ABSTRACT
Objective To analyze the efficacy and safety of hypofractionated stereotactic radiotherapy ( FSRT ) combined with temozolomide ( TMZ ) for large brain metastases ( BMs ) in a prospective phaseⅡclinical trial.Methods From 2010 to 2015, a total of 33 patients were enrolled as subjects.The median Karnofsky Performance Status scores before and after treatment were 70 and 80, respectively.The major primary tumor was non-small cell lung cancer (57.6%).The brain metastasis had a diameter of≥3 cm or a volume of ≥6 cm3 .The radiation dose was 52 Gy in 13 fractions or 52.2 Gy in 15 fractions.Patients received TMZ at a dose of 75 mg/m2 per day concurrently.The radiotherapy was followed by 6 cycles of adjuvant treatment with TMZ (150 mg/m2, days 1-5, 28 days per cycle).Patients were reexamined by magnetic resonance imaging ( MRI) during the treatment.The radiation field would be shrunk if the gross target volume ( GTV) was reduced by≥20%.The treatment outcomes were evaluated by MRI at 2-3 months after treatment.Results The total numbers of tumors and GTVs were 95 and 38, respectively. Twenty-four (63%) out of the 38 GTVs had a volume larger than 10 cm3 and the median GTV was 15.3 cm3 (5.7-142.8 cm3).Twenty-two (67%) out of the 33 patients achieved field shrinking during the treatment, and the median reduction rate of GTV was 44%( 21%-88%) .The median total dose was 59.5 Gy, and 100%and 21.2%of patients completed the concurrent and adjuvant treatment with TMZ, respectively.In all patients, the overall response rate was 97.0%;the 1-year local control, intracranial progression-free survival, and overall survival rates were 97%, 70%, and 62%, respectively;the median survival time was 15.3 months.The main adverse reactions were grade 1-2 nausea and vomiting.One patient got grade 3 liver function impairment.Conclusions FSRT combined with TMZ is a safe and effective approach for treating large BMs.More than 50%of patients can achieve field shrinking to shorten treatment duration and reduce toxicity.Clinical Trial Registry ClinicalTrials.gov,registration number:NCT02654106.
ABSTRACT
Background and purpose: Radiation therapy is still the most primary treatment of brain metastases, and prognosis is affected by many factors. The aim of this study was to identify the prognostic factors and to establish a prognostic index model in patients with brain metastases after whole-brain radiotherapy (WBRT). Methods: We reviewed the clinical date of 140 patients with brain metastases radiotherapy in our hospital from Jan. 2008 to Jul. 2011. The signiifcance of prognostic variables in the survival was resulted from both univariate analysis and multivariate analysis. The prognostic index (PI) was established based on Cox regression analysis and subgrouping values. It was assessed whether recursive partitioning analysis classes (RPA), basic score for brain metastases (BS-BM) and the graded prognostic assessment index (GPA) were related to prognosis. Results:The median survival time was 222 days. The univariate analysis showed that the independent prognostic factors were KPS performance status, number of brain metastases, presence of extracranial metastases, primary tumor status, radiation dose, hemoglobin. The multivariate analysis showed that KPS performance status (P=0.002, Wald=9.700), presence of extracranial metastases (P=0.018, Wald=5.604) and primary tumor status (P=0.001, Wald=10.212) were signiifcantly correlated with overall survival. RPA, BS-BM and GPA were closely related to their prognosis by Log-rank test. In predicting 3 months and 6 months of survival for patients, PI was better than other modes. Conclusion:Our data suggest that the 3 indexes RPA,BS-BM and GPA are valid prognostic index models, but PI model is better.