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E.K. Cho
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MINI 17 - WT EGFR, Angiogenesis and OMD (ID 131)
- Event: WCLC 2015
- Type: Mini Oral
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:R. Feld, R. Dziadziuszko
- Coordinates: 9/08/2015, 16:45 - 18:15, Mile High Ballroom 4a-4f
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MINI17.06 - Subgroup Analysis of East Asian Patients in the Phase III REVEL Trial (ID 729)
16:45 - 18:15 | Author(s): E.K. Cho
- Abstract
- Presentation
Background:
The REVEL trial demonstrated that second-line treatment with ramucirumab (RAM) plus docetaxel (DOC) significantly improved overall survival (OS) compared to placebo (PBO) plus DOC in the intent-to-treat (ITT) population (N=1253) of patients with stage IV non-small cell lung cancer. The REVEL trial also significantly improved progression-free survival (PFS) and objective response rates (ORRs). Results from the East Asia (EA) subgroup (Taiwan and Korea) analysis are presented.
Methods:
Subgroup analyses were performed in the EA ITT population, which consisted of all patients who were randomized in Taiwan (n=27) and Korea (n=62). Endpoints evaluated in the EA subgroup were OS, PFS, ORR, and safety. OS and PFS were analyzed using the Kaplan-Meier method and Cox proportional hazard model. Response was compared using the Cochran-Mantel-Haenszel test. ClinicalTrials.gov number NCT01168973.
Results:
In the 89 ITT EA patients, median OS was 15.44 months for the RAM plus DOC arm (n=43) and 10.17 months for PBO plus DOC arm (n=46) (HR: 0.762, 95% CI: 0.444–1.307). Median PFS was 4.88 months for the RAM plus DOC arm and 2.79 months for the PBO plus DOC arm (HR: 0.658, 95% CI: 0.408–1.060). The ORRs were 25.6% (95% CI: 13.5–41.2) in the RAM plus DOC arm and 9% (95% CI: 2.4–20.8) in the PBO plus DOC arm. Approximately two years after the enrollment of the first patient, in May 2012, the independent data monitoring committee recommended a reduction in the dose of DOC from 75 mg/m[2] to 60 mg/m[2] for newly enrolled EA patients, based on a higher incidence of neutropenia and febrile neutropenia associated with 75 mg/m[2] in EA patients compared to non-EA patients. This amendment resulted in a reduction in the toxicity associated with the original treatment regimen (Table). Table: Select grade ≥3 treatment-emergent adverse events, regardless of causality, by treatment arm and DOC dose in EA patients
Data are n (%). *Consolidated term.Preferred term RAM plus DOC (75 mg/m[2]) (n = 32) PBO plus DOC (75 mg/m[2]) (n = 33) RAM plus DOC (60 mg/m[2]) (n = 11) PBO plus DOC (60 mg/m[2]) (n = 13) Any 31 (96.9) 26 (78.8) 6 (54.5) 7 (53.8) Neutropenia* 26 (81.3) 24 (72.7) 6 (54.5) 5 (38.5) Febrile neutropenia 14 (43.8) 4 (12.1) 0 1 (7.7)
Conclusion:
Although not statistically powered to demonstrate significant improvement, the improved OS, PFS, and ORR observed in the EA subgroup treated with RAM plus DOC is consistent with the treatment effect observed in the overall ITT population in the REVEL trial. A dose reduction in DOC from 75 mg/m[2] to 60 mg/m[2] was associated with an improved safety profile and a reduction in the incidence of febrile neutropenia in the EA subgroup.
