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Te-Chun Hsia
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P1.01 - Advanced NSCLC (Not CME Accredited Session) (ID 933)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Track:
- Presentations: 3
- Moderators:
- Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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P1.01-13 - A Study of S-1 Plus Cisplatin in Patients with Advanced Non-Small-Cell Lung Cancer (ID 12886)
16:45 - 18:00 | Author(s): Te-Chun Hsia
- Abstract
Background
Oral administration of S-1 (Tegafur/Gimeracil/Oteracil potassium fixed combination capsules, 1.0:0.4:1.0 in molar ratio) in combination with cisplatin has been proven non-inferior to the standard-of-care doublet regimen containing docetaxel plus cisplatin in a randomized phase III trial in Japanese patients with advanced non-small-cell lung cancer (NSCLC). The aim of the study was to evaluate the efficacy and safety profiles of oral S-1 plus cisplatin in Taiwanese patients with NSCLC.
a9ded1e5ce5d75814730bb4caaf49419 Method
Patients with previously untreated stage IIIB or IV NSCLC were treated with 40 to 60 mg (based on body surface area) of oral S-1 twice daily on days 1–21 plus cisplatin 60 mg/m2 on day 8 in a 5-week cycle for up to six cycles.
4c3880bb027f159e801041b1021e88e8 Result
A total of 55 patients from 5 sites in Taiwan were enrolled and received the study medication. Among the 46 patients who completed at least 2 cycles of treatment and had tumor assessments, disease control rate was achieved at 69.6% (partial response: 19.6%, stable disease: 50.0%), with median overall survival (OS) and progression free survival (PFS) of 15.1 months (95%CI: 11.5, 25.6) and 5.7 months (95%CI: 3.3, 8.4), respectively. Grade ≥ 3 adverse events (AEs) related to study treatment occurred in 11 patients (20.0%). The most commonly observed treatment-related AEs were nausea (41.8%), followed by decreased appetite, anemia and diarrhea. No febrile neutropenia or treatment-related death were observed in this study.
8eea62084ca7e541d918e823422bd82e Conclusion
The study demonstrated similar efficacy and well-tolerated safety profiles as the previous Phase III study in Japan for patients with advanced NSCLC who received oral S-1 plus cisplatin as the first-line doublet chemotherapy regimen in Taiwan.
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P1.01-28 - Impact of Afatinib Dosing on Safety and Efficacy Real-World in Patients with EGFR Mutation-Positive Advanced NSCLC (ID 13276)
16:45 - 18:00 | Author(s): Te-Chun Hsia
- Abstract
Background
Tolerability-guided dose adjustment of afatinib reduced incidence and severity of adverse drug reactions (ADRs) without affecting efficacy in the LUX-Lung (LL) studies in patients with EGFR mutation-positive (EGFRm+) NSCLC. We evaluated the impact of modifying the recommended starting dose of afatinib (40mg) on efficacy and safety in a real-world setting.
a9ded1e5ce5d75814730bb4caaf49419 Method
This non-interventional, observational, multi-country/site study used medical records of TKI-naïve patients with EGFRm+ (Del19/L858R) NSCLC treated with first-line afatinib. Primary outcomes were % patients with ADRs by severity, time on treatment (TT), and time to progression (TTP), relative to LL3. Secondary outcomes were % of patients with/reasons for modified starting dose.
4c3880bb027f159e801041b1021e88e8 Result
228 patients from 13 countries were included. Baseline characteristics were generally similar to LL3, but with more Del19 patients (78% vs 49%) and fewer Asian patients (44% vs 72%); 12% had ECOG PS 2–3. 31% of patients received an afatinib starting dose of <40 mg; 20% of patients starting with <40 mg increased their dose during the study. 67% of 40 mg starters underwent dose reductions, with 86% of those occurring in the first 6 months. Dose reductions were more frequent in females, Eastern Asian patients, and those with lower body weight. The main reason for dose modification was ADRs. In <40 mg starters, overall ADR incidence was similar to that in ≥40 mg starters, with fewer G3 (17% vs 25%) and no G4 ADRs. There were no new safety signals, and fewer ≥G3 ADRs and serious adverse events (SAEs) than in LL3 (28% vs 49% and 5% vs 14%, respectively). >60% of patients received medications to treat diarrhea and manage skin AEs. Median TT and TTP were 18.7 months and 20.8 months, respectively, and were not impacted by reduced starting dose or dose modification (19.4/17.7/19.5 and 25.9/20.0/29.0 months for patients who started on ≤30 mg/reduced to <40 mg/remained on ≥40 mg, respectively). The efficacy of afatinib was demonstrated across all patient subgroups analysed (ECOG PS 0/1 vs 2/3, age <75 yrs vs ≥75 yrs, EGFR mutational status); TT and TTP were significantly longer in patients with ECOG PS0/1 versus PS2/3.
