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Enric Carcereny

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    ES04 - Multimodality Management of Small Cell and Neuroendocrine Cancers (ID 7)

    • Event: WCLC 2019
    • Type: Educational Session
    • Track: Small Cell Lung Cancer/NET
    • Presentations: 6
    • Now Available
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      ES04.01 - Update in Systemic Treatment of SCLC (Now Available) (ID 3168)

      10:30 - 12:00  |  Presenting Author(s): Sumitra Thongprasert

      • Abstract
      • Presentation
      • Slides

      Abstract

      Chemotherapy combination of cisplatin plus etoposide is the standard option for extensive stage Small Cell Lung Cancer (SCLC); though the response rate was very high, however most cases of the extensive stage recurred within one year and there was no good regimen for second line. Several chemotherapeutic agents such as topotecan, irinotecan, amrubicin or combination of cyclophosphamide, doxorubicin and vincristine (CAV) had been used as second line treatment with minimal benefit.

      Within the past couple years there’re the new way of treating lung cancer especially the use of immunotherapy, which several agents had their roles in the treatment of Non-Small Cell Lung Cancer (NSCLC). The study of immunotherapy in SCLC was very slow. The use of T cell immune-checkpoint inhibitors (anti-PD1: nivolumab, pembrolizumab; anti-PD-L1: atezolizumab, durvalumab; anti-CTLA-4: ipilimumab, tremelimumab) have shown promising antitumor activity with the potential to prolong survival in SCLC patients.

      Nivolumab was the first immunotherapy agent that had approved by The US Food and Drug Administration (FDA) 2018 to be the third line drug according to the outcome in CheckMate-032, which’s a multicenter, open-label trial in patients with metastatic solid tumors. This subgroup comprised 109 patients with metastatic SCLC, with disease progression after platinum-based therapy and at least one other prior line of therapy, regardless of tumor PD-L1 status. All patients received nivolumab at3 mg/kg by intravenous infusion over 60 minutes every 2 weeks. The ORR was 12% (95% CI: 6.5, 19.5). Responses were durable for 6 months or longer in 77%, 12 months or longer in 62%, and 18 months or longer in 39% of the 13 responding patients. PD-L1 tumor status did not appear to be predictive of response.

      Pembrolizumab has been granted a priority review designation by the FDA for the treatment of patients with advanced small cell lung cancer (SCLC) whose disease has progressed following ≥2 prior lines of therapy. Data from the phase II KEYNOTE-158 and phase Ib KEYNOTE-028 studies, pembrolizumab at 200 mg intravenously (IV) every 3 weeks for 2 years or until disease progression, unacceptable toxicity, or study withdrawal elicited 19% and 33% overall response rates (ORRs) in patients with extensive-stage SCLC, respectively.

      Atezolizumab plus carboplatin and etoposide, was approved by FDA for the first-line treatment of adult patients with extensive-stage small cell lung cancer based on the data from IMpower133 which is a randomized treatment using atezolizumab 1200 mg and carboplatin AUC 5 mg/mL/min on day 1 and etoposide 100 mg/m2 intravenously on days 1, 2 and 3 of each 21-day cycle for a maximum of 4 cycles, followed by atezolizumab 1200 mg once every 3 weeks until disease progression or unacceptable toxicity, or placebo and carboplatin AUC 5 mg/mL/min on day 1 and etoposide 100 mg/m2 intravenously on days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles, followed by placebo once every 3 weeks until disease progression or unacceptable toxicity. Overall survival (OS) was 12.3 months for patients receiving atezolizumab with chemotherapy and 10.3 months for those receiving placebo with chemotherapy (hazard ratio 0.70; 95% CI: 0.54, 0.91; p=0.0069). Median PFS was 5.2 months (4.4, 5.6) compared with 4.3 months (4.2, 4.5) in the atezolizumab and placebo arms, respectively (HR 0.77; 0.62, 0.96; p=0.0170).

      In conclusion, there are several new ways and also new agents that target the immune cell and should be able to improve the outcome and survival of SCLC.

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      ES04.02 - Pathology Overview for Carcinoid and NE Spectrum (Now Available) (ID 3169)

      10:30 - 12:00  |  Presenting Author(s): Elisabeth Brambilla

      • Abstract
      • Presentation
      • Slides

      Abstract

      Pathology Overview for carcinoid and Neuroendocrine Spectrum

      The spectrum of neuroendocrine (NE) tumors ranges from low grade typical carcinoid (TC) to intermediate grade Atypical carcinoids to high grade small cell lung carcinoma (SCLC) and large cell neuroendocrine carcinoma (LCNEC) Although very different from high grade tumors in their molecular genetics and expression profiling, carcinoid are included in the spectrum of NE tumors since WHO 2015 (1) on the basis of their common NE epithelial differentiation.Carcinoids display many clinical differences with high grade NE tumors being not strongly associated with smoking (only 20-40% smokers), their specific association with Multiple Endocrine Neoplasia type 1 (MEN1 ) not seen in High grade tumors and their occurrence on the background of NE cell hyperplasia and tumorlets in 60% of TC and AC, very rare in high grade tumors . Whereas carcinoid are never combined with conventional lung cancer , 20 to 25% of SCLC and LCNEC are combined. Since the NE markers are common in the full spectrum , morphology , mitoses and KI 67 (proliferations markers) are useful to differentiate carcinoids from SCLC and LCNEC . The accurate diagnosis of each is critical in view of their eminently different therapeutic management .

      Small cell lung carcinoma (SCLC

      SCLC is the most frequent NE lung tumor (15-20% of lung cancer) and has the worse prognosis in the spectrum. Most are proximal,70% perihilar forming peribronchial growth involving lymph nodes .Less than 5% are solitary primary nodules stage I. SCLC is a high grade malignant epithelial NE tumor with characteristic cytopathologic features recognizable in routine microscopy without use of immunohistochemistry (IHC) in optimal cell preservation. IHC may be used in suboptimal condition (crush artifact) to confirm the diagnosis.

      SCLC is made of sheets of small cells ,round/oval or spindle shaped forming whorls, with little cytoplasm , nuclei with unconspicuous nucleoli , finely granular dispersed chromatin , and nuclear molding . Mitotic rate is very high more than 50 reaching 100 for 2mm2 and KI67 exceeds 50% (50-100%).Extensive necrosis is frequent .Most SCLC express NE markers Chromogranine A, Synaptophysin and CD56 . 75% express TTF1 (recommended clone 8G7G3 1) . Less than 10% remain negative for all 3 NE markers and TTF1 . In these cases a P40 staining is mandatory to eliminate a basaloid carcinoma (P40 Positive) with which it may be confused in suboptimal preparations .

