复发转移乳腺癌联合化疗后卡培他滨维持 治疗的临床研究

doi:10.3760/cma.j.issn.1673422X.2015.09.002

摘要/Abstract

摘要： 目的评价复发转移乳腺癌联合化疗后未进展患者卡培他滨维持治疗的PFS和安全性及其预后影响因素。方法收集2011年1月—2013年6月在兰州大学第一医院肿瘤内科治疗的复发转移乳腺癌患者38例，给予长春瑞滨联合卡培他滨化疗，未进展患者给予单药卡培他滨口服维持治疗，每日2次，2 000 mg·m-2·d-1，连续服用14 d后停药7 d，治疗周期21 d，至少治疗2个周期，直至PD或不良反应不能耐受。观察并记录不良反应及PFS。采用χ2检验和多因素COX风险比例模型分析患者临床特征与总有效率和PFS的关系。结果 38例患者中CR 4例，PR 17例，SD 11例，PD 6例，总有效率55.26%（21/38）。32例（84.21%）临床获益患者（CR+PR+SD）给予卡培他滨单药维持治疗至PD，中位PFS为10.0个月。Karnofsky功能状态（KPS）评分≥80分的患者PFS为14.1个月，＜80分的患者PFS为6.8个月，两组差异有统计学意义（χ2=6.251，P=0.000）。多因素COX风险比例模型分析显示，患者年龄（RR=3.561，95%CI：1.372～5.216，χ2=4.025，P=0.031）、绝经状态（RR=1.895，95%CI：1.124～4.452，χ2=5.725，P=0.048）、KPS评分（RR=4.553，95%CI：1.131～7.703，χ2=11.205，P=0.005）、肿瘤转移数目（RR=5.781，95%CI：2.321～11.243，χ2=3.925，P=0.011）是患者重要的预后影响因素。主要不良反应为Ⅰ～Ⅱ级手足综合征，1例重度手足综合征患者2周期后停止卡培他滨的治疗。结论复发转移性乳腺癌患者联合化疗达到缓解或稳定后给予卡培他滨维持化疗，可显著延长患者PFS，且耐受性良好，患者年龄、绝经状态、KPS评分、肿瘤转移数目可作为该联合方案后维持化疗的预后影响因素。

关键词: 乳腺肿瘤/ 药物疗法, 联合/ 预后/ 卡培他滨

Abstract: ObjectiveTo investigate the therapeutic effect, safety and its prognostic factors of capecitabine as maintenance treatment agent for prolonging the PFS of patients with recurrent and metastatic breast cancer after they received combination chemotherapy. MethodsFrom January 2011 to June 2013, 38 cases with recurrent and metastatic breast cancer were collected in the department of medical oncology of the First Hospital of Lanzhou University. All the 38 patients received NX scheme (vinorelbine combined capecitabine chemotherapy), and some patients among of them had stabile disease after chemotherapy and were administered X scheme (capecitabine, twice a day, 2 000 mg/m2 daily, withdrawal for 7 days after a consecutive intake of 14 days, 21 days as a cycle, at least 2 cycles) until disease progressed or toxicity could not be tolerated. Adverse reactions and PFS were observed and recorded. Single factor chi square test and multivariate COX proportion hazard model were used to evaluate the relationships between clinic features and RR, PFS. ResultsThe overall response rate (CR+PR) was 55.26% (21/38), clinical benefit patients rate (CR+PR+SD) was 84.2% (32/38), with 4 patients of CR (4/32), 17 patients of PR, 11 patients of SD, 6 patients of PD. Thirtytwo no progressived patients were administered capecitabine until PD. The median PFS was 10.0 months. Stratification analysis showed that patients whose Karnofsky (KPS)≥80 had an average PFS of 14.1 months, while an average PFS of 6.8 months for patients whose KPS<80, with a statistical significance (χ2 =6.251, P=0.000). Cox proportion hazard model also showed that age (RR=3.561, 95%CI：1.3725.216, χ2=4.025, P=0.031), menopausal status (RR=1.895, 95%CI：1.1244.452, χ2=5.725, P=0.048), KPS score (RR=4.553, 95%CI：1.1317.703, χ2=11.205, P=0.005), the number of metastasis (RR=5.781, 95%CI：2.321～11.243, χ2=3.925, P=0.011) were important prognostic factors for the patients with breast cancer. Major treatmentrelated adverse reaction was grade ⅠⅡ handfoot syndrome. One patient discontinued treatment because of grade Ⅲ handfoot syndrome. ConclusionCapecitabine as maintenance treatment can significantly prolong the PFS of patients with recurrent and metastatic breast cancers at remission or stable stage after combination chemotherapy with a better tolerance. Age of patients, menopausal status, KPS score, the number of metastasis are the prognostic factors for the efficacy of NXX regimen.

令晓玲, 杨景茹, 陈蕊, 袁芳芸, 李春梅, 赵达. 复发转移乳腺癌联合化疗后卡培他滨维持治疗的临床研究[J]. 国际肿瘤学杂志, 2015, 42(8): 644-.

LING Xiao-Ling, YANG Jing-Ru, CHEN Rui, YUAN Fang-Yun, LI Chun-Mei, ZHAO Da. A clinical study on capecitabine maintenance treatment after combination chemotherapy to the patients with recurrent and metastatic breast cancer[J]. Journal of International Oncology, 2015, 42(8): 644-.

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