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J.H. Kang
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MA16 - Novel Strategies in Targeted Therapy (ID 407)
- Event: WCLC 2016
- Type: Mini Oral Session
- Track: Chemotherapy/Targeted Therapy/Immunotherapy
- Presentations: 1
- Moderators:G. Purkalne, J. Von Pawel
- Coordinates: 12/07/2016, 14:20 - 15:50, Strauss 2
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MA16.05 - For EGFR Mutant Non-Small Cell Lung Cancer, Treatment Sequence Matters? (ID 5678)
14:20 - 15:50 | Author(s): J.H. Kang
- Abstract
- Presentation
Background:
EGFR tyrosine kinase (TKI) showed better progression free survival (PFS) in EGFR-mutant non-small cell lung cancer (NSCLC), but the overall survival (OS) benefit were not clear so far. Treatment sequence may contribute to OS, but there are little data so far. We aimed to analyze the impact of treatment sequence of EGFR TKI and chemotherapy on outcomes in EGFR-mutant NSCLC.
Methods:
Among NSCLC patients who had EGFR exon 18–21 mutation test results between 2009 and 2014 at Seoul St. Mary’s Hospital, 114 patients who had recurrent or metastatic disease, EGFR mutation positive excluding T790M mutation, and received both EGFR tyrosine kinase inhibitor (TKI) and chemotherapy as the 1[st] or 2[nd] line of treatment were included. Patients were categorized into two groups according to the treatment sequence: 1[st] line EGFR TKI followed by chemotherapy (group A), 1[st] line chemotherapy followed by EGFR TKI (group B). The median follow-up duration was 64.6 (15.8–202.8) months.
Results:
Among total 114 patients, 69 patients received EGFR TKI first and then chemotherapy (group A), and the remaining 45 patients received vice versa (group B). Group A was younger (P = 0.029) and less frequently received platinum-doublet agents than Group B (P <0.001). Performance status and EGFR mutation status were not different. Overall response or disease control rate were significantly better for EGFR TKI comparing to chemotherapy regardless of treatment sequence. However, PFS on both treatment were longer in group B (P = 0.008), especially for patients with exon 19 deletion (P = 0.002). On multivariate analyses, performance status (P = 0.006 for PFS, P <0.001 for OS) and treatment sequence [hazard ratio (HR) = 0.027, P = 0.027 for PFS; HR = 0.64, P = 0.065 for OS] were related to prognosis.
Conclusion:
For exon 19 deletion subtype of EGFR-mutant NSCLC patients, the sequence of cytotoxic chemotherapy followed by EGFR TKI showed better PFS comparing with the reverse sequence, EGFR TKI followed by cytotoxic chemotherapy . We will present the data from larger cohorts the WCLC meeting.
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P1.06 - Poster Session with Presenters Present (ID 458)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/05/2016, 14:30 - 15:45, Hall B (Poster Area)
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P1.06-024 - Distinctive Patterns of Primary Metastases and Clinical Outcomes According to the Histological Subtypes in Stage IV Non-Small Cell Lung Cancer (ID 3963)
14:30 - 15:45 | Author(s): J.H. Kang
- Abstract
Background:
The purpose of this study was to compare the primary patterns of metastases and clinical outcomes between adenocarcinoma (Adenoca) and squamous cell carcinoma (SQ) in initially diagnosed stage IV Non-small cell lung cancer (NSCLC).
Methods:
Between June 2007 and June 2013, a total of 427 eligible patients were analyzed. These patients were histologically confirmed as Adenoca or SQ and underwent systemic imaging studies, including 18F-fluorodeoxyglucose positron emission tomography/computed tomography and brain imaging. Synchronous metastatic sites were categorized into 7 areas, and whole-body metastatic scores were calculated from 1 to 7 by summation of each involved region. We compared the patient, tumor, and metastatic characteristics according to the histological subtypes, and examined clinical outcomes.
