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Nemunaitis, J.; Swisher, S.G.; Timmons, T.; Connors, D.; Mack, M.; Doerksen, L.; Weill, D.; Wait, J.; Lawrence, D.D.; Kemp, B.L.; Fossella, F.; Glisson, B.S.; Hong, W.K.; Khuri, F.R.; Kurie, J.M.; Lee, J.J.; Lee, J.S.; Nguyen, D.M.; Nesbitt, J.C.; Perez-Soler, R.; Pisters, K.M. W.; Putnam, J.B.; Richli, W.R.; Shin, D.M.; [...]

Adenovirus-Mediated p53 Gene Transfer in Sequence With Cisplatin to Tumors of Patients With Non–Small-Cell Lung Cancer

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  • Medientyp: E-Artikel
  • Titel: Adenovirus-Mediated p53 Gene Transfer in Sequence With Cisplatin to Tumors of Patients With Non–Small-Cell Lung Cancer
  • Beteiligte: Nemunaitis, J.; Swisher, S.G.; Timmons, T.; Connors, D.; Mack, M.; Doerksen, L.; Weill, D.; Wait, J.; Lawrence, D.D.; Kemp, B.L.; Fossella, F.; Glisson, B.S.; Hong, W.K.; Khuri, F.R.; Kurie, J.M.; Lee, J.J.; Lee, J.S.; Nguyen, D.M.; Nesbitt, J.C.; Perez-Soler, R.; Pisters, K.M. W.; Putnam, J.B.; Richli, W.R.; Shin, D.M.; [...]
  • Erschienen: American Society of Clinical Oncology (ASCO), 2000
  • Erschienen in: Journal of Clinical Oncology, 18 (2000) 3, Seite 609-609
  • Sprache: Englisch
  • DOI: 10.1200/jco.2000.18.3.609
  • ISSN: 0732-183X; 1527-7755
  • Entstehung:
  • Anmerkungen:
  • Beschreibung: PURPOSE: To determine the safety and tolerability of adenovirus-mediated p53 (Adp53) gene transfer in sequence with cisplatin when given by intratumor injection in patients with non–small-cell lung cancer (NSCLC). PATIENTS AND METHODS: Patients with advanced NSCLC and abnormal p53 function were enrolled onto cohorts receiving escalating dose levels of Adp53 (1 × 106 to 1 × 1011 plaque-forming units [PFU]). Patients were administered intravenous cisplatin 80 mg/m2 on day 1 and study vector on day 4 for a total of up to six courses (28 days per course). Apoptosis was determined by the terminal deoxynucleotidyl- transferase-dUTP nick–end labeling assay. Evidence of vector-specific sequences were determined using reverse-transcriptase polymerase chain reaction. Vector dissemination and biodistribution was monitored using a series of assays (cytopathic effects assay, Ad5 hexon enzyme-linked immunosorbent assay, vector-specific polymerase chain reaction assay, and antibody response assay). RESULTS: Twenty-four patients (median age, 64 years) received a total of 83 intratumor injections with Adp53. The maximum dose administered was 1 × 1011 PFU per dose. Transient fever related to Adp53 injection developed in eight of 24 patients. Seventeen patients achieved a best clinical response of stable disease, two patients achieved a partial response, four patients had progressive disease, and one patient was not assessable. A mean apoptotic index between baseline and follow-up measurements increased from 0.010 to 0.044 (P = .011). Intratumor transgene mRNA was identified in 43% of assessable patients. CONCLUSION: Intratumoral injection with Adp53 in combination with cisplatin is well tolerated, and there is evidence of clinical activity.