接受蒽环类药物、紫杉烷类药物和卡培他滨治疗的晚期乳腺癌患者的治疗模式：描述性报告。

Bristol-Myers Squibb Company, Wallingford, Connecticut, USA.

Clin Ther. 2010 Mar;32(3):546-54. doi: 10.1016/j.clinthera.2010.03.007.

OBJECTIVE

The aim of this work was to analyze chemotherapy treatment patterns in patients with advanced breast cancer who had been previously exposed to an anthracycline, a taxane, and capecitabine.

METHODS

This retrospective cohort study used medical and pharmacy administrative claims with health-plan enrollment data and medical-record review from a large, US-based health insurer database, the HealthCore Integrated Research Database. Women were included if they were aged > or =18 years at the initial breast cancer diagnosis between January 1999 and July 2005 and had received all 3 drug classes of interest, as well as an initial diagnosis of American Joint Committee on Cancer stage I to III breast cancer with metastatic recurrence or an initial diagnosis of stage IV disease. Information about demographics, clinical and pathologic characteristics, survival, and treatments were obtained from computerized data and medical record review. Descriptive analyses were conducted to characterize the treatment patterns.

RESULTS

One hundred forty-four women with advanced breast cancer were identified. Patients ranged in age from 28 to 76 years, with a mean (SD) age of 48.2 (9.1) years, and with 54 patients (37.5%) aged 40 to 49 years and 48 patients (33.3%) aged 50 to 59 years at the time of initial diagnosis. Ninety-three patients (64.6%) were white, 15 (10.4%) were black, 7 (4.9%) were Hispanic, and 4 (2.8%) were Asian. Overall, 89 patients (61.8%) received > or =1 additional chemotherapy regimen after exposure to all 3 chemotherapy agents of interest; 55 (38.2%) received > or =2 additional regimens. A variety of chemotherapeutic regimens were prescribed; 14 monotherapy regimens and 37 combination therapy regimens were used. The most common regimens (both as single agents and combination therapy) included gemcitabine, vinorelbine, or retreatment with a taxane. Of the 89 patients who received > or =1 retreatment, 7 (7.9%) were retreated with anthracycline, 12 (13.5%) with a taxane, and 9 (10.1%) with capecitabine. For first and second treatment after exposure to all 3 agents of interest, the most common single-agent regimens were gemcitabine (first: 17 patients [19.1%]; second: 9 patients [16.4%]) and vinorelbine (first: 14 patients [15.7%]; second: 9 patients [16.4%]). The most common combination therapies for first retreatment were carboplatin based (6 patients [6.7%]).

CONCLUSIONS

Of these patients with advanced breast cancer, 61.8% received > or =1 additional chemotherapy regimen after previous treatment with an anthracycline, a taxane, and capecitabine. The variety of agents prescribed suggests a lack of standard of care. Rigorous clinical effectiveness studies of common regimens in heavily pretreated and chemotherapy-resistant populations with breast cancer are warranted.

目的

本研究旨在分析既往接受过蒽环类药物、紫杉烷类药物和卡培他滨治疗的晚期乳腺癌患者的化疗治疗模式。

方法

本回顾性队列研究使用了来自一家大型美国健康保险公司数据库——HealthCore 综合研究数据库的医疗和药房管理索赔数据、健康计划入组数据和病历审查数据。如果患者在 1999 年 1 月至 2005 年 7 月期间首次确诊乳腺癌时年龄≥18 岁，且接受了所有 3 种感兴趣的药物类别治疗，以及初始诊断为美国癌症联合委员会（AJCC）I 至 III 期乳腺癌伴转移性复发或初始诊断为 IV 期疾病，那么患者将被纳入研究。通过计算机数据和病历审查获取患者的人口统计学、临床和病理特征、生存和治疗信息。采用描述性分析对治疗模式进行特征描述。

结果

本研究共纳入 144 例晚期乳腺癌患者。患者年龄 28 岁至 76 岁，平均（SD）年龄为 48.2（9.1）岁，54 例（37.5%）患者在首次确诊时年龄为 40 岁至 49 岁，48 例（33.3%）患者年龄为 50 岁至 59 岁。93 例（64.6%）患者为白人，15 例（10.4%）为黑人，7 例（4.9%）为西班牙裔，4 例（2.8%）为亚洲人。总体而言，在接受所有 3 种感兴趣的化疗药物治疗后，89 例（61.8%）患者接受了≥1 种额外的化疗方案；55 例（38.2%）患者接受了≥2 种额外的化疗方案。处方了多种化疗方案；使用了 14 种单药方案和 37 种联合治疗方案。最常用的方案（包括单药和联合治疗）包括吉西他滨、长春瑞滨或紫杉烷类药物的再治疗。在接受≥1 次再治疗的 89 例患者中，7 例（7.9%）患者接受了蒽环类药物治疗，12 例（13.5%）患者接受了紫杉烷类药物治疗，9 例（10.1%）患者接受了卡培他滨治疗。在接受所有 3 种药物治疗后的首次和第二次治疗中，最常见的单药方案是吉西他滨（首次：17 例[19.1%]；第二次：9 例[16.4%]）和长春瑞滨（首次：14 例[15.7%]；第二次：9 例[16.4%]）。首次接受挽救性化疗时最常用的联合治疗方案是卡铂为基础的方案（6 例[6.7%]）。