SAFETY AND EFFICACY OF NIMOTUZUMAB IN COMBINATION WITH RADIOTHERAPY IN GLIOBLASTOMA PATIENTS; SYSTEMMATIC REVIEW OF CLINICAL TRIALS
Author(s)
Gadi HR, Ganta mR, Gurram H, Rayavarapu jE
Excelra Knowledge Solutions, Hyderabad, India
OBJECTIVES : Glioblastoma is the most aggressive cancer that begins within the brain. Epidermal growth factor receptor (EGFR) is one of the major genetic factors affecting the pathogenesis and prognosis of High-grade gliomas (HGG). Nimotuzumab (h-R3) is a humanized IgG1 isotype monoclonal antibody that binds to the extracellular domain of EGFR, inhibiting tyrosine kinase activation. METHODS : Clinical trials which included Nimotuzumab in combination with radiotherapy as an intervention for Glioblastoma, were identified in databases such as, Cochrane, and MEDLINE (via PubMed). Two researchers independently reviewed studies using the Cochrane methodology for systematic reviews. Outcomes of interest included progression-free survival (PFS), overall survival (OS), overall response rate (ORR), and safety. RESULTS : In total, 210 potentially relevant studies were screened. Five clinical trials involving 291 patients with Glioblastoma met the inclusion criteria. Three trials are single arm studies and two comparative studies. Results were not pooled due to clinical heterogeneity with the limitation of only one trial with each comparator. Nimotuzumab in combination with radiotherapy has shown survival gain in high-grade glioma patients. Overall, longer duration of PFS (26.6% at 60 month) and increased OS (30.3% at 60 month) were observed with Nimotuzumab plus radiotherapy. Nimotuzumab caused no exacerbation of the radiotherapy-expected toxicity and also lacking cumulative toxicity after many maintenance doses. CONCLUSIONS : Though the survival times were similar to those seen in historical data of standard therapy, Nimotuzumab is a very well-tolerated drug, lacking cumulative toxicity and shows a significant survival benefit in combination with irradiation. However, the results have to be interpreted cautiously due to limited number of trials available
Conference/Value in Health Info
2018-05, ISPOR 2018, Baltimore, MD, USA
Value in Health, Vol. 21, S1 (May 2018)
Code
PCN28
Topic
Clinical Outcomes
Topic Subcategory
Comparative Effectiveness or Efficacy
Disease
Oncology