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Patricia Cruz



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    EP1.01 - Advanced NSCLC (ID 150)

    • Event: WCLC 2019
    • Type: E-Poster Viewing in the Exhibit Hall
    • Track: Advanced NSCLC
    • Presentations: 1
    • Now Available
    • Moderators:
    • Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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      EP1.01-07 - Definitive Results of a Clinical and Molecular Multicentric Characterization of Long-Term Survivors with Advanced Non-Small Cell Lung Cancer  (Now Available) (ID 1191)

      08:00 - 18:00  |  Author(s): Patricia Cruz

      • Abstract
      • Slides

      Background

      Long survivors (LS) in non-small-cell lung cancer (NSCLC), defined as an overall survival (OS) greater than 2 years, are less than 10% in most series. Classical prognosis factors include stage, weight loss and ECOG, but more information is missing in the literature. Recently, EGFR, ALK and ROS 1 population (less than 20%) reach OS longer than 2 years. Immunotherapy has demonstrated very promising results with more LS compared to chemotherapy in first and second line setting. In this study, we focused in the analysis of LS patients with advanced NSCLC EGFR wt (wild type) and ALK nt (non-translocated), defined as those with OS greater than 36 months, in 7 hospitals in Madrid.

      Method

      In this serie, first of all, we will try to make a clinical, histopathological characterization collecting data from clinical reports according to a previously defined information. In a second step, we will carry out a genetic analysis of these patient samples comparing to an opposite extreme short survivors (SS) samples (OS less than 9 months). Initially, we used a NGS method of RNA-seq technology to identify differentiating profiles of gene expression between the two opposite populations. And finally, we confirmed this preliminary profile by RT-PCR in the rest of samples.

      Result

      Ninety-six patients were initially included. The majority were men, smokers or former with adenocarcinoma and ECOG 0- 1. We have obtained a differential transcriptome expression between samples from 6 LS and 6 SS, resulting 13 over-expressed and 42 down-expressed genes in LS comparing to SS transcriptome expression. Some of the genes involved in this initial profile belong to different cellular pathways: Secretin Receptor, Surfactant Protein, Trefoil Factor 1, Serpin Family, Ca-bindings Protein channel and Toll like Receptor family. Finally, we carried on by RT-PCR in 40 samples of SS and LS survivors and only four genes were significantly down-regulated in SS compared to LS in the multivariate analysis. These 4 genes were related to Surfactant Proteins: SFTPA1 (p = 0.023), SFTPA2 (p = 0.027), SFTPB (p = 0.02) and SFTPC (p = 0.047)

      Conclusion

      We present a sequential genetic analysis of a LS population with NSCLC EGFR wt (wild type) and ALK nt (non-translocated), obtaining a differential RNA seq- and RT-PCR gene profile based on different surfactant proteins expression. A further confirmation in a larger sample is ongoing.

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    EP1.06 - Mesothelioma (ID 196)

    • Event: WCLC 2019
    • Type: E-Poster Viewing in the Exhibit Hall
    • Track: Mesothelioma
    • Presentations: 3
    • Now Available
    • Moderators:
    • Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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      EP1.06-02 - Association of Inflammatory Biomarkers with Overall Survival in Patients with Advanced Malignant Pleural Mesothelioma (Now Available) (ID 1964)

      08:00 - 18:00  |  Author(s): Patricia Cruz

      • Abstract
      • Slides

      Background

      The inflammation process has been proposed as a mechanism of immunoresistance in patients with cancer, promoting cancer growth and dissemination. Derived neutrophil to lymphocyte ratio (dNLR) greater than 3 and lactate dehydrogenase (LDH) level greater than upper limit of normal (ULN) are associated with poor outcomes in patients with advanced non–small cell lung cancer. The aim of this study is to determine whether pretreatment levels of dNLR and LDH as well as PD-L1 status are associated with overall survival in patients with malignant pleural mesothelioma.

      Method

      We conducted a retrospective study, which included all patients with malignant pleural mesothelioma diagnosed in a tertiary referral hospital from December 2009 to March 2019. PDL1 status, complete blood cell counts and LDH levels were collected. A descriptive analysis was carried out, followed by a survival analysis using the Kaplan-Meier estimator.

