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Luis Enrique Chara
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EP1.06 - Mesothelioma (ID 196)
- Event: WCLC 2019
- Type: E-Poster Viewing in the Exhibit Hall
- Track: Mesothelioma
- Presentations: 1
- Now Available
- Moderators:
- Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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EP1.06-09 - Mesothelial Tumors Registry in Spain: A Retrospective Multicenter Study (Now Available) (ID 2327)
08:00 - 18:00 | Author(s): Luis Enrique Chara
- Abstract
Background
Malignant mesothelioma is an unusual tumor associated with poor prognosis. Currently, there are no effective treatments after the progression to the first line. The aim of this study is to analyze the experience in 7 spanish centers.
Method
We conducted a retrospective analysis including patients with malignant mesotheliomas of 7 centers in Spain. Demographic, clinical and pathological variables, tumor response, progression date and death were collected.
Result
We enrolled 63 patients with diagnosis of malignant mesothelioma. The average age was 70 years. 73,4% were men and 26,4% women. The most frequent location was the pleural (78,1%) and biopsy was the main diagnostic method (92,2%). 76,6% were diagnosed as epitheloid mesothelioma subtype, whereas sarcomatoid and mixed subtypes were less frequent. Tumor in stage IV was presented at diagnosis in 75 % cases. The most frequent first treatment was chemotherapy, 95,2% of patients received treatment based on platinum doublet with pemetrexed, followed by pemetrexed maintenance. Best response was partial response in 20,6% , stable disease in 41,3% , complete response in 22,2% and progressive disease in 15,9%.The median progression free survival of the sample was 8,8 months, and the median overall survival was 12 months.
Conclusion
The demographics and baseline characteristics as well as the survival data obtained in our sample are consistent with the previously reported.
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P1.01 - Advanced NSCLC (ID 158)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Advanced NSCLC
- Presentations: 1
- Now Available
- Moderators:
- Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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P1.01-130 - Clinical Experience with Nintedanib in Previously Treated Non-Small Cell Lung Cancer in Spain: A Retrospective Multicenter Study (Now Available) (ID 2260)
09:45 - 18:00 | Author(s): Luis Enrique Chara
- Abstract
Background
Lung cancer is the leading cause of cancer deaths worldwide. Nintedanib is a triple angiokinase inhibitor approved with docetaxel for non-small cell lung cancer after chemotherapy. The aim of this study is to analyze the efficacy and safety of nintedanib in combination with docetaxel in patients treated in various Spanish centers.
Method
We conducted a retrospective multicenter study, which included all patients with non-small cell lung cancer who received nintedanib with docetaxel in second o third line of treatment.
Result
We enrolled 124 patients from ten different Spanish centers. The male –female ratio was 3:2, with an average age of 62 years. 82,7% were smokers, 12,2% never smokers and 5,7% former smoker. The most frequent histology was adenocarcinoma (97,6%) and respect mutational state only 5 patients were EGFR mutate and 1 patient presented ALK translocation. PDL1 status was unknown in 46,3% of cases, negative in 32,5% and positive in 21,1%. The majority of patients were diagnosis in stage IV (74%) and in stage III (13,8%). In the first line, 98,4% had received platinum-based chemotherapy and 40,7 % had received previous bevacizumab therapy with an average of 4,1 cycles.
The average of nintedanib cycles was 6 and the median time of treatment was 496 days. 65,9% of patients included had progressed to the first line in less than 9 months. The disease control rate was 61% (25,2% stable disease, 34,1% partial response and 1,6% complete response). Progression free-survival was 4,1 months and the overall survival was 26,9 months. The most common adverse events were: fatigue ( 82,1%), diarrhea (63,4%), nausea (32,5%), neutropenia (33,3%) and cough (18,2%). Thirty-one patients (25,2%) required dose adjustment (15 patients decrease to 200 mg daily and 18 patients to 300 mg daily).
Conclusion
The efficacy and safety of nintedanib in our cohort is similar to the previously reported. Nintedanib in combination with docetaxel is an effective treatment option for patients with advanced non-small cell lung cancer.
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P1.04 - Immuno-oncology (ID 164)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Immuno-oncology
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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P1.04-16 - Early Antibiotic Use Affects the Efficacy of First Line Immunotherapy in Lung Cancer Patients but Route of Administration Seems to be Decisive (ID 1155)
09:45 - 18:00 | Author(s): Luis Enrique Chara
- Abstract
Background
Several studies found that cancer patients treated with PD-1 immune checkpoint inhibitors (CKIs) who receive antibiotics (ATX) had worse efficacy outcomes because ATX can dysregulate gut microbiota. There are some data in pretreated non-small-cell lung cancer (NSCLC) and few data about the route of ATX administration, but it`s unkown whether ATX administration can also affect efficacy of CKIs in first line setting in patients treated with pembrolizumab monotherapy.