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MINI 26 - Circulating Tumor Markers (ID 148)
- Event: WCLC 2015
- Type: Mini Oral
- Track: Biology, Pathology, and Molecular Testing
- Presentations: 1
- Moderators:M. Macmanus, C. Aggarwal
- Coordinates: 9/09/2015, 16:45 - 18:15, 205+207
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MINI26.11 - Longitudinal Monitoring of EGFR Mutations in Plasma of EGFR Mutant NSCLC Patients Treated with EGFR TKIs: Korean Lung Cancer Consortium (ID 1130)
16:45 - 18:15 | Author(s): E.K. Cho
- Abstract
- Presentation
Background:
Detection of epidermal growth factor receptor (EGFR) mutation in non-small cell lung cancer (NSCLC) patients is mainly based on tissue biopsy, which is invasive and time consuming. Furthermore, there is still a need for serial monitoring of EGFR mutations and detection of EGFR tyrosine kinase inhibitors (TKIs) resistance. We hypothesized that plasma-based EGFR mutation analysis may be feasible for monitoring response to EGFR TKIs and could be used to predict the resistance.
Methods:
From January 2012 to October 2014, 200 EGFR mutant NSCLC patients were enrolled and treated with EGFR TKIs (141 patients for gefitinib, 46 patients for erlotinib, and 13 patients for afatinib). Plasma samples were prospectively obtained every 2 months from baseline until disease progression. The longitudinally collected plasma samples (n = 368) from 81 patients who progressed were analyzed using droplet digital PCR (ddPCR). We identified an association between serial EGFR mutant titers in plasma cell-free DNA (cfDNA) samples and the patient’s clinical response to EGFR TKIs.
Results:
Of a total 58 baseline cfDNA samples available for ddPCR, 43 (74%) samples demonstrated same mutation in the matched tumors (i.e. sensitivity: 70.8% (17/24) for L858R vs 76.5% (26/34) for exon 19 deletions). The concordance rate of plasma with tissue results of EGFR mutation was 88% for L858R and 86% for exon 19 deletion, respectively. Of the 54 patients with both before and after treatment plasma samples, 40 patients showed a dramatic decrease of mutant copies (greater than 50%) in blood in the first 2 months after treatment. We also found the secondary mutation (T790M) emerged in 28 patients around 3~13 months after treatment and in 4 patients before the treatment. Elevated circulating mutations (L858R/ex19/T790M) can be detected in 5 patients before disease progression as determined by CT scan.
Conclusion:
These results suggest that ddPCR is an appropriate method for determining plasma-based EGFR mutation status and may aid in monitoring response to EGFR TKIs and early detection of EGFR TKIs resistance.
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P1.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 206)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/07/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P1.01-041 - Prognostic Significance of CT Emphysema Score in Patients with Advanced Squamous Cell Carcinoma of the Lung (ID 680)
09:30 - 17:00 | Author(s): E.K. Cho
- Abstract
Background:
Although the contribution of emphysema to lung cancer risk has been recognized, no study has focused the prognostic impact of CT emphysema score for advanced stage of lung cancer. The aim of our study was to analyze the prognostic value of CT emphysema score in patients with advanced squamous cell carcinoma of the lung (SCCL).
Methods:
We analyzed 84 consecutive patients with advanced stage (stage IIIB and IV) of SCCL who underwent palliative chemotherapy. The severity of emphysema was semi-quantitatively scored using baseline chest CT images according to the Goddard scoring system, ranging from 0 to 24. Data on clinical characteristics and survival were retrospectively collected. Survival was estimated by the Kaplan-Meier method and compared with the log-rank test. A multivariable Cox proportional hazard model was used to identify prognostic factors.
Results:
Most patients were male (89%) and current/ex-smokers (90%). The median CT emphysema score was five (range, 0 to 22). In univariable analysis, patients with higher CT emphysema score (> 6) showed a trend toward poor survival (6.3 months vs. 11.4 months in those with lower score, p=0.076). In the multivariable model, higher CT emphysema score was a significant independent prognostic factor for poor survival (HR,1.85; 95% CI, 1.14 to 3.00; p=0.012) along with response to first-line therapy (p=0.001) and second-line therapy (p<0.001).
Conclusion:
The CT emphysema score is significantly associated with poor prognosis in patients with advanced SCCL.
