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10-year follow-up of gene-modified adenoviral-based therapy in 146 non-small-cell lung cancer patients

Cancer Gene Therapy volume 14, pages 762–763 (2007)Cite this article

In the last 10 years, several thousand patients have been treated with gene-modified adenoviral vectors in experimental studies. From a safety standpoint, low-grade febrile episodes and flu-like symptoms have been common acute treatment-related symptoms. However, long-term follow-up has not been reported. We report here more than 10 years of follow-up of 146 patients with stage IIIB or IV non-small-cell lung cancer (NSCLC) who underwent treatment through involvement in eight FDA/IRB-approved clinical trials from 1995 to 20051, 2, 3, 4, 5, 6 with gene-modified adenoviral-based therapeutics. All patients were managed at the Mary Crowley Medical Research Center (MCMRC).

Mean survival was 334 days (95% CI: 269–400). Gender, age, histologic type or stage (IIIB, IV) did not significantly affect survival. The proportion of patients alive at 1 year (30%), 2 years (12%) and 5 years (6%) is consistent with historical experience.7 Recent large randomized controlled trials involving current therapeutic choices for second line advanced NSCLC with Alimta, Docetaxel and Tarceva reveal 30, 30 and 28% 1-year survival, respectively.7, 8, 9 Historical survival of placebo-treated patients at 1 year was 18%.8 Several limitations exist when comparing historical data to prospective trial results in an uncontrolled analysis. We conclude, however, given the lack of any significant long-term reported adverse events and comparable survival to similar historical patients, that there are no obvious concerns towards the long-term effect of therapy involving adenoviral vectors in NSCLC patients. In conclusion, with respect to safety, these results support continued development of adenoviral-based therapy as a primary oncolytic and as a gene delivery vehicle.

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Authors and Affiliations

  1. Mary Crowley Medical Research Center, Dallas, TX, USA

    J Nemunaitis, J S Vorhies, B Pappen & N Senzer

  2. Baylor University Medical Center, Dallas, TX, USA

    J Nemunaitis & N Senzer

  3. Texas Oncology PA, Dallas, TX, USA. E-mail: jnemunaitis@mcmrc.com,

    J Nemunaitis & N Senzer

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  1. J Nemunaitis
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Nemunaitis, J., Vorhies, J., Pappen, B. et al. 10-year follow-up of gene-modified adenoviral-based therapy in 146 non-small-cell lung cancer patients. Cancer Gene Ther 14, 762–763 (2007). https://doi.org/10.1038/sj.cgt.7701048

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