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Jin-Hyoung Kang



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    MA08 - Clinical Trials in Brain Metastases (ID 906)

    • Event: WCLC 2018
    • Type: Mini Oral Abstract Session
    • Track: Advanced NSCLC
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/24/2018, 15:15 - 16:45, Room 203 BD
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      MA08.07 - Real World Data of Osimertinib in Patients with Central Nervous System (CNS) Metastasis in ASTRIS Korean Subset. (ID 13581)

      15:50 - 15:55  |  Presenting Author(s): Jin-Hyoung Kang

      • Abstract
      • Presentation
      • Slides

      Background

      More than 40% of non-small cell lung cancer (NSCLC) patients develop CNS metastasis in their lifetime. Osimertinib is a third-generation EGFR-TKI which selectively inhibits both EGFR-sensitizing and EGFR T790M resistance mutations. Clinical studies have shown superior efficacy of osimertinib in CNS compared to platinum chemotherapy. Treatment efficacy in patients with or without CNS metastasis were observed within the second interim analysis of ASTRIS (NCT02474355). Data cut-off (DCO) was 20 October 2017.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      In ASTRIS, advanced NSCLC patients with a locally confirmed T790M mutation, WHO performance status 0-2, prior EGFR-TKI therapy were enrolled. Patients with stable CNS metastases were allowed. The primary endpoint was overall survival (OS); other endpoints included investigator-assessed response rate (RR), progression-free survival (PFS), time to treatment discontinuation (TTD) and safety. These endpoints were also analyzed according to presence of CNS metastasis.

      4c3880bb027f159e801041b1021e88e8 Result

      A total of 466 patients received at least one dose of osimertinib 80mg from 31 Korean sites. CNS metastasis was evaluated in 310 patients and was present in 211 (68.1%) patients (CNS-met); 181 brain only, 1 leptomeningeal only, 29 both. 99 (31.9%) patients did not have CNS metastasis (CNS-no), and 155 patients were not evaluated (CNS-ne). At DCO, 236 patients (50.6%) were ongoing and median duration of exposure was 11.2 (0–19) months. In patients evaluable for response, defined as at least one dose of osimertinib and one response assessment, RR was 71.0% (320/451; 95% CI, 66.5–75.1): Patients with (N=211), without (N=99), and not-evaluated CNS metastasis (N=155) had RR of 68% (134/197; 95% CI, 61.0-74.5), 79.6% (78/98; 95% CI, 70.3-87.1), and 69.7% (108/155; 95% CI, 61.8-76.8), respectively. Median PFS was 12.4 months (95% CI, 11.1-13.6 months); 10.8 months (95% CI, 9.5-11.5) in CNS-met,11.0 months (95% CI, 9.2-14.5) in CNS-no, and 15.1 months (95% CI, 13.6-18.2) in CNS-ne. Median TTD was 16.5 months (95% CI, 14.1-NC); 11.2 months (95% CI, 9.4-14.8) in CNS-met, 14.7 months (95% CI, 12.2-NC) in CNS-no, and NC (95% CI, 15.5-NC) in CNS-ne. OS was not reached (data maturity: 19.7%). Serious adverse event (AE) regardless of causality were reported in 116 patients (24.9%) and AEs leading to death in 13 patients (2.8%). ILD/pneumonitis-like events were reported in 8 patients (1.7%), and QTc prolongation in 7 patients (1.5%).

      8eea62084ca7e541d918e823422bd82e Conclusion

      In ASTRIS Korean subset, patients with or without CNS metastasis had comparable efficacy outcome. This data continues to support osimertinib’s clinical benefit on EGFRm T790M NSCLC patients with CNS metastasis.

