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乳腺癌是女性最常见的恶性肿瘤之一[1],近年发病率正在逐渐上升。尽管有新的靶向药物及化疗方案不断推出,但大多数乳腺癌病人仍会出现复发和转移,复发转移性乳腺癌病人的生存率较低,特别是经历三线治疗失败的病人,目前没有标准的化疗方案,并且出现多药耐药[2],如何提高这类病人生存质量,改善生存期是值得我们研究的方向。甲磺酸阿帕替尼是我国自主研制的一种小分子抗血管生成的口服靶向药物[3],在我国批准用于至少接受过2种系统化疗后进展或复发的晚期胃腺癌,主要抑制作用靶点为血管内皮生长因子受体-2(VEGFR-2)。目前国内外学者[4-5]对于阿帕替尼治疗晚期乳腺癌病人的临床效果也在不断研究中。我们通过回顾性分析25例晚期复发转移性乳腺癌病人口服阿帕替尼的临床资料,分析其有效率和不良反应。现作报道。
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25例病人中,无完全缓解病例,部分缓解4例,病情稳定11例,疾病进展10例,客观有效率为16.0%,疾病控制率为60.0%。随访至2019年3月31日,因病情进展导致病人死亡12例,失访2例,11例存活,中位无进展生存期3.68个月,总生存期16.06个月(见图 1~2)。
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COX比例风险模型结果显示,既往化疗数和ER状态是乳腺癌病人无进展生存期的影响因素(P<0.05)(见表 1)。
因素 B SE Wald P Exp(B) 既往化疗数 1.087 0.528 4.234 0.040 2.964 内脏转移 0.807 0.768 1.103 0.294 2.241 年龄 0.035 0.053 0.420 0.517 1.035 ER -2.210 0.970 5.194 0.023 0.110 PR 1.126 1.144 0.969 0.325 3.084 HER-2 1.814 1.059 2.934 0.087 6.136 表 1 复发转移性乳腺癌病人无进展生存期的多因素分析
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25例病人无一例严重不良反应,服用阿帕替尼后主要不良反应为高血压(20.0%)、乏力(20.0%)、手足综合征(16.0%)和腹泻(16.0%)(见表 2)。
不良反应 1~2级 3~4级 合计 高血压 4(16.0) 1(4.0) 5(20.0) 手足综合征 3(12.0) 1(4.0) 4(16.0) 蛋白尿 2(8.0) 1(4.0) 3(12.0) 乏力 5(20.0) 0 5(20.0) 腹泻 4(16.0) 0 4(16.0) 恶心、呕吐 2(12.0) 0 2(8.0) 皮疹 1(4.0) 0 1(4.0) 白细胞减少 1(4.0) 0 1(4.0) 合计 22(88.0) 3(12.0) 25(100.0) 表 2 25例复发转移性乳腺癌病人不良反应情况[n;百分率(%)]
甲磺酸阿帕替尼治疗复发转移性乳腺癌的临床观察
The clinical efficacy of apatinib mesylate in the treatment of recurrent metastatic breast cancer
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摘要:
目的探讨晚期复发转移性乳腺癌病人口服甲磺酸阿帕替尼的有效率和不良反应。 方法回顾性分析25例经3线治疗失败以上的晚期复发转移性乳腺癌病人临床资料,给予口服甲磺酸阿帕替尼,分析其客观有效率、疾病控制率、无进展生存期、总生存期及不良反应。 结果25例病人中,病情稳定11例,部分缓解4例,疾病进展10例,客观有效率16.0%,疾病控制率60.0%,中位无进展生存期3.68个月,总生存期16.06个月。多因素分析显示,既往化疗数和雌激素受体状态均为乳腺癌病人无进展生存期的影响因素(P < 0.05)。病人服用阿帕替尼主要不良反应为高血压(20.0%)、乏力(20.0%)、手足综合征(16.0%)和腹泻(16.0%),25例病人中无一例严重不良反应。 结论晚期复发转移性乳腺癌病人口服甲磺酸阿帕替尼获益率较高,不良反应可控,生活质量有所提高,值得进一步研究。 Abstract:ObjectiveTo investigate the efficacy and safety of apatinib mesylate in the treatment of advanced recurrent metastatic breast cancer. MethodsThe clinical data of 25 advanced recurrent metastatic breast cancer patients with more than 3-line treatment failure were retrospectively analyzed.The objective response rate, disease control rate, progress free survival, overall survival and safety in patients treated with oral apatinib mesylate were evaluated. ResultsAmong 25 patients, the disease stabliation in 11 cases, partial remission in 4 cases and disease progression in 10 cases were identified.The objective response rate, disease control rate, median progress free survival and overall survival were 16.0%, 60.0%, 3.68 months and 16.06 months, respectively.The results of multi-factor analysis showed that the number of chemotherapy and ER status were the influencing factors of progress free survival(P < 0.05).The hypertension, fatigue, hand-foot syndrome and diarrhea were the main adverse reactions of apatinib, and no serious adverse reactions in 25 patients were found. ConclusionThe apatinib mesylate in the treatment of advanced recurrent metastatic breast cancer has high efficacy, the adverse reactions is controllable, and the quality of life of patients can be improved, which is worthy of further study. -
Key words:
- breast neoplasms /
- apatinib mesylate /
- progress free survival /
- adverse reaction
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表 1 复发转移性乳腺癌病人无进展生存期的多因素分析
因素 B SE Wald P Exp(B) 既往化疗数 1.087 0.528 4.234 0.040 2.964 内脏转移 0.807 0.768 1.103 0.294 2.241 年龄 0.035 0.053 0.420 0.517 1.035 ER -2.210 0.970 5.194 0.023 0.110 PR 1.126 1.144 0.969 0.325 3.084 HER-2 1.814 1.059 2.934 0.087 6.136 表 2 25例复发转移性乳腺癌病人不良反应情况[n;百分率(%)]
不良反应 1~2级 3~4级 合计 高血压 4(16.0) 1(4.0) 5(20.0) 手足综合征 3(12.0) 1(4.0) 4(16.0) 蛋白尿 2(8.0) 1(4.0) 3(12.0) 乏力 5(20.0) 0 5(20.0) 腹泻 4(16.0) 0 4(16.0) 恶心、呕吐 2(12.0) 0 2(8.0) 皮疹 1(4.0) 0 1(4.0) 白细胞减少 1(4.0) 0 1(4.0) 合计 22(88.0) 3(12.0) 25(100.0) -
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