Martin-Romano Patricia, Baraibar Iosune, Espinós Jaime, Legaspi Jairo, López-Picazo Jose M, Aramendía Jose Manuel, Fernández Oscar A, Santisteban Marta
Department of Medical Oncology. Clínica, Universidad de Navarra, Pamplona, Navarra, Spain.
Breast J. 2018 Jul;24(4):473-479. doi: 10.1111/tbj.12975. Epub 2017 Dec 29.
The combination of Pegylated Liposomal Doxorubicin (PLD) plus Gemcitabine (GEM) has been previously investigated in the treatment of metastatic breast cancer (MBC). PLD is a doxorubicin formulation with prolonged circulation time and better tissue distribution. GEM is a nucleoside analog with nonoverlapping toxicity compared to PLD. The aim of our study was to assess efficacy, toxicity, and long-term outcome of this combination. Patients with heavily treated MBC were retrospectively analyzed. Chemotherapy consisted of PLD 25 mg/m and GEM 800 mg/m day 1, on a three-week schedule. Cardiac function was evaluated baseline and during treatment. Radiological response was graded according to RECIST criteria v1.1. Toxicity was scored according to CTCAE v4.0. Progression-free survival (PFS) and overall survival (OS) were evaluated. From 2001 to 2014, 122 pts were included. Median age was 55 (range: 28-84). Median previous treatment schedules in the metastatic scenario were 3 (range: 1-15). Most patients received prior anthracyclines (85%). Median number of metastatic sites was 2 (range: 1-7). Median number of cycles delivered was 5 (range: 1-36). Overall response rate was 31% (5% complete responses; 26% partial responses). Stable and progressive diseases were observed in 32% and 26% of patients. Grade ≥3 neutropenia was observed in 29 patients (24%). Grade ≥3 hand-foot syndrome was detected in 17 patients (14%), mostly since cycle 3 (88%). Median cumulative PLD dose was 125 mg/m . At a median follow-up of 101 months, median PFS and OS were 7 and 22 months, respectively. PLD-GEM combination achieves remarkable long-term outcomes with an acceptable toxicity profile in patients with MBC.
聚乙二醇化脂质体阿霉素（PLD）联合吉西他滨（GEM）治疗转移性乳腺癌（MBC）的疗效此前已得到研究。PLD是一种阿霉素制剂，具有延长的循环时间和更好的组织分布。GEM是一种核苷类似物，与PLD的毒性不重叠。我们研究的目的是评估这种联合治疗的疗效、毒性和长期结果。对接受过大量治疗的MBC患者进行回顾性分析。化疗方案为第1天给予PLD 25mg/m²和GEM 800mg/m²，每三周一次。在基线和治疗期间评估心功能。根据RECIST标准v1.1对放射学反应进行分级。根据CTCAE v4.0对毒性进行评分。评估无进展生存期（PFS）和总生存期（OS）。2001年至2014年，共纳入122例患者。中位年龄为55岁（范围：28 - 84岁）。转移性疾病患者既往治疗方案的中位数为3个（范围：1 - 15个）。大多数患者接受过蒽环类药物治疗（85%）。转移部位的中位数为2个（范围：1 - 7个）。给药周期的中位数为5个（范围：1 - 36个）。总缓解率为31%（完全缓解5%；部分缓解26%）。32%和26%的患者分别观察到病情稳定和进展。29例患者（24%）出现≥3级中性粒细胞减少。17例患者（14%）检测到≥3级手足综合征，大多从第3周期开始（88%）。PLD的中位累积剂量为125mg/m²。中位随访101个月时，PFS和OS的中位数分别为7个月和22个月。PLD - GEM联合治疗在MBC患者中取得了显著的长期疗效，且毒性可接受。