      SCLC can present as pure or combined. Any association of small cells with another NSCLC (Adenocarcinoma, Squamous cell carcinoma , large cell or large cell NE carcinoma , sarcomatoid giant and spindle cells ) is diagnosed as combined SCLC (20%) .

      Several studies of their molecular characteristics were recently published and compared with other tumors of the NE spectrum . Theses are specific , closer from a part of LCNEC but distinct from theses of carcinoids (Georges 2016 , Georges 2018 ) . Small cell carcinoma in non-smokers should be looked for EGFR mutation (acquired after TKI therapy of an Adenocarcinoma or spontaneous ).

      Large cell neuro endocrine carcinoma (LCNEC)

      LCNEC is a high grade NE lung tumor accounting for 3% of lung cancers .The diagnosis is based on the necessary association of NE morphology (organoid nesting ,rosettes ,palisading) and expression of NE markers (at least one) : chromogranine A, synaptophysin and CD56. Seventy-nine % develop in the lung periphery , 5% show endobronchial growth .They form circonscribed nodular mass intensely necrotic .They lack typical cytology in contrast with SCLC .The mitotic rate is more than 10 per 2mm2to distinguish them from atypical carcinoid (2 -10/2mm 2) ,ranging from 20 to 80-100 with KI67 very high exceeding 50% usually 80-100%. They are composed of large cells with low nuclear to cytoplasmic ratio , a conspicuous nucleoli and vesicular chromatin .A spectrum of morphologies range from SCLC (small cell –like) to non small cell-like or to a few atypical carcinoids-like , showing the need for an accurate diagnosis using objective criteria (proliferation). A constellation of multiple criteria should be used to distinguish them fro SCLC or AC .Combined LCNEC is the association of any LCNEC component with a conventional component ( 25% ). Due to spatial heterogeneity of NE morphology and NE expression the diagnostic may be difficult on small biopsies .However a NSCLC without NE morphology but 1 or 2 NE markers is diagnosed as a NSCLC (with unclear phenotype ) since 15 % of NSCLC also express 1 or 2 NE markers.TTF1 is expressed in 41 % of LCNEC specially when combined with adenocarcinoma.Molecular genomics and expression profiling classify in 2 categories one simiilar to SCLC with biallelic inactivation of P53 and RB genes and another with KEAP 1 or LKB1 mutations looking like NSCLC .LCNEC are very different from Carcinoids (Georges 2018 )

      Carcinoids tumors : Typical and Atypical Carcinoids

      Carcinoids account for 1-2 % of lung tumors of which 10% are Atypical carcinoid .Typical ( low grade) and atypical carcinoids(intermediate grade) are distinquished on objective criteria (mitoses index (table I) and necrosis, but KI67 has no defined cut- off to separate them.

      They develop centrally as endobronchial growth or in the lung periphery (16-40 %) Cytology allows accurate recognition . NE morphology is well achieved with organoid patterns( glandular, follicular ,trabecular , angiomatoid…) most often multiple .Spindle cell pattern is more frequent in the peripheral carcinoids.

      All express the 3 NE markers and TTF1 is usually negative (except in a few peripheral carcinoids )

      References

      Travis WD, Brambilla E, Burke AP, Marx A, Nicholson AG. WHO classification of tumours of the lung, pleura, thymus and heart, 4th ed. Lyon: IARC; 2015. 


      Travis WD ,Nicholson AG ,Geisinger KR, Brambilla E.Tumors of the lower respiratory tract AFIP Atlas of Tumor pathology series 4 ed. AFIP Press Bethesda 2019

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      ES04.03 - Surgery for Early and Locally Advanced Small Cell Lung Cancer (Now Available) (ID 3170)

      10:30 - 12:00  |  Presenting Author(s): Eric Lim

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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      ES04.04 - Role of Stereotactic Body Radiation in Early and Advanced SCLC (Now Available) (ID 3171)

      10:30 - 12:00  |  Presenting Author(s): Roy Decker

      • Abstract
      • Presentation
      • Slides

      Abstract

      Stereotactic Body Radiotherapy (SBRT) has been rapidly adopted as the standard of care for patients with early-stage Non-Small Cell Lung Cancer (NSCLC) who are medically inoperable, and more recently for selected patients with oligometastatic cancer. The utilization of SBRT in patients with Small Cell Lung Cancer (SCLC) is markedly lower, reflecting both the lower incidence and the lack of clinical data, but it has been increasing over the past several years. Given the aggressive nature and high metastatic potential of SCLC, the optimal integration of SBRT into the multimodality treatment of early-stage SCLC patients is critical, so that we don’t delay or otherwise compromise systemic therapy. In patients with advanced or recurrent SCLC, SBRT offers a valuable treatment option for well selected patients, a group that may be increasing as new therapeutic options emerge.

      Small Cell Lung Cancer (SCLC) represents less than 20% of all new lung cancer diagnoses. Compared to NSCLC, SCLC is less likely to present with localized disease, carries a higher risk of metastatic failure, and stage for stage is associated with worse overall survival. The majority of limited stage SCLC patients have locally advanced tumors, and the standard of care remains concurrent chemotherapy with fractionated thoracic radiation. Stage I SCLC is diagnosed in less than 5% of incident cases. Given the propensity for nodal metastasis, invasive staging of the mediastinum is indicated in all of these patients. For those who are node negative, there is a limited amount of data to guide decisions about optimal management. Surgery has emerged as a standard of care for operable patients, based on favorable outcomes in population-based studies. Following surgery, adjuvant chemotherapy is recommended regardless of tumor size, based on the high risk of subsequent metastatic failure.

      For those patients who won’t tolerate lobectomy, consensus guidelines now recognize that Stereotactic Body Radiotherapy (SBRT) is a treatment option, and a reasonable alternative to conventional chemoradiotherapy. This is largely justified by the observed increased efficacy of SBRT compared to fractionated radiation in stage I NSCLC, an observation which is now supported by a randomized trial. The published data to date suggests that the utilization of SBRT in stage I SCLC has been increasing. Single- and multi-institutional case series suggest, unsurprisingly, that this approach appears to be safe, and the efficacy in terms of local control appears to be similar to that seen in NSCLC patients. In the US, the use of SBRT in SCLC appears to be more common in elderly patients, and the utilization seems to be driven by large institutions.

      Chemotherapy is an essential part of multimodality care of SCLC in all stages of disease. The addition of adjuvant chemotherapy sequentially after SBRT in early stage patients is associated with improved survival in retrospective studies, similar to the better outcomes seen with surgery and chemotherapy in operable SCLC patients. Recent and ongoing prospective efforts are evaluating concurrent chemotherapy with SBRT, including both traditional short-course and more extended hypo-fractionated radiation schedules.

