Department of Breast Cancer, Hospital Affiliated to Academy Military Medical Science, No 8, Dong Street, 100071 Fengtai District, Beijing, People's Republic of China.
Med Oncol. 2012 Mar;29(1):56-61. doi: 10.1007/s12032-010-9814-7. Epub 2011 Jan 25.
This study was conducted to evaluate the response rate of gemcitabine and cisplatin as second-line combination chemotherapy in patients with metastatic breast cancer (MBC) previously treated with anthracyclines and taxanes. Thirty-eight eligible women with measurable disease and anthracycline- and taxane-pretreated MBC were enrolled. The chemotherapy treatment consisted of gemcitabine (1,250 mg/m(2) by intravenous infusion over 30 min on days 1 and 8) and cisplatin (75 mg/m(2) by intravenous infusion over 1 h on day 1), which were administered every 21 days. Thirty-seven of 38 (97.4%) of patients were assessable for response. The objective response rate was 42.1% (95% CI, 26.4-57.8%) with 16 partial responses. The median time to progression (TTP) and overall survival (OS) for all patients were 5.4 months (95% CI, 2.7-8.1 months) and 13.9 months (95% CI, 9.4-18.4 months), respectively. The most frequent hematologic-related adverse events were grade 3/4 leucopenia and thrombocytopenia, observed in 10 patients (27.0%) and 11 (29.7%), respectively. Grade 3 stomatitis was observed in 3 (8.1%) patients. No grade 4 nonhematologic toxicity was observed in this study. No treatment-related deaths occurred during the study. In conclusion, the combination of gemcitabine and cisplatin is a safe and tolerable regimen as second-line combination for patients with anthracycline- and taxane-pretreated MBC.
本研究旨在评估吉西他滨和顺铂作为二线联合化疗方案在既往接受蒽环类和紫杉类药物治疗的转移性乳腺癌（MBC）患者中的缓解率。38 名符合条件的有可测量疾病且接受过蒽环类和紫杉类药物预处理的 MBC 女性患者入组。化疗方案包括吉西他滨（1250mg/m2，静脉输注 30 分钟，第 1 天和第 8 天）和顺铂（75mg/m2，静脉输注 1 小时，第 1 天），每 21 天给药一次。38 名患者中有 37 名（97.4%）可评估疗效。客观缓解率为 42.1%（95%可信区间，26.4%-57.8%），其中 16 名患者有部分缓解。所有患者的中位无进展生存期（TTP）和总生存期（OS）分别为 5.4 个月（95%可信区间，2.7-8.1 个月）和 13.9 个月（95%可信区间，9.4-18.4 个月）。最常见的血液学相关不良事件为 3/4 级白细胞减少和血小板减少，分别在 10 名（27.0%）和 11 名（29.7%）患者中观察到。3 名（8.1%）患者出现 3 级口腔炎。本研究未观察到 4 级非血液学毒性。研究期间无治疗相关死亡。总之，吉西他滨和顺铂联合方案作为蒽环类和紫杉类药物预处理的 MBC 患者的二线联合方案，是一种安全且可耐受的方案。