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    P2.12 - Small Cell Lung Cancer/NET (Not CME Accredited Session) (ID 961)

    • 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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      P2.12-01 - Efficacy of Belotecan as Second-Line Treatment for Recurrent Small Cell Lung Cancer: A Phase IIb Randomized Multicenter Study (ID 13658)

      16:45 - 18:00  |  Presenting Author(s): Jin-Hyoung Kang

      • Abstract
      • Slides

      Background

      Topotecan is recommended as second-line treatment for patients with progressive/recurrent extensive-stage small cell lung cancer (ES-SCLC) after platinum-based combination chemotherapy. Although some topotecan-treated patients may have at least an objective response (OR), response duration is often short. Belotecan, a camptothecin derivative topoisomerase I inhibitor, has shown promising antitumor activity and modest toxicities against advanced SCLC and ovarian cancers. We report efficacy data from a phase IIb randomized multicenter study of belotecan as second-line treatment for progressive/recurrent limited-disease (LD)- or ES-SCLC.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      This study, conducted from March 2010 to March 2018, was designed to prove the non-inferiority of belotecan to topotecan. Patients were randomized (1:1) to belotecan 0.5 mg/m2 or topotecan 1.5 mg/m2 intravenously for 5 consecutive days every 3 weeks for 6 cycles or until disease progression. The primary endpoint was objective response rate (ORR; complete response [CR] or partial response [PR]) based on RECIST criteria; secondary endpoints were progression-free survival (PFS), overall survival (OS).

      4c3880bb027f159e801041b1021e88e8 Result

      Overall, 148 patients (belotecan, n=72; topotecan, n=76) were eligible in the full analysis set (FAS; patients who received at least one dose); 113 patients (belotecan, n=62; topotecan; n=51) were evaluable in the per-protocol set (PPS; patients who completed the study protocol). Clinical characteristics were well balanced between the two treatment arms. In the FAS, ORR was 33.33% (belotecan) and 21.05% (topotecan), respectively (95% CI: −0.0195 to 0.2651, p=0.0927). One belotecan recipient had a CR. Median OS was 396 days (belotecan) and 247 days (topotecan), respectively (p=0.0178); median PFS was 144 and 115 days, respectively (p=0.9608). Similar efficacy outcomes were observed in the PPS.

      wclc_2018_abstract_efficacy only_final_4 may 2018.jpg

      8eea62084ca7e541d918e823422bd82e Conclusion

      Our data met the hypothesis that the antitumor efficacy of belotecan is non-inferior to that of topotecan as second-line treatment for patients with progressive/recurrent LD- or ES-SCLC. Belotecan was also associated with significantly longer OS. (ClinicalTrials.gov. ID: NCT01497873; https://clinicaltrials.gov/ct2/show/NCT01497873)

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    P2.17 - Treatment of Locoregional Disease - NSCLC (Not CME Accredited Session) (ID 966)

    • 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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      P2.17-25 - Post-Treatment Neutrophil to Lymphocyte Ratio in Locally Advanced NSCLC Patients Treated with Concurrent Chemoradiotherapy (ID 12815)

      16:45 - 18:00  |  Author(s): Jin-Hyoung Kang

      • Abstract
      • Slides

      Background

      We aimed to investigate the relationship between NLR and prognosis in patients with locally advanced NSCLC who received concurrent chemoradiotherapy as the first line treatment.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      We retrospectively analyzed 62 patients with locally advanced NSCLC treated with definitive CCRT between 2008 and 2016 at Seoul St. Mary’s hospital. We excluded patients who received induction chemotherapy to eliminate their influence on NLR. CCRT consisted of weekly chemotherapy using paclitaxel/carboplatin, docetaxel/cisplatin, docetaxel/carboplatin, and etoposide/cisplatin. Radiotherapy was performed with intensity-modulated radiotherapy (IMRT) or three-dimensional conformal RT (3D-CRT). The median radiation dose was 66 Gy in 33 fractions (range, 52 – 70 Gy). The pre-CCRT NLR was calculated from the nearest CBC within 1 week before CCRT and post-CCRT NLR was calculated using CBC 4 weeks after CCRT. Change of NLR before/after CCRT was also analyzed. The maximally selected log rank test was used to acquire the most significant NLR level related with overall survival (OS).

