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Navneet Singh

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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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    EP1.01 - 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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      EP1.01-57 - Clinical Profile and Treatment Outcomes of NSCLC in Elderly Subjects with Poor Performance Status from India (ID 1577)

      08:00 - 18:00  |  Author(s): Navneet Singh

      • Abstract
      • Slides

      Background

      Background: Elderly population and subjects with poor performance status (PS) are generally excluded from Lung cancer (LC) trials evaluating various treatment modalities, and their outcome is unclear. Herein, we report the clinical profile, treatment and overall survival (OS) of elderly non-small cell LC (NSCLC) subjects with poor PS.

      Method

      Methods: We retrospectively reviewed our database (from Jan 2016-Dec 2017) to identify NSCLC subjects aged ≥65 years and having an Eastern cooperative oncology group PS (ECOG-PS) ≥2 at presentation. Demographic profile, treatment details, PS after treatment and OS (as on 15th November 2018) were retrieved. We also report the incidence of grade 3 or 4 adverse events (AE) following chemotherapy.

      Result

      Results: 122 patients with a median (interquartile range [IQR]) age of 72.5 (65-88) years were included. Majority were men (86.1%) and smokers (79.5%). ECOG-PS was 2, 3 and 4 in 64.8%, 27.9% and 7.4% patients. Squamous cell carcinoma (53, 43.4%) and adenocarcinoma (51, 41.8%) were the most common histologic subtypes. 69% had TNM (8th edition) stage IV (A in 41%, B in 28%) and 26% had stage III (IIIA 8%, IIIB 10% and IIIC in 8%). Chemotherapy with or without radiotherapy (86%), tyrosine kinase inhibitors (6%) and immunotherapy (1%) were the common treatment modalities, while 10 patients did not receive any treatment. In whom response could be assessed (n=61), the best response achieved was partial response in 38%, stable disease in 49%, complete response in 5% and progressive disease in 8%. Of the subjects undergoing chemotherapy (n=102), 33 experienced grade 3 or 4 AE and 14 subjects had to discontinue chemotherapy before 4 cycles. ECOG PS improved to 0/1 in 22 (19.6%) subjects who underwent any form of treatment. The median survival of the study cohort was 250 days. On a multivariate analysis, the presence of brain metastases was associated with poor OS (HR [95% CI] 7.6 [1.4-41.6])

      Conclusion

      Conclusions: Most of the Elderly patients with NSCLC and poor PS had an advanced stage at presentation. Majority tolerate chemotherapy well and some have an improvement in their PS. The presence of brain metastases is associated with a poor survival.

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

    • Event: WCLC 2019
    • Type: E-Poster Viewing in the Exhibit Hall
    • Track: Treatment of Locoregional Disease - NSCLC
    • Presentations: 1
    • Now Available
    • Moderators:
    • Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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      EP1.18-14 - Algorithm for Deciding Radiotherapy Technique in Stage III Non-Small Cell Lung Cancer (Now Available) (ID 2560)

      08:00 - 18:00  |  Author(s): Navneet Singh

      • Abstract
      • Slides

      Background

      Concurrent chemoradiotherapy has shown superior survival outcomes in inoperable, Stage III non-small cell lung cancer (NSCLC) with good performance status. Usage of 3-dimensional conformal radiotherapy (3D-CRT) technique is commonest with intensity modulated radiotherapy (IMRT) gaining popularity owing to its ability to spare normal tissues. In our study we analysed the tumour and nodal characteristics of patients to predict which technique maybe beneficial by generating optimised plans of both 3D-CRT and volumetric modulated arc radiotherapy (VMAT), a type of IMRT.

      Method

      A total of 27 Stage III NSCLC patients underwent PET-CT (in the treatment position) co-registered treatment planning using either 3D-CRT or VMAT. The total prescription dose was 60 Gy in 30 fractions over 6 weeks with concurrent cisplatin based chemotherapy. Retrospectively alternate treatment plans were generated to obtain two sets of plans (3D-CRT and VMAT) of each patient for dosimetric comparison. The tumour and nodal characteristics and treatment technique were analysed to identify predictive factors limiting total dose delivery. The angle of contact of the PTV with the circumference of the vertebral body was calculated for patients where the tumour or nodal mass was in contact with the vertebral body (Figure 1).

