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Y. Lee



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    P3.02b - Poster Session with Presenters Present (ID 494)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Advanced NSCLC
    • Presentations: 1
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      P3.02b-126 - Clinical Activity of Olmutinib (HM61713) Used on a Compassionate IND Basis for Patients with Lung Adenocarcinoma (LADC) in Korea (ID 5605)

      14:30 - 15:45  |  Author(s): Y. Lee

      • Abstract

      Background:
      Olmutinib (HM61713) is an oral EGFR tyrosine kinase inhibitor (TKI), which selectively inhibits EGFR mutations, including both activating mutations and T790M, but not EGFR wild-type. It showed good safety profile and promising anti-tumor activity in patients with EGFR mutated NSCLC that progressed after EGFR-TKIs, especially in those with T790M mutation.

      Methods:
      Between 08/2014 and 05/2016, we treated 27 LADC patients (11 male, 16 female) with Olmutinib on a compassionate IND basis, which was provided by Hanmi Pharmaceutical Co. Ltd. The starting dose of oral Olmutinib was 650 mg/day in 12 patients and 800 mg/day in 15 patients. The EGFR mutation status was assessed either by direct sequencing after PCR or by PNA mediated real-time PCR clamping or both, and ddPCR of cell-free plasma DNA. Tumor response was assessed using RECICT criteria every 2-3 cycles of treatment with repeat CT chest, MRI brain, and PET/CT, as appropriate.

      Results:
      The median age was 62 years (range 42-74); ECOG was 0/1/2/3 in 6/12/7/2 patients. All but one patient had prior treatment with EGFR-TKIs (17 as first[t]-line therapy, 9 upon PD after chemotherapy). In 5 patients, EGFR-TKI was the only treatment given before Olmutinib while 21 patients received median of 2 (range 1-5) chemotherapy regimens in addition (18 platinum-based, 3 non-platinum-based). Prior EGFR-TKIs used were gefitinib in 14, erlotinib in 10, and both in 2 patients; 2 patients received afatinib in addition. Overall, 15 of 27 received 3 or more regimens of chemo and/or EGFR-TKI (median, 3; range, 0-7). While one patient had wild type EGFR only, 26 patients had EGFR mutations. One patient had de novo EGFR T790M mutation in resected tumor sample, and 14 had Ex19 del, 9 had L858R mutation, 1 had both Ex19 del & L858R and 1 had Ex 20 P772S mutation. T790M mutation was detected in 18, not detected in 7, and unknown in 2 patients. Of 24 patients evaluable for tumor response, 14(58.3%) achieved PR, 2 SD, and 8 PD. Patients with T790M mutation tend to have better ORR than those without or unknown (12/16 [75.0%] vs. 2/6 [33.3%] vs. 0/2 [0.0%]). Olmutinib was well tolerated with no additional major adverse effects other than what was previously reported in phase I/II studies.

      Conclusion:
      Olmutinib showed promising anti-tumor activity for patients with EGFR mutated LADC that progressed after prior treatment with EGFR-TKIs, especially in those with T790M mutation, including the one who had de novo T790M mutation.

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    P3.06 - Poster Session with Presenters Present (ID 492)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Trial Design/Statistics
    • Presentations: 1
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      P3.06-007 - The Consequence of Incomplete Follow-up in Hospital-based Survival Study as Compared with National Vital Status-based Results (ID 5887)

      14:30 - 15:45  |  Author(s): Y. Lee

      • Abstract

      Background:
      Loss to follow-up (FU) is an important issue in survival analysis using the data based on hospital records. To better address the magnitude of this issue in a real clinical setting, we compared survival outcomes from hospital database with those from national cancer registry data which incorporated national vital status record.

      Methods:
      From the hospital database of National Cancer Center Hospital, Korea, we identified 970 small cell lung cancer (SCLC) patients who were treated between 04/2001 and 04/2013. Most of them were male (n = 854) and smokers (n = 906). Median age was 63 years (range, 32–80 years). We made two survival datasets, hospital-based dataset (HD) and cancer registry-based dataset (CD).

      Results:
      Of 352 LD-SCLC patients, there were 144 deaths in the HD and 107 additional deaths were identified in the CD (Total= 251). There was no difference in median progression free survival (PFS) between the HD and CD (12.7 months [95% CI, 10.9-14.6] vs. 12.3 months [95% CI, 10.8-14.2]). But, median OS in the HD was significantly longer than in the CD (55.7 months [95% CI, 35.8-115.6] vs. 26.3 months [95% CI, 22.8-30.8]). The 5-year survival rate of LD-SCLC was 48.7% vs. 29.6% in the HD and CD, respectively. For 618 ED-SCLC patients, there were 234 deaths in the HD while 341 additional deaths were confirmed in the CD (Total= 575). Median PFS from the HD was similar to that from the CD (6.5 months [95% CI, 6.2-6.9] vs. 6.4 months [95% CI, 6.1-6.8]). Median OS of HD was 14.5 months [95% CI, 13.5-16.9], significantly longer than that of CD (11.9 months [95% CI, 11.2-12.9]). The 5-year survival rate of ED-SCLC in the HD and CD was 11.5% and 3.5%, respectively. In the simulation analysis, the estimated median OS increased as the proportion of patients who were actually dead but censored in the HD increased. When this proportion was 25%, 50% and 75%, the estimated median OS was 27.8 months, 33.8 months, and 37.2 months for LD-SCLC, respectively, and 12.5 months, 13.1 months, and 13.7 months for ED-SCLC. Obviously, this discrepancy reflects the limitation of HD-based survival analysis since medical records do not trace all patients until death, especially for those who did not return for subsequent follow-up care.

      Conclusion:
      Incomplete follow-up, by increasing the number of censoring events, could result in spurious prolongation of overall survival, which warrants caution in interpreting the HD-based survival analysis.