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L. Havel
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IA02 - Interactive Session Staging Group I (Ticketed Session) (ID 287)
- Event: WCLC 2016
- Type: Interactive Session
- Track: Radiology/Staging/Screening
- Presentations: 1
- Moderators:
- Coordinates: 12/05/2016, 11:00 - 12:30, Schubert 3
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IA02.01 - Interactive Session Staging (ID 6528)
11:00 - 12:30 | Author(s): L. Havel
- Abstract
- Presentation
Abstract not provided
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IA06 - Interactive Session Staging Group II (Ticketed Session) (ID 292)
- Event: WCLC 2016
- Type: Interactive Session
- Track: Radiology/Staging/Screening
- Presentations: 1
- Moderators:K. Dieckmann, H. Prosch
- Coordinates: 12/06/2016, 11:00 - 12:30, Schubert 3
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IA06.01 - Interactive Session Staging (ID 6520)
11:00 - 12:30 | Author(s): L. Havel
- Abstract
Abstract not provided
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P2.03a - Poster Session with Presenters Present (ID 464)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)
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P2.03a-026 - Pemetrexed (Alimta) in Maintenance Therapy of 194 Patients with Advanced Non-Small-Cell Lung Cancer (NSCLC) (ID 4206)
14:30 - 14:30 | Author(s): L. Havel
- Abstract
Background:
The effectiveness and safety of continuation maintenance therapy with pemetrexed versus the watch-and-wait approach was proved by a large randomised phase III trial (Paz-Ares et al., 2013). We focused on continuance maintenance therapy with pemetrexed (Alimta) in routine clinical practice in the Czech Republic.
Methods:
The primary objective of our analysis was to evaluate the overall survival, defined as the length of time from the start of maintenance therapy to the date of death. Data was summarised using the standard descriptive statistics, absolute and relative rates for categorial variables, averages for continuous variables, 95% confidence intervals, as well as median, minimum and maximum values. Kaplan-Meier survival curves were used to display the patient survival. All analyses and graphical outputs were performed in the SAS 9.4 Software.
Results:
The analysed cohort of NSCLC patients treated with pemetrexed maintenance therapy in the Czech Republic as on March 2016 involved 194 patients. The median age was 64,0 years; stage IV was the predominant clinical stage (84,5%), 52.6% of patients were men, and 47,4% women. Adenocarcinoma was in 190 patients. From a total of 194 patients, treatment response was assessed in 173 patients. Among the assessed patients one showed complete regression (CR), 34 of them (19.7%) showed partial regression (PR), stable disease (SD) was the most frequent response, reported in 95 patients (54,9%); progression occurred in 36 patients (20.8%). Adverse events led to the termination of treatment in only 6 (3.5%) patients. The median number of cycles of maintenance therapy in our study was 5.0 (1.0; 24.0), and the median duration of maintenance therapy was 13.0 weeks. In the registration trial, the median number of cycles was 4.0 (1.0; 44.0). Median overall survival (median OS), was 15.4 months (95% CI: (12,7-18.18).
Conclusion:
The continuation maintenance therapy with pemetrexed (Alimta) has been shown to be effective and well tolerated in the Czech population. Treatment had to be terminated only in 6 (3.5%) patients due to adverse events. In the registration trial involving 359 patients (Paz-Ares et al., 2013), the continuation maintenance therapy with pemetrexed led to the median OS of 13.9 months, whereas in the Czech Republic, the median OS has been 15,4 months so far. However, a lower number of patients treated in the Czech Republic must be taken into account, and therefore this result is considered as preliminary.
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P3.02b - Poster Session with Presenters Present (ID 494)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
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P3.02b-082 - Gefitinib in First-Line Treatment of Caucasian Patients with NSCLC and EGFR Mutations in Exons 19 or 21 (ID 4207)
14:30 - 14:30 | Author(s): L. Havel
- Abstract
Background:
This study evaluates treatment outcomes in 182 NSCLC of Caucasian patients from Czech Republic according to activated mutations located in exons 19 (Del19) and 21 (L858R).
