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  • WCLC 2018

    19th World Conference on Lung Cancer

    Access to all presentations that occur during the 19th World Conference on Lung Cancer in Toronto, ON

    Presentation Date(s):
    • Sept 23 - 26, 2018
    • Total Presentations: 2384

    To review abstracts of the presentations below, narrow down your search by using the Filter options below, and then select the session listing of your choice. Click the "+" for a presentation to expand & view the corresponding Abstract details.

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    P1.09 - Pathology (Not CME Accredited Session) (ID 941)

    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 40
    • Moderators:
    • Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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      P1.09-19 - Positive Correlation Between Whole Genomic Copy Number Variant Scoring and the Grading System in Lung Non-Mucinous Invasive Adenocarcinoma  (ID 12047)

      16:45 - 18:00  |  Presenting Author(s): Zheng Wang  |  Author(s): Shenglei Li, Lin Zhang, Lei He, Di Cui, Chenglong Liu, Yuyan Gong, Bi Liu, Xiaoyu Li, Wang Wu, David Cram, Dongge Liu

      • Abstract
      • Slides

      Background

      Grading systems of Lung adenocarcinoma have been proposed by Sica and Kadota in stage I tumors,but the predominant architectural subtypes grading system is applicable for resection samples mostly. The correlation between the histological subtypes and grading with whole genomic copy number variation(WGCNV) is unknown, and was investigated in lung non-mucinous invasive adenocarcinoma (LNMIA) at this study.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      The predominant histological subtype from 58 resection specimens of LNMIA and 20 para-cancerous lung tissues were collected by laser microdissection from HE staining FrameSlides PEN-Membrane slides.7 of 58 specimens,two predominant subtypes in one cancerous nodule were collected simultaneously. Whole genome amplification followed by high-throughput sequencing was used to deteted WGCNV with the para-cancerous lung tissues as normal reference set and WGCNV was scored by a particular formula.
      .

      4c3880bb027f159e801041b1021e88e8 Result

      table 1.jpgfigure 1  upload.jpg

      WGCNV median scores of 5 histological subtypes of LNMIA with three tiered architectural grades are shown in Table1. The WGCNV scores have a positive correlation with either histological subtypes and architectural grading system (Figure1 A and B). The differences of WGCNV scores are detected betweem two predominant subtypes in one cancerous nodule.

      8eea62084ca7e541d918e823422bd82e Conclusion

      GWCNV scores display a positive correlation with three tiered architectural grading system and may has a potential value to predict prognosis in LNMIA.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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      P1.09-20 - Correlation Between Whole Genomic Copy Number Variant Scoring and Pathological Classification, Staging in Lung Non-Mucinous Adenocarcinoma (ID 12126)

      16:45 - 18:00  |  Presenting Author(s): Zheng Wang  |  Author(s): Dongge Liu, Shenglei Li, Lin Zhang, Shurong He, Jun Du, Jing Di, Min Zhang, Yuyan Gong, Bi Liu, Xiaoyu Li, Wang Wu, David Cram

      • Abstract
      • Slides

      Background

      The new classification of lung adenocarcinoma composing of adenocarcinoma in situ (AIS), minimally invasive adenocarcinoma (MIA) and invasive adenocarcinoma (IA) has been applicable worldwide. Both the histological classification and TNM staging of lung adenocarcinoma have important values in indicating prognosis, but their correlations with whole genomic copy number variation (WGCNV) are still unknown.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Lung non-mucinous adenocarcinoma(LNMA) including AIS, MIA and IA resection specimens, malignant pleural effusion (MPE), metastatic nodules (MN) biopsy and 20 para-cancerous non-tumor lung tissue samples were selected. The cells of predominant histological subtype from each LNMA and non-tumor smaples were collected by laser microdissection from HE staining FrameSlides PEN-Membrane slides. Whole genome amplification followed by high-throughput sequencing was used to detect the somatic CNV with the para-cancerous lung tissues as normal reference set. WGCNV was scored by a particular formula.

      4c3880bb027f159e801041b1021e88e8 Result

      12126 figure upload.jpg12126 table upload.jpg

      WGCNV median scores and distributions of pathological subcategories and TNM staging were shown in Table 1 and their trends were displayed in Figure 1.WGCNV scores display the positive correlation or significant differences among diversified histological subcategories of LNMA, but not in T & TMN staging

      8eea62084ca7e541d918e823422bd82e Conclusion

      WGCNV scoring displays the positive correlation or significant differences among diversified subcategories and may has a potential value prediecting prognosis in LNMA.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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    P1.12 - Small Cell Lung Cancer/NET (Not CME Accredited Session) (ID 944)

    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 23
    • Moderators:
    • Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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      P1.12-03 - A Prospective Study of Apatinib in Advanced Small Cell Lung Cancer Patients Failed from Two or More Lines of Chemotherapy (ID 13140)

      16:45 - 18:00  |  Presenting Author(s): Yutao Liu  |  Author(s): Xingsheng Hu, Shengyu Zhou, Junling Li, Peng Liu, Yan Wang, Xueyu Hao, Yuankai Shi, Jun Jiang

      • Abstract
      • Slides

      Background

      Small lung cancer (SCLC), a highly malignant neoplastic, chemoresponsive disease. For SCLC patients who with worsening status after second-line treatment, there is currently no affirmative and widely accepted chemotherapy regimen. Apatinib is a novel oral multi-target small-molecule TKI mainly targeting the intracellular ATP-binding domain of VEGFR-2, which has a significant effect of anti-angiogenesis to suppress the growth of tumors. This study evaluated the efficacy and safety of Apatinib in SCLC patients who failed from second- or further-line chemotherapy.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Data was collected from the files of patients treated with Apatinib 500mg qd who diagnosed with advanced SCLC and failed from second or more lines of chemotherapy. Efficacy assessed after one cycles (4 weeks), then every two cycles (8 weeks) once again. The primary endpoint was PFS and the tumor response was determined according to the RECIST 1.1. PFS were graphed by Kaplan-Meier curves of progression-free survival. AEs were also evaluated and toxicity grade was determined based on CTCAE 4.0.

