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M. Pesek
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P1.04 - Poster Session with Presenters Present (ID 456)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Pulmonology
- Presentations: 2
- Moderators:
- Coordinates: 12/05/2016, 14:30 - 15:45, Hall B (Poster Area)
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P1.04-012 - Single Center Experience with Nivolumab Administration in NSCLC Patients from EAP Program (ID 4862)
14:30 - 14:30 | Author(s): M. Pesek
- Abstract
Background:
Immunotherapy using monoclonal antibody against PD-1 receptor (nivolumab) offers another possibility to improve tumor control in patients with advanced squamous (SQ) and non-squamous (NSQ) NSCLC.
Methods:
We present first experience with nivolumab in Early Access Program (EAP). Nivolumab tolerability, safety data, frequency of therapeutic responses and ADRs will be presented in 42 patients with advanced SQ and NSQ NSCLC.
Results:
22 patients with SQ-NSCLC entered EAP, 3 patients did not start therapy (2 early deaths and 1 refusal) and 19 patients received treatment (16 males, 3 females). Therapy was discontinued in 9 patients (7x disease progression, 2x serious ADR). Therapy is currently withold in 4 patients due to management of ADRs and 7 patients continue to receive nivolumab. 5 patients died (26%) with median follow up of 9 months in this group. 20 patients with NSQ histology were included in EAP, 2 patients from this group died before initiation of therapy and 1 patient did not receive nivolumab due to worsening of her performance status. 17 patients were treated with at least one dose of nivolumab (10 males, 7 females). Therapy was discontinued in 8 patients (7x disease progression, 1x due to gastrointestinal toxicity with grade 3 diarrhea). Treatment is currently withold in 6 patients due to management of ADRs and 4 patients continue to receive nivolumab. 5 patients (29%) in this group died with median follow up of 5 months. So far, we have seen 7 partial remissions in all 36 treated patients with NSCLC (19%) which corresponds to data from registration studies of nivolumab. Disease stabilization was reported in other 7 patients giving the disease control rate of 38%. As expected from nivolumab mechanism of action, adverse drug reactions are usually immune related. Serious ADRs were rarely observed including neurological toxicity (difficulty to swallow and diplopia), diarrhea, pneumonitis and skin toxicity (lichen ruber planus).
Conclusion:
In general, patients from EAP program were more pretreated compared to patients in registration studies (therapy allowed in 3rd and 4th line), also patients with PS2 were included (only PS 0 and 1 in the trials). Treatment with nivolumab was well tolerated and it brings the benefit for some patients after 1-3 lines of previous anticancer therapy. Although serious ADRs are relatively rare, management of side effects requires good cooperation with the patients as well as cooperation with highly specialized departments (gastroenterologists, endocrinologists, dermatologists).
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P1.04-013 - Diagnostics and Treatment of ALK-Positive NSCLC Patients - A Single Center Experience (ID 5152)
14:30 - 14:30 | Author(s): M. Pesek
- Abstract
Background:
ALK positive advanced NSCLC patients could get significant benefit of targeted therapy. In Czech Republic, targeted therapy is payed just as second-and more line treatment, required positive FISH result of ALK-positive NSCLC tumour.
Methods:
We investigate ALK-rearrangement in selected group of NSCLC patients starting from January 2011 via fluorescence in situ hybridization (FISH) with the Vysis ALK Break Apart FISH Probe Kit (Abbott Molecular). We evaluate frequence of positive and inconclusive results. In the group of ALK positive patients we evaluate clinical behaviour of tumours and effectivity and side effects of ALK inhibitors.
Results:
From January 2011 till June 2016, 798 nonsquamous NSCLC tumour samples were evaluated by FISH method. 20 (3.2 %) of evaluable 660 samples were positive, 138 tumour samples were clasified as ALK break inconclusive (17.3 %). ALK break positive group of patients consist of 13 men and 7 women, median age 68.5 years. 17 of them were adenocarcinomas, in two there were adenosquamous histology and in one NSCLC-NOS was found. The limit of ALK positivity was 10 % positive cells, the range of our positive results were 10 – 72 %. 6/20 patients were treated by crizotinib. Two of them received second ALK inhibitor ceritinib after failure of crizotinib, those patients are alive and well 5 and 8 years from diagnosis of adenocarcinoma st. IV. Three patients died before they could get an access to targeted therapy, seven others with low PS died before start of targeted therapy, in three others there is not actual need for targeted treatment. One patient on crizotinib died after 11 months of targeted treatment, two other died after one month of treatment, in one patient targeted therapy was refused due to intolerance.
Conclusion:
Patients suffering from advanced ALK rearranged NSCLC should have perspectives of long lasting tumour response on ALK inhibitors. ALK rearrangement investigations should be done in nonsquamous NSCLC routinely. In our departments, we have relatively high frequency of inconclusive ALK testing results. However, it is not easy to get adequate tissue sample from routine investigations. Positive results are found most frequently in adenocarcinoma patients. We consider due to rapid progression of ALK positive tumours on chemotherapy that targeted therapy should be realised as a first line option.
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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): M. Pesek
- 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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P2.03b - Poster Session with Presenters Present (ID 465)
- 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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P2.03b-045 - Assessment of microRNAs in FFPE Tissue for Prediction of the Effect of Palliative Chemotherapy for Squamous Cell Carcinoma of the Lung (ID 4182)
14:30 - 14:30 | Author(s): M. Pesek
- Abstract
Background:
Background: Due to their pathophysiological role and stability in biological samples, microRNAs have the potential to become valuable predictive markers for non-small cell lung cancer (NSCLC). Samples of biopsy tissue constitute suitable material for microRNA profiling with the aim of predicting the effect of palliative chemotherapy.
Methods:
Patients and Methods: Our study group consisted of 81 patients (74 males, 7 females, all of them smokers or former smokers) with late stage (3B, 4) of squamous cell carcinoma (SCC) histological subtype of NSCLC. All patients underwent palliative chemotherapy based on platinum derivatives in combination with paclitaxel or gemcitabin. The expression of 17 selected microRNAs was measured by quantitative RT PCR in tumor tissue macrodissected from formalin-fixed paraffin-embedded (FFPE) tissue samples. To predict the effect of palliative chemotherapy, the relationship between gene expression levels and overall survival (OS) was analysed.
Results:
Results: From the set of the 17 microRNAs of interest, we found relation of high expression levels of miR-34a and miR-224 to shorter OS.
Conclusion:
Conclusions: In routinely available FFPE tissue samples, we found microRNAs with a relation to OS, which may be candidate predictors of the effectiveness of palliative treatment in SCC lung cancer patients. Such microRNAs could help in decision about the type of palliative chemotherapy - patients with predicted poor treatment effect could be candidates to available clinical trials.
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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): M. Pesek
- 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): M. Pesek
- 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:
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Conclusion:
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