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(Chest. 2000;118:966-970.)
© 2000 American College of Chest Physicians

Adenoviral-Mediated p53 Gene Transfer to Non-small Cell Lung Cancer Through Endobronchial Injection*

David Weill, MD; Michael Mack, MD; Jack Roth, MD; Stephen Swisher, MD; Scott Proksch; James Merritt, MD and John Nemunaitis, MD

* From the Medical City Dallas Hospital (Drs. Weill and Mack), Dallas; University of Texas (Drs. Roth and Swisher), MD Anderson Cancer Center, Houston; Introgen Therapeutics (Mr. Proksch and Dr. Merritt), Houston; and US Oncology (Dr. Nemunaitis), Dallas, TX.

Correspondence to: John Nemunaitis, MD, Associate Director, Clinical Research, 3535 Worth St, Collins Bldg, 5th Floor, Dallas, TX 75246; e-mail: John.Nemunaitis{at}USOncology.com

Objective: The objective was to determine the degree of toxicity and antitumor activity following bronchoscopic injection of an adenoviral-mediated p53 gene (Adp53) into tumors causing airway obstruction.

Dosing: This was a subset analysis of a phase I dose escalation trial.

Setting: Patients were treated in the outpatient clinics at the University of Texas (MD Anderson Cancer Center, Houston, TX) and at Medical City Dallas Hospital (US Oncology, Dallas, TX).

Patients: Twelve patients (median age, 60 years) with advanced endobronchial non-small cell lung cancer (NSCLC) (squamous cell carcinoma, six patients; adenocarcinoma, six patients) were entered into trial. The median tumor area was 5 x 3.2 cm. All patient tumors contained a p53 gene mutation.

Interventions: Adp53 (dose range, 1 x 106 to 1 x 1011 plaque-forming units) was administered by bronchoscopic intratumoral injection once every 28 days.

Measurements and results: Toxicity attributed to the Adp53 vector was minimal. Six of the 12 patients had significant improvement in airway obstruction, and 3 patients met the criteria for partial response.

Conclusions: Direct bronchoscopic injection of Adp53 into endobronchial NSCLC is safe, with acceptable levels of toxicity. The initial clinical results demonstrating relief of airway obstruction warrant further clinical investigation.

Key Words: adenovirus • lung cancer • p53




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