Synergistic Effect of Elemene Plus TKIs Compared With TKIs in EGFR-mutated Advanced NSCLC：Retrospective Study
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Registration Number
- NCT04397432
- Lead Sponsor
- Tian Xie
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 878
- 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.
- Accompanied by other active tumors.
- The researchers did not consider it appropriate to participate in this study for other reasons.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method DCR June 2021 Disease Control Rate (DCR) = Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) as defined by RECIST 1.1.
ECOG score June 2021 Eastern Cooperative Oncology Group (ECOG) performance status adopted the zubrod-ecog-who scoring standard.
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.
KPS score June 2021 Performance status were measured by Karnofsky Performance Scale (KPS).
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.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.
Trial Locations
- Locations (19)
Tongde Hospital of Zhejiang Province
🇨🇳Hangzhou, Zhejiang, China
Cancer Hospital Chinese Academy of Medical Sciences
🇨🇳Beijing, China
Chongqing University Cancer Hospital
🇨🇳Chongqing, China
Affiliated Hospital of Nantong University
🇨🇳Nantong, Jiangsu, China
The Second People's Hospital of Yangcheng County
🇨🇳Jincheng, Shanxi, China
Hangzhou Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China
Panjin Central Hospital
🇨🇳Panjin, Liaoning, China
Shenyang Tenth People's Hospital
🇨🇳Shenyang, Liaoning, China
Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital
🇨🇳Chendu, Sichuan, China
Zhejiang Hospital
🇨🇳Hangzhou, Zhejiang, China
Zhejiang Xiaoshan Hospital
🇨🇳Hangzhou, Zhejiang, China
Dongfang Hospital Beijing University of Chinese Medicine
🇨🇳Beijing, China
Hangzhouwan Hospital
🇨🇳Ningbo, Zhejiang, China
Cancer Hospital of Huanxing Chaoyang District Beijing
🇨🇳Beijing, China
Beijing Cancer Hospital
🇨🇳Beijing, China
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
🇨🇳Shanghai, China
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
🇨🇳Shanghai, China
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
🇨🇳Tianjin, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, China