      4c3880bb027f159e801041b1021e88e8 Result

      22 patients were enrolled from November 10, 2016 to April 18, 2018, the number of patients that can be evaluated is 19. One patients obtained partial response, and 15 obtained stable disease, representing a DCR of 84.11%. Median PFS was 140 days (95% confidence interval [CI] 94.84–185.16). Although only one patient showed PR, all the patients’ target lesions were reduced. A total of 46 AEs were reported during the trial, grade 3-4 AEs were hypertension (9.09%), leukopenia (4.55%) and proteinuria (4.55%) which most could be relieved by dose reduction. figure 1..jpg

      8eea62084ca7e541d918e823422bd82e Conclusion

      In conclusion, Apatinib has a certain therapeutic effect in patients with advanced SCLC (third- or further-line). To further investigate the role of Apatinib in advanced SCLC patients, large sample and additional clinical trials are needed.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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      P1.12-04 - A Ph3 Study of Niraparib as Maintenance Therapy in 1L Platinum Responsive Extensive Disease Small Cell Lung Cancer Patients (ID 12119)

      16:45 - 18:00  |  Presenting Author(s): Shun Lu  |  Author(s): Liyan Jiang, Xinghao Ai, Junling Li, Xiaorong Dong, Dan Zhang, Qi Liu

      • Abstract
      • Slides

      Background

      Small cell lung cancer (SCLC) accounts for 15% of lung cancer, characterized by early dissemination and rapid development of chemo-resistant disease after platinum response (60-80%). Less than 2% of extensive disease SCLC (ED-SCLC) patients survive 5 years. The bi-allelic loss or inactivation of TP53 and RB1 is common in SCLC, the poly(ADP-ribose) polymerase-1 (PARP-1), a critical DNA damage repair enzyme, is highly expressed in SCLC, and SCLC is sensitive to platinum based chemotherapy, suggesting that the defect in DNA damage repair pathways plays an important role in SCLC. ZL2306/ Niraparib is a highly selective PARP-1/2 inhibitor which was exclusively licensed for development in China by Zai Laboratory from TESARO. In SCLC PDX model, niraparib demonstrated anti-tumor activities as monotherapy. In addition, niraparib demonstrated promising tumor growth inhibition in maintenance post platinum treatment in platinum sensitive SCLC PDX models. Clinically, in phase III NOVA study, niraparib demonstrated clear clinical benefit as maintenance treatment by significantly extending progression free survival in all platinum-sensitive recurrent ovarian cancer patients regardless gBRCA or HRD status which led to the approval by FDA and EMA in ovarian cancer. It is suggested that niraparib maintenance therapy could provide potential clinical benefit in platinum responsive SCLC. ZL-2306-005 is a randomized double-blind multi-center phase 3 study to evaluate the efficacy and safety of niraparib versus placebo as maintenance therapy in ED-SCLC patients who have had responses to platinum based chemotherapy.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Approximately 590 Chinese patients with histologically or cytologically confirmed ED-SCLC who have achieved either complete response or partial response to their platinum based chemotherapy to their newly diagnosed disease will be randomized (2:1) to 2 groups, receiving either ZL-2306 or placebo in ZL-2306-005 study. Patients need to complete 4 cycles of etoposide + cisplatin/ carboplatin. All patients will be stratified by gender, LDH level and history of prophylactic cranial irradiation. ZL-2306 will be started with 300mg PO QD for patients with a baseline body weight ≥77 kg and a baseline platelet count ≥150,000/μL, or 200 mg PO QD for patients with a baseline body weight <77 kg or a baseline platelet count <150,000/μL based on RADAR analysis in NOVA study. Patients will remain on treatment until disease progression or intolerable toxicity. The co-primary endpoints are PFS assessed by independent central radiologic review and OS; the secondary endpoints are PFS assessed by investigator, CFI, QoL, safety and tolerability.

      4c3880bb027f159e801041b1021e88e8 Result

      Section not applicable

      8eea62084ca7e541d918e823422bd82e Conclusion

      Section not applicable

      6f8b794f3246b0c1e1780bb4d4d5dc53

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    P1.13 - Targeted Therapy (Not CME Accredited Session) (ID 945)

    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 45
    • Moderators:
    • Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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      P1.13-08 - Distribution, Differences in Clinical Characteristics and Resistance Mechanism of ALK Variants in Chinese Lung Cancer Patients. (ID 13678)

      16:45 - 18:00  |  Presenting Author(s): Xuefeng Xia  |  Author(s): Jun Zhao, Qin Li, Gen Lin, Xiaorong Dong, Li Liu, Likun Chen, Jianhua Chen, Yong He, Xinghao Ai, Renhua Guo, Wenxian Wang, Chunwei Xu, Rongrong Chen, Yi Xin

      • Abstract
      • Slides

      Background

      ALK rearrangements are established targetable drivers in NSCLC. Recent reports indicate differential progression-free survival to ALK inhibitors according to specific EML4-ALK variant.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      A total of 172 unique Chinese lung cancer patients with tumors harboring ALK rearrangements (ALK+) were enrolled in the study from 2016 to 2018. ALK+ were detected by Ventana, FISH, or next-generation sequencing based ER-Seq method, which enables simultaneously assess single-nucleotide variants, insertions/deletions, rearrangements, and somatic copy-number alterations across at least 59 genes (59-1021). Tissue biopsy was the first choice for NGS mutation profiling, and ctDNA or pleural effusion testing was used as an alternative.

      4c3880bb027f159e801041b1021e88e8 Result

      Of these 172 cases, the median diagnosis age was 50 (range 24-78), 58% were female, 90% was NSCLC. Of the 147 ALK+ cases detected by NGS, we identified 65 (44%) EML4-ALK v1 (E13; A20), 18 (12%) EML4-ALK v2 (E20; A20), 43 (29%) EML4-ALK v3 (E6; A20), 13 (9%) other EML4-ALK, and 8 (5%) non-EML4-ALK rearrangements. 2 new fusion genes were found in non EML4-ALK rearrangements (SRBD1-ALK (EX20; EX20) and CLIP4-ALK (EX9; EX20)), and the CLIP4-ALK patient’s tissue was also ALK positive by Ventana. V1 found a higher proportion of pleural effusion at baseline than non-v1 (12% v.s.5%). Mutation profiling by NGS were performed after disease progression in 55 patients treated with crizotinib. mPFS was 8.1 months, no significant difference existed between v1 and v3 (P=0.69). But the presence of known ALK resistance mechanisms was significantly higher in v3 as compared to non-v3 (67% v.s. 27%, P=0.038).

      8eea62084ca7e541d918e823422bd82e Conclusion

      Next generation sequencing allows for detection of the specific ALK fusion partner and variants, increases the understanding of the biology of ALK+ NSCLC, and may have value to foretell potential mechanisms of resistance.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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      P1.13-11 - PRO-CTCAE Toxicities in Advanced NSCLC Patients with EGFR Mutations: A Real World Assessment (ID 12998)

      16:45 - 18:00  |  Presenting Author(s): Katrina Hueniken  |  Author(s): Manjusha Hurry, Shirley Xue Jiang, Catherine Labbe, M Catherine Brown, Lawson Eng, Hiten Naik, Mindy Liang, Devalben Patel, Penelope Bradbury, Natasha B Leighl, Frances A Shepherd, Wei Xu, Grainne Mary O'Kane, Ryan N. Walton, Geoffrey Liu

      • Abstract
      • Slides

      Background

      The Patient Reported Outcomes of the CTCAE (PRO-CTCAE) tool has not been evaluated in a real-world study of EGFR-mutation positive patients treated with TKIs/chemotherapies. We evaluated its role in capturing clinically-significant toxicities.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      A longitudinal observational study evaluated common EGFR-TKI toxicities using PRO-CTCAE, measured on a five-point scale (1=no symptoms to 5=very severe symptoms) in outpatients with EGFR-mutated (EGFRm) advanced NSCLC.

