most common cause of brain metastases (BM). Optimal management of BM from BC is still debated. In an attempt to provide appropriate treatment and to assist with optimal patient selection, several specific prognostic classifications for BM from BC have been established. We evaluated the prognostic value and validity of the 6 proposed scoring systems in an independent population of BC patients with BM.MethodsWe retrospectively reviewed all consecutive BC patients referred to our institution for newly diagnosed BM between October 1995 and July 2011 (n = 149). Each of the 6 scores proposed for BM from BC (Sperduto, Niwinska, Park, Nieder, Le Scodan, and Claude) was applied to this population. The discriminative ability of each score was assessed using the Brier score and the C-index. Individual prognostic values of clinical and histological factors were analyzed using uni-and multivariate analyses.ResultsMedian overall survival was 15.1 months (95% CI,11.5-18.7). Sperduto-GPA (P <. 001), Nieder (P <. 001), Park (P <. 001), Claude (P <. 001), Niwinska (P <. 001), and Le Scodan (P =. 034) scores all showed significant prognostic value. The Nieder score showed the best discriminative ability (C-index, 0.672; Brier score error reduction, 16.1%).ConclusionThe majority of prognostic scores were relevant for patients with BM from BC in our independent population, and the Nieder score seems to present the best predictive value but showed a relatively low positive predictive value. Thus, these results remain insufficient and challenge the routine use of these scoring systems. © 2013 The Author(s).
Menager N.-E.,LInstitut Paoli Calmettes |
Coulomb M.-A.,LInstitut Paoli Calmettes |
Lambaudie E.,LInstitut Paoli Calmettes |
Michel V.,LInstitut Paoli Calmettes |
And 3 more authors.
Gynecologie Obstetrique Fertilite | Year: 2011
Objective: This survey evaluated if residents felt a benefit to their participation in robot-assisted procedures and highlights the interest of robot in the initial surgical training. Patients and methods: A questionnaire was submitted to 33 residents participating as assistants in robot-assisted surgical procedures in our department and to seven residents of the Chapel Hill hospital, North Carolina, USA. Items rated their experience with the robot, their feeling during the surgical procedures and whether they thought they improved their technical skills. Results: The majority of French residents felt passive during the procedures (97%) or bored (75%); most of them found an immediate interest to learn anatomy (72.7%) and surgical procedures (66.7%). Then, a minority of them reported an improvement of their knowledge in anatomy (39.4%), in surgical procedures (24.2%), and conventional laparoscopy (9.1%). Most of French residents are not willing to repeat the experience as an assistant (81.8%), whereas they showed great interest in practicing robot-assisted surgery later. The oldest residents benefited more than younger in learning anatomy and surgical procedures. US resident' ratings concerning the contribution of the robot in their training were generally more positive. They were all convinced they made progress in anatomy, as in surgical techniques and they all wanted to repeat such procedures. Discussion and conclusion: This work demonstrates the pedagogical value of using the robot for teaching surgical procedures and anatomy. It also suggests the establishment of training programs dedicated to the learning of robot-assisted surgery in gynaecology, in parallel with training in conventional laparoscopy. © 2011 Elsevier Masson SAS. All rights reserved.