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Yuichiro Ohe



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    OA08 - Mesothelioma: Immunotherapy and microRNA for Diagnosis and Treatment (ID 907)

    • Event: WCLC 2018
    • Type: Oral Abstract Session
    • Track: Mesothelioma
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/24/2018, 15:15 - 16:45, Room 201 BD
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      OA08.01 - Long-Term Efficacy and Safety of Nivolumab in Second- or Third-Line Japanese Malignant Pleural Mesothelioma Patients (Phase II: MERIT Study) (ID 11833)

      15:15 - 15:25  |  Author(s): Yuichiro Ohe

      • Abstract
      • Presentation
      • Slides

      Background

      Malignant Pleural Mesothelioma (MPM) is a rare and highly aggressive malignancy with poor prognosis and no treatment is approved for patients (pts) progressing after 1st line pemetrexed-platinum doublet. Here, we report latest analysis of MERIT study in previously treated Japanese MPM pts to update the previous report (WCLC 2017, Goto Y, et al).

      a9ded1e5ce5d75814730bb4caaf49419 Method

      This open-label study enrolled advanced or metastatic MPM pts previously treated with up to two regimens of chemotherapy including pemetrexed-platinum doublet. Enrollment criteria also included histologically-confirmed, unresectable MPM without prior surgery, measurable lesion and ECOG performance status 0-1. There was no restriction of PD-L1 status. Pts received Nivolumab 240 mg flat dose Q2W until progression or unacceptable toxicity. Primary endpoint was objective response rate (ORR) (modified RECIST by independent review committee, expected response rate was 19.2%); secondary endpoints included disease control rate (DCR), duration of response (DOR), progression-free survival (PFS), overall survival (OS) and safety.

      4c3880bb027f159e801041b1021e88e8 Result

      Thirty-four pts received Nivolumab in this study. Males: 85.2%, median age: 68.0 years (range 43-78), PS 1: 61.8%, epithelial/sarcomatoid/biphasic: 79.4%/8.8%/11.8%, 1 prior regimen: 70.6% and PD-L1 (≧1%)/PD-L1 (<1%)/not evaluable: 58.8%/35.3%/5.9%. At a median follow-up of 16.8 months (range: 1.8-20.2), ORR was 29.4 % (n=10, 95%CI: 16.8-46.2). DCR was 67.6% (n=23, 95%CI: 50.8-80.9). Median DOR was 11.1 months (95%CI: 3.5-16.2). Median PFS was 6.1 months (95%CI: 2.9-9.9) in all pts, 7.2 months (2.8-15.0) in PD-L1 (≧1%) and 2.9 months (1.4-9.3) in PD-L1 (<1%). Median OS was 17.3 months (95%CI: 11.5-NR) in all pts, 17.3 months (8.2-NR) in PD-L1 (≧1%), 11.6 months (5.8-NR) in PD-L1 (<1%), across tissue types, 15.7 months (95%CI: 8.0-NR) in epithelioid and not reached in sarcomatoid/biphasic pts. Six- and 12-month survival rates were 85.3% (95%CI: 68.2-93.6) and 58.8% (95%CI: 40.6-73.2). Twenty-six (76.5%) pts experienced treatment-related adverse event (TRAE), and 11 (32.4%) experienced grade 3/4 TRAEs. Most commonly reported TRAEs were skin disorder (n=6, 17.6%), elevated lipase (n=5, 14.7%), elevated amylase and diarrhea (n=4, 11.8%). Four pts required dose discontinuation because of interstitial pneumonia (n=2, grade2 and 3) and pneumonitis (n=2, grade3).

      8eea62084ca7e541d918e823422bd82e Conclusion

      Nivolumab shows durable long term efficacy and manageable safety profile in Japanese 2nd/3rd line MPM pts.