      4c3880bb027f159e801041b1021e88e8 Result

      The pre-, post-CCRT NLR, and NLR change (post-CCRT NLR/pre-CCRT NLR) cut-off levels were 1.9, 3.15, and 1.6, respectively. The median follow up duration was 11 months (range, 2–71 months). The 3-year OS, loco-regional progression free survival (LRPFS), and distant metastasis free survival (DMFS) were 45.4%, 9.3%, and 6.2%, respectively. The post-CCRT NLR and NLR change were significantly associated with OS and LRPFS. The high post-CCRT NLR group (> 3.15) showed significantly worse OS and LRPFS compared to the low post-CCRT NLR group (≤ 3.15) (3-year OS: 21.2% vs. 46.9%, p=0.005; median LRPFS: 7.7 months vs. 11.3 months, p=0.04). The high NLR change group (> 1.6) had significantly worse OS and LRPFS than the low NLR change group (≤ 1.6) (3-year OS: 32.7% vs. 36.9%, p=0.026; median LRPFS 7.7 months vs. 10.4 months, p=0.025). The pre-CCRT NLR showed a marginally significant difference in OS (3-year OS: 29.1% vs. 56.9%, p=0.062). There was no correlation between NLR and DMFS.

      8eea62084ca7e541d918e823422bd82e Conclusion

      The pre-, post-CCRT high NLR and increased NLR after CCRT are associated with poor prognosis of survival in patients for locally advanced NSCLC. An elevated NLR after CCRT might be an indicator of an increased risk of loco-regional failure. Further studies are needed to confirm the predictive value of NLR and the treatment strategies using NLR.

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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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      P3.01-56 - Hyperprogression and Pseudoprogression in Patients with Non-Small Cell Lung Cancer on Checkpoint Blocking Immunotherapy (ID 13837)

      12:00 - 13:30  |  Author(s): Jin-Hyoung Kang

      • Abstract
      • Slides

      Background

      Immune checkpoint inhibitors in metastatic non-small cell lung cancer (NSCLC) can result in improved quality of life and survival when compared with cytotoxic chemotherapy. While immune checkpoint inhibitors are disrupting the management of patients with cancer, some patients experienced pseudoprogression,On the other hand there is another special response pattern of occurrences of rapid progression (i.e., hyperprogressive disease or HPD), suggesting potentially effects of these drugs. Due to HPD is not only different from the pseudoprogression, but also tremendous progression, clinicians must evaluate the efficacy of these novel drugs and avoid either premature withdrawal of the treatment or prolonging ineffective treatment

      a9ded1e5ce5d75814730bb4caaf49419 Method

      We idendified the medical records of all consecutive in non-small cell lung cancer patients (n=118) analyzed retrospectively who treated with monotherapy by anti-PD-1 or an anti-PD-L1 at Seoul & Bucheon St. Mary's Hospital between December 2015 and April 2018.

      Tumor size (D) was defined as the sum of the longest diameters of the target lesions as per the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria. We calculated the TGK across clinically relevant treatment periods. As per the RECIST system, patients with nonmeasurable disease only at baseline could not be assessed by TGK. For patients who had disease progression with new lesions, the TGK was computed on the target lesions only (new lesions were not included in the RECIST sum).

      4c3880bb027f159e801041b1021e88e8 Result

      Median age was 65.4 years with a majority being Male(94.4%) and non current smoker (66.6%, consists in never smoker 11.1% and Ex smoker 55.5%). Their average smoking history was 38.6 pack years

      The rate of over-growth was 15.2%(n=18), among them, the rate of hyperprogression was 72.2%(n=13).

      The probability of expression of the EGFR gene mutation on the over-growth group was 16.6%.

      We found increasing the probability of hyperprogression was seen at the EGFR expression group compared to non-hyperproliferation group(p=0.440)

      8eea62084ca7e541d918e823422bd82e Conclusion

      While immunotherapy can produce a significant and durable response in patients with NSCLC, physicians must be recognized of the potential for an aggressive pattern of accelerated progression in a subset of patients. Even though the improved recognition of hyperprogression and pseudoprogression, the etiology of HPD remains unclear, apart from the pseudoprogression. However we found that patients with EGFR genetic mutations may show the hyperprogression-excess growth when they used immune checkpoint inhibitors.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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