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H. Kimura



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    MO08 - NSCLC - Early Stage (ID 117)

    • Event: WCLC 2013
    • Type: Mini Oral Abstract Session
    • Track: Medical Oncology
    • Presentations: 1
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      MO08.07 - Randomized controlled phase III trial of adjuvant chemo-immunotherapy with activated killer T cells and dendritic cells in patients with resected primary lung cancer. (ID 665)

      16:55 - 17:00  |  Author(s): H. Kimura

      • Abstract
      • Presentation
      • Slides

      Background
      We conducted a phase III randomized controlled study to investigate the efficacy of post-surgical adjuvant chemo-immunotherapy using activated killer T cells and dendritic cells (AKT-DC) obtained from regional lymph nodes of lung cancer patients. The target of immunotherapy is the residual micrometastases after surgery and the resistant clones to chemotherapy.

      Methods
      Between April 2007 and July 2012, 103 patients with post-surgical non-small cell lung cancer were randomly assigned to receive either chemo-immunotherapy (group A) or chemotherapy (group B). Immunotherapy was consisted of adoptive transfer of autologous activated killer T cells and dendritic cells (AKT-DC) obtained from regional lymph nodes of lung cancer patients. The primary end point of this study was overall survival. Secondary end points were recurrence free survival, toxicity, and adverse effects of immunotherapy.

      Results
      Two and five years over all survival were 93.4% and 81.4% in group A and 66.0% and,48.3% in group B respectively. The difference was statistically significant (log-rank test p=0.0005, generalized Wilcoxon test p=0.0005) in favor of chemo-immunotherapy group A. Hazard ratio was 0.229 (95% CI 0.093 to 0.564).Two year recurrence free survival was 68.5%(53.2 to 79.7%: group A) and 41.4% (27.5 to 54.7: group B). The difference was statistically significant (log-rank test p=0.0020 and HR 0.423(95% CI 0.241 to 0.743) in favor of group A. [Adverse effects of immunotherapy.] Chill and shiver: Out of total 762 courses, 52 courses (6.8%) were accompanied with chill and shiver and 47 courses (6.2%) fever (>38) thereafter. Out of 50 cases treated by immunotherapy, 28 cases had no side effect and 22 cases had at least more than one side effect of chill, shiver and/or fever.

      Conclusion
      Immunotherapy using this modality is effective in recurrence control of post-surgical lung cancer patients by inhibiting the growth of disseminated micrometastases.

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