Department of Oncology, Georgetown-Lombardi Comprehensive Cancer Center, Washington, DC, USA.
Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY, USA.
Cancer Med. 2022 Jan;11(2):297-307. doi: 10.1002/cam4.4084. Epub 2021 Dec 16.
Extending endocrine therapy from 5 to 10 years is recommended for women with invasive estrogen receptor (ER)-positive breast cancers. We evaluated the benefits and harms of the five additional years of therapy.
An established Cancer Intervention and Surveillance Network (CISNET) model used a lifetime horizon with national and clinical trial data on treatment efficacy and adverse events and other-cause mortality among multiple birth cohorts of U.S. women ages 25-79 newly diagnosed with ER+, non-metastatic breast cancer. We assumed 100% use of therapy. Outcomes included life years (LYs), quality-adjusted life years (QALYs), and breast cancer mortality. Results were discounted at 3%. Sensitivity analyses tested a 15-year time horizon and alternative assumptions.
Extending tamoxifen therapy duration among women ages 25-49 reduced the lifetime probability of breast cancer death from 11.9% to 9.3% (absolute difference 2.6%). This translates to a gain of 0.77 LYs (281 days)/woman (undiscounted). Adverse events reduce this gain to 0.44 QALYs and after discounting, gains are 0.20 QALYs (73 days)/woman. Extended aromatase inhibitor therapy in women 50-79 had small absolute benefits and gains were offset by adverse events (loss of 0.06 discounted QALYs). There were greater gains with extended endocrine therapy for women with node-positive versus negative cancers, but only women ages 25-49 and 50-59 had a net QALY gain. All gains were reduced with less than 100% treatment completion.
The extension of endocrine therapy from 5 to 10 years modestly improved lifetime breast cancer outcomes, but in some women, treatment-related adverse events may outweigh benefits.
对于患有浸润性雌激素受体（ER）阳性乳腺癌的女性，建议将内分泌治疗延长至 5 至 10 年。我们评估了额外 5 年治疗的益处和危害。
采用既定的癌症干预和监测网络（CISNET）模型，从美国多个年龄在 25-79 岁新诊断为 ER+、非转移性乳腺癌的女性出生队列中，使用国家和临床试验数据，在终生范围内评估了治疗效果和不良反应以及其他原因死亡率。我们假设 100%使用治疗。结果包括生命年（LY）、质量调整生命年（QALY）和乳腺癌死亡率。结果贴现率为 3%。敏感性分析测试了 15 年的时间范围和替代假设。
在 25-49 岁女性中延长他莫昔芬治疗时间可将终生乳腺癌死亡概率从 11.9%降低至 9.3%（绝对差异为 2.6%）。这相当于女性获得 0.77 LY（281 天）。不良反应会减少这种获益，为 0.44 QALY，贴现后获益为 0.20 QALY（73 天）。50-79 岁女性延长芳香化酶抑制剂治疗的绝对获益较小，而不良反应则会抵消获益（丧失 0.06 个贴现 QALY）。对于淋巴结阳性和阴性的癌症患者，延长内分泌治疗会带来更大的获益，但只有 25-49 岁和 50-59 岁的女性才会有净 QALY 获益。未完成 100%的治疗都会降低所有获益。
将内分泌治疗从 5 年延长至 10 年，适度改善了乳腺癌的终生预后，但在某些女性中，治疗相关的不良反应可能超过获益。