Method
This is a multicenter retrospective study. We included consecutive patients with advanced NSCLC with high PD-L1 expression (50%) treated with pembrolizumab monotherapy in first line, between September 2016 and March 2019, from 12 hospitals in Spain. The aim of the study was to evaluate if patients taking ATX 2 months before or within the first month after starting CKIs had worse OS, and if OS was affected by the route of administration and type of prescribed ATX.
Result
121 patients were evaluated. Median age was 68 years (38-88). 90 (74,4%) were male and 90 (74,4%) had PS1. Predominant histologies were adenocarcinoma (68,6%) and squamous-cell carcinoma (23,1%). Median number of cycles was 7 (1-33). Median follow-up: 6,5 months. Most were current or former smokers (95,9%). Only 1 patient had driver mutation (ALK rearrangement). 66,9% had 2 or more metastatic locations, 18,2% had central nervous system (CNS) disease, 17,4% liver metastasis, and 41,3% bone metastasis. 45,5% received ATX, 65,5% of them intravenously and 34,5% orally. Most prescribed ABX were quinolones (40,7%) and penicillin or derivatives (35,2%). 21,5% received subsequent chemotherapy. Response rate was 40,4% according to RECISTv1.1 criteria. 11% had hyperprogression and 7,2% pseudoprogression. Estimated 12-month-OS was 62% (95%CI: 49.1%-72.5%) and estimated 12-month-PFS was 44.2% (95%CI: 31.1%-56.5%) Patients who received ABX had more risk of disease progression as best response (52,2% vs 24,5%,RR: 2.1, 95%CI: 1.2-3.7, p=0.007). Patients who received ATX had shorter OS (HR:1.9, 95%CI: 1.1-3.7, p=0.047) and shorter PFS (HR:2.6, 95%CI: 1.4-4.8, p=0.002). Patients who received ATX intravenously had shorter OS than those not treated (HR:2.8, 95%CI: 1.4-5.6) and than those who received ABX orally (HR:3.5, 95%CI: 1.2-10.3, p=.025) ). Patients treated with ABX also had shorter PFS than those not treated (HR: 3.5, 95%CI:1.8-6.8, p<0.001) and than those who received ABX orally (HR: 2.2, 95%CI:1-4.8, p=0.05). Similar HR were estimated adjusting by age, gender, stage, and hepatic and bone metastasis presence. There were no OS and PFS differences between patients who received ABX orally and those who did not received them. There were no survival differences according to type of ABX.
Conclusion
Our results suggest that use of intravenous ABX has a negative impact on disease control rate and survival outcomes (PFS and OS) in patients with naïve advanced NSCLC and high PD-L1 expression treated with pembrolizumab monotherapy in first line setting. Patients who received oral ABX had similar efficacy than those not treated with ABX. To our knowledge, this is the first retrospective study evaluating the impact of ATX on the efficacy of CKIs in first-line treatment setting of NSCLC patients.
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P2.01 - Advanced NSCLC (ID 159)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Advanced NSCLC
- Presentations: 3
- Now Available
- Moderators:
- Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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P2.01-55 - Immunotherapy First or After Nintedanib?: A Spanish Experience (Now Available) (ID 2308)
10:15 - 18:15 | Author(s): Luis Enrique Chara
- Abstract
Background
Anti PD-1 and PD-L1 immunotherapies have demonstrated improved survival as second line treatment of patients with advanced lung cancer, and actually, this is a standard of care. In addition, Nintedanib-docetaxel is an option for few patients, and have demonstrated efficacy in second line treatment after platinum-based chemotherapy. The doubt is if immunotherapy could be change efficacy of nintedanib-docetaxel treatment.
Method
We conducted a retrospective multicenter study, which included all patients with non-small cell lung cancer who received nintedanib with docetaxel in second o third line of treatment. The objective of this study was to determine the efficacy of the nintedanib-docetaxel combination before and after immune checkpoint inhibitors.
Result
We enrolled 120 patients from 10 different Spanish centers. 72.4% had not received previous immunotherapy, while 27.6% had received it. Of those who had received previous immunotherapy: 10.6% received pembrolizumab, 10.6% received nivolumab and 3,3% received atezolizumab. Receiving previous immunotherapy had no impact on the PFS (4.5 months vs 3.2 months) or on the OS of the patients (25 months vs 20 months). Best response was partial response in 11 patients, stable disease in 11 patients and progressive disease in 10 patients. After the progression to nintedanib/docetaxel, 21.9% received immunotherapy. 15 patients received nivolumab, 10 patients atezolizumab and 2 patients pembrolizumab. Best response was partial response in 13 patients, stable disease in 5 patients, complete response in 1 patient and progressive disease in 8 patients. Subsequent treatment with immunotherapy was not associated with increased SLP or OS in our study.
