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Yuh-Min Chen
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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: 2
- Moderators:
- Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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P1.01-11 - Named Patient Use Program for Afatinib in Advanced NSCLC with Progression on Prior Therapy: Experience from Asian Centers (ID 12968)
16:45 - 18:00 | Author(s): Yuh-Min Chen
- Abstract
Background
A global named patient use (NPU) program for afatinib in patients with advanced/metastatic NSCLC who had progressed during prior therapy was conducted between May 2010 and January 2016 (Cappuzzo F et al, Future Oncol 2018). Here we describe treatment outcomes for patients at Asian centers.
a9ded1e5ce5d75814730bb4caaf49419 Method
Eligible patients had progressed after clinical benefit on prior erlotinib/gefitinib and/or had an activating EGFR/HER2 mutation, had exhausted all other treatments, and were ineligible for afatinib trials. Patients received afatinib (starting dose:30-50 mg/day). Dose modifications were allowed as tolerated. Time to treatment failure (TTF) was calculated from treatment initiation to discontinuation. Adverse event (AE) reporting was mandatory.
4c3880bb027f159e801041b1021e88e8 Result
Data were collected from 2242 NSCLC patients across 10 Asian countries. Patients were heavily pretreated, 62% received ≥2 prior chemotherapy lines, and for most, afatinib was 4th-line therapy; almost all had received erlotinib/gefitinib (Table 1). 97% of patients with known tumor status were EGFR mutation-positive (m+). Median TTF was 7.6 months overall, and 7.2 months in patients with EGFR m+ tumors (Table 1). TTF was >12 months in patients with EGFR exon20 insertions and Her2 mutations. ORR was numerically higher in patients with exon20 insertions and G719X/L861Q/S761I mutations than other subgroups (Table 1). Disease control rate was 78% overall. The most frequently reported AEs were rash and diarrhea; no new/unexpected safety signals were identified.
Table 1. Named patient use (NPU) program for afatinib in advanced/metastatic NSCLC: results from Asian centers Total number of patients 2242 Age; years, median 61 Female/male; % 60/40 Any prior treatment; n (%) 2223/2242 (99.2) Prior erlotinib and/or gefitinib; n (%) 2202/2223 (99.1) Prior erlotinib only; n (%) 866/2202 (39) Prior gefitinib only; n (%) 927/2202 (42) Prior lines of chemotherapy ≥3, 32%; ≥2, 62%; 1, 23%; 0, 15% Prior lines of systemic therapy ≥4, 37%; ≥3, 65%; 2, 21%; 1, 14%; 0, 0% EGFR m+; n (%) 1240/1281 (97) Specified EGFR mutation; n (%) 1101/1240 (89) TTF; months* n ORR, % n All patients with data available 7.6 1550 24.4 431 EGFR m+ 7.2 834 27.7 267 EGFR mutation specified 6.5 740 - - Common mutations (Del19 or L858R) 6.4 692 27.4 230 Uncommon mutations (all) 8.0 84 30.3 33 T790M 6.0 34 21.1 19 G719X, L861Q, or S761I 7.8 28 42.9 7 Exon 20 insertion 18.0 25 42.9 7 Her2 m+ 12.2 12 14.2 7 p.A775 G776insYVMA 12.4 7 25.0 4 *median
m+ve, mutation-positive; ORR, objective response rate;
TTF, time to treatment failure
8eea62084ca7e541d918e823422bd82e Conclusion
This analysis from Asian countries in the afatinib NPU program revealed clinically meaningful TTF/ORR in this heavily pre-treated and refractory advanced NSCLC patient population, including activity in common and uncommon EGFR mutations. TTF was numerically longer in patients with uncommon mutations (particularly EGFR exon20 insertions) and HER2 mutations than in those with common EGFR mutations. The safety profile of afatinib was consistent with non-Asian centers.
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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 | Presenting Author(s): Yuh-Min Chen
- 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
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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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P3.01-15 - Efficacy of Paclitaxel Plus TS1 Against Non-Small Cell Lung Cancer Previously Treated (ID 13593)
12:00 - 13:30 | Presenting Author(s): Yuh-Min Chen
- Abstract
Background
Salvage chemotherapy is frequently used. However, the efficacy of salvage chemotherapy of paclitaxel plus TS1 (TTS1) is still unknown.
a9ded1e5ce5d75814730bb4caaf49419 Method
We retrospectively reviewed the chart records of our non-small cell lung cancer patients who were treated between 2010 and 2013. Clinical characteristics, type of tumor EGFR mutation, response to first-line EGFR-TKI treatment or not, and efficacies of TTS1, were collected.
4c3880bb027f159e801041b1021e88e8 Result
Total 25 patients were enrolled in this study. No patients archived complete response and six patients had partial response (ORR: 24%). The disease control rate was 60% (15/25). The progression free survival (PFS) was 4.8 months and overall survival (OS) was 12.4 months. Among these 25 patients that received TTS1, 17 of them had driver mutations. Patients with driver mutations had better PFS (4.9 months vs 1.8 months) and OS (15.5 months vs 7.2 months) compared with those without driver mutations.
8eea62084ca7e541d918e823422bd82e Conclusion
TTS1 are effective salvage chemotherapeutic agents, especially in tumor EGFR mutated patients. Paclitaxel plus TS1 is another treatment of choice for NSCLC patients before a more efficient salvage treatment strategy is found.
6f8b794f3246b0c1e1780bb4d4d5dc53
