Levine Cancer Institute, Atrium Health, Charlotte, North Carolina.
21st Century Oncology, Farmington Hills, Michigan.
Int J Radiat Oncol Biol Phys. 2019 Oct 1;105(2):296-306. doi: 10.1016/j.ijrobp.2019.06.014. Epub 2019 Jun 15.
Hormone therapy without radiation therapy is considered appropriate for women age 70 or above with low-risk, hormone-positive breast cancer after partial mastectomy. However, some patients may prefer radiation without hormone therapy, for which there is minimal modern data. We modeled the comparative efficacy of aromatase inhibition alone without radiation versus radiation alone without hormone therapy.
We constructed a patient-level Markov model and compared 5 years of anastrozole to a 15-fraction course of radiation without boost or anastrozole. The relative effectiveness between treatments was based on the National Surgical Adjuvant Breast and Bowel Project B-21 trial, which was further adjusted such that the endocrine-alone arm matched the Cancer and Leukemia Group B 9343 and PRIME II trials. Common or severe side effects were considered. Eight survival metrics were assessed and validated against clinical trial data. The cost-efficacy of each strategy was considered using the quality-adjusted life year and incremental cost-effectiveness ratio (ICER).
The model's predicted outcomes matched those demonstrated by modern trials. Aromatase inhibitors were superior in preventing contralateral cancers, with a small impact on the risk of distant metastatic disease. Radiation was superior in preventing ipsilateral breast tumor recurrence with a small impact on regional failure. No clinically significant differences were seen in the other 4 oncologic endpoints. Differences in quality-adjusted life years were small, but radiation therapy was $3809 more expensive over the average lifetime. The ICER suggested anastrozole was cost-effective in 62% of probabilistic simulations. However, the ICER was unstable owing to a denominator that approached zero.
Women age 70 or above with low-risk early breast cancer who are reluctant or unable to pursue adjuvant aromatase inhibition can safely pursue adjuvant radiation alone with limited differences in outcome and a modest increase in costs.
对于行部分乳房切除术的低危、激素阳性乳腺癌且年龄 70 岁或以上的女性，激素治疗而不进行放射治疗被认为是合理的选择。但是，有些患者可能更喜欢不进行激素治疗而进行放射治疗，而对于这种治疗方法，现代数据很少。我们建立了模型来比较单独使用芳香化酶抑制剂而不进行放射治疗与单独进行放射治疗而不使用激素治疗的疗效。
我们构建了一个患者水平的马尔可夫模型，并比较了 5 年的阿那曲唑与 15 次分割放射治疗（无增敏剂）或阿那曲唑。治疗之间的相对有效性基于 National Surgical Adjuvant Breast and Bowel Project B-21 试验，该试验进一步进行了调整，以使内分泌治疗组与 Cancer and Leukemia Group B 9343 和 PRIME II 试验相匹配。考虑了常见或严重的副作用。评估了 8 种生存指标，并与临床试验数据进行了验证。使用质量调整生命年和增量成本效益比（ICER）考虑了每种策略的成本效益。
模型的预测结果与现代试验的结果相符。芳香化酶抑制剂在预防对侧癌症方面具有优势，对远处转移疾病的风险影响较小。放射治疗在预防同侧乳房肿瘤复发方面具有优势，对区域失败的影响较小。在其他 4 个肿瘤学终点上没有明显的差异。质量调整生命年的差异较小，但放射治疗在平均寿命内的费用增加了 3809 美元。ICER 表明在 62%的概率模拟中，阿那曲唑具有成本效益。但是，由于分母接近零，ICER 不稳定。
对于年龄 70 岁或以上、患有低危早期乳腺癌且不愿意或无法接受辅助芳香化酶抑制治疗的女性，可以安全地单独接受辅助放射治疗，其疗效差异有限，费用略有增加。
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