Universitätsklinikum Mainz, Germany.
West German Study Group, Mönchengladbach, Germany.
Eur J Cancer. 2023 Nov;194:113324. doi: 10.1016/j.ejca.2023.113324. Epub 2023 Sep 7.
Evaluation of the impact of a de-escaleted chemotherapy regimen consisting of capecitabine (Cap) on invasive disease-free survival (iDFS) in patients ≥65 years with node-positive/high-risk node-negative early breast cancer (BC) receiving ibandronate (Ib).
ICE (Ib with or without Cap in Elderly patients with early breast cancer) was a multicentre phase 3 clinical trial with a 2020 update of long-term follow-up for overall survival enroling node-positive/high-risk node-negative patients ≥65 years with early BC. Patients were randomised to Cap 2000 mg/m² day 1-14 q3w for 6 cycles plus Ib (50 mg p.o. daily or alternatively 6 mg intravenous q4w) or Ib alone for 2 years. Endocrine therapy was recommended for hormone receptor (HR)-positive patients. The primary endpoint was iDFS analysed using Cox proportional hazards regression and log-rank analysis.
1358 (96.4%) of 1409 randomised patients started treatment. 564 (83.4%) completed 6 cycles of Cap. 513 (77.7%) and 516 (78.8%) completed Ib in the Cap+Ib and Ib alone arm, respectively. Median age was 71 (range 64-88) years, 1099 (81%) were HR-positive, 705 (51.9%) node-negative. At a median follow-up of 61.3 months, 5-year iDFS was 78.8% for Cap+Ib versus 75.0% for Ib alone (p = 0.80). Effects were independent of age, nodal, and HR status. The addition of Cap caused significantly higher skin and gastrointestinal toxicity.
The adjuvant combination of Cap+Ib did not show significantly better iDFS than Ib alone in node-positive/high-risk node-negative older BC patients, of whom HR-positive patients were also treated with endocrine therapy.
Study in elderly patients with early breast cancer (ICE), NCT00196859, https://clinicaltrials.gov/ct2/show/NCT00196859?term=NCT00196859.
评估卡培他滨（Cap）降阶梯化疗方案对接受伊班膦酸盐（Ib）治疗的淋巴结阳性/高危淋巴结阴性早期乳腺癌（BC）老年患者（≥65 岁）浸润性无病生存（iDFS）的影响。
ICE（伊班膦酸盐联合或不联合卡培他滨治疗老年早期乳腺癌患者）是一项多中心 III 期临床试验，在 2020 年对总生存进行了长期随访更新，纳入了≥65 岁的淋巴结阳性/高危淋巴结阴性早期 BC 患者。患者随机接受 Cap 2000 mg/m² 第 1-14 天 q3w 治疗 6 个周期，加 Ib（50 mg po. 每日或替代 6 mg 静脉 q4w）或 Ib 单药治疗 2 年。对于激素受体（HR）阳性患者建议进行内分泌治疗。主要终点是采用 Cox 比例风险回归和对数秩分析的 iDFS。
1409 名随机患者中有 1358 名（96.4%）开始治疗。564 名（83.4%）完成了 6 个周期的 Cap。Cap+Ib 组和 Ib 单药组分别有 513 名（77.7%）和 516 名（78.8%）完成了 Ib 治疗。中位年龄为 71 岁（范围 64-88 岁），1099 名（81%）为 HR 阳性，705 名（51.9%）为淋巴结阴性。中位随访 61.3 个月时，Cap+Ib 组的 5 年 iDFS 为 78.8%，Ib 单药组为 75.0%（p=0.80）。疗效独立于年龄、淋巴结和 HR 状态。加用 Cap 导致皮肤和胃肠道毒性显著增加。
在淋巴结阳性/高危淋巴结阴性老年 BC 患者中，Cap+Ib 辅助治疗并未显示出比 Ib 单药治疗更显著的 iDFS 获益，其中 HR 阳性患者也接受了内分泌治疗。
早期乳腺癌老年患者研究（ICE），NCT00196859，https://clinicaltrials.gov/ct2/show/NCT00196859?term=NCT00196859.
