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    MA16 - Prioritizing Use of Technology to Improve Survival of Lung Cancer Subgroups and Outcomes with Chemotherapy and Surgery (ID 142)

    • Event: WCLC 2019
    • Type: Mini Oral Session
    • Track: Treatment in the Real World - Support, Survivorship, Systems Research
    • Presentations: 12
    • Now Available
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      MA16.01 - Project PRIORITY: A Patient-Founded and Patient-Driven Research Partnership on Real-World Data on EGFR-Positive Lung Cancer (Now Available) (ID 2918)

      15:45 - 17:15  |  Presenting Author(s): Ivy Elkins  |  Author(s): Upal Basu Roy, Anita Figueras, Teri Kennedy

      • Abstract
      • Presentation
      • Slides

      Background

      Despite increases in PFS in EGFR-positive lung cancer patients due to EGFR TKIs, patients eventually develop resistance to these drugs. Project PRIORITY (Patient Reported Initiative On Resistance, Incidence, Treatment studY) is a patient-founded and patient-driven longitudinal study aimed at understanding unmet needs of the global EGFR-positive lung cancer community.

      Method

      A comprehensive 103-question, IRB-approved patient-facing survey about the diagnostic and treatment journey of patients (including risk factor exposure, treatments, symptom and side-effect management, access to biomarker testing and clinical trials) was developed with input from US FDA statisticians and expert clinicians, and then pilot-tested among English-speaking patients both locally and internationally. Differences between US and international participants were analyzed by Chi-square (for categorical variables) and ANOVA.

      Result

      Of the 253 respondents, 27.7% were international participants. In line with previous studies with EGFR patients, participants reported low rates of active tobacco exposure (16.4%) and high rates of second-hand tobacco exposure (34.7%). Also, first-line use of afatinib (OR = 2.5, p <0.05) and erlotinib (OR = 3.3, p< 0.05) were associated with the development of a T790M mutation reflecting similarity in clinical characteristics.

      US participants were more likely to report childhood exposure to secondhand smoke, family history of cancer (other than lung cancer), use of more than one line of therapy, and combination first-line therapy (P<0.05 for all variables).

      International participants were more likely to report first-line treatment with 1st/2nd generation TKI, less use of tissue and plasma NGS, lower clinical trial participation, and more use of whole-brain radiation for brain metastasis (P<0.05 for all variables).

      priority abstract figure.jpg

      Conclusion

      This first-of-its-kind international study provides a comprehensive picture of the treatment of EGFR-positive lung cancer patients in the real-world setting and highlights the existence of diagnostic (low NGS rates) and treatment gaps (low clinical trial participation and different treatment sequencing) both within the US and internationally.

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      MA16.02 - T790M Allelic Fraction Level Did Not Correlate Survival in T790M Positive NSCLC – Observations from an Early Access Program (Now Available) (ID 1809)

      15:45 - 17:15  |  Presenting Author(s): Oscar Siu Hong Chan  |  Author(s): Kwok Chi Lam, Victor Lee, Shi Fung Nyaw, Mei Wan Rebecca Yeung

      • Abstract
      • Presentation
      • Slides

      Background

      Osimertinib is an irreversible third-generation EGFR-TKI indicated for patients with metastatic EGFR T790M mutation positive NSCLC after progression of initial TKI therapy. An early access program (EAP) was started in 2015 providing ethical access of Osimertinib to patients with metastatic NSCLC running out of treatment options in Hong Kong. As some prior data suggested that T790M allele fraction (AF) correlated survival outcomes in patients receiving Osimertinib, we try to validate it with data from this EAP. Survival outcomes and safety data of Osimertinib in the real world practice under this EAP were also analysed. (NCT03219970)

      Method

      This retrospective analysis included EAP patients who had advanced or metastatic NSCLC harbouring EGFR T790M mutation that progressed on prior TKI ± chemotherapy. EAP subjects received Osimertinib at 80mg daily until disease progression, intolerable toxicities or death. The T790M mutation can be assessed by any approved molecular tests in any specimen types.

      The AF levels in patients with T790M mutation confirmed by quantitative plasma genotyping (QPG) using ddPCR technique of the same vendor were retrieved. The primary objective was to assess the relationship of post-Osimertinib overall survival (OS) and T790M AF level. Secondary objectives included investigator-assessed response, time to discontinuation (TTD) of Osimertinib, safety (Osimertinib-related adverse events of special interest, AESIs) and OS of all EAP participants.