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P1.07 - Poster Session/ Small Cell Lung Cancer (ID 221)
- Event: WCLC 2015
- Type: Poster
- Track: Small Cell Lung Cancer
- Presentations: 1
- Moderators:
- Coordinates: 9/07/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P1.07-008 - Preliminary Results from a Phase Ib/II Trial of Belotecan plus Ifosfamide in Patients with Extensive-Stage Small-Cell Lung Cancer (ID 1325)
09:30 - 17:00 | Author(s): E.K. Cho
- Abstract
Background:
Belotecan is a novel camptothecin analogue, topoisomerase I inhibitor. Belotecan, alone or in combination with cisplatin, has shown activity in small cell lung cancer. The objective of the phase Ib part was to determine the maximum tolerated dose (MTD) and safety of belotecan plus ifosfamide in patients with extensive-stage small-cell lung cancer.
Methods:
Patients with age ≥ 18 years, no previous chemotherapy, measurable disease, ECOG PS 0-2, and adequate organ function were eligible. The phase Ib portion of the trial is a conventional 3+3 dose-escalation design. The following dose levels (belotecan/ifosfamide, mg/m[2]) were explored: 0.5 x 4d/1200 x 2d (level 1), 0.5 x 4d/1000 x 3d (level 2, starting dose), 0.5 x 4d/1000 x 4d (level 3), 0.5 x 5d/1000 x 4d (level 4), and 0.5 x 5d/1000 x 5d (level 5) every 21 days.
Results:
Here we report the phase Ib portion of the trial. Thirteen patients were enrolled and completed at least one cycle. The median age is 68 years (range, 48-77). ECOG PS was 0/1/2:1/6/6, respectively. A total of 53 cycles (median, 5; range, 1-6) of chemotherapy were administered. The MTD was belotecan 0.5 mg/m[2] on days 1-4 in combination with ifosfamide 1000 mg/m[2] on days 1-4 (level 3). Three patients experienced dose-limiting toxicities; death from neutropenic sepsis and grade 3 fatigue at dose level 4, and febrile neutropenia at dose level 3. The most frequent grade 3-4 toxicities were myelosuppression, including neutropenia (54%), anemia (23%), and febrile neutropenia (23%). Eleven patients were evaluable for response and 9 (82%) had partial responses.
Conclusion:
The combination of bleotecan and ifosfamide is feasible and active. The recommended phase II dose is belotecan 0.5 mg/m[2] on days 1-4 and ifosfamide 1000 mg/m[2] on days 1-4 of a 21-day cycle. The phase II trial is currently ongoing. Clinical trial information:NCT01784107.
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P2.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 207)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P2.01-009 - EGFR Mutation and Brain Metastasis in Patients with Non Small Cell Lung Cancer (ID 407)
09:30 - 17:00 | Author(s): E.K. Cho
- Abstract
Background:
It has been demonstrated that lung cancer is the most common cause of brain metastases(BM). This study was designed to analyse the association of timing and survival of BM according to histology and epidermal growth factor receptor (EGFR) mutation status in patients with metastatic nonsmall cell lung cancer (NSLCL).
Methods:
We retrospectively analysed the medical records of 268 patients with NSCLC in single center in Incheon, Korea who were tested for EGFR mutation analysis from January 2010 to August 2013. We analysed the cumulative incidence of BM regard to EGFR mutation status, the time from the diagnosis to the development of BM, the time from BM to death and median survival. Survival was estimated by the Kaplan-Meier method and compared with the log-rank test.
