The West Clinic, Memphis, TN 38120, USA.
Clin Breast Cancer. 2012 Apr;12(2):87-93. doi: 10.1016/j.clbc.2011.10.004. Epub 2011 Dec 6.
Capecitabine, a tumor-activated oral fluoropyrimidine, and albumin-bound paclitaxel (ab-paclitaxel) have substantial single-agent activity in patients with metastatic breast cancer (MBC). Taxane and antimetabolite doublets have improved efficacy compared with single agents. This phase II open-label trial was designed to test the safety and efficacy of capecitabine and ab-paclitaxel in previously untreated MBC.
Patients received capecitabine (825 mg/m(2) orally twice daily, approximately 12 hours apart, on days 1 to 15) and ab-paclitaxel (125 mg/m(2) intravenously on days 1 and 8 of each cycle with no premedication) every 3 weeks. The primary endpoint was overall objective response rate (ORR), with evaluation performed after every 2 cycles. Entry criteria included measurable MBC, human epidermal growth factor receptor 2 (HER2) negativity, Eastern Cooperative Oncology Group (ECOG) performance status 0-2, no previous chemotherapy for metastatic disease, and > 6 months since adjuvant fluoropyrimidine or paclitaxel treatment.
Fifty patients received at least 1 dose of study drug, with 46 patients evaluable for efficacy evaluation. Three hundred seventy-four cycles of therapy were delivered. Eighty percent of patients completed 8 cycles. The ORR was 61% (complete response [CR], 4%; partial response [PR], 57%), and 7 patients had sustained (≥ 24 weeks) stable disease for a clinical benefit rate of 76.1%. The median progression-free survival (PFS) was 10.6 months, and the median overall survival was 19.9 months. The most common adverse events (AEs) that were ≥ grade 3 were pain, hand-foot syndrome, and neutropenia.
The combination of weekly ab-paclitaxel plus daily capecitabine orally at these doses and scheduling was well tolerated and showed substantial efficacy.
卡培他滨是一种肿瘤激活的口服氟嘧啶，白蛋白结合紫杉醇（ab-paclitaxel）在转移性乳腺癌（MBC）患者中具有显著的单药活性。与单药治疗相比，紫杉烷和抗代谢物联合治疗具有更高的疗效。本Ⅱ期开放标签试验旨在测试卡培他滨和 ab-paclitaxel 在未经治疗的 MBC 患者中的安全性和疗效。
患者接受卡培他滨（825 mg/m2 口服，每天两次，间隔约 12 小时，第 1 至 15 天）和 ab-paclitaxel（125 mg/m2 静脉注射，每个周期的第 1 和第 8 天，无需预处理）每 3 周一次。主要终点是总客观缓解率（ORR），每 2 个周期进行评估。入组标准包括可测量的 MBC、人表皮生长因子受体 2（HER2）阴性、东部合作肿瘤组（ECOG）表现状态 0-2、转移性疾病无先前化疗和辅助氟嘧啶或紫杉醇治疗后 > 6 个月。
50 例患者至少接受了 1 剂研究药物，46 例患者可进行疗效评估。共给予 374 个周期的治疗。80%的患者完成了 8 个周期的治疗。ORR 为 61%（完全缓解[CR]，4%；部分缓解[PR]，57%），7 例患者持续（≥ 24 周）稳定疾病，临床获益率为 76.1%。中位无进展生存期（PFS）为 10.6 个月，总生存期为 19.9 个月。≥3 级最常见的不良事件（AE）是疼痛、手足综合征和中性粒细胞减少症。
每周 ab-paclitaxel 联合每日卡培他滨口服，剂量和方案耐受良好，疗效显著。
