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Junling Li
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P2.01 - Advanced NSCLC (ID 618)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Advanced NSCLC
- Presentations: 2
- Moderators:
- Coordinates: 10/17/2017, 09:00 - 16:00, Exhibit Hall (Hall B + C)
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P2.01-029 - Real World Report of Clinical Outcomes of Bevacizumab in First-Line or Later-Line Treatment for Patients with Advanced NSCLC (ID 8999)
09:00 - 09:00 | Author(s): Junling Li
- Abstract
Background:
Bevacizumab combined therapy has been demonstrated superior efficacy and well tolerability in first-line and later-line treatment by various scales of prospective control trials. But it is still lack of direct evidence endorsing bevacizumab as first-line (1L) over later-line (LL) use.
Method:
We retrospectively evaluated the effectiveness of bevacizumab contained therapy as 1L or LL treatment in patients with advanced NSCLC. Primary outcome was progression-free survival (PFS), and the secondary objectives were objective response rate (ORR), disease control rate (DCR) and safety. Subsequently, an exploratory analysis was conducted in subgroups regarding to patients drive genes status including EGFR and ALK.
Result:
From Jul. 2009 to Dec. 2016, a total of 159 patients with NSCLC were enrolled. Baseline characteristics were well balanced between 1L and LL groups. The median follow-up time was 10.7 months. Comparing to LL, the median PFS in 1L was significant longer (9.7 months vs 4.1 months, HR=0.28, 95% CI 0.15-0.52, P＜0.0001). Short term effects of ORR and DCR both had improved trends in 1L than LL. Interestingly in subgroups, WT group (median PFS 11.3 vs 3.4 months, HR 0.2, 95% CI 0.08-0.48, P<0.0001) and WT+UN group (median PFS 11.3 vs 3.4 months, HR 0.25, 95% CI 0.12- 0.51, P<0.0001) had better effectiveness as 1L than LL over the whole population. The ORR and DCR had consistently similar response in subgroups comparison (Table 1). There was no unexpected safety issue documented. Figure 1
Conclusion:
Although it was limited in retrospective design, this precious real world evidence indeed exhibited superior clinical effectiveness in first-line use of bevacizumab indicating a better choice rather than later line use, particularly to EGFR&ALK wild type or unknown patients.
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P2.01-033 - Leptomeningeal Metastasis from Non-Small Cell Lung Cancer: A Single Center Experience in Chinese Patients (ID 9187)
09:00 - 09:00 | Presenting Author(s): Junling Li
- Abstract
Background:
Leptomeningeal carcinomatosis（LM）is a rare type of metastatic tumors of the central nervous system. In recent years, with the improvement of neoplasms therapies and longer survival of patients by better systemic control , incidence of LM has increased every year.The incidence of LM in patients with non-small cell lung cancer（NSCLC） ranges from 1%-5%.However, no standard therapy has been established yet.This study is to investigate the clinical characteristics and prognostic factors of LM from NSCLC and to develop better treatment strategies.
Method:
We collected and reviewed retrospectively the clinical characteristics,treatment methods as well as the outcomes of 45 consecutive patients with LM from NSCLC diagnosed and treated in our hospital from 2002 to 2017.Survival rates were analyzed using the Kaplan-Meier method.The multi-variate Cox proportional hazards model was used to determine the independent prognostic factors associated with improved survival.
Result:
Figure 1Among 45 patients who were enrolled, 7(15.6%) had EGFR 19 deletion, 2(4.4%) had EGFR 20 mutation, 22(48.9%) had EGFR 21 mutation, 1(2.2%) had EGFR 18 and also EGFR 20 mutation(T790M negative), 2(4.4%) were ALK-positive, 5(11.1%) were EGFR wild-type, 6(13.3%) patients didn't perform EGFR test. The median overall survival from the diagnosis of LM for all the patients was 15（range, 1–34）months. Gender, gene mutation and Tyrosine kinase Inhibitors (TKIs) treatment were correlated with survival time for the patients(P<0.05 for all). Other prognostic variables such as age, initial ECOG, time to leptomeningeal dissemination, CSF cytology, CSF pressure, CSF biochemical, brain radiotherapy, chemotherapy and intrathecal chemotherapy were not statistically correlated to overall survival. In the multivariate analysis, Cox proportional hazard regression showed that TKIs treatment was the independent prognostic factor(P<0.05).