      4c3880bb027f159e801041b1021e88e8 Result

      Toxicity information was collected for 709 follow-up visits (encounters) from 232 patients. Median age was 64 (range:29-96), 161 (69%) were female and 124 (53%) were Asian. 85 (37%) already had brain metastases at first encounter. 485 encounters were observed from patients stable on treatment, and 187 from patients progressing or with documented progression on their current treatment. 24 patients were treated with osimertinib (97 encounters, 97% in second/subsequent-line), 136 with gefitinib (324 encounters, 95% in first line therapy), 42 were receiving other EGFR-TKIs (118 encounters, 53% in second/subsequent-line), and 29 with chemotherapy (73 encounters, 96% second/subsequent-line). The table below summarizes the treatment-related PRO-CTCAE toxicities self-graded as moderate-to-very-severe by EGFRm patients.

      Proportion of patients reporting highest grade of toxicity as grade 3-5, by PRO-CTCAE

      Gefitinib

      Osimertinib

      Other EGFR TKI

      Chemotherapy

      Diarrhea

      17%

      18%

      24%

      8%

      Constipation

      12%

      4%

      12%

      16%

      Decreased appetite

      10%

      7%

      14%

      26%

      Nausea

      6%

      3%

      4%

      24%

      Vomiting

      1%

      2%

      3%

      16%

      Fatigue

      18%

      12%

      23%

      42%

      Numbness and Tingling

      6%

      7%

      10%

      16%

      Skin Rash

      23%

      12%

      20%

      9%

      Visual Disorders

      (includes dry eye)

      4%

      0%

      3%

      4%

      Total PRO-CTCAE Score, MEDIAN [IQR]

      4 [0,16]

      0 [0,15]

      6 [0,17]

      10 [0,21]

      8eea62084ca7e541d918e823422bd82e Conclusion

      Osimertinib therapy had the most favorable self-reported toxicity profiles of all the therapies in EGFRm patients, followed by gefitinib. Chemotherapy generated the greatest toxicities. The use of PRO-CTCAE was well-accepted by patients in a clinical setting. This confirms trial data supporting favorable toxicities with osimertinib compared to other therapies for EGFRm NSCLC patients.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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      P1.13-15 - Detection of EGFR Mutations in cfDNA and Development of Resistance (ID 12634)

      16:45 - 18:00  |  Presenting Author(s): Grainne Mary O'Kane  |  Author(s): Geoffrey Liu, Tracy Stockley, Muqdas Shabir, Tong Zhang, Lisa Le, Frances A Shepherd, Penelope Bradbury, Natasha B Leighl

      • Abstract

      Background

      Peripheral blood sampling for T790M in patients (pts) failing initial EGFR-TKIs is now standard practice. The value of longitudinal sampling in pts is unknown.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      A study of cell free (cf) DNA analysis in pts with EGFR mutated(m) non-small cell lung cancer (NSCLC) is ongoing at the Princess Margaret Cancer Centre. The ThermoFisher OncomineTM lung assay detecting single nucleotide variants and indels to a limit of 0.05-0.1% variant allele frequency (VAF) was used. Patient clinical details and outcomes were collected prospectively.

      4c3880bb027f159e801041b1021e88e8 Result

      From Oct 2016-Feb 2017, 73 pts with EGFRm NSCLC enrolled and first blood samples were analysed. Most (92%) had mutations in del19 or L858R, including 1 pt with del19/S768I. Uncommon EGFRm were present in 6 (G718X, L861Q, exon20ins). Detectable levels of cfDNA were found in 50 pts (68%). Of 64 pts either starting an EGFR-TKI (n=11,17%), receiving a TKI without progression (PD) (23, 36%) or with PD on a TKI (30, 47%), the presence of the primary EGFRm (n=39, 61%) strongly associated with pre- 1st TKI or PD, p=0.03. Of 53 pts receiving a TKI, the presence of T790M in 31 (58%) associated with PD (p=0.04). Where pts had no radiologic PD evident, the median progression free survival (PFS), taken from blood draw, was 2.1 months (mths) versus 10 mths (HR 2.22, 95% CI: 0.89-5.54 p=0.08) when the primary EGFRm was detected. If T790M was present in cfDNA, the median PFS was 3.0 months versus 9.7 mths, (HR 4.59, 95% CI: 1.43-14.73 p=0.005). In univariable regression analyses the %VAF of the primary EGFRm correlated with PFS (HR 1.15, 95%CI: 1.02-1.29, p=0.02) with a trend in the %VAF of T790M (HR 1.16 95% CI:0.99-1.37, p=0.08). T790M was detected in 3 of 4 pts with T790M -ve tissue, and other co-occurring EGFRm were found in 10 pts including K745R in a pt receiving first-line osimertinib. TP53 (n=10), KRAS (1), PI3KCA(1) and ALK(2)gene mutations were also detected. Interestingly, in 1 pt receiving chemotherapy with T790M+ disease, both the primary EGFRm and T790M were detected in blood at the time of PD.

      8eea62084ca7e541d918e823422bd82e Conclusion

      In addition to the emergence of resistance mutations, the presence of the primary EGFRm in pts receiving EGFR-TKIs may associate with a shorter PFS and therefore may be useful in longitudinal analyses of cfDNA to direct therapy.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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      P1.13-18 - Exploring the Resistance Mechanism of Osimertinib and Monitoring the Treatment Response Using Plasma ctDNA in Chinese NSCLC Patients (ID 13297)

      16:45 - 18:00  |  Presenting Author(s): Yuankai Shi  |  Author(s): Puyuan Xing, Xiaohong Han, Sha Wang, Yutao Liu, Peng Liu, Junling Li, Lianpeng Chang, Yanfang Guan, Zhishang Zhang, Di Wu, Jiarui Yao, Yi Xin

      • Abstract
      • Slides

      Background

      Osimertinib (AZD9291; Tagrisso) is a third generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) known to be effective for patients harboring the EGFR-T790M variant, which is accounts for more than half of the acquired resistance mechanisms to the first generation EGFR-TKIs. However, limited osimertinib resistance-mechanism was reported. Study on potential osimertinib-resistance mechanisms in advanced NSCLC is necessary.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      This study enrolled eight T790M-positive (tissue validated) patients, treated with osimertinib after first generation EGFR-TKI (Erlotinib, Gefitinib, Icotinib) resistance and progressed rapidly. Serial plasma samples were collected until disease progressed. Plasma DNA was extracted and sequenced by target-capture deep sequencing of 1021 previously annotated genes related to solid tumors. Clonal EGFR T790M mutation was defined if mutation was in the cluster with the highest mean variated allele frequency with PyClone, and otherwise subclonal EGFR T790M mutation. Molecular tumor burden index (mTBI) was calculated with the mean variant allele frequency of mutations in trunk clonal population.

