PURPOSE: To compare the efficacy and safety profile of whole-brain radiotherapy (WBRT) with or without Nimustine hydrochloride (ACNU) concurrently delivered in lung cancer patients with brain metastasis.
METHODS: Between July 2007 and October 2010, 275 eligible lung cancer patients with brain metastasis and stable external brain lesions were randomized to receive WBRT in 2-Gy fractions administered five times weekly to a total dose of 40 to 60Gy with or without concurrent ACNU (75mg/m2 every 6 weeks for 2 cycles). The primary end points of the study were the response rate and progression free survival (PFS) of brain metastasis lesions.
RESULTS: There were no significant differences in the patient characteristics of either group. The response rate of concurrent ACNU plus WBRT was statistically significantly better than the WBRT arm (72.3% vs 51.4%, p=0.0005). The median progression free survival time of brain metastasis lesions was 9.14 months for patients receiving concurrent ACNU plus WBRT therapy and 5.29 months for patients receiving WBRT alone (p=0.0028). No significant difference of Karnofsky score were found between each group during the baseline and therapeutic course, while it was improved in ACNU plus WBRT arm at the 12th week, 24th week and 36th week follow up with statistical significance (p=0.0015, p=0.0297, p=0.0378 respectively). The concurrent administration of ACNU did not affect the patients’ quality of life. Central nervous system symptoms and signs scores of both arms were statistically significantly improved after the treatment, while no difference was found between two arms. The concurrent administration of ACNU increases the incidence of manageable hematologic toxicity.
CONCLUSIONS: This study confirmed that concurrent WBRT with ACNU in the treatment of lung cancer patients with brain metastasis was effective superior and safe as compared to WBRT alone.
CLINICAL IMPLICATIONS: Lung cancer patients harboring brain metastasis with stable external brain lesions might be good candidates for concurrent WBRT with ACNU.
DISCLOSURE: The following authors have nothing to disclose: Jie Hu, Chun Li, Li Zhu, Qisen Guo, Lin Yang, Xude Yin, Ping-bai Feng, Nan Du, Lin-bo Cai, Shu-cai Zhang, Sen-ming Wang, Jia-ming Wang, Qibin Song, Yuan Chen, Chang-qing Bai, Ye-ning Jin, Chun-xue Bai
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