Medical Oncology, Dana-Farber Cancer Institute, Boston.
CALGB Statistical Center, Duke University Medical Center, Durham.
Ann Oncol. 2012 Dec;23(12):3075-3081. doi: 10.1093/annonc/mds133. Epub 2012 Jul 5.
Cyclophosphamide-methotrexate-5-fluorouracil (CMF) is often selected as adjuvant chemotherapy for older patients with early-stage breast cancer due to perceived superior tolerability. We sought to measure persistence with CMF, adherence to oral cyclophosphamide, and the association of these with toxic effects.
CALGB 49907 was a randomized trial comparing standard chemotherapy (CMF or AC, provider/patient choice) with capecitabine in patients aged ≥65 with stage I-IIIB breast cancer. Those randomized to standard therapy and choosing CMF were prescribed oral cyclophosphamide 100 mg/m(2) for 14 consecutive days in six 28-day cycles. Persistence was defined as being prescribed six cycles of at least one of the three CMF drugs. Adherence was the number of cyclophosphamide doses that women reported they had taken divided by the number prescribed. Persistence and adherence were based on case report forms and medication calendars.
Of 317 randomized to standard chemotherapy, 133 received CMF. Median age was 73 (range 65-88). Seventy-one percent submitted at least one medication calendar; 65% persisted with CMF. Non-persistence was associated with node negativity (P = 0.019), febrile neutropenia (P = 0.002), and fatigue (P = 0.044). Average adherence was 97% during prescribed cycles.
Self-reported adherence to cyclophosphamide was high, but persistence was lower, which may be attributable to toxic effects.
由于认为环磷酰胺-甲氨蝶呤-5-氟尿嘧啶（CMF）具有更好的耐受性，因此常被选择作为老年早期乳腺癌患者的辅助化疗。我们旨在测量 CMF 的持续时间、口服环磷酰胺的依从性，并研究这些与毒性作用的相关性。
CALGB 49907 是一项随机试验，比较了标准化疗（CMF 或 AC，由提供者/患者选择）与卡培他滨在年龄≥65 岁、I 期至 IIIB 期乳腺癌患者中的疗效。那些随机接受标准治疗且选择 CMF 的患者被开出口服环磷酰胺 100mg/m²，每 28 天周期连续服用 14 天，共 6 个周期。持续时间定义为至少接受了其中一种三种 CMF 药物的六个周期。依从性是指女性报告已服用的环磷酰胺剂量数除以规定剂量数。持续时间和依从性基于病例报告表和药物日历。
在随机分配至标准化疗的 317 名患者中，有 133 名接受了 CMF 治疗。中位年龄为 73 岁（范围为 65-88 岁）。71%的患者至少提交了一份药物日历；65%的患者持续使用 CMF。无持续治疗与淋巴结阴性（P=0.019）、发热性中性粒细胞减少（P=0.002）和疲劳（P=0.044）相关。在规定的周期内，平均依从率为 97%。
自我报告的环磷酰胺依从性较高，但持续时间较低，这可能归因于毒性作用。
