PDF(Pubmed)
Abstract：
Patients with metastatic triple-negative breast cancer (mTNBC) typically have a poor prognosis. The purpose of this study was to prospectively evaluate the efficacy and toxicity of biweekly combination of vinorelbine and oxaliplatin (NVBOX) in second- or third-line setting for mTNBC. Eligible patients were female with 18-70 y old, and had mTNBC that had progressed after 1or 2 prior chemotherapy regimens in the metastatic setting. NVBOX was given biweekly every 4 week for a maximum of 6 cycles. The primary endpoint was progression-free survival (PFS). Forty-4 patients were recruited. All patients had been exposed to anthracyclines and/or taxanes; 56.8% of patients were cis/carbo-platin pretreated. Among the 38 evaluable patients, overall response rate was 31.6% and 7 lasted ≥ 6 months. The median PFS and overall survival (OS) were 4.3 (95% CI, 3.6-5.0) months and 12.6 (95% CI, 8.1-17.0) months, respectively. PFS and OS was significantly shorter in patients with interval from diagnosis to recurrence ≤ 1 y and time to progression (TTP) of 1-2 previous regimens before recruitment ≤ 3 months. For 34 patients who were treated in second line setting, prior platinum was a factor significantly compromising the PFS of NVBOX. Grade 3/4 hematologic toxicities included neutropenia (70.5%), thrombocytopenia (27.3%) and anemia (15.9%). The most frequent grade 3/4 non-hematologic toxicities were constipation/abdominal distension (20.5%) and nausea/vomiting (13.6%). We conclude that biweekly NVBOX regimen is effective with a good safety profile in the second- or third-line mTNBC, which warrants further investigation in a phase III study. This trial was registered with www.clinicaltrials.gov (no. NCT01528826).
摘要：
转移性三阴性乳腺癌(mTNBC)患者通常预后不良。这项研究的目的是前瞻性评估双周联合长春瑞滨和奥沙利铂（NVBOX）在二线或三线治疗mTNBC的疗效和毒性。符合条件的患者为18-70岁的女性，并且mTNBC在转移背景下经过1或2次先前的化疗方案后进展。每4周一次给予NVBOX,最多6个周期。主要终点是无进展生存期（PFS）。招募了44名患者。所有患者均暴露于蒽环类和/或紫杉烷类；56.8％的患者接受了顺式/碳铂预处理。在38名可评估的患者中，总缓解率为31.6%,7例持续≥6个月.中位PFS和总生存期(OS)分别为4.3(95%CI,3.6-5.0)个月和12.6(95%CI,8.1-17.0)个月,分别。从诊断到复发的时间间隔≤1y，并且招募前1-2个方案的进展时间（TTP）≤3个月的患者的PFS和OS明显缩短。对于34例接受二线治疗的患者，之前的铂金是显著影响NVBOXPFS的一个因素。3/4级血液学毒性包括中性粒细胞减少症（70.5%），血小板减少（27.3%）和贫血（15.9%）。最常见的3/4级非血液学毒性是便秘/腹胀（20.5%）和恶心/呕吐（13.6%）。我们得出的结论是，每两周一次的NVBOX方案在二线或三线mTNBC中具有良好的安全性，这需要在III期研究中进行进一步调查。该试验已在www上注册。clinicaltrials.gov（没有。NCT01528826)。
