Prognostic factors and outcome of patients with hematological malignancies in phase I trials: the Gustave Roussy scoring system
| العنوان: | Prognostic factors and outcome of patients with hematological malignancies in phase I trials: the Gustave Roussy scoring system |
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| المؤلفون: | Christophe Massard, Capucine Baldini, Jean-Marie Michot, Laura Faivre, Sophie Postel-Vinay, Jean-Charles Soria, Stéphane de Botton, Lina Benajiba, Andrea Varga, Anas Gazzah, Vincent Ribrag, Ecaterina Ileana, Rastilav Balheda |
| المساهمون: | Département d’Innovation Thérapeutique et essais précoces [Gustave Roussy] ( DITEP ), Institut Gustave Roussy ( IGR ), Rheumatology Unit ( Rheum Unit - PISA ), University of Pisa [Pisa], Service de biostatistique et d'épidémiologie ( SBE ), Direction de la recherche clinique [Gustave Roussy], Institut Gustave Roussy ( IGR ) -Institut Gustave Roussy ( IGR ), Lipides - Nutrition - Cancer [Dijon - U1231] ( LNC ), Université de Bourgogne ( UB ) -AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement-Institut National de la Santé et de la Recherche Médicale ( INSERM ), Centre de génétique - Centre de référence des maladies rares, anomalies du développement et syndromes malformatifs (CHU de Dijon), Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand ( CHU Dijon ), Université Paris-Sud - Paris 11 ( UP11 ), Caractérisation et sécurité biologique des surfaces nanostructurées ( C-BIOSENSS ), Université d'Auvergne - Clermont-Ferrand I ( UdA ), Université Paris-Saclay, Département d'hématologie [Gustave Roussy] |
| المصدر: | Anti-Cancer Drugs Anti-Cancer Drugs, Lippincott, Williams & Wilkins, 2017, 28 (5), pp.540-545 |
| بيانات النشر: | HAL CCSD, 2017. |
| سنة النشر: | 2017 |
| مصطلحات موضوعية: | Adult, Male, 0301 basic medicine, Cancer Research, medicine.medical_specialty, Multivariate analysis, Scoring system, Antineoplastic Agents, Severity of Illness Index, [ SDV.CAN ] Life Sciences [q-bio]/Cancer, Young Adult, 03 medical and health sciences, 0302 clinical medicine, Refractory, Internal medicine, medicine, Humans, Pharmacology (medical), Aged, Aged, 80 and over, Pharmacology, Clinical Trials, Phase I as Topic, Performance status, business.industry, Hazard ratio, Phase i trials, Middle Aged, Prognosis, Confidence interval, Survival Rate, Treatment Outcome, 030104 developmental biology, Oncology, Hematologic Neoplasms, 030220 oncology & carcinogenesis, Cohort, Female, business |
| الوصف: | International audience; Despite considerable progress in hematological malignancies (HM) biology during the last decades, translation into clinical benefit remains a major challenge. To improve patient selection and identify patients most likely to benefit from phase I trials, we designed and validated, in an independent cohort, a simple prognostic score. Treatment outcome, toxicity, and survival data from 82 consecutive patients enrolled in 14 phase I trials were reviewed (January 2008-February 2012). We validated these results on a prospectively collected cohort (17 phase I trials, February 2012-May 2014, 88 patients). Within a median follow-up of 19.1 months (range: 2.1-43.8 months), the median progression-free and overall survival (OS) were, respectively, 4.1 months [95% confidence interval (CI): 3.0-5.3] and 19.8 months (95% CI: 16.1-36.8). Best overall response and disease control rates were similar to HM salvage regimens (28 and 64%, respectively). Through multivariate analysis of independent prognostic factors, we designed and prospectively validated a simple prognostic score based on histological subtype, performance status, and albumin. Patients with a low-risk score experienced significantly better OS compared with patients with an intermediate or a high score (median OS: 37 vs. 17 vs. 5 months; hazard ratio=11.68, 95% CI: 4.09-33.3). Our data indicate the safety and efficacy of phase I trials in a significant number of relapsed/refractory HM patients, with clinical benefit achieved in more than half of patients. Our simple scoring system offers a valuable selection tool encouraging HM patient inclusions in phase I trials. |
| اللغة: | English |
| تدمد: | 0959-4973 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::25d59ef266913e78b5872f50bfd3f4bb https://hal.archives-ouvertes.fr/hal-01567955 |
| رقم الانضمام: | edsair.doi.dedup.....25d59ef266913e78b5872f50bfd3f4bb |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 09594973 |
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