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M. Tsuboi
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OA 16 - Treatment Strategies and Follow Up (ID 686)
- Event: WCLC 2017
- Type: Oral
- Track: Early Stage NSCLC
- Presentations: 1
- Moderators:Jun Nakajima, T. Demmy
- Coordinates: 10/18/2017, 14:30 - 16:15, Room 315
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OA 16.07 - Radiological Feature on TSCT for Predicting a Pathological Less-Invasive Lung Cancer According to the 8th TNM Classification (ID 8608)
14:30 - 16:15 | Author(s): M. Tsuboi
- Abstract
- Presentation
Background:
The limited resection for lung cancer has become more prevalent for patients who show a compromised pulmonary or cardiac function. As of now standard care of lung cancer is lobectomy with lymph node dissection or sampling even for early lung cancer. Japan clinical oncology group (JCOG) study 0201 has proposed the criteria to diagnose pathological less-invasive lung adenocarcinoma by using consolidation to tumor ratio (CTR) on preoperative thin-sliced computed tomography (TSCT) scan. Three clinical trials have been ongoing based on this result, but the TNM classification was drastically revised in 2016, especially in T category. The aim of this study is to propose the new radiological criteria to predict pathological less-invasive lung cancer before surgery in accordance with the new TNM classification.
Method:
We analyzed the 744 patients who have peripheral Tis-T1cN0M0 non-small cell lung cancer with 3cm or less in size and underwent complete resection by lobectomy from 2003 to 2011. We defined a lung cancer with no nodal involvement and no vessel invasion pathologically as a pathological less-invasive cancer, and investigated the radiological criteria corresponding to the new T category by using TSCT to predict a pathological less-invasive cancer with the specificity of 97% or more. We also re-evaluated the criteria by adding the parameter of CTR and presence of ground-glass opacity (GGO), and prognostic parameters; overall survival (OS) and relapse-free survival (RFS).
Result:
The cTis/T1ami/T1a patients showed no pathological invasive cancer except for only 1 patient (specificity: 99%). In the cT1b/T1c patients, the specificity of cT1b with CTR 0.5 or less, cT1b with C/T ratio 0.75 or less, and cT1b with GGO presence were 100%, 97.1%, 94.4%, respectively. The new criteria of cT1a or less and cT1b with CTR 0.75 or less showed excellent prognosis for OS and RFS.
Conclusion:
As most of the patients with cTis/T1ami/T1a and cT1b with CTR 0.75 or less showed pathological less-invasive cancers and extremely good survival, they will be more likely to be obtained good outcomes by sublobar resection including wide-wedge resection as well. The further prospective study will be required to confirm the hypothesis.
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P2.04 - Clinical Design, Statistics and Clinical Trials (ID 705)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Clinical Design, Statistics and Clinical Trials
- Presentations: 1
- Moderators:
- Coordinates: 10/17/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P2.04-006 - ADAURA: PhIII, Double-Blind, Randomized Study of Osimertinib vs Placebo in EGFR Mutation-Positive NSCLC Post-Tumor Resection (ID 8989)
09:30 - 16:00 | Author(s): M. Tsuboi
- Abstract
Background:
EGFR-TKIs are standard first-line therapy in patients with EGFR sensitizing mutation (EGFRm)-positive advanced NSCLC. EGFR T790M resistance mutation is observed in >50% of patients with acquired resistance to EGFR-TKIs. Osimertinib is a third-generation, irreversible, CNS-active EGFR-TKI selective for EGFRm and T790M, recommended in patients with T790M-positive advanced NSCLC who have progressed on first-line EGFR-TKIs. In a recent study (NCT01405079), gefitinib treatment in patients with resected EGFRm-positive NSCLC significantly increased disease-free survival (DFS) vs vinorelbine+cisplatin: median 28.7 vs 18.0 months (hazard ratio 0.60 (95% CI 0.42–0.87), p=0.005), warranting further investigation of EGFR-TKIs in this setting (Wu et al, J Clin Oncol 2017;35:suppl;abs8500). Osimertinib may prolong DFS in adjuvant EGFRm-positive NSCLC.
