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T. Ohira



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    MO24 - NSCLC - Chemotherapy III (ID 110)

    • Event: WCLC 2013
    • Type: Mini Oral Abstract Session
    • Track: Medical Oncology
    • Presentations: 1
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      MO24.11 - A prospective multicenter observational study of chemotherapy induced nausea and vomiting in lung cancer patients (ID 862)

      11:30 - 11:35  |  Author(s): T. Ohira

      • Abstract
      • Presentation
      • Slides

      Background
      Chemotherapy-induced nausea and vomiting (CINV) is one of the major causes to deteriorate patient’s quality of life. Therefore, it is important to assess the current status of CINV nationwide for the appropriate treatment method to manage CINV. For this purpose, prospective multi-center observational study was performed in Japan.

      Methods
      Between 2011/Apr and 2012/Dec, 458 lung cancer patients who underwent systemic chemotherapy with high (HEC) or moderate emetogenic agents (MEC) were registered and the data in 429 patients were analyzed. CINV status was assessed in acute phase (within 24 hours from chemotherapy start) and late phase (after 24 hours) separately. Multivariate analysis was performed to clear the predictive factors in patient background for CINV.

      Results
      Patient background was as follows; median age 65, 318 male and 111 female patients, 190 patients treated with HEC and 239 with MEC. In acute phase, nausea and vomiting were observed in 5.6% (HEC 6.8%, MEC 4.6%) and 1.2 % (HEC 0.5%, MEC 1.7%) of all patients, respectively. In late phase, nausea and vomiting were observed in 40.1% (HEC 46.3%, MEC 35.2%) and 9.6 % (HEC 7.9%, MEC 10.9%) of all patients, respectively. The frequency of nausea in late phase is significantly higher in HEC than that in MEC. The predictive factors for nausea were a younger age in female patients, and younger age, no drinking history, decreased hemoglobin in male patients. The prediction of CINV by physician was relatively poor in late phase vomiting.

      Conclusion
      In this study, the current status of CINV and antiemetic therapy in lung cancer patients in Japan were elucidated. CINV was frequently observed in late phase and the appropriate management for late emesis is needed according to the guideline.

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    O28 - Endoscopy (ID 124)

    • Event: WCLC 2013
    • Type: Oral Abstract Session
    • Track: Pulmonology + Endoscopy/Pulmonary
    • Presentations: 1
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      O28.06 - Comprehensive management of central type early lung cancer (ID 1558)

      11:25 - 11:35  |  Author(s): T. Ohira

      • Abstract
      • Presentation
      • Slides

      Background
      Tumor localization and the precise evaluation of tumor invasion are most important for the management of central type early stage lung cancer (CELC) and Photodynamic therapy (PDT) has come to be considered as the first choice of treatment for CELC. The present guidelines of PDT for CELC were established based mainly on the data obtained from studies since 1980’s. CELCs less than 1 cm in diameter showed a favorable cure rate by PDT, thus this was a good standard to decide the indications of PDT. To obtain complete response (CR) by PDT, evaluation of each lesion is extremely important, including the extent of the tumor on the bronchial surface and the depth of invasion in the bronchial wall. We postulate that the combination of comprehensive diagnosis and the new generation of photosensitizers may increase the CR rate and expand the indications of PDT for larger tumors.

      Methods
      Autofluorescence bronchoscopy (AFB) has been used in the objective evaluation of the margin of the tumor before endoscopic treatment and Endobronchial ultrasonography (EBUS) has been employed to determine the depth of tumor invasion. Ooptical coherence tomography (OCT) has been investigated for clinical use as well. Also, the relatively newer photosensitizer NPe6, which has a stronger antitumor effect than Photofrin has been extensively used for PDT. We routinely used these diagnostic methodologies and NPe6 since 2004.

      Results
      A total of 122 consecutive CELCs were treated by PDT using NPe6 in Tokyo Medical University and CR was obtained in 115 lesions (CR rate 94.3%). Of the 122 lesions examined in this study, 78 had a diameter of ≦1.0 cm and the rest of the 44 cancer lesions were >1.0 cm in size. The CR rate of CELC ≦1.0 cm in diameter was 93.6% (73/78) and for those >1.0 cm in diameter, 95.5% (42/44), respectively. There was no significant difference between tumor size and clinical response. The CR rate to NPe6-PDT is higher than that of Photofrin-PDT in our previous studies. This early result suggests that PDT with NPe6 has a stronger antitumor effect than Photofrin therefore similar treatment outcome even for larger tumors >1.0 cm in diameter should be possible.

      Conclusion
      Objective evaluation by a comprehensive approach using AFB and EBUS enables to select the optimal therapeutic strategy for CELC. These results suggest that PDT with NPe6 may have a similar treatment outcome regardless of tumor size, as long sufficient laser illumination of the entire tumor is possible.