Conclusion:
TKIs treatment was the independent prognostic factor for leptomeningeal metastases from non-smalll cell lung cancer. We suggest that in LM patients from NSCLC giving TKIs treatment may prolong survival.
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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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P2.04-003 - Phase II Trial of X-396 (Ensartinib) for Chinese Patients with ALK (+) Non–Small-Cell Lung Cancer Who Progressed on Crizotinib (ID 8849)
09:30 - 09:30 | Author(s): Junling Li
- Abstract
Background:
Crizotinib has been established as the standard first-line treatment for patients with ALK-rearranged non-small-cell lung cancer. However, despite its superiority to chemotherapy, resistance occurs within approximately 12 months. New ALK-inhibitors are needed to overcome the resistance to crizotinib and to increase drug penetration to CNS. X-396 (ensartinib) is a novel, potent ALK tyrosine kinase inhibitor (TKI). Its phase I/II study showed X-396 is well-tolerated with favorable anti-tumor activities in both ALK TKI-naïve and crizotinib-resistant NSCLC patients, as well as patients with CNS metastases. The recommended phase II dose (RP2D) was established at 225 mg, once daily.
Method:
A phase II, multi-center study is evaluating the efficacy and safety of single-agent X-396 in Chinese patients with ALK (+) non–small-cell lung cancer after progression on crizotinib. Eligible patients will have documentation of a positive ALK rearrangement and progression on crizotinib. X-396 225 mg is orally administered until disease progression or intolerable toxicity. The primary endpoint is RECIST 1.1 response rate. Secondary endpoints include PFS, duration of response, and safety. The sample size is calculated using the test for inequality method, assuming that X396 have an ORR of 50% in patients with ALK-positive NSCLC, 15% higher than that from existing second-line therapy. Therefore, up to 144 patients will be enrolled with a significance level and power of 5% and 90%, respectively. Recruitment will be started on September, 2017.
Result:
Section not applicable
Conclusion:
Section not applicable
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P3.04 - Clinical Design, Statistics and Clinical Trials (ID 720)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Clinical Design, Statistics and Clinical Trials
- Presentations: 1
- Moderators:
- Coordinates: 10/18/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P3.04-007 - A Prospective Study of Apatinib in Advanced Small Cell Lung Cancer Patients Failed from Two or More Lines of Chemotherapy (ID 10041)
09:30 - 09:30 | Author(s): Junling Li
- Abstract
Background:
Small cell lung cancer (SCLC) is an aggressive and invasive variant of lung tumors，and its treatment strategy is poor. Apatinib is an oral TKI against VEGFR-2. We determined the efficacy of Apatinib as third- or later-line treatment in advanced SCLC.
Method:
The study was expected to enroll 30 patients diagnosed with advanced SCLC. Patients received oral Apatinib 500mg QD and make an efficacy evaluation after first cycle, then every two cycles once again. The primary endpoint was progression-free-survival (PFS).
Result:
From November 10, 2016 to June 18, 2017, 10 patients were enrolled. 1 patient showed PR when make efficacy evaluation the first time, 8 patients were evaluated SD and 1 patient showed PD due to liver metastasis. Although only one patient showed PR, all the patients’ target lesions were reduced, as figure 1. Figure 1 Up to June 18, 4 patients out of the group due to PD, the PFS is 28 weeks, 19.8 weeks, 13 weeks and 4.7 weeks respectively. Another 6 patients are still investigated, as figure 2, the blue bars are their PFS . Figure 2
Conclusion:
Apatinib in advanced SCLC is worth expecting.To further investigate the role of Apatinib in SCLC patients, large sample and additional clinical trials are needed.