      Result

      From Sep 2015 to Feb 2017, 156 patients enrolled in the EAP and received treatment. At time of data cut-off (11 Oct 2018), 74 (47%) were alive. Median follow-up was 23.4 (range: 1–30) months, median age 62 years, 62% female, 26% ECOG PS ≥2, 96.8% with metastatic disease. Besides T790M, 56% of patients had exon 19 deletions and 41% had exon 21 L858R mutations.

      Ninety-one patients had QPG using ddPCR method with AF data. OS, best response rate and TTD were not significantly related to T790M AF level as a continuous variable (p=0.20; hazard ratio 1.022, 95% CI 0.989 to 1.057), confirmed through sensitivity analysis with different AF threshold values.

      The investigator assessed best response rate was 41.7% (65/156) and disease control rate was 62.2% (97/156). Median TTD was 15.77 (12.43, 18.98) months. Median OS was 21.88 (95% CI 19.14–26.21) months. AESIs were reported in 7.7% of patients overall: 5.8% QTc prolongation and 1.9% pneumonitis.

      Conclusion

      T790M AF level did not correlate with TTD and OS in this EAP cohort but the limitations should not be overlooked. The survival outcomes concurs other reported series.

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      MA16.03 - Big Data Analysis for Personalized Medicine in Lung Cancer Patients (Now Available) (ID 2532)

      15:45 - 17:15  |  Presenting Author(s): Maria Torrente  |  Author(s): Beatriz Núñez-García, Fabio Franco, Virginia Calvo De Juan, Ernestina Menasalvas, Alejandro Rodríguez-González, Consuelo Parejo, Mariano Provencio

      • Abstract
      • Presentation
      • Slides

      Background

      The use of Big Data in healthcare is in its early days, and most of the potential for value creation remains unclaimed.

      Electronic Health Records (EHR) contain a large amount of information about the patient's condition, which can potentially revolutionize the clinical practice, such information is seldom considered due to the complexity of its extraction and analysis. We report on a first integration of an NLP framework for the analysis of clinical records of lung cancer in Puerta de Hierro University Hospital (HUPHM).

      Method

      A cohort of 1000 patients diagnosed of non-small cell lung cancer (NSCLC) from 2009 to 2018 at HUPHM were included in this observational study. Unstructured clinical data were obtained from the EHR. The semantic indexing and the information analysis was performed by the Politecnica University of Madrid, using Big Data and machine learning techniques. Clinical notes were converted into usable data, and combined with genomic data, images and bibliography, such as PubMed or Drugbank.

      Result

      A total of 251.730 documents were analyzed (240.851 notes and 10.879 reports). These heterogeneous sources of information were analyzed and integrated in an interactive user interface (Figure 1). As a result, all this large amounts of data turns into actionable and exploitable information for clinicians and authorities for planning public health policies and also create new clinical trials.

      The interactive platform will allow the clinician obtain immediate and personalized information of each patient and will elaborate predictive models for long survivors, identify risk patients, reduce overtreatments, etc.

      Conclusion

      By using Big Data we will be able to exploit large amounts of clinical information and combine them with multiple databases developing interactive user interface, increasing lung cancer knowledge and directing medicine towards a more personalized one.

      This work was supported by the EU H2020 programme, under grant agreement Nº 727658 ( Project iASiS).

      captura de pantalla 2019-04-10 a las 21.07.09.png

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      MA16.04 - Discussant - MA16.01, MA16.02, MA16.03 (Now Available) (ID 3783)

      15:45 - 17:15  |  Presenting Author(s): Sukhmani Padda

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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      MA16.05 - Wearable Technology for Preconditioning Before Thoracic Surgery: A Feasibility Study (Now Available) (ID 2642)

      15:45 - 17:15  |  Presenting Author(s): Yogita S. Patel  |  Author(s): Danielle Hylton, Matthew Rok, Marla Beauchamp, Joshua Wald, Lawrence Mbuagbaw, Christian Finley, John Agzarian, Yaron Shargall, Christine Fahim, Wael C. Hanna

      • Abstract
      • Presentation
      • Slides

      Background

      Preconditioning before surgery can lower complication rates, but there are significant barriers to its adoption in the lung cancer population, which is characteristically older, suffers multiple comorbidities, and is averse to exercise. In an effort to overcome these barriers, we designed Move For Surgery (MFS), a home-based, preoperative preconditioning program which involves aerobic exercise using wearable technology and deep breathing exercises. We aimed to test the feasibility of MFS in preparation for a randomized controlled clinical trial.

