Synergistic Real-world Study and Evidence-based Medicine Evaluation of Elemene Combined With Tyrosine Kinase Inhibitors（TKIs）in the Treatment of Advanced Non-small Cell Lung Cancer（NSCLC）：Retrospective Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Sponsor
- Tian Xie
- Enrollment
- 878
- Locations
- 19
- Primary Endpoint
- OS
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
This is a nationwide, multicenter and retrospective cohort study. The purpose of this study is to evaluate the synergistic effect and safety of Elemene plus TKIs in EGFR-mutated advanced non-small cell lung cancer.
Detailed Description
About 9.2%-45.8% of Chinese patients with Non-small cell lung cancer were positive for EGFR gene mutation. Gefitinib, Erlotinib, Icotinib, Afatinib showed efficacy superior to that of chemotherapy in the treatment of EGFR mutation positive advanced NSCLC, and lower rates of serious adverse events. However, after a median of 8 to 13 months of disease control, patients ultimately progress due to acquired resistance of EGFR-TKIs. Elemene, a chemotherapeutic isolated from the Chinese medicinal herb Rhizoma Zedoariae, has been shown to have a comprehensive anti-tumor effect and the potential effect on reversing drug resistance. The study is a real-world study and the case records of patients with advanced non-small cell lung cancer who visited the research centers from January 2014 to December 2017 and met the inclusion criteria will be collected. Medical data including patient demographic, tumor characteristics, laboratory examination, history of treatments, adverse reactions, and so on will be extracted to evaluate the synergistic effect and safety of Elemene plus TKIs in EGFR-mutated advanced non-small cell lung cancer.
Investigators
Tian Xie
Professor
Hangzhou Normal University
Eligibility Criteria
Inclusion Criteria
- •Histologically or cytologically confirmed advanced non-small cell lung cancer(stage IIIB\~IV).
- •Patients with EGFR mutation.
- •Received EGFR-TKIs at least once.
- •Received Elemene Injectable Emulsion and/or Elemene Oral Emulsion at least once ( only for Elemene plus TKIs group).
- •Completeness of important outcome measures and medical records related to the study.
Exclusion Criteria
- •Accompanied by other active tumors.
- •The researchers did not consider it appropriate to participate in this study for other reasons.
Outcomes
Primary Outcomes
OS
Time Frame: June 2021
OS was defined as the interval from the date of the administration of the first-dose TKIs to date of death from any cause, or the date of last known follow-up alive.
Secondary Outcomes
- DCR(June 2021)
- ECOG score(June 2021)
- ORR(June 2021)
- KPS score(June 2021)
- Incidence and severity of AE or SAE(Start of treatment until 30 days after the last dose.)
- PFS(June 2021)