Deng Qian-Qian, Huang Xin-En, Ye Li-Hong, Lu Yan-Yan, Liang Yong, Xiang Jin
Department of Chemotherapy, The Affiliated Jiangsu Cancer Hospital of Nanjing Medical University, Nanjing, China.
Asian Pac J Cancer Prev. 2013;14(1):413-7. doi: 10.7314/apjcp.2013.14.1.413.
This phase II study was undertaken to determine the efficacy and safety of Loubo® (Lobaplatin) in combination with pemetrexed in treating patients with metastatic breast cancer who failed to respond to anthracycline or taxanes.
Metastatic breast cancer cases who had previously received an anthracycline and a taxane in either adjuvant or metastatic settings, were enrolled. All patients were recruited from Jiangsu Cancer Hospital and Research Institute, and were treated with Loubo® (Lobaplatin) 35 mg/m2 (intravenous; on day 1) and pemetrexed 500 mg/m2 (intravenous; on day 1) every 21 days. Efficacy and side effects were evaluated after at least two cycles of chemotherapy.
All eligible 19 patients completed at least 2 cycles of chemotherapy with pemetrexed and lobaplatin, and were evaluable. Overall, 3 (15.8%) patients achieved partial response, 11 (57.9%) stable disease, 5 (26.3%) progression of disease, with no complete remission. Response rate was 15.8%, disease control rate was 42.1%. The median survival time was 10.3 months. Neutrophil suppression occurred in 36.8% of patients who had grade 2 toxicity, and 26.3% had grade 3, 26.4% had grade 4. Thrombocytopenia was encountered as follows: 21.1% grade 2, 15.8% grade 3 and 5.5% grade 4. Incidences of anemia were 10.5% in grade 2, 5.3% grade 3 and 0% grade 4. Only 5.3% of patients required packed red blood cell transfusion. Grade 3 digestive tract toxicity occurred in 5.5% of patients. Other toxicities included elevated transaminase, oral mucositis and skin rashes.
The regimen of lobaplatin and pemetrexed is modestly active in metastatic breast cancer patients who failed anthracycline or taxanes, and the toxicity profile suggesting that the doses of chemotherapy should be further modified.
本II期研究旨在确定洛铂（乐铂）联合培美曲塞治疗对蒽环类药物或紫杉类药物无反应的转移性乳腺癌患者的疗效和安全性。
纳入既往在辅助或转移治疗中接受过蒽环类药物和紫杉类药物治疗的转移性乳腺癌病例。所有患者均来自江苏省肿瘤医院暨研究所，接受洛铂35mg/m²（静脉滴注；第1天）和培美曲塞500mg/m²（静脉滴注；第1天）治疗，每21天为一个周期。至少两个化疗周期后评估疗效和副作用。
所有符合条件的19例患者均完成了至少2个周期的培美曲塞和洛铂化疗，且可进行评估。总体而言，3例（15.8%）患者达到部分缓解，11例（57.9%）疾病稳定，5例（26.3%）疾病进展，无完全缓解病例。缓解率为15.8%，疾病控制率为42.1%。中位生存时间为10.3个月。36.8%的患者出现2级毒性的中性粒细胞减少，26.3%为3级，26.4%为4级。血小板减少情况如下：2级为21.1%，3级为15.8%，4级为5.5%。贫血发生率2级为10.5%，3级为5.3%，4级为0%。仅5.3%的患者需要输注浓缩红细胞。5.5%的患者出现3级消化道毒性。其他毒性包括转氨酶升高、口腔黏膜炎和皮疹。
洛铂和培美曲塞方案对蒽环类药物或紫杉类药物治疗失败的转移性乳腺癌患者有一定活性，且毒性特征提示化疗剂量应进一步调整。