      Method

      In this prospective feasibility study, patients undergoing resection for NSCLC were preoperatively enrolled and provided with a wearable activity tracker (Fitbit) and a booklet describing various aerobic exercises, deep breathing exercises, and nutritional and smoking cessation tips. The daily step count, sleep cycle, and calories burned were synced and tracked remotely. Daily step goals were set by increasing the participants’ baseline step count by 600 steps each week until the day of surgery. Participants were encouraged and motivated to reach their daily step goal by daily automatic reminders through the Fitbit. Participants completed the EQ-5D-5L health-related quality of life instrument at baseline and on the day of surgery. Data is presented as mean +/- SD and median (range). Continuous variables were compared using Student’s t-test, and categorical variables were compared using Chi-square or Fischer’s exact test, with a level of significance p<0.05.

      Result

      Of the 40 patients screened, 62.5% (25/40) were eligible and enrolled. Of the 15 not eligible, 80% (12/15) did not have a smartphone. Participants (n=25) were enrolled from 11/2017 to 07/2018. Median age was 62 (33-82) and 72% (18/25) were women. The mean predicted FEV1 and DLCO were 88.9% +/- 23.4% and 74.9% +/- 19.8% respectively. Participants spent a median of 25 days (8-55) on trial, and wore their Fitbits 90.0% +/- 25.2% of the time. The mean baseline daily step count for this cohort was 7,586 +/- 4,082, and the participants were able to achieve the daily step goal in 40.8% +/- 30.0% of the time. Participants with higher baseline step counts (≥6,000/day) were more likely to achieve the daily step goals (52.2% vs 20.5%; p=0.0083). Significant improvement was seen in the overall health component of the EQ-5D-5L from before the intervention (76.4 +/- 15.45) to after the intervention (80.4 +/- 14.57; p=0.03). Overall, 96.0% (24/25) of the participants completed the recommended deep breathing exercises, 100% (25/25) recommended MFS for future patients, and 96.0% (24/25) stated they will buy their own Fitbits and continue this lifestyle post-surgery.

      Conclusion

      A preoperative preconditioning trial with wearable technology prior to lung cancer resection is feasible based on encouraging enrollment rates, use of the device, and goal achievement, but it is only applicable to participants with smart devices. MFS motivates patients to undergo preconditioning before lung cancer resection and to continue with a healthy lifestyle after surgery. A revision of the daily step goal is required to improve compliance. A randomized trial is in progress to determine the impact of MFS on postoperative outcomes in the thoracic surgery population.

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      MA16.06 - Deterioration in Health-Related Quality of Life Diminishes Benefit of Lung Cancer Resection in Older Adults (Now Available) (ID 2875)

      15:45 - 17:15  |  Presenting Author(s): Jae Y. Kim  |  Author(s): Andrew M Blakely, Hengrui Hu, Lennie Wong, Dan J Raz, Loretta Erhunmwunsee, Virginia Sun

      • Abstract
      • Presentation
      • Slides

      Background

      Outcomes of oncologic resection are related to tumor biology as well as patient-reported health factors. However, data regarding changes in functional status and health-related quality of life (HRQOL) before and after lung surgery are currently lacking.

      Method

      We identified lung cancer patients from the SEER-Medicare Health Outcomes Survey (MHOS) linked database. HRQOL survey data captured physical/mental health, activities of daily living (ADLs), and medical comorbidities. Patients who underwent surgery with 1) baseline HRQOL survey prior to cancer diagnosis and 2) follow-up survey at least one year after diagnosis were selected. Patient, disease, and HRQOL measures were analyzed using Cox proportional hazards regression in regard to overall survival (OS) and disease-specific survival (DSS).

