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Luis Raez



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    EP1.01 - Advanced NSCLC (ID 150)

    • Event: WCLC 2019
    • Type: E-Poster Viewing in the Exhibit Hall
    • Track: Advanced NSCLC
    • Presentations: 1
    • Now Available
    • Moderators:
    • Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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      EP1.01-88 - Next-Generation Sequencing in Hispanic Patients with Advanced Lung Cancer and Correlation with Response to Immunotherapy (Now Available) (ID 2784)

      08:00 - 18:00  |  Author(s): Luis Raez

      • Abstract
      • Slides

      Background

      Cancer is a leading cause of death among Hispanics (HISP); the largest ethnic minority in the United States (17% of the total population). With the approvals of checkpoint immunotherapy in advanced lung cancer, many patients (pts) are starting to see long-lasting remissions and longer survival rates. However, response to a given treatment often depends on the tumor’s genomic profile. Our aim was to analyze NGS results for HISP pts living in the US in an effort to better understand this population’s genomic profile and prognosis.

      Method

      Retrospective analysis on pts with biopsy proven advanced NSCLC who received checkpoint immunotherapy at two large institutions in the US. Patient charts were reviewed to obtain data on demographic characteristics including race, gender, age, and smoking history. Next generation sequencing (NGS) results were obtained from Guardant Health and Foundation One testing in blood and in tissue, respectively. We assessed progression-free survival (PFS) and overall survival (OS) associated with outcome.

      Result

      Seventy HISP pts receiving immunotherapy underwent NGS testing from 10/2013 to 4/2018. 46% were male, 76% were smokers, 89% had adenocarcinoma, and 39% were PD-L1 positive (with 67% of those having TPS ≥ 50%). Thirty pts (43%) had one genetic aberration (GA), and 15 pts (22%) had >5 GA. The most frequent actionable GA was EGFR mutation (26%) and nonactionable mutation was KRAS (40%). Other less common GA were BRAF (10%), MET (10%), and STK11 (9%).

      Survival

      1 Genetic Aberration

      >5 Genetic Aberrations

      P value

      Median PFS

      3.57m

      3m

      0.2767

      Median OS

      14.96m

      3.8m

      0.0117

      Conclusion

      The presence of >5 GA (actionable and nonactionable) on NGS testing was associated with worse OS when compared to pts with one GA. There was no difference in PFS. In addition, PD-L1 incidence in HISP pts is high with a larger proportion of pts expressing ≥ 50% TPS compared to what is reported for NHW. Given the numerous nonactionable GA encountered, it is clear that continued development of targeted therapies would keep benefitting pts. Increased NGS profiling in HISP pts could potentially broaden treatment and clinical trial options to serve this purpose.

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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
    • Now Available
    • Moderators:
    • Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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      EP1.04-46 - Immunotherapy at Any Line Improves Survival in Hispanic Patients with Advanced Metastatic NSCLC Compared to Chemotherapy (Quijote-CLICaP) (Now Available) (ID 2776)

      08:00 - 18:00  |  Author(s): Luis Raez

      • Abstract
      • Slides

      Background

      Immunotherapy for NSCLMC offers a significant advantage to chemotherapy in selected cases. This benefit starts to disapear as the patients start two progress and requiere change in medication or even chemotherapy. The objective of this study was to compare survival outcomes of patients with advanced or metastatic NSCLC who received immunotherapy at first, second or beyond versus matched patients receiving standard chemotherapy.

      Method

      A retrospective multicenter international cohort study of 296 patients with unresectable/ metastatic NSCLC treated with immunotherapy either as first, second, third or fourth line was conducted. A matched comparison with a historical cohort of first line chemotherapy was conducted.