      4c3880bb027f159e801041b1021e88e8 Result

      The median progression-free survival (PFS) of these eight rapidly-progressed patients was 3.82 months [95% CI 2.05-5.01] .Targeted capture sequencing of pretreatment ctDNA showed all of the eight patients (100%) were EGFR-positive (Exon19del [n=6] and L858R [n=2]), and seven patients (88%) harbored EGFR T790M mutation, except for the only one patient (P006) who showed an extremely low level of ctDNA. During the Osimertinib treatment, five patients (63%) had osimertinib resistance-related mutations: EGFR C797S (in cis position), G724S, KRAS G12D, PIK3CA E542K, EGFR amplification, and ERBB2 amplification. Among them, two patients had more than one resistance mechanisms: patient P034 had EGFR G724S, KRAS G12D and EGFR amplification, simultaneously; patient P013 had amplification in both EGFR and ERBB2. Other potential resistance mechanisms were identified including EGFR T751I and K754E mutations in P002 and ERBB2 S603 in P013. Notably, the only one patient (P004) who had not been detected to have any known osimertinib resistance mechanism but progressed in 3 months, was demonstrated to harbor a subclonal EGFR T790M mutation by analysis of ctDNA clonal structure. Serial ctDNA monitoring showed mTBI increased when disease progressed in 88% (7/8) patients, except P006, whose mutation were negative at second (stable disease) and third (progressed disease) therapeutic evaluations due to the extremely low level of ctDNA.

      8eea62084ca7e541d918e823422bd82e Conclusion

      This study presented comprehensive the resistance mechanism of osimertinib progressed rapidly in ctDNA including multiple mechanisms co-occurred in same patient. Serial monitoring of plasma ctDNA may be a promising approach to explore resistance mechanism and monitored the treatment response of third generation EGFR-TKI.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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      P1.13-26 - First-Line Continual EGFR-TKI Plus LAT Demonstrated Survival Benefit in Egfr-Mutant Nsclc Patients with Oligoprogressive Disease (ID 11143)

      16:45 - 18:00  |  Presenting Author(s): Qinghua Xu  |  Author(s): Hui Liu, Tao Jiang, Shengxiang Ren, Caicun Zhou

      • Abstract

      Background

      The effect of local ablative therapy (LAT) for oligoprogressive epidermal growth factor receptor (EGFR) mutation non-small cell lung cancer (NSCLC) remains undetermined. This study aimed to investigate the survival benefit of addition of LAT to EGFR-TKIs in EGFR-mutant NSCLC patients with oligoprogression during TKI therapy.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Patients with stage IIIB/IV EGFR mutant NSCLC who had oligoprogressive disease during the first-line EGFR-TKI therapy from March 2011 to February 2016 were identified. The primary research point were progression-free survival1 (PFS1), defined as time of initiation of TKI therapy to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 defined progress disease (PD) or death and PFS2, defined as time of initiation of TKI therapy to off-TKI PD. The second research piont inclued overal survival (OS) and safety.

      4c3880bb027f159e801041b1021e88e8 Result

      A total of 206 patients were included. The median follow-up time was 42 months (20.0-69.6 months). The median PFS1, median PFS2 and median OS for the related cohort were 10.7 months (95% CI, 10.1-13.3 months), 18.3 months (95% CI, 17.4-19.2 months) and 37.4 months (95% CI, 35.9-38.9 months) respectively. Survival rates of 1 year, 2 years and 3 years were 94.1%, 78.9%, and 54.7%, respectively. Multivariate analysis revealed that female, EGFR exon 19 mutation, one metastatic lesion, partial or complete response to prior EGFR TKIs therapy were the independent prognostic factors. No unexpected toxicities were observed.

      8eea62084ca7e541d918e823422bd82e Conclusion

      The current study suggested that the addition of LAT to EGFR-TKI could provide satisfactory survival benefit for EGFR-mutant NSCLC patients with oligoprogression during first-line EGFR-TKI treatment.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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      P1.13-28 - The Functional MDM4 Genetic Polymorphsim as Prognostic Biomarker for Advanced Lung Adenocarcinoma Patients' Survival to EGFR-TKIs Therapy (ID 11773)

      16:45 - 18:00  |  Presenting Author(s): Ming Yang  |  Author(s): Nasha Zhang, Huaixin Xing, Jibing Liu

      • Abstract

      Background

      As a mostly used epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI), gefitinib significantly prolongs survival of lung adenocarcinoma patients with sensitizing EGFR mutations. However, more than 10% of EGFR mutation-positive patients do not respond and a substantial fraction of responded patients progress after 8-12 months’ treatment. Identification of new biomarkers associated with EGFR-TKIs prognosis would have great clinical potential for individualized treatments. The objective of this study is to investigate associations between the functional MDM4 genetic variant and survival of lung adenocarcinoma patients treated with gefitinib, especially in the patients with active EGFR mutations.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      In this study, a total of 384 patients with stage IIIB or IV lung adenocarcinoma were recruited between January 2009 and June 2013. All patients were treated with gefitinib orally at a daily dose of 250 mg as 1st-line monotherapy. MDM4 rs4245739 A>C genotypes were determined using the MassArray system (Sequenom Inc., San Diego, USA). Dual luciferase reporter gene assays were used to evaluate the function of MDM4 rs4245739 genetic variant in lung adenocarcinoma cell lines A549 and H1299. The differences of patient clinical characteristics and different reporter gene assays were calculated using student's t test or χ2 test. The genotype effects on PFS or OS was estimated using the Kaplan-Meier method and a comparison between survival curves was done with log-rank test. Multivariate Cox regression analysis assessed prognostic factors for PFS or OS. A P value of less than 0.05 was used as the criterion of statistical significance, and all statistical tests were two-sided.

      4c3880bb027f159e801041b1021e88e8 Result

      Among 384 patients, EGFR mutations were positive in 181 patients (47.1%). Median progression-free survival (PFS) and overall survival (OS) for all patients with the rs4245739AC genotype were significantly longer than that of the AA carriers (PFS: 22.9 vs. 10.9 months, P < 0.001; OS: 27.3 vs. 16.5 months, P = 0.003). Notably, in the EGFR mutation-positive subgroup, individuals with MDM4 rs4245739AC genotype showed 14.1 months prolonged PFS (28.8 months vs. 14.7 months; P = 0.022) and 12.2 months prolonged OS (31.4 months vs. 19.2 months; P = 0.047)compared to the AA group. In support of this, reporter gene assays showed that the rs4245739A allele leads to significantly increased MDM4 expression in lung adenocarcinoma cells compared to the C allele (P < 0.05).