      Result

      We selected 25 patients. No correlation was found between dNLR and LDH levels. 5 patients (20%) had a dNLR greater than 3, of which 3 patients had stable disease and 2 patients received supportive care. Patients with a dNLR greater than 3 had a median overall survival (mOS) of 8,5 months, whereas patients with a dNLR less than 3 had a mOS of 17,0 months, with statistically significant differences (P:0.038). 2 patients (8%) had a LDH level greater than ULN, of which 1 patient achieved a partial response and 1 patient had stable disease. Regarding the LDH level no difference in overall survival was found.

      Regarding to the PD-L1 status, 10 (40%) of 25 patients had PD-L1 ≥ 1%, 8 (32%) had PD-L1 < 1% and 7 (28%) had unknown PD-L1. Patients with PD-L1 ≥ 1% had a mOS of 8,5 months, whereas patients with PD-L1 <1% had a mOS of 15,7 months, with no statistically significant association (P> 0.05).

      Conclusion

      In our sample, pretreatment levels of dNLR greater than 3 were correlated with worse overall survival in patients with malignant pleural mesothelioma. Furthermore, pretreatment levels of LDH greater than ULN and PD-L1 greater than or equal to 1% could be correlated with worse overall survival, although due to the size of our sample we are not able to conclude statistical significance. Further studies are needed to explore this relationship.

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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): Patricia Cruz

      • Abstract
      • Slides

      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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      EP1.06-11 - Advanced Malignant Pleural Mesothelioma: A Single Institution Experience (Now Available) (ID 1993)

      08:00 - 18:00  |  Author(s): Patricia Cruz

      • Abstract
      • Slides

      Background

      Malignant pleural mesothelioma is a rare and highly aggressive tumor that typically presents with advanced disease. The prognosis of patients with malignant pleural mesothelioma is poor and there is currently a lack of effective treatment options. The aim of this study is to analyze the experience of our center in the management of this pathology.

      Method

      We conducted a retrospective study, which included all patients with malignant pleural mesothelioma diagnosed in a tertiary referral hospital from December 2009 to March 2019. Data regarding baseline characteristics, treatment response and survival were collected. A descriptive analysis was carried out, followed by a survival analysis using the Kaplan-Meier estimator.

      Result

      We selected 25 patients. Table 1 summarizes the main sociodemographic characteristics, the histological subtype and the stage.

      Table 1 Nº (%)

      Sex: Male/Female

      19 (76%) / 6 (24%)

      Age (years):

      71 (51 – 89)

      Histology:

      – Epithelioid mesothelioma

      – Sarcomatoid mesothelioma

      – Mixed mesothelioma

      22 (88%)

      1 (4%)

      2 (6%)

      Stage:

      – Stage III

      – Stage IV

      4 (16%)

      21 (84%)

      22 (88%) of 25 patients received first line chemotherapy with platinum doublet with pemetrexed followed by pemetrexed maintenance and 3 (12%) received palliative care. The proportion of patients who received six cycles of platinum doublet with pemetrexed was 55%. 5 (20%) of 22 patients who received first line chemotherapy with platinum doublet with pemetrexed achieved a partial response, 15 (60%) had stable disease and 2 (8%) experienced disease progression.

      After a median follow-up duration of 15,17 months, 19 (76%) patients had died. The median progression free survival was 13,1 months (IC 95%: 6,7 – 19,5), and the median overall survival was 15,7 months (IC 95%: 11,3 – 20,0). The major cause of death was cancer in 18 patients (95%) and 1 patient dead of heart disease.

      Conclusion

      Demographics and baseline characteristics as well as the survival data obtained in our sample are consistent with the previously reported. Further studies are needed to determine other treatment options to improve the prognosis of these patients.