8eea62084ca7e541d918e823422bd82e Conclusion
As in pivotal trials, dose adjustments with afatinib in real-world practice reduced the frequency and intensity of ADRs without impacting efficacy. RealGido demonstrated long TT/TTP regardless of afatinib dose adjustment or reduced starting dose, and an acceptable safety profile. The results highlight the benefit of tailoring afatinib dose based on individual patient characteristics and ADRs to optimize outcomes.
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P1.01-62 - The Third Generation Irreversible EGFR Inhibitor HS-10296 in Advanced Non-Small Cell Lung Cancer Patients (ID 13138)
16:45 - 18:00 | Author(s): Te-Chun Hsia
- Abstract
Background
The epidermal growth factor receptor (EGFR) T790M mutation is the most common mechanism of drug resistance to EGFR tyrosine kinase inhibitors (TKIs) in non-small cell lung cancer (NSCLC) patients with sensitizing EGFR mutations. The third generation irreversible EGFR inhibitor HS-10296 has been shown to be safe and effective against both EGFR TKI-sensitizing and T790M resistance mutations in preclinical studies.
a9ded1e5ce5d75814730bb4caaf49419 Method
A Phase I, open-label, multi-center clinical trial was conducted in patients with locally advanced or distant metastatic NSCLC who have progressed following prior therapy with EGFR TKIs. The study was consisted of dose-escalation cohorts (55, 110, 220 and 260 mg) and dose-expansion cohorts (55, 110 and 220 mg) with once daily oral administration of HS-10296. In each expansion cohort, tumor biopsies were collected for central determination of EGFR T790M status. Patients were assessed for safety, tolerability, pharmacokinetics and efficacy of HS-10296.
4c3880bb027f159e801041b1021e88e8 Result
A total of 117 patients (median age 60) received at least one dose of HS-10296 across multiple sites in China (43 patients), Taiwan (69 patients) and the United States (5 patients). Maximum tolerated dose（MTD）has not been reached in this study. The most common adverse events were grade1/2 rash, pyrexia, upper respiratory tract infection, constipation, diarrhoea and blood creatine phosphokinase elevation. Drug-related serious adverse events were anemia (0.8%), blood creatinine elevation (0.8%), anemiarhabdomyolysis (0.8%) and blood creatine phosphokinase elevation (0.8%) occurred mainly in the cohorts with higher doses at 220 mg or 260 mg, respectively. These data demonstrated favorable tolerability and safety of HS-10296 in patients enrolled. The pharmacokinetics of HS-10296 was dose proportional and the plasma half-life was 30.7~37.5 hours. Among 82 evaluable patients (18 in escalation cohorts and 64 in expansion cohorts) with the EGFR T790M mutation, the overall objective response rate (ORR) was 52.4% (43/82; 95% CI, 41.6 to 63.3), while disease control rate (DCR) was 91.5% (75/82; 95% CI, 85.4 to 97.5). 110mg cohort showed better DCR (97.2% VS. 86.1%) than 55mg cohort. Phase II study is ongoing with the dose at 110 mg.
8eea62084ca7e541d918e823422bd82e Conclusion
HS-10296 has the potential to provide clinical benefit to locally advanced or distant metastatic NSCLC patients with EGFR T790M mutation who had disease progression following prior therapy with EGFR TKIs.
(The study was sponsored by Jiangsu Hansoh Pharmaceutical Co., Ltd.; ClinicalTrials.gov number, NCT02981108)
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