      8eea62084ca7e541d918e823422bd82e Conclusion

      MDM4 rs4245739 genotypes may act as prognostic biomarker for patients’ survival to gefitinib therapy and offer help to patient-tailored treatment strategy in lung adenocarcinoma patients with EGFR mutations.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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    P1.14 - Thymoma/Other Thoracic Malignancies (Not CME Accredited Session) (ID 946)

    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 30
    • Moderators:
    • Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
    • +

      P1.14-28 - Frequent Genetic Alterations and Their Clinical Significance in Patients with Thymic Epithelial Tumors (ID 13977)

      16:45 - 18:00  |  Presenting Author(s): Song Xu  |  Author(s): Hongyi Zhang, Xiongfei Li, Renwang Liu, Tao Shi, Jun Chen

      • Abstract

      Background

      Thymic epithelial tumors (TETs) are relatively rare neoplasms originating from the epithelial cells of the thymus. Due to the variety of different histology and low incidence, the current knowledge about the genetic alterations and prognostic factors of these tumors is still limited.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Twenty-four specimens from Chinese patients with resected TETs were collected and sequenced by next-generation technology with 56 cancer-related hotspot genes. The somatic mutation data of TETs was also retrieved from TCGA database (The Cancer Genome Atlas) (n=123). Overall survival was evaluated using Kaplan-Meier methods and compared with log-rank tests.

      4c3880bb027f159e801041b1021e88e8 Result

      We analyzed 12 thymoma (type A, n =3; type AB, n=2; type B1/B2, n = 4; type B3, n = 3) and 12 thymic carcinoma in this study. At least one gene mutation was detected in 15 cases out of total 24 tumors. Half of thymoma and seventy-five percent of thymic carcinoma exhibited genetic alterations, respectively. Twenty-seven gene mutations were detected in total 24 tumors. The most frequent gene mutation of thymoma is BRCA1(25.0%, 3/12), while TP53 mutation is the most commen in thmic carcinoma (25.0%, 3/12). CDKN2A mutaion was exclusively observed in thymic carcinoma (16.7%, 2/12). Our and TCGA cohorts both demonstrated that TETs who presented TP53 mutation had a worse disease free survival and overall survival.

      8eea62084ca7e541d918e823422bd82e Conclusion

      Comprehensive genomic analysis suggests that the molecular phenotype of thymoma and thymic carcinoma has a distinct difference. TP53 and CDKN2A mutations might play an essential role in the pathogenesis in thymic carcinoma. Lastly, TP53 is the potential biomarker of poor prognosis in TETs.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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    P1.15 - Treatment in the Real World - Support, Survivorship, Systems Research (Not CME Accredited Session) (ID 947)

    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 37
    • Moderators:
    • Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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      P1.15-09 - Trends in Lung Cancer Survival in Lithuania (ID 11138)

      16:45 - 18:00  |  Presenting Author(s): Vaida Gedvilaite  |  Author(s): Edvardas Danila, Saulius Cicenas, Giedre Smailyte

      • Abstract
      • Slides

      Background

      Lung cancer is the most common cancer-related death worldwide. The prognosis of lung cancer is unfavourable and improvements in survival in recent decades have been minimal. The aim of this study is to describe the most recent survival rates by sex, age group, extent of disease and histology of lung cancer in Lithuania.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      The study is based on the Lithuanian Cancer Registry database covering a population of around 3 million residents according to 2011 census. The analysis included patients with primary invasive lung cancer diagnosed in 1998-2012 who were at least 15 years old at the time of diagnosis. Patients were followed-up with respect to vital status until December 31, 2012. Cases notified by the death certificate only were excluded. Five-year relative survival estimates were calculated using period analysis. Relative survival was calculated as the ratio of the observed survival of cancer patients and the expected survival of the underlying general population. The latter was calculated according to the Ederer II method using national life tables for Lithuanian population stratified by age, gender and calendar year.

      4c3880bb027f159e801041b1021e88e8 Result

      In our study the overall 5-year relative survival was low, but increased slightly from 6,4% in 2003-2008 to 7.9 % 2009-2012. Positive changes in survival were evident in both sexes, in almost all age groups and for all histological groups and disease stages. Adenocarcinoma relative survival increased from 6.7% in 2003-2008 to 12.8% in 2009-2012 and squamous cell carcinoma increased from 7.4% in 2003-2008 to 11.1% in 2009-2012. Patients with small cell carcinoma had the worst survival (2.9% in 2003-2008 and 3.6% in 2009-2012). Only less than 10% of lung cancer cases were diagnosed localised and proportion of those tumours decreased slightly (from 8.5% to 7.6%). In 2009-2012 relative survival of localised stage lung cancer was 43 %, locally advanced – 19,9%, regional disease - 6% and metastatic disease – 0.7%.The highest number of lung cancer was diagnosed with distant metastases and proportion of metastatic tumours increased from 35.1% to 37.8%. 5-year relative survival was higher in women (9.4 % in 2003-2008 and 12.6 % in 2009-2012) than in men (5.8 % in 2003-2008 and 7% in 2009-2012).

      8eea62084ca7e541d918e823422bd82e Conclusion

      Despite low overall survival, there were positive changes in survival in both sexes, in almost all age groups and for all histological groups and disease stages. The high proportion of metastatic disease at the time of diagnosis was the main factor that influenced low survival rates.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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      P1.15-17 - Risk Factors of Local Recurrence in EGFR-Mutant Stage III-pN2 Adenocarcinoma After Complete Resection: A Multi-Center Real-World Cohort Study (ID 12740)

      16:45 - 18:00  |  Presenting Author(s): Hui Liu  |  Author(s): Qi-Wen Li, Bo Qiu, Wenhua Liang, Jun-Ye Wang, Wan-Ming Hu, Shuang-Bing Xu, Steven H Lin, José Luis López, Nai-Bin Chen, Tian Zhang, Minzhang Guo, Yi Zhao, Song-Ran Liu, Qianwen Liu, Jin-Yu Guo, Ling-Zhi Cai, Si-Yu Wang, Xin Wang, Lan-Jun Zhang, Tie-Hua Rong, Zhen-Tao Yu, Jing-Ping Yun, Gang Wu, Li Zhang, Vincent (Wentao) Fang, Hao Long, Qing-Song Pang

      • Abstract

      Background

      Postoperative radiotherapy (PORT) of complete resected stage IIIA non-small cell lung cancer with N2 nodal involvement remained contentious. Our previous study suggested low locoregional recurrences in epidermal growth factor receptor (EGFR) mutant patients. We sought to launch a multi-center large cohort study to evaluate the risk factors of locoregional recurrence in R0 resected EGFR mutant III-pN2 patients without PORT, producing evidence for the design of adjuvant regimens.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Three-hundred and fifty-nine consecutive patients with complete resected, pathological approved stage III-pN2 lung adenocarcinoma with sensitive EGFR mutation (exon 19 or exon 21) have been investigated. Patients were excluded if they received induction therapy (7.5%) or PORT (9.6%). Three hundred cases have been analyzed. Clinicopathologic characteristics, pretreatment work-ups, EGFR mutant status and patterns of failure were documented. Patients were sub-staged by the International Association for the Study of Lung Cancer (IASLC)/ the Union for International Cancer Control (UICC) 7th classification on N2 disease. Risk factors of locoregional recurrence-free survival (LRFS) were evaluated by univariate and multivariate analyses.

