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T. Hsia
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P1.03 - Chemotherapy/Targeted Therapy (ID 689)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Chemotherapy/Targeted Therapy
- Presentations: 1
- Moderators:
- Coordinates: 10/16/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P1.03-053 - Taiwan Real Word Efficacy of 1st Line EGFR TKIs Treatment in EGFR Mutation Positive Advanced Non Small Cell Lung Cancer (ID 9995)
09:30 - 16:00 | Author(s): T. Hsia
- Abstract
Background:
Previous studies have shown EGFR TKIs provided superior 1[st] line efficacy to chemotherapy for advanced non-small cell lung cancer (NSCLC) patients harboring activating EGFR mutation. LUX-Lung7, a phase IIB randomized head-to-head study, showed afatinib significantly improved PFS, TTF, and ORR compared with gefitinib. However, it is still unclear how to choose among these three EGFR TKIs in clinical setting, especially for uncommon mutation, which was excluded in most studies. This retrospective study is aimed to evaluate the treatment pattern in our hospital and efficacy of three EGFR TKI for patients with common mutations and uncommon mutations.
Method:
Patients with advanced NSCLC were retrospectively reviewed in a university hospital in central Taiwan from Jan 2013 to Mar 2017. In this population, patients with EGFR mutations and have to be taking EGFR TKIs as 1[st] line treatment more than 30 days were recorded for analysis.
Result:
1,951 patients with advanced lung cancer were reviewed. About 75% of lung cancer were adenocarcinomas and 55% were EGFR mutation rate. Clinical data of 467 patients with advanced EGFR mutation lung adenocarcinomas were extracted, 95.7% of them used EGFR TKI as 1[st] line therapy including gefitinib (n=210), erlotinib (n=147), and afatinib (n=110). The median age was 64 years old. More female was included in the gefitinib cohort and afatinib cohort tended to have higher component of uncommon mutations. The TTF among gefitinib (G), erlotinib (E) and afatinib (A) were 9.8 vs 11.4 vs 12.2 months (p = 0.094). Patients treated with afatinib had improved TTF compared with gefitinib (HR= 0.72, 95% CI: 0.54-0.97, p = 0.035) and showed a trend compared with erlotinib without significantly difference. In del 19, TTF among G, E and A were 9.4 vs 12.0 vs 12.2 months ( p = 0.074). In L858R, TTF among G, E and A were 10.4 vs 10.9 vs 11.7 months ( p = 0.721). Intriguingly, afatinib showed excellent TTF in uncommon mutations (median TTF G vs E vs A: 7.5 vs 7.0 vs 19.7 months, p = 0.506). Afatinib dose reduction didn’t have impact TTF (median TTF 30 mg vs 40 mg: 16.1 vs 10.3 months. p = 0.923)
Conclusion:
Consistently, our findings supported improved efficacy as observed from LUX-Lung7. In more resistance mutation type such as uncommon mutation, afatinib tended to have better efficacies. Due to insufficient sample size and the retrospective study design, further confirmatory study is warranted.
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P2.03 - Chemotherapy/Targeted Therapy (ID 704)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Chemotherapy/Targeted Therapy
- Presentations: 2
- Moderators:
- Coordinates: 10/17/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P2.03-003 - Cost Effectiveness of Gefitinib for Lung Adenocarcinoma Patients with Mutant Epidermal Growth Factor Receptor (ID 7382)
09:30 - 16:00 | Author(s): T. Hsia
- Abstract
Background:
Tyrosine kinase inhibitor such as Gefitinib rather than conventional chemotherapy is the standard of care for advanced lung adenocarcinoma (LA) with mutant epidermal growth factor receptor (mEGFR). However, its cost-effectiveness is less clear. The aim of our study is to compare the cost and effectiveness of 1[st] line gefitinib vs platinum-based chemotherapy for clinical stage IV LA via this population-based propensity score (PS) matched analysis.
Method:
We identified eligible patients diagnosed within 2011 through a comprehensive population-based database containing cancer and death registries, and reimbursement data in Taiwan. The primary duration of interest (DOI) was two years within diagnosis. Effectiveness was measured as survival whereas direct medical cost was measured from the health care sector’s perspective. In supplementary analysis (SA), we estimated the cost-effectiveness under potential unmeasured confounder(s) and the cost-effectiveness if the DOI was three years.
