Supplementary data: A clinical systematic literature review of treatments among patients with advanced and/or metastatic human epidermal growth factor receptor 2 positive breast cancer

These are peer-reviewed supplementary materials for the article 'A clinical systematic literature review of treatments among patients with advanced and/or metastatic human epidermal growth factor receptor 2 positive breast cancer' published in the Journal of Comparative Effectiveness Research.Table A 1: Search Strategy for EmbaseTable A 2: Search Strategy for MEDLINETable A 2: Search Strategy for Cochrane CentralTable A 3: Risk f of bias assessment for RCTsTable A 4: Risk of bias assessment for observational studiesAim: This systematic literature review aims to summarize the efficacy/effectiveness of treatments, including eribulin (ERI)-based and anti-human epidermal growth factor receptor 2 (HER2) treatments in advanced/metastatic HER2+ breast cancer. Methods: Three databases from 2016 to September 2021 were searched for clinical trials and observational studies in patients receiving first-line (1L) standard of care (SOC), second-line (2L) SOC or third-line or subsequent lines (3L+). Results: 2692 citations were screened, and 38 studies were included. Eleven studies were randomized-controlled trials (RCTs; 5 in 1L, 6 in 3L+), 6 were single-arm trials (5 in 1L, 1 in 3L+) and 21 were observational studies (13 in 1L, 6 in 2L, 4 in 3L+ [note that studies with subgroups for 1L, 2L, 3L+ are double-counted]). Longer overall survival (OS) was associated with 1L and 2L treatment, and for 3L+ studies that included ERI, ERI or trastuzumab (Tmab) + ERI led to longer OS than treatments of physician’s choice (median OS of 11, 10 and 8.9 months, respectively). Progression-free survival was 9 months in Tmab + pertuzumab (Pmab) + ERI, 4 months in mTmab + ERI and 3.3 months in ERI. Conclusion: Available treatments provide a wide range of efficacy. However, later lines lack standardization and conclusions on comparative effectiveness are limited by differing trial designs. Thus, the chance of prolonged survival with new agents warrants further research.

本数据集为发表于《比较有效性研究杂志》的论文《关于晚期和/或转移性人类表皮生长因子受体2阳性乳腺癌治疗系统文献综述》的同行评审补充材料。表A1：Embase数据库的搜索策略；表A2：MEDLINE数据库的搜索策略；表A2：Cochrane Central数据库的搜索策略；表A3：随机对照试验（RCT）的偏倚风险评估；表A4：观察性研究的偏倚风险评估。研究目标：本系统文献综述旨在总结治疗方案的疗效/有效性，包括以厄瑞布林（ERI）为基础和针对人表皮生长因子受体2（HER2）的疗法在晚期/转移性HER2+乳腺癌中的应用。研究方法：检索了2016年至2021年9月间的三个数据库，以查找接受一线（1L）标准治疗（SOC）、二线（2L）SOC或三线及以上（3L+）治疗的患者的临床试验和观察性研究。研究结果：筛选出2692篇文献，并纳入了38项研究。其中11项为随机对照试验（RCT；1L阶段5项，3L+阶段6项），6项为单臂试验（1L阶段5项，3L+阶段1项），21项为观察性研究（1L阶段13项，2L阶段6项，3L+阶段4项[注：1L、2L、3L+阶段的子组研究被重复计算]）。较长的总生存期（OS）与1L和2L治疗方案相关，对于包含ERI的3L+研究，ERI或曲妥珠单抗（Tmab）+ERI的治疗方案相较于医生选择的治疗方案（中位OS分别为11、10和8.9个月）能够延长生存期。无进展生存期（PFS）在Tmab+帕妥珠单抗（Pmab）+ERI治疗方案中为9个月，在mTmab+ERI方案中为4个月，在ERI方案中为3.3个月。研究结论：现有的治疗方案提供了广泛的疗效。然而，后续治疗方案缺乏标准化，且比较有效性的结论受不同试验设计的限制。因此，新药延长生存期的可能性需要进一步研究。