      Result

      Median age was 64 years (Range 34-90) and 40.2% were female patients. 91.2% of patients had an ECOG performance score ≤ 1. Immunotherapy as first line was given to 39 patients (13.7%), second line to 140 (48.8%), and as third line and beyond to 108 (37.6%). Median overall survival was 19.9 months (95% CI 14.5-22.7 months) and progression-free survival was 3.73 months (95% CI 2.8-4.2). Factors associated with increased survival included treatment as first-line (p < 0.001), type of response (p < 0.001) and PD-L1 status (p = 0.0039). Compared with the historical cohort, immunotherapy proved to be superior in terms of OS (p= 0.05) but not PFS (p= 0.2).

      Conclusion

      Patients who receive immune checkpoint inhibitors as part of their treatment for NSCLC have better OS compared with matched patients treated with standard chemotherapy, regardless of treatment line.

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    MA01 - Oligometastatic Disease (ID 114)

    • Event: WCLC 2019
    • Type: Mini Oral Session
    • Track: Oligometastatic NSCLC
    • Presentations: 1
    • Now Available
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      MA01.11 - Improving Survival in Lung Cancer Patients with Oligometastatic Disease Progression Using Stereotactic Body Radiation Therapy (Now Available) (ID 1836)

      10:30 - 12:00  |  Presenting Author(s): Luis Raez

      • Abstract
      • Presentation
      • Slides

      Background

      In patients (pts) with stage IV non-small cell lung cancer (NSCLC) receiving systemic therapy, stereotactic body radiation therapy (SBRT) can eliminate oligometastatic disease progression (OMP). This allows NSCLC pts to continue the same systemic therapy, and its is especially important when the therapy is well tolerated as is the case for many pts receiving immunotherapy (IMMUNO) and targeted therapy (TARGET). The purpose of this study is to quantify the progression free survival (PFS) and overall survival (OS) of pts receiving systemic therapy who experience OMP that is treated with SBRT, and subsequently continue the same systemic therapy.

      Method

      Retrospective review of one hundred pts with metastatic NSCLC undergoing chemotherapy (CHEMO), IMMUNO or TARGET that had OMP defined as less than 4 sites of metastasis and underwent SBRT were evaluated for PFS and OS. PFS1: Time between initiation of systemic therapy and development of OMP. PFS2: Time between OMP treated with SBRT and development of further PD requiring a change in systemic therapy. Pts received IMMUNO for second line and beyond. SBRT doses were determined based on the disease site and dose tolerance of the adjacent organs. SBRT was delivered in 1-5 fractions on consecutive days or every other day. Radiation dose was determined by target volume and adjacent dose-limiting organs.

      Result

      OMP presented as brain metastasis (BM) in 45 pts and extracranial metastasis (EM) in 55 pts. 34 pts were receiving CHEMO, 34 TARGET and 32 IMMUNO at the time of OMP. Pts with BM that received SBRT were able to continue the same therapy for a period of 6.5-9 extra months due to the control of BM. Pts with EM that have developed PD were able to continue the same therapy an 17-21 extra months due to the ablation of OMP by SBRT. For the entire cohort PFS was: 16.5m for BM and 34m for EM and the OS were: 31m and 53m respectively.

      Location of oligometastatic progression (OMP)

      Median PFS1

      Median PFS2

      PFS

      Median OS

      Extracranial (N=55)

      13

      21

      34

      53

      chemo

      7

      17

      24

      47

      Immuno

      13.5

      20.5

      34

      49

      Target

      12

      21

      33

      53

      Brain (N=45)

      9

      7.5

      16.5

      31

      Chemo

      5.5

      6.5

      12

      25.5

      Immuno

      7

      8

      15

      27

      Target

      11

      9

      20

      47

      Conclusion

      PFS and OS may be prolonged due to the use of SBRT in pts that develop OMP. This intervention allowed patients to continue with the same systemic treatment. Our CHEMO cohort is composed of long term survivors under therapy and may not represent the average PFS/OS of pts on CHEMO. Prospective trials are needed to verify these results.

