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Gee-Chen Chang
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MA02 - Improving Outcomes for Patients with Lung Cancer (ID 895)
- Event: WCLC 2018
- Type: Mini Oral Abstract Session
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/24/2018, 10:30 - 12:00, Room 201 BD
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MA02.03 - ASTRIS: A Real World Treatment Study of Osimertinib in Patients with EGFR T790M-Positive NSCLC (ID 12972)
10:40 - 10:45 | Author(s): Gee-Chen Chang
- Abstract
- Presentation
Background
Osimertinib is a third-generation, CNS-active EGFR-TKI that potently and selectively inhibits both EGFR-TKI sensitizing and EGFR T790M resistance mutations. We report results from a second planned protocol, optimal interim analysis of the ongoing ASTRIS study (NCT02474355).
a9ded1e5ce5d75814730bb4caaf49419 Method
Eligible patients receive osimertinib 80 mg once daily. Inclusion criteria: stage IIIB/IV T790M-positive non-small cell lung cancer (NSCLC); T790M status confirmed locally by validated test, not restricted by sample type; prior EGFR-TKI therapy received; WHO performance status (PS) 0−2; acceptable organ and bone marrow function and no history of interstitial lung disease (ILD) or QTc prolongation. Asymptomatic, stable CNS metastases are permitted. The primary efficacy outcome is overall survival (OS).
4c3880bb027f159e801041b1021e88e8 Result
From Sept 18, 2015, first patient in, to Oct 20 2017 data cut-off (DCO), 3014 patients were enrolled across 16 countries and received ≥1 dose of osimertinib (full analysis set [FAS]): median follow-up 7.9 months (range <1−24), median age 62 yrs (27–92), 64% female, 69% Asian, 30% White, 11% WHO PS 2, 45% prior chemotherapy, 34% prior radiotherapy. All patients had T790M-positive status, identified from tissue in 1610 patients (53%), plasma ctDNA in 1241 patients (41%) and from other sources in 162 patients (5%). At DCO, 1276 patients (42%) had discontinued treatment (1738 [58%] ongoing); median duration of exposure 7.4 months (<1–25); 1289 patients (43%) had a progression-free survival (PFS) event, 1276 (42%) had a time to treatment discontinuation (TTD) event, and 593 (20%) had died. In patients evaluable for response, the investigator-assessed clinical response rate was 56.6% (1625/2872; 95% confidence interval [CI] 54.7, 58.4). In the FAS, estimated median PFS was 11.0 months (95% CI 10.6, 11.1), median TTD was 12.6 months (95% CI 12.2, 13.7), and median OS was not reached (OS at 12 months was 75.8% (95% CI 73.7, 77.8). Adverse events (AEs) leading to dose modification and treatment discontinuation were reported in 321 patients (11%) and 147 patients (5%), respectively. Serious AEs were reported in 505 patients (17%). ILD/pneumonitis-like events were reported in 41 patients (1%), and QTc prolongation in 48 patients (2%).
8eea62084ca7e541d918e823422bd82e Conclusion
ASTRIS, the largest reported study of osimertinib in T790M-positive NSCLC, demonstrates clinical activity similar to that observed in the osimertinib clinical trial program with no new safety signals.
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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: 1
- 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): Gee-Chen Chang
- 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.
6f8b794f3246b0c1e1780bb4d4d5dc53