      Result

      Overall, 138 patients were evaluated, of whom 67 (49%) were male. Mean age at diagnosis was 74 years. The majority of patients were Caucasian (n=112, 81%). Disease extent was localized for 75 (54%), regional for 58 (42%), and distant for 5 (4%). In general, the cohort experienced a decline in physical HRQOL, mental HRQOL, and ADLs; and an increase in the number of major comorbidities (see Table). Median OS was 74 months. Decreased OS was independently associated with male sex (HR 1.7, p=0.03), more advanced disease (regional vs. localized: HR 1.8; distant vs. localized: HR 2.1; p=0.04), and decline in ADLs (HR 1.8, p=0.02). Decreased DSS was independently associated with male sex (HR 2.2, p=0.03), more advanced disease (regional vs. localized: HR 2.9; distant vs. localized: HR 3.1; p=0.01), and decline in mental HRQOL (OR 2.1, p=0.02).

      table.png

      Conclusion

      The potential survival benefit of lung resection for malignancy is diminished by declines in physical and mental health. Among older surgical patients at risk for functional and HRQOL deterioration, identification and mitigation of such deterioration may in turn optimize oncologic outcomes.

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      MA16.07 - Implementation of a Smartphone App to Face Postoperative Period in Patients with NSCLC Undergoing Lung Resection Surgery (Now Available) (ID 1028)

      15:45 - 17:15  |  Presenting Author(s): Carlos Alfredo Fraile Olivero  |  Author(s): Lucia Milla Collado, José Ramón Jarabo Sarceda, Elena Fernández Martín, Carlos Cerdan Santacruz, Joaquin Calatayud Gastardi, Ana María Gómez Martínez, Pedro Daniel Arribas Manzanal, Passio Santos Capa, Micaela Martínez Tardido, Veronica Alen, Florentino Hernando-Trancho

      • Abstract
      • Presentation
      • Slides

      Background

      Preoperative patient education and counseling helps to set expectations about surgical procedure and to prepare for it. Thoracic surgery procedures are related to postoperative complications and strategies to reduce them begin prior to surgery. Lung expansion maneuvers, the importance of early ambulation and pain control are best taught before the procedure. The aim of this prospective study was to implement the use of a smartphone application in a cohort of patients undergoing lung resection surgery and describe their feedback results.

      Method

      We created a Smartphone application as a multidisciplinary tool including: peri-operative medical advice (stop smoking, mouth health, early mobilization and pain control) (Fig1), ten chest physical exercises (with animated images) and programmable Smartphone daily notifications. Complete information to download, set up and interaction with the software was given to patients. A Multiple-Choice-Question survey was applied to patients at the moment of hospital discharge in order to evaluate their experience. This prospective and observational study included clinical data and results of surveys applied.

      image1 (3).png

      Result

      A total of 68 patients interacted with the application before surgery and answered the survey after the procedure. Median age was 66.5 years and 67.6% were males. Of them, 51 patients (75%) considered the content “very compressible”. 54 patients (79.4%) considered “positive” the contribution of the application to face the postoperative period. Additionally, 31 patients (45.6%) deemed “appropriate” the quantity of time and physical effort needed to complete the interaction with the tool and reach the goals.

      Conclusion

      This is the first smartphone application created by thoracic surgeons to improve patient´s education and helps them to prepare for surgery. This new technological tool was successfully implemented in our thoracic surgery department. For patients, it is easy to download, setup and contents comprehensible information that contributes to face positively the postoperative period with an adequate physical effort and quantity of time.

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      MA16.08 - Discussant - MA16.05, MA16.06, MA16.07 (Now Available) (ID 3784)

      15:45 - 17:15  |  Presenting Author(s): Sabita Jiwnani

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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      MA16.09 - Clinical Practice and Outcomes in Patients with Stage III Unresectable Non-Small-Cell Lung Canceran Academic Centre, Canada (Now Available) (ID 818)

      15:45 - 17:15  |  Presenting Author(s): Jason Scott Agulnik  |  Author(s): Goulnar Kasymjanova, David Small, Carmela Pepe, Lama Sakr, Victor Cohen, Magali Lecavalier, Hangjun Wang, Alan Spatz, Manjusha Hurry, Ryan Walton

      • Abstract
      • Presentation
      • Slides

      Background

      The prognosis of patients with stage III unresectable non-small cell lung (NSCLC) cancer is poor: five-year OS is only 19-24% for stage IIIA and 7- 9% for stage IIIB. In light of the approval of immunotherapy maintenance treatment, after completion of CRT, we undertook a retrospective study to characterize management and report outcomes of patients with stage III, unresectable NSCLC treated with chemoradiation (CRT) at the Jewish General Hospital, Montreal.