Conclusion
Our experience suggests that the efficacy of nintedanib-docetaxel treatment is not modified by the treatment of previous or subsequent with immunotherapy.
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P2.01-81 - Predictive Factors of Survival in Patients Treated with Nintedanib: A Multicenter Retrospective Spanish Study (Now Available) (ID 2275)
10:15 - 18:15 | Author(s): Luis Enrique Chara
- Abstract
Background
Nintedanib is a triple angiokinase inhibitor that blocks the proangiogenic pathways mediated by vascular endothelial growth factor receptors, platelet-derived growth factor receptors and fibroblast growth factor receptors. Nintedanib in combination with docetaxel is indicated for adults with adenocarcinoma metastatic lung cancer after chemotherapy. Although, as in other antiangiogenic therapies, we do not have a predictive response marker. The aim of this study is to analyze probably factors that influence in the response to the nintedanib-docetaxel scheme.
Method
We conducted a retrospective multicenter study, which included all patients with non-small cell lung cancer who received nintedanib with docetaxel in second or third line of treatment. Explorative analyses were conducted according to therapy antiangiogenic previous, status PDL1, nintedanib or docetaxel dose adjustment and time to treatment fail in previous line (> 9 months or < 9 months) , age, sex and smoking.
Result
We enrolled 124 patients from 10 different Spanish centers. Progression free-survival was 4,1 months and the overall survival was 26,9 months. Of the factors studied, only the dose adjustment of docetaxel during treatment (5,7 months vs 2,7 months, p<0,05) and the dose adjustment of nintedanib ( 7,2 months vs 4,7 months, p<0,05 ) were associated with an increase in PFS. The dose adjustment level of nintedanib (100 mg vs 150 mg twice) did not reach statistical significance. The only factors that achieved statistical significance in overall survival were progression to the first line> 9 month (36,5 months vs 19,3 months, p <0.05) and the dose adjustment of nintedanib (37 months vs 22 months, p < 0.05). Therapy antiangiogenic previous, status PDL1, age, sex and smoking did not increase survival.
Conclusion
In our study, nintedanib- docetaxel concluded significant OS benefits in adenocarcinoma lung cancer patients with time to relapse to first line >9 months and in patients with dose adjustment during treatment. Further studies are needed to verify this data.
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P2.01-98 - Neutrophil-Platelet Score (NPS), a Predictive Systemic Inflammation Score for Pembrolizumab in First Line of Advanced NSCLC Patients (ID 2711)
10:15 - 18:15 | Author(s): Luis Enrique Chara
- Abstract
Background
Systemic inflammation response can be characterized by changes of peripheral blood cell amounts. Several blood cell-based scores have been found to have prognostic value in some tumors treated with ICI. Neutrophil-platelet score (NPS) is a systemic inflammation-based score characterizing 3 prognostic groups: good (0), neutrophils <=7500 and platelets <=400000; intermediate (1), neutrophils >7500 or platelets >400000; poor (2), neutrophils >7500 and platelets >400000). It has never been evaluated as prognostic biomarker in first line treatment setting of non-small-cell lung cancer (NSCLC) patients treated with pembrolizumab.
Method
This is a multicenter retrospective study with the aim to evaluate prognostic value of NPS in patients with advanced NSCLC and high PD-L1 expression treated with pembrolizumab monotherapy between September 2016 and March 2019. Clinical data were contributed by 12 medical centers in Spain. Primary endpoint was association of NPS with overall survival (OS).
Result
121 patients were evaluated. Median age was 68 years (38-88). 90 (74,4%) were male and 90 (74,4%) had PS1. Predominant histologies were adenocarcinoma (68,6%) and squamous-cell carcinoma (23,1%). Median number of cycles was 7 (1-33). Median follow-up: 6,5 months. Most were current or former smokers (95,9%). Only 1 patient had driver mutation (ALK rearrangement). 66,9% had 2 or more metastatic locations, 18,2% had central nervous system (CNS) disease, 17,4% liver metastasis, and 41,3% bone metastasis. Response rate was 40,4% according to RECISTv1.1 criteria. 11% had hyperprogression and 7,2% pseudoprogression. Estimated 12-month-OS was 62% (95%CI: 49.1%-72.5%) and estimated 12-month-PFS was 44.2% (95%CI: 31.1%-56.5%). Higher NPS was associated with poor PFS: NPS1 HR 1,23 (95%CI, 0,61-2,46), p=0,56; NPS2 HR 3,56 (95%CI, 1,61-7,86), p=0,002. NPS was not associated with disease control rate (DCR) or overall response rate (ORR).
