التفاصيل البيبلوغرافية
| العنوان: |
Granulocyte-macrophage colony-stimulating factor gene-modified autologous tumor vaccines in non-small-cell lung cancer. |
| المؤلفون: |
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 |
| المصدر: |
JNCI: Journal of the National Cancer Institute; 2/18/2004, Vol. 96 Issue 4, p326-331, 6p, 2 Diagrams, 1 Chart, 1 Graph |
| مصطلحات موضوعية: |
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 |
| مستخلص: |
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. [ABSTRACT FROM AUTHOR] |
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| قاعدة البيانات: |
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