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全脑放疗及后程三维适形放疗补量联合同期拓普替康化疗治疗肺癌脑转移的Ⅱ期临床试验
Phase Ⅱ clinical trial of whole-brain irradiation plus three-dimensional conformal boost with concurrent topotecan in patients with brain metastases from lung cancer
【摘要】 目的 :前瞻性评价全脑放疗及后程三维适形放疗补量联合同期拓普替康化疗治疗肺癌脑转移的初步疗效及安全性。方法 :2009年3月—2012年3月,前瞻性入组肺癌脑转移全脑放疗(40 Gy/20次)及后程三维适形放疗补量(脑转移瘤数目≤3个且直径≥2 cm,补量至总剂量为56~60 Gy)联合同期拓普替康化疗(1.75 mg/m2,1次/周,共4~6次/4~6周)患者38例(同期放化疗组)。选取同期仅接受肺癌脑转移全脑放疗及后程三维适形放疗补量的38例患者作为对照(单纯放疗组)。评价疗效和不良反应。对所有患者进行随访,分析生存情况。结果 :同期放化疗组和单纯放疗组患者脑转移瘤的中位无进展生存期分别为6和3个月,1年无进展生存率分别为42.8%和11.6%,2年无进展生存率分别为21.6%和8.7%;同期放化疗组的无进展生存优于单纯放疗组(χ2=6.020,P=0.014)。同期放化疗组和单纯放疗组的中位生存期分别为13和10个月,1年生存率分别为50.8%和40.4%,2年生存率分别为37.9%和16.5%;同期放化疗组的总生存未明显优于单纯放疗组(χ2=1.811,P=0.178)。同期放化疗组和单纯放疗组的1年脑转移瘤控制率分别为75.9%和41.6%,2年脑转移瘤控制率分别为65.2%和31.2%;两组的脑转移瘤控制率差异有统计学意义(χ2=3.892,P=0.049)。同期放化疗组和单纯放疗组的1年颅外病灶控制率分别为47.8%和32.5%,2年颅外病灶控制率分别为28.7%和24.4%;两组的颅外病灶控制率差异无统计学意义(χ2=0.610,P=0.435)。两组患者的主要不良反应是骨髓抑制和胃肠反应,差异均无统计学意义(P>0.05)。结论 :与单纯放疗相比,同期放化疗可显著提高肺癌脑转移患者的无进展生存率和脑转移瘤控制率,未明显增加不良反应。
【Abstract】 Objective: To prospectively evaluate the preliminary efficacy and safety of whole-brain irradiation plus three-dimensional conformal boost combined with concurrent topotecan in patients with brain metastases from lung cancer. Methods: Between March 2009 and March 2012, 38 lung cancer patients with brain metastases were prospectively recruited in concurrent radiochemotherapy(CRCT) group to receive whole-brain irradiation(40 Gy/20 fractions) plus three-dimensional conformal boost(for patients with no more than 3 lesions and the diameter ≥ 2 cm, a three-dimensional conformal localized boost was given to increase the dosage to 56-60 Gy) combined with concurrent topotecan(1.75 mg/m2, once a week for 4-6 weeks). Another 38 patients with brain metastasis from lung cancer were selected to be recruited in simple radiotherapy(SRT) group to receive simple radiotherapy in the same period. The efficacy and the adverse reactions were evaluated. All the patients were followed-up, and the survival was analyzed. Results: In CRCT group and SRT group, the median progression-free survival(PFS) time of intracranial metastases were 6 and 3 months, respectively; one-year PFS rates were 42.8% and 11.6%, respectively; two-year PFS rates were 21.6% and 8.7%, respectively; the PFS of CRCT group was higher than that of SRT group(χ2 = 6.020, P = 0.014). In CRCT group and SRT group, the median survival(OS) time were 13 and 10 months, respectively; one-year OS rates were 50.8% and 40.4%, respectively; twoyear OS rates were 37.9% and 16.5%, respectively; the OS of CRCT group was not obviously higher than that of SRT group(χ2 = 1.811, P = 0.178). In CRCT group and SRT group, the one-year control rates of intracranial metastases were 75.9% and 41.6%, respectively; two-year control rates of intracranial metastases were 65.2% and 31.2%, respectively; there was a significant difference between the CRCT group and SRT group(χ2 = 3.892, P = 0.049). In CRCT group and SRT group, the one-year control rates of extracranial lesions were 47.8% and 32.5%, respectively; two-year control rates of extracranial lesions were 28.7% and 24.4%, respectively; there was no significant difference between the CRCT group and SRT group(χ2 = 0.610, P = 0.435). The major adverse reactions were myelosuppression and gastrointestinal reactions with no significant difference between the two groups(P > 0.05). Conclusion: Compared with simple radiotherapy, whole-brain irradiation plus three-dimensional conformal boost combined with concurrent topotecan can significantly improve the PFS rate and the control rate of intracranial lesion in patients with brain metastases from lung cancer, and no significant increase in side effects was observed.
【Key words】 Lung neoplasms; Brain metastasis; Radiotherapy; Topotecan; Three-dimensional conformal radiotherapy; Survival; Adverse reaction;
- 【文献出处】 肿瘤 ,Tumor , 编辑部邮箱 ,2014年12期
- 【分类号】R734.2
- 【被引频次】7
- 【下载频次】113