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.
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.
Study Type
OBSERVATIONAL
Enrollment
878
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
Panjin Central Hospital
Panjin, Liaoning, China
OS
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.
Time frame: June 2021
PFS
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.
Time frame: June 2021
ORR
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.
Time frame: June 2021
DCR
Disease Control Rate (DCR) = Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) as defined by RECIST 1.1.
Time frame: June 2021
KPS score
Performance status were measured by Karnofsky Performance Scale (KPS).
Time frame: June 2021
ECOG score
Eastern Cooperative Oncology Group (ECOG) performance status adopted the zubrod-ecog-who scoring standard.
Time frame: June 2021
Incidence and severity of AE or SAE
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.
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Shenyang Tenth People's Hospital
Shenyang, Liaoning, China
The Second People's Hospital of Yangcheng County
Jincheng, Shanxi, China
Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Hangzhou Cancer Hospital
Hangzhou, Zhejiang, China
Tongde Hospital of Zhejiang Province
Hangzhou, Zhejiang, China
Zhejiang Hospital
Hangzhou, Zhejiang, China
Zhejiang Xiaoshan Hospital
Hangzhou, Zhejiang, China
Hangzhouwan Hospital
Ningbo, Zhejiang, China
...and 9 more locations
Time frame: Start of treatment until 30 days after the last dose.