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H.Y. Kim
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P1.03 - Poster Session with Presenters Present (ID 455)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Radiology/Staging/Screening
- Presentations: 1
- Moderators:
- Coordinates: 12/05/2016, 14:30 - 15:45, Hall B (Poster Area)
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P1.03-039 - Is It Necessary to Repeat Lung Cancer Screening with Low-Dose CT(LDCT) in Female Never Smokers? (ID 4422)
14:30 - 14:30 | Author(s): H.Y. Kim
- Abstract
Background:
Lung cancer (LC) screening is not recommended for low-risk subjects, including never smokers. However, LDCT is often performed in Korea as a part of cancer screening program even for healthy female never smokers (FNS). To examine the role of LDCT screening in FNS, we estimated the risk of subsequent development of LC according to their initial LDCT findings and age groups.
Methods:
This retrospective cohort study included FNS aged 40 to 79 years who performed initial LDCT from Aug 2002 to Dec 2007. Lung cancer diagnosis was identified from the Korea Central Cancer Registry Database (Dec 2013) and vital status (Dec 2014) from Statistics Korea. LDCT findings were reviewed using Lung Imaging Reporting and Data System (Lung-RADS). LC risk and outcomes were analyzed according to initial LDCT findings and age groups using the national data up to 12 years after the LDCT. .
Results:
There were 4,365 FNS with mean age of 51.1±7.6 years (median F/U time = 9.7 years). Overall, twenty-two LCs (0.5%) were identified with an incidence rate of 52.58 (95% CI 34.62-79.86) per 100,000 person-years. The incidence rates were 8.53 (2.75-26.44), 75.16 (24.24-233.04), 0 and 1665.58 (1020.38-2718.72) in subjects with category 1, 2, 3 and 4, respectively. The cumulative incidence is shown in Fig 1. The incidence rates were 35.30 (95% CI 18.99-65.00) and 88.84 (50.45-156.44) in age with 40~54 years and 55~79, respectively. Three women among 16 classified into category 4 died of LC, while no death in those with category 1 , 2, or 3 [median time to LC diagnosis= 5.1 years (range, 2.8-8.8)]. Fig 1. Cumulative incidence of lung cancer according to lung-RADS Figure 1
Conclusion:
Although, the effectiveness of lung cancer screening is in FNS still unclear, repeat LDCT seems to be unnecessary in those with category 1, 2 and 3, at least within 5 years after initial LDCT.
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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
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
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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 - 14:30 | Author(s): H.Y. Kim
- 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.