      Method

      Patients diagnosed with stage III unresectable NSCLC,and treated with combined CRT, either concurrent (cCRT) or sequential (sCRT) treatment,between January 2007 to December 2018 were included in the study. Overall survival was calculated using the Kaplan-Meier approach and calculated from the start of radiotherapy. Physician defined progression-free survival was calculated from the start of radiotherapy until documented progression based on radiologic assessment. A multivariate analysis using Cox regression was carried out to assess clinical factors impacting survival.

      Result

      134/263 patients were deemed unresectable and received combined CRT. 124/134 (92.5%) received CRT as initial treatment and 10(7.5%) received CRT after progression to stage 3 post surgery for an earlier stage NSCLC.114/134 received cCRT and 20/134 received sCRT. Patients on cCRT were significantly younger with a slight prevalence of non-squamous histology and had N1 or single station N2 disease.Median OS (mOS) was 18.7 months (95%CI, 12.4-24.8) for the overall cohort; mOS in cCRT of 23.3 months (95%CI,14.3-32.2) was significantly better compared to 11.33 months with sCRT (95% CI, 10.2-24.8 p=0.01). PFS was slightly better in patients with cCRT (7.97mo, 95%CI 1.75-11.18) compared to sCRT (5.26mo, 95% CI 4.06-6.48 p=0.08).86/134 (64%) progressed and received subsequent therapy: 49 (57%)-chemotherapy alone, 15 (17.4%)–radiation alone, 13 (15.1%)-immunotherapy and 9 (10.5%)-targeted therapy.In multivariate analysis, the tumor size (HR 1.5, 95%CI 1.08-1.97) and nodal status (HR 2.5, 95%CI 3.34-4.74) were the only prognostic factors for OS. Gender, age, ECOG, smoking status, histology, chemotherapy protocol, subsequent therapy, mutation status and cCRT were not statistically significantin multivariate analysis. cCRT was not significant, likely due to patient selection.

      Conclusion

      Unresectable stage III NSCLC is a heterogenous group that is challenging to manage. Combined CRT has beenthe standard of care for this group of pts. In our patient cohort, a trend of improved survival was seen in the cCRT group. Tumor size and nodal status were prognostic factors for OS. Future studies evaluating survival with newer IO therapies is of interest.

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      MA16.10 - Antioxidative Effect of Erdosteine on Platinum-Based Doublet Chemotherapy Induced Nephrotoxicity (Now Available) (ID 1080)

      15:45 - 17:15  |  Presenting Author(s): Chang Youl Lee  |  Author(s): Seung Hun Jang, Myung-Goo Lee

      • Abstract
      • Presentation
      • Slides

      Background

      Many classes of antineoplastic agents including the platinum coordination complexes are also known to generate free radicals which have a role in the side effects of chemotherapy. Despite the introduction of new treatments including target and immunotherapy, platinum-based doublet chemotherapy is one of the most widely used and most potent chemotherapy drugs to treat lung cancer patients especially with small cell lung cancer. However, side effects in normal tissues and organs, notably nephrotoxicity in the kidneys, limit the use of platinum-based doublet chemotherapy. There are several experimental evidences which support the protective effect of erdosteine in acute injury induced by a variety of pharmacological or noxious agents, mediated by products of oxidative stress. Erdosteine is a multifactorial drug currently used in lung disease. In the last decade, data from several studies to the possible antitussive and anti-inflammatory properties of erdosteine and an indirect anti-inflammatory mechanism of action related to the ROS scavenging activity was suggested. The purpose of this study is to investigate whether erdostein can reduce the renal toxicity of lung cancer with platinum-based doublet chemotherapy by antioxidant role.

