| Background: The non-small cell lung cancer(NSCLC)patients with multiple brain metastases have a worse prognosis.Whole brain radiotherapy(WBRT)plus simultaneous in-field boost is an effective approach for the NSCLC patients with multiple brain metastases and prolong the survival of those patients.However,the adverse reactions of radiation brain injury after radiotherapy,such as headache,nausea,vomiting and cognitive impairment,seriously affect the quality of life of patients.Objective: To observe the clinical efficacy and safety of whole brain radiotherapy plus simultaneous in-field boost combined with endostatin in the treatment of NSCLC with multiple brain metastases,and provid e a safe and effective treatment for NSCLC patients with multiple brain metastases.Methods: 1.Case selection and grouping: After screening by inclusion and exclusion criteria,the clinical data of 96 NSCLC patients with multiple brain metastases admitted to the Department of Oncology,Renmin Hospital,Hubei University of Medicine were retrospectively analyzed.All patients were treated with WBRT plus simultaneous in-field boost combined with endostatin or WBRT plus simultaneous in-field boost only.The patients were divided into the combined treatment and radiotherapy group according to the different treatment methods.2.Evaluation criteria of curative effect and observation indexes: The short-term curative effect was evaluated 8 weeks after the completio n of radiotherapy,and the patients have an MRI scan every 3 months.The efficacy was evaluated according to the response evaluation criteria in solid tumours.Objective response rate(O RR),disease control rate(DC R),intracranial local progression-free survival(i LPFS)and overall survival(OS)were evaluated.C hi-square test or Fisher ’s exact test was used to compare differences in constituent ratios or rates.Kaplan-Meier method and log-rank test were performed for i LPFS and OS analysis.3.Safety evaluation: The safety evaluation mainly included the manifestations of acute radiation brain injury and late radiation brain injury,and the changes in quality of life before radiotherapy and 2 months after treatment.The main adverse reactions observed in the acute phase were dizziness,headache,nausea and vomiting,and deterioration of pre-existing neurologic symptoms.The changes of cognitive dysfunction were measured by mini-mental state examination(MMSE)in patients with late radiation brain injury.The quality of life(Qol)of patients was assessed according to the QOL scale for cancer patients formulated by C hina in 1990.Wicoxon rank-sum test was used to compare the difference of scale scores before and after treatment in the same group,and Mann-Whitney U test was performed to compare the difference of scale scores before and after treatment between the two groups.4.Prognostic analysis: Prognostic factors of long-term survival in patients were analyzed by univariate and multivariate Cox regression model.Results: There was no significant difference in demographic data and clinical characteristics between the two groups before treatment,and the data of the two groups after treatment were comparable.1.There was no significant difference in median o verall survival(m OS)between the two groups(337 vs 313 days,P=0.06>0.05).The median intracranial local progression-free survival(mi LPFS)of all patients was 202 days.The mi LPFS of the combined treatment group was higher than that of the simple radiot herapy group and the difference was statistically significant(223 vs 189 days,P<0.01).There were no significant differences in ORR(78.4% vs 75.6%,P=0.738)and DCR(98.0% vs 95.6%,P=0.598)between two groups.2.Safety evaluation: After the addition o f endostatin,the incidence of dizziness,headache and deterioration of existing neurological symptoms in patients had a downtrend,but with no significant difference.The incidence of nausea and vomiting was significantly reduced in the combined treatment group(25.5% vs 51.1%,P=0.01<0.05).Most of the adverse reactions in the two groups were grade 1 and grade 2,and most of them were relieved after symptomatic treatment.During the treatment and follow-up,no intracranial hemorrhage occurred in the two groups,and no radiation brain necrosis was found in the clinical and imaging follow-up of all patients.Although the MMSE score of the treatment group was lower than that of the combined treatment group(25.96±1.93 vs26.63±1.33)six months after the end o f treatment,the difference was not significant.(P=0.059>0.05).Two months after the completion of treatment,the Q OL score of the simple treatment group was significantly lower than that of the combined treatment group(45.27±4.94 vs 47.35±2.94,P=0.025<0.05).3.Prognostic analysis: Univariate Cox regression analysis showed that the hazard ratio(HR)of treatment method was 0.679(95% CI: 0.447-1.030,P=0.068>0.05),and the addition of recombinant human endostatin did not improve the survival of patients.As expected,age,KPS score,GPA score,and extracranial metastasis were important prognostic factors.Multivariate Cox regression analysis showed that KPS score,GPA score and extracranial metastasis were the independent factors affecting the survival o f patients.KPS score [HR=0.294,95% CI:(0.171-0.504)] and GPA score [HR=0.483,95%CI:(0.234-0.999)] were protective factors.While,extracranial metastasis [HR=2.975,95% CI:(1.716-5.159)] was a risk factor.Conclusion: 1.The patients treated with WBRT plus simultaneous in-field boost combined with endostatin exhibited better short-term effects and prolonged intracranial local progression-free suivival but with no improvement in the overall survival.2.WBRT plus simultaneous in-field boost combined with endostatin was beneficial to reduce the incidence of acute radiation brain injury and did not increase the incidence of intracranial hemorrhage.Although it did not reduce the cognitive decline in patients,it could improve the quality of life of patie nts.It showed a benefit in NSCLC patients with multiple brain metastases.3.KPS score,GPA score and extracranial metastasis were the independent factors affecting the survival time of NSCLC patients with multiple brain metastases. |
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