      Trends in stereotactic body radiation therapy for stage I small cell lung cancer. Stahl JM, Corso CD, Verma V, Park HS, Nath SK, Husain ZA, Simone CB 2nd, Kim AW, Decker RH. Lung Cancer. 2017 Jan;103:11-16.

      Multi-Institutional Experience of Stereotactic Ablative Radiation Therapy for Stage I Small Cell Lung Cancer. Verma V, Simone CB 2nd, Allen PK, Gajjar SR, Shah C, Zhen W, Harkenrider MM, Hallemeier CL, Jabbour SK, Matthiesen CL, Braunstein SE, Lee P, Dilling TJ, Allen BG, Nichols EM, Attia A, Zeng J, Biswas T, Paximadis P, Wang F, Walker JM, Stahl JM, Daly ME, Decker RH, Hales RK, Willers H, Videtic GM, Mehta MP, Lin SH. Int J Radiat Oncol Biol Phys. 2017 Feb 1;97(2):362-371.

      Clinical Outcomes of Stereotactic Body Radiotherapy for Patients With Stage I Small-Cell Lung Cancer: Analysis of a Subset of the Japanese Radiological Society Multi-Institutional SBRT Study Group Database. Shioyama Y, Onishi H, Takayama K, Matsuo Y, Takeda A, Yamashita H, Miyakawa A, Murakami N, Aoki M, Matsushita H, Matsumoto Y, Shibamoto Y; Japanese Radiological Society Multi-Institutional SBRT Study Group (JRS-SBRTSG). Technol Cancer Res Treat. 2018 Jan 1;17:1533033818783904.

      Stereotactic body radiotherapy with concurrent chemotherapy extends survival of patients with limited stage small cell lung cancer: a single-center prospective phase II study. Li C, Xiong Y, Zhou Z, Peng Y, Huang H, Xu M, Kang H, Peng B, Wang D, Yang X. Med Oncol. 2014 Dec;31(12):369.

      Outcomes of Stereotactic Body Radiotherapy for T1-T2N0 Small Cell Carcinoma According to Addition of Chemotherapy and Prophylactic Cranial Irradiation: A Multicenter Analysis. Verma V, Simone CB 2nd, Allen PK, Lin SH. Clin Lung Cancer. 2017 Nov;18(6):675-681.e1.

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      ES04.05 - Advances in Radionuclide Treatment for Neuroendocrine Tumours (Now Available) (ID 3172)

      10:30 - 12:00  |  Presenting Author(s): Angela Lamarca

      • Abstract
      • Presentation
      • Slides

      Abstract

      Lung carcinoids (LC) are rare tumours, however incidence is increasing due to improvement in diagnostic techniques. They account for approximately 2% of all lung malignancies and around 20-30% of all neuroendocrine tumours (NETs). They characteristically have an indolent clinical behaviour with longer survival intervals compared to poorly differentiated lung neuroendocrine malignancies. LC are divided into typical or atypical carcinoid tumours according to pathological characteristics, such as amount of mitosis and necrosis.

      A significant proportion of LC expresses somatostatin receptors by immunohistochemistry. Nuclear medicine imaging, such as somatostatin receptor scintigraphy, has been employed for staging of LC for years. Development of new nuclear medicine imaging techniques, including Positron Emission Tomography (PET) combined with CT has improved diagnosis, staging and treatment of patients diagnosed with LC. 68-Gallium(68Ga)-radiolabelled PET (68Ga-DOTA-PET) tracers for functional NET imaging have emerged as potentially useful tools for diagnosis and staging.

      For localised stages of LCs, surgery is the treatment of choice, performed with curative intent. Locally advanced inoperable or metastatic tumours are treated with palliative approaches based on somatostatin analogues (SSAs), temozolomide-based chemotherapy combination and targeted therapies (everolimus). Recently, the use of Peptide Receptor Radionuclide Therapy (PRRT) has revolutionised the treatment of extra-pulmonary neuroendocrine tumours. Based on the results of the NETTER-1 study, PRRT has been approved for the management of small bowel and pancreatic NETs and it is considered a standard of care after progression to SSA for patients with uptake in 68Ga-DOTA-PET (theranostic approach).

      This lecture will summarise the state of the art of LC with a focus behind the rationale of PRRT and its potential role in the management of LCs.

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      ES04.06 - Systemic Treatment of Large Cell Neuroendocrine Cancer (Now Available) (ID 3173)

      10:30 - 12:00  |  Presenting Author(s): Fiona Blackhall

      • Abstract
      • Presentation
      • Slides

      Abstract

      Large cell neuroendocrine cancer (LCNEC) is a rare, aggressive cancer that accounts for approximately 3% of all lung cancer. It is characterised by high-grade features (>10 mitoses/2mm2) and the presence of neuroendocrine morphology and markers (1). The diagnosis of LCNEC is distinct from both non-small cell lung cancer (NSCLC) and other pulmonary neuroendocrine tumours such as carcinoids and small cell lung cancer (SCLC). Survival is poor with only 5% of patients alive at 5 years from diagnosis regardless of stage at presentation. Conventionally treatment has mirrored that of SCLC despite limited evidence for this approach. The recommended standard of care is a combination of platinum with etoposide based on the results of one single arm phase 2 study in which there were only 29 evaluable patients (2). The median progression free survival (PFS) and overall survival (OS) rates were 5 months and 8 months respectively. Of note the observed objective response rate was 34%, lower than reported ORRs in SCLC of ~70%. Similar worse outcomes in the LCNEC population are observed for treatment with irinotecan and cisplatin (3). The explanation for this disparity is provided by emerging evidence that LCNEC can be subcategorised into two major and clinically relevant subsets according to genomic characteristics (4). A ‘SCLC-like’ genomic profile is estimated to account for about 40% of LCNEC, characterised by RB1 and TP53 that hallmark SCLC and ‘SCLC-like’ LCNEC has clinical behaviour consistent with SCLC. The other subset is ‘NSCLC-like’ with wild-type RB1 as the main distinction alongside mutations that also occur recurrently, at various frequencies, in NSCLC such as STK11, KRAS, KEAP1 and NFE2L2. The latter were hypothesised to be relatively more sensitive to chemotherapy approved for NSCLC. Consistent with this, in a carefully conducted retrospective analysis patients with NSCLC-like LCNEC (RB1 wild type) who received platinum with gemcitabine or a taxane had a median OS of 9.6 months whereas those who received platinum and etoposide had a significantly shorter median OS of 5.8 months (p=0.026) (5). These results question the current standard of care for LCNEC and highlight the need for prospective examination of molecular subtyping to direct treatment decision making. The molecular heterogeneity underpinning LCNEC may also have implications for selection of immune checkpoint inhibitors (6) and other precision medicines targeting actionable mutations (7). The advent of specific KRAS inhibitors that appear promising in early phase development (8) generates further impetus to redesign our therapeutic algorithms for LCNEC according to genomic context if we are to improve outcomes for patients with this orphan disease.