      Method

      This study was a prospective, randomized, double-blind clinical trial on 153 patients with lung cancer(small cell lung cancer and non-small cell lung cancer). Patients who was treated with platinum-based doublet chemotherapy were randomly assigned into 2 groups of intervention(erdostein) group and control(non-erdostein) subjects regardless of the type of lung cancer. Intervention group took erdosteine 600 mg orally twice a day. We measured CCr, serum/urine NGAL, serum/urine Cystatin C, urine KIM-1 of the lung cancer patients who underwent platinum-based doublet chemotherapy to assess renal injury. And also we measured the activity of specific antioxidant enzymes, such as catalase and superoxide dismutase to evaluate oxidative stress. Serum and urine samples were collected from the patient before and after chemotherapy.

      Result

      There was no significant difference of renal status between intervention and control groups at baseline. However, Statistically there was a significant decline in CCr among control group regardless of the type of lung cancer and the resimen of chemotherapy. NGAL expression of blood and urine was decreased in intervention group (especially patient treated with cisplatin and small cell lung carcer patients) but Cystatin C levels showed no difference between two groups. The decrease in urinary KIM-1 after cisplatin-based doublet chemotherapy in intervention group were observed compared to control group. Superoxide dismutase levels of serum were approximately increased to twice the initial level to the level measured after chemotherapy in the treatment group while the level of catalase did not change significantly in both the groups.

      Conclusion

      These results show that erdosteine may be a promising drug for protection against platinum-based doublet chemotherapy-induced nephrotoxicity, especially for patients with cisplatin-based doublet chemotherapy and small cell lung cancer. However, further studies with different dose of erdosteine are warranted for clarifying the issue.

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      MA16.11 - Early and Late Survival Comparison Between Oncological Versus Non-Oncological Patients Admitted to a General Intensive Care Unit in Chile (Now Available) (ID 1948)

      15:45 - 17:15  |  Presenting Author(s): Suraj Rajesh Samtani  |  Author(s): Rene Lopez, Jeronimo Graf, Jose Miguel Montes, Rodrigo Perez

      • Abstract
      • Presentation
      • Slides

      Background

      Cancer patients are a heterogeneous population and usually admission to ICU units was discouraged due to negative outcomes. In the past years, literature supports the admission at ICU for oncological patients that need invasive mechanical ventilation (IMV) with new admission policy known as the ICU-trial, with aim to recognize a group of patients that may benefit of limited time of intensive support and treatment. The purpose of this trial is to describe the characteristics and overall survival of a prospective cohort of invasive mechanical ventilation (IMV) patients admitted to an ICU of Clinica Alemana.

      Method

      This is an observational, prospective and analytical cohort study conducted in Clínica Alemana de Santiago. We included patients with cancer > 18 years old, with baseline Eastern Cooperative Oncology Group (ECOG) performance status classification from 0 to 3, who were admitted to ICU and needed IMV between October 2017 and February 2019. Demographic, physiologic, laboratory, clinical and treatment data were extracted prospectively in a database-updated daily. Survival data was obtained from national death registry database.

      Result

      A total of 1,490 patients were admitted between October 2017 and February 2019. A total of 358 patients (24%) had oncological diagnosis and 100 patients were supported with IMV. According to ICU plan, 76 patients were treated as full code and 24 patients as ICU-trial. Among all IMV patients ICU mean of length of stay (LOS) was of 7 days. At the comparison between oncological vs non-oncological patients, APACHE II score and the first-day SOFA score were not statistically different between both groups. Among oncological patients, 73,3% of patients were ECOG 1 and solids tumors were more common than hematological malignancies (90% vs 10%). Lung and digestive cancer were the most frequent malignancies. Full code management was the most frequent strategy at ICU admission in comparison to ICU-trial (76% vs 24%). Survival at day 28 between oncological and non-oncological patients was 76.3% vs 79.3% respectively (p=0.588). However, survival was significantly different at day 90 (64.3% vs 78.8% respectively, p=0.015) and at end of following period (52% vs 76.2% respectively, p<0.001). Remarkably, survival adjusted by cox regression showed a significant lower survival in oncological patients with ECOG 2 and ECOG 3 while the patients with ECOG 0 and 1 had a similar survival to non-oncological patients. According to ICU plan management statistically significant difference was observed in the group of oncological patients with higher survival in full code vs ICU-trial (59.5% vs 29.2% respectively, p=0.015) with a hazard ratio 0.52 [0.28-0.94].

