This study is a prospective, national, multi-center, non-interventional study. The main purpose is to explore the initial adjuvant treatment pattern after radical resection for early-stage NSCLC patients with EGFR Mutation-Positive in the real world. The secondary purpose was to observe the postoperative follow-up treatment pattern and its subgroups (based on different EGFR mutation status and different clinical stages).
About 2,000 eNSCLC patients who received radical resection from about 50 research centers across the country will be included in this study, and will be followed up to 2 years after enrollment according to the actual clinical situation. The analysis method of this study is mainly based on descriptive statistics. The information about the human genetic resources of the subjects to be collected includes: demography, physical examination, WHO fitness status, medical history, smoking history, disease characteristics, surgical information, initial and follow-up adjuvant treatment pattern, laboratory tests, survival status, and adverse events related to gefitinib/osimertinib, serious adverse events/non-severe ADR, measures taken for adverse events, outcome of adverse events.
Study Type
OBSERVATIONAL
Enrollment
1,490
Surgeries
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Beijing Chest Hospital，Capital Medical university
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Peking University People'S Hospital
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
The distribution of participants with initial adjuvant treatment pattern after radical resection surgery for early-stage NSCLC patients
Descriptive summary statistics ( total number of cases, number of missing cases, frequency, and percentage of each category) were used to describe the distribution of participants with initial adjuvant treatment patterns, including chemical, targeted, combined, or other therapy. Set subgroup analysis for different initial adjuvant treatment pattern, including different clinical stages (according to phase I/ Phase II/ stage III) and different EGFR mutation status (19del or 21 L858R);
Time frame: 2 years
Time on initial adjuvant treatment
Calculate the time from the start date to the end of initial adjuvant treatment. The total number of cases, number of missing cases, mean, standard deviation, median, 25th and 75th percentiles, minimum and maximum were used for statistical description.
Time frame: 2 years
The interval from the date of operation to the start date of initial adjuvant therapy with EGFR-TKI.
Calculate the interval of operation to the adjuvant therapy with EGFR-TKI, which is classified into single-drug therapy and combined therapy. The total number of cases, number of missing cases, mean, standard deviation, median, 25th and 75th percentiles, minimum and maximum were used for statistical description.
Time frame: 2 years
Numbers of therapy cycles of initial adjuvant treatment
The patients with chemotherapy were mainly calculated, divided into chemotherapy and targeted combination chemotherapy. The total number of chemotherapy cycles, the number of missing cases, the mean, standard deviation, the median, the 25th and 75th percentiles, the minimum and the maximum were statistically described
Time frame: 2 years
The distribution of participants with follow-up treatment pattern after initial adjuvant treatment.
Descriptive summary statistics ( total number of cases, number of missing cases, frequency, and percentage of each category) were used to describe the distribution of participants with follow-up treatment patterns after advanced events evaluated by an investigator, including chemical, targeted, combined, or other therapy. Set subgroup analysis for different follow-up treatment pattern including different clinical stages (according to phase I/ Phase II/ stage III) and different EGFR mutation status (19del or 21 L858R);
Time frame: 2 years
Time on follow-up treatment
Calculate the time from the start date to the end of follow-up treatment. The results are shown in months, to one decimal place. The total number of cases, number of missing cases, mean, standard deviation, median, 25th and 75th percentiles, minimum and maximum were used for statistical description.
Time frame: 2 years
The interval from the date of operation to the start date of the follow-up treatment with EGFR-TKI.
Calculate the interval of operation to the follow-up treatment with EGFR-TKI, which is classified into single-drug therapy and combined therapy. The results are shown in months, to one decimal place. The total number of cases, number of missing cases, mean, standard deviation, median, 25th and 75th percentiles, minimum and maximum were used for statistical description.
Time frame: 2 years
Numbers of therapy cycles of follow-up treatment
The patients with chemotherapy of follow-up treatment were mainly calculated, divided into chemotherapy and targeted combination chemotherapy. The total number of chemotherapy cycles, the number of missing cases, the mean, standard deviation, the median, the 25th and 75th percentiles, the minimum and the maximum were statistically described
Time frame: 2 years
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Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China
Fujian Provincial Hospital
Fuzhou, Fujian, China
Cancer Center of Guangzhou Medical university
Guangzhou, Guangdong, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
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