Method:
Trial Design ADAURA (NCT02511106) is a global, Phase III, double-blind, randomized study, assessing efficacy and safety of osimertinib vs placebo in patients with stage IB–IIIA non-squamous EGFRm-positive NSCLC with complete tumor resection. Approximately 700 patients from 210 sites will be randomized. A planned 60% of patients will be recruited from Asia, 40% from non-Asian countries; 70% stage II–IIIA, 30% stage IB. Patients must be adults ≥18 years (Japan/Taiwan: ≥20) with primary NSCLC staged post-operatively as IB/II/IIIA, and central confirmation of Ex19del or L858R (alone or combined with other EGFR mutations including T790M). Complete surgical resection of the primary NSCLC is mandatory; patients will have baseline CT scans within 28 days prior to treatment confirming radiographic absence of residual disease. Complete surgical recovery is required for randomization; treatment to start at least 4 weeks following surgery. Patients who have received radiation therapy, pre-operative chemotherapy, prior anticancer therapy or neoadjuvant/adjuvant EGFR-TKI treatment are exempt. Standard post-operative adjuvant chemotherapy, consisting of a platinum-based doublet for 4 cycles maximum, is allowed; no more than 10 and 26 weeks may have elapsed between surgery and randomization for patients who have not or have received adjuvant chemotherapy, respectively. Patients will be randomized 1:1 to once-daily osimertinib 80 mg or placebo and stratified by stage (IB/II/IIIA), mutation type (Ex19Del/L858R) and race (Asian/non-Asian). Treatment may continue for 3 years in absence of discontinuation criteria including disease recurrence. Primary objective is to assess the efficacy of osimertinib vs placebo, measured by investigator-assessed DFS. Secondary objectives include assessment of the safety profile of osimertinib vs placebo; DFS rate at 2, 3, 5 years; overall survival (OS); 5-year OS rate; health-related quality of life; pharmacokinetics. Estimated primary completion date (final DFS data collection date): July 2021.
Result:
Section not applicable.
Conclusion:
Section not applicable.
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P2.16 - Surgery (ID 717)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Surgery
- Presentations: 1
- Moderators:
- Coordinates: 10/17/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P2.16-015 - Log Data of Digital Drainage System Is a Potential Predictive Factor of Pleurodesis Efficacy for Postoperative Air Leak After Pulmonary Resection (ID 9629)
09:30 - 16:00 | Author(s): M. Tsuboi
- Abstract
Background:
Digital drainage system (DDS) has been recently recognized as a useful device in postoperative chest drainage. However, there is no past study predicting the efficacy of pleurodesis using DDS for postoperative air leak. The aim of this study is to identify predictive factors of the efficacy of pleurodesis including the observed data in DDS log.
Method:
The 857 patients underwent pulmonary resection and were made use of DDS for chest drainage postoperatively from January 2015 to December 2016. We retrospectively reviewed clinical database and log data of DDS, and compared the patient who stopped postoperative air leak by single pleurodesis with the patient who needed two or more pleurodesis. Fisher’s exact test was used to compare categorical values, and Mann-Whitney U test was used to analyze continuous values. The cut-off values were decided by receiver operating characteristic curve.
Result:
The 40 patients underwent pleurodesis for postoperative air leak. The median age was 70 years (range, 51 to 86), and 83% of patients were men. The most common type of surgery was lobectomy (90%). Postoperative air leaks in the 23 patients (58%) were stopped by single pleurodesis, and those in the 17 patients (42%) needed pleurodesis more than two times to stop air leak. The predictive factors to stop air leak by single pleurodesis were lower air leak flow at the time of pleurodesis (P = 0.02), and lower average of air leak flow for 24 hours before pleurodesis (P = 0.05). The cut-off value of air leak flow was 100 ml/min, and average of air leak flow for 24 hours was 130ml/min.
Conclusion:
Air leak flow at the time of pleurodesis and the average for 24 hours in DDS log were useful predicters of stopping air leak by single pleurodesis.
