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© 2004 Oxford University Press
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Granulocyte–Macrophage Colony-Stimulating Factor Gene-Modified Autologous Tumor Vaccines in Non–Small-Cell Lung Cancer
Affiliations of authors: US Oncology, Dallas, TX (JN, PM); University of Pennsylvania, Philadelphia (DS); University of California, San Francisco (DJ); Earl A. Chiles Research Institute/Providence Medical Center, Portland, OR (JWS, BF); Cell Genesys Inc., South San Francisco, CA (SH, FB, AL, SM, KH).
Correspondence to: John Nemunaitis, MD, 3535 Worth St., Collins Bldg., 5th Fl., Dallas, TX 75246 (e-mail: john.nemunaitis{at}usoncology.com)
To evaluate the feasibility, safety, and efficacy of vaccination with autologous tumor cells genetically modified with an adenoviral vector (Ad-GM) to secrete human granulocyte–macrophage colony-stimulating factor (GM-CSF), we conducted a phase I/II multicenter trial in patients with early and advanced stage non–small-cell lung cancer (NSCLC). Vaccines were generated from autologous tumor harvests. Intradermal injections were given every 2 weeks for a total of three to six vaccinations. Tumors were harvested from 83 patients, 20 with early-stage NSCLC and 63 with advanced- stage NSCLC; vaccines were successfully manufactured for 67 patients, and 43 patients were vaccinated. The most common toxicity was a local injection-site reaction (93%). Three of 33 advanced-stage patients, two with bronchioloalveolar carcinoma, had durable complete tumor responses (lasting 6, 18, and 
22 months). Longer survival was observed in patients receiving vaccines secreting GM-CSF at more than 40 ng/24 h per 106 cells (median survival = 17 months, 95% confidence interval [CI] = 6 to 23 months) than in patients receiving vaccines secreting less GM-CSF (median survival = 7 months, 95% CI = 4 to 10 months) (P = .028), suggesting a vaccine dose–related survival advantage.
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- Re: Granulocyte–Macrophage Colony-Stimulating Factor Gene-Modified Autologous Tumor Vaccines in Non–Small-Cell Lung Cancer
- Kadri Altundag, Ozden Altundag, Mustafa Cengiz, Mehmet Gunduz, and Yavuz Ozisik
J Natl Cancer Inst 2004 96: 558-559.[Extract] [Full Text] [PDF]
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