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T. Nakajima



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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)

      16:15 - 17:45  |  Author(s): T. Nakajima

      • 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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    P2.05 - Poster Session 2 - Preclinical Models of Therapeutics/Imaging (ID 158)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Biology
    • Presentations: 1
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      P2.05-009 - Porphysome-enhanced bronchoscopic fluorescence detection and photothermal ablation of peripheral lung cancer: Preliminary in vivo studies (ID 1105)

      09:30 - 16:30  |  Author(s): T. Nakajima

      • Abstract

      Background
      Bronchoscopic ablation of lung cancer has to date been limited to carcinoma in-situ located in the central airway or, using high-power lasers, to palliation in advanced obstructive disease . Bronchoscopic ablation of peripheral lung cancer is still under development. We are developing a new technology platform for localization (by fluorescence) and enhanced photothermal therapy (PTT) of peripheral lung lesions, based on porphysomes, which are novel, multi-functional, all-organic porphyrin-lipid nanoparticles. Even without active targeting, porphysomes accumulate within tumor through the enhanced permeability and retention (EPR) effect. In parallel, we have developed a prototype fluorescent endoscope system that allows visualization of peripheral lesions by the porphyrin fluorescence. Using this combination of novel instrumentation and nanoparticles, endoscopic PTT of lung cancer is demonstrated in preclinical lung cancer animal models in vivo.

      Methods
      The in vivo porphysome biodistribution was evaluated in both orthotopic lung tumors (A549, H460, H520) in mice and in VX2 tumors implanted directly in rabbit lung. Porphysomes were administered intravenously at a dose of 20 mg/kg, and the tumor fluorescence was imaged in vivo daily for 3 days (excised lung in the mouse model and endoscopically in the rabbit model). Ex vivo VX2 tissue was illuminated using a 670 nm diode laser to determine the optimized treatment parameters for PTT. Subsequently, in vivo bronchoscopic visualization of VX2 fluorescence and PTT was demonstrated in the rabbit model. The extent of ablation was histologically evaluated by NADH metabolic activity staining.

      Results
      The highest tumor-to-normal lung fluorescence ratio was achieved at 48 h post-injection of porphysomes(Rabbit VX2: n=4). The same trend was confirmed in the 3 kinds of orthotopic lung cancer mouse Xenografts (n=8). The ex vivo study revealed that 250 mW and 10 min of 670 nm laser irradiation raised the tumor tissue temperature by more than 20[o]C, so that this setting was used also in vivo and achieved thermal coagulation zones within the tumor of up to 13 mm diameter. In comparison, laser treatment alone without porphysomes caused minimal ablation zones of < 1.5 mm diameter.

      Conclusion
      Systemically administrated porphysomes accumulated in the lung cancer tissue with a high enough concentration to enable marked photothermal coagulation. The combination of systemically-administrated porphysomes with endoscopic near-infrared laser irradiation is a promising strategy for minimally-invasive bronchoscopic interventional therapy for peripherally-located lung cancer.

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    P3.21 - Poster Session 3 - Diagnosis and Staging (ID 171)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Prevention & Epidemiology
    • Presentations: 1
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      P3.21-008 - Effective Diagnosis of Postoperative Mediastinal Recurrence of Lung Cancer by Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (ID 2057)

      09:30 - 16:30  |  Author(s): T. Nakajima

      • Abstract

      Background
      Diagnosis of postoperative recurrence of lung cancer usually depends on radiologic examinations. However, the diagnostic yield of radiological examination is limited and it often times show false-positive result. Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is well accepted modality for the pre-operative lymph node staging in patients with lung cancer; however, the efficacy of diagnosis for post-operative recurrence still remains unclear. In this study, usefulness of EBUS-TBNA pathologic confirmation of regional node metastasis was investigated in comparison with 18F-fluorodeoxyglucose positron emission tomography (FDG-PET).

      Methods
      The patients who were suspected to have lymph node recurrence by routine chest CT follow-up after radical surgery for lung cancer were retrospectively investigated, and diagnostic yields of FDG-PET and EBUS-TBNA for the recurrence were compared. The cut-off value for positive results by PET was standard uptake value (SUV max) more than 2.5. Rapid on-site cytological evaluation was performed during the procedure of EBUS-TBNA for convenience and pathological diagnosis was employed by independent pathologist. A dedicated 22-gauge needle was used for TBNA. Final decision of presence of nodal recurrence was made based on pathological findings of cancer recurrence for EBUS-TBNA sample, and that of absence of the recurrence was made based on radiologic follow-up for more than 6 month.

      Results
      A total of 40 patients were eligible for this study. The mean duration between thoracotomy and EBUS-TBNA was 23.5 months, and the median follow-up period after EBUS-TBNA was 21.8 months. Diagnostic sensitivity, specificity and accuracy of EBUS-TBNA was 100% for each whereas those of FDG-PET were 95.8%, 12.5%, and 62.5%, respectively. 24 patients with metastatic lymph node confirmed by EBUS-TBNA showed significantly unfavorable prognosis than 16 patients with negative result by EBUS-TBNA (p=0.024). 22 out of the 24 patients who diagnosed as recurrence received anti-cancer treatments properly. 14 patients with positive results by FDG-PET but negative by EBUS-TBNA were determined as negative (false positive) since no deterioration of the nodal status was confirmed by radiological follow-up. Pathological findings of these false-positive lymph nodes showed 12 anthracosis and 2 non-specific granuloma.

      Conclusion
      Minimally-invasive diagnosis by EBUS-TBNA should be indicated when regional lymph node recurrence is suspected since radiologic modalities frequently recognize benign lesions as positive. The accurate diagnosis by EBUS-TBNA reduces fertile cancer treatment and improves patient management. Figure 1