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P3.02 - Biology/Pathology (ID 620)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Biology/Pathology
- Presentations: 1
- Moderators:
- Coordinates: 10/18/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P3.02-074 - Podoplanin-Positive CAF Is Associated with a Higher Number of Single Nucleotide Variants in Cancer Cells in Lung Adenocarcinoma (ID 9885)
09:30 - 16:00 | Author(s): M. Tsuboi
- Abstract
Background:
Podoplanin-positive cancer-associated fibroblasts (CAFs) play an essential role in tumor progression. However, it is still unclear whether specific genomic alterations of cancer cells are required to recruit podoplanin-positive CAFs. The aim of this study was to investigate the relationship between the mutation status of lung adenocarcinoma cells and the presence of podoplanin-positive CAFs.
Method:
Ninety-seven lung adenocarcinomas for which whole exome sequencing data were available were enrolled. First, we analyzed the clinicopathological features of the cases with podoplanin-positive CAFs, and then, we evaluated the relationship between genetic features of cancer cells (major driver mutations and the number of single nucleotide variants, or SNVs) and the presence of podoplanin-positive CAFs.
Result:
Patients with podoplanin-positive CAFs had a significantly lower 5-year recurrence-free proportion than those with podoplanin-negative CAFs (p = 0.027). We could not find any significant correlations between major genetic mutations (EGFR, KRAS, TP53, MET, ERBB2, BRAF, and PIC3CA) in cancer cells and the presence of podoplanin-positive CAFs. However, cases with podoplanin-positive CAFs had a significantly higher number of SNVs in cancer cells than the podoplanin-negative CAFs cases (median; 84 vs 37, respectively; p = 0.001). This was also detected in a non-smoker subgroup (median: 64 vs 32, respectively; p = 0.037). Multivariate analyses revealed that the number of SNVs in cancer cells was the only statistically significant independent predictor for the presence of podoplanin-positive CAFs (p = 0.044).
Conclusion:
In lung adenocarcinoma, the presence of podoplanin-positive CAFs was associated with higher numbers of SNVs in cancer cells, suggesting a relationship between accumulations of SNVs in cancer cells and the generation of a tumor- promoting microenvironment.
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P3.13 - Radiology/Staging/Screening (ID 729)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Radiology/Staging/Screening
- Presentations: 1
- Moderators:
- Coordinates: 10/18/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P3.13-036 - Immunohistochemical and Genetic Characteristics of Lung Cancer Mimicking Organizing Pneumonia (ID 10476)
09:30 - 16:00 | Author(s): M. Tsuboi
- Abstract
Background:
Lung cancer mimicking organizing pneumonia (LCOP) is a novel radiological entity of lung adenocarcinoma that could be misdiagnosed as inflammatory lesions.. However, the characteristic biological and genetic features of LCOP are not fully clarified.
Method:
We used thin-section CT images to select cases of (LCOP) among surgically resected lung adenocarcinoma patients. We compared the clinicopathological characteristics and the immunophenotypes of LCOP (n = 44) and other lepidic-predominant adenocarcinomas (non-LCOP, n = 56). We also analyzed the genomic mutation features of LCOP (n = 4) by whole-exome sequencing (WES).
Result:
All LCOP lesions were lepidic-predominant invasive adenocarcinoma. Patients with LCOP had significantly superior recurrence-free survival, compared to non-LCOP patients (95.5% and 74.4%; P = 0.006, respectively). Vascular invasion and lymph node metastasis were less frequent in LCOP than in non-LCOP patients (P = 0.001 and P = 0.03, respectively). The cancer cell expression levels of aggressiveness-related molecules, including ezrin, ALDH-1, laminin-5 were similar between LCOP and non-LCOP. On the contrary, the number of tumor promoting stromal cells, i.e., podoplanin-positive cancer-associated fibroblasts and CD204-positive tumor associated macrophages, was significantly lower in LOCP (P = 0.021 and P = 0.037, respectively). WES revealed that ABCB1, DNAH3, MSI2, and SLITRK2 were specifically mutated in LCOP.
Conclusion:
Our results indicate that LCOP is characterized by fewer tumor-promoting stromal cells, which may contribute to the better prognosis of LCOP patients. Moreover, recognition of specific somatic mutations of LCOP patients may provide information regarding the development and progression of this type of lung cancer.