      References

      1. Travis WD, Brambilla E, Nicholson AG, Yatabe Y, Austin JHM, Beasley MB, et al. The 2015 World Health Organization Classification of Lung Tumors. Journal of Thoracic Oncology.10(9):1243-60.

      2. Multicentre phase II study of cisplatin-etoposide chemotherapy for advanced large-cell neuroendocrine lung carcinoma: the GFPC 0302 study. Le Treut J et al. Ann Oncol. 2013: 24(6):1548-52.

      3. Combination chemotherapy with irinotecan and cisplatin for large-cell neuroendocrine carcinoma of the lung: a multicentre phase II study. Niho et al. J Thoracic Oncol 2013: 8:980-4

      4. Next-Generation Sequencing of Pulmonary Large Cell Neuroendocrine Carcinoma Reveals Small Cell Carcinoma–like and Non–Small Cell Carcinoma–like Subsets. Rekhtman N et al. Clinical Cancer Research. 2016;22(14):3618.

      5. Molecular Subtypes of Pulmonary Large-cell Neuroendocrine Carcinoma Predict Chemotherapy Treatment Outcome. Derks JL et al. Clinical Cancer Research. 2018;24(1):33.

      6. Genomic Alterations (GA) and Tumor Mutational Burden (TMB) in Large Cell Neuroendocrine Carcinoma of Lung (L-LCNEC) as Compared to Small Cell Lung Carcinoma (SCLC) as Assessed Via Comprehensive Genomic Profiling (CGP). Chae et al. J Clin Oncol 2017; 35:15 suppl, 851

      7. Comparison of genomic landscapes of large cell neuroendocrine carcinoma, small cell lung carcinoma, and large cell carcinoma. Zhou Z et al. Thorac Cancer 2019 10(4):839-847

      8. Direct Ras G12C Inhibitors : Crossing the Rubicon. Lindsay C and Blackhall F. BJC. 2019 In press

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Author of

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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
    • Moderators:
    • Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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      EP1.01-37 - Platinum-Based Chemotherapy (CT) Rechallenge in Advanced Non Small Cell Lung Cancer (NSCLC) Patients (p): A Single Institution Experience (ID 2689)

      08:00 - 18:00  |  Presenting Author(s): Enric Carcereny

      • Abstract
      • Slides

      Background

      No phase III trials have been carried out to prove the value of a platinum-doublet rechallenge in p with NSCLC. Currently, the availability of different effective drugs makes the platinum-based salvage therapy unusual. Moreover, the potential cumulative toxicity related to cisplatin or carboplatin can be an issue. However, retreatment with platinum-based CT could be hypothetically proposed for p with a long time to progression (TTP) from the last platinum treatment, in p with a good performance status, who may be symptomatic and with no formal contraindication to receive such treatment We have retrospectively reviewed experience at our institution of platinum-based chemotherapy rechallenge in stage III and IV NSCLC p

      Method

      A cohort of 376 p with stage III and IV NSCLC treated with first-line platinum doublets from January 2012 to December 2017 were included. We extracted information on clinical and molecular characteristics, as well as treatment details. Time to progression was evaluated by Kaplan-Meier curves and groups were compared using Log-rank test.

      Result

      Overall, 57 p were rechallenged with platinum-based CT (group A). Median age was 57 years (51.5-65) for rechallenged p versus (vs) 62 (56.2-68.8) for the entire cohort (group B)[p=0.001]. Group A include more p with stage III p( 54.4% vs. 30.7%; p=0.001), as well as more p with better ECOG Performance Status (PS) (PS 0 70.2% vs. 44.5%; p=0.001). No differences in gender, smoking status, histology and comorbidities were observed between both groups (20.7% and 29.8% were women and 38.6% and 53.9% were smokers in groups A and B, respectively).

      No differences in molecular profile (EGFR, ALK, ROS1, KRAS, BRAF) were observed. The most common platinum doublet administered in first line setting was cisplatin plus pemetrexed. Group A received more frequently carboplatin plus gemcitabine or vinorelbine. Disease Control Rate (DCR) was 57.9% in p included in group A. No differences in DCR were observed in first line between both groups. Time to progression or death was 9.6 m for gropuo B(5-18.1) vs 20.5 m (14.6-37.3) p <0,001 for p in group A.

      Conclusion

      Rechallenge with platinum-based CT doublets could represent an option for NSCLC p with good PS and no contraindications for such therapy.

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    EP1.04 - Immuno-oncology (ID 194)

    • Event: WCLC 2019
    • Type: E-Poster Viewing in the Exhibit Hall
    • Track: Immuno-oncology
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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      EP1.04-25 - Increased PD-L1 Expression in MET Amplified (AMP) Advanced Non Small Cell Lung Cancer (NSCLC) Patients (P) (ID 2764)

      08:00 - 18:00  |  Presenting Author(s): Enric Carcereny

      • Abstract
      • Slides

      Background

      MET amp has been reported in a subset of NSCLC p and treatment with crizotinib has proved clinical activity in cases of MET exon 14 alterations and MET amp.. Recently, immunotherapy has emerged as a new approach to treat NSCLC. The development and success of programmed cell death 1 (PD-1)/program death-ligand 1 (PD-L1) checkpoint inhibitors has been correlated with PD-L1 status, particularly in NSCLC p whose tumors express high PD-L1 levels by tumor proportion score (TPS) ⩾ 50%. In this study we have reviewed the PD-L1 status in a cohort of advanced NSCLC p with a METamp.

      Method

      PDL1 expression has been evaluated in a retrospective cohort of NSCLC p with MET amp and wild type for EGFR, KRAS, BRAF mutations and ALK and ROS1 rearrangements. Overall Survival (OS) was evaluated with Kaplan-Meier curves and groups were compared using log-rank test. Clinical and tumor characteristics, as well as treatment details, were evaluated. MET amp was analyzed by FISH, while PD-L1 status was assessed by immunochemistry by SP 263. antiboby

      Result

      A total of 50 p were included, 15 p has high or intermediate Met amp and 35 p had low or negative Met amp. Median age were 66 years old. 39 (78%) p were male, 43 (86%) p were smokers or former smokers, 37 p (74%) were ECOG PS 0-1, 37 p (74%) were stage IV. PD-L1 were negative ( < 1%) in 21 p (42%), positive ( >1%) in 26 p ( 52%). PD-L1 highly positive in 18 p ( 36%). Statistically significant more p had PD-L1 positive ( TPS > 1%) in high or intermediate Met amp p versus low or negative ( 92.9% vs 39.4%; p 0.001). And high or intermediate Met amp p had PD-L1 high expression ( TPS > 50%) than negative or low Met amp p ( 64.3% vs 27.3%; p 0.020). No differences in PD-L1 expression was observed by gender, ECOG PS or smoking status. Median OS was 16.367 m (2.295-30.438). No differences in OS were seen by PD-L1 expression or Met amp status.