Results:
The enrolled study cohort comprised 81% (n=346) Adenoca patients and 19% (n=81) SQ patients. The median age of the study population was 65 years (range, 30–94 years), and 263 (61.6%) patients were male. The most common metastatic sites were thoracic lymph nodes (LNs) (84.3%), followed by lung to lung/lymphangitic spread (59%) and bone (54.8%). The distribution of patient characteristics revealed that age 65 years (69.1% vs 50.6%; P=0.003) and male sex (84% vs 56.4%; P<0.001) were more frequently found in SQ patients. Regarding metastatic features, bone metastasis (60.4% vs 30.9%; P<0.001), lung to lung/lymphangitic metastasis (63% vs 42%; P=0.001), and brain metastasis (35% vs 16%; P=0.001) were significantly and more frequently found in Adenoca patients. Patients with high metastatic scores (score 3–6) were more frequently found to have Adenoca (91.6% vs 73.4%; P<0.001). In multivariate prognostic evaluation, sex (P=0.001), age (P<0.001), histology (P<0.001), LN status (P=0.032), pleural/pericardial metastasis (P=0.003), abdomen/pelvis metastasis (P<0.001), axilla/neck metastasis (P=0.006), and treatment factors (P<0.001) remained independent prognostic factors affecting overall survival.
Conclusion:
We observed distinctive patterns of primary metastases and clinical outcomes according to the histological subtypes in stage IV NSCLC. Future studies need to disclose the underlying mechanism of these unique metastatic features and tumor biologies.
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P2.05 - Poster Session with Presenters Present (ID 463)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Radiotherapy
- Presentations: 1
- Moderators:
- Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)
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P2.05-021 - Stereotactic Radiosurgery for Brain Metastasis in Non-Small Cell Lung Cancer: Predictor of Intracranial Progression (ID 6266)
14:30 - 15:45 | Author(s): J.H. Kang
- Abstract
Background:
Stereotactic radiosurgery (SRS) has been introduced for small-sized single and oligo-metastases in the brain. The aim of this study is to assess treatment outcome, efficacy, and prognostic variables associated with survival and intracranial recurrence.
Methods:
This study retrospectively reviewed 123 targets in 64 patients with non-small cell lung cancer (NSCLC) treated with SRS between January 2006 and December 2012. All patients underwent SRS with 2000~3000cGy/1~3Fx for each brain metastasis as a initial treatment or salvage treatment for recurrence after whole brain RT. Median target number and size were 2 targets and 1cm in diameter. Every patient was evaluated according to Eastern Cooperative Oncology Group (ECOG) performance status, RPA class, number and size of brain metastasis and other systemic metastasisdisease staus before SRS. We evaluated overall survival (OS), local tumor control and intracranial progression free survival rate (IPFS) of patients. We also evaluated quality of life immediate after SRS.Treatment responses were evaluated using magnetic resonance imaging.
Results:
The median follow-up was 13.9 months. The median OS and IPFS were 14.1 and 8.9 months, respectively. Fifty-seven patients died during the follow-up period. The 5-year local control rate was achieved in 85% of 108 evaluated targets. The 1- and 2-year OS rates were 55% and 28%, respectively. On univariate analysis, primary disease control (p < 0.001), the Eastern Cooperative Oncology Group (ECOG) performance status (0 or 1 vs. 2; p = 0.002), recursive partitioning analysis class (1 vs. 2; p = 0.001), and age (<65 vs. ≥65 years; p = 0.036) were significant predictive factors for OS. Primary disease control (p = 0.041) and ECOG status (p = 0.017) were the significant prognostic factors for IPFS. Four patients experienced radiation necrosis and no other neurocoginitive deficit by SRS was reported within follow up duration.
Conclusion:
SRS is a safe and effective local treatment for brain metastases in patients with NSCLC. Uncontrolled primary lung disease and ECOG status were significant predictors of OS and intracranial failure. SRS might be a tailored treatment option along with careful follow-up of the intracranial and primary lung disease status. Omission of WBRT can be option for patient with primary disease controlled and better ECOG with close image follow up.
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P3.02b - Poster Session with Presenters Present (ID 494)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 2
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
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P3.02b-053 - A Randomized, Open Label, Phase II Study Comparing Pemetrexed plus Cisplatin versus Pemetrexed Alone in EGFR Mutant NSCLC after EGFR-TKI: QOL Data (ID 5401)
14:30 - 15:45 | Author(s): J.H. Kang
- Abstract
Background:
Various therapeutic strategies are available for NSCLC patients who develop disease progression on first-line EGFR-TKI. Platinum doublet is usually recommended, however, it has not been established which cytotoxic regimens are preferable for these patients. We conducted a prospective randomized phase II trial to compare the clinical outcomes between pemetrexed plus ciplatin combination therapy with pemetrexed monotherapy after failure of first-line EGFR-TKI.