Result:
Our study population constituted 240 patients [Table 1]. Within 2 years, gefitinib was both more effective [mean overall survival 1.48 vs 1.47 life-year] and cost-saving [mean 78770 vs 82684, 2015 US dollars] when compared to chemotherapy. In SA, our results was sensitive to potential unmeasured confounder(s) but remained cost-effective when DOI was 3 years.Table 1. Patient characteristics of the propensity-score matched final study population
Gefitinib Platinum-based chemotherapy standardized difference (rounded) number (%) number (%) age <65 76 (63.33) 75 (62.5) 0.017 >=65 44 (36.67) 45 (37.5) gender female 60 (50) 60 (50) 0 male 60 (50) 60 (50) residency non-north 55 (45.83) 56 (46.67) 0.017 north 65 (54.17) 64 (53.33) comorbidity without 62 (51.67) 64 (53.33) 0.033 with 58 (48.33) 56 (46.67) smoking history no 79 (65.83) 79 (65.83) 0 yes 41 (34.17) 41 (34.17) performance status 0-1 113 (94.17) 113 (94.17) 0 2 7 (5.83) 7 (5.83)
Conclusion:
1[st] line gefitinib was cost-effective for clinically stage IV LA with mEGFR from health care sector’s perspective when compared to platinum-based chemotherapy.
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P2.03-058 - Tiger-3: A Phase 3 Randomized Study of Rociletinib Vs Chemotherapy in EGFR-mutated Non-small Cell Lung Cancer (NSCLC) (ID 8395)
09:30 - 16:00 | Author(s): T. Hsia
- Abstract
Background:
Rociletinib, an oral, irreversible tyrosine kinase inhibitor (TKI), selectively targets activating mutations in EGFR and the acquired resistance mutation T790M and demonstrated antitumor activity in the phase 1/2 TIGER-X study (NCT01526928). Initial results are reported from the TIGER-3 study (NCT02322281) of rociletinib vs chemotherapy in EGFR TKI-resistant patients with EGFR-mutated NSCLC.
Method:
Eligibility criteria included: metastatic or unresectable, locally advanced, EGFR-mutated NSCLC; radiological progression on most recent TKI therapy; ≥1 line of platinum doublet chemotherapy. Patients were not selected based on T790M status. Patients (N=900) were to be randomized (1:1:1) to rociletinib 500 or 625 mg BID or investigator’s choice of chemotherapy (pemetrexed, gemcitabine, docetaxel, or paclitaxel). The primary endpoint was investigator-assessed progression-free survival (PFS) (RECIST v1.1); objective response rate (ORR) was a secondary endpoint. The rociletinib dosing groups were combined and compared with chemotherapy in a step-down procedure (patients with a centrally confirmed T790M mutation, followed by all randomized patients).
Result:
TIGER-3 enrollment was halted upon discontinuation of rociletinib development in NSCLC in 2016; therefore, target enrollment was not achieved. TIGER-3 enrolled 75 patients in the rociletinib groups [500 mg BID, n=53; 625 mg BID, n=22] and 74 in the chemotherapy group. Median age was 62 years, 69.1% had ECOG Performance Status of 1, 39.6% were Asian, 58.4% were female, and median number of prior therapies was 3. PFS and ORR data are presented in the Table. The most common adverse events (all grade; grade ≥3) in the rociletinib group were diarrhea (62.7%; 2.7%), hyperglycemia (58.7%; 24.0%), nausea (37.3%; 4.0%), fatigue (37.3%; 8.0%), and decreased appetite (37.3%; 0%) and in the chemotherapy group were nausea (27.4%; 5.5%), anemia (24.7%; 2.7%), and fatigue (24.7%; 9.6%).Outcome Centrally Confirmed T790MPositive Centrally Confirmed T790MNegative Intent-to-Treat Population* Rociletinib[†] (n=25) Chemotherapy (n=20) Rociletinib[†] (n=36) Chemotherapy (n=41) Rociletinib[†] (n=75) Chemotherapy (n=73) Median PFS, mo (95% CI) 6.8 (3.7–12.2) 2.7 (1.3–7.0) 4.1 (2.5–4.6) 1.4 (1.3–2.7) 4.1 (2.8–5.5) 2.5 (1.4–2.9) HR (95% CI) 0.570 (0.285–1.140); P=0.105 0.532 (0.322–0.878); P=0.011 0.609 (0.423–0.875); P=0.006 Confirmed ORR, n (%) [95% CI] 9 (36.0) [18.0%–57.5%] 3 (15.0) [3.2%–37.9%] 3 (8.3) [1.8%–22.5%] 2 (4.9) [0.6%–16.5%] 13 (17.3) [9.6%–27.8%] 6 (8.2) [3.1%–17.0%] *Includes patients with undetermined T790M mutation status. [†]Rociletinib 500 mg BID and 625 mg BID dose groups were pooled for the analysis. CI, confidence interval; HR, hazard ratio.
Conclusion:
Incomplete enrollment precluded hypothesis testing. However, the data show a trend toward longer PFS and higher ORR with rociletinib.
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P2.07 - Immunology and Immunotherapy (ID 708)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Immunology and Immunotherapy
- Presentations: 1
- Moderators:
- Coordinates: 10/17/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P2.07-027 - Efficacy and Safety of Nivolumab Therapy for Advanced NSCLC in the Expanded Access Named Patient Program in Taiwan (ID 8711)
09:30 - 16:00 | Author(s): T. Hsia
- Abstract
Background:
Nivolumab is current standard of care for patients with pretreated advanced non-small cell lung cancer (NSCLC). The patients’ and physicians’ experience of using nivolumab in real-world clinical practice in Taiwan is unknown. We aimed to evaluate the efficacy and safety of nivolumab therapy in Taiwan.
