曲妥珠单抗和替莫唑胺对HER-2阳性乳腺癌脑转移患者的生存影响

Comparison of Trastuzumab and Temozolomide Effect on Survival in Patients with HER-2 Positive Breast Cancer Brain Metastasis

目的观察人类表皮生长因子受体2（human epidemal growth factor receptor 2,HER-2）阳性乳腺癌患者出现脑转移后局部放疗加曲妥珠单抗或替莫唑胺治疗的疗效及安全性。方法经4~6周期化疗后取得缓解或稳定的62例HER-2阳性的乳腺癌患者,均存在脑转移,随机分为治疗组A（30例）和治疗组B（32例）。A组全脑放疗＋曲妥珠单抗6 mg/kg q21,B组全脑放疗＋替莫唑胺150 mg/m2d1~5 q28,4周期,5个月后评估疾病控制率,随访比较两组生存情况并观察药物不良反应。结果 5个月时脑部病灶A组疾病控制率（disease control rate,DCR）与B组相当（86.67%vs 84.38%）,差异无统计学意义（P=0.798）;内脏病灶A组DCR优于B组（83.34%vs 56.25%）,差异有统计学意义（P=0.021）。A组平均疾病无进展生存期（progression-free survival,PFS）为7个月,B组为6.8个月（P=0.248）,无统计学差异。A组平均生存时间（overall survival,OS）为11.4个月,B组为10.3个月个月（P=0.171）亦无统计学差异。两组患者均未出现严重药物不良反应。结论 HER-2阳性的乳腺癌脑转移患者放疗期间联合曲妥珠单抗对于内脏疾病控制率优于联合替莫唑胺组,脑部控制率和生存可与替莫唑胺组疗效相当,进一步的验证需要增大样本量来证实。

Objective To observe the HER2 positive breast cancer patients with brain metastasis occurred after radiotherapy plus trastuzumab or TMZ treatment efficacy and safety.Methods The period after chemotherapy achieved remission or stable 62 advanced HER-2 positive breast cancer patients, there are brain metastasis, were randomly divided into treatment group A （30） and group B （32） . Group A whole brain radiotherapy plus trastuzumab 6 mg/kg q21, group B whole brain radiotherapy ＋ TMZ 150 mg/mR D1-5 Q28 4 cycles, assessment of disease control rates were compared between the two groups after 5 months , and observe the survival situation of adverse drug reactions.Results After 5 months, brain lesions disease control rate （IX]R） between group A and B group （86.67 % vs. 84.38 %） , the difference was not statistically significant （P = 0.798） ;visceral lesions DCR between group A than that of B group （83.34% vs. 56.25%） , the difference was statistically significant （P = 0.021）. The average disease progression-free survival （PFS） in A group was 7 months, 6.8 months in the B group （P = 0.248）, no significant difference. In group A, the average overall survival time （OS） for 11.4 months, group B was 10.3 months （P = 0.171） and there was no difference. Serious adverse drug reactions were not found in two groups of patients. Conclusion During the radiotherapy in patients with HER-2 positive breast cancer brain metastases in combination with trastuzumab for visceral disease control rate is better than that of united TMZ group,brain control rate and survival and TMZ group curative effect quite, further verify need to increase the sample size to confirm.