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    MA19 - Looking at PROs in Greater Detail - What Patients Actually Want and Expect (ID 147)

    • Event: WCLC 2019
    • Type: Mini Oral Session
    • Track: Treatment in the Real World - Support, Survivorship, Systems Research
    • Presentations: 1
    • Now Available
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      MA19.05 - Improving Lung Cancer Outcomes and Quality in the US Community Setting with the Creation of Lung Cancer Centers of Excellence Program (Now Available) (ID 1939)

      11:30 - 13:00  |  Author(s): Luis Raez

      • Abstract
      • Presentation
      • Slides

      Background

      The Addario Lung Cancer Foundation community hospital Centers of Excellence (COE) Program encourages community cancer centers in the US to implement ‘best practices’ across the lung cancer care continuum, including provision of coordinated, multidisciplinary care. By comparing performance metrics within and outside the network of COEs, the program seeks to ensure that lung cancer patients (pts) receive the highest quality of care in their local area whilst also enabling COE hospitals to gain insights that facilitate the rapid implementation of quality improvement cycles.

      Method

      The Impact Study was launched to conduct a comprehensive comparative analysis of COE member and non-member institutions across numerous quantitative and qualitative metrics from within the lung cancer care continuum. The 2018 analysis included 17 COE sites and 19 non-COE community hospitals representing approximately 5,000 pts in each cohort. The COE Impact study captured pts’ demographic and clinical information as well as performance metrics from early stage screening through late stage diagnosis and all aspects of pts’ care.

      Result

      Variable

      COE

      Non-COE

      P value

      # Cancer centers/hospitals

      17

      19

      Answers collected by nurse navigator

      41%

      100%

      <0.001

      Average # of hospital beds

      565

      342

      0.104

      Average # of lung cancer pts/institution

      497

      470

      0.968

      Lung cancer screening program

      94%

      42%

      0.001

      Endoscopic Bronchoscopy Ultrasound (EBUS)

      23%

      16%

      0.323

      Screening of pts for clinical trials

      81%

      35%

      <0.001

      Race: Caucasians

      81%

      37%

      <0.001

      Pathologist in tumor boards

      100%

      67%

      0.012

      ER visits the first 4 months of therapy

      14%

      32%

      0.022

      Molecular testing of pts with metastatic disease

      81%

      48%

      0.001

      Next generation sequencing

      58%

      22%

      0.009

      Conclusion

      Improved structure and processes of care delivery at COE hospitals may translate into improved quality of care, outcomes, and patient experiences. The Lung Cancer COE program, now including 38 community cancer centers encompassing 12,000 lung cancer patients, plans to conduct this study annually with prospective, longitudinal data collection for future trend analyses as a means of facilitating continuous quality improvement in community-level lung cancer care.

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    MS04 - New Systemic Adjuvant/Neo-Adjuvant Strategies in Early Stage Lung Cancer: Targeted Therapy and I/O (ID 67)

    • Event: WCLC 2019
    • Type: Mini Symposium
    • Track: Treatment of Early Stage/Localized Disease
    • Presentations: 1
    • Now Available
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      MS04.02 - Neo-Adjuvant PD-(L)1 Checkpoint Inhibitors (Now Available) (ID 3456)

      15:15 - 16:45  |  Presenting Author(s): Luis Raez

      • Abstract
      • Presentation
      • Slides

      Abstract

      Neoadjuvant chemotherapy never made to become standard of care for non-small cell lung cancer (NSCLC) and until today it is being used in special circumstances. However neoadjuvant immunotherapy as single agent or in combination with chemotherapy has become a very promissory intervention. In 2018 we had the publication from Forde et al in the NEJM showing that using nivolumab as neoadjuvant approach did not delay surgery in any of the treated patients (pts) and there were no unexpected safety signals were seen. Very interesting 45% of resected tumors demonstrated a major pathologic response (MPR) that correlated with mutational burden. MPR was defined as less than 10% viable tumor in the resected specimen [1]. Following these results there were also several presentations at ASCO 2018: The LCMC study Rusch et al [2] (treats pts with atezolizumab for 2 cycles follow by surgery then standard of care chemotherapy follow by immunotherapy for 1 year) showed 4/19 (21%) pts had MPR after 2 doses of atezolizumab. Shu et al (Abstract 8532) showed that 4 cycles carboplatin/nab-paclitaxel/atezolizumab had 7/14 (50%) pts with MPR and 3/14 (21%) had pCR. [3]

