Ghosn Marwan, Kattan Joseph, Farhat Fadi, Younes Fariha, Gasmi Jamal
Department of Oncology-Hematology, Hôtel-Dieu de France University Hospital, Achrafieh, Blvd Alfred Naccache, P.O. Box: 166830, Beirut, Lebanon, France.
Anticancer Res. 2006 May-Jun;26(3B):2451-6.
Vinorelbine is one of the most active cytotoxic agents in metastatic breast cancer. Its association with 5-Fluorouracil generates objective responses, varying between 44 and 55%, and improves the tolerance profile. The aim of this multicenter phase II trial was to assess the combination of capecitabine and vinorelbine as first-line chemotherapy in patients with metastatic breast cancer (MBC).
Thirty patients with MBC received a 3-week cycle combining capecitabine 825 mg/m2 twice a day on days 1 through 14, with 25 mg/m2 of vinorelbine on days 1 and 8. Treatment continued until progression, unacceptable toxicity or patient refusal to continue. The median age was 54 years (30-77) and the median WHO-PS was 1. Twenty patients (67%) received adjuvant chemotherapy including anthracycline and taxanes.
Objective responses occurred in 21 patients (70%). Stable disease lasting more than 6 months was observed in six patients (20%). The clinical benefit rate was 90%. The median progression-free survival and overall survival were 10 months and 30.4 months, respectively. The most frequent treatment-related toxicities were: WHO grades 3 and 4 neutropenia (two patients), febrile neutropenia (two patients), grade 3 asthenia (two patients) and grade 3 nausea/vomiting (one patient). No grade 3 hand-foot syndrome was observed.
The combination of capecitabine and vinorelbine is an active and safe regimen for first-line treatment of MBC.
长春瑞滨是转移性乳腺癌中最有效的细胞毒性药物之一。它与5-氟尿嘧啶联合使用可产生客观缓解率，在44%至55%之间变化，并改善耐受性。这项多中心II期试验的目的是评估卡培他滨和长春瑞滨联合作为转移性乳腺癌（MBC）患者的一线化疗方案。
30例MBC患者接受为期3周的化疗周期，在第1至14天每天两次给予卡培他滨825 mg/m²，在第1天和第8天给予长春瑞滨25 mg/m²。治疗持续至疾病进展、出现不可接受的毒性或患者拒绝继续治疗。中位年龄为54岁（30 - 77岁），中位世界卫生组织体能状态（WHO-PS）为1。20例患者（67%）接受过包括蒽环类和紫杉类的辅助化疗。
21例患者（70%）出现客观缓解。6例患者（20%）观察到疾病稳定持续超过6个月。临床获益率为90%。中位无进展生存期和总生存期分别为10个月和30.4个月。最常见的与治疗相关的毒性反应为：世界卫生组织3级和4级中性粒细胞减少（2例患者）、发热性中性粒细胞减少（2例患者）、3级乏力（2例患者）和3级恶心/呕吐（1例患者）。未观察到3级手足综合征。
卡培他滨和长春瑞滨联合是MBC一线治疗的一种有效且安全的方案。