      Conclusion

      Our data suggest that in oncological patients the short-term survival is determined for severity of the critical illness and the late survival is lower respect to non-oncological patients if poor performance status is documented. In patients with cancer admitted under ICU-trial criteria and supported with invasive mechanical ventilation a late survival close to 30% was observed. Similar to previous studies, our study emphasizes that ICU admission should not be limited only on the basis of a patient having a neoplastic disease and different variables should be considered from patient to patient.

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      MA16.12 - Discussant - MA16.09, MA16.10, MA16.11 (Now Available) (ID 3785)

      15:45 - 17:15  |  Presenting Author(s): Apar Kishor Ganti

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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Author of

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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: 1
    • Moderators:
    • Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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      EP1.12-21 - Treatment Patterns and Prognostic Factors in Small-Cell Lung Cancer Patients in Israel – Real World Analysis of a Health Services Database (ID 769)

      08:00 - 18:00  |  Author(s): Jair Bar

      • Abstract
      • Slides

      Background

      Small-Cell Lung Cancer (SCLC) is an aggressive smoking-associated malignancy, with rapid growth and early metastatic dissemination that accounts for 10-15% of all lung cancers. Data on current epidemiology and clinical aspects of the disease in Israel are lacking.

      In this observational study, we analyzed treatment patterns and prognostic factors in patients with SCLC in Maccabi Healthcare Services (MHS), a public integrated care organization in Israel.

      Method

      Patients with newly diagnosed, histologically confirmed SCLC who initiated systemic anti-cancer treatment between 2011 to 2017 were identified from the MHS cancer registry. Their demographic, clinical and treatment data were retrospectively analyzed.

      Result

      235 SCLC patients were identified; 61% male, median age 64 years (IQR: 58, 70), 95% ever smokers, 62% had extensive stage disease (ES), 11% had brain metastases and 60% had 0-1 ECOG performance status (PS), all at treatment initiation.

      First-line treatment was platinum-etoposide regimen for the whole cohort. 107 of 235 patients (46%) continued to 2nd-line therapy and 29 patients (12%) received 3rd-line regimen.

      Median overall survival (OS) for the study population was 11.8 months. Patients with limited stage disease (LS) had a significant longer survival than those with ES (23.5 vs 9.1 months, P<0.001). In a multivariable model for all-cause mortality, males had a HR of 1.59 (95% CI 1.14-2.21, P=0.006) compared to females, and patients with ES had a HR of 4.76 (95% CI 1.37-16.49, P=0.014) compared to LS. Additionally, risk of death increased significantly with ECOG PS at presentation (ECOG PS 2 vs 0-1, HR=1.49 (95% CI 0.93, 2.40), ECOG PS 3-4 vs 0-1, HR=3.29 (95% CI 1.10, 9.84)).

      For LS disease, female sex and concurrent chemo-radiation were associated with significantly longer survival.

      Median survival after initiation of 2nd line was significantly longer for those re-challenged with platinum-based regimen compared with those switched to topotecan: 9.1(95% CI 6.1-12.1) vs. 4.5 months (95% CI 3.3-5.7), P=0.001. Results were not affected by platinum sensitivity (i.e. interval from end of first-line to beginning of second line ≥3 months). A multivariable model considering 2nd line patients and incorporating age, sex, stage, PS and brain metastasis at diagnosis confirmed these results.

      Conclusion

      Overall survival for SCLC patients in a real world setting was found to be similar to those reported in clinical trials. Extent of disease, sex and PS were significantly associated with prognosis. Re-challenge of platinum-based doublet was associated with longer OS compared to switching to topotecan treatment.

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    OA11 - Decomplexifying Molecular Targets, Immunotherapy and Treatment Settings in the Real World (ID 137)

    • Event: WCLC 2019
    • Type: Oral Session
    • Track: Treatment in the Real World - Support, Survivorship, Systems Research
    • Presentations: 1
    • Now Available
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      OA11.06 - Alternative Nivolumab (N) Duration and Scheduling in Advanced Non-Small Cell Lung Cancer (aNSCLC): Real-Life Data (Now Available) (ID 1921)

      14:00 - 15:30  |  Author(s): Jair Bar

      • Abstract
      • Presentation
      • Slides

      Background

      Little is known regarding the optimal scheduling and treatment (Tx) duration of N in aNSCLC. Stopping N after 1 year of Tx negatively affects outcomes.