Results:
Out of 268 patients, 74 (28%) had BM, 54(73%) patients already at the time of diagnosis. Synchronous BM was more frequent in patient with EGFR mutation than WT EGFR patient (79% vs. 69%). But patients with metachronous BM, time to BM diagnosis was not significantly different according to EGFR status. (p=0.298) Among the 67 patients with BM, 25(37%) had mutations in EGFR, including 13 exon 19 deletions and 12 L858R mutations and 40 had WT (60%). The time from diagnosis of first brain metastases to death(BM-OS) was significantly longer in patient with EGFR mutation than WT (22.28 vs. 7.55 month, p<0.005). The BM-OS in EGFR mutated patients with synchronous BM was longer than in EGFR WT patients (25.42 vs. 8.86 month, p<0.005). But the BM-OS in EGFR mutated patients with metachronous BM was not significant different from WT EGFR patients. (p=0.16).
Conclusion:
NSCLC patients with EGFR mutations were more prevalent with synchronous BM than those with EGFR WT patients. EGFR mutation was associated with significantly longer survival from BM diagnosis, especially in those with synchronous BM.
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P2.02 - Poster Session/ Treatment of Localized Disease – NSCLC (ID 210)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Localized Disease - NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P2.02-040 - Clinical Outcome of Fiducial-Less CyberKnife Stereotactic Ablative Body Radiotherapy for Stage I Non-Small Cell Lung Cancer (ID 1221)
09:30 - 17:00 | Author(s): E.K. Cho
- Abstract
Background:
CyberKnife[TM] is a dedicated system for radiosurgery, with a capability of real-time tumor tracking; Synchrony[®] Respiratory tracking system. Xsight[®] lung tracking system with Synchrony[®] Respiratory tracking system make possible direct lung tumor tracking without fiducial markers. However, there was no establised indication of fiducial-less Cyberknife Radiosurgery (CKRS). So, to ascertain whether indication of fiducial-less CKRS can be extended or not , we had evaluated treatment outcome of fiducial-less CKRS using Xsight[®] lung tracking system at AMC and tested accuracy of CyberKnife Xsight[®] lung tracking system without fiducial marker by phantom experiment. Here are the results of fiducial-less CKRS using Xsight[®] lung tracking system for stage I NSCLC.
Methods:
From June 2011 to November 2013, 58 patients received Cyberknife Radiosurgery to lung at Asan medical center. We retrospectively reviewed records of 44 patients of stage I lung cancer exclude 14 patients (6 with Advanced NSCLC, 6 with Rec. lung cancer within 5 years, 2 with lung metastasis from other primary cancer). All analyses were performed using SPSS, version 21.
Results:
Median age at diagnosis was 75 years. Man was 37 (84.1%). Most of patients were inoperable primary lung cancer with poor PFT (mean FEV1: 63.0 % (range 24-138%), mean DLCo : 50.8 % (range 43- 96 %)) or comorbidity or old age. Clinical stage was IA in 30 (68.2 %), IB in 14 (31.8 %) patients. Mean tumor size was 2.6 cm. (1.2 cm-4.8cm, smaller than 2 cm was 12 (27.3%)) Radiation dose were 48 – 60 Gy per 3 - 4 fx. With median follow-up of 23.1 months, there were LR in 3 patients ( 1Y LRFSR : 94.9%, 2Y LRFSR : 90.4% ) and DM in 13 patients (DM only, n= 7). All patients tolerated the radiosurgery well, only 2 patients had grade 3 dyspnea (1 of 2 suffered from ILD aggravation). Most common complication was RT-induced fibrosis & pneumonitis. Eight patients have died due to cancer progression.(1Y OSR : 86%, 2Y OSR : 80.3%)
Conclusion:
Fiducial-less cyberknife radiosurgery showed good local tumor control and survival in medically inoperable stage I NSCLC, which was comparable with that of linac-based stereotactic body radiosurgery or CKRS with fiducial marker. Even though there were some limitations to apply Xsight [®] lung tracking system without fiducial marker, but it could be used safely in relatively small tumor located in not recommended site.