      12134c4d-efe6-4961-b2c1-5ff1aef8eccc.png

      Result

      Of the 27 patients enrolled, 6 patients could not be planned to the complete dose of 60 Gy in a single phase by 3D-CRT. Dose limiting factors were high spinal cord doses due to vertebral body erosion (2 out of 6) and bilateral bulky mediastinal lymphadenopathy (4 out of 6). Alternate VMAT plans for these patients could achieve the dose constraints in all but the two patients with vertebral body erosion. Differences in the normal tissue doses of bilateral normal lungs, esophagus, heart and spinal cord were compared between both techniques to ascertain statistical significance.

      Conclusion

      The spatial location of the tumour and nodal burden rather than the volume limited the maximum dose delivered. For tumours with vertebral body contact of more than 90 degrees, VMAT should be used. With gross vertebral body erosion, even VMAT falls short if the PTV includes the spinal cord. In view of high patient volume and limited resources, VMAT is not an economical option for all patients. A simple clinical algorithm is outlined (Figure 1) which will help select patients who will best benefit from VMAT.

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    ES09 - How I Do It - Real World Issues in the Diagnosis and Treatment of Metastatic NSCLC (ID 12)

    • Event: WCLC 2019
    • Type: Educational Session
    • Track: Treatment in the Real World - Support, Survivorship, Systems Research
    • Presentations: 1
    • Now Available
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      ES09.04 - How I Decide 2nd Line Treatment Options for Relapsed/Refractory Metastatic NSCLC (Now Available) (ID 3202)

      13:30 - 15:00  |  Presenting Author(s): Navneet Singh

      • Abstract
      • Presentation
      • Slides

      Abstract

      Management of advanced and metastatic non-small cell lung cancer (NSCLC) has been revolutionized in the past decade with the advent of testing for ‘druggable’ molecular driver alterations and availability of therapies for the same. More recently, immunotherapy (in particular PD-1/PD-L1 immune check point inhibitors) have opened up a fifth frontier for the treatment of this disease. However, barring exceptions, patients with advanced/metastatic NSCLC relapse irrespective of whether they received a targeted therapy or chemotherapy (with/without immunotherapy) or immuno(mono)therapy in the front line setting. This is understandable as cures are uncommon in metastatic disease although sustained and durable responses to immunotherapy and targeted therapies are well known. Treatment of relapsed disease presents a greater challenge as performance status, ability to bear cost of treatment and finally wishes of patients and caregivers often change as opposed to the treatment naïve state. Additional factors also come into play in low and middle income group countries (LMICs) and resource constrained settings.

      Practicing precision medicine remains the goal even for the relapsed setting. However, finding additional targets or drugs for identified secondary targets mandates rebiopsy which may be limited by ease of access to the desired site for rebiopsy as well as patients’ willingness to undergo the same. Liquid biopsy (typically blood and less commonly other body fluids) appears to be an increasingly promising alternative to conventional tissue biopsy with the availability of highly sensitive testing platforms (especially NGS) and the ability of the former to provide ‘global’ assessment of biomarker status as opposed to the latter. Tissue heterogeneity is more pronounced in the setting of relapsed disease as compared to treatment naïve settings.

      In case of EGFR mutated NSCLC, the advent of T790M inhibitors (osimertinib) was the preferred treatment approach for patients progressing on 1st/2nd generation EGFR TKIs and with a demonstrable exon 20 T790M mutation on either tissue or liquid biopsy (AURA trial). However, the FLAURA trial led to osimertinib moving to the frontline setting and therefore relapses on osimertinib is typically followed by chemotherapy unless specific mechanisms of resistance can be demonstrated which can be further targeted by available drugs. It is likely that 4th generation TKIs will be available for patients in the coming few years thus providing an opportunity to use another TKI following progression on osimertinib.