Methods:
Patients with non-squamous NSCLC harboring activating EGFR mutation who have progressed on first-line EGFR-TKI were randomly assigned in a ratio of 1:1 to pemetrexed plus cisplatin or pemetrexed alone. Patients were treated with pemetrexed 500 mg/m[2] and cisplatin 70 mg/m[2] for four cycles, followed by maintenance pemetrexed as single agent every 3 weeks or treated with pemetrexed 500 mg/m[2] monotherapy every 3 weeks until progression. Primary objective wasPFS, and secondary objectives include overall response rate (ORR), OS, health-related quality of life (HRQOL), safety and toxicity profile. The HRQOL was assessed every 2 cycles by using EORTC QLQ-C30 and EORTC QLQ-LC13.
Results:
96 patients were randomized and 91 patients were treated at 14 centers in Korea. The characteristics of pemetrexed plus cisplatin (PC) arm (N=48) and pemetrexed alone (P) arm (N=48) were well balanced; the median age was 60 vs. 64 years old; 37 vs. 33 patients were females; 39 vs. 43 patients were ECOG PS 1. The ORR of PC arm (N=46) was 34.8% (16/46), while P arm (N=45) was 17.8% (8/45). With 20.4 (range 4.1-33.4) months of follow-up, the median PFS was 5.4 months (95% confidence interval [CI], 4.5-6.3) in PC arm and 6.4 months (95% CI, 3.6-9.2) in P arm (p=.313). One-year survival rate was 77% for PC arm, 68% for P arm, respectively. The most common adverse events include anorexia (N=34, 37.4%), nausea (N=24, 26.4%), neuropathy (N=10, 11.0%) and skin change (N=10, 11.0%). Adverse events ≥ Grade 3 were in 12 patients (26.1%) in PC arm and 8 patients (17.8%) in P arm. Dose reduction (5 vs. 2 patients) and dose delay (10 vs. 4 patients) were required more often in PC arm. With 385 pairs of questionnaire of EORTC QLQ-C30 and QLO-LC13 obtained from 94 patients, overall, the time trends of HRQOL were not significantly different between two arms. Further analysis of survival data will be updated.
Conclusion:
Pemetrexed plus cisplatin combination therapy showed higher response rate than pemetrexed monotherapy without significant difference in PFS. There was no significant difference in quality of life between two arms.
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P3.02b-072 - A Multicenter Phase II Study of Gefitinib in Squamous NSCLC Patients Who Failed First-Line Chemotherapy (ID 4320)
14:30 - 15:45 | Author(s): J.H. Kang
- Abstract
Background:
The role of EGFR tyrosine-kinase inhibitors in the second-line for patients with squamous non-small-cell lung cancer (NSCLC) remains unclear. We conducted a prospective phase II study to assess use of gefitinib in patients with squamous NSCLC as second-line chemotherapy, and investigated the predictive and prognostic value of a proteomic signature using VeriStrat test.
Methods:
Between December 2011 and October 2015, 56 patients with histologically confirmed, second-line, Stage IIIB or IV NSCLC were enrolled in 9 centres in Republic of Korea. Patients were treated with gefitinib (250 mg per day orally). The proteomic test classification was masked for patients and investigators. The primary end point was disease control rate (DCR) at 8-weeks, and the secondary end points included toxicity, progression-free survival (PFS), overall survival (OS), and correlation between the serum proteomic test classification and treatment. This study is registered with ClinicalTrials.gov, number NCT01485809.
Results:
The median age was 69 years (range, 41-83) and 55 (98%) patients were male, and 49 (88%) had an ECOG PS of 1. Fifty five (98%) of patients had received platinum-based chemotherapy. The DCR at 8 weeks was 50.0% (95% confidence interval [CI] 34.8-63.4). With a median follow-up of 5.5 months, the median PFS and OS were 2.8 (95% CI 1.3-4.3) and 6.4 (5.4-7.4) months, respectively. The most common adverse event were rash (16 [29%]) and diarrhea (14 [25%]). Pretreatment plasma was available for 50 samples, and VeriStrat testing was successful in 45 samples (90%) with 71% classified as Good. The median PFS were 3.2 (95% CI 1.9-4.7) and 2.4 (1.5-3.3) months for VeriStrat Good vs. Poor patients, respectively (p=0.639). The median OS of VeriStrat Good was longer than those of VeriStrat Poor (11.4 [5.7-17.0] vs 4.8 [2.5-7.0] months), which was not statistically significant (p=0.052).
Conclusion:
These data suggest that gefitinib is modest activity as second-line chemotherapy in patients with squamous NSCLC. Serum proteomic test using VeriStrat is not prognostic for both OS and PFS among squamous NSCLC patients treated with gefitinib.
