Unit of Advanced Palliative Home Care, Linköping University Hospital, Linköping, Sweden.
Acta Oncol. 2010;49(1):35-41. doi: 10.3109/02841860903268031.
The aim of this study was to explore the clinical value of gemcitabine combined with capecitabine (GC) in heavily pre-treated patients with metastatic breast cancer.
All patients had failed anthracyclines and taxanes. In 14 patients (41%), more than two metastatic sites were diagnosed with bone (68%) and liver (62%) being the most prominent. Gemcitabine (1,250 mg/m(2), d1+8) and capecitabine (800 mg/m(2) twice daily, d1-14) were administered according to a 3-week schedule. The majority of patients received GC as 3rd or 4th line chemotherapy for metastatic disease. Laboratory tests were done on day 1+8 in cycles. Subjective toxicity was recorded according to the NCI-CTC v. 2.0 criteria. Tumour evaluations were done every 12th week according to the RECIST criteria. The primary objective was to investigate time to progression. Secondary objectives were response rate with special focus on the proportion of patients achieving PR or SD of at least three months, toxicity and survival.
A total of 34 patients were enrolled. All subjects are eligible for toxicity, response and time to event analyses. Treatment was given until progressive disease, severe toxicity or until the patient wanted to withdraw. The Kaplan-Meier median time to progression was estimated to 4.3 months and the overall survival time to 13.7 months. Partial response was noted in 12 of 29 evaluable patients (41%). The best outcome amongst remaining patients was stable disease in nine (31%) or tumour progression in eight (28%). A delay of disease progression of more than three months was noted in 53% of the study population. The main side effect was granulocytopenia with 44% and 15% of patients suffering from grade 3 or grade 4 events respectively however, no neutropenic infections were observed. Pre-dominant grade 3 subjective toxicities were: fatigue (21% of patients) and hand-foot syndrome (15% of patients).
We investigated the value of the GC combination as a treatment for late stage breast cancer patients. Tumour progression was delayed and the treatment was well tolerated. We believe that the GC therapy can achieve meaningful palliation.
本研究旨在探讨吉西他滨联合卡培他滨（GC）在转移性乳腺癌患者中的临床价值。
所有患者均已接受蒽环类和紫杉类药物治疗。在 14 例患者（41%）中，有超过两个转移部位，其中以骨转移（68%）和肝转移（62%）最为突出。吉西他滨（1250mg/m2，d1+8）和卡培他滨（800mg/m2，每日 2 次，d1-14）按 3 周方案给药。大多数患者在转移性疾病中接受 GC 作为第 3 或第 4 线化疗。在每个周期的 d1+8 进行实验室检查。根据 NCI-CTC v.2.0 标准记录主观毒性。根据 RECIST 标准每 12 周进行一次肿瘤评估。主要目标是研究无进展生存期。次要目标是反应率，特别关注至少 3 个月达到 PR 或 SD 的患者比例、毒性和生存情况。
共纳入 34 例患者。所有患者均符合毒性、反应和时间事件分析的条件。治疗直至疾病进展、严重毒性或患者要求退出。Kaplan-Meier 无进展生存期估计为 4.3 个月，总生存期为 13.7 个月。在 29 例可评估患者中，12 例（41%）有部分缓解。其余患者中最好的结果是 9 例（31%）稳定疾病或 8 例（28%）肿瘤进展。研究人群中有 53%的患者疾病进展延迟超过 3 个月。主要的副作用是粒细胞减少，分别有 44%和 15%的患者发生 3 级或 4 级事件，但未观察到中性粒细胞感染。主要的 3 级主观毒性为：疲劳（21%的患者）和手足综合征（15%的患者）。
我们研究了 GC 联合治疗晚期乳腺癌患者的价值。肿瘤进展得到延缓，且治疗耐受性良好。我们认为 GC 治疗可以实现有意义的姑息治疗。
