口服长春瑞滨联合卡培他滨（口服长春新碱方案）用于晚期乳腺癌（ABC）患者。意大利南部肿瘤协作组（GOIM）的一项II期研究。
Oral vinorelbine plus capecitabine (oral vincap) combination in patients with advanced breast cancer (ABC). A phase II study of the GOIM (Gruppo Oncologico dell'Italia Meridionale).
作者信息
Lorusso V, Spada M, Giampaglia M, Misino A, Calabrese R, Latorre A, Monticelli G, Guida M, Sambiasi D, Colucci G
机构信息
Medical Oncology Unit, Vito Fazzi Hospital, Lecce.
出版信息
Ann Oncol. 2006 Jun;17 Suppl 7:vii15-7. doi: 10.1093/annonc/mdl942.
BACKGROUND
Vinorelbine i.v. and capecitabine are two of the most effective single agents in previously treated advanced breast cancer (ABC). A number of studies have been reported with the combination of these agents. Actually, the availability of oral formulation for vinorelbine allows a full oral combination of the two agents. The aim of this study was to evaluate the activity and toxicity of this novel combination.
PATIENTS AND METHODS
Thirty-eight advanced breast cancer patients refractory to anthracyclines and taxanes were included in this study. Treatment consisted of vinorelbine 60 mg/m(2) (days 1 + 8), and capecitabine 2000 mg/m(2) (days 2-7 and 9-16) every 3 weeks.
RESULTS
A total of 228 courses were given with a mean of three cycles/patient (range 1-12). Five patients (13.1%) had no toxicity at all. Hematologic side-effects were: neutropenia grade 2-3 in seven patients (18.9%) and grade 4 in one patient (2.7%), anemia grade 1 in 11 patients (29.7%), grade 2-3 in five patients (13.5%), thrombocytopenia grade 1 in six patients (16.2%) and grade 3 in one patient (2.7%). Non-hematologic side-effects were: fatigue grade 1 in five patients (13.5%), hand-foot syndrome grade 1 in two patients (5.4%) and grade 2 in two patients (5.4%), nausea/vomiting grade 1 in two patients (5.4%), grade 2 in three patients (8.1%) and grade 3 in one patient (2.7%), constipation grade 1 in two patients (5.4%), peripheral neurotoxicity grade 1 in three patients (8.1%) and grade 2 in one patient (2.7%), gastric pain grade 1 in two patients (5.4%), stomatitis grade 1 in three patients (8.1%) and grade 2 in one patient (2.7%). Out of 38 patients assessable, we observed two (5.4%) CR, 13 (34 %) PR, 14 (37.8%) SD and nine (26.3%) PD. The median time to progression was 4.5 months (range 1-18 months), the median response duration was 7 months (range 2-18 months) and the median survival duration was 10 months (range 2-26+).
CONCLUSIONS
The oral vincap should be considered as an alternative to single agent capecitabine or vinorelbine in ABC refractory to antra-taxane combination.
背景
长春瑞滨静脉注射剂和卡培他滨是既往治疗过的晚期乳腺癌（ABC）中最有效的两种单药。已有多项关于这两种药物联合使用的研究报道。实际上，长春瑞滨口服制剂的可得性使得这两种药物能够完全口服联合使用。本研究的目的是评估这种新型联合用药的活性和毒性。
患者与方法
本研究纳入了38例对蒽环类药物和紫杉类药物耐药的晚期乳腺癌患者。治疗方案为每3周给予长春瑞滨60mg/m²（第1天和第8天），卡培他滨2000mg/m²（第2 - 7天和第9 - 16天）。
结果
共给予228个疗程，平均每位患者3个周期（范围1 - 12个周期）。5例患者（13.1%）完全没有毒性。血液学副作用包括：7例患者（18.9%）出现2 - 3级中性粒细胞减少，1例患者（2.7%）出现4级中性粒细胞减少；11例患者（29.7%）出现1级贫血，5例患者（13.5%）出现2 - 3级贫血；6例患者（16.2%）出现1级血小板减少，1例患者（2.7%）出现3级血小板减少。非血液学副作用包括：5例患者（13.5%）出现1级疲劳；2例患者（5.4%）出现1级手足综合征，2例患者（5.4%）出现2级手足综合征；2例患者（5.4%）出现1级恶心/呕吐，3例患者（8.1%）出现2级恶心/呕吐，1例患者（2.7%）出现3级恶心/呕吐；2例患者（5.4%）出现1级便秘；3例患者（8.1%）出现1级周围神经毒性，1例患者（2.7%）出现2级周围神经毒性；2例患者（5.4%）出现1级胃痛；3例患者（8.1%）出现1级口腔炎，1例患者（2.7%）出现2级口腔炎。在38例可评估的患者中，我们观察到2例（5.4%）完全缓解（CR），13例（34%）部分缓解（PR），14例（37.8%）疾病稳定（SD），9例（26.3%）疾病进展（PD）。中位疾病进展时间为4.5个月（范围1 - 18个月），中位缓解持续时间为7个月（范围2 - 18个月），中位生存时间为10个月（范围2 - 26 +个月）。
结论
对于对蒽环类 - 紫杉类联合治疗耐药的ABC患者，口服长春瑞滨联合卡培他滨可作为卡培他滨或长春瑞滨单药治疗的替代方案。
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