Department of Medicine, Breast Cancer Medicine Service, Memorial Sloan-Kettering Cancer Center at Rockville Centre, 1000 North Village Ave., Rockville Centre, NY 11570, USA.
Clin Breast Cancer. 2010 Dec 1;10(6):440-4. doi: 10.3816/CBC.2010.n.057.
Cyclophosphamide/methotrexate/fluorouracil (CMF) is a proven adjuvant option for patients with early-stage breast cancer. Randomized trials with other regimens demonstrate that dose-dense (DD) scheduling can offer greater efficacy. We investigated the feasibility of administering CMF using a DD schedule.
Thirty-eight patients with early-stage breast cancer were accrued from March 2008 through June 2008. They were treated every 14 days with C 600, M 40, F 600 (all mg/m2) with PEG-filgrastim (Neulasta®) support on day 2 of each cycle. The primary endpoint was tolerability using a Simon's 2-stage optimal design. The design would effectively discriminate between true tolerability (as protocol-defined) rates of ≤ 60% and ≥ 80%.
The median age was 52-years-old (range, 38-78 years of age). Twenty-nine of the 38 patients completed 8 cycles of CMF at 14-day intervals.
Dose-dense adjuvant CMF is tolerable and feasible at 14-day intervals with PEG-filgrastim support.
环磷酰胺/甲氨蝶呤/氟尿嘧啶（CMF）是一种经过验证的早期乳腺癌辅助治疗选择。其他方案的随机试验表明，密集剂量（DD）方案可以提供更高的疗效。我们研究了使用 DD 方案给予 CMF 的可行性。
2008 年 3 月至 2008 年 6 月期间，共纳入 38 例早期乳腺癌患者。他们每 14 天接受一次治疗，方案为 C 600、M 40、F 600（均为 mg/m2），每个周期的第 2 天给予 PEG-粒细胞集落刺激因子（Neulasta®）支持。主要终点是使用 Simon 的两阶段最优设计来评估耐受性。该设计可有效区分真实的可耐受性（如方案定义）率≤60%和≥80%。
中位年龄为 52 岁（范围为 38-78 岁）。38 例患者中有 29 例完成了 8 个周期的 14 天间隔 CMF 治疗。
在 PEG-粒细胞集落刺激因子支持下，14 天间隔的密集剂量辅助 CMF 是可耐受且可行的。
