Stereotactic Body Radiation Therapy
Conditions
Brief summary
The purpose of this study is to determine whether stereotactic radiosurgery combination with Anlotinib could improve the efficacy and outcomes for non-small cell lung cancer with limited brain metastases.
Detailed description
This is a retrospective study. The purpose of this study is to determine whether stereotactic radiosurgery combination with Anlotinib could improve the efficacy and outcomes for non-small cell lung cancer with limited brain metastases. Patients in Anlotinib group took Anlotinib 1 week before the MRI-based simulation，12mg/d QD，day1\ 14, 21d/cycle. Patients in SBRT group took no anti-angiogenic drugs. All patients received SBRT for brain metastases.
Interventions
DRUGAnlotinib
Anlotinib is a novel multi-target tyrosine Kinase inhibitor that inhibits VEGFR2/3, FGFR1-4, PDGFD α/β, c-Kit and Ret. Stereotactic Radiosurgery Stereotactic Radiosurgery as the initial treatment of non small cell lung cancer patients with limited brain metastases
Sponsors
Huashan Hospital
Tianjin Medical University
Peking University Third Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Inclusion criteria
1. Patients pathologically diagnosed as non-small cell lung cancer, with brain metastases and measurable lesions; 2. Patients aged between 18 -80 years; with expected survival time\>3 months. 3. Patients with no more than 5 brain metastases 4. Patients with normal organ function within 7 days prior to treatment, the following criteria are met: 1. blood routine examination criteria : i) hemoglobin (HB) ≥90g/L; ii) absolute neutrophil count (ANC) ≥1.5×10e9/L; iii) platelet (PLT) ≥80×10e9/L; b) biochemical tests meet the following criteria: i) total bilirubin (TBIL) ≤1.5 times of upper limit of normal (ULN); ii) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 ULN, if liver metastasis occurred, ALT and AST ≤5 ULN; iii) serum creatinine (Cr) ≤1.5 ULN or creatinine clearance (CCr) ≥60mL/min;
Exclusion criteria
1. Patients who had previously used antiangiogenic agents within 1 month; 2. Patients with small cell lung cancer (including small cell carcinoma and non-small cell carcinoma mixed lung cancer); 3. Patient with lung squamous cell carcinoma that involved pulmonary hilar, or non-small cell lung cancer with hemoptysis; 4. Patients with cerebral infarction and cerebral hemorrhage; 5. Patients without perilesional edema； 6. Patients with more than grade 2 (NCI-CTCAE v4.0) acute toxicity reaction due to any previous treatment. 7. Patients with factors that affect oral medication (such as cannot swallow, chronic diarrhea and intestinal obstruction, etc.); 8. Patients with visceral dissemination or severe symptoms, which could cause death in short term; 9. Patients with any other severe and/or uncontrolled disease; 10. Patients who received a surgery, a biopsy or a significant traumatic injury within 1 month; 11. Patients with any signs or medical history of bleeding, unhealed wounds, ulcers or fractures, regardless of the severity; 12. Patients underwent artery or venous thrombotic events within 2 months, such as deep vein thrombosis and pulmonary embolism; 13. Patients with a history of psychotropic medicine abuse and cannot quit or have mental disorders; 14. Patients with disease which will severely endanger their security and could not complete this study, according to the judgement of researchers；
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | 1 years | progression-free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS | 1 years | overall survival |
| ORR | 3 months | objective response rate |
| DCR | 3 months | disease control rate |
| iORR | 3 months | intracranial objective response rate |
| iPFS | 3 months | intracranial progression-free survival |
Countries
China
Outcome results
None listed