Andersson M, Storm H H, Mouridsen H T
Danish Cancer Registry, Institute of Cancer Epidemiology, Copenhagen.
J Natl Cancer Inst. 1991 Jul 17;83(14):1013-7. doi: 10.1093/jnci/83.14.1013.
The incidence of new primary cancers was evaluated in 3538 postmenopausal patients who had received surgical treatment for primary breast cancer. Of these patients, 1828 with a low risk of recurrence received no further treatment. High-risk patients were randomly assigned to one of two groups. The first group (n = 846) received postoperative radiotherapy, while the second group (n = 864) received radiotherapy plus tamoxifen at a dose of 30 mg given daily for 48 weeks. The median observation time was 7.9 years. In comparison with the number of new cancers in the general population, the number of new cancers in the three groups was elevated mostly due to a high number of cancers of the contralateral breast and of colorectal cancers in the high-risk groups. The cumulative risk of nonlymphatic leukemia was increased among patients who received postoperative radiotherapy (P = .04). Cancer incidence in the high-risk tamoxifen-treated group relative to that in the high-risk group not treated with tamoxifen was not significant (1.3). No protective effect of tamoxifen on the opposite breast was seen (rate ratio for breast cancer = 1.1), but a tendency to an elevated risk of endometrial cancer was observed (rate ratio = 3.3; 95% confidence interval = 0.6-32.4). Continued and careful follow-up of women treated with tamoxifen is necessary to clarify the potential cancer-suppressive or cancer-promoting effects of this drug.
对3538例接受原发性乳腺癌手术治疗的绝经后患者的新发原发性癌症发病率进行了评估。在这些患者中，1828例复发风险较低的患者未接受进一步治疗。高危患者被随机分为两组。第一组（n = 846）接受术后放疗，而第二组（n = 864）接受放疗加他莫昔芬治疗，剂量为每日30 mg，共48周。中位观察时间为7.9年。与普通人群中的新发癌症数量相比，三组中的新发癌症数量增加主要是由于高危组中对侧乳腺癌和结直肠癌的数量较多。接受术后放疗的患者中非淋巴细胞白血病的累积风险增加（P = .04）。他莫昔芬治疗的高危组相对于未接受他莫昔芬治疗的高危组的癌症发病率无显著差异（1.3）。未观察到他莫昔芬对侧乳房的保护作用（乳腺癌的率比 = 1.1），但观察到子宫内膜癌风险升高的趋势（率比 = 3.3；95%置信区间 = 0.6 - 32.4）。有必要对接受他莫昔芬治疗的女性进行持续且仔细的随访，以明确该药物潜在的抑癌或促癌作用。
