Department of Medical Oncology, Cancer Hospital, Institute, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100021, China.
Chin Med J (Engl). 2012 Mar;125(5):775-9.
Treatment option for metastatic breast cancer (MBC) patients pre-treated with chemotherapy is limited. Oral etoposide has shown some promises in these patients. However, patients who received heavy prior chemotherapy may have poor tolerance to prolonged oral etoposide exposure. This study is a single-arm clinical trial that evaluates the efficacy and safety of short-term oral etoposide in Chinese patients with MBC who had received heavy prior therapy.
MBC patients receiving at least two chemotherapy regimens prior to the enrollment were treated with repeated cycles of oral etoposide (60 mg×m(-2)×d(-1) on days 1-10, followed by 11 days of rest). The primary end point was the progression free survival (PFS). The secondary end points were objective response rate (ORR), clinical benefit rate (CBR), overall survival (OS), and toxicity profiles.
Thirty-two patients received 230 cycles of oral etoposide with a median of 6 cycles (range, 2-20 cycles) per patient. Eight patients (25%) had partial response (PR) and 14 patients achieved stable disease (SD). The ORR was 25%. Nine patients achieved SD for more than 24 weeks and CBR was 53%. The median PFS and OS were 5 (range, 1.5-17.0 months) and 16 months (range, 3.0-51.0 months), respectively. The patients who achieved clinical benefit had longer survival time than those who did not (25.0 versus 11.0 months, P<0.01). Among the 16 patients who received more than four regimens prior to this study, four patients achieved PR and four achieved SD for more than 24 weeks, with a CBR of 50%. The most common hematologic adverse events were anemia (43.8%) and neutropenia (38.5%). Nausea/vomiting (75.0%) and alopecia (62.5%) were the most frequent non-hematologic toxicities.
Oral etoposide is effective and well tolerated in Chinese women with heavily pretreated MBC.
接受过化疗的转移性乳腺癌（MBC）患者的治疗选择有限。口服依托泊苷在这些患者中显示出一定的疗效。然而，接受过大量先前化疗的患者可能对延长口服依托泊苷暴露的耐受性差。本研究是一项单臂临床试验，评估了重复周期口服依托泊苷治疗先前接受过大量治疗的中国 MBC 患者的疗效和安全性。
入组前至少接受过两种化疗方案的 MBC 患者接受重复周期的口服依托泊苷（第 1-10 天，每天 60mg×m(-2)×d(-1)，随后休息 11 天）。主要终点是无进展生存期（PFS）。次要终点是客观缓解率（ORR）、临床获益率（CBR）、总生存期（OS）和毒性谱。
32 例患者接受了 230 个周期的口服依托泊苷，中位周期数为 6 个周期（范围为 2-20 个周期）/患者。8 例（25%）患者有部分缓解（PR），14 例患者有稳定疾病（SD）。ORR 为 25%。9 例患者 SD 持续时间超过 24 周，CBR 为 53%。中位 PFS 和 OS 分别为 5（范围为 1.5-17.0 个月）和 16 个月（范围为 3.0-51.0 个月）。达到临床获益的患者生存时间长于未达到临床获益的患者（25.0 个月与 11.0 个月，P<0.01）。在本研究之前接受过 4 种以上方案治疗的 16 例患者中，4 例患者 PR，4 例患者 SD 持续时间超过 24 周，CBR 为 50%。最常见的血液学不良反应是贫血（43.8%）和中性粒细胞减少症（38.5%）。恶心/呕吐（75.0%）和脱发（62.5%）是最常见的非血液学毒性。
口服依托泊苷在中国大量预处理的 MBC 女性中是有效且耐受良好的。
