Carcinoma, Non-Small-Cell Lung
Conditions
Keywords
Elemene, TKI, EGFR, Real world study
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.
Interventions
None listed
Sponsors
LinkDoc Technology (Beijing) Co. Ltd.
Tian Xie
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Histologically or cytologically confirmed advanced non-small cell lung cancer(stage IIIB\ IV). 2. Patients with EGFR mutation. 3. Received EGFR-TKIs at least once. 4. Received Elemene Injectable Emulsion and/or Elemene Oral Emulsion at least once ( only for Elemene plus TKIs group). 5. Completeness of important outcome measures and medical records related to the study.
Exclusion criteria
1. Accompanied by other active tumors. 2. The researchers did not consider it appropriate to participate in this study for other reasons.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| OS | 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
| Measure | Time frame | Description |
|---|---|---|
| ORR | June 2021 | ORR was defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) based on RECIST 1.1. |
| DCR | June 2021 | Disease Control Rate (DCR) = Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) as defined by RECIST 1.1. |
| PFS | June 2021 | PFS was defined as the interval from date of the administration of the first-dose TKIs to the date of first evidence of disease progression or death, whichever occurs first. Disease progression was defined according to RECIST 1.1. |
| ECOG score | June 2021 | Eastern Cooperative Oncology Group (ECOG) performance status adopted the zubrod-ecog-who scoring standard. |
| Incidence and severity of AE or SAE | Start of treatment until 30 days after the last dose. | Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. A serious adverse event (experience) or reaction is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. |
| KPS score | June 2021 | Performance status were measured by Karnofsky Performance Scale (KPS). |
Countries
China
Outcome results
None listed