Method:
We retrospectively reviewed the medical records of the patients with age > 20 years who were diagnosed to have advanced NSCLC and received nivolumab therapy through the Expanded Access Named Patient Program in 2016. Nivolumab 3 mg/kg was administered intravenously every 2 weeks.
Result:
A total of 94 patients were included in this analysis. The median age was 60 years (range, 31-76), and 63.8% of these patients were non-smoker. Most of the patients (75.5%) had adenocarcinoma histology, and 34.0% of the patients harbored an EGFR mutation. The median cycle number of nivolumab therapy was 9 (range, 1-28). The median treatment duration was 4.6 months (95% CI, 3.0-6.6). Nivolumab monotherapy is still ongoing in 16 patients (17.0%) on the date of data cutoff. The objective response rate was 13.8%. The median overall survival was 12.0 months (95% CI, 9.2 to not reached). In univariate analysis, sex, age, smoking history, EGFR mutation, squamous histology, and previous extracranial irradiation therapy were not predictors of prolonged survival. Only ECOG performance status (PS) < 2 before starting nivolumab therapy was a predictor of prolonged survival (HR: 0.32; 95% CI, 0.17-0.59). The most common treatment related adverse events (AEs) included fatigue (34.0%), nausea (17.0%), rash (12.8%), asthenia (8.5%), and pyrexia (5.3%). Grade ≧ 3 AEs developed in 7.4% of the patients. All grades interstitial lung disease developed in 4.3% of the patients. One patient died of grade 5 diarrhea after one dose of nivolumab therapy.
Conclusion:
The efficacy and safety data in Taiwan were in line with previous clinical trial reports. Patients with PS < 2 may have better survival outcome after receiving nivolumab therapy.
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P3.01 - Advanced NSCLC (ID 621)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 10/18/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P3.01-016 - Factors Associated with Symptoms Improvement and HRQoL for First-Line EGFR-TKIs in NSCLC: A Multicenter Prospective SMILE Study (ID 8750)
09:30 - 16:00 | Author(s): T. Hsia
- Abstract
Background:
First-line epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI) offer an advantage compared to doublet chemotherapy in progression free survival, tolerability, and quality of life (QOL) in EGFR-mutated advanced non-small cell lung cancer (NSCLC) patients. In Taiwan, gefitinib, erlotinib and afatinib are all reimbursed as first-line therapy. It provides a rare opportunity to investigate factors associated with the extent of symptoms and QOL improvement in real-world patient population.
Method:
We conducted a multicenter, prospective, observational study to evaluate the QOL and disease-related symptoms at baseline, 2, 4, and 12 weeks in EGFR-mutated advanced NSCLC patients with first-line EGFR TKI treatment. QOL was assessed by the instrument of Functional Assessment of Cancer Therapy-Lung questionnaire (FACT-L) and Treatment Outcome Index (TOI) derived from FACT-L. Symptoms assessment was evaluated by the Lung Cancer Subscale (LCS). The mean change from baseline of QoL and LCS score was analyzed by paired t-test.
Result:
The average age was 65.1± 12.5 (range 31.4–92.9) years old, with a larger proportion of females (62.6%) than males, and more never-smokers (74.0%) than ever-smokers. Patients were treated with gefitinib 250 mg (72.4%), erlotinib 150 mg (18.9%) or afatinib 40 mg (8.7%). For FACT-L, the total score was increased by 4.0 ± 15.49 at week 2, 4.9 ± 18.31 at week 4, and 4.1 ± 20.44 at week 12 (all p<0.001). Similarly, increased TOI of 2.4 ± 11.61 (p<0.001), 3.1 ± 13.48 (p<0.001), and 2.4 ± 14.35 (p=0.009) were observed at week 2, 4, and 12, respectively. For LCS, it was slightly increased by 1.7 ± 4.59 at week 2, 2.0 ± 5.48 at week 4, and 1.9 ± 5.35 at week 12 (all p<0.001). In general, subgroup analyses indicate that patients with more than 2 metastatic sites and ex-smokers were associated with clinically meaningful improvement in terms of LCS (change in LCS ≥ 2 points). Other subgroup analyses show that patients with characteristics such as at least 3 metastatic sites, ex-smoker, PS of 1, and treatment with gefitinib group, were associated with improved QOL in terms of TOI and FACT-L.
Conclusion:
In EGFR mutated NSCLC patients, first-line EGFR-TKI treatment was associated with improvement in disease-associated symptoms and QOL. Patients with 2 or more metastatic sites and ex-smokers were associated with symptoms and QOL improvement. In addition, PS of 1 and treatment with gefitinib were associated with clinical meaningful improvement in global QOL.