      Conclusion

      PD-L1 expression in NSCLC p is positively correlated with MET amp, especially in p with PD-L1 > 50%. Our data suggests that MET amp may play a direct role in up-regulating PD-L1 expression in NSCLC p. Additionally, combination therapy targeting MET and checkpoint inhibition should be considered as a potential therapeutic strategy for NSCLC p with high and intemediate MET amp.

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    EP1.16 - Treatment in the Real World - Support, Survivorship, Systems Research (ID 206)

    • Event: WCLC 2019
    • Type: E-Poster Viewing in the Exhibit Hall
    • Track: Treatment in the Real World - Support, Survivorship, Systems Research
    • Presentations: 1
    • Now Available
    • Moderators:
    • Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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      EP1.16-17 - Management of Inappropriate Use of Opioids (IUO) in Patients (P) with Lung Cancer (LC) (Now Available) (ID 612)

      08:00 - 18:00  |  Author(s): Enric Carcereny

      • Abstract
      • Slides

      Background

      Pain represents one of the main symptoms in patients (p) with lung cancer (LC). Currently, the molecular classification and targeted therapies and immunotherapy for LCp yield a prolonged survival in some p. In this context, analgesia with opioid therapy (OT) requires special caution. The prevalence of IUO LCp is unknown and its assessment is suboptimal. There is no current recommendation to assess IUO risk in cancer p, other than in long cancer survivors with chronic pain. Several scales are validated for the screening of aberrant OT-behaviors. The Addiction Unit (AU) role could be key in the evaluation and minimization of the IUO risk (Fig.1)

      STUDY DESIGN:Prospective study for the evaluation of IUO risk in LCp. P with intermediate/high risk of IUO will be referred to the AU for evaluation and follow-up (Fig.1)

      OBJECTIVES:Determine if screening scales are capable of detecting the risk of IUO in LCp. Reduce the impact of IUO in LCp by assessment and follow-up in the AU.

      VARIABLES: Main: To determine if the Cut down-Annoyed-Guilty-Eye opener (CAGE-AD) and Opioid Risk Tool (ORT) scales are able of detecting the risk of IUO in LCp. Secondary: Determine if the urine and blood drug testing (DT) reinforces the information of such scales. Determine the risk reduction of IUO after the intervention of the AU.

      Method

      ELIGIBILITY CRITERIA (Fig.1)

      SCALES:The MO team will use the following scales for the IUO risk assessment: CAGE-AID, ORT. Visual Analogic Scale (VAS) and Edmonton Symptom Assessment Scale (ESAS) will be used for pain evaluation. LABORATORY: DT (urine/ blood ethanol)

      ASSESSMENT OF IUO RISK: Proposed timeline and strategies at the AU are summarized in Fig.1.

      SAMPLE SIZE:Study will include 45 p in a 1-year period.

      Approved by IRB-Hospital Germans Trias in Pujol, Nov, 23th2018 (UIO-pulmon 2018)

      picture1.png

      Result

      Section not applicable

      Conclusion

      Section not applicable

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    MA03 - Clinomics and Genomics (ID 119)

    • Event: WCLC 2019
    • Type: Mini Oral Session
    • Track: Advanced NSCLC
    • Presentations: 1
    • Now Available
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      MA03.06 - Efficacy Results of Selective AXL Inhibitor Bemcentinib with Pembrolizumab Following Chemotherapy in Patients with NSCLC (Now Available) (ID 2271)

      10:30 - 12:00  |  Author(s): Enric Carcereny

      • Abstract
      • Presentation
      • Slides

      Background

      The RTK AXL is implicated in epithelial-to-mesenchymal transition, negative regulation of anti-tumour immunity and resistance to multiple therapies including immune checkpoint inhibitors.

      Bemcentinib (BGB324) is a first-in-class, oral, highly selective and potent AXL inhibitor which has been demonstrated to enhance anti-PD1 therapy.

      Method

      This phase II trial (Cohort A, NCT03184571) enrolled 48 advanced lung adenocarcinoma patients with progression on or after no more than one prior line of platinum-based chemotherapy. Patients with EGFR/ALK mutations were included in this study and must have progressed on or after at least one standard targeted therapy. The primary endpoint was ORR according to RECIST v1.1. Additional endpoints included efficacy according to biomarker expression, DCR, PFS, OS, and safety. Tumour biopsies were analysed for PD-L1 expression (22C3 pharmDx), AXL by IHC, and infiltrating immune cells.

      Result

      As of April 2019, the trial was fully recruited: median age 65 (range 39-82) yrs, 61% male, 76% smokers or ex-smokers.

      At time of writing, a total of 210 treatment cycles had been completed by all patients. 17 patients were ongoing.

      17 of 32 biomarker-evaluable patients (53%) were PD-L1 negative, 13 (41%) had TPS 1-49%, and 2 (6%) had TPS >50%. Of 28 biomarker-evaluable patients, 14 (50%) expressed AXL on their tumours.

      Among patients who had at least 1 evaluable on-treatment scan: 5 responses were observed in 13 AXL positive patients (38%), and 7 in 30 patients with TPS 0-49% (23%). There were 10 responses observed among 34 evaluable patients overall (29%).

      In Stage 1, two of the 4 AXL positive responses are ongoing; mDoR is not mature in the AXL positive patients. mPFS was 5.9 mo in AXL positive patients (n=10, 3.0-NR) and 4.0 mo (95% CI 1.9-NR) overall (n=24). mOS was not mature.

      The most common TRAEs (occurring in >10% of patient in both stages) were transaminase increases (34%), asthenia/fatigue (30%), diarrhoea (26%), nausea (13%), anaemia (11%), decreased appetite (11%), and pruritus (11%). All cases of transaminase increase were reversible and resolved with concomitant administration of systemic corticosteroids and interruption of study treatments.

      Conclusion

      Patients had predominantly low or no PD-L1 expression; approximately half were AXL positive. The combination of bemcentinib and pembrolizumab was well tolerated and showed promising efficacy in previously treated IO-naïve NSCLC patients, particularly in those with AXL positive disease, including PD-L1 negative patients. Mature ORR for both stages, as well as 12-month OS for stage 1 will be presented at the meeting.

