Department of Breast Surgery, Cancer Center and Cancer Institute, Fudan University, 399 Ling-Ling Road, Shanghai, 200032, People's Republic of China.
Department of Oncology, Medical College, Fudan University, Shanghai, 200032, People's Republic of China.
Breast Cancer Res Treat. 2019 Jan;173(2):407-415. doi: 10.1007/s10549-018-5024-3. Epub 2018 Oct 25.
This study was designed to determine the safety and clinical efficacy of metronomic chemotherapy combined with aromatase inhibitors (AIs) for hormone receptor (HR)-positive advanced breast cancer (ABC) patients who cannot tolerate conventional-dose chemotherapy.
Postmenopausal patients with HR-positive ABC, who exhibited disease progression after first-line AIs treatment and who could not tolerate or rejected conventional chemotherapy, were enrolled in this study. Patients received capecitabine 500 mg PO TID (could be reduced to 500 mg QD in case of adverse effects) and exemestane 25 mg QD (after PD with letrozole) or letrozole 2.5 mg QD (after PD with exemestane). The primary endpoints were safety and tolerance, the secondary endpoints were objective response rate (ORR), clinical benefit rate (CBR), progression-free survival (PFS), and time to treatment failure (TTF).
In our analysis of 44 patients, the median age was 64 years (range 38-90) and 68.2% patients had at least two recurrences or metastatic lesions. Grade 3 toxicities (hand-foot syndrome) were observed only in 4 of the patients. Most patients exhibited no or mild toxicities. After a median follow-up of 14.8 months, ORR was 70.5%, CBR-77.3%, PFS-16.2 months, and TTF-14.4 months.
Metronomic oral capecitabine combined with AIs showed good efficacy, minimal toxicities, and good tolerance in HR-positive patients with ABC. It is a potential treatment option especially for postmenopausal HR-positive ABC patients in poor general condition who cannot tolerate conventional chemotherapy.
Clinicaltrials.gov NCT01924078.
本研究旨在确定节拍化疗联合芳香化酶抑制剂（AIs）治疗不能耐受常规剂量化疗的激素受体（HR）阳性晚期乳腺癌（ABC）患者的安全性和临床疗效。
本研究纳入了一线 AI 治疗后疾病进展且不能耐受或拒绝常规化疗的绝经后 HR 阳性 ABC 患者。患者接受卡培他滨 500mg PO TID（出现不良反应时可减至 500mg QD）和依西美坦 25mg QD（来曲唑耐药后）或来曲唑 2.5mg QD（依西美坦耐药后）治疗。主要终点为安全性和耐受性，次要终点为客观缓解率（ORR）、临床获益率（CBR）、无进展生存期（PFS）和治疗失败时间（TTF）。
在对 44 例患者的分析中，中位年龄为 64 岁（范围 38-90），68.2%的患者至少有 2 次复发或转移病灶。仅 4 例患者出现 3 级毒性（手足综合征）。大多数患者表现出无或轻度毒性。中位随访 14.8 个月后，ORR 为 70.5%，CBR-77.3%，PFS-16.2 个月，TTF-14.4 个月。
节拍口服卡培他滨联合 AIs 治疗 HR 阳性 ABC 患者疗效好，毒性低，耐受性好。对于一般状况较差、不能耐受常规化疗的绝经后 HR 阳性 ABC 患者，这是一种潜在的治疗选择。
Clinicaltrials.gov NCT01924078。