      Later at the 2018 World lung Cancer Conference in Toronto in September, we have had the Spanish Lung Cancer Group presenting the study NADIM by Provencio-Pulla that was briefly presented before at ASCO 2018 [4,5]. They had a phase II open label study for patients with stage IIIA NSCLC that received carboplatin/paclitaxel/nivolumab for 3 cycles follow by surgery and adjuvant immunotherapy for 1 year. The CR was 10%, PR 60% and SD 30% for a DCR of 100%. MPR was 80% and complete response 75%. The toxicity profile was tolerable and not unexpected. During the same meeting Rusch [6] did an updated of the LCMC study this time with 45 pts: the ORR was 10% and the DCR 100%. 22% of the pts had MPR. There was no observable correlation between pathologic and radiographic responses. Neoadjuvant atezolizumab did not cause major delays to surgery or interfere with surgical resection, and there were no unexpected safety findings.

      There was also a poster presentation of the CheckMate 816 [7]: Phase 3 Neoadjuvant Trial of Chemotherapy with and without nivolumab for stage I-IIIA NSCLC presented by Enriqueta Felip with 21 pts in the nivolumab arm that have 10% CR and 45% MPR.

      Following this success from 2018 at this year in ASCO 2019 there will be 2 important presentations Neoadjuvant nivolumab (N) or nivolumab plus ipilimumab (NI) for resectable non-small cell lung cancer (NSCLC): the NEOSTAR study for pts with stage I-IIIA [8] and another updated of the LCMC study that is expected to showed data with larger number of pts [9]. There are also several studies with targeted agents for NSCLC that will be presented at 2019 World Lung Cancer Conference where we will have the opportunity to review the updates of some of the studies mentioned before and new ones.

      References:

      1) Forde PM1, Chaft JE1, Smith KN1, et al. 1. Neoadjuvant PD-1 Blockade in Resectable Lung Cancer.N Engl J Med. 2018 May 24; 378(21):1976-1986. doi: 10.1056/NEJMoa1716078. Epub 2018 Apr 16.

      2) Rusch, Valerie et al. Neoadjuvant atezolizumab in resectable non-small cell lung cancer (NSCLC): Initial results from a multicenter study (LCMC3) J Clin Oncol 36, 2018 (suppl; abstr 8541)

      3) Catherine A. Shu, Claud Grigg, Codruta Chiuzan, Neoadjuvant atezolizumab + chemotherapy in resectable non-small cell lung cancer (NSCLC). J Clin Oncol 36, 2018 (suppl; abstr 8532)

      4) Provencio-pulla et al. Neoadjuvant chemo/immunotherapy for the treatment of stages IIIA resectable non-small cell lung cancer (NSCLC): A phase II multicenter exploratory study—NADIM study-SLCG. J Clin Oncol 36, 2018 (suppl; abstr 8521)

      5) M. Provencio, E. Nadal, A. Insa, R. et al. OA01.05 Phase II Study of Neo-adjuvant hemo/Immunotherapy for Resectable Stages IIIA Non-Small Cell Lung Cancer- Nadim Study-SLCG Journal of Thoracic Oncology, Vol. 13, Issue 10, S320

      6) V. Rusch, J. Chaft, B. Johnson, et al. MA04.09 Neoadjuvant Atezolizumab in Resectable Non-Small Cell Lung Cancer (NSCLC): Updated Results from a Multicenter Study (LCMC3) Journal of Thoracic Oncology, Vol. 13, Issue 10, S369