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    MA22 - Partnering with Patients to Understand Stigma, Disparities and Values Leading to Improved Lung Cancer Care (ID 154)

    • Event: WCLC 2019
    • Type: Mini Oral Session
    • Track: Advocacy
    • Presentations: 1
    • Now Available
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      MA22.05 - Assessment of Gender Differences in the Psychosocial and Economic Impact on Patients with Stage IV Non-Small Cell Lung Cancer (Now Available) (ID 718)

      15:45 - 17:15  |  Author(s): Enric Carcereny

      • Abstract
      • Presentation
      • Slides

      Background

      Incidence of lung cancer in women is rising overtime reporting evident gender-based differences in epidemiology, biology, and treatment outcome. However, little is known about gender-differences regarding psychological, economic and social aspects. The objectives of this prospective study are to evaluate the psychosocial and economic impact of metastatic non-small cell lung cancer (NSCLC), according to gender. Additionally, to assess the emotional burden and the economic impact of the disease on the primary caregiver from a gender perspective

      Method

      Multicenter, prospective, observational, study of two cohorts of patients with metastatic NSCLC (male and female) in Oncology departments of 20 Spanish hospitals. The following measurement tools were used: the APGAR questionnaire (family functionality: adaptability, partnership, growth, affection, and resolve), the Relationship impact scale, the DUKE-UNC scale (perceived socio-affective support), the patient and the caregiver economic impact scale and the Zarit scale (caregiver burden). All questionnaires were performed at the first visit, repeated 4 months later and following the first and second disease progression.

      Result

      Of the 333 pts included, 104 were females and 229 male, of whom 63% and 97%, respectively, were smokers/ex-smokers (p=0.0001). More women than men (85% vs 70%) had adenocarcinomas . The median overall survival was longer in women but did not reach statistical significance [17.1 vs 11.0 months, HR 0.732 (95% CI 0.534 to 1.005), p=0.0524]. Most families considered themselves functional (high score in APGAR questionnaire) with no changes in their partner relationship and social support was evaluated as optimal for majority of patients. Around a quarter of interviewed patients said their economic situation was a little worse after the lung cancer diagnosis, without remarkable differences by gender. Statistically significant differences were found between both groups regarding the caregiver´s relationship to the patient (more parents were the caregiver in females than in males) (p <0.0001) and the caregiver’s employment situation (more employed caregivers in females) (p<0.0001). Most caregivers of both sexes considered that taking care of their relative did not pose a significant burden. No remarkable differences by gender were found between the different variables across the study.

      Conclusion

      This study provides a preliminary insight into gender-related characteristics in the management of advanced NSCLC and its impact on the emotional, social and economic burden of patients and their caregivers, and recall the high priority of researching in cancer from a gender perspective

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    P1.01 - Advanced NSCLC (ID 158)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Advanced NSCLC
    • Presentations: 3
    • Now Available
    • Moderators:
    • Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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      P1.01-54 - Somatic Genome Alterations in Lung Cancer Patients Diagnosed with Li Fraumeni Syndrome (Now Available) (ID 1014)

      09:45 - 18:00  |  Author(s): Enric Carcereny

      • Abstract
      • Slides

      Background

      Li-Fraumeni syndrome (LFS) is a rare hereditary condition that consists of TP53 mutations inherited in autosomal dominant manner that confer high risk of developing cancer, including lung adenocarcinoma (LUAD). EGFR-mutated LUAD were reported in the context of LFS but there is no systematic description of somatic mutations and characteristics of lung cancer (LC) patients with LFS.

      Method

      We present a retrospective analysis of clinical and molecular characteristics of patients with LFS diagnosed with LC at the Catalan Institute of Oncology from 1999 to 2019. We collected demographical and clinicopathological features, germline and somatic mutational alterations, treatment and progression-free survival (PFS) and overall survival (OS).

      Result

      A total of 7 patients with LC and LFS were identified in the Genetic Counseling Unit database. They were carriers of germline mutations in TP53. Five of them were classified as pathogenic: c.638G>A; p.(Arg213Gln), c.725G>A; p.(Cys242Tyr), c.742C>T; p.(Arg248Trp), c.844C>T; p.(Arg282Trp) and c.1010G>A; p.(Arg337His) and two of them as likely pathogenic: c.374C>T; p.(Thr125Met) and c.473G>A; p.(Arg158His). Six out of 7 patients were female and 5 out of 7 never smoker. Median age at diagnosis was 38 year-old (range: 29-74). Five patients had stage IV at diagnosis and the most common histologic subtype was LUAD (5). Six patients had first grade family history of cancer with a median of 2 family members (range: 1-4) and 2 patients had prior history of cancer. Tumor somatic profile in LC was obtained in 6 patients, consisting on a ROS-1 rearrangement in one patient and EGFR mutations in 5 patients (exon 19 deletion in 3 patients and missense mutations in 2 patients, p.(Gly719Ala) at exon 18 and p.(Leu858Arg) at exon 21) and in 1 patient was unknown. All patients with mutant EGFR received EGFR tyrosine kinase inhibitors (TKI) with a median PFS of 29 months (95% CI 0-67). Four had partial response and one a complete response to TKI treatment. At disease progression, one patient had small cell transformation and another acquired EGFR T790M mutation. Median lines of treatment were 4 (range 1-6). Two patients are alive at data cut off. Median OS is 47 months (95% CI 32-62).

      Conclusion

      Patients diagnosed with LC and LFS are enriched with actionable genomic alterations and have an earlier onset of the disease. Clinical outcome of patients with EGFR mutations and LFS did not differ from EGFR mutated LC patients who do not carry TP53 germline mutations.

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      P1.01-72 - A Phase II Study of Selective AXL Inhibitor Bemcentinib and Pembrolizumab in Patients with NSCLC Refractory to Anti-PD(L)1 (ID 1632)

      09:45 - 18:00  |  Author(s): Enric Carcereny

      • Abstract

      Background

      The RTK AXL is implicated in epithelial-to-mesenchymal transition, negative regulation of anti-tumour immunity and resistance to multiple therapies including immune checkpoint inhibitors.

      Bemcentinib (BGB324) is a first-in-class, oral, highly selective and potent AXL inhibitor which has been demonstrated to enhance anti-PD1 therapy.

      The combination of bemcentinib and pembrolizumab was well tolerated and showed promising efficacy in previously treated IO-naïve NSCLC patients (Cohort A, NCT03184571), particularly in those with AXL positive disease, including PD-L1 negative patients.

      The novel combination is now being assessed in patients refractory to anti-PD-(L)1 therapy, considering the emerging need in this population and AXL’s role as a mediator of resistance.