      For ALK rearranged NSCLC, there is a similar story. 2nd generation ALK inhibitors (alectinib, ceritinib and brigatinib) were developed and initially approved for patients intolerant to or having progressed on the 1st generation ALK inhibitor crizotinib. The ALEX/J-ALEX trials (for alectinib) and ASCEND-4 trial (for ceritinib) meant that these drugs moved to the front-line setting. In particular data from ASCEND-8 trial showed that 450 mg of ceritinib with a low-fat meal was as effective and better tolerated than the conventional 750 mg taken empty stomach. For resource constrained settings, this has an additional implication of lower cost of treatment. Lorlatinib, a 3rd generation ALK inhibitor, approved for use following progression on the 1st/2nd generation ALK inhibitors described above is also attempting to move to the frontline setting pending results of ongoing trials for this purpose.

      For both EGFR and ALK, the debate on using the best and most effective drug first vs. sequencing lower followed by higher generation drugs continues to be hotly debated as treatment options for progressors on 3rd generation TKIs given upfront are mostly limited to chemotherapy or experimental therapies as part of ongoing clinical trials.

      Platinum based doublet chemotherapy (pemetrexed based for non-squamous histology and gemcitabine/paclitaxel/nab-paclitaxel for squamous histology) was the cornerstone of treatment for patients without a targetable genetic alteration. Docetaxel single agent was the standard 2nd line treatment option and attempts were made to enhance its efficacy by combining it with VEGF inhibitors like ramucirumab (REVEL trial) or nintedanib (non-squamous only; LUME LUNG-1). Simultaneous time period saw the results of PD-1 inhibitors (nivolumab; CheckMate 017 and 057 and pembrolizumab; KEYNOTE 001 & 010) as well as PD-L1 inhibitor (atezolizumab; OAK) and thus these drugs become the preferred and standard 2nd line treatment. However, a similar story as for EGFR and ALK happened herein as well with the KEYNOTE 024 trial (pembrolizumab monotherapy for PD-L1 expression of 50% or higher) and KEYNOTE 189 and 407 trials (pembrolizumab combined with chemotherapy irrespective of PD-L1 expression) leading this drug to be part of front line treatment. Atezolizumab as part of a 4 drug regiment (paclitaxel-carboplatin-bevacizumab-atezolizumab) also appeared to provide similar efficacy in the front line setting (IMPOWER 150) for non-squamous NSCLC although concerns about toxicity remain. The effect of immunotherapy coming to the front line treatment setting (alone or in combination with chemotherapy) also implies that these drugs have no proven role in relapse as there is no data currently that patients treated initially with immune check point inhibitors benefit from the same class of drugs on relapse.

      Patients in LMICs and resource constrained settings tend to get treatment in more conventional ways than listed above as newer drugs and regimens are either not available or are not approved as fast as in the US/Europe or are very expensive. Hence it is fairly common for EGFR mutated patients to receive 1st generation EGFR TKIs, for ALK rearranged patients to receive crizotinib and for those without any driver mutations/rearrangements to receive only platinum doublet chemotherapy in the first line setting. This sort of represents a time lag compared to what is applicable in the US/Europe. The need to provide affordable yet effective treatment remains the primary aim of clinical oncologists in LMICs and precision medicine is therefore informally and practically adapted to the available resources.

      Navneet Singh MD DM

      Email: navneetchd@hotmail.com; singh.navneet@pgimer.edu.in

      [The author is a thoracic medical oncologist and pulmonologist currently working as an Additional Professor of Pulmonary Medicine at PGIMER, Chandigarh, India. He is a member of IASLC’s Staging & Prognostic Factors Committee; Publications and its Regent for South Asia. Additionally, he is Chair of American Society of Clinical Oncology’s(ASCO) International-Development-and-Education-Award(IDEA) Working Group and Thoracic-Cancer Guideline Advisory Group. His detailed profile is accessible at http://www.linkedin.com/in/navneet-singh-160012.]

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