      7) E. Felip, J. Brahmer, S. Broderick, et al. P2.16-03 CheckMate 816: A Phase 3 Trial of Neoadjuvant Nivolumab Plus Ipilimumab or Chemotherapy vs Chemotherapy in Early-Stage NSCLC

      8) Tina Cascone et al., Neoadjuvant nivolumab (N) or nivolumab plus ipilimumab (NI) for resectable non-small cell lung cancer (NSCLC): Clinical and correlative results from the NEOSTAR study.J Clin Oncol 37, 2019 (suppl; abstr 8504)8)

      9) Rusch V et al. Neoadjuvant atezolizumab in resectable non-small cell lung cancer (NSCLC): Interim analysis and biomarker data from a multicenter study (LCMC3). J Clin Oncol 37, 2019 (suppl; abstr 8503)

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    P1.01 - Advanced NSCLC (ID 158)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Advanced NSCLC
    • Presentations: 1
    • Now Available
    • Moderators:
    • Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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      P1.01-68 - Monitoring Clinical Responses Measuring PD-L1 in cfRNA in Plasma of Non-Small Cell Lung Cancer Patients Undergoing Systemic Therapy (Now Available) (ID 2356)

      09:45 - 18:00  |  Presenting Author(s): Luis Raez

      • Abstract
      • Slides

      Background

      .Cell-free circulating tumor RNA (cfRNA) extracted from plasma of cancer patients (pts) can measure dynamic changes in gene expression that can help to evaluated disease status and predict outcome to anti-tumoral therapy in solid tumors [T. Ishiba et al. Biochem Biophys Res Commun. 2018 Jun 7; 500 (3):621-625]. We want to show that PD-L1 assessed by RNA RT-PCR is a potential biomarker that can be used to follow Immunotherapy responses in non-small cell lung cancer (NSCLC).

      Method

      54 pts with NSCLC undergoing systemic therapy (STX) were enrolled in a 1-year study. cfRNA was extracted from resulting plasma and generated random-primed cDNA. Total cfRNA was quantitated by qPCR of β-actin, and correlated with pt response (CR/PR/SD/PD) determined by CT scans. All gene expressions were measured relative to β-actin. Changes in PD-L1 expression were used to monitor response to immunotherapy in lung cancer pts. Ten milliliters of blood were collected in each of two tubes containing a proprietary nucleic acid preservation cocktail. Blood was drawn every 6-8 weeks with an average of 5 collections were done per pt.

      Result

      Of the 54 enrolled pts, 30 completed 1-3 lines of STX with outcomes. The overall mutation frequency was 33% (10/30), with 27% in KRAS and 6% in EGFR. Increases or emergence of mutant allele fractions were predictive of PD status (later determined by imaging), while decreases or disappearance of mutations were predictive of SD and PR status after treatment. PD-L1 expression was detected in 87% (26/30) of pts in at least one blood draw.

      Immunotherapy: (Nivolumab, Pembrolizumab, Atezolizumab), 11/30 pts underwent immunotherapy (IO) txt at some point. Changes in PD-L1 during IO were associated with STX outcomes. Increases in PD-L1 were associated with PD, while decreases or no changes in PD-L1 were associated with SD and PR. Of the 23 blood draws from these 11 pts, the overall concordance between changes in PD-L1 and IO outcome was 91% (21/23). Chemotherapy: 19/30 pts were given carbo/pemetrexed at some point during their STX. Increases or decreases in PD-L1 across 28 blood draws during therapy were likewise associated with resistance or sensitivity to STX outcome (increases infer resistance; decreases infer sensitivity) in 24/28 (86%).

