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目的探讨含卡培他滨联合化疗方案治疗晚期转移性乳腺癌(MBC)后继续予卡培他滨单药维持治疗的疗效和安全性。方法选取2012年6月至2016年6月间湖南省肿瘤医院收治的158例MBC患者,分别接受3种不同的含卡培他滨联合化疗方案治疗后,将疗效评价为缓解或稳定的139例患者分为维持治疗组(73例)和未维持组(66例)。维持治疗组患者予以口服卡培他滨单药维持治疗,未维持组患者予以定期随访观察。评价所有患者的疗效和不良反应。结果维持治疗组患者中位无进展生存时间(PFS)明显长于未维持组患者,差异有统计学意义(P<0.05)。158例患者联合治疗近期客观有效率(ORR)为48.1%,疾病控制率(DCR)为88.0%。年龄>45岁的患者有较高的ORR(P<0.05)。维持治疗组患者维持阶段ORR为16.4%,DCR为68.5%。在亚组分析中,联合化疗采用GX方案的患者中位PFS较TX或NX联合化疗有延长的趋势,转移灶≥3处患者的中位PFS较转移灶数目为1~2处有缩短的趋势,转移后2线及以上治疗患者的中位PFS较转移后1线治疗的患者也有缩短的趋势,但差异均无统计学意义(均P>0.05)。主要不良反应为血液学不良反应、手足综合征和胃肠道不良反应,患者均可以耐受。结论卡培他滨是MBC维持治疗的有效药物,能够延缓患者的疾病进展,且具有较轻的不良反应。
Objective To investigate the efficacy and safety of capecitabine combined with chemotherapy in the treatment of advanced metastatic breast cancer (MBC) followed by capecitabine monotherapy. Methods A total of 158 MBC patients admitted to Hunan Cancer Hospital from June 2012 to June 2016 were selected and treated with three different capecitabine combined chemotherapy regimens. The curative effect was evaluated as relieved or stable in 139 cases Patients were divided into maintenance treatment group (73 cases) and non-maintenance group (66 cases). Patients in the maintenance treatment group were given oral capecitabine monotherapy for maintenance treatment, and patients in the maintenance group were followed up regularly. All patients were evaluated for efficacy and adverse reactions. Results The median progression-free survival time (PFS) of maintenance therapy group was significantly longer than that of non-maintenance therapy group (P <0.05). In 158 patients, the objective and effective rate (ORR) was 48.1% and the disease control rate (DCR) was 88.0%. Patients> 45 years of age had a higher ORR (P <0.05). Patients in maintenance group maintained ORR of 16.4% and DCR of 68.5%. In the subgroup analysis, the median PFS of patients receiving combination GX regimen was longer than that of TX or NX. The median PFS of patients with metastasis> 3 was shorter than the number of metastases The median PFS of patients who were treated with 2 lines or more after the transfer was shorter than that of the patients treated with the first line after the transfer. However, the differences were not statistically significant (all P> 0.05). The main adverse reactions were hematological adverse reactions, hand-foot syndrome and gastrointestinal adverse reactions, patients were tolerated. Conclusion Capecitabine is an effective drug for MBC maintenance therapy, which can delay the progression of the disease in patients with mild adverse reactions.