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    P1.07 - Poster Session 1 - Surgery (ID 184)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Surgery
    • Presentations: 1
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      P1.07-009 - Preoperative simulation and navigation using the combination of high-speed 3D-image analysis system and Robotic surgery increase the efficacy and accuracy in thoracic surgery (ID 980)

      09:30 - 09:30  |  Author(s): T. Ohira

      • Abstract

      Background
      Previously, we reported the utility of the da Vinci[®] Surgical System (dVS: Intuitive Surgical, Inc., Sunnyvale, CA) for various types of anterior and middle mediastinal tumors in clinical practice. We evaluated the feasibility, safety and appropriate settings of this system for the surgical treatment of these tumors. One review reports about the importance of the appropriate settings according to tumor location in robot-assisted thoracic surgery (RATS), because no target always exists in the same location within the thoracic cavity. In this report, we evaluated the efficacy of a high-speed three-dimensional (3D) image analysis system (SYNAPSE VINCENT; Fuji Photo Film Co., Ltd.) for preoperative simulation and navigation during a RATS procedure.

      Methods
      In this study, a high-speed 3D-image analysis system was used to decide the best positioning of robotic-arms and instruments preoperatively. Moreover, this system has capable of detecting the tumor location and extracting surrounding tissues quickly, accurately and safely. Accurate and speedy set-up of the da Vinci S[® ]Surgical System was possible for this operation. Synapse Vincent facilitated determining the best positioning of robot arms and instruments, and was an excellent device for navigation in real time. All patients who underwent RATS in our institution provided written informed consent to receive robotic surgery using the dVS, and the institutional review committees of each institution gave their permission. In this report, a representative mediastinal tumor which was located in the upper thoracic cavity was selected to establish the merits of this procedure.

      Results
      The patient, a 38-year-old woman, had a posterior mediastinal tumor located at the upper level of Th 1 to 3. Accurate and speedy set-up of the dVS was capable on this operation. It was feasible to decide the best positioning of robot-arms and instruments, and excellent device for the navigation on real time. The total operation time was 270 minutes, the time of the dVS setting was 21 minutes, and the console time (the dVS working time) was 132 minutes. The amount of bleeding was 167 mL and the drainage time was 2 days after the operation and this patient had no complications. The pathological report revealed a schwannoma (85 × 42 × 20 mm) with no malignancy.

      Conclusion
      For the optimal performance of RATS, the positioning of all units and the locations of instrument ports need suitable directional setting. Preoperative simulation and navigation during of operation using SYNAPSE VINCENT for the RATS has efficacy for planning the setting, especially in deciding the points of instrument ports and the angle of robot arms, and very useful as a device of the navigation software and education use operating on it.

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    P2.06 - Poster Session 2 - Prognostic and Predictive Biomarkers (ID 165)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Biology
    • Presentations: 1
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      P2.06-010 - Analytical Performance of the cobas EGFR Mutation Assay for Japanese Non-Small Cell Lung Cancer (ID 1101)

      09:30 - 09:30  |  Author(s): T. Ohira

      • Abstract

      Background
      Patients’ EGFR mutation status prior to treatment impacts outcomes and, EGFR testing has been developed as a companion diagnostic; this relationship between therapeutic and diagnostic agents is known as personalized healthcare. Recently, it was reported that about half of patients may acquire resistance to EGFR-TKIs following therapy, mainly by appearance of EGFR mutations, such as T790M. Thus, it is important to assess EGFR mutation status before and during treatment to determine the most appropriate treatment regimens for patients. A number of PCR-based techniques are used in the assessment of EGFR mutations. In Japan, the “Scorpion-ARMS” therascreen® EGFR Rotor-Gene Q PCR Kitis (therascreen EGFR assay) the only available in vitro diagnostic (IVD) test. The cobas® EGFR Mutation Test (cobas EGFR assay) is the only FDA-approved kit for IVD testing in the US.In this study, we compared the performance of the cobas EGFR assay and the therascreen® EGFR assay using FFPE tissue specimens from NSCLC patients.

      Methods
      We extracted DNA from 149 FFPE tissues of NSCLC, according to the manufacturer’s instructions and performed a comparative study of cobas EGFR and therascreen EGFR methods.

      Results
      EGFR mutations were identified in 63 NSCLC specimens (42.3%) using the cobas EGFR assay and 61 samples (41.2%) using the therascreen EGFR assay. The concordance rate between the cobas EGFR assay and therascreen EGFR assays was 145/149 (97.3%). Only three discordants between these EGFR assays were observed. One T790M mutation in combination with an L858R mutation was identified by the cobas EGFR assay. No invalid assay results occurred with the cobas EGFR assay.

      Conclusion
      The cobas EGFR assay has two advantages. One is that the process is easily performed by stable methods. It takes only 8 hours, from tumor specimen to results generated using the semi-automated system. Thus, patients assessed using the cobas EGFR assay can begin the most appropriate treatment quickly. The other advantage is that only a very small amount of DNA (150 ng) is required to detect mutation status using the cobas EGFR assay. Our results show a high concordance rate (97.3%) of cobas EGFR with an existing IVD product, the therascreen EGFR assay. In this study, one double mutant, T790M in combination with L858R, was only identified by the cobas EGFR assay. The cobas EGFR assay appears to give the most accurate and appropriate results for NSCLC patients.