Systematic review and meta-analysis of phase I/II targeted therapy combined with radiotherapy in patients with glioblastoma multiforme: quality of report, toxicity, and survival

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• 作者：Marcos A. dos Santos ; Jean-Pierre Pignon ; Pierre Blanchard…
• 关键词：Glioblastoma ; Radiotherapy ; Molecularly targeted therapy ; Phase 1 ; Phase 2 ; Severe adverse events ; Meta ; analysis ; Quality
• 刊名：Journal of Neuro-Oncology
• 出版年：2015
• 出版时间：June 2015
• 年：2015
• 卷：123
• 期：2
• 页码：307-314
• 全文大小：411 KB
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• 作者单位：Marcos A. dos Santos (1) (2) (5)
  Jean-Pierre Pignon (2) (3)
  Pierre Blanchard (1) (3) (5)
  Delphine Lefeuvre (2)
  Antonin Levy (1) (4) (5)
  Mehdi Touat (1) (4)
  Guillaume Louvel (1)
  Frédéric Dhermain (1)
  Jean-Charles Soria (4) (5)
  Eric Deutsch (1) (4) (5)
  Gwéna?l Le Teuff (2) (3)
  
  1. Department of Radiation Oncology, INSERM 1030 “Molecular Radiotherapy- Gustave Roussy, Gustave Roussy Cancer Campus, 114 Rue édouard Vaillant, 94805, Villejuif Cedex, France
  2. Department of Biostatistics and Epidemiology, Gustave Roussy, Villejuif, France
  5. Faculté de médecine du Kremlin-Bicêtre, Paris-Sud University, Kremlin Bicêtre, France
  3. CESP Centre for Research in Epidemiology and Population Health, INSERM U1018, Paris-Sud University, Villejuif, France
  4. Drug Development Department, Gustave Roussy, Villejuif, France
  
• 刊物类别：Medicine
• 刊物主题：Medicine & Public Health
  Oncology
  
• 出版者：Springer Netherlands
• ISSN：1573-7373

文摘

To perform a systematic review and meta-analysis of severe adverse events (SAE) reported in early trials combining molecularly targeted therapies (MTT) with radiotherapy (RT), and to compare them to standard therapy. A summary data meta-analysis was performed and compared to the historical standard. Inclusion criteria were phase I and/or II trials published between 2000 and 2011, with glioblastoma multiforme patients treated with RT and MTT. Pooled incidence rates (IR) of SAE were estimated as well as the pooled median progression-free survival (PFS) and overall survival (OS). Nineteen prospective trials (9 phase I, 1 phase I/II and 9 phase II) out of 29 initially selected were included (n?=?755 patients). The exact number of patients who had experienced SAE was mentioned in 37?% of the trials, concerning only 17?% of the patients. Information such as the period during which adverse events were monitored, the planned treatment duration, and late toxicity were not reported in the trials. The pooled IR of overall SAE was 131.2 (95?% CI 88.8-93.7) per 1000 person-months compared to 74.7 (63.6-7.8) for standard therapy (p?<?0.01). Significant differences were observed for gastrointestinal events (p?=?0.05) and treatment-related deaths (p?=?0.02), in favour of standard therapy. No significant difference was observed in PFS and OS. Reporting a summary of toxicity data in early clinical trials should be stringently standardized. The use of MTT with RT compared to standard therapy increased SAE while yielded comparable survival in glioblastoma multiforme patients.