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H. Coupkova
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P2.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 207)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P2.01-071 - TULUNG REGISTRY: Data Analysis of Patients with Non-Squamous NSCLC Treated with Bevacizumab in the Czech Republic (ID 2934)
09:30 - 17:00 | Author(s): H. Coupkova
- Abstract
Background:
We conducted a systematic review of data from patients reported in the TULUNG registry (data cut-off 26-Jan-15). The TULUNG registry is Czech national oncology registry which prospectively collects data from all NSCLC patients treated with new targeted therapies in Czech Republic since 2008.
Methods:
Analysis was performed on a group of patients with non-squamous NSCLC with good performance status (PS 0-2), treated with bevacizumab. Since 2008 bevacizumab has been used for treatment in 193 patients (full record criteria met). 10 patients with incomplete records were not included to the review
Results:
In this group of patients 35.8% were female; the median age at bevacizumab treatment initiation was 60 years (range 29-83). The majority of patients were smokers and ex-smokers (37.8% and 34.7% respectively) and 91.7% of tumors were adenocarcinomas by histology. 91.7% patients were at the metastatic stage at the initiation of bevacizumab treatment, 6.2% of patients were in stage IIIb and only 2.1% of patients in stage IIIa (UICC6). The performance status was distributed between ECOG PS0 and PS1 mainly (40.9% PS0 and 58% PS1)at the initiation of the bevacizumab treatment. Majority of patients received bevacizumab treatment in the first line (96.4%). Two main chemotherapy regimens were used; carboplatin+paclitaxel (68.4%) and cisplatin+gemcitabine (9.8%). In this group of 193 patients analyzed, bevacizumab therapy was terminated in 152 (78.8%) patients at data cut-off. The most frequent reasons for termination were disease progression, in 55.9%, termination of treatment according to plan in 8.6% and death, in 7.9% of patients. Treatment with bevacizumab is ongoing in 41 (21.2%) patients. In 152 of patients with terminated treatment, the median duration of treatment was 15.6 weeks (95% CI 0.3 – 51.3). Response assessment showed CR in 0.7%, PR in 40.8% and SD in 35.5% of patients. Median progression free survival was 6.9 months (95% CI 5.8 – 8.1), median overall survival 16.7 months (95% CI 11.7 – 21.7). 1-year survival from bevacizumab treatment initiation was 67.9%. Adverse events were reported in 9.8% of patients, the most frequently reported adverse events were thromboembolic events (5.2%) and neutropenia (1.6%). Tromboembolic events were observed in 10 patients, none of these was fatal. We didn´t observe any severe episode of bleeding event.
Conclusion:
Therapy with bevacizumab in non-squamous NSCLC was active and very well tolerated. In eligible patients, only 7 patients (4.6%) had to discontinue bevacizumab therapy due to safety reasons. In patients with completed bevacizumab therapy 77.0% disease control rate was reached with a median survival of approximately 16.7 months from initiation of first line therapy with bevacizumab.
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P3.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 208)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P3.01-008 - Gefitinib in Front-Line Treatment of 161 Caucasian Patients with NSCLC of the Czech Republic (ID 424)
09:30 - 17:00 | Author(s): H. Coupkova
- Abstract
Background:
Gefitinib is a potent oral non-cytotoxic, active and selective epidermal growth factor receptor tyrosine kinase inhibitor. This study evaluates treatment outcomes in 161 NSCLC patients from Czech Republic according to activated mutations located in exons 19 and 21.
Methods:
Data treated patients with gefitinib are collected in the TULUNG registry, which is a common project of the Czech Pneumological Society, Czech Oncological Society, and Institute Biostatistics and Analyses Masaryk University Brno. NSCLC patients with EGFR activated mutations were treated in first line between 02/2010 and 12/2014 in 10 institutions. Retrospective analyses were carried out to assess the effectiveness and safety of gefitinib treatment according to activated mutations located in exons 19 and 21. The analysed outcomes include following: treatment response rate, median Overall Survival (mOS), median Progression Free Survival (mPFS) and occurrence of types adverse events.
Results:
Out of 161 treated patients, 105 (70 female, 35 male) had EGFR mutations in exon 19, and 56 (39 female, 17 male) had EGFR mutations in exon 21. Median age was 66 years in the group with mutations in exon 19 and 69 years in the group with mutations in exon 21. There was no statistically significant difference in sex (p=0.727) and in age (p=0.204). No statistically significant difference was observed in the representation in smoking (p=0.354). There was statistically borderline significant difference in adenocarcinoma proportion (p=0.045). In the group with mutations in exon 19 were 96% patients with adenocarcinoma and in the group with mutations in exon 21 were 85% patients with adenocarcinoma. Between these two groups, there was no statistically significant difference according to performance status (p=0.547); no statistically significant difference according to disease control (CR+PR+SD) (p=0.479); no statistically significant difference according the response to the treatment (CR + PR) (p=0.052). There was no statistically significant difference in mOS (p=0.390). In the group of patients with mutations located in exon 19, the overall survival was 22.7 months (CI 95%: 17.7; 27.8), in the group with mutations in exon 21, overall survival was 16.3 months (CI 95%: 10.8; 21.8). There was no statistically significant difference (p=0.202) in mPFS; in the group of patients with mutations in exon 19 it was 11,0 months (CI 95%:9.1; 12.8) and in the group with mutations in exon 21 it was 9.4 months (CI 95% 6.6; 12.2). SimiIar numbers of adverse effects were observed in either group (35.2% and 35.7%). Almost 70% of patients with mutations in exon 19 and almost 60% of patients with mutations in exon 21 are still alive or were lost to follow up. These patients are censored to the date of last update.
Conclusion:
In both groups of patients, the treatment was very safe. Median PFS and median OS were satisfactory without statistically significant differences between the two groups; however, a better trend was observed in the group of patients with mutations in exon 19. Consequently survival estimates shows great variability and longer potential follow up is needed to confirm these results.
