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The goal of this retrospective real-world study is to evaluate the effectiveness and safety of first-line osimertinib combined with early intracranial stereotactic radiotherapy (SRT) in patients with EGFR-mutant non-small cell lung cancer (NSCLC) with symptomatic brain metastases. Eligible patients include adults with stage IV EGFR-mutant NSCLC who received first-line osimertinib monotherapy and early intracranial SRT. Data will be extracted from hospital medical records across multiple centers. The primary endpoint is real-world progression-free survival (rwPFS). Secondary endpoints include overall survival (OS), rwPFS2, time to next treatment or death (TTNT), and time to treatment discontinuation or death (TTD). Exploratory endpoints include CNS progression patterns, CNS progression-free survival (CNS PFS), CNS objective response rate (CNS ORR), and incidence of symptomatic CNS radiation necrosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First-line osimertinib plus early intracranial SRT | Patients receiving first-line osimertinib combined with early intracranial stereotactic radiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Osimertinib | Drug | Eligible patients received first-line osimertinib monotherapy for systemic treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Real-world Progression-Free Survival (rwPFS) | The time from index date (i.e. first-line initiation) until documented disease progression or death, whichever occurs first. Any patient not known to have progressed or died at the time of analysis will have rwPFS censored at the date of last assessment showing no progression. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | The time from index date until death due to any cause. Any patient not known to have died at the time of analysis will have OS censored at the date they were last known to be alive. | 5 years |
| rwPFS2 |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will include Stage IV EGFR-mutant NSCLC patients with symptomatic brain metastases who were initially treated with first-line Osimertinib and upfront intracranial SRT during the enrollment period meeting the inclusion and exclusion criteria. First-line therapy must be initated within 6 weeks after initial diagnosis of stage IV EGFRm NSCLC. The patients will be collected across multiple centers in China.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Shanghai | China | 200032 | China | ||
| Wuhan Tongji Hospital |
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| intracranial stereotactic radiotherapy | Radiation | Early intracranial stereotactic radiotherapy (SRT) was administered for brain metastases before disease progression on first-line osimertinib. Treatment and follow-up data were collected retrospectively from hospital medical records. |
|
The time from index date to the earliest of the progression event (following the initial investigator-assessed progression) after first subsequent therapy, or death. Any patient not known to have progressed on first subsequent therapy or died at the time of analysis will have rwPFS2 censored at the date of last assessment showing no progression.
| 5 years |
| TTNT (Time to Next Treatment or Death) | The time from index date to the start date of the first subsequent treatment or death, whichever occurs first. Any patient not known to have a subsequent treatment or died at the time of analysis will have TTNT cencored at the date of last follow-up without a record of new treatment. | 5 years |
| TTD (Time to Treatment Discontinuation or Death) | The time from first-line Osimertinib iniation to discontinuation due to any reason or death, whichever occurs first. Any patient not known to have discontinued first-line Osimertinib or died at the time of analysis will have TTD censored based on the last recorded date on which the patient was known to be on treatment.. | 5 years |
| Wuhan |
| Hubei |
| China |
| Shanghai Jiao Tong University Affiliated Chest Hospital | Shanghai | China |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000596361 | osimertinib |
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