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P2.07 - Poster Session/ Small Cell Lung Cancer (ID 222)
- Event: WCLC 2015
- Type: Poster
- Track: Small Cell Lung Cancer
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P2.07-017 - Body Composition Analysis Using Computed Tomography in Patients with Small Cell Lung Cancer (ID 2542)
09:30 - 17:00 | Author(s): E.K. Cho
- Abstract
Background:
Although the clinical significance of body composition has been recognized as associated with performance status and prognoses for solid tumors, no study has specifically evaluated baseline body composition in detail using computed tomography (CT) images for patients with small cell lung cancer (SCLC).
Methods:
We analyzed skeletal muscle mass and fat mass in 150 patients with pathologically proven SCLC between January 2010 and November 2014 in our institution. Cross-sectional areas of skeletal muscle (Hounsfield unit, HU ranges -29 to 150) and fat tissue (HU, -190 to -30) were measured on the level of 3rd lumbar vertebra using the baseline CT images. Data on clinical characteristics were retrospectively collected.
Results:
Mean age was 69 ± 9 years (85.3% were male). At the time of diagnosis, mean body mass index (BMI) was 22.1, with 40.7% of patients being overweight or obese (BMI ≥ 23). Only 16.7% overall were underweight as conventionally understood (BMI < 18.5). The overall prevalence of severe muscle depletion (sarcopenia) was 53.3% and was present in patients in all BMI categories (84.0% in underweight patients, 45.2% in overweight and obese patients). A much higher proportion of men (60.2%) than women (13.6%) met the criteria of sarcopenia.
Conclusion:
Wasting of skeletal muscle is a prominent feature of patients with small cell lung cancer, despite normal or heavy body weights.
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P3.03 - Poster Session/ Treatment of Locoregional Disease – NSCLC (ID 214)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Locoregional Disease – NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P3.03-020 - Outcomes of Concurrent Chemoradiotherapy in Elderly Patients with Stage III Non-Small Cell Lung Cancer (ID 2252)
09:30 - 17:00 | Author(s): E.K. Cho
- Abstract
Background:
The aim of this study was to assess the outcomes of concurrent chemoradiotherapy(CCRT) in elderly patients with stage III non-small cell lung cancer(NSCLC), focusing on the survival outcomes, prognostic factors and toxicities.
Methods:
From January 2006 to May 2012, 39 elderly patients older than 60 years (median 68 years; range 62~78 years) with stage III NSCLC were enrolled in this study. Radiotherapy (RT) was administered to the primary tumor and regional lymph nodes with concomitant administration of chemotherapy. The total RT dose was 46.8-79 Gy in daily 1.8-2.5 Gy fractions (median 66.6 Gy). Overall survival (OS) and progression free survival (PFS) were estimated with the Kaplan-Meyer method. Prognostic factors (gender, age, smoking, pathology, ECOG performance status, body weight, RT dose and tumor response) were analyzed by the log-rank test and Cox regression model. Acute toxicities were assessed according to Radiation therapy oncology group(RTOG) criteria.
Results:
The median follow-up period was 18.4 months. The 1, 2 and 3-year overall survival(OS) rates were 61.5%, 41.0% and 30.8%, respectively. The 1, 2 and 3-year progression free survival(PFS) rates were 51.7%, 30.0% and 21.8%, respectively. Multivariable analysis showed that ECOG performance status(p=0.002) and tumor response(p=0.001) significantly influenced OS. The tumor response(p=0.013) was a significant prognostic factor for PFS in multivariable analysis. The grade 3 or higher radiation pneumonitis and esophagitis were developed in 9 (23.1%) and 4 (10.3%) patients. Neutropenia with grade 3 or higher was developed in 8 patients (20.8%).
Conclusion:
Survival (OS and PFS) of elderly patients with stage III NSCLC treated with CCRT is significantly affected by tumor response. However, the survival outcomes for elderly patients with stage III NSCLC treated with CCRT showed comparable results with previous reports. The CCRT related toxicity such as pneumonitis and neutropenia were relatively higher. These results means that CCRT is effective in increasing survival, however, the careful selection of elderly NSCLC patients for CCRT is also required.