      Conclusion

      A noteworthy concordance was observed between clinical responses and changes in plasma PD-L1 done by RT-PCR cfRNA levels in NSCLC pts treated with IO or chemotherapy. Monitoring cfRNA expression levels of PD-L1 is a reliable method for predicting response and resistance to IO as well as chemotherapy irrespective of KRAS and EGFR

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    P1.04 - Immuno-oncology (ID 164)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Immuno-oncology
    • Presentations: 3
    • Now Available
    • Moderators:
    • Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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      P1.04-47 - Tumor Mutation Burden Through Hybrid Capture – Circulating Tumor DNA May Predict Response to Immunotherapy in NSCLC (ID 3011)

      09:45 - 18:00  |  Author(s): Luis Raez

      • Abstract

      Background

      Immunotherapy has become the therapy backbone for patients with NSCLC. Currently, prediction to therapy response is based on tissue biopsy biomarkers such as PD-L1 expression, tumor mutation burden (TMB), genomic alterations in EGFR/ALK/ROS1 and KRAS/TP53/STK11 mutations, all competing for limited tissue biopsy samples. Therefore, we investigated whether these biomarkers can be detected from a non-invasive plasma sample. Challenges of assessment of TMB with cell-free DNA next-generation sequencing (NGS) include the limited size of liquid biopsy gene panels and the fact that low shedding of tumor DNA into circulation may fail to detect hypermutated tumors.

      Method

      In this retrospective study, data was collected from 100 NSCLC patients treated in medical centers in Israel and USA between 2014 and 2018. NGS on ctDNA was used to evaluate whether mutational burden influence the response to immunotherapy in these patients. Response to immunotherapy was defined by a cutoff of four months of progression free survival (PFS). Liquid biopsy tests were obtained three months or less before immunotherapy treatment start.

      Result

      Overall, 100 NSCLC patients underwent NGS on ctDNA.

      Clinical treatment information and full clinical data was available for 66 patients. 23 patients underwent liquid biopsy tests within a range of 3 months or less before immunotherapy initiation. 9 patients were considered responders and 14 patients progressors by a cutoff of 4 months PFS. Preliminary results showed that in the group of responders, the median TMB was 5 with a standard deviation of 5.49. An average TMB of 2.3 was calculated for the group of progressors with a standard deviation of 1.44.

      ctDNA signature will be further presented based on a 73-gene ctDNA NGS panel that adjusts for the degree of tumor shedding.

      Conclusion

      ctDNA collection was feasible in 66 patients, amongst which 23 underwent liquid biopsy testing 3 months or less before immunotherapy treatment initiation. As the preliminary data is promising on this pilot cohort, we are planning on expending the cohort study and presenting a complex analysis that includes multifactorial mutation load approach that integrates TMB and prediction to immunotherapy response.

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      P1.04-75 - Immune-Related Adverse Events and the Neutrophil to Lymphocyte Ratio as Predictors of Clinical Response to Immunotherapy (Now Available) (ID 1969)

      09:45 - 18:00  |  Presenting Author(s): Luis Raez

      • Abstract
      • Slides

      Background

      Several immune checkpoint inhibitors (ICPis) have been approved for the treatment of non-small cell lung cancer (NSCLC). PD-L1 expression seems to correlate with activity of ICPis; however, it is not a completely accurate biomarker. Therefore, other clinical or molecular predictors of response are needed.

      Method

      The purpose of this study was to assess the value of immune-related adverse events (irAEs) and the neutrophil to lymphocyte ratio (NLR) in predicting response to ICPis. Furthermore, since Hispanics (H) are often not stratified in clinical trials, we sought to evaluate if incidence of irAEs and the baseline NLR were similar between H and non-Hispanic (NH) patients (pts). This was a retrospective review of 70 pts diagnosed with NSCLC and treated with ICPis at our institution between July 2014 and 2017. The electronic medical record was utilized to collect pt demographics, occurrence of irAEs, baseline NLR (categorized as < 5 or > 5), progression free survival (PFS) and overall survival (OS). The data cutoff date was March 31, 2019.

