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Z. Qiong
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MA 03 - Chemotherapy (ID 651)
- Event: WCLC 2017
- Type: Mini Oral
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:Jin-Hyoung Kang, W. Su
- Coordinates: 10/16/2017, 11:00 - 12:30, Room 502
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MA 03.03 - Nedaplatin plus Docetaxel versus Cisplatin plus Docetaxel as First-Line Chemotherapy for Advanced Squamous Cell Carcinoma of the Lung (ID 8154)
11:10 - 11:15 | Author(s): Z. Qiong
- Abstract
- Presentation
Background:
A previous phase III randomized trial improved overall survival of patients with advanced or relapsed squamous cell lung carcinoma, compared with cisplatin plus docetaxel. However, evaluation of nedaplatin plus docetaxel’s effect on progression free survival (PFS) and time to progression (TTP) was limited.
Method:
To compare the efficacy and safety of nedaplatin plus docetaxel and cisplatin plus docetaxel. In this randomized, open-label, multicenter trial, patients diagnosed with advanced or relapsed squamous cell carcinoma pathologically or cytologically were enrolled in China. All the patients have no previous oncology medication. Patients were randomly assigned (1:1) to 80 mg/m² nedaplatin and 75 mg/m² docetaxel intravenously, or 75 mg/m² cisplatin and 75 mg/m² docetaxel, every 3 weeks for four cycles. The primary end points was PFS. Secondary endpoints included TTP and best overall response. The efficacy endpoint were analyzed in the intention-to-treat set and in the per protocol set. （Clinical trial number: NCT02088515; Funding:Jiangsu Simcere Pharmaceutical Co., Ltd.）
Result:
From December 2013 to December 2015, 286 patients were randomly assigned. Two hundred and eighty patients were included in the modified intention-to-treat analysis (141 in the nedaplatin group and 139 in the cisplatin group). In the intention-to-treat analysis set, median PFS was 4.63 months (95% confidence interval (CI), 4.43-5.10) in the nedaplatin group and 4.23 months (95% CI, 3.37-4.53) in the cisplatin group. PFS did not differ significantly between two groups (log-rank test, p =0.056). In per protocol set, PFS was significantly longer in the nedaplatin group (median 4.63 months, 95% CI, 4.43-5.10) than in the cisplatin group (median 4.27 months, 95% CI, 3.37-4.53; hazard ratio 0.760, 95% CI 0.585-0.989; p=0.039, log-rank test). Best overall response and TTP were improved in nedaplatin group than in cisplatin group (p= 0.002, median 4.57(4.30-4.80) vs 3.67(3.13-4.43) p= 0.020, respectively) in the intention-to-treat analysis set. Grade III or IV adverse events was more frequent in the cisplatin group than in the nedaplatin group (46 of 141 patients in the nedaplatin group and 62 of 139 in the cisplatin group, p=0.039). Grade 3 or worse nausea (0 vs 7) and fatigue (1 vs 3) were more frequent in the cisplatin group than in the nedaplatin group.
Conclusion:
There was no significant difference of PFS between cisplatin group and nedaplatin group. However, more adverse events was observed in the cisplatin group than in the nedaplatin group. Nedaplatin plus docetaxel could be a new treatment option for advanced or relapsed squamous cell lung cancer.
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P3.01 - Advanced NSCLC (ID 621)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 10/18/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P3.01-031 - ctDNA Assessment of EGFR Mutation Status in Chinese Patients with Advanced Non–Small-Cell Lung Cancer in Read World Setting (ID 9173)
09:30 - 09:30 | Author(s): Z. Qiong
- Abstract
Background:
EGFR mutation in plasma circulating free tumor-derived DNA (ctDNA) by ARMS methods has been widely used in clinical settings in China. However, the prevalence of EGFR mutations in ctDNA was still unknown in the real world. This large-scale study (NCT02623257) aimed to explore the prevalence of EGFR mutations and determine the correlation of EGFR mutation status with clinical characteristics.
Method:
Plasma DNA samples from 721 patients with stage III/IV NSCLC who received ≤1 line chemotherapy were collected from 65 hospitals. EGFR mutations were tested by ARMS method. The EGFR mutation rate was calculated and the associations between EGFR mutant and patients’ demographic data, disease status as well as treatment pattern were explored.
Result:
EGFR mutations were detected in 176 of 721 (24.4%) patients, 165 of 620 (26.6%) in adenocarcinoma and 8 of 85 (9.4%) in squamous carcinoma. 138 (19.1%) harbored sensitizing mutations (66 19del, 62 L858R, 7 G719X, 2 L861Q, and 1 S768I) alone, 20 (2.8%) had resistance mutations (13 T790M, 7 Ins20) alone, 2 (0.3%) had a combination of activating mutations, and 16 (2.2%) had a combination of activating and resistance mutations. Twenty-eight (3.8%) patients were detected de novo T790M mutation either existed alone or combination, but no difference of clinical characteristics was observed. Higher detection rate was observed in 566 chemotherapy-naïve patients than in 155 patients received 1[st] line chemotherapy (27.2% versus 14.2%; p<0.001). Of which, the mutation rate of exon 19 deletion was 11.3% for naïve patients and 8.4% for the patients with 1[st] line chemotherapy; while the mutation rate of L858R decreased most obviously from 11.9%(naïve) to 1.9%(1[st] line). We also noticed 117 patients had ≥ 2 organ metastases and the mutation rate was 35.0% in these patients. Multivariate analysis showed female, chemotherapy native, or patients with ≥2 metastatic organs had higher percentage of EGFR mutation. Additionally, in 194 patients who had the follow-up treatment records, 34 of 49 patients (69.4%) with sensitive EGFR mutations received EGFR-TKI, 96 of 136 (70.6%) patients without sensitive EGFR mutation received chemo±radiation.
Conclusion:
Using plasma samples to detect EGFR mutation is feasible. ctDNA based EGFR mutation test could be a surrogate when tissue biopsy is not available due to limited tissue availability and procedural feasibility.
