Xiao Hong, Jiang Xinyi, Chen Cheng, Montero Alberto J, Diaby Vakaramoko
Department of Pharmaceutical Outcomes and Policy, University of Florida College of Pharmacy, HPNP Building Room 3338, 1225 Center Drive, Gainesville, FL, 32610, USA.
Department of Pharmaceutical Outcomes and Policy, University of Florida College of Pharmacy, HPNP 2309, 1225 Center Drive, Gainesville, FL, 32610, USA.
Pharmacoecon Open. 2018 Dec;2(4):359-369. doi: 10.1007/s41669-018-0070-7.
Anti-estrogen (ER) endocrine therapy is an effective treatment strategy in reducing breast cancer mortality. This therapy has a better therapeutic index than chemotherapy but can still affect patients' quality of life (QOL) over time.
The objectives of this systematic review were to (1) describe QOL instruments used in ER-positive (ER+) non-metastatic breast cancer trials and (2) document the longitudinal effects of adjuvant endocrine therapy on the QOL of post-menopausal women with ER+ non-metastatic breast cancer.
We searched three electronic bibliographic databases for articles published from inception to October 2017 that described (1) a randomized controlled trial (RCT) of non-metastatic breast cancer containing an adjuvant endocrine regimen in at least one arm; (2) the use of a patient self-report measure assessing general or breast cancer-specific QOL; and (3) QOL outcomes at multiple time points during follow-up of at least 5 years. All included trials were independently evaluated by two reviewers, and data were extracted using standardized forms.
In total, 13 studies met our inclusion criteria and were assessed in this review. The quality of the trials was reasonably good. The top three most commonly used QOL instruments in the trials were the Functional Assessment of Cancer Therapy/Functional Assessment of Chronic Illness Therapy, the Short Form-36 and the Menopause-Specific Quality of Life. Most studies found no differences between tamoxifen and aromatase inhibitor groups in terms of global QOL. QOL data affected treatment regimen recommendations in a few cases. A meta-analysis was not feasible because the RCTs included in our review varied in terms of sample size, comparators, QOL instrument used, and timing of QOL measurement. Additionally, as no search strategy has perfect sensitivity, specificity and accuracy, there is always a chance that potentially relevant articles were missed.
This systematic review suggests that the QOL of post-menopausal women is unlikely to be adversely affected by long-term use of adjuvant endocrine therapy. Efforts are needed to improve the quality of QOL reporting in clinical trials.
抗雌激素（ER）内分泌治疗是降低乳腺癌死亡率的一种有效治疗策略。该疗法的治疗指数优于化疗，但随着时间推移仍会影响患者的生活质量（QOL）。
本系统评价的目的是：（1）描述雌激素受体阳性（ER+）非转移性乳腺癌试验中使用的生活质量评估工具；（2）记录辅助内分泌治疗对绝经后ER+非转移性乳腺癌女性生活质量的纵向影响。
我们检索了三个电子文献数据库，查找从建库至2017年10月发表的文章，这些文章需描述：（1）一项非转移性乳腺癌的随机对照试验（RCT），其中至少有一组采用辅助内分泌治疗方案；（2）使用患者自我报告测量方法评估总体或乳腺癌特异性生活质量；（3）在至少5年的随访期间多个时间点的生活质量结果。所有纳入的试验均由两名 reviewers 独立评估，并使用标准化表格提取数据。
共有13项研究符合我们的纳入标准并在本评价中进行评估。试验质量总体较好。试验中最常用的三种生活质量评估工具是癌症治疗功能评估/慢性病治疗功能评估、简明健康状况调查简表（Short Form-36）和绝经特异性生活质量量表。大多数研究发现，他莫昔芬组和芳香化酶抑制剂组在总体生活质量方面没有差异。在少数情况下，生活质量数据影响了治疗方案的推荐。由于我们纳入评价的随机对照试验在样本量、对照、使用的生活质量评估工具和生活质量测量时间方面存在差异，因此无法进行荟萃分析。此外，由于没有一种检索策略具有完美的敏感性、特异性和准确性，总是有可能遗漏潜在相关的文章。
本系统评价表明，长期使用辅助内分泌治疗不太可能对绝经后女性的生活质量产生不利影响。需要努力提高临床试验中生活质量报告的质量。