Conclusion
NPS predicted OS and PFS in advanced NSCLC patients with high PD-L1 expression treated with first line pembrolizumab monotherapy. NPS2 subgroup has an especially bad prognosis in spite of high PD-L1 expression and frontline treatment with pembrolizumab. These results need to be validated in prospective studies.
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P2.03 - Biology (ID 162)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Biology
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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P2.03-33 - ctDNA Levels Significantly Predicts Survival in NSCLC Patients with an EGFR Activating Mutation (ID 2016)
10:15 - 18:15 | Author(s): Luis Enrique Chara
- Abstract
Background
Circulating tumor DNA (ctDNA) have been shown to be useful for non-invasive biomarker testing in non-small cell lung cancer (NSCLC). In addition, there is growing evidence supporting that ctDNA levels can be useful for tumor response to treatment monitoring. Nevertheless, data from large prospective clinical longitudinal studies still limited.
Method
300 plasma samples from 100 advanced NSCLC patients, with tumors harboring an EGFR activating mutation and treated with a first line tyrosine Kinase inhibitor were analyzed. Samples were collected before the start of treatment, at first follow up evaluation, at 7 month and at disease progression. ctDNA was analyzed by dPCR.
Result
Median follow up was 11.3 months. There were not significant differences in progression free survival (PFS) or overall survival (OS) according to treatment (erlotinib, afatinib or gefitinib). Patients harboring a deletion in exon 19 or a mutation in exon 21 exhibited better survival than those with an insertion in exon 20 (P<0.001). dPCR detected EGFR sensitizing mutation in 77% of the pre-treatment samples. ctDNA levels before the start of the treatment did not significantly predict survival, although a tendency was observed, with patients with high levels of ctDNA showing poorer outcome. On the contrary, patients in which the EGFR sensitizing mutation was undetectable at first follow up had a markedly better PFS and OS (HR=2.7; 95IC= 1.4-5.5 and HR= 5.5 95IC: 1.8-17 respectively). In the same way, patients in which the EGFR sensitizing mutation remained negative at 7months had a significantly increased PFS (HR: 2.8; 95IC: 1.2-6.6). None of the patients with undetectable levels at 7 months has deceased.
Conclusion
ctDNA levels is of prognostic significance in EGFR positive NSCLC patients with advance disease and can be useful to monitor treatment outcome
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P2.05 - Interventional Diagnostic/Pulmonology (ID 168)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Interventional Diagnostics/Pulmonology
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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P2.05-10 - Liquid Biopsy: Association Between the Burden of Disease in Patients with EGFR-Mutated NSCLC and the Frequency of Its Detection in Blood (ID 2384)
10:15 - 18:15 | Author(s): Luis Enrique Chara
- Abstract
Background
In the management of patient’s whit non small cell lung cancer (NSCLC) with EGFR mutations after progression to first and second generation tyrosine kinasa inhibitors (TKI), the mechanism of resistance is very important. Our objective is to analyse the appearance kinetics of the T790M by means of digital PCR techniques in liquid biopsy.
Method
We conducted a multicenter study with 100 patients with EGFR-mutated NSCLC, treated with first-line TKI therapy. We analyze the ctDNA by dPCR before the start of treatment, at first follow up evaluation, at 6 months and at disease progression.
Result
We included a total of 100 patients from July 2016 to December of 2017. Seven patients with Exon 20 insertion in EGFR were excluded (final sample 93). The median of follow-up was 12 months. There were not significant differences in progression free survival (PFS) or overall survival (OS) according to treatment (erlotinib, gefitinib or afatinib). dPCR detected EGFR sensitizing mutation in 77% of the pre-treatment samples. Of these cases, EGFR sensitizing mutation was detected in 75% of the patients with stage IVA and 85% in stage IVB respectively, p=0,075. The resistance mutation p.T790M was detected in 52% of the samples collected at disease progression. The probability to detect the resistance mutation p.T790M by liquid biopsy, is greater if the pre-treatment sample was positive for EGFR sensitizing mutation (11% vs 62%) p 0,009. In cases with progression of the disease the percent of detection of p.T790M was 52% and 54% in patients with Exon 19 deletion and L858R mutation respectively. The OS in patients with progression of the disease and p.T790M negative was 85% at 12 months (95%CI: 60%-94%) and 75% with p.T790M positive (95%CI: 49%-88%), p=0,01.
Conclusion
The burden of disease in patients with NSCLC mutated with EGFR is related to the appearance of sensitivity and resistance mutations in liquid biopsy. The probability to detect the resistance mutation p.T790M in blood, is greater if the pre-treatment sample was positive for EGFR sensitizing mutation.