      Result

      The median age of the pts was 65.5 years (range 51 to 89 years). The male to female ratio was 1.2. There were 19 H and 51 NH pts. Most of the pts were treated with single agent ICPis. The irAEs positive group had increased median PFS (7.5 vs 2.1 months; p-value 0.001) and OS (14.7 vs 4.7 months; p-value 0.001) compared to the irAEs negative group. OS at 12 months was 58.1% in the irAEs positive group compared to 20.5% in the irAEs negative group (p-value 0.001). There was a non-statistically significant trend towards improved outcomes in pts with baseline NLR < 5 vs > 5. The overall incidence of irAEs was similar between H and NH pts; however, hypothyroidism was observed more frequently in H than NH pts (45% vs 20%; p-value 0.020). Baseline NLR < 5 vs > 5 was similar between H and NH pts.

      Conclusion

      Occurrence of irAEs might be useful in identifying potential responders to ICPis. H pts on ICPis might be at a higher risk for developing hypothyroidism. Since our total number of pts is small, these findings should be further evaluated in prospective studies.

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      P1.04-81 - Characterization of Hispanic Patients Who Experienced Hyperprogression During Treatment for Advanced NSCLC with Immunotherapy (ID 2922)

      09:45 - 18:00  |  Author(s): Luis Raez

      • Abstract

      Background

      Immunotherapy related hyperprogression is poorly characterized in Latin American patients. In this study we sought to characterize and identify factors associated with the presentation of hyperporgression after initiation of immunotherapy in patients with advanced non-small cell lung cancer (NSCLC).

      Method

      A multicenter international retrospective study on 110 patients was conducted. Clinical variables as well as routine blood studies were recorded before initiation of treatment. Regression analysis was used to find associations. A random forest tree analysis (RFTA) based on continuous and discrete variables was used to subcategorize patients based on occurrence of hyperprogression.

      Result

      Median age was 64 years (Range 34-90) and 59.8 % were male patients. ECOG performance status was >1 on 8.8% of patients. Median overall survival was 12.7 months (95% CI 9.67-14 months) and progression-free survival of 4.27 months (95% CI 3.97-5.0). 44 hyperprogressors were documented (19.8%, [95%CI 14.5-25.1%]). Median time to progression was approximately 5 weeks after initiation of treatment. Factors associated included albumin and hemoglobin levels (p = 0.046 and 0.037 respectively), presence of CNS (p= 0.0009) and bone metastasis (p = 0.004) and weight loss (p= 0.004). RFTA revealed that a leucocyte count over 5.300 cells/dl was present in all hyperprogressors.

      Conclusion

      Hyperprogression is a phenomenon after initiation of immunotherapy which is associated with clinical and paraclinical variables. These associations could be used to withhold certain agents and prevent its occurrence in NSCLC treatment.

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    P2.16 - Treatment in the Real World - Support, Survivorship, Systems Research (ID 187)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Treatment in the Real World - Support, Survivorship, Systems Research
    • Presentations: 2
    • Now Available
    • Moderators:
    • Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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      P2.16-15 - Survival and Clinical Immunotherapy Outcomes in Hispanic Patients vs Non-Hispanic White Patients with Non-Small Cell Lung Cancer   (Now Available) (ID 1514)

      10:15 - 18:15  |  Presenting Author(s): Luis Raez

      • Abstract
      • Slides

      Background

      The number of Hispanic (HISP) patients (pts) enrolled in immunotherapy (IMMUNO) trials is minimal or non-existent in non-small cell lung cancer (NSCLC). It’s well known that HISP pts with NSCLC have not only a different genomic profile than Non-Hispanic Whites (NHW)- like higher expression of EGFR mutations- but also better outcomes than NHW (“Hispanic Paradox”); thus the need to validate outcomes in HISP pts treated with IMMUNO.

