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J. He
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Poster Display Session (ID 63)
- Event: ELCC 2017
- Type: Poster Display Session
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 5/07/2017, 12:30 - 13:00, Hall 1
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142TiP - A prospective multi-center study to investigate the EGFR-TKI resistance profile, treatment algorithm and clinical outcome in Chinese patients with advanced EGFRm+ NSCLC who have received prior first generation EGFR TKI (PRECENT study, CCTC-1601, NCT02988141) (ID 280)
12:30 - 13:00 | Author(s): J. He
- Abstract
Background:
The resistance mechanism is impactful to make treatment strategy after prior first generation epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) failure and the profile has well established in western population; while without solid data among Asian population. In addition, methods used in determining previously reported resistance profiles are flawed in failing to detect concomitant or heterogeneous mechanisms. High throughput next-generation sequencing (NGS), which allows parallel multiplex genotyping with tissue or plasma sample, can help in addressing these issues. Furthermore, little was known about the treatment algorithms and clinical outcomes of different mechanisms in China. Thus, the study aims to investigate the resistance mechanism, treatment strategy and clinical outcome for those patients with prior EGFR-TKI in China.
Trial design:
We are going to perform a prospective, multi-center study to obtain: a) the biomarker profile of EGFR-TKI acquired resistance detected based on paired tissue and blood respectively; b) concordance of T790M detection by NGS in blood sample with that in tissue sample as reference; c) the clinical outcomes (ORR, DCR, PFS of subsequent treatment and OS) of patients with different resistance mechanisms by NGS in tissue samples and blood samples. All the paired re-biopsy tissue and blood samples will be collected and subjected to NGS panel testing by central lab. Treatment strategy will be summarized and described. The assessment will be performed every 6 weeks until objective disease progression as defined by RECIST1.1. Survival follow-up will be conducted every 6 weeks until death, lost to follow-up, withdrawal of consent or the DCO (data cut off). A sample size of 100 patients will provide 80% power to detect at least 1 case of resistance mechanism with a proportion of 1.5% and a precision of 9% for an assumed concordance 70% of T790M mutation between tissue and blood samples. First subject will be enrolled in Feb 2017.
Clinical trial identification:
NCT02988141
Legal entity responsible for the study:
Guangdong Association of Thoracic Disease (China)
Funding:
AstraZeneca
Disclosure:
L. Zhang: Member on an advisory board and receives lecture fees from AstraZeneca. All other authors have declared no conflicts of interest.
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SCLC and early stage NSCLC (ID 62)
- Event: ELCC 2017
- Type: Proffered Paper session
- Track:
- Presentations: 1
- Moderators:S. Popat, P. Van Schil
- Coordinates: 5/07/2017, 09:00 - 10:30, Room C
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59O - The impact of EGFR mutations on the prognosis of resected non-small cell lung cancer: A meta-analysis of literatures (ID 372)
09:00 - 10:30 | Author(s): J. He
- Abstract
- Presentation
Background:
Epidermal growth factor receptor (EGFR) mutation represents a favorable prognostic factor in advanced-stage non-small cell lung cancer (NSCLC), which is predominantly contributed by its good response to EGFR-tyrosine kinase inhibitor. However, its impact on the prognosis of resectable NSCLC after complete surgery, which more closely reflects its natural course, remains controversial. Diverse results have been reported partially due to the small sample size of these studies; small studies bring bias especially in postoperative setting. Therefore, we sought to pool all current evidence to show the true effects.
Methods:
Electronic databases were searched for eligible studies. The primary endpoint was disease free survival (DFS), which will be less influenced by subsequent treatments after recurrence. The DFS between EGFR mutated and wild-type patients were compared with special interest in stage I patients who are rarely subjected to adjuvant therapy. In addition, DFS of patients with 19 exon deletion (19del) and 21 exon L858R mutation (L858R) were compared. Random effects models were used.
Results:
A total of 13 studies involving 2,652 cases were included; 1033 (39.0%) patients were EGFR-mutated, 47.7% were 19del and 44.1% were L858R. Most studies detected EGFR mutations with PCR-based methods. The DFS of EGFR-mutated patients were similar to wild type patients in overall population (HR 0.87, 95% CI 0.65 to 1.16) and stage I subgroup (HR 0.82, 95% CI 0.40 to 1.69). DFS of 19del patients was potentially inferior to L858R patients but the difference was not significant (HR 1.38, 95% CI 0.76 to 2.52).
Conclusions:
EGFR-mutated patients showed no significant difference in postoperative disease-free survival compared with wild-type resected NSCLC. There is still no sufficient evidence to support different postoperative treatment strategy (especially for stage I) for mutated and wild-type patients. However, 19del might be an adverse factor through indirect reasoning, which might require more intensive management. Thus, we strongly encouraged reporting specific prognostic impacts of different mutation types compared with wild-type patients in the following studies.
Clinical trial identification:
Legal entity responsible for the study:
The clinical research center of the first affiliated hospital of Guangzhou Medical Univeristy
Funding:
The 1st Affiliated Hospital of Guangzhou Medical University, Guangzhou, China
Disclosure:
All authors have declared no conflicts of interest.
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