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    P1.17 - Treatment of Locoregional Disease - NSCLC (Not CME Accredited Session) (ID 949)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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      P1.17-06 - Salvage Surgery After Chemotherapy and/or Radiotherapy Including SBRT and Proton: Consecutive Analysis of 46 Patients   (ID 13342)

      16:45 - 18:00  |  Author(s): Yuichiro Ohe

      • Abstract

      Background

      Local recurrence after definitive chemotherapy and/or radiotherapy with curative intent is frequently experienced in patients with locally advanced lung cancer. We evaluated the frequency, feasibility, and efficacy of salvage pulmonary resection after definitive chemotherapy and/or radiotherapy.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      We analyzed the characteristics and medical courses of consecutive patients who had undergone salvage pulmonary resection after local relapse or progression after chemotherapy, chemoradiotherapy and radiotherapy including stereotactic body radiation therapy (SBRT) and proton beam therapy (PBT). In this analysis, local relapse or progression were defined as increase in remaining tumor size or detection of new lesions by CT and/or FDG/PET-CT. Indications of resectability was assessed by multidisciplinary tumor board.

      4c3880bb027f159e801041b1021e88e8 Result

      Between January 2000 and January 2018, 46 patients (0.63%) received salvage surgery out of 7,290 patients underwent surgery for primary lung cancer at National Cancer Center Hospital, Tokyo, Japan. Median follow-up time was 24.5 months (range, 2-157.6). Of 46 patients evaluated, 30 (65.2%) were men, the median age was 64.5 years (range, 20-78 years), 22 (47.8%) underwent chemotherapy, 18 (39.1%) underwent resection after definitive chemoradiotherapy, 3 (6.5%) underwent resection after SBRT and 3 (6.5%) underwent resection after PBT. The number of patients undergoing salvage surgery has increased in recent years: 9 patients were between 2000 and 2009, whereas 37 patients were between 2010 and 2018. Method of surgical resection was as follows: 28 lobectomies (2 bilobectomy, 15 right upper, 1 right middle, 6 right lower, 2 left upper, 2 left lower), 10 pneumonectomies (left:right=7:3). One patient received a wedge resection, and one recieved wedge resection with chest well resection, and 2 segmentectomy and lymphadectomy for residual lymph nodes respectively. A complete resection (R0) was achieved in 42 cases (91.3%). Postoperative complications were observed in 3 patients (6.5%): prolonged air leakage, bronchopleural fistula, and atrial fibrillation. There were no post-operative deaths within 30 days after surgery. The five-year progression free and overall survival rate after surgical resection was 39.1% (95% CI.: 19.9-57.9) and 64.1% (95% CI.: 39.3-80.9), respectively.

      8eea62084ca7e541d918e823422bd82e Conclusion

      The frequency of salvage surgery after initial treatment has been increasing possibly due to a better treatment course using novel medical and radiation oncology technique. Salvage pulmonary resections demonstrated acceptable morbidity and mortality with promising long-term efficacy in selected patients.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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    P2.06 - Mesothelioma (Not CME Accredited Session) (ID 955)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/25/2018, 16:45 - 18:00, Exhibit Hall
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      P2.06-11 - A Phase I/II Study of Intrapleural Ad-SGE-REIC Administration in Patients with Refractory Malignant Pleural Mesothelioma (ID 11328)

      16:45 - 18:00  |  Author(s): Yuichiro Ohe

      • Abstract

      Background

      Reduced expression in immortalized cell (REIC)/Dickkopf-3 (Dkk-3) is a tumor-suppressor gene and REIC/Dkk-3 expression was markedly downregulated in various human cancer cells. REIC/Dkk-3 protein is also known as a key player, namely an antagonist of the Wnt signaling pathway. Ad-SGE-REIC is an adenoviral vector carrying REIC/Dkk-3 that mediates cancer cell death induction and anti-cancer immunity augmentation.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      We conducted a phase I/II, 3+3 design, dose escalation study in malignant pleural mesothelioma (MPM) patients (pts) with measurable lesions. Pts with refractory to or unsuitable for standard chemotherapy received 2 intrapleural administrations of Ad-SGE-REIC on days1 and 4. Three escalating doses of level (DL) 1: 3.0×1011, DL2: 1.0×1012 and DL3: 3.0×1012 viral particles were employed. This dosage and regimen were set by considering the reason of manufacturing and neutralizing anti-body for adenovirus. The safety and dose-limiting toxicities (DLTs) of Ad-SGE-REIC were evaluated for 32 days. Continuous safety and efficacy were assessed for 172 days using modified RECIST (mRECIST). The concentrations of REIC/Dkk-3 in pleural fluid also were measured as indirect indication of targeted gene expressions.

