J Natl Compr Canc Netw. 2019 Jan;17(1):47-56. doi: 10.6004/jnccn.2018.7066.
Comparative real-world outcomes for patients with HER2-positive (HER2+) breast cancer receiving adjuvant trastuzumab outside of clinical trials are lacking. This study sought to retrospectively characterize outcomes for patients with node-negative and node-positive breast cancer receiving adjuvant trastuzumab in combination with docetaxel/cyclophosphamide (DCH), docetaxel/carboplatin/trastuzumab (TCH), or fluorouracil/epirubicin/cyclophosphamide followed by docetaxel/trastuzumab (FEC-DH) chemotherapy in Alberta, Canada, from 2007 through 2014. Disease-free survival and overall survival (OS) analyses for node-negative cohorts receiving DCH (n=111) or TCH (n=371) and node-positive cohorts receiving FEC-DH (n=146) or TCH (n=315) were compared using chi-square, Kaplan-Meier, or Cox multivariable analysis where appropriate. Median follow-up was similar in node-negative (63.9 months) and node-positive (69.0 months) cohorts. The 5-year OS rates in patients with node-negative disease receiving DCH or TCH were similar (95.2% vs 96.9%; =.268), whereas 5-year OS rates were higher but nonsignificant for patients with node-positive disease treated with FEC-DH compared with TCH (95.2% vs 91.4%; =.160). Subgroup analysis of node-positive cohorts showed significantly improved OS with FEC-DH versus TCH in patients with estrogen receptor (ER)/progesterone receptor (PR)-positive breast cancer (98.3% vs 91.6%, respectively; =.014). Conversely, patients with ER/PR-negative disease showed a nonsignificant trend toward higher OS rates with TCH versus FEC-DH (91.6% vs 83.3%, respectively; =.298). Given the retrospective design, we were unable to capture all potential covariates that may have impacted treatment assignment and/or outcomes. Furthermore, cardiac toxicity data were unavailable. Survival rates of patients with HER2+ breast cancer in our study are comparable to those seen in clinical trials. Our findings support chemotherapy de-escalation in patients with node-negative disease and validate the efficacy of FEC-DH in those with node-positive disease.
在临床试验之外，接受曲妥珠单抗辅助治疗的 HER2 阳性（HER2+）乳腺癌患者的真实世界疗效比较结果尚不清楚。本研究旨在回顾性分析 2007 年至 2014 年期间在加拿大阿尔伯塔省，接受曲妥珠单抗联合多西他赛/环磷酰胺（DCH）、多西他赛/卡铂/曲妥珠单抗（TCH）、或氟尿嘧啶/表柔比星/环磷酰胺序贯多西他赛/曲妥珠单抗（FEC-DH）化疗的淋巴结阴性和淋巴结阳性乳腺癌患者的无病生存期（DFS）和总生存期（OS）。采用卡方检验、Kaplan-Meier 或 Cox 多变量分析比较淋巴结阴性组接受 DCH（n=111）或 TCH（n=371）以及淋巴结阳性组接受 FEC-DH（n=146）或 TCH（n=315）的无病生存和总生存分析。淋巴结阴性（63.9 个月）和淋巴结阳性（69.0 个月）队列的中位随访时间相似。接受 DCH 或 TCH 治疗的淋巴结阴性疾病患者的 5 年 OS 率相似（95.2% vs 96.9%；=.268），而接受 FEC-DH 治疗的淋巴结阳性疾病患者的 5 年 OS 率较高，但与 TCH 相比无统计学意义（95.2% vs 91.4%；=.160）。淋巴结阳性队列的亚组分析显示，在 ER/PR 阳性乳腺癌患者中，FEC-DH 与 TCH 相比，OS 显著改善（分别为 98.3% vs 91.6%，P=.014）。相反，在 ER/PR 阴性疾病患者中，TCH 与 FEC-DH 相比，OS 率有升高趋势，但无统计学意义（分别为 91.6% vs 83.3%，P=.298）。鉴于回顾性设计，我们无法捕获可能影响治疗分配和/或结局的所有潜在协变量。此外，心脏毒性数据不可用。本研究中 HER2+乳腺癌患者的生存率与临床试验中的生存率相当。我们的研究结果支持淋巴结阴性疾病患者的化疗降阶梯治疗，并验证了 FEC-DH 在淋巴结阳性疾病患者中的疗效。
