Department of Medical Oncology, Oscar Lambret Center, Lille, France.
Department of Biostatistics, Institut Curie, Paris, France.
Breast Cancer Res Treat. 2019 Dec;178(3):505-512. doi: 10.1007/s10549-019-05423-5. Epub 2019 Sep 5.
Outcome of HER2-positive metastatic breast cancer (MBC) patients has improved since the use of trastuzumab. However, most HER2-positive MBC patients will progress within 1 year of trastuzumab-based therapy. Only limited data are available concerning long-term responders.
The primary objective of this study was to compare overall survival (OS) of HER2+ MBC patients with long-term response to first-line trastuzumab with overall survival of those with non-long-term response, based on two institutional databases: the French Epidemiological Strategy and Medical Economics program and the Breast Database. Long-term responders (LTR) were defined as patients with non-progressive disease for ≥ 2 years on first-line trastuzumab. Secondary objectives included progression-free survival (PFS), and predictive factors for LTR status.
From 2004 to 2014, 422 HER2-positive MBC patients received first-line trastuzumab. With a median follow-up of 48 months, median OS and PFS were 63 months (CI95%, 50-71), and 18 months (CI95%, 15-21) respectively. In 111 patients (26.3%) classified as LTR, median OS was 110 months (CI95%, 95-not reached) versus 56 months in non-LTR patients (CI95%, 47-68). In multivariate logistic regressions, the following factors were independently associated with LTR status: number of metastatic sites (≤ 2 versus > 2, p = 0.01); endocrine therapy for metastatic disease (p = 0.001) and taxane-based first-line chemotherapy (p = 0.003).
Several features are associated with long-term response to trastuzumab: few metastatic sites, taxane-based chemotherapy and maintenance endocrine therapy in HR+ patients. Further studies are needed to identify patients in whom trastuzumab can be stopped after several years of sustained response.
自曲妥珠单抗问世以来，HER2 阳性转移性乳腺癌（MBC）患者的预后得到了改善。然而，大多数 HER2 阳性 MBC 患者在曲妥珠单抗为基础的治疗后 1 年内会进展。仅有有限的数据涉及长期缓解者。
本研究的主要目的是根据两个机构数据库（法国流行病学策略和医学经济学项目和乳腺癌数据库）比较一线曲妥珠单抗治疗的 HER2+MBC 患者中具有长期缓解的患者的总生存（OS）与非长期缓解患者的 OS。长期缓解者（LTR）定义为在一线曲妥珠单抗治疗期间无进展疾病≥2 年的患者。次要目标包括无进展生存（PFS）和 LTR 状态的预测因素。
2004 年至 2014 年，422 例 HER2 阳性 MBC 患者接受一线曲妥珠单抗治疗。中位随访 48 个月时，中位 OS 和 PFS 分别为 63 个月（95%CI95%，50-71）和 18 个月（95%CI95%，15-21）。在 111 例（26.3%）被分类为 LTR 的患者中，中位 OS 为 110 个月（95%CI95%，95-未达到），而非 LTR 患者为 56 个月（95%CI95%，47-68）。在多变量逻辑回归中，以下因素与 LTR 状态独立相关：转移部位数量（≤2 与>2，p=0.01）；转移性疾病的内分泌治疗（p=0.001）和紫杉烷类一线化疗（p=0.003）。
有几个特征与曲妥珠单抗的长期缓解相关：转移部位少、紫杉烷类化疗和 HR+患者的维持内分泌治疗。需要进一步研究以确定在持续缓解数年之后可以停止曲妥珠单抗治疗的患者。
