Key laboratory of Carcinogenesis and Translational Research (Ministry of Education), Medical Oncology Department, Peking University School of Oncology, Beijing Cancer Hospital & Institute, 52 Fucheng Rd, Beijing 100142, China.
Cancer Chemother Pharmacol. 2012 May;69(5):1315-22. doi: 10.1007/s00280-012-1830-1. Epub 2012 Feb 4.
To evaluate the efficacy and safety of gemcitabine in combination with vinorelbine in elderly patients with anthracycline- and taxane-pretreated metastatic breast cancer (MBC).
Elderly patients with MBC received gemcitabine 1,000 mg m(-2) and vinorelbine 25 mg m(-2) on days 1 and 8 every 3 weeks for a maximum of 6 cycles. The primary end points were objective response and toxicity. The secondary end points included progression-free survival (PFS), overall survival (OS), and prognostic factors associated with disease control, PFS, and OS.
Fifty-one patients with a median age of 73 years (range, 65-84 years) were included. The response rate according to Response Evaluation Criteria in Solid Tumors was 33.3% (95% confidence interval [CI], 20.4 to 46.2%). At a median follow-up of 16.2 months, median PFS and OS were 6.2 (95% CI, 4.6 to 7.8) and 17.0 months (95% CI, 14.5 to 19.5), respectively. Grade 3 to 4 adverse events included neutropenia (25.5%), anemia (13.7%), thrombocytopenia (9.8%), fatigue (5.9%), constipation (3.9%), neuropathy (3.9%), and hepatotoxicity (3.9%). Neutropenic fever occurred in 2 patients. There was one toxic death due to massive gastrointestinal hemorrhage. The study of prognostic factors did not reveal any predictive factor of disease control, while response to treatment and Eastern Cooperative Oncology Group performance status was the main factor conditioning PFS and OS, respectively.
Gemcitabine in combination with vinorelbine is active and safe in elderly patients with anthracycline- and taxane-pretreated metastatic breast cancer.
评估吉西他滨联合长春瑞滨治疗蒽环类和紫杉类预处理的转移性乳腺癌（MBC）老年患者的疗效和安全性。
MBC 老年患者接受吉西他滨 1000mg/m²和长春瑞滨 25mg/m²，第 1 天和第 8 天，每 3 周为 1 个周期，最多 6 个周期。主要终点为客观缓解率和毒性。次要终点包括无进展生存期（PFS）、总生存期（OS）和与疾病控制、PFS 和 OS 相关的预后因素。
51 例患者的中位年龄为 73 岁（范围，65-84 岁）。根据实体瘤反应评价标准，缓解率为 33.3%（95%可信区间[CI]，20.4 至 46.2%）。中位随访 16.2 个月时，中位 PFS 和 OS 分别为 6.2（95%CI，4.6 至 7.8）和 17.0 个月（95%CI，14.5 至 19.5）。3-4 级不良事件包括中性粒细胞减少（25.5%）、贫血（13.7%）、血小板减少（9.8%）、乏力（5.9%）、便秘（3.9%）、周围神经病变（3.9%）和肝毒性（3.9%）。2 例患者发生中性粒细胞发热。有 1 例因大量胃肠道出血导致毒性死亡。预后因素的研究未发现任何疾病控制的预测因素，而对治疗的反应和东部合作肿瘤组表现状态是分别影响 PFS 和 OS 的主要因素。
吉西他滨联合长春瑞滨治疗蒽环类和紫杉类预处理的转移性乳腺癌老年患者有效且安全。