      Method

      This is an open-label, single-arm, 2-stage phase II study (Cohort B, NCT03184571) to evaluate the safety and efficacy of bemcentinib (200mg/d) in combination with pembrolizumab (200mg/q3wk) in patients post anti-PD-(L)1 therapy. The primary endpoint is overall response rate (ORR), and additional endpoints include efficacy by biomarker expression, duration of response (DoR), disease control rate (DCR), progression free survival (PFS), overall survival (OS), and safety. Clinical efficacy endpoints are based on tumour imaging evaluable by RECIST v1.1.

      Eligible patients received a maximum of 2 prior lines of therapy, with the most recent course having included a PD-(L)1 inhibitor. To be eligible, patients must have exhibited disease control (CR/PR/SD) for at least 6 months on prior PD-(L)1 inhibitor therapy with disease progression occurring within 12 weeks since last dose.

      Bemcentinib will be administered as a loading dose of 400mg on days 1, 2 and 3 followed by a dose of 200mg once daily. A fixed dose of 200 mg pembrolizumab will be given by intravenous infusion over 30 minutes every 3 weeks. Bemcentinib and pembrolizumab will be given until disease progression, unacceptable dose toxicity, or for a maximum of 35 cycles.

      Tumour specimens will be analysed for PD-L1 expression (22C3 pharmDx), AXL by IHC, and infiltrating immune cells.

      The pre-specified efficacy threshold for continuation into the second stage is 1 objective response among the first 13 patients, at which point up to a further 16 patients may be evaluated, for a total of 29 patients.

      Result

      Section not applicable

      Conclusion

      Section not applicable

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      P1.01-93 - Metastases Sites as a Prognostic Factor in a Real-World Multicenter Cohort Study of Spanish ALK-Positive NSCLC Patients (p) (ID 1377)

      09:45 - 18:00  |  Author(s): Enric Carcereny

      • Abstract

      Background

      ALK gene rearrangements are detected in 3-7% of Non-Small-Cell-Lung-Cancer (NSCLC) p. EML4-ALK translocation was first identified as an oncogene in NSCLC p in 2007. To date, published real-world data on the prognostic factors of patients with ALK-positive advanced NSCLC in Spain are limited. We aim to evaluate the effect of number of metastases (M1) organs on overall survival (OS) in a multicenter cohort of Spanish ALK-positive NSCLC p diagnosed between 2008 and 2017.

      Method

      We included p with stage IV at diagnosis since 2011 to April 2018. OS (months [m]) was estimated with the Kaplan-Meier method. Survival curves were compared between groups of p using the log-rank test. Hazard risk (HR) to death was estimated with multivariable Cox model, adjusted by site of metastases, gender, age and first line type of treatment.

      Result

      Out of the 163 p in the cohort a total of 98 p were included, with a median follow-up of 28.6 m and 45 deaths reported. Characteristics at diagnosis were median age 58 years, female 46.9%, never-smokers 59.2%, 50% with comorbidities, PS by ECOG 0-1 93%, 58.2% lung M1, 45.9% central nervous system M1, 42.9% bone M1, 22.4% liver M1 and 29.6% pleural M1.

      54.3% p and 89.4% p were treated with ALK inhibitors as first line and second line respectively. The median OS was 34.4 months, being 46.9 months in p treated with ALK inhibitors and 38.8 months in p treated with chemotherapy as first line (p= 0.9).

      There were 72 p who presented M1 in more than one organ and 26 p in a single organ. The risk of death increased with greater number of organs involved at diagnosis (HR= 3.0, p=.016), and presenting liver M1 at diagnosis (HR=2.2, p=.046, with OS of 19.1 m), compared to p single site involvement (OS: 45.4 m).

      Conclusion

      OS was worse with increased metastatic sites involved at diagnosis in p with ALK positive NSCLC, being liver M1 associated with the highest risk of mortality. Brain metastases at diagnosis were not a prognostic factor for OS in our series.

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    P1.16 - Treatment in the Real World - Support, Survivorship, Systems Research (ID 186)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Treatment in the Real World - Support, Survivorship, Systems Research
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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      P1.16-44 - Multiple Primary Cancers (MPC) in a Cohort of Lung Cancer (LC) Patients (P): Incidence and Clinical Features (ID 2236)

      09:45 - 18:00  |  Author(s): Enric Carcereny

      • Abstract

      Background

      The prognosis of p with LC has drastically changed during the last decade due to the improvement in prevention, diagnosis and treatment. Therefore, the number of LC survivor ps has significantly increased and subsequently the incidence of MPC is also rising. This study investigates the co-occurrence of MPC among p diagnosed with LC.

      Method

      We reviewed of clinical data of patients with histologically confirmed LC visited at our institution between February 2016 and December 2018.

      Result

      A total of 492 p out of 777 p, (63.3%) had adenocarcinoma and 223 p (28.7%) had squamous LC. The most frequently related comorbidities were hypertension (42.5%), dyslipidemia (36.2%), COPD (21%), cardiovascular disease (15.7%) and diabetes mellitus (14.5%). Molecular analysis was perform in 402 p (51.7%). EGFR mutation was detected in 77 p (exon 19 in 14% and exon 21 in 5% of p). ALK and ROS1 translocation were diagnosed in 27 and 7 p, respectively.

      Two primary cancers occurred in 111 cases (14%), including 15 p (1.9%) with three or more primary cancers. Patients with MPC were predominantly males (76.8%), smokers (85%) and 34% had prior family history of MPC. Median age at the first tumor diagnosis was 64 years (57-71). LC occurred as first neoplasm in 8.1% of the cases, 92 p (83%) developed metachronic MPC and 19 p (17%) synchronous MPC. Most common secondary primary cancer were head and neck in 19%, non-melanoma skin cancer in 19%, prostate in 12.6%, bladder and upper urinary tract cancer in 10%, colorectal in 6.3% and breast in 5.4%.

      First-line treatment for advanced or locally advance LC included chemotherapy in 65.6%, concomitant chemoradiotherapy in 14%, targeted therapy in 4% and immunotherapy in 4%. Overall response rate (ORR) to first-line treatment was 43.7%. Second-line treatment included chemotherapy in 47.6% and immunotherapy in 30.4%, with and ORR of 30%.

      Conclusion

      In our series, the frequency of the co-occurrence of MPC among LC p is 14%, suggesting that surveillance strategies are recommended in this population. Most frequent MPC in LC patients are related to smoking. ORR in first and second-line are consistent with the literature.