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    EP1.12 - Small Cell Lung Cancer/NET (ID 202)

    • Event: WCLC 2019
    • Type: E-Poster Viewing in the Exhibit Hall
    • Track: Small Cell Lung Cancer/NET
    • Presentations: 3
    • Now Available
    • Moderators:
    • Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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      EP1.12-20 - Retrospective Study About the Impact of Metastatic Site in Small Cell Lung Cancer (Now Available) (ID 1980)

      08:00 - 18:00  |  Author(s): Patricia Cruz

      • Abstract
      • Slides

      Background

      Small cell lung cancer (SCLC) is a very aggressive type of lung cancer. It is characterized by a high cellular proliferation and an early development of widespread metastases (nearly 70% of patients presents macroscopic metastases at diagnosis). SCLC spread mainly to bone, brain and liver. In extensive disease, metastatic involvement of the liver, bone and central nervous system seems to have a worse prognosis comparing with other sites, though the studies are quite inconclusive.

      Method

      We conducted a descriptive and retrospective study including all patients diagnosed with metastatic SCLC between January 2012 and December 2018. A Kaplan Meier survival analysis (log-rank analysis) was carried out to study the impact of the metastatic involvement (depending on the localization) at diagnosis and at recurrence.

      Result

      Of the 58 patients included, 58.6% presents liver involvement at diagnosis. These patients present a worse overall survival (OS), with a mean of 1.9 months, and a clear trend to worse progression-free survival (PFS, with a mean of 5.6 months (P=0.56). Bone involvement was presented in 41.4% of the patients. No difference was observed neither in OS (with a median of 6 vs 7.9 months) nor PFS (3.9 vs 3.3 months). Lastly, only the 19% present brain metastases at diagnosis, and it didn’t show significant differences in OS (8.3 vs 6.7 months) but it did in SLP (2.6 vs 5 months). When the tumor relapses, it usually does in multiple localizations (51.3%) and the main organ involved is the lung (78.3%). It didn´t show any difference in prognostic between sites.

      Conclusion

      SCLC is a very aggressive tumor. Due to its biological behavior, a large proportion of the patients presents an advanced staged at diagnosis. In extensive disease, the number of organ sites involved is related to prognosis, but it´s not clear which localizations have a greater impact on survival rates. In our studies, liver and bone metastases are related to worse prognosis and short survival. Surprising, in our series, brain metastases don´t seem to impact in patient’s prognosis. When the tumor relapses, tumor extent (limited vs extensive) is a factor that affects the prognosis. However, in our experience, there are not clear differences between one or another, all of them related to poor prognosis. More studies will be needed to be able to clarify the prognostic impact of the metastases site, both at diagnosis and relapse.

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      EP1.12-26 - Retrospective Study About the Impact of Brain Metastases and Cranial Irradiation in Small Cell Lung Cancer (Now Available) (ID 1987)

      08:00 - 18:00  |  Author(s): Patricia Cruz

      • Abstract
      • Slides

      Background

      Small cell lung cancer (SCLC) is a very aggressive type of lung cancer. Due to this behavior, it presents early development of metastases. Brain metastases (BM) are very common and are related with a great impact on both survival and quality of life. Prophylactic cranial irradiation (PCI) is used for patients without detectable brain metastases, improving survival and decreasing the incidence of brain relapses (BR). Cranial irradiation (CI) for affected patients are usually used in patients with clinical BM, but its benefits are less clear.

      Method

      We conducted a descriptive and retrospective study including all patients diagnosed with SCLC tumor between January 2012 and December 2018 (both localized and metastatic). We study the impact of PCI and CI in both patients with/without BM at diagnosis. A Kaplan Meier survival analysis (log-rank analysis) was carried out to study the overall survival and the impact of the radiotherapy treatment.

      Result

      Of the 98 patients included, 60.2% presents extensive-stage, while 39% were locally advanced. Of the advanced stages, only 18.4% presented brain involvement at the diagnosis. 34.7% of the patients received RT at the diagnosis (37.5% PCI and 50% of the patients with BM received CI).

      Over the course of the disease, 35.1% of the patients present BR. 67.6% of the patients treated with RT at diagnosis (both PCI and CI) relapsed in the brain, meanwhile, the 54.8% in the group without RT (no significant differences). However, in the RT group, 69.5% of patients relapse outside the brain (mainly the lung). Chemosensitive didn´t show any relation with the incidence of BR (30.4% RT group vs. 35.7% in no-RT group). Overall, there were no significant differences in survival (p 0.19) between the group treated with RT (both PCI and CI) and the group which didn´t.

