Burdens and benefits of adjuvant cyclophosphamide, methotrexate, and fluorouracil and tamoxifen for elderly patients with breast cancer:: The International Breast Cancer Study Group Trial VII
Burdens and benefits of adjuvant cyclophosphamide, methotrexate, and fluorouracil and tamoxifen for elderly patients with breast cancer:: The International Breast Cancer Study Group Trial VII
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DOI：
10.1200/jco.2000.18.7.1412
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发表时间：
2000-04-01
影响因子：
45.3
通讯作者：
Goldhirsch, A
中科院分区：
文献类型：
--
作者：
Crivellari, D;Bonetti, M;Goldhirsch, A
目的：关于老年妇女辅助化疗内分泌治疗的耐受性和有效性的信息有限。我们使用作为国际乳腺癌研究小组试验VII的一部分收集的数据来研究这些问题。患者和方法：患有可手术的、结节阳性的乳腺癌的绝经后妇女随机接受他莫昔芬治疗5年(306名患者)或他莫昔芬加连续三个周期的经典环磷酰胺(100 mg/m(2)口服第1至14天)、甲氨蝶呤(40 mg/m(2)静脉注射第1天和第8天)和氟尿嘧啶(600 mg/m(2)静脉注射第1天和第8天(CMF；302名患者)。结果：在接受至少一次CMF治疗的299例患者中，65岁或以上的女性(n=76)的毒性级别高于65岁以下的女性(n=223)(P=.004)，与年轻女性相比，年龄较大的女性出现任何类型的3级毒性(分别为17%对7%)、3级血液毒性(分别为9%对5%)和3级粘膜毒性(分别为4%对1%)，与年轻的绝经后妇女相比，老年患者接受的CMF剂量也低于他们的预期剂量(P=.0008)。然而，根据生活质量测量指标(表现状况、应对方式、身体健康状况、情绪和食欲)，年轻患者和老年患者的主观治疗负担相似，远高于老年患者，CMF加他莫昔芬和单用他莫昔芬的5年无病生存率(DFS)分别为63%和61%(风险比[HR]，1.00；95%可信区间[CI]，0.65至1.52；P=.99)。对于年轻患者，相应的5年DFS率分别为61%和53%(HR，0.70；95%CI，0.53~0.91；P=.008)，但CMF效应按年龄组的异质性检验没有统计学意义，老年女性CMF疗效的降低不能归因于根据接受的剂量减少。结论：与接受他莫昔芬治疗5年的年轻绝经后淋巴结阳性乳腺癌患者相比，老年患者的CMF耐受性和有效性都降低了。对于高危老年患者，需要开发和评估毒性更小、更有效的化疗方案。(C)2000年，由美国临床肿瘤学会提供。
Purpose: Information on the tolerability and efficacy of adjuvant chemoendocrine therapy for older women is limited. We studied these issues using the data collected as part of the International Breast Cancer Study Group Trial VII.Patients and Methods: Postmenopausal women with operable, node-positive breast cancer were randomized to receive either tamoxifen atone for 5 years (306 patients) or tamoxifen plus three consecutive cycles of classical cyclophosphamide (100 mg/m(2) orally days 1 to 14), methotrexate (40 mg/m(2) intravenous days 1 and 8), and fluorouracil (600 mg/m(2) intravenous days 1 and 8) every 28 days (CMF; 302 patients). The median follow-up was 8.0 years.Results: Among the 299 patients who received at least one dose of CMF, women 65 years of age or older (n = 76) had higher grades of toxicity compared with women less than 65 years old (n = 223) (P = .004), More women in the older age group compared with the younger women experienced grade 3 toxicity of any type (17% v 7%, respectively), grade 3 hematologic toxicity (9% v 5%, respectively), and grade 3 mucosal toxicity (4% v 1%, respectively), Older patients also received less than their expected CMF dose compared with younger postmenopausal women (P = .0008). The subjective burdens of treatment, however, were similar for younger and older patients based on quality-of-life measurer (performance status, coping, physical wellbeing, mood, and appetite), Far older patients, the 5-year disease-free survival (DFS) rates were 63% for CMF plus tamoxifen and 61% for tamoxifen alone (hazards ratio [HR], 1.00; 95% confidence interval [Cl], 0.65 to 1.52; P = .99). For younger patients, the corresponding 5-year DFS rates were 61% and 53% (HR, 0.70; 95% Cl, 0.53 to 0.91; P = .008), hut the test for heterogeneity of CMF effect according to age group was not statistically significant, The reduced effectiveness of CMF among older women could not be attributed to doss reductions according to dose received.Conclusion: CMF tolerability and effectiveness were both reduced for older patients compared with younger postmenopausal node-positive breast cancer patients who received tamoxifen for 5 years. The development and evaluation of less toxic and more effective chemotherapy regimens are required for high-risk elderly patients. (C) 2000 by American Society of Clinical Oncology.