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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
    • Now Available
    • Moderators:
    • Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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      P2.05-15 - Radial Endobronchial Ultrasound-Guided Transbronchial Biopsy in Peripheral Lung Lesions. What Can Cryobiopsy Contribute? (Now Available) (ID 865)

      10:15 - 18:15  |  Author(s): Enric Carcereny

      • Abstract
      • Slides

      Background

      Radial probe endobronchial ultrasound (RP-EBUS) is a modern technique for diagnosis of peripheral lung lesions. The addition of transbronchial cryobiopsy (TBCB) could increase the diagnostic value for RP-EBUS. AIM: To evaluate the efficacy of RP-EBUS guided TBCB for diagnosis of peripheral lung lesions.

      Method

      We collected 60 patients with peripheral lung diseases. Were excluded 15 patients for not be fit for general anesthesia (necessary for TBCB) or high risk of bleeding. 45 patients were subjected to forceps transbronchial biopsy (forceps TBB) and TBCB guided by RP-EBUS. The diagnostic outcomes including digital assessment for qualitative and quantitative measures of collected samples were detected. Also, the associated complications were recorded.

      Result

      The diagnostic yields for forceps TBB versus TBCB is detailed in Table 1. TBCB has achieved higher accuracy than forceps TBB (ROC area of 0.88 versus 0.84 respectively), with no statistical difference between their values (p=0.32). The combination between both techniques has achieved excellent accuracy (ROC area 0.91). In 36 cases were possible the anatomopathological diagnosis with both type of samples, there were significant statistical differences (p ≤ 0.05) in favour of TBCB when compared to forcep TBB regarding; mean biopsy diameter, mean biopsy surface area, mean biopsy necrosis, percentage and mean biopsy viable tissue area. Only two patients had significant complications (pneumothorax; hypoxemia), and 8 moderate bleeding.

      tabla crio lcc.jpg

      Conclusion

      Conclusions: RP-EBUS guided TBCB is a safe and effective technique for diagnosis of peripheral lung lesions. TBCB could achieve higher diagnostic value than forceps TBB due to better quantity and quality of the samples.

      The project was partially funded by SEPAR, grant AEER 2016, grant FUCAP 2017 and Egyptian Ministry of Higher Education.

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    P2.10 - Prevention and Tobacco Control (ID 176)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Prevention and Tobacco Control
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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      P2.10-02 - Smoking Habit in Lung Cancer in Spain   (ID 732)

      10:15 - 18:15  |  Presenting Author(s): Enric Carcereny

      • Abstract
      • Slides

      Background

      Tobacco is the leading cause of lung cancer. The fight against the smoking habit is essential and should be continuous, to detect the national situation that makes it possible to design health care policies against this consumption. To do so, the Grupo Español de Cáncer de Pulmón (Spanish Lung Cancer Group) made this analysis within the context of the Thoracic Tumor Registry (TTR).

      Method

      The TTR is an observational cohort multicenter study in Spain. The study is conducted according to the Declaration of Helsinki and approved by the institutional review board of each participating site. The registry was approved by the Spanish Drug Agency, as a non-post-authorization, non-interventional study.

      Result

      We collected data from 6,600 patients diagnosed of lung cancer from 58 different Spanish hospital sites.

      A total of 3,039 patients were former smokers (46%), 2,611 were active smokers (39%) and only 866 (12%) patients stated to be non-smokers; the status in 2% is unknown. If we make a comparison by gender regarding the presence of this habit, large differences (p-valor < 0.001) are observed, with a greater number of non-smokers in women (37 % vs. 4.5% in males), while the percentage of former smokers is much higher in the males (53.4% vs. 27.9% in women) and a minor difference in active smokers (42.1% vs. 34.4% in women).

      Significant differences were observed in the study on the distribution of the smoking habit by gender and year of diagnosis. An increase is also observed in the last two years regarding the percentage of patients who were active smoked, both for the total population as well as for each one of the two genders separately. The increase is greater among the women and, also, the number of women who are active smokers is greater in recent years.

      Mean age of onset of the smoking habit is 18.2 years. Significant differences are observed between both genders (p-valor < 0.001), with a mean age of initiation of 17.9 years in the men (95%CI 17.6-18.2 years) and 19.2 years in the women (95%CI 18.5-19.8 years). Significant differences between Regional Communities were also found in the mean age at onset of the habit, with much lower levels in the Valencian Community (16.6 years) or Navarra (16.9 years) regarding other communities, such as the Region of Murcia (22.9 years) or the Balearic Islands (21.6 years)

      Conclusion

      Lung cancer in Spain is associated to tobacco consumption in 85% of the cases diagnosed. Consumption has shown an increase in both genders in recent years and is especially rapid and worrisome in women. Anti-smoking campaigns should be reactivated and the causes of the regional differences analyzed in depth

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    P2.13 - Staging (ID 315)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Staging
    • Presentations: 1
    • Now Available
    • Moderators:
    • Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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      P2.13-05 - Endobronchial Ultrasound for Mediastinal Restaging in Non-Small Cell Lung Cancer (Now Available) (ID 858)

      10:15 - 18:15  |  Author(s): Enric Carcereny

      • Abstract
      • Slides

      Background

      The adequate mediastinal restaging following neo-adjuvant therapy (NAT) in operable patients with non-small cell lung cancer (NSCLC) and N2 spread is crucial. Mediastinoscopy is the gold standard for mediastinal restanging, but endosonographic procedures are less invasive and can be an alternative. AIM: Evaluate the role of endobronchial ultrasound-guided transbronchial needle aspirate EBUS-TBNA in mediastinal the restaging of NSCLC.

      Method

      Prospective study with 32 patients with CPNCP N2 spread confirmed by TNBA-EBUS, collected from June 2010 to October 2018. These patients were subjected to neoadjuvant treatment (chemotherapy or radio-chemotherapy), subsequently were performed mediastinum restage with TNBA-EBUS. The negative cases were subjected to mediastinoscopy or thoracotomy.

      Result

      Of the 32 cases, the basal characteristics are detailed in table 1. Were analysed 229 lymph nodes, 42 of these were malignant (18%). TNBA-EBUS after neoadjuvant treatment showed persistence of N2 spread in 19 cases (52%). In negative cases (n=13; 41%) were performed mediastinoscopy (n=11) or surgery (n=1). After these procedures were confirmed mediastinal disease in 3 cases, 9 lymph nodes of 43 removed. The sensitivity, specificity, positive predictive value, negative predictive value and diagnostic accuracy were 86.4%, 100%, 100%, 72.7% and 90% respectively. There was recurrence of the disease in 15 cases (47%). We found a significant difference between recurrence and the type of neoadjuvant treatment (chemotherapy vs. radio-chemotherapy), p=0.047.

      Table 1.

      reest.jpg

      Conclusion

      TBNA-EBUS is an appropriate semi-invasive tool in mediastinal restage after neoadjuvant treatment, with high diagnostic accuracy. Nevertheless, in negative cases is still necessary support with invasive procedures.

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