      Conclusion

      SCLC presents early dissemination. Brain is one of the main organs involved. PCI for patients without detectable BM decrease the incidence of brain relapses and improve survival. The impact of CI is less clear in patients that already have BM. Surprisingly, in our series, we didn´t find any difference with PCI or CI in overall survival and BR. A high proportion of the patients in both groups (with/without BM at diagnosis) didn´t receive radiotherapy, due to a very poor clinical status (which can may lead to bias). More studies will be needed to be able to clarify the prognostic impact of these metastases and the effectiveness of this treatment nowadays.

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      EP1.12-29 - Retrospective Study About Small Cell Lung Cancer: Our Experience in a Spanish Hospital (Now Available) (ID 1976)

      08:00 - 18:00  |  Author(s): Patricia Cruz

      • Abstract
      • Slides

      Background

      Incidence of small cell lung cancer (SCLC) has been decreased during the last decades. This neoplasm appears almost exclusively in smokers and it is characterized by aggressive biology and early development of metastases. Due to this aggressiveness, a large proportion of patients present a poor performance status at the time of diagnosis. Though the tumor is initially highly responsive to therapies, most of the patients will relapse after treatment. The prognosis is generally poor, even in limited stage disease.

      Method

      We conducted a descriptive and retrospective study including all patients diagnosed with SCLC tumor between January 2012 and December 2018 (both localized and metastatic forms were included). A Kaplan Meier survival analysis (log-rank analysis) was carried out to study the overall survival.

      Result

      diagnosed in advanced stages (60.2%), while 29.6% were locally advanced and only 8.2%, localized. In metastatic stage, the main organ affected was the liver (35.7%), followed by the bone (24.5%). Only 12% presented brain metastases at the diagnosis. The vast majority were smokers (68.4%) or ex-smokers (27.6%), with only one patient that had never smoked.

      The 78.4% of the patients received chemotherapy (36.7% with concomitant radiotherapy). After the initial treatment, up to 55.4% of the patients recurred, mainly involving various localizations (50%). Only 39% received a second line of chemotherapy, and 24% a third line.

      At the end of the study, 84.6% of the patients had died (median of 19.7 months since diagnosis). Log-rank analysis (Kaplan-Meier estimates) showed significant differences (p<0.05) between tumor stages and platinum-sensitive status. On the contrary, there wasn´t significant difference related to sex, smoke status, type of recurrence or type of chemotherapy chosen in second line.

      Conclusion

      SCLC is heavily related with smoke. Most of them exhibit an aggressive behavior, with an advanced stage at diagnosis (in our study, up to 60.2%, and 29.6% locally advanced). Thought usually presents high chemosensitivity, most of the patients recur. At this point, the prognosis is poor, with a low benefit with the treatment, in our series regardless of the drug. Unlike the previous series, we haven´t seen a worse outcome related to sex or smoke status. More studies will be needed to be able to clarify the prognostic impact of factors such as the smoke status, sex, type of relapse or second line treatment.

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    EP1.14 - Targeted Therapy (ID 204)

    • Event: WCLC 2019
    • Type: E-Poster Viewing in the Exhibit Hall
    • Track: Targeted Therapy
    • Presentations: 1
    • Now Available
    • Moderators:
    • Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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      EP1.14-31 - Retrospective Study About EGFR Mutations in Lung Cancer: Our Experience in a Spanish Hospital (Now Available) (ID 1995)

      08:00 - 18:00  |  Author(s): Patricia Cruz

      • Abstract
      • Slides

      Background

      Mutations in the epidermal growth factor receptor (EGFR) tyrosine kinase are observed in approximately 15% of lung adenocarcinomas and usually occur in nonsmokers. The detection of these mutations can be detected either in liquid biopsies or solid tissue biopsies. EGFR mutations are a predictive biomarker for high response and longer survival (both progression-free and overall) with tyrosine kinase inhibitors (TKIs), namely gefitinib, erlotinib, afatinib and osimertinib.

      Method

      We conducted a descriptive and retrospective study including all patients diagnosed with EGFR mutations between January 2007 and September 2018 (both locally advanced and metastatic forms were included).