      4c3880bb027f159e801041b1021e88e8 Result

      From 07/2015 to 09/2017, a total of 13 pts have been treated at DL1 (n=4 included one fatal case within 32 days), DL2 (n=3) and DL3 (n=6). Male: 100%; median age 70; PS 0: 23%, 1: 69%, 2: 8%; epithelial/biphasic histology: 69%/15%; Stage III-IV: 77%; previous chemotherapy use with platinum-pemetrexed: 92%. Treatment-related AEs (TRAEs) were all Grade 1-2 and no DLTs occurred. The most frequent TRAEs were fever and CRP increase based on adenovirus infection. Tumor responses assessed by independent central review showed that there was no objective response and DCR was 62% (8/13 pts). Median PFS was 3.4 months at all groups and 5.7 months at DL3. A remarkable increase of REIC/Dkk-3 concentration in pleural fluid was determined (6/13 pts, prominently high in DL3).

      8eea62084ca7e541d918e823422bd82e Conclusion

      The intrapleural administration of Ad-SGE-REIC up to 2 cycles was safe and well tolerated in MPM pts and promising results of efficient REIC/Dkk-3 expression and durable disease control were obtained. We are planning phase II study using repeated intrapleural or intratumoral administration.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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    P3.01 - Advanced NSCLC (Not CME Accredited Session) (ID 967)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/26/2018, 12:00 - 13:30, Exhibit Hall
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      P3.01-30 - Treatment Sequencing in Patients With Anaplastic Lymphoma Kinase (ALK)-Positive Non-Small Cell Lung Cancer (NSCLC) in Japan (ID 12786)

      12:00 - 13:30  |  Author(s): Yuichiro Ohe

      • Abstract
      • Slides

      Background

      Limited data are available on real-world treatment patterns and outcomes of ALK inhibitors used sequentially. Access to a large medical records database and availability of multiple ALK inhibitors in Japan, the first country to approve alectinib in 2014, presents a unique opportunity to evaluate real-world treatment sequencing and outcomes in ALK-positive NSCLC patients.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      This descriptive, retrospective observational study used inpatient/outpatient medical and prescription records, claims and diagnoses from the Japan Medical Data Vision (MDV) Database. Included patients had confirmed diagnosis of lung cancer, an ALK test and first prescription order for an ALK inhibitor (prescription date = index date) on or before March 31, 2017. Descriptive analyses included demographics, baseline characteristics, treatment patterns including ALK inhibitor sequences, non-ALK inhibitor treatments received, and treatment duration.

      4c3880bb027f159e801041b1021e88e8 Result

      Overall, 378 patients (mean age 61 years; 53% female; 48% no history of smoking) met inclusion criteria. Baseline characteristics were similar among mutually exclusive groups of patients receiving 1, 2, or 3 ALK inhibitors. Similar proportions of patients received crizotinib (52%) and alectinib (48%) as index ALK inhibitor. Prior to the index date, 40% of patients received chemotherapy. ALK inhibitor sequences are shown (Table). In patients who had discontinued all ALK inhibitors, the next treatments were chemotherapy (46%) and immunotherapy (6%). The most common sequence was a crizotinib-led sequence of 2 ALK inhibitors; median duration of treatment was 53 months. Changes in treatment patterns over time and further duration of treatment data will be presented.

      Sequence

      Overall Population

      N = 378

      n (%)
      1 ALK inhibitor (n=261)
      Crizotinib 91 (24.07)
      Alectinib 170 (44.97)
      2 ALK inhibitors (n=98)
      Crizotinib -> Alectinib 89 (23.54)
      Crizotinib -> Ceritinib 1 (0.26)
      Alectinib -> Crizotinib 7 (1.85)
      Alectinib -> Ceritinib 1 (0.26)
      3 ALK inhibitors (n=19)
      Crizotinib -> Alectinib -> Ceritinib 16 (4.23)
      Alectinib -> Crizotinib -> Ceritinib 3 (0.79)
      8eea62084ca7e541d918e823422bd82e Conclusion

      Treatment patterns in ALK-positive NSCLC patients have evolved over time. The most common sequence for patients receiving > 1 ALK inhibitor was crizotinib-led. Median duration of treatment with crizotinib-led sequences is consistent with what has been reported previously. Additional research is warranted to evaluate non-crizotinib-led sequences as data mature.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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