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J.H. Kang



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    Poster Display Session (ID 63)

    • Event: ELCC 2017
    • Type: Poster Display Session
    • Track:
    • Presentations: 2
    • Moderators:
    • Coordinates: 5/07/2017, 12:30 - 13:00, Hall 1
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      114P - Phase II study of nivolumab in patients with advanced non-small cell lung cancer (NSCLC) in Korea (ID 441)

      12:30 - 13:00  |  Author(s): J.H. Kang

      • Abstract

      Background:
      Nivolumab (BMS-936558/ONO-4538), a fully human IgG4, PD-1 immune-checkpoint inhibitor antibody, has shown durable clinical activity in several tumor types. Recently, two phase III studies (CheckMate-017 and -057) demonstrated that nivolumab improved overall survival (OS) than docetaxel in second-line of squamous (SQ) and non-squamous (NSQ) Non-Small Cell Lung Cancer (NSCLC), respectively. Here, we report the results of a phase II study to evaluate the efficacy and safety of nivolumab in Korean patients (pts) with previously treated advanced SQ and NSQ NSCLC.

      Methods:
      This study requires pts aged ≥ 20 years with ECOG Performance Status (PS) of 0 or 1, stage IIIB/IV or recurrent NSCLC and at least one prior chemotherapy including platinum containing regimen. Pts received nivolumab 3 mg/kg IV Q2W until progression or unacceptable toxicity. The primary endpoint in this study was the objective response rate (ORR) (RECIST v1.1).

      Results:
      Nivolumab was administered to 100 NSCLC pts (SQ: 44, NSQ: 56), male/female: 78 (SQ: 44, NSQ: 34)/22 (SQ: 0, NSQ: 22); PS 0/1: 14 (SQ: 6, NSQ: 8)/86 (SQ: 38, NSQ: 48); aged 29 to 80 [median: 66.5] years (SQ: 40 to 80 [median: 69.5], NSQ: 29 to 77 [median: 63.5]); Stage IIIB/IV/recurrence: 6 (SQ: 5, NSQ: 1)/91 (SQ: 37, NSQ: 54)/3 (SQ: 2, NSQ: 1)). In SQ and NSQ NSCLC, ORR was 15.9% (7/44) and 23.2% (13/56), respectively. Median progression-free survival was 2.6 mo and 5.3 mo, respectively. Complete Response was observed in 2.3% (1/44) and 1.8% (1/56), respectively. Median OS was 12.3 mo and 16.3 mo, respectively. Median follow-up was 8.9 mo and 12.3 mo, respectively. Most common adverse drug reaction (ADR) was decreased appetite 15.9% (7/44), followed by pyrexia 9.1% (4/44) in SQ NSCLC, and decreased appetite 12.5% (7/56), followed by pruritus 10.7% (6/56), fatigue 8.9% (5/56), pyrexia 5.4% (3/56) and nausea 5.4% (3/56) in NSQ NSCLC. Grade 3-4 ADR was observed in 6.8% (3/44) and 10.7% (6/56) of SQ and NSQ NSCLC, respectively. No interstitial lung disease and no grade 5 ADRs were observed in this study.

      Conclusions:
      Nivolumab was considered to be effective and used safely in Korean pts with SQ and NSQ NSCLC as well as in non-Korean pts with SQ and NSQ NSCLC.

      Clinical trial identification:
      NCT02175017

      Legal entity responsible for the study:
      Ministry of Food and Drug Safety in Korea

      Funding:
      Ono Pharmaceutical

      Disclosure:
      J.H. Kang: Honoraria; Bristol-Myers Squibb, Boehringer Ingelheim Consulting or Advisory Role; Bristol-Myers Squibb, Amgen Research Funding; AstraZeneca, Lilly. K. Park: Consulting or Advisory Role; Astellas Pharma, AstraZeneca, Boehringer Ingelheim, Clovis Oncology, Lilly, Hanmi, Kyowa Hakko Kirin, Novartis, Ono Pharmaceutical, Roche, Speakers\' Bureau; Boehringer Ingelheim Research Funding: AstraZeneca. All other authors have declared no conflicts of interest.

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      156P - Clinical outcome of cyberknife radiosurgery in brain metastases of non-small cell lung cancer: A single institutional experience (ID 444)

      12:30 - 13:00  |  Author(s): J.H. Kang

      • Abstract

      Background:
      Stereotactic radiosurgery is a less invasive therapeutic modality for brain metastasis of non-small cell lung cancer (NSCLC). We retrospectively reviewed a single institutional experience using Cyberknife radiosurgery (CKRS).

      Methods:
      The patients diagnosed with brain metastasis of NSCLC who were treated with CK-RS from 2006 to 2016 in Seoul St. Mary’s Hospital were analyzed. Total 304 targets from 150 patients were included. The histology of NSCLC patients was as follows: adenocarcinoma (85%), squamous cell carcinoma (9%), and others (7%). Median 22 Gy (range: 17-30Gy, 1-8 fx) was given. Median 2 targets (range: 1-7 targets) were treated per patient. Whole brain radiotherapy (WBRT) was given to 44.7% of the patients. Total 68 patients (45.5%) were mutation positive and targeted therapy was given to 95 patients (63.3%).

      Results:
      Median follow-up time was 11.4 mo (range: 0-94.6 mo) from the last day of CKRS. Response to CKRS was observed in 86.1% of the targets. Median time to response was 2.9 mo (range: 0.2-58.8 mo). At the time of analysis, there were 14 recurrences (4.6%) and median time to recurrence was 13.3 mo (range: 4.1-62.6 mo). Intracranial failure defined as appearance of new metastasis other than sites previously treated with CKRS was observed in 81 patients (54.7%) at median 8.9 mo (range: 7-10.8 mo). The 1-year intracranial failure rates of the patients who received targeted therapy were 64.8% versus 55.3% of those who did not, respectively (P = 0.38). The 1-year intracranial failure rates of the patients who received CKRS alone were 64% versus 58.3% of those who received both CKRS and WBRT, respectively (P = 0.58). Radiation-associated change on MRI was observed in 98 targets (32.3%) at median 7.0 mo (range: 0.4-68.8 mo). Eleven patients (7.3%) required steroids for symptom alleviation at median 21 days (range: 7-42 days). Five patients (3.0%) underwent surgery after median 7.0 mo (range: 2.8-74.2 mo). The patients survived median 12.6 mo (range: 0.3-94.8 mo) after CKRS.

      Conclusions:
      According to our institutional experience, CKRS achieved adequate local control with tolerable toxicity in patients with brain metastasis of NSCLC.

      Clinical trial identification:


      Legal entity responsible for the study:
      The institutional review board reviewed and approved of the study.

      Funding:
      N/A

      Disclosure:
      All authors have declared no conflicts of interest.