      Result

      Of the 67 patients, the mean age was 67.2 years. The majority were adenocarcinoma (82.5%), with only 7.9% of squamous and 6.4% large cell carcinoma. The main mutations registered were exon 21 deletion (41%) and exon 19 deletion (4.9%). Only 24.6% had history of smoking. 71.6% of patients present stage IV disease at diagnosis. The main organ involved was the bone (45.8%), followed by the lung (44.1%) and brain (25.4%). Also 13.6% presents pleural, 10.2% liver, 5.1% adrenal and 5.6% lymph node involvement.

      84.1% of the patients were treated with TKIs (erlotinib 49.2%, gefitinib 16% and afatinib 19%) while 16% were treated with chemotherapy. With first line treatment, 94.7%presented disease control (41.8% partial response, 41.9% stable disease and 11% complete response). With a mean of 23.6 months, 56.9% of them progressed, mainly involving the lung (28.6%) and the bone (20.6%). Only 9.5% presented brain progression. At the end of the study, 34% had died (overall survival´s mean of 27.5 months).

      Conclusion

      In patients with oncogenic driver mutations in EGFR, treatment with TKIs results in a better outcome than standard chemotherapy. This mutation predicts sensitivity to EGFR (our study shows up to 94.7% presents some type of response). Also, this response is longer (23.6 months in our experience) and better tolerated than chemotherapy. Overall survival of these patients is longer too, in our series, round to 27.5 months of overall survival, and mainly related to the tumor stages. More studies will be needed to be able to clarify the prognostic impact of factors such as the smoke status, sex, type of relapse or second line treatment.

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    EP1.18 - Treatment of Locoregional Disease - NSCLC (ID 208)

    • Event: WCLC 2019
    • Type: E-Poster Viewing in the Exhibit Hall
    • Track: Treatment of Locoregional Disease - NSCLC
    • Presentations: 1
    • Now Available
    • Moderators:
    • Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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      EP1.18-28 - Neoadjuvant Therapy Among Patients Undergoing Resection for Non-Small-Cell Lung Cancer: A Single Institution Experience (Now Available) (ID 2002)

      08:00 - 18:00  |  Author(s): Patricia Cruz

      • Abstract
      • Slides

      Background

      Lung cancer is the leading cause of cancer deaths worldwide. Surgery alone results in poor overall survival in patients with stage III non-small cell lung cancer (NSCLC). Neoadjuvant therapy offers the ability to treat micrometastatic tumor cell dissemination preoperatively and increased resectability due to tumor regression. The aim of this study is to analyze the experience of our center and to identify clinical and pathological characteristics related to greater relapse-free survival (RFS).

      Method

      We conducted a retrospective study, which included all patients with NSCLC treated with neoadjuvant therapy follow by surgery in a tertiary referral hospital from April 2013 to March 2019. Data regarding clinical and pathological characteristics, treatment response, type of surgery and survival were collected.

      Result

      We selected 10 patients. Table 1 summarizes the main sociodemographic characteristics, the histological subtype, the stage, the regimens of neoadjuvant therapy and the types of surgery.

      Table 1 Nº (%)
      Sex: Male/Female 6 (60%) / 4 (40%)
      Age (years): 62 (44 – 77)

      Performance status:

      – 0

      – 1

      6 (60%)

      4 (40%)

      Smoking:

      – No

      – Yes

      1 (10%)

      9 (90%)

      Weight loss before diagnosis:

      – High (≥5%)

      – Low (<5%)

      1 (10%)

      9 (90%)

      Histology:

      – Squamous cell carcinoma

      – Adenocarcinoma

      – Large-cell cancer

      3 (30%)

      6 (60%)

      1 (10%)

      Stage:

      – Stage IIIA

      – Stage IIIB

      6 (60%)

      4 (40%)

      Node status:

      – N0

      – N1

      – N2

      3 (30%)

      1 (10%)

      6 (60%)

      ALK translocation:

      – No

      – Yes

      – Unknown

      8 (80%)

      0 (0%)

      2 (20%)

      EGFR mutation:

      – No

      – Yes

      – Unknow

      8 (80%)

