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- Title
Granulocyte-macrophage colony-stimulating factor gene-modified autologous tumor vaccines in non-small-cell lung cancer.
- Authors
Nemunaitis, John; Sterman, Daniel; Jablons, David; Smith II, John W.; Fox, Bernard; Maples, Phil; Hamilton, Scott; Borellini, Flavia; Lin, Andy; Morali, Sayeh; Hege, Kristen; Smith, John W 2nd
- Abstract
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 >or=22 months). Longer survival was observed in patients receiving vaccines secreting GM-CSF at more than 40 ng/24 h per 10(6) 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.
- Subjects
CANCER vaccines; VACCINES; LUNG cancer; GRANULOCYTE-macrophage colony-stimulating factor; COLONY-stimulating factors (Physiology); MACROPHAGES; ANTIGENS; CLINICAL trials; COMPARATIVE studies; DOSE-effect relationship in pharmacology; LUNG tumors; RESEARCH methodology; MEDICAL cooperation; RESEARCH; SURVIVAL analysis (Biometry); PILOT projects; EVALUATION research; TREATMENT effectiveness; PROPORTIONAL hazards models
- Publication
JNCI: Journal of the National Cancer Institute, 2004, Vol 96, Issue 4, p326
- ISSN
0027-8874
- Publication type
journal article
- DOI
10.1093/jnci/djh028