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Qing Chang
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EP1.01 - Advanced NSCLC (ID 150)
- Event: WCLC 2019
- Type: E-Poster Viewing in the Exhibit Hall
- Track: Advanced NSCLC
- Presentations: 1
- Now Available
- Moderators:
- Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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EP1.01-65 - The Relationship Between Preliminary Efficacy and Prognosis After First-Line EGFR-TKI Treatment of Advanced NSCLC (Now Available) (ID 711)
08:00 - 18:00 | Author(s): Qing Chang
- Abstract
Background
Nowadays, patients with EGFR-TKI-sensitive advanced non-small cell lung cancer (NSCLC) receive EGFR tyrosine kinase inhibitors (EGFR-TKIs) as first-line treatment. We aimed to analyze the relationship between preliminary efficacy (tumor shrinkage within 1 month) and progression-free survival (PFS) after first-line EGFR-TKI treatment.
Method
A total of 82 patients with EGFR-TKI-sensitive advanced NSCLC confirmed by histopathology from January 2013 to January 2017 were retrospectively analyzed. All patients received first-line EGFR-TKI treatment and follow-up at Shanghai Chest Hospital.
Result
Of 82 patients, 42 (51.2%) patients achieved partial response (PR) within 1 month, and 40 (48.8%) patients achieved stable disease (SD: -30%~0) within 1 month. The median PFS among all patients was 10 months. The median PFS in patients achieving PR within 1 month was 10 months. The median PFS in patients achieving SD (-30%~0) within 1 month was 9.3 months. There was no statistically significant difference between PR within 1 month and SD (-30%~0) within 1 month (P=0.620). In the EGFR-sensitive mutation subgroup, there was also no statistically significant difference between PR within 1 month and SD (-30%~0) within 1 month. Univariate and multivariate analysis of first-line EGFR-TKI treatment showed that age, EGFR mutation type, and T staging had effects on PFS. Patients who were more than 65 years old, had EGFR 19del mutation, along with a T staging less than 4, had a longer PFS; these differences were statistically significant. Liver metastasis, bone metastasis, and brain metastasis were not shown to be related to PFS.
Conclusion
For patients with EGFR-TKI-sensitive advanced NSCLC, there is no correlation between preliminary efficacy (tumor shrinkage within 1 month) and PFS after first-line EGFR-TKI treatment.
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P2.01 - Advanced NSCLC (ID 159)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Advanced NSCLC
- Presentations: 1
- Now Available
- Moderators:
- Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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P2.01-31 - Preliminary Results of Second Generation ALK Inhibitor PLB1003: A Phase La Study (Now Available) (ID 1741)
10:15 - 18:15 | Author(s): Qing Chang
- Abstract
Background
ALK rearrangements have been described in approximately 4-5% of patients with non-squamous non-small cell lung cancer (NSCLC). Crizotinib is initially effective in the treatment of ALK-rearranged NSCLC, but the disease eventually progresses. PLB1003, a high-efficiency second generation ALK inhibitor, was developed due to the increased resistance of EML4-ALK fusion genes. Preclinical data show that PLB1003 is safe and effective in cell-based assays and Crizotinib-resistant animal models. This is the ongoing phase Ia study of PLB1003.
Method
An open-label, multicenter phase I clinical trial was conducted in patients with locally advanced or metastatic NSCLC who had previously failed or were intolerable to Crizotinib or chemotherapy. It consisted of dose-escalation cohorts and dose-expansion cohorts. In the dose-escalation cohorts, patients were orally given 50-500mg/d of PLB1003 at 6 dose levels . In each cohort, patients' plasma were collected for pharmacokinetic evaluation. The safety, tolerability, pharmacokinetics, maximum tolerated dose (MTD), dose limiting toxicities (DLT) and recommended phase 2 dose (RP2D) of PLB1003 were determined.
Result
A total of 21 patients were enrolled in dose-escalation cohorts as of 31 August 2018. The dose-escalation cohort is ongoing at the dose of 200 and 250 mg BID. A lipase elevation of DLT event was observed at 250 mg BID. MTD has not been reached in this study. Additionally, the most common treatment-emergent adverse events (TEAEs) (>10%) were grade1/2, including: (1) gastrointestinal toxicities: diarrhea (24%), vomiting (14%); (2) hepatotoxicity: increased GGT (g-glutamyltransferase) (48%), increased ALP (33%), elevated ALT (43%) and AST (33%); (3) others: increased blood glucose level (43%), hyperuricemia (24%), increased creatinine (19%), anemia (19%), hypercholesterolemia (14%). All the treatment-related adverse events (TRAEs) were reversible. TRAEs of grade 3, increasing of GGT (-glutamyl transferase) (33%), alkaline phosphatase (10%) and lipase (10%) , mostly appeared during 7-13 weeks of initial study. Patients all recovered from TRAEs of grade 3 with symptomatic treatments. Among the 14 evaluable patients in ≥200mg/d cohorts, 10 patients had PR (71%), 2 patients had SD (14%), and the disease control rate (DCR) was 86%. Among the 7 patients who progressed with previous treatment of Crizotinib, 5 patients had PR (71%), 1 patient had SD (14%), and the DCR was 86%.
Conclusion
PLB1003 is safe, tolerable and has potential clinical benefit to locally advanced or metastatic NSCLC patients with ALK rearrangement mutation and had disease progression or were intolerable to previously treatment of Crizotinib or chemtherapy. (ClinicalTrials.gov number, NCT03130881)