      0 (0%)

      2 (20%)

      Percentage of PD-L1 at diagnosis:

      – < 1%

      – 1 – 49%

      – ≥ 50%

      – Unknow

      5 (50%)

      1 (10%)

      2 (20%)

      2 (20%)

      Neoadjuvant therapy regimens:

      – Platinum – pemetrexed

      – Platinum – vinorelbine

      – Platinum – paclitaxel – bevicizumab

      – Platinum – vinorelbine – gemcitabine

      – Platinum – paclitaxel – nivolumab

      5 (50%)

      1 (10%)

      1 (10%)

      1 (10%)

      2 (20%)

      Types of surgery:

      – Lobectomy

      – Bilobectomy

      – Pneumonectomy

      6 (60%)

      1 (10%)

      3 (30%)

      Percentage of PD-L1 after neoadjuvant therapy:

      – < 1%

      – 1 – 49%

      – ≥ 50%

      – Pathological complete remission

      – Unknow

      2 (20%)

      1 (10%)

      4 (40%)

      2 (20%)

      1 (10%)

      Regarding tumour response rates after neoadjuvant chemotherapy, 2 (20%) of 10 patients achieved a complete response and 8 (80%) achieved a partial response. Furthermore, 5 (71%) of 7 patients with mediastinal lymph node involvement achieved a nodal downstaging. Using the Wilcoxon signed-rank test, there are statistically significant differences in the stage of the patients before and after the neoadjuvant chemotherapy (Z: -2,82, p:0,005).

      After a median follow-up duration of 38 months, 5 (50%) patients had relapsed. The median RFS was 22 months (IC95%: 2–41). We did a multivariate logistic regression analysis, in which no statistically significant associations were found between clinical and pathological characteristics studied and the RFS (p>0,05).

      Conclusion

      Neoadjuvant therapy followed by surgery should be considered as standard treatment for a selective group of patients with stage III of NSCLC, in our sample all patients yielded excellent results. In the multivariate analysis no statistically significant associations were found due to the small size of our sample.

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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): Patricia Cruz

      • 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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    P1.03 - Biology (ID 161)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Biology
    • Presentations: 1
    • Now Available
    • Moderators:
    • Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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      P1.03-12 - Preclinical Validation of an Epigenetic Panel of Seven miRNAs at Early Stages NSCLC Patients and Its Prognostic Implications (Now Available) (ID 1385)

      09:45 - 18:00  |  Author(s): Patricia Cruz

      • Abstract
      • Slides

      Background

      Despite radical intent, many patients in early stages of NSCLC will recur. There is a need to find novel biomarkers able to help to identify patients in higher risk. Previous results from our group provide a miRNA signature from “in vitro” studies that might be involved in worst prognosis in NSCLC patients (PMID: 29158814). The main objective of this work is to analyse and compare the miRNA seven-panel signature in paired plasma (CIRmiARN) and tumor tissue samples (TmiARN) obtained from early stages NSCLC patients and to study the clinical implications.

      Method

      We conducted a descriptive study including 16 paired samples of patients diagnosed with early stage NSCLC. Both RNA from fresh tissue and plasma were extracted and the seven mRNAs levels were measured by qRTPCR(miR-7, -132, -335, -148, -10a, -124 and -9). Association between qualitative variables was analyzed using the chi-square test or Fisher's exact test. Mann-Whitney U test and the t-student test were used for qualitative and quantitative data comparison. A Kaplan Meier survival analysis (log-rank analysis) was carried out to study the overall survival and progression-free survival. Patients were also clustered in terms of tissue and plasma values, and then subgroups analyzed in terms of Survival. Difference between groups was analyzed with Cox Regression.

      Result

      There was no association between CIRmiARN and TmiARN expression levels and between clinical parameters. We found significant data associated with three miRNAs. There were significant differences (p<0.05) with low TmiR-132 expression level and worse survival and also a clear trend towards the group of patients with high levels of CIRmiR-7 and CIRmiR-124 and worst survival. Interestingly, we found an inverse correlation between CIRmiARN-132 and -124(p<0.05). Patients clustered regarding TmiR132 and CIRmiR-124 and -7levels, segregate in three clusters statistically significant in terms of survival (p<0.005), identifying a group of patients with a reduced risk of 78,6% (Hazard Ratio of 0.214 p<0,005).

