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B. Chewaskulyong
Author of
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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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P3.01-042 - Efficacy & Tolerability of Afatinib in NSCLC Patients Prior Exposure to 1st Generation EGFR TKI: Thailand Multicenter Study (ID 9455)
09:30 - 09:30 | Author(s): B. Chewaskulyong
- Abstract
Background:
The Compassionate-Use-Program (CUP) was available in Thailand for requesting afatinib during 2012-2014 for patients whom had failed at least one-line of platinum-based-chemotherapy and progressed following at least 6 months on 1[st]-generation EGFR-TKIs. This is a multicenter-retrospective-study in Thailand aimed to explore the efficacy and tolerability of afatinib in this group of patients.
Method:
Full medical-records of 79 patients from 7 institutions were reviewed. Clinical and tumor characteristics were analyzed using descriptive statistics. The efficacy in brain metastases was explored. Survival curves were constructed using the Kaplan-Meier method. All analysis was done in Stata version14.
Result:
Sixty-eight percent of patients were younger than 65 years old, 60% were female, and 67% received more than 2 of prior-regimen. EGFR-mutation was tested in 75% of patients; comprise of 86% common-mutations, 14% uncommon-mutations. Eleven patients had T790M acquired-resistance in combination with sensitive-mutation before receiving afatinib. One patient had De-novo-T790M. The mOS, mPFS, and mTTF were 11.5, 3.9, and 5.1 months, respectively. Eighteen patients had brain-metastases at enrollment and 6 patients had new brain-metastases during afatinib treatment. The mOS, mPFS, and mTTF were not statistically different among new brain-metastases or pre-existing brain-metastases. There was no dose-reduction in 38%, 1 dose-reduction 44%, 2 dose-reductions 12%, and 3 dose-reductions 6% of patients. The mean dose for every patient was 35 mg. Time-to-first-dose-reduction significantly affected the mPFS and mTTF as shown in Table. Furthermore, number of prior-treatment more than 2 was the significant factor causing first-dose-reduction within 1 month and age younger than 65 years-old was the significant factor causing first-dose-reduction within 2 and 3 months in multivariate and univariate model, respectively.Time to 1[st] dose reduction OS PFS TTF Hazard ratio (95%CI) P-value Hazard ratio (95%CI) P-value Hazard ratio (95%CI) P-value > 1 month <= 1 month 1 1.59 (0.74-3.41) 0.23 1 1.52 (0.82-2.82) 0.19 1 1.45 (0.77-2.74) 0.25 >2 month <= 2 months 1 1.54 (0.72-3.3) 0.27 1 2.11 (1.14-3.92) 0.02 1 1.63 (0.88-3.04) 0.12 >3 months <= 3 months 1 2.31 (0.98-5.45) 0.06 1 2.67 (1.38-5.20) 0.004 1 2.12 (1.09-4.12) 0.03
Conclusion:
The mOS, mPFS, and mTTF of our study were comparable with LUX-Lung1 study. Number of prior-treatment and age were the significant factors causing dose-reduction. Taken together with time-to-first-dose-reduction also affected the survival of patients.