      4c3880bb027f159e801041b1021e88e8 Result

      According to IASLC/UICC 7th classification, there were 198 (66.0%) patients with unforeseen N2 (N2a), 36 (12.0%) with minimal/single station N2 (N2b), 41 (13.7%) with selectively centrally located N2 (N2c) and 25 (8.3%) with bulky and/or multilevel N2 (N2d). After surgery, 70 (23.3%) patients were treated with adjuvant tyrosine-kinase inhibitors (TKIs), while other 230 (76.7%) were free from adjuvant TKIs. With median follow-up of 28.5 (range:6-133) months, the 2-year LRFS, distant metastasis-free survival (DMFS), disease-free survival (DFS) and overall survival (OS) were 88.3%, 65.3%, 57.7% and 89.7%. Ultimately, 15.7% (47/300) patients developed locoregional recurrences. Distant metastasis was the predominant failure pattern. Multivariate analysis indicated that N2d disease (HR: 2.65, p=0.030) and extranodal extension (HR: 3.48, p<0.001) were risk factors of LRFS.

      8eea62084ca7e541d918e823422bd82e Conclusion

      R0 resected stage III-pN2 NSCLC patients with sensitive EGFR mutation (exon 19 or exon 21) tended to present limited N2 disease and low locoregional recurrences. Patients without bulky N2, multilevel N2, and extranodal extension might be refrained from PORT. Further studies evaluating the optimal radiotherapy approach for completely resected N2-positive NSCLC are required for validation.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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    P1.16 - Treatment of Early Stage/Localized Disease (Not CME Accredited Session) (ID 948)

    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 64
    • Moderators:
    • Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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      P1.16-40 - Evaluating the Tumor Heterogeneity in Lung Cancer by Constructing Tumor Heterogeneity Index (THI) from Magnetic Resonance Imaging (ID 13134)

      16:45 - 18:00  |  Presenting Author(s): Hui Liu  |  Author(s): Qi-Wen Li, Nanjie Gong, Bo Qiu, Hao-Qiang He, Ji-Hong Wang, Yong-Quan Ye, Jin-Yu Guo, Steven H Lin, Pei-Qiang Cai, Qun Chen, Hong-Di Li, Chuanmiao Xie

      • Abstract

      Background

      To improve the evaluation of primary lung cancer heterogeneity using clinical routine magnetic resonance imaging (MRI), we proposed a method based on basic measurements from T1- and T2-weighted MRI.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      As a novel technique of magnetic resonance imaging analysis, we investigated a total of 203 patients with biopsy-proven primary lung cancer and with different T stages. All patients previously received positron emission tomography/computed tomography (PET/CT) scan. Gross lesions were manually contoured on T1-weighted, T1-enhanced, T2-weighted and T2 fat suppression (T2fs) images. The ratios of standard deviation (SD) / mean tumor value from each sequence were calculated. Correlation analyses were performed between T stages and the ratios. P value <0.05 was defined as statistical significant. Then a linear regression was performed to determine the weight of each related ratio. A model was built to calculate Tumor Heterogeneous Index (THI). One hundred and one patients were analyzed as the training set and another 102 as validating set.

      4c3880bb027f159e801041b1021e88e8 Result

      There were 56 patients diagnosed with T1 disease, 60 with T2 disease, 51 with T3 disease and 36 with T4 disease. Pair matching was performed between training set and validating set. As a result of the correlation analyses, SD/mean ratio showed significantly correlations with T stages in T1-enhanced (p=0.003), T2-weighted (p<0.0001) and T2fs sequences (p=0.002). Based on a linear regression model, THI was established for assessing the heterogeneity of lung tumor, consisting the three ratio measurements. Correlation analysis demonstrated that Higher THI was significantly related to more advanced T stages (p<0.0001).

      fig.1.jpg

      8eea62084ca7e541d918e823422bd82e Conclusion

      The proposed SD/mean ratio measurements and the calculation of THI according to clinical routine MR images could be clinical biomarkers that correlated with T stages, and were capable of evaluating heterogeneity of lung cancers.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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      P1.16-41 - The Role of Surgery in Pulmonary Large Cell Neuroendocrine Carcinoma: A Propensity-Score Matching Analysis of SEER Database (ID 12772)

      16:45 - 18:00  |  Presenting Author(s): Zhichao Liu  |  Author(s): Hengrui Liang, Guanping Qiu, Yaokai Wen, Jianxing He, Wenhua Liang

      • Abstract
      • Slides

      Background

      Pulmonary large cell neuroendocrine carcinoma (LCNEC) is a rare and aggressive subset of non-small-cell lung cancer with poor prognosis. Due to its rarity, the optimal therapy strategy for pulmonary LCNEC remains undefined. We aimed to evaluate the role of surgery for stage I-III LCNEC using the Surveillance, Epidemiology, and End Results (SEER) database.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Patients with stage I-III LCNEC were extracted from the SEER database (2004-2014). Propensity-score matching was performed to reduce the effect of potential confounders. Kaplan-Meier curves were constructed for overall survival (OS) and cancer-specific survival (CSS) for patient strata based on surgery use or nonuse. Multivariable Cox-regression was used to explore the efficacy of different treatment strategies.

      4c3880bb027f159e801041b1021e88e8 Result

      A total of 944 LCNEC patients were identified, of which 674 (71.4%) received surgery. Both OS and CSS of surgery use group were superior to surgery nonuse group in the whole cohort (HR=0.48, P<0.001 and HR=0.41, P<0.001, respectively). Among matched cohort, significantly greater benefits in OS and CSS (Figure 1) from surgery was observed in both stage I-II (HR=0.47, P=0.001 and HR=0.43 P<0.001, respectively) and stage III (HR=0.66, P=0.039 and HR=0.63, P=0.031, respectively). On multivariable analysis of surgical group, there was no significant difference in either OS or CSS between surgery alone and the addition of chemotherapy or (and) radiation for stage I-II patients, whereas favorable survival outcomes of surgery plus chemotherapy (OS: HR=0.26, P<0.001; CSS: HR=0.30, P=0.001) and surgery plus chemotherapy and radiation (OS: HR=0.33, P<0.001; CSS: HR=0.34, P=0.002) were significantly evident for stage III patients.

