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Carlos Aguado



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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): Carlos Aguado

      • Abstract
      • Slides

      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): Carlos Aguado

      • 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): Carlos Aguado

      • Abstract
      • Slides

      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): Carlos Aguado

      • Abstract
      • Slides

      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): Carlos Aguado

      • 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).

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      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.