      Method

      45 consecutive aNSCLC patients (pts) receiving N for ≥2 years (y) were identified in the electronic databases of 4 Israeli cancer centers. These were divided into Groups A (N continued for >2y at a dose 3mg/kg q2w/240mg q2w; n-21), B (N continued for >2y at a dose 3mg/kg q3w-q8w/480mg q4w; n-17), and C (N stopped at 2y for reason other than progressive disease or intolerable toxicity; n-7). PFS (RECIST 1.1) and safety since 2y after N initiation were assessed.

      Result

      Baseline, treatment characteristics and outcomes are presented in the Table and the Picture. Allocation to Group B and C was associated with HR for PFS-2.4 (95%CI, 0.3-18.8, p-0.4) and HR for PFS-3.3 (95%CI, 0.3-30.9, p-0.3), respectively. After 2y since N initiation, new N-related toxicity developed in 24%, 18%, and 28% of pts in Groups A, B, and C, respectively (p-NS).

      table wclc.jpgpicture wclc.jpg

      Conclusion

      A trend for worse outcomes was observed with alternative N scheduling/N quitting 2y after initiation. So far, continuing N at a standard dose until disease progression/ intolerable toxicity remains the standard treatment option.

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    P2.06 - Mesothelioma (ID 170)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Mesothelioma
    • Presentations: 1
    • Now Available
    • Moderators:
    • Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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      P2.06-14 - BAP1 Mutant Malignant Pleural Mesothelioma (MPM): Outcomes with Chemotherapy, ICPi and PARPi (Now Available) (ID 1244)

      10:15 - 18:15  |  Author(s): Jair Bar

      • Abstract
      • Slides

      Background

      Little is known regarding the outcomes of systemic treatments (Tx) in BAP1 altered MPM.

      Method

      45 patients (pts) with advanced MPM (Group A: 8 MPM with a BAP1 inactivating mutation/copy number loss (FoundationOne CDx/TEMPUSxT), selected from the electronic databases (eD) of 4 Israeli cancer centers (ICC); Group B: 37 consecutive (years 2016-2018) MPM without a BAP1 alteration/not tested, selected from the eD of 2 ICC) were analyzed for ORR, PFS (mRECIST 1.1) and OS with platinum/pemetrexed+/-bevacizumab/nintedanib (CT, n-28), immune check-point inhibitors (ICPi, n-16) and poly (ADP-ribose) polymerase inhibitors (PARPi, n-4). OS since diagnosis (OSDx) was assessed.

      Result

      Pt and Tx characteristics are presented in the Table. There were no differences in ORR, mPFS or mOS with CT between the Groups: ORR-50% in both Groups, mPFS-9.1mo (95%CI, 1.2-16.1) vs 9.2mo (95%CI, 2.9-17.8) (log-rank-0.01, p-0.9), mOS-NR (95%CI, 6.6-NR) vs 18.5mo (95%CI, 5.4-46.3) (log-rank-1.1, p-0.3), in Groups A and B, respectively. There were no differences in ORR, mPFS or mOS with ICPi between the Groups: ORR- 33% vs 50% (p>0.5), mPFS-2.5mo (95%CI, 1.4-3.7) vs 3.0mo (95%CI, 0.3-10.5) (log-rank-0.5, p-0.4), mOS-NR (95%CI, 4.0-NR) vs 5.8mo (95%CI, 0.3-13.2) (log-rank-0.1, p-0.7), in Groups A and B, respectively. In Group A, no responses were seen with PARPi; PFS with PARPi was 1.8mo (95%CI, 1.8-1.9). OSDx was NR (95%CI, 9.7-NR) vs 19.5mo (95%CI, 9.7-82.2) in Groups A and B, respectively (log-rank-1.6, p-0.2). In the univariate analysis, sex (p-0.04), histology (p-0.002), ECOG PS (p-0.03), but not BAP1 mutation (p-0.3) correlated with OSDx.wclc table.jpg

      Conclusion

      Outcomes with CT and ICPi in BAP1 mutant MPM are similar to non-selected MPM. No responses were seen so far with PARPi. According to our data, presence of BAP1 mutation does not affect OS. Additional follow-up is needed.

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