      Conclusion

      Many patients diagnosed in early stages of NSCLC present a tumor relapse during the first 5 years. Genetic and epigenetic profiles help us to identify tumors with a greater risk of recurrence. In our study, we have identified three potential molecular candidates, both in liquid and tissue biopsies, which could have potential clinical use stratifying patients with higher risk of recurrence. Further studies will be needed to gain insight into the prognostic impact of these biomarkers in early and advanced stages NSCLC patients.

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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): Patricia Cruz

      • 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): Patricia Cruz

      • 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): Patricia Cruz

      • 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): Patricia Cruz

      • 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).

      captura de pantalla 2019-04-10 a las 23.42.03.png

      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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      P2.03-16 - Agreement Between Different Methodologies for Non-Invasive p.T790M and EGFR Sensitizing Mutation Testing (ID 1965)

      10:15 - 18:15  |  Author(s): Patricia Cruz

      • Abstract
      • Slides

      Background

      Tyrosine kinase inhibitors (TKIs) are the current standard of care for patients with advanced EGFR-mutant non-small cell lung cancer (NSCLC). However, most patients progressed within 1 to 2 years. The EGFR p.T790M mutation is the most common resistance mechanism to first and second generation EGFR TKIs. The identification of p.T790M mutation is of considerable clinical relevance as osimertinib has demonstrated clinical efficacy in this setting. Guidelines recommend testing for the p.T790M mutation in blood at relapse to TKIs, and re-biopsy only in case of a negative result. Several blood based methodologies for detection of EGFR mutations have been developed in the recent years. However, the number of comparison studies between platforms is very limited.

      Method

      This is a multicenter, cross-sectional study (ClinicalTrials.gov Identifier: NCT03363139) performed by the Spanish Lung Cancer Group. Samples from 75 consecutive EGFR mutant NSCLC patients were collected at disease progression to first line TKI treatment. The presence of EGFR mutations in the cfDNA was evaluated in 39 samples by 7 methodologies, namely: Cobas® EGFR Mutation Test v2 (Roche Diagnostics), Therascreen EGFR Plasma RGQ PCR Kit (Qiagen), QuantStudio® 3D Digital PCR System (Thermofisher), a 5′-nuclease real-time PCR (TaqMan®) assay in presence of PNA, OncoBEAM EGFR (Sysmex Inostics), NGS with two different gene panels: Oncomine® (Thermofisher) and Lung Cancer Panel (Qiagen). The agreement between methodologies was assessed using the kappa coefficient (K) and its corresponding 95% confidence intervals (95% CI). For quantitative variables the concordance correlation coefficient (ccc) was used.

      Result

      Complete results are available for 39 patients. Overall, the agreement between all methodologies for the detection of p.T790M mutation as well as the original EGFR sensitizing mutation was good (K=0.669; 95CI: 0.504-0.835 and K=0.750 95CI: 0.599-0.899 respectively). Remarkably, the agreement between FDA-approved methodologies for p.T790M detection was almost perfect (K=0.926; 95CI: 0.712-1) and good for the EGFR sensitizing mutations (K=0.657; 95CI: 0.417-0.902). Similarly, the agreement between NGS-based methodologies for the detection of p.T790M and the EGFR activating mutations was very high (K=0.843; 95CI: 0.567-1 and K=0.872 95CI: 0.595-1 respectively). Moreover, concordance between both technologies for p.T790M and EGFR sensitizing mutation mutant allele frequency was excellent (ccc=0.956; 95CI: 0.906-1 and ccc=0.980 95CI: 0.950-1 respectively). The proportion of samples that were positive for p.T790M detection varied from 28% (PCR based technologies) to 37% depending on the methodology.

      Conclusion

      NGS and PCR-based methodologies show a good to excellent agreement for the detection of EGFR mutations, including the p.T790M. Our results support the use of liquid biopsies for non-invasive testing of clinically relevant mutations (Data from the whole cohort will be presented at the meeting).

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