      Method

      We present data in 436 NSCLC pts treated with IMMUNO at 5 large institutions (3 in the US, 2 in Latin America). The agents evaluated include: nivolumab, pembrolizumab and atezolizumab. 256 pts were HISP and 180 pts were NHW. Most of the pts were treated with single agent therapy as second line or beyond while a small group of pts were treated as first line. The primary endpoints of the study were: response rate (ORR), progression free survival (PFS) and overall survival (OS). Secondary endpoints were disease control rate (DCR), PD-L1 expression and others.

      Result

      The results are consolidated in the table below.

      Hispanics (n=256)

      NHW (n=180)

      p value

      Sex (males)

      52%

      45%

      0.2059

      ORR

      First Line

      35%

      30%

      0.6590

      Second Line

      18%

      19%

      0.3236

      Adeno

      22%

      24%

      0.6714

      SQCC

      24%

      23%

      1.0000

      PDL1 (+)

      29%

      32%

      0.4839

      PDL1 (-)

      5%

      17%

      0.3040

      Disease Control Rate: ORR+SD (DCR)

      Adeno

      68%

      67%

      0.8989

      SQCC

      67%

      46%

      0.0777

      Median PFS

      4m

      4m

      0.7509

      Median OS

      22m

      22m

      0.2004

      There were no statistical significant differences among HISP and NHW pts regarding ORR, DCR, PFS, OS, and responses according to PD-L1 status.

      Conclusion

      No significant differences were found in the clinical outcomes between these 2 ethnic groups despite the “Hispanic Paradox” and expected genomic differences; however pts with actionable mutations were excluded as they usually do not get IMMUNO as first or second line; an approach that might change after IMPOWER 150. This is the largest comparison of NSCLC immunotherapy outcomes in HISP vs NHW pts. These results are comparable to the ones seen in Checkmate and Keynote studies. As expected, higher response rates were seen in first line therapy and pts with PD-L1 (+) status. Further comparisons will be better addressed by a larger prospective study.

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      P2.16-25 - Epidemiology of Advanced Lung Cancer in Peru (ID 2855)

      10:15 - 18:15  |  Author(s): Luis Raez

      • Abstract

      Background

      Epidemiology and survival data of lung cancer is scarce in Latin America. This information is essential to understand the regional burden that cancer represents and to design and implement targeted interventions for cancer control. Similarly to what happens in the rest of the world, most of our lung cancer patients present with advanced disease.

      Method

      Retrospective analysis of metastatic lung cancer cases diagnosed at Instituto Nacional de Enfermedades Neoplasicas (INEN) Lima-Peru between 2010 to 2014 were reviewed. Data was manually curated from clinical files.

      Result

      993 patients were included, corresponding to 85% of total lung cancer cases diagnosed within the same time period. Median age at diagnosis was 63 years old (range 20-91y) and 55% were females. 25% of patients had history of exposure to biomass fumes from cooking inside the house and 20% of patients were smokers. The histologic type was adenocarcinoma, squamous cell carcinoma, adenosquamous carcinoma and large cell carcinoma in 89.2%, 9.8%, 0.8% and 0.2% of the cases, respectively. The adenocarcinoma/squamous cell carcinoma ratio was 9/1. With a median follow-up of 78 months, median overall survival (OS) was 7 months. Median OS for adenocarcinoma, squamous cell carcinoma and adenosquamous carcinoma was 7, 6, and 5 months, respectively.

      Conclusion

      The epidemiological profile of lung cancer in Peruvian patients is unique as it is characterized by a younger age at presentation, a preponderance of females over males and a strikingly high frequency of adenocarcinomas. This may be in concordance with the low prevalence of tobacco smoking and the high prevalence of EGFR mutations previously reported for our population as well as with special exogenous exposures. The low survival could be partially attributed to the lack of access to targeted therapy during those years. The molecular characterization of this cohort of patients is ongoing.