新辅助内分泌治疗的临床反应对患者预后的影响：JFMC34 - 0601多中心前瞻性新辅助内分泌试验的随访研究
Impact of clinical response to neoadjuvant endocrine therapy on patient outcomes: a follow-up study of JFMC34-0601 multicentre prospective neoadjuvant endocrine trial.
作者信息
Ueno Takayuki, Saji Shigehira, Masuda Norikazu, Kuroi Katsumasa, Sato Nobuaki, Takei Hiroyuki, Yamamoto Yutaka, Ohno Shinji, Yamashita Hiroko, Hisamatsu Kazufumi, Aogi Kenjiro, Iwata Hiroji, Yamanaka Takeharu, Sasano Hironobu, Toi Masakazu
机构信息
Department of Breast Surgery, Breast Oncology Center, The Cancer Institute Hospital, The Japanese Foundation for Cancer Research, Tokyo, Japan.
Department of Medical Oncology, Fukushima Medical University, Fukushima, Japan.
出版信息
ESMO Open. 2018 Feb 14;3(2):e000314. doi: 10.1136/esmoopen-2017-000314. eCollection 2018.
BACKGROUND
Neoadjuvant endocrine therapy (NET) has been demonstrated to improve breast-conserving rate and is a widely accepted treatment option for postmenopausal patients with hormone receptor-positive breast cancer. There are few reports on the association of NET response and long-term outcomes.
OBJECTIVES
To investigate the prognostic value of clinical response to NET.
METHODS
Long-term outcomes of NET were examined in 107 patients who participated in the multicentre prospective neoadjuvant exemestane study, JFMC34-0601. Patients were treated with 25 mg/day exemestane for 16 weeks followed by an 8-week extension depending on the treatment response.
RESULTS
Clinical response included partial response (PR) in 58 patients, stable disease in 41 patients and progressive disease (PD) in 8 patients. Clinical response was significantly associated with disease-free survival (DFS), distant disease-free survival (DDFS) and overall survival (OS) (P<0.0001 for all). Especially, patients with PD showed markedly poor outcomes with median DFS=17.8 months (HR (vs PR): 7.7 (95% CI 1.6 to 33)) and median OS=37.7 months (HR (vs PR): 26.3 (95% CI 2.4 to 655)). Preoperative endocrine prognostic index (PEPI) were associated with DFS and marginally with OS (P=0.022 and 0.066, respectively). PEPI=0 indicated an excellent prognosis with 95% 5-year DFS (95% CI 73 to 99). In the multivariate analysis including T stage, nodal status and Ki67, clinical response was an independent prognostic factor for DFS, DDFS and OS (P=0.032, 0.0007 and 0.020, respectively), whereas PEPI was marginally associated with DFS and OS (P=0.079 and 0.068, respectively).
CONCLUSIONS
Clinical response to NET showed an independent prognostic value. Patients with PD had markedly poor prognosis, indicating a need of additional therapy. PEPI=0 indicated an excellent prognosis. The integration of clinical response and PEPI would improve decision-making with regard to treatment options for endocrine-responsive breast cancer when these results are validated in a larger clinical trial.
TRIAL REGISTRATION NUMBER
UMIN C000000345.
背景
新辅助内分泌治疗（NET）已被证明可提高保乳率，是绝经后激素受体阳性乳腺癌患者广泛接受的治疗选择。关于NET反应与长期预后之间关联的报道较少。
目的
探讨NET临床反应的预后价值。
方法
对参加多中心前瞻性新辅助依西美坦研究JFMC34 - 0601的107例患者的NET长期预后进行了研究。患者接受每日25mg依西美坦治疗16周，然后根据治疗反应延长8周。
结果
临床反应包括58例部分缓解（PR）、41例疾病稳定和8例疾病进展（PD）。临床反应与无病生存期（DFS）、远处无病生存期（DDFS）和总生存期（OS）显著相关（所有P<0.0001）。特别是，PD患者的预后明显较差，中位DFS = 17.8个月（HR（与PR相比）：7.7（95%CI 1.6至33）），中位OS = 37.7个月（HR（与PR相比）：26.3（95%CI 2.4至655））。术前内分泌预后指数（PEPI）与DFS相关，与OS边缘相关（分别为P = 0.022和0.066）。PEPI = 0表明预后极佳，5年DFS为95%（95%CI 73至99）。在包括T分期、淋巴结状态和Ki67的多变量分析中，临床反应是DFS、DDFS和OS的独立预后因素（分别为P = 0.032、0.0007和0.020），而PEPI与DFS和OS边缘相关（分别为P = 0.079和0.068）。
结论
NET的临床反应显示出独立的预后价值。PD患者的预后明显较差，表明需要额外治疗。PEPI = 0表明预后极佳。当这些结果在更大规模的临床试验中得到验证时，将临床反应和PEPI相结合将改善内分泌反应性乳腺癌治疗方案的决策制定。
试验注册号
UMIN C0０0000345。
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