© 1999 by Oxford University Press
Journal of the National Cancer Institute, Vol. 91, No. 9, 763-771,
May 5, 1999
© 1999 Oxford University Press
Adenovirus-Mediated p53 Gene Transfer in Advanced Non-Small-Cell Lung Cancer
Affiliations of authors: S. G. Swisher, J. A. Roth, J. B. Putnam, Jr., G. L. Walsh (Section of Thoracic Molecular Oncology, Department of Thoracic and Cardiovascular Surgery), D. D. Lawrence, C. H. Carasco, W. R. Richli, M. K. A. Waugh (Department of Diagnostic Imaging), F. Fossella, B. S. Glisson, W. K. Hong, F. R. Khuri, J. M. Kurie, J. S. Lee, R. Perez-Soler, K. M. W. Pisters, D. M. Shin (Department of Thoracic/Head and Neck Medical Oncology), J. J. Lee (Department of Biomathematics), B. L. Kemp, A. K. El-Naggar (Department of Pathology), The University of Texas M. D. Anderson Cancer Center, Houston; J. Nemunaitis, PRN Research Inc., Baylor University Medical Center, Houston; D. G. Connors, J. A. Merritt, Introgen Therapeutics, Inc., Houston; M. Mack, M. Savin, A. Shulkin, J. Wait, D. Weill, Medical City Dallas Hospital, TX; D. M. Nguyen, D. S. Schrump, National Cancer Institute, Bethesda, MD; J. C. Nesbitt, C/V Associates, Nashville, TN.
Correspondence to: Stephen G. Swisher, M.D., Department of Thoracic and Cardiovascular Surgery, The University of Texas M. D. Anderson Cancer Center, 1515 Holcombe Blvd., Box 109, Houston, TX 77030.
BACKGROUND: Preclinical studies in animal models have demonstrated tumor regression following intratumoral administration of an adenovirus vector containing wild-type p53 complementary DNA (Ad-p53). Therefore, in a phase I clinical trial, we administered Ad-p53 to 28 patients with non-small-cell lung cancer (NSCLC) whose cancers had progressed on conventional treatments. METHODS: Patients received up to six, monthly intratumoral injections of Ad-p53 by use of computed tomography-guided percutaneous fine-needle injection (23 patients) or bronchoscopy (five patients). The doses ranged from 106 plaque-forming units (PFU) to 1011 PFU. RESULTS: Polymerase chain reaction (PCR) analysis showed the presence of adenovirus vector DNA in 18 (86%) of 21 patients with evaluable posttreatment biopsy specimens; vector-specific p53 messenger RNA was detected by means of reverse transcription-PCR analysis in 12 (46%) of 26 patients. Apoptosis (programmed cell death) was demonstrated by increased terminal deoxynucleotide transferase-mediated biotin uridine triphosphate nick-end labeling (TUNEL) staining in posttreatment biopsy specimens from 11 patients. Vector-related toxicity was minimal (National Cancer Institute's Common Toxicity Criteria: grade 3 = one patient; grade 4 = no patients) in 84 courses of treatment, despite repeated injections (up to six) in 23 patients. Therapeutic activity in 25 evaluable patients included partial responses in two patients (8%) and disease stabilization (range, 2-14 months) in 16 patients (64%); the remaining seven patients (28%) exhibited disease progression. CONCLUSIONS: Repeated intratumoral injections of Ad-p53 appear to be well tolerated, result in transgene expression of wild-type p53, and seem to mediate antitumor activity in a subset of patients with advanced NSCLC.
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