Methods:
NSCLC patients with EGFR activated mutations were treated with gefitinib in first line between 02/2010 and 3/2016 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 (Del 19) and 21 (L858R).
Results:
Out of 182 patients, 119 (80 female, 39 male) had EGFR mutations in exon 19, and 63 (43 female, 20 male) in exon 21. Median age was 66 years in group with mutations in exon 19 and 69 years in group with mutations in exon 21. There was no statistically significant difference in gender ( p=0.999) and in age (p=0.093). No statistically significant difference was observed in the representation in smoking (p=0.0999). There was statistically significant difference in adenocarcinoma proportion (p=0.034). In the group with Del 19 were 97.56% patients with adenocarcinoma and in the grpup with L858R 88.9%. Between these two groups, there was no statistically significant difference according to performance status (p=0.999); according clinical stages (p=0.999). There was no statistically significant difference according to disease control (CR+PR+SD) (p=0.524); no statistically significant difference according the response to the treatment (CR + PR) (p=0.864). Statistically significant difference in the overall survival (OS) of patients was not proved on the chosen significance level of α=0.05. P-value of the Log-rank test: p=0.452. In the group of patients with Del19, the median OS was 21,4 months (CI 95%: 18.77- 24.28), in the group with L858R the median OS was 16.3 months (CI 95%: 10.1- 21.8). Median OS in both groups together was 20.2 months (CI 95%: 16.9- 23.5). There was no statistically significant difference (p=0.142) in progression free survival (PFS); in the group of patients with Del 19 it was 11,7 months (CI 95%:10.0-13.5), and in the group with L858R it was 8,8 months (CI 95% 6.9-10.6). Median PFS in both groups together was 10,6 months (CI 95%: 8.9-12.3). SimiIar numbers of adverse effects were observed in either group (33.6% and 33.3%).
Conclusion:
In both groups of patients, the treatment with gefitinib was very safe. 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.
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P3.06 - Poster Session with Presenters Present (ID 492)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Trial Design/Statistics
- Presentations: 1
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
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P3.06-001 - Phase I/II Study to Evaluate Safety and Efficacy DCVAC/LuCa with 1st Line Chemotherapy +/- Immune Enhancers vs Chemotherapy, Stage IV NSCLC (ID 4591)
14:30 - 14:30 | Author(s): L. Havel
- Abstract
Background:
Lung cancer (LuCa) has been the most common cancer in the world for several decades and also the most common cause of death from cancer worldwide. Immunotherapy, for induction of tumor cell specific immune responses destroying tumor cells, has emerged as a promising treatment modality in solid malignant tumors. Studies have shown that chemotherapy can be combined with vaccine without impairing the immune response.
Methods:
SLU01 is a randomized, open, parallel-group, multicenter, international phase I/II study to evaluate the efficacy and safety of DCVAC/LuCa (active cellular immunotherapy based on dendritic cells) added to standard first line chemotherapy with carboplatin and paclitaxel +/- immune enhancers (interferon-α and hydroxychloroquine) vs chemotherapy alone in patients with Stage IV NSCLC. The study was initiated in December 2014 and plans to enroll 105 patients at approximately 12 sites in Czech and Slovak Republics. Eligible patients are required to present with metastatic NSCLC defined by histologically or cytologically confirmation and ECOG score 0-1. All patients will receive Standard of Care (SoC) carboplatin and paclitaxel, and will be randomized 1:1:1 to DCVAC/LuCa or DCVAC/LuCa + immune enhancers (pegylated IFN-α2b and hydroxychloroquine) or SoC only. Patients will be stratified by histology subtype adenomatous or squamous cell carcinoma and smoking history. The primary objective is to compare efficacy of DCVAC/LuCa + chemotherapy +/- immune enhancers vs. chemotherapy alone in patients with stage IV NSCLC, as measured by progression free survival (PFS). Secondary objectives include assessments of safety, objective response rate (ORR), duration of response (DoR) and overall survival (OS). Exploratory objectives include comparison of changes in immune responses and search for prognostic biomarkers. Clinical trial information: EudraCT number 2014-003084-37.
Results:
Section is not applicable
Conclusion:
Section is not applicable
