Phase II study of pegylated liposomal doxorubicin plus vinorelbine in breast cancer with previous anthracycline exposure.
Phase II study of pegylated liposomal doxorubicin plus vinorelbine in breast cancer with previous anthracycline exposure.
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DOI：
10.3816/cbc.2004.n.041
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发表时间：
2004-12-01
影响因子：
3.1
通讯作者：
Diaz-Rubio, Eduardo
中科院分区：
文献类型：
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作者：
Martin, Miguel;Garcia-Donas, Jesus;Diaz-Rubio, Eduardo
35 名转移性乳腺癌 (MBC) 患者进入了一项 II 期研究，第 1 天静脉注射聚乙二醇化脂质体多柔比星 35 mg/m2，加长春瑞滨 30 mg/m2 静脉注射。每 4 周的第一天。患者需要患有可测量的疾病、既往接受过含有蒽环类药物的化疗，并且左心室射血分数（LVEF）正常。对 34 名患者的反应和毒性进行了评估。总体缓解率（以意向治疗为基础）为 35%（34 例中的 12 例；95% CI，20%-54%）。注意到 1 份完整答复和 11 份部分答复。此外，14 名患者 (41%) 病情稳定，持续时间 > 4 个月，7 名患者 (20.5%) 出现疾病进展。当该组合用作一线和二线化疗时，其反应率分别为 31%（13 例中的 4 例）和 38%（21 例中的 8 例）。疾病进展的中位时间为 7 个月（范围，1-35 个月），中位总生存期为 13 个月（范围，2 至 > 62 个月）。中性粒细胞减少症是最常见的毒性（44% 的患者和 19% 的周期为 4 级），但中性粒细胞减少症发热仅见于 3 例。没有发生脓毒症死亡。非血液学 3 级副作用包括皮肤毒性（掌跖红肿感觉综合征，6%）和粘膜炎（15%）。 53% 的患者出现晚期脱发（41% 为 1 级，12% 为 2 级）。基线时中位 LVEF 为 64%（范围为 50%-81%），治疗后为 62%（范围为 37%-70%）。 3 名患者的 LVEF 降低至 < 50%；然而，没有发现临床心力衰竭，其中 2 名患者在停止治疗后恢复了正常值。聚乙二醇化脂质体多柔比星和长春瑞滨的组合可以安全地给予接受过蒽环类药物治疗的 MBC 患者，并且在该人群中有效。
Thirty-five patients with metastatic breast cancer (MBC) entered a phase II study of pegylated liposomal doxorubicin 35 mg/m2 intravenously (i.v.) on day 1 plus vinorelbine 30 mg/m2 i.v. on day 1 every 4 weeks. Patients were required to have measurable disease, previous chemotherapy with an anthracycline-containing regimen, and a normal left ventricular ejection fraction (LVEF). Thirty-four patients were assessable for response and toxicity. The overall response rate (on an intent-to-treat basis) was 35% (12 of 34; 95% CI, 20%-54%). One complete response and 11 partial responses were noted. In addition, 14 patients (41%) had stable disease of > 4 months duration, and 7 patients (20.5%) had disease progression. The response rates to the combination when it was used as first- and second-line chemotherapy were 31% (4 of 13) and 38% (8 of 21), respectively. Median time to disease progression was 7 months (range, 1-35 months) and median overall survival was 13 months (range, 2 to > 62 months). Neutropenia was the most frequent toxicity (grade 4 in 44% of patients and 19% of cycles), but neutropenic fever was seen in only 3 cases. No septic deaths occurred. Nonhematologic grade 3 side effects included skin toxicity (palmar-plantar erythrodysesthesia syndrome, 6%) and mucositis (15%). Late alopecia was seen in 53% of patients (grade 1 in 41%, and grade 2 in 12%). The median LVEFs were 64% (range, 50%-81%) at baseline and 62% (range, 37%-70%) after treatment. Three patients presented an LVEF decrease to < 50%; however, no clinical heart failure was noted, and 2 of these patients recovered normal values after cessation of therapy. The combination of pegylated liposomal doxorubicin and vinorelbine can be safely administered to patients with anthracycline-pretreated MBC and is active in this population.