The Short-term Efficacy Of β-elemene Injection Combined With Radiotherapy In Treatment For Non-small Cell Lung Cancer Patients With Brain Metastasis

Background:Lung cancer is the most common malignant tumor. Nowadays, both its morbidity and mortality rank first in all of the malignant tumor, and 80% of it is the non-small cell lung cancer(NSCLC). The brain metastasis is the common cause of the treatment failure in the non-small cell lung cancer patients. Nowadays the whole brain radiation therapy (WBRT) is the standard treatment for these patients.β-elemene injection is the new anti-cancer drug developed by our Chinese. Some studies showβ-elemene injection has the sensitizing effect combined with the external radiation and has the protective effect to normal cell.Purpose:The study combined the the whole brain radiation therapy (WBRT) with theβ-elemene injection to treat non small cell lung cancer patients with brain metastasis, then evaluate the short-term efficacy, the symptom improvement, and the side effect.Method:The clinic data of 19 NSCLC patients with brain metastases and stable extracranial lesions from July 2009 to December 2009 were randomly assigned into combined treatment group(8 cases) and radiation alone group(7 cases). The patients of the radiation alone group accepted the radiation therapy for 4 weeks(2Gy each day,5day a week, for 4 weeks, total dose 40Gy), and then into the assessment phase. The patients of the combined treatment group accepted the WBRT for 4 weeks as the radiation alone group, and accepted the first cycleβ-elemene injection therapy (20mg/kg·d, each day,5day a week, for 4 weeks) at the same time. After two weeks" rest(the fifth and sixth weeks), the combined treatment group accepted the second cycleβ-elemene injection therapy for another 4weeks(the7th week to the 10th week). Then we evaluated the control rate of at the 12th weeks, and analysed the relationship with the sex, age, number of brain metastases, and the histological type respectively. And observed the changes of the main symptom,the tumor mark(CEA and CA125),the Quality of life,and the adverse events during the progress.Result:The control rates (PR+CR+SD)of intracranial lesion are similar in the two groups, but the remission rates (PR+CR) are different. The combined treatment group's remission rate (62.5%) is significantly higher then the radiation alone group's (18.2%), P=0.045, there is statistically significant meaning.The subgroup analyses shows femal or young patients have the good remission rate and the control rates of intracranial lesion. The number of brain metastases, and the histological type are not significantly related to the good remission rate and the control rates of intracranial lesion.The combined treatment group has the more better control function (decrease or stablize) to the tumor markers(CEA,CA125), especially the CEA.The main symptoms in both groups improved, and the changes in the Quality of life, the adverse events are not statistically significant.Conclusion:1.From this prospective, randomized, controlled study, we know that combining the WBRT with theβ-elemene injection therapy can improve the short-term intracranial remission rate (PR+CR) for the NSCLC patients with mutable brain metastases, but the control rate of intracranial lesion is relatively stable.The subgroup analyses shows the femal or young patients have the good remission rate and the control rates of intracranial lesion. The number of brain metastases, and the histological type are not significantly related to the good remission rate and the control rates intracranial lesion.3.The combined treatment group has the more better control function (decrease or stablize) to the tumor markers(CEA,CA125), especially the CEA. 4.The main symptoms in both groups improved, and the changes in the Quality of life, the adverse events are not statistically significant.