      figure-abstract 12772.jpg

      8eea62084ca7e541d918e823422bd82e Conclusion

      This is the largest study exploring the benefit of surgery for stage I-III pulmonary LCNEC. Regardless of stage, surgery showed remarkable survival benefits for LCNEC patients. It is suggested that surgery alone may be sufficient for stage I-II, whereas the multimodal combination of surgery and other therapies should be considered for stage III disease.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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      P1.16-48 - The Impact of Segmentectomy Versus Lobectomy on Pulmonary Function of Patients with Non-Small Cell Lung Cancer: A Meta-Analysis (ID 12839)

      16:45 - 18:00  |  Presenting Author(s): Guanping Qiu  |  Author(s): Yaokai Wen, Hengrui Liang, Zhichao Liu, Jianxing He, Wenhua Liang

      • Abstract
      • Slides

      Background

      Lobectomy (Lob) and lymph node dissection is considered as the standard surgical procedure for non-small cell lung cancer (NSCLC). Segmentectomy (Seg) has been recently regarded as an alternative in early peripheral NSCLC owing to its advantages of lung function reservation. Thus, we performed a meta-analysis with the aim of evaluating whether Seg offers a better lung functional advantage over Lob.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      A comprehensive search of online databases was performed. Perioperative outcomes and lung functional index and were synthesized. The odds ratio (OR) or SMD and its 95% CI was calculated using a random effects model. Subgroup was conducted according to different time points. Single-arm meta-analysis was conducted for lung function at each visit time. Repeated-measures analysis of variance (ANOVA) was used to compare the lung function between at each visit.

      4c3880bb027f159e801041b1021e88e8 Result

      A total of 5 eligible studies including 958 patients were recruited. There were no significant differences according to baseline characteristics before surgery between groups (Seg and Lob). Seg correlated with a greater postoperative preserved pulmonary function than Lob in FVC (SMD=0.23, p=0.009) (Figure A) and FEV1 (SMD=0.27, p=0.002) (Figure B), especially before 12 months. ANOVA showed there were no differences between two groups in FVC (p=0.647) and FEV1 (p=0.468) according to each visit time (Figure C). Seg group showed significantly less postoperative complications compared with the Lob. (OR=0.64, p=0.045) and the recurrence rate were same between groups (OR=0.89, p=0.623).

      figure.tif

      8eea62084ca7e541d918e823422bd82e Conclusion

      Seg offers a better lung functional preservation in short time and reduces postoperative complication compared with Lob. However, two groups showed no significant difference on lung function and tumor relapse according to long follow up.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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    P1.17 - Treatment of Locoregional Disease - NSCLC (Not CME Accredited Session) (ID 949)

    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 20
    • Moderators:
    • Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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      P1.17-18 - Treatment for Patients with T4 Superior Sulcus Non-Small Cell Lung Cancer: A Propensity-Matched Analysis of SEER Database (ID 12319)

      16:45 - 18:00  |  Presenting Author(s): Min Fan  |  Author(s): Junmiao Wen, Donglai Chen, Jiayan Chen, Di Liu, Yongbing Chen, Chang Chen

      • Abstract
      • Slides

      Background

      Superior sulcus tumors (SSTs), a unique subgroup of locally advanced non–small-cell lung carcinoma (NSCLC), remain a great challenge for clinicians. T4 SSTs used to be a contraindication for operations, and the optimal treatment modality for T4 SS NSCLCs remains uncertain. The aim of our study is to evaluate the roles of surgical treatment and radiotherapy for patients with T4 SSTs.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      We used the SEER database [1973-2015] to identify patients diagnosed with T4 stage SS NSCLC (according to 7th edition AJCC staging system) between 2004 and 2015, those with M1 disease were excluded. Propensity score matching with Kaplan-Meier and Cox proportional hazards model were performed to estimate prognosis.

      4c3880bb027f159e801041b1021e88e8 Result

      A total of 384 patients were included (mean 66.4±11.71 years-of-age). Among them, the majority was male (59.4%) with lesions located in the left lung (52.3%) and diagnosed with IIIB stage (56.6%). 47 patients underwent cancer-directed surgery, and radiotherapy was received by 66.9% of patients. Median overall survival (OS) and lung cancer specific survival (LCSS) was 12 and 17 months, and 5-year OS, LCSS was 15.8%, 25.4%, respectively. In the matched population, the median survival outcomes were better with receipt of surgery (OS: 51.3 vs 35.1 months; p=0.049 LCSS: 67.1 vs 36.3 months; p=0.003). Multivariate Cox analysis showed that age ≧ 66 years (hazard ratio [HR] = 1.639, 95% confidence interval [CI] 1.214-2.213, p=0.001), unmarried status (HR = 1.356, 95% CI 1.023-1.798, p=0.034), tumor sized ≧ 6.0 cm (HR = 1.694, 95% CI 1.263-2.273, p<0.001) were associated with inferior OS. Cancer-directed surgery (HR = 0.537, 95% CI 0.337-0.855, p=0.009) and radiotherapy (HR = 0.644, 95% CI 0.472-0.878, p=0.006) were independent protective factors for patients with T4 superior sulcus NSCLC. However, neither adjuvant nor neoadjuvant radiotherapy was independent prognostic factor for those received surgery (p>0.05). Conversely, in the subgroup analysis, favorable impacts of radiotherapy were observed for non-surgery patients (OS: HR = 0.58, 95% CI 0.42-0.79, p<0.001; LCSS: HR = 0.55, 95% CI 0.37-0.75, p<0.001).

      8eea62084ca7e541d918e823422bd82e Conclusion

      Our study shows superior sulcus NSCLC patients with T4 stage have dismal prognosis. Surgical resection remains the optimal option for those with resectable disease. Moreover, for non-surgery tumors, the use of radiotherapy should be considered.

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    PL02 - Presidential Symposium - Top 5 Abstracts (ID 850)

    • Type: Plenary Session
    • Track: Advanced NSCLC
    • Presentations: 11
    • Moderators:
    • Coordinates: 9/25/2018, 08:15 - 09:45, Plenary Hall
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      PL02.07 - IMpower 133: Primary PFS, OS and Safety in a PH1/3 Study of 1L Atezolizumab + Carboplatin + Etoposide in Extensive-Stage SCLC (ID 12892)

      09:00 - 09:10  |  Presenting Author(s): Stephen V Liu  |  Author(s): Aaron S. Mansfield, Aleksandra Szczesna, Libor Havel, Maciej Krzakowski, Maximilian Johannes Hochmair, Florian Huemer, Gyorgy Losonczy, Melissa L. Johnson, Makoto Nishio, Martin Reck, Tony S. Mok, Sivuonthanh Lam, David S. Shames, Juan Liu, Beiying Ding, Fairooz Kabbinavar, Wei Lin, Alan Sandler, Leora Horn

      • Abstract
      • Presentation
      • Slides

      Background

      First-line (1L) standard-of-care treatment for extensive-stage small cell lung cancer (ES-SCLC) is platinum (carboplatin or cisplatin) with etoposide. Despite high initial response rates, there has been limited progress in the last two decades and outcomes remain poor with a median overall survival (OS) of ~10 months. IMpower133 (NCT02763579), a global Phase 1/3, double-blind, randomized, placebo-controlled trial evaluated efficacy and safety of adding atezolizumab, a humanized monoclonal anti–PD-L1 antibody, or placebo to 1L carboplatin and etoposide in ES-SCLC.

      Patients with measurable (RECIST v1.1) ES-SCLC, ECOG performance status 0 or 1, who had not received prior systemic treatment for ES-SCLC were enrolled. PD-L1 immunohistochemical testing was not required. Patients were randomized 1:1 to receive four 21-day cycles of carboplatin (AUC 5 mg/mL/min IV, Day 1) plus etoposide (100 mg/m2 IV, Days 1-3) with either atezolizumab (1200 mg IV, Day 1) or placebo, followed by maintenance therapy with atezolizumab or placebo until intolerable toxicity or progressive disease per RECIST v1.1. Patients meeting predefined criteria could receive treatment beyond progression. Co-primary endpoints were OS and investigator-assessed progression-free survival (PFS). Adverse events (AEs) were graded per NCI-CTCAE v4.0. Blood-based tumor mutation burden (bTMB) was assessed using prespecified cutoffs of ≥16 vs. <16 and ≥10 vs. <10 mutations/Mb.

      In total, 201 patients were randomized to the atezolizumab group, and 202 to the placebo group. Median follow-up was 13.9 months. Median OS was 12.3 months in the atezolizumab group and 10.3 months in the placebo group (hazard ratio [HR] 0.70 [95% confidence interval (CI): 0.54, 0.91; P=0.0069]). Median PFS was 5.2 months and 4.3 months, respectively (HR 0.77 [95% CI: 0.62, 0.96; P=0.017]). OS and PFS benefits were consistent across key patient subgroups. Investigator-assessed confirmed objective response rates were 60.2% and 64.4% in the atezolizumab and placebo groups, respectively; median duration of response, 4.2 and 3.9 months. Exploratory analyses showed OS survival benefits in subgroups above and below prespecified bTMB cutoffs. Grade 3-4 treatment-related AEs were reported in 56.6% vs. 56.1% patients in atezolizumab vs. placebo groups, respectively; serious treatment-related AEs occurred in 22.7% and 18.9% patients, respectively.

      Addition of atezolizumab to carboplatin and etoposide provided a significant improvement in OS and PFS in 1L ES-SCLC in an all-comer patient population. No unexpected safety signals were identified. Atezolizumab plus carboplatin and etoposide may represent a new standard regimen for patients with untreated ES-SCLC.

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    PR02 - Press Conference (ID 1000)

    • Type: Press Conference
    • Track:
    • Presentations: 0
    • Moderators:
    • Coordinates: 9/25/2018, 09:45 - 10:30, Plenary Hall
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    MA13 - Interventional Pulmonology (ID 914)

    • Type: Mini Oral Abstract Session
    • Track: Interventional Diagnostics/Pulmonology
    • Presentations: 12
    • Moderators:
    • Coordinates: 9/25/2018, 10:30 - 12:00, Room 206 AC
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      MA13.06 - Endosonography with Lymph Nodes Sampling for Restaging the Mediastinum in Lung Cancer: A Systematic Review and Pooled-Data Analysis (ID 11918)

      11:05 - 11:10  |  Presenting Author(s): Long Jiang  |  Author(s): Jun Liu, Wenlong Shao, Kassem Harris, Lonny Yarmus, Weizhe Huang, Jianxing He

      • Abstract
      • Presentation
      • Slides

      Background

      Mediastinal restaging after induction treatment is still a difficult and controversial issue. We aimed to investigate the diagnostic accuracy of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) and endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) for restaging the mediastinum after induction treatment in patients with lung cancer.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Embase and PubMed databases were searched from conception to July 2017. Data from relevant studies were analyzed to assess sensitivity and specificity of EBUS-TBNA and EUS-FNA, and to fit the Hierarchical Summary Receiver-Operating Characteristic curves.

      4c3880bb027f159e801041b1021e88e8 Result

      A total of nine studies consisting of 542 patients fulfilled the inclusion criteria. All patients were restaged by EBUS-TBNA, EUS-FNA or both. Negative results were confirmed by subsequent surgical approaches. There were no complications reported during any endosonography approaches reviewed. The pooled sensitivities of EBUS-TBNA and EUS-FNA were 66%(95% CI, 60%-72%) and 73%(95% CI, 52%-87%), respectively; and specificities were 100%(95% CI, 98%-100%) and 99%(95% CI, 90%-100%), respectively. The area under the HSROC curves(AUC) were 0.84(95% CI, 0.81-0.87) for EBUS-TBNA and 0.99(95% CI, 0.98-1) for EUS-FNA. Moreover, for patients who received chemotherapy alone, the pooled sensitivity of endosonography with lymph node sampling for restaging was 69% (95% CI, 63%-75%), and specificity was 100% (95% CI, 97%-100%); and for patients who received chemoradiotherapy, the results seemed similar with sensitivity of 65% (95% CI, 50%-78%) and specificity of 100% (95% CI, 96%-100%).

      Variables

      No. of patients

      Pooled sensitivity (95% CI)

      Pooled specificity (95% CI)

      Negative Likelihood Ratio

      AUC

      In all mediastinal stations

      Overall

      543

      0.70 (0.65-0.75)

      1.00 (0.98-1.00)

      0.30 (0.21-0.43)

      0.93 (0.91-0.95)

      EBUS-TBNA

      424

      0.66 (0.60-0.72)

      1.00 (0.98-1.00)

      0.38 (0.26-0.54)

      0.84 (0.81-0.87)

      EUS-FNA

      226

      0.73 (0.52-0.87)

      0.99 (0.90-1.00)

      0.27 (0.14-0.53)

      0.99 (0.90-1.00)

      Combine

      106

      0.67 (0.53–0.79)

      0.96 (0.86–0.99)

      N/A

      0.81 (0.73–0.87)

      Subgroup analysis

      Chemo alone

      365

      0.69 (0.63-0.75)

      1.00 (0.97-1.00)

      0.35 (0.26-0.48)

      0.90 (0.88-0.94)

      Chemo radiotherapy

      130

      0.65 (0.50-0.78)

      1.00 (0.96-1.00)

      0.25 (0.06-1.02)

      0.97 (0.95-0.98)

      If negative Likelihood Ratio(LR-) is smaller: essentially a definite diagnosis when negative result.

      8eea62084ca7e541d918e823422bd82e Conclusion

      Endosonography with lymph node sampling is an accurate and safe technique for mediastinal restaging of lung cancer. For nondiagnostic results, a further more invasive approach should be thoroughly considered.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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