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Takashi Kijima



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    ES03 - How to Manage Pleural Plaques and Pleural Effusion with Negative Pleural Biopsy (ID 771)

    • Event: WCLC 2018
    • Type: Educational Session
    • Track: Mesothelioma
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/25/2018, 15:15 - 16:45, Room 206 AC
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      ES03.05 - Role of Surgery in T0 Mesothelioma (ID 11365)

      16:15 - 16:30  |  Author(s): Takashi Kijima

      • Abstract

      Abstract not provided

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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): Takashi Kijima

      • 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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    P2.01 - Advanced NSCLC (Not CME Accredited Session) (ID 950)

    • 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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      P2.01-112 - Prognostic Value of Changes in Neutrophil-To-Lymphocyte Ratio in Patients with Lung Cancer Treated with Nivolumab (ID 13715)

      16:45 - 18:00  |  Author(s): Takashi Kijima

      • Abstract

      Background

      Nivolumab, an anti-programmed cell death 1(PD-1) antibody, is a standard regimen for the second-line treatment of non-small cell lung cancer (NSCLC). However, compared with molecular-targeted drugs, the response rate to nivolumab is low, and biomarkers of efficacy are currently lacking. It has been recently reported that the neutrophil-to-lymphocyte ratio (NLR) can be a biomarker of efficacy. Here, we examined the possibility for NLR to predict efficacy of nivolumab.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      We retrospectively examined all patients with NSCLC who were treated with nivolumab at our institution.

      4c3880bb027f159e801041b1021e88e8 Result

      We compared 35 patients with NLR of ≥3 and 44 with NLR of <3, all of whom were treated with nivolumab. There was no difference in response rates between the two groups. The median (m) PFS and mOS were 130 and 583 days in the NLR≥3 group, whereas those were 169 days and not reached (NR) in the NLR<3 group. Longer PFS and OS were observed in the NLR<3 group than in the NLR≥3 group. Next, we analyzed the relationship between treatment efficacy and relative change of NLR (NLR), the ratio of the value at 4 weeks after the administration of nivolumab to the value at baseline. In 42 patients with NLR of 1, mPFS and mOS were 122 and 564 days, respectively. In 31 patients with NLR of <1, mPFS and mOS were 280 days and NR, respectively. PFS and OS were significantly better in the group with NLR of <1. With respect to adverse events, grade 1-2 rashes were observed in 29% of patients in the group with NLR of <1 and in 9.5% of patients in the group with NLR of 1.

      8eea62084ca7e541d918e823422bd82e Conclusion

      Relative ratio of NLR at 4 weeks/at baseline is a predictive biomarker in patients with NSCLC who are treated with nivolumab.

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