a Medical Oncology Unit , ASL Frosinone , Frosinone , Italy.
b Medical Oncology , Sandro Pertini Hospital , Roma , Italy.
Cancer Biol Ther. 2019;20(2):192-200. doi: 10.1080/15384047.2018.1523095. Epub 2018 Nov 7.
We carried out a retrospective observational study of 264 HER2-positive advanced breast cancer (ABC) patients to explore the efficacy of first-line treatment with pertuzumab/trastuzumab/taxane in real-world setting. Survival data were analyzed by Kaplan Meier curves and log rank test. Median follow-up, length of pertuzumab/trastuzumab/taxane treatment and of pertuzumab, trastuzumab maintenance were 21, 4 and 15 months, respectively. The response rate was 77.3%, and the clinical benefit rate 93.6%. Median progression-free survival (mPFS) was 21 months, and median overall survival (mOS) was not reached. When comparing patients by trastuzumab-pretreatment, similar PFS were observed, although a longer OS was reached in trastuzumab-naïve patients (p = 0.02). Brain metastases at baseline and their development in course of therapy were associated with significantly shorter PFS (p = 0.0006) and shorter OS, although at a not fully statistically relevant extent (p = 0.06). The addition of maintenance endocrine therapy (ET) to pertuzumab/trastuzumab maintenance was associated with longer PFS (p = 0.0001), although no significant differences were detected in OS (p = 0.31). Results were confirmed by propensity score analysis (p = 0.003 and p = 0.46, respectively). In multivariate models, longer PFS was related to lower Performance Status (PS) (p = 0.07), metastatic stage at diagnosis (p = 0.006) and single metastatic site (p < 0.0001). An OS advantage was observed with lower PS (p < 0.0001), single metastatic site (p = 0.004), no prior exposure to trastuzumab (p = 0.004) and response to pertuzumab-based treatment (p = 0.003). Our results confirm that trastuzumab/pertuzumab/taxane is the standard of care as first-line treatment of patients with HER2-positive ABC even in the real-world setting. Moreover, the double-maintenance therapy (HER2 block and ET) is strongly recommended when feasible.
我们进行了一项回顾性观察研究，纳入了 264 例 HER2 阳性晚期乳腺癌（ABC）患者，以探索在真实环境中曲妥珠单抗/帕妥珠单抗/紫杉烷类药物作为一线治疗的疗效。采用 Kaplan-Meier 曲线和对数秩检验分析生存数据。中位随访时间、曲妥珠单抗/帕妥珠单抗/紫杉烷类药物治疗时间和曲妥珠单抗、帕妥珠单抗维持治疗时间分别为 21 个月、4 个月和 15 个月。客观缓解率为 77.3%，临床获益率为 93.6%。中位无进展生存期（mPFS）为 21 个月，中位总生存期（mOS）尚未达到。根据曲妥珠单抗预处理情况进行患者比较时，观察到了相似的 PFS，但在曲妥珠单抗初治患者中观察到了更长的 OS（p=0.02）。基线时存在脑转移和治疗过程中出现脑转移与显著更短的 PFS（p=0.0006）和 OS 相关，尽管在统计学上尚未完全相关（p=0.06）。曲妥珠单抗/帕妥珠单抗维持治疗联合维持内分泌治疗（ET）与更长的 PFS 相关（p=0.0001），但在 OS 方面未观察到显著差异（p=0.31）。倾向评分分析结果得到了证实（p=0.003 和 p=0.46）。在多变量模型中，较低的体能状态（PS）（p=0.07）、诊断时的转移性分期（p=0.006）和单一转移部位（p<0.0001）与更长的 PFS 相关。PS 较低（p<0.0001）、单一转移部位（p=0.004）、既往未使用曲妥珠单抗（p=0.004）和对基于曲妥珠单抗的治疗有反应（p=0.003）与 OS 获益相关。我们的研究结果证实，即使在真实环境中，曲妥珠单抗/帕妥珠单抗/紫杉烷类药物也是 HER2 阳性 ABC 患者一线治疗的标准治疗方法。此外，当可行时，强烈推荐双